[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
REFORMING THE DRUG COMPOUNDING REGULATORY FRAMEWORK
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
FIRST SESSION
__________
JULY 16, 2013
__________
Serial No. 113-70
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
RALPH M. HALL, Texas HENRY A. WAXMAN, California
JOE BARTON, Texas Ranking Member
Chairman Emeritus JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky Chairman Emeritus
JOHN SHIMKUS, Illinois FRANK PALLONE, Jr., New Jersey
JOSEPH R. PITTS, Pennsylvania BOBBY L. RUSH, Illinois
GREG WALDEN, Oregon ANNA G. ESHOO, California
LEE TERRY, Nebraska ELIOT L. ENGEL, New York
MIKE ROGERS, Michigan GENE GREEN, Texas
TIM MURPHY, Pennsylvania DIANA DeGETTE, Colorado
MICHAEL C. BURGESS, Texas LOIS CAPPS, California
MARSHA BLACKBURN, Tennessee MICHAEL F. DOYLE, Pennsylvania
Vice Chairman JANICE D. SCHAKOWSKY, Illinois
PHIL GINGREY, Georgia JIM MATHESON, Utah
STEVE SCALISE, Louisiana G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio JOHN BARROW, Georgia
CATHY McMORRIS RODGERS, Washington DORIS O. MATSUI, California
GREGG HARPER, Mississippi DONNA M. CHRISTENSEN, Virgin
LEONARD LANCE, New Jersey Islands
BILL CASSIDY, Louisiana KATHY CASTOR, Florida
BRETT GUTHRIE, Kentucky JOHN P. SARBANES, Maryland
PETE OLSON, Texas JERRY McNERNEY, California
DAVID B. McKINLEY, West Virginia BRUCE L. BRALEY, Iowa
CORY GARDNER, Colorado PETER WELCH, Vermont
MIKE POMPEO, Kansas BEN RAY LUJAN, New Mexico
ADAM KINZINGER, Illinois PAUL TONKO, New York
H. MORGAN GRIFFITH, Virginia
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Missouri
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina
Subcommittee on Health
JOSEPH R. PITTS, Pennsylvania
Chairman
MICHAEL C. BURGESS, Texas FRANK PALLONE, Jr., New Jersey
Vice Chairman Ranking Member
ED WHITFIELD, Kentucky JOHN D. DINGELL, Michigan
JOHN SHIMKUS, Illinois ELIOT L. ENGEL, New York
MIKE ROGERS, Michigan LOIS CAPPS, California
TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee JIM MATHESON, Utah
PHIL GINGREY, Georgia GENE GREEN, Texas
CATHY McMORRIS RODGERS, Washington G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey JOHN BARROW, Georgia
BILL CASSIDY, Louisiana DONNA M. CHRISTENSEN, Virgin
BRETT GUTHRIE, Kentucky Islands
H. MORGAN GRIFFITH, Virginia KATHY CASTOR, Florida
GUS M. BILIRAKIS, Florida JOHN P. SARBANES, Maryland
RENEE L. ELLMERS, North Carolina HENRY A. WAXMAN, California (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)
C O N T E N T S
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Page
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 16
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 17
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 18
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania, prepared statement............... 140
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, prepared statement................................... 143
Witnesses
Janet Woodcock, M.D., Director, Center for Drug Evaluation and
Research, Food and Drug Administration......................... 20
Prepared statement........................................... 22
Answers to submitted questions............................... 155
B. Douglas Hoey, Chief Executive Officer, National Community
Pharmacists Association........................................ 57
Prepared statement........................................... 60
Answers to submitted questions............................... 165
Kasey Thompson, Vice President, American Society of Health-System
Pharmacists.................................................... 67
Prepared statement........................................... 69
Answers to submitted questions............................... 173
Jeffrey Francer, Assistant General Counsel, Pharmaceutical
Research and Manufacturers of America.......................... 74
Prepared statement........................................... 76
Answers to submitted questions............................... 177
David Gaugh, Senior Vice President for Sciences and Regulatory
Affairs, Generic Pharmaceutical Association.................... 88
Prepared statement........................................... 90
Answers to submitted questions............................... 181
Allan Coukell, Senior Director, Drug and Medical Devices, The Pew
Charitable Trusts.............................................. 102
Prepared statement........................................... 104
Answers to submitted questions............................... 185
David G. Miller, Executive Vice President and CEO, International
Academy of Compounding Pharmacists............................. 109
Prepared statement........................................... 60
Answers to submitted questions \*\
Carmen Catizone, Executive Director, National Association of
Boards of Pharmacy............................................. 123
Prepared statement........................................... 125
Answers to submitted questions............................... 189
----------
\*\ Mr. Miller did not respond to submitted questions.
Submitted Material
Discussion draft................................................. 3
Statement of Express Scripts, submitted by Mr. Griffith.......... 145
Statement of the National Association of Chain Drug Stores,
submitted by Mr. Griffith...................................... 147
Statement of Public Citizen, submitted by Mr. Griffith........... 152
REFORMING THE DRUG COMPOUNDING REGULATORY FRAMEWORK
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TUESDAY, JULY 16, 2013
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 3:05 p.m., in
room 2322, Rayburn House Office Building, Hon. Joseph R. Pitts
(chairman of the subcommittee) presiding.
Present: Representatives Pitts, Burgess, Shimkus, Murphy,
Blackburn, Lance, Griffith, Bilirakis, Ellmers, Dingell,
Schakowsky, Green, Barrow, Christensen, Castor, and Waxman (ex
officio).
Staff Present: Clay Alspach, Chief Counsel, Health; Sean
Bonyun, Communications Director; Noelle Clemente, Press
Secretary; Paul Edattel, Professional Staff Member, Health;
Julie Goon, Health Policy Advisor; Sydne Harwick, Legislative
Clerk; Carly McWilliams, Professional Staff Member, Health;
Andrew Powaleny, Deputy Press Secretary; Chris Sarley, Policy
Coordinator, Environment and Economy; Heidi Stirrup, Health
Policy Coordinator; John Stone, Counsel, Oversight; Alli Corr,
Minority Policy Analyst; Eric Flamm, Minority FDA Detailee;
Elizabeth Letter, Minority Assistant Press Secretary; Karen
Lightfoot, Minority Communications Director and Senior Policy
Advisor; Karen Nelson, Minority Deputy Committee Staff Director
for Health; and Rachel Sher, Minority Senior Counsel.
OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Pitts. The time of 3 o'clock having arrived, we will
call the meeting of the subcommittee to order.
The chair will recognize himself for an opening statement.
As we all know, in the summer and fall of 2012, a
Massachusetts company, the New England Compounding Center,
NECC, shipped over 17,000 vials of an injectable steroid
solution from three contaminated lots to healthcare facilities
across the country. And after receiving injections of NECC's
contaminated steroid, over 50 people died from complications
associated with fungal meningitis and 700 others were stricken
with meningitis and other persistent fungal infections. The
outbreak ranks as one of the worst public health crises
associated with contaminated drugs in the history of the United
States.
Shortly after the contamination came to light, the
committee began an investigation into the matter, requesting
documents from the Food and Drug Administration and the
Massachusetts Department of Public Health, examining whether
the outbreak could have been prevented and reviewing existing
Federal and State regulatory authority over compounding
pharmacies acting as manufacturers.
Both this subcommittee and the Oversight and Investigations
Subcommittee have held multiple hearings on the issues
surrounding compounded drugs. Today's witnesses are here to
discuss three legislative proposals released since the
outbreak, including a discussion draft authored by my
colleague, Morgan Griffith.
[The discussion draft follows:]
[GRAPHIC] [TIFF OMITTED]
Mr. Pitts. The Griffith draft includes targeted provisions
that both clarify FDA's authority as it relates to Section 503
of the Food, Drug, and Cosmetics Act, while ensuring that
traditional compounding remains within the purview of State
boards of pharmacy.
I would like to welcome our witnesses.
And I will yield the balance of my time to Representative
Griffith.
[The prepared statement of Mr. Pitts follows:]
Prepared statement of Hon. Joseph R. Pitts
The subcommittee will come to order.
The Chair will recognize himself for an opening statement.
As we all know, in the summer and fall of 2012, a
Massachusetts company, the New England Compounding Center
(NECC), shipped over 17,000 vials of an injectable steroid
solution from three contaminated lots to health care facilities
across the country.
After receiving injections of NECC's contaminated steroid,
over 50 people died from complications associated with fungal
meningitis, and 700 others were stricken with meningitis or
other persistent fungal infections.
The outbreak ranks as one of the worst public health crises
associated with contaminated drugs in the history of the United
States.
Shortly after the contamination came to light, the
Committee began an investigation into the matter, requesting
documents from the Food and Drug Administration (FDA) and the
Massachusetts Department of Public Health; examining whether
the outbreak could have prevented; and reviewing existing
federal and state regulatory authority over compounding
pharmacies acting as manufacturers.
Both this subcommittee and the Oversight and Investigations
Subcommittee have held multiple hearings on the issues
surrounding compounded drugs.
Today's witnesses are here to discuss three legislative
proposals released since the outbreak, including a discussion
draft authored by my colleague, Morgan Griffith.
The Griffith draft includes targeted provisions that both
clarify FDA's authority as it relates to Section 503 of the
Food, Drug and Cosmetics Act while ensuring that traditional
compounding remains within the purview of state boards of
pharmacy.
I would like to welcome our witnesses, and I would yield
the remainder of my time to Rep. Griffith.
Mr. Griffith. Thank you, Mr. Chairman. I appreciate that
very much.
The fungal meningitis outbreak that was associated with the
tainted sterile compounded drugs from the NECC is something
that I have followed since the beginning. Obviously, you are
always concerned when something affects anybody in the United
States but particularly when it has the impact that it had in
my district and in the areas immediately around my district,
where we had 2 deaths, 50 confirmed cases, approximately 1,400
patients that were notified that they had gotten the tainted
injects, creating great concern.
Now, I do acknowledge, and we have had hearings on it--and,
Dr. Woodcock, you have been very good about answering my
questions, and I appreciate that--where we looked into it and
found that the split in the circuits was caused by the issue on
the advertising portions of the original bill. And as we
previously discussed, it is a shame that this issue wasn't
taken up sometime ago, but it wasn't. And we are here now, and
we are going to try to clarify the law to make sure that we
don't have this problem again. And I appreciate the fact that
you are going to help us work on that.
You know, we have been following this. And what we want to
do is make sure that we do, as the chairman said, protect
public health and ensure that small businesses, like the 130
legitimate community pharmacists that are located in my area,
are not subject to unnecessary and burdensome Federal
regulations. I also recognize the importance, as a former State
legislator, that we continue to have the States be primary over
the true local compounding pharmacies.
We have before us a draft. We are still working on it. We
want to clarify the FDA's authority in this realm, particularly
in regard to compounders who try to pretend that they are not
manufacturers. And that is sometimes difficult, and I
understand that, but we think that we have a bill that will
help on that.
There are still questions that we are trying to get
answered from stakeholders to complete the legislation. That is
why in the draft you will see a couple of places where we have
some blanks. I am proud to be trying to work out those
differences with my colleagues across the aisle, Congressman
Green and Congresswoman DeGette, to see if we can reach a
bipartisan consensus and something that works to protect the
health of Americans and protect the interests of small
compounding pharmacies, which provide a great service to our
public.
My goal has always been to draw a clear line on defining
what a traditional compounding pharmacy is, and that should be
regulated by the States, and what a manufacturer, a drug
manufacturer is, which properly should be regulated by the FDA.
I look forward to today's hearing and from hearing from all
of our witnesses as we continue this process to clarify FDA's
authority when it comes to compounding pharmacies.
And I thank you, Mr. Chairman, for this opportunity and
yield back my time.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the ranking member of the full committee, Mr.
Waxman, for 5 minutes for an opening statement.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you, Mr. Chairman.
It has been 10 months since we saw the tragic fungal
meningitis outbreak caused by the New England Compounding
Center in Massachusetts. More than 60 people have died, over
740 people were sickened, and more than 13,000 others in 20
States are still waiting to see whether they will get
meningitis. This is the largest outbreak of healthcare-
associated infections in U.S. history and one of the Nation's
worst public health disasters in recent memory.
We have learned a lot through our investigation, especially
that FDA's authorities over compounding pharmacies are broken
and inadequate. And I am glad we have finally begun the process
of repairing them.
FDA has repeatedly testified that the agency desperately
needs new authority to protect the public from another
contamination incident. The agency has described how circuit
court decisions have forced FDA to cobble together a piecemeal
approach to regulating compounding pharmacies that are
different in some parts of the country that in others. This has
created loopholes that companies, like the New England
Compounding Center, have been able to exploit.
FDA has also described the fact that the pharmacy
compounding industry has changed dramatically since 1997, when
Congress last legislated. Hospitals have grown dependent on so-
called outsourcers, which are very large compounding pharmacies
that mix batches of customized drugs for a particular hospital.
FDA says it is not enough to simply fix the defect in the
current statute. We need a new paradigm to handle this new
state of affairs. The reason we need a new paradigm is that the
new class of outsourcers does not fit neatly within the binary
structure that exists in the current statute. They are neither
traditional compounders nor drug manufacturers, so we need to
tailor FDA's authorities to fit the reality that the agency
faces.
But we also need to ensure that we properly circumscribe
what these outsourcers can make so that they cannot become an
avenue for undercutting FDA's gold-standard drug approval
process. FDA needs strong records-inspection authority to be
able to determine whether a compounding pharmacy is performing
only a traditional compounding or has crossed the line into
becoming an outsourcer or even a drug manufacturer.
In addition, these nontraditional compounders or
outsourcers need to register with the FDA and tell FDA what
drugs they are producing. They should be required to follow
good manufacturing practices as set by the FDA and label their
products as compounded so that healthcare providers and
patients know that the products are not FDA-approved drugs.
As illustrated by the recent tragedy, these entities should
also be required to promptly report adverse events to FDA so
that FDA and the States can work together to identify dangerous
compounded drugs and prevent them from reaching consumers.
In order for FDA to be successful at carrying out these new
authorities, we need to ensure that FDA has a steady stream of
resources. We will not have accomplished much if we enact a new
statutory scheme but deny the FDA the dollars it needs to use
its new authorities.
We have learned that there is a gaping hole in our drug
safety laws. American families expect us to work together to
develop an effective legislative response, and we need to do
this as quickly as possible. We know that, otherwise, it will
not be if another dangerous catastrophe occurs with compounded
medicines, but when.
Thank you, Mr. Chairman. I yield back the balance of--
unless any of my colleagues on the Democratic side would like
the minute?
OK. I yield back the time.
Mr. Pitts. The chair thanks the gentleman and recognizes
the vice chairman of the committee, Dr. Burgess, for 5 minutes
for an opening statement.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. Thank you, Mr. Chairman.
You and the ranking member have said it very well. This is
a continuation in this committee's examination of the
meningitis outbreak that was caused by contaminated
methylprednisolone acetate prepared in a preservative-free
fashion that killed 53 Americans and harmed over 700, many of
whom will suffer for the remainder of their lives with
significant medical complications.
So 53 Americans are no longer here because the Food and
Drug Administration refused to use their statutory authority to
enforce existing regulations. I am willing to update the
authority that the FDA already has. I don't know that I am
willing to vest the FDA with new authority.
Besides refusing to use their existing statutory authority,
the Food and Drug Administration is stalling the process to
clarify existing regulations. We have been meeting for weeks
now, both this subcommittee and the Oversight and
Investigations Subcommittee, trying to determine how best to
clarify existing regulations.
The Food and Drug Administration refuses to give an inch.
They say they want clarity. Well, when we ask what kind of
clarity, there is no answer. When we suggest a volume
limitation by which to define a manufacturer, they say it is
not workable. When we suggest a time period to determine
whether an entity is a manufacturer, we get back, ``It is not
workable.''
So my ask to the FDA is: Stop telling us it is not
workable, and start helping us with a practical solution. If
you are holding out for a power grab for a vast, new, unfunded
authority, I am not going to help you get there.
So far, the only thing I have heard from the Food and Drug
Administration are complaints about sequestration. I get it.
They complain that user fees don't address their financial
needs, especially under sequestration. I really get it. But to
have the Food and Drug Administration come to Congress, seeking
completely new user fees and authorizations to inspect
facilities, when existing regulations clearly give the
authority to inspect anyone who is a manufacturer, I have to
tell you, I just don't get it.
The fact that the Food and Drug Administration has
continued to inspect facilities--they have closed facilities.
How are they inspecting these facilities if they have no
authority to do so?
Representative Griffith's bill represents the best effort
to date to address some of the FDA concerns while adhering to
the spirit of the law. And I am comfortable supporting that
bill. But, honestly, all the laws in the world are not going to
save a single patient if there is no one enforcing the law.
We read the chain of emails from two administrations of the
Food and Drug Administration. It was painful to read those
emails. They would come right up to the edge, right up to the
point where they might close someone down, and then say, well,
we can't send another warning letter because we have already
sent too many, so we don't know what to do. Well, I know what
to do: Close the place down. It was the right answer, and it
still is today.
Who at the Food and Drug Administration has been fired over
this incident? Again, 53 Americans died, 700 are living with a
disability. Who has been fired in this exercise?
So I would say enough is enough. Let's put pen to paper and
make sure the bad actors are not able to hide from clear
enforcement authority, but let's make sure the enforcement
authority is actually going to be enforced.
Mr. Chairman, I thank you for the time, and I yield back to
you.
Mr. Pitts. The chair thanks the gentleman.
I would like to thank all of our witnesses for coming.
On our first panel today, we have Dr. Janet Woodcock,
director of the Center for Drug Evaluation Research of the U.S.
Food and Drug Administration.
Thank you very much for coming, Dr. Woodcock. You will have
5 minutes to summarize your testimony. Your written testimony
will be entered into the record. So, at this time, you are
recognized for 5 minutes for your opening statement.
STATEMENT OF JANET WOODCOCK, M.D., DIRECTOR, CENTER FOR DRUG
EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION
Dr. Woodcock. Thank you.
Since the last hearing before this subcommittee, which was
just 7 weeks ago, we have had another multi-State outbreak
involving contaminated methylprednisolone acetate,
preservative-free. Even with all the publicity and attention
surrounding this problem, we are still seeing multiple
contaminated compounded products on the market.
We really appreciate the committee's interest in exploring
legislative options to try to help prevent future tragedies.
And I would like to start with what I think are the common
legislative goals I hope we all share.
Any legislation that is passed should provide clarity so
that people know who is on first--FDA, the States, compounders,
and healthcare providers all know their roles and
responsibilities and obligations under the law.
We feel that there should be a legal framework that is a
better fit for the industry that has now evolved and is well
beyond compounding by a corner pharmacy for a single patient,
by prescription, in response to a practitioner from a medical
need. It has gone well beyond that. We have outsourcers who
supply large amounts of sterile products to hospitals across
the country.
Enforceability: We need legislation that we can implement
on the ground, that we can actually make work, and is resourced
to be successful.
We need to preserve the benefits of traditional
compounding. We have always recognized these benefits, where
there is a medical need not met by the products that are FDA-
approved. And we need to preserve the ability of pharmacists to
compound and physicians and other prescribers to order
compounded products to meet those medical needs.
And, most importantly, we need better protection of the
public by bringing the highest-risk practices under Federal
oversight. This includes really focusing on prevention rather
than reaction when outbreaks are occurring.
We want to work with you to achieve those goals. We believe
that for the highest-risk compounding pharmacies we do need
legislation that requires Federal registration so we know who
they are and where they are, that holds them to Federal quality
standards, which we call the GMPs, for production, that also
requires the compounders to tell us when serious adverse events
related to their products are reported to them so that we can
intervene before these problems get out of hand.
And we think for all pharmacy compounding, certain basic
protections should be in place, including clear authority for
us to inspect records so we can determine the cause of an
outbreak or decide whether a compounder actually fits into the
highest-risk category; restrictions on compounding complex
products that even conventional drug manufacturers, who test
their products, find difficult to produce safely; and a
requirement to start with safe and high-quality ingredients
when you are compounding.
And, finally, we feel that clear labels on compounded drugs
to allow prescribers and patients to make informed choices are
important.
We appreciate the leadership of Mr. Griffith, Mr. Markey,
and the Senate HELP Committee in drafting legislation to try
and tackle these issues. It is not easy. While the
administration has not taken a position on any of these bills,
I am happy to provide my views on the extent to which they
address the goals that we have for any new compounding
legislation.
The fungal meningitis outbreak has been a nightmare that
continues for over 700 people sickened by these drugs and their
families. And it is just the worst of a long series of
outbreaks over the past 2 decades that include deaths,
blindness, and hospitalizations.
And this continues. As we proceed with our inspections--we
have had 61 and counting--of the industry, we continue to see a
pattern of profoundly disturbing lapses in basic sterile
practices that should be in place to assure the sterile drugs--
the drugs that are injected in the blood, the spine, the eye,
and so forth--are actually sterile.
So I reiterate my statement from the hearing you held 7
weeks ago. It is a matter of when this is going to occur, not
whether it is going to occur. We owe it to the public and the
victims of this incident and the numerous other outbreaks over
the years to enact legislation that provides better protection
in the future.
I look forward to answering your questions.
[The prepared statement of Dr. Woodcock follows:]
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Mr. Pitts. The chair thanks the gentlelady.
And I will begin the questioning and recognize myself for 5
minutes for that purpose.
Dr. Woodcock, isn't it true that, assuming the circuit
split ambiguity is resolved, FDA now has the authority to
regulate nontraditional compounders as manufacturers?
Dr. Woodcock. Yes, that is true.
Mr. Pitts. Doesn't that mean that FDA could already require
that such compounders pay user fees and submit applications to
show that they can produce drugs under GMP conditions?
Dr. Woodcock. That is a possible outcome. We would have to
find out who they are, because they don't register, and where
they operate. And it is possible even if we close one entity
down, another could quickly grow up.
There is no real preventive structure here; this is a
reactive structure that would rely upon us finding these folks
and taking action. And it isn't clear in the judiciary if we
would prevail because of still-remaining ambiguities in the
law.
Mr. Pitts. In your testimony, you note that there is need
for appropriate and effective oversight of the pharmacy
compounding industry. According to the FDA, this industry and
the healthcare industry have evolved and outgrown the law.
How do you recommend we draft this legislation to ensure
that this industry does not outgrow this legislation?
Dr. Woodcock. Well, I think one of the keys--and I
recognize it is very hard--is making that distinction between
traditional pharmacy compounding, which was for a single
patient, medical need, prescription for that compounded
product, and the kind of practices that are going on now. And
those practices involve making large batches often, small to
large batches, and of course shipping them many places, often
without a prescription.
Mr. Pitts. Now, are large-scale compounders, compounding
manufacturers we would call them, more similar to pharmacies or
manufacturers? What qualities do they share with manufacturers?
Dr. Woodcock. They share with manufacturers the fact that
they are manipulating drug products and making them in batches,
large to small batches, and shipping them to various places.
They share with pharmacies that many of the practices that
they are doing used to be done in the hospital pharmacy, and
the hospital pharmacies have outsourced much of these
operations because they don't have the appropriate facilities.
But, frankly, no one is looking to see if these new outsourcers
have the appropriate facilities and practices.
Mr. Pitts. Considering that they are more similar in
function to manufacturers, should they be regulated within the
manufacturing framework?
Dr. Woodcock. They are similar but not identical. Most of
them make large numbers of different products in much smaller
amounts than a pharmaceutical manufacturer would make. Many of
them are starting from FDA-approved products and putting them
in syringes or little IV bags and all sorts of things for the
particular doctor or practice or hospital and what their needs
are, all right?
So if you wish to have NDAs and the entire panoply of the
FDA review process, what we do for regular pharmaceutical
manufacturers, this industry could probably not exist, all
right? So that is a choice that you have to make. Do you create
a new framework that encompasses this, or do you want to stick
to the current binary structure that we have?
Mr. Pitts. Would it be better to regulate large-scale
compounders under the manufacturing standards rather than
establishing a new category?
Dr. Woodcock. We believe that the main issue with these
large-scale, especially sterile, compounders is that they are
not following what we call aseptic processing practices that
are appropriate, which are part of our good manufacturing
processes, OK, and practices.
And we feel that if that was required, to use appropriate
sterile processing and certain other aspects of the good
manufacturing practices, that they could make quality products
that would be safe.
Mr. Pitts. Under the proposed Senate framework, FDA would
be barred from requiring compounding manufacturers to submit
NDAs and ANDAs pre-inspection and labeling requirements before
these drugs reach patients.
Would any of these tools be available to FDA as it relates
to compounding manufacturers, even if agency regulators
identified high-risk compounding manufacturers where they, upon
inspection, thought such tools were appropriate to utilize in
order to protect public health?
Dr. Woodcock. Well, we need to have tools that prevent this
industry in general from subverting the new drug review process
and the generic drug review processes that were established by
Congress a long time ago and have served us very well. So there
have to be provisions that make a distinction between what
constitutes manufacturing a new drug or a generic drug and
these practices. And that is not easy or straightforward to do.
But we have proposed that for all compounding pharmacies
that there be certain things that they would not be doing. They
would not be making copies of FDA-approved drugs, for example.
Why would you need a higher-risk product if there were approved
drugs available?
We have also proposed that medical need might be a
criterion. That is really the reason you use a compounded drug,
is because there isn't an FDA-approved drug available for that
medical need. And so that is the reason that compounding
exists, to meet that need.
Mr. Pitts. Thank you. My time has expired.
The chair recognizes, filling in for Ranking Member
Pallone, Mr. Green of Texas, for 5 minutes for questions.
Mr. Green. Thank you, Mr. Chairman.
Dr. Woodcock, thank you for continuing your willingness to
advise the subcommittee on this subject. The question that has
been at the forefront of our policymaking is how to establish a
bright line between State and Federal jurisdiction between the
traditional compounders and those operating closer to
manufacturers. No approach is without its challenges, and
certainly none are perfect.
I understand that a lot of the FDA answers are premised on
the fact that you cannot know what you don't know before you
know it. However, under the assumption that you get the records
inspection authority necessary to look at the records of the
suspect entities, that there are other factors that Congress
gives you to establish risk, such as sterility, interstate
commerce, and the existence or not of a prescription.
With that in mind, how can we go about setting a production
volume level threshold as a proxy for assessing risk? Other
than the options that are on the table from the Markey,
Griffith, and Senate drafts, how else can we go about targeting
our regulations toward the highest-risk entities?
Dr. Woodcock. Well, one thing we don't want to do, in
talking about volume or those types of things, is create a
large loophole so that manufacturers can actually circumvent
the entire legislation.
The problem with volume is that the traditional compounding
volume unit is one. It is one compounded product that is made
in response to one patient's medical need----
Mr. Green. Which is currently regulated under State law.
Dr. Woodcock. Yes. And that is the way it should be, we
feel. That is a traditional pharmacy practice.
The risk of that is limited by many things. If you make one
sterile product, one transfer, you have less personnel, you
have less manipulations. Obviously, the exposure, if you make a
lot, 17,000 or 7,000, then the risk is spread across many
people. But the actual risk as you go from 1 to 10 to 100
increases, and so it is hard to make a bright line on----
Mr. Green. OK. There is other criteria other than volume.
Length of time. I have seen 7 days, we have seen 10 days.
Because if you are warehousing this product on a shelf, it can
deteriorate and bacteria can grow, which is, I assume, what
happened up in Massachusetts. So we are looking at, also, some
kind of timeframe for the use of that drug; is that correct?
Dr. Woodcock. Timeframe could be a criterion that could be
used. You know, we have put forth criteria----
Mr. Green. Well, we are looking at multiple criteria, I
hope.
Dr. Woodcock. Certainly, the longer any sterile drug
product is stored, or any drug product for that matter, the
riskier it becomes.
And one of the reasons the hospitals gave the IG, when they
did their survey, of why they outsourced the products is they
say that compounded products have a longer beyond-use date.
They might have up to 6 months. But, in our inspections, what
we found is they didn't establish that by testing. They just
maybe looked in a compendium or something and said, well, 6
months looks like a good beyond-use date. They had no data to
back it up.
Mr. Green. OK.
Dr. Woodcock, the National Association of Boards of
Pharmacy are testifying on our second panel, and they suggest a
revision of the FDA's proposed statutory framework for
traditional compounders. Their goal is to allow patients to
access limited amounts of compounding products made by
traditional compounders in advance of a prescription when they
are in clinics, doctors' offices, or other healthcare settings.
And I would use the example of a hospital, for example, made by
from a compounder because of, you know, the volume.
Specifically, one of the limitations they suggest is to
limit the total quantity provided to a healthcare provider to a
10-day patient supply. What are your views on that?
Dr. Woodcock. Well, my understanding is that 10 days would
be the amount that that entity, healthcare entity or clinic,
whatever, needed for 10 days. Right? And so, say they needed 50
vials; they used up 50 vials in 10 days. And then the clinic
shifted to 100 providers. That would be 5,000, right?
So I don't know that that is a very good--and then you
would make a batch of 5,000 and that would be OK. So I am not
sure that is OK.
Mr. Green. Well, the other concern from your earlier
testimony is that we want to make sure that that longevity, the
efficiency of that compounding substance is actually 10 days
instead of whatever you guess it is. Other pharmaceuticals have
to show that their shelf life----
Dr. Woodcock. Yes. Under the GMPs, if we had Federal
regulation of a sector, we would require that stability be
demonstrated.
Mr. Green. Well, again, I am out of time, but I appreciate
you working with both Congressman Griffith Congresswoman
DeGette and I and our ranking members to see how we can get
this right.
Thank you, Mr. Chairman.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the vice chairman, Dr. Burgess, for 5 minutes for
questions.
Mr. Burgess. I thank the chairman.
So, Dr. Woodcock, you know, we have these large
outsourcers. And is that part of the problem, you don't know
who they are?
Dr. Woodcock. We have large outsourcers; we don't know who
they are. They are doing a variety of things, including making
a lot of convenience dosage forms for hospitals and clinics.
They are also compounding from bulk for shortages, making
hyperalimentation and so forth----
Mr. Burgess. Let me ask you a question about that then. Are
they not already required to register with the Food and Drug
Administration under Section 510 of the act?
Dr. Woodcock. Not according to them.
Mr. Burgess. But according to you. I mean, you are the
enforcer.
Dr. Woodcock. If we can find them and we can conclude that
they are, you know, violating--that they are required to
register. But, according to them, they are registered
pharmacies in their--whatever State, doing pharmacy operations.
Mr. Burgess. Those small pharmacies that compound as a
result of receipt of a prescription, I mean, they are exempt
under the law.
Dr. Woodcock. Yes.
Mr. Burgess. And there is value in that. I mean, we all get
it, that if a kid needs Tamiflu and there is no pediatric
formulation available, someone needs to be able to crush up the
tablet and mix it with the cherry favoring so that the kid gets
it. We all want that.
But this is not that situation. These are companies that
make a large volume, and they make it not on receipt of a
prescription. They make it well in advance of anyone ordering
it. So, for all the world, they look like a manufacturer to
anyone else.
Dr. Woodcock. Well, I wish the distinction were that
simple. However, as I just stated, if you have a pharmacy that
is making office stock and they are going to give that clinic
50 vials a week, all right, in response to a usual need, which
is a practice in many States that is allowed, all right, and
they have 100 customers, then they are going to be making a
batch every week or perhaps every 2 weeks of 5,000 to 10,000
vials.
Mr. Burgess. But----
Dr. Woodcock. And is that different? I mean, they are
allowed under the State pharmacy laws to have anticipatory
compounding.
Mr. Burgess. So they would be regulated by the State boards
of pharmacy, would they not?
Dr. Woodcock. Yes. They have to have a pharmacy license,
uh-huh.
Mr. Burgess. So they are licensed and regulated. Now, when
they engage in interstate sales, that seems like it would come
under your jurisdiction, would it not?
Dr. Woodcock. My understanding is there are reciprocal
licensing agreements amongst the various boards of pharmacy in
all the different States.
Mr. Burgess. I just have to tell you, it doesn't sound like
a gap in the statute, it sounds like an enforcement issue. And
from everything that we received on the events leading up to
the New England Compounding Center disaster, I mean, there were
people within your agency over and over again that said,
``Well, we can't just send them another warning letter. We have
to actually do something.'' And then they would get to the
point of doing something, and no one would do it.
Let me just ask you again. I mean, I assume there has been
some sort of internal look at the breakdowns in the system as
they existed in the Food and Drug Administration; am I correct?
Dr. Woodcock. Yes.
Mr. Burgess. And have there been disciplinary actions taken
against any individuals?
Dr. Woodcock. Well, this is more a collective failure than
an individual failure. We are now using our authorities very
aggressively----
Mr. Burgess. OK, let me stop you for a second. A collective
failure, and we want to give you new authority? I mean,
honestly, do you see the problem with that logic?
Dr. Woodcock. I understand your problem. However, we are
right now being very aggressive in using our existing
authority.
Mr. Burgess. Correct. And you are using that existing
authority, and you are using it to the end that you are
inspecting people, and you have closed some people down, have
you not? I mean, before Main Street Pharmacy, you had closed
other entities down. When either you or Dr. Hamburg came here
earlier this year, you probably told us about some people you
had closed down.
Dr. Woodcock. We have taken actions. You know, basically,
the State boards of pharmacy have closed a number of entities
down. We have taken other judicial actions. It remains to be
seen if these are contested.
Mr. Burgess. Right. But the Food and Drug Administration
has--I mean, they have shown up with their official FDA jackets
and seized records and seized product and closed facilities
down, did you not?
Dr. Woodcock. We have done 61 inspections, and we found
many serious violations of sterile practices and many products
that are posing risk to the public.
Mr. Burgess. So this is what I just don't get. You have the
authority, since October of 2012 or whenever it was that we
decided to do this, but you didn't have it the year before. And
nothing has changed in statute over that time. So you had the
authority in 2006, 2007, 2008, 2009, did you not?
Dr. Woodcock. We had the authority we have now. We feel----
Mr. Burgess. Yes.
Dr. Woodcock [continuing]. Our authority is limited. But we
can do the things that you say, and we are doing those.
Mr. Burgess. It doesn't look limited to somebody looking
from the outside. It looks like you are exercising your
authority and it is working.
Dr. Woodcock. Well, for example, we have received reports
of contaminated products and injuries of people from pharmacies
we have never heard of. Now, it is hard for me to imagine--you
know, I am somebody who is an executive. OK, manage things. How
am I going to find these and anticipate that they are going to
cause problems and shut them down if I have never even heard of
them?
Mr. Burgess. Well, Mr. Chairman, I know my time has
expired.
I may ask you this question in writing. I would just really
like to know how you expect to do that under the new authority
that the Senate bill is proposing or that Mr. Markey has
proposed.
But I will yield back my time, Chairman.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the ranking member of the full committee, Mr.
Waxman, for 5 minutes for questions.
Mr. Waxman. Thank you, Mr. Chairman.
There was a provision, Dr. Woodcock, in the bill that Mr.
Griffith introduced that I want to ask you about. It says that
so long as a company holds a valid State pharmacy license and
receives assurances from the healthcare providers to whom they
are sending compounded drugs that the providers will send back
prescriptions within 7 days after administering the compounded
drug, that the company is considered to be doing traditional
pharmacy compounding within the scope of State law.
In other words, regardless of the quantity of compounded
medicines a company is making and whether the company is
shipping those medicines all over the country, so long as that
company receives prescriptions from their customers within 7
days after the medicines are actually given to the patient--who
knows when that will be--there will be no Federal oversight of
that company.
This seems like a particularly dangerous structure to me.
It would allow a company like NECC, which caused the fungal
meningitis outbreak, to operate freely without FDA oversight so
long as it made a relatively minor change in its business
practice: keeping copies of prescriptions sent to it after the
fact.
Now, I am sure that wasn't the intent of the provision.
And, actually, this provision is based on FDA's unreleased
compliance policy guide, which was part of the documents that
FDA provided in the context of the Oversight and Investigations
Subcommittee investigation. FDA has indicated that this
guidance was never released because the NECC meningitis
outbreak made the agency rethink its approach.
Can you describe why FDA included this provision in the
draft policy guidance? Do you still believe there is some merit
in this provision, in the wake of the NECC outbreak?
Dr. Woodcock. Well, like the Members here and in the
Senate, we are struggling to put some type of quantitative
limits on what can be done. And we are working within the
framework that existed at the time and still exists.
We have learned a lot since then. And one of the things we
have learned is that this approach can be worked around, as you
said. And you can do the math on that and see that you can get
up to a very large volume of shipping if you are able to
receive names back, similar to if you have a 10-day limit or
whatever, you are able to get up to a very large volume if you
have enough customers. And then that raises the risk up very
high.
I don't think we have, you know, the magic answer about how
to identify those highest-risk facilities and what
characteristics they should have. And we want to work with the
Congress on this because it is a difficult line to draw.
But I feel that the 7-day--there is a loophole there that
would allow a proliferation, a very large volume of shipping as
long as there was receipt of those names. And that would be
very difficult for us to enforce. So we go into a pharmacy, we
look, there are lists of names. You know, what are we going to
do then?
It really puts the onus, actually, the way I think the bill
is drafted, on whoever receives the stuff to send it back, to
kind of promise to send the names back in 7 days.
Mr. Waxman. It appears to me that you are operating within
the confines of the current statutory framework and doing the
best you could under that regime. Now, you have suggested that
Congress should enact an updated statutory framework that would
be better tailored to this new class of large compounding
companies.
If we adopt a framework like the one you have described, do
you think this 7-day reconciliation provision is still
necessary or useful in some way?
Dr. Woodcock. It depends on probably how the definition of
``traditional compounding'' is taken forward. Because we feel
that for the large-volume outsourcers, they are really not
getting prescriptions. That is not the business they are in. As
I said, much of their business is doing what the hospital
pharmacies did in their pharmacy years ago. And that has been
outsourced--that is why we call them outsourcers--to larger
facilities.
Mr. Waxman. Are you worried, though, that this 7-day
provision might become a loophole?
Dr. Woodcock. Well, it could be a loophole. It absolutely
could be a loophole. And so I think, collectively, we have to
think very clearly about how we draw those lines so that
something like NECC does not happen again.
Mr. Waxman. Yes. OK. Thank you.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the gentleman from Virginia, Mr. Griffith, for 5
minutes for questions.
Mr. Griffith. Thank you, Mr. Chairman. I appreciate that
very much.
Let's talk about this 7-day issue and related to the
volume. One of the frustrations that we have had with some
other folks is that we have actually been asking--and you will
see some blanks in the bill, because we are trying to sort that
out, which is why sometimes it is nice to have hearings and you
can ask these questions in public.
We are trying to figure out at what volume do you all
consider them to be large enough that they ought to be
considered manufacturers, no matter what they call themselves,
that they are, in fact, manufacturers.
And what I have heard from your testimony today is, you
said that under the bill, you know, there could be 5,000 to
10,000 vials a week being sent out, and that is too much. So
now we have a number at least of 250,000 a year. I multiplied
it by 50 instead of 52, figuring there might be a little break
in there somewhere. But we have that minimum of 250,000.
So the question is, we are not trying to just say the 7
days; we are looking for something else that we can identify?
Dr. Woodcock. Yes.
Mr. Griffith. Crossing States lines doesn't do it, because
in my district, I have two cities that are shared, Bristol,
Virginia/Tennessee, Bluefield, Virginia/West Virginia, and all
kinds of places where the lines--you know, you can get from
West Virginia, Kentucky, Tennessee, and North Carolina all in
the span of about an hour and a half if you drive the right
routes. And so, you know, saying that just crossing the State
line won't do it.
So we are looking for some help from you all as the
experts. And you indicated that is a difficult line to draw.
And I understand that, but we have to draw it. And I think it
is our responsibility, with your help, to draw that line.
So I would say to you, do you have an answer to that
question today? And if not today, can you give me one?
Because if the right number is, if you produce more than
20,000 vials, then I think we have something we can work with
and we can discuss. And I understand you may not be able to
give me an exact answer today, but I think that is part of what
we need.
Because Congressman Waxman is absolutely right; I don't
think 7 days, acting alone, works. With a volume or some other
qualifier and the 7 days--the 7 days is to make sure we don't
put everybody out of business who is trying to do it right. But
the volume number would really help us a lot.
Or if you have some other fix that works besides, you know,
just crossing over State lines when you have small-town
pharmacies that could be hit when they are in a split city.
What do you say to that, and what can you help us on?
Dr. Woodcock. Well, we----
Mr. Griffith. We are just trying to get this thing worked
out and do it right.
Dr. Woodcock. Yes. We would really like to work with you.
Any number that we come up with, any set of limits, have
challenges, right, as far as how they are defined. The
existing----
Mr. Griffith. But here is the problem: We are not going to
get it perfect. We----
Dr. Woodcock. Right.
Mr. Griffith [continuing]. Are never going to get it
perfect. But, you know, in that football field analogy, let's
get it 80, 90 yards down the field. Then we can start worrying
about how we get the last 10 yards. Right now we don't have any
yards on that.
And I am just trying to, you know, solve a problem. And
let's not throw out the really good, trying to get to the
perfect.
Dr. Woodcock. Well, the traditional definition of
``compounding,'' the number is one. I would just like to make
that very clear. It is a pharmacist compounding in response to
a prescription for an individual patient need.
So, as we get above one, we start going into practices that
are batch manufacturing, basically. And what your pharmacy
community will probably say is, well, we like to do that
because we have multiple----
Mr. Griffith. It is not just the pharmacies. It is the docs
and some of the hospitals.
Dr. Woodcock. Yes.
Mr. Griffith. Because if you are an ophthalmologist and you
need those drugs, if you have an emergency eye surgery going on
and you need something right away, you can't wait for it to be
compounded up, so you do want to have a supply.
Now, in that regard, as well, you know, we are looking for
some help on that number. If 120 days is just picked out of the
air and it is the wrong number, help us find the right number
for how long, you know, these drugs have a shelf life, or give
us some guidelines on how we figure that out.
Because, again, we are not trying to make it hard on
anybody. We want the ophthalmologist to be able to provide
emergency services. We want the hospitals to be able to have
what they need there. But we also want the safeguards that the
American public expects and it has a right to expect when we
are doing something this complicated.
Dr. Woodcock. Well, with regard to the stability numbers or
the shelf-life numbers, all right, for pharmaceuticals, those
are generated using the actual product and doing actual
testing. So then we have a hard number; we know how long it is
stable, whether it deteriorates with the stopper that is used
and, you know, the degree of the bacterial contamination and so
forth, which is not supposed to be in there anyway.
So, other than doing testing like that, you are going to
need a very short shelf life to retain confidence that the
products are still good.
Mr. Griffith. And I think that is something that we can
work out, is a short shelf life. If you can give us some help
on what that should be, whether it is 10 days or 20 days. As
long as the hospitals and the people doing those emergency
surgeries know, then they can adapt to that. But, you know,
that is one of those issues that we are trying to figure out.
You know, I know this is difficult, and I really appreciate
the work that you have done and the fact that you have given us
what I believe to be very clear and honest answers. But
sometimes we have to pull the trigger and figure out what the
numbers are.
Dr. Woodcock. Yes, we do have to act.
Mr. Griffith. So if you could help us with that, I would
greatly appreciate it.
This is not, as you know, a Republican or a Democrat issue.
This is just trying to get it right.
But I do agree with Dr. Burgess that we can clarify but I
don't think that there is new authority that is needed. But
clarifying the authority that we believe exists will help you,
will it not? And we only have time for a ``yes'' or ``no.''
Dr. Woodcock. Yes.
Mr. Griffith. All right. I appreciate that and yield back.
Thank you, Mr. Chairman.
Mr. Waxman. Mr. Chairman, may I ask unanimous consent----
Dr. Woodcock. Without objection, so ordered.
Mr. Waxman [continuing]. To submit a statement?
Mr. Griffith. And, Mr. Chairman, I did, likewise, forget to
do a unanimous consent on a couple of documents, if I might.
Mr. Pitts. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Waxman. And I have a document also. And I also wanted
to thank Mr. Griffith for his willingness to talk this through
and work it out.
Mr. Pitts. All right. At this time, the chair recognizes
the ranking member emeritus, Mr. Dingell, for 5 minutes for
questions.
Mr. Dingell. Mr. Chairman, thank you. I commend you for
holding this hearing.
Dr. Woodcock, welcome. My questions will require ``yes'' or
``no'' answers.
Nearly 9 months after the initial outbreak of fungal
meningitis from contaminated steroid injections at New England
Compounding Center, it is clear to me that Food and Drug needs
strong and clear authority over compounding pharmacies, which
it now lacks.
My home State of Michigan has been especially hard-hit. To
date, there have been 264 cases related to NECC and 17 deaths
in Michigan alone, the most in the Nation.
I am confident we can come together in a bipartisan manner
to clarify and strengthen the authority of FDA over compounding
pharmacies.
Today we have three bills before us which take different
responses and answers to solving the problem. Each has its
strengths and weaknesses. I am going to focus my questions on
important authorities that I believe should be included.
Question one: Does FDA believe that classifying an entity
according to the existing statutory scheme of either a
traditional compounding pharmacy or a conventional drug
manufacturer could cause disruptions in our healthcare system,
yes or no?
Dr. Woodcock. Yes.
Mr. Dingell. Does FDA have the authority to require all
compounding pharmacies to register with the agency, yes or no?
Dr. Woodcock. No.
Mr. Dingell. No?
Dr. Woodcock. No.
Mr. Dingell. Would you submit for the record what authority
you need?
Dr. Woodcock. Certainly.
Mr. Dingell. Does FDA have authority to require all
compounding pharmacies to report adverse events, yes or no?
Dr. Woodcock. No.
Mr. Dingell. Does it need that authority?
Dr. Woodcock. Yes.
Mr. Dingell. Submit to us, please, what you think you need,
for the purposes of the record.
Does the FDA have the authority to require all compounding
pharmacies to follow good manufacturing practices, yes or no?
Dr. Woodcock. No.
Mr. Dingell. Do you need it, yes or no?
Dr. Woodcock. ``All'' might be an overstatement. Yes, for
some.
Mr. Dingell. All right. I would like to have you define
what it is you happen to feel you have need of.
Does FDA believe nontraditional compounders should be
subject to appropriate good manufacturing practices like
manufacturers are, yes or no?
Dr. Woodcock. Yes.
Mr. Dingell. Please elaborate for the record.
Dr. Woodcock. Certainly.
Mr. Dingell. Does FDA believe a risk-based inspection
schedule is appropriate for nontraditional compounders, yes or
no?
Dr. Woodcock. Yes.
Mr. Dingell. Tell us why for the record, if you please.
Next question: Does FDA have full authority to see all
records when inspecting any compounding pharmacy, yes or no?
Dr. Woodcock. No.
Mr. Dingell. Does it need it?
Dr. Woodcock. Yes.
Mr. Dingell. Please define for the record what you think
you have need of.
Has FDA faced litigation regarding its ability to inspect
records in pharmacies, yes or no?
Dr. Woodcock. Yes.
Mr. Dingell. Please describe for the record what you feel
you have need of.
Now, do you need this authority to effectively regulate
compounding pharmacies, yes or no?
Dr. Woodcock. Yes.
Mr. Dingell. Please state why for the record.
I have long believed that we must provide agencies like FDA
with the necessary authorities and researchers and resources to
properly protect public health. FDA has a user-fee system for
the approval of pharmaceuticals and medical devices, amongst
others. If we give FDA increased authority in this area, which
I believe we should, then I believe we should also have a
stronger user-fee program.
Now, would the user-fee provisions contained in the Senate
bill provide FDA with the necessary resources to carry out
these authorities, yes or no?
Dr. Woodcock. Yes.
Mr. Dingell. Would you discuss for the record, please?
Now, the American people deserve a response to the NECC
outbreak so that we can ensure that this never happens again. I
am committed, like most of my colleagues here, to seeing to it
that we work towards a proper bipartisan solution to the
problem. And I plan on continuing my discussions with my
friends on both sides of the aisle until we reach agreement on
the best way forward.
I would like to have you discuss a little further some of
the comments that you made in response to Mr. Griffith's rather
excellent questions.
I have a curiosity. Is the number of shipments by the
compounder as important as to whom they are shipped and what
the compounding might happen to be and who the individual is
that is making the shipments?
Dr. Woodcock. We feel that the highest risk relates to
sterile products. So that is number one. Things are going to be
injected into your body, right? And the contamination, that----
Mr. Dingell. So you need authority to define those things,
don't they?
Dr. Woodcock. That is one.
We propose using interstate commerce as a proxy for risk,
because if you are shipping all over the country, you are
making more, it is taking longer, right? So the shelf life is
going to be longer, and there is time for bacteria or fungi to
grow and so forth. And your batches are probably larger, and
that increases the risk of errors, and, also, it just simply
increases the number of people who could be harmed.
Mr. Dingell. I am running out of time. And out of respect
for my colleagues, would you please submit for the record a
statement on this particular point?
Dr. Woodcock. Certainly.
Mr. Dingell. Thank you.
Thank you, Mr. Chairman.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the gentlelady from Tennessee, Ms. Blackburn, for 5
minutes for questions.
Mrs. Blackburn. Thank you, Mr. Chairman.
And thank you for being with us. We appreciate your time
and coming back. I know that you probably and your staff
probably feels like we have talked about this issue nonstop,
but it is of tremendous concern to us. For those of us in
Tennessee, it is especially concerning. We have 14 individuals
that lost their lives and so many who are still suffering.
And I will just associate myself with Mr. Burgess's remarks
in regard to it being a collective failure. We do realize that
there were actions that you all should have and could have
taken, and it is of concern to us.
A couple of things I just want to ask you about. Looking at
drug shortages, are there any instances where FDA is permitting
compounding pharmacies to make products on that drug-shortage
list without having those facilities go through the inspections
and qualifications?
And, then, are there people that are on the ANDA list that
have submitted those applications where you have not gotten
around to approving those applications?
Dr. Woodcock. Well, first of all, we prioritize any generic
drug application that is related to a shortage and try to get
it through the process as quickly as possible.
As far as compounding pharmacies, yes, they are making
drugs to address shortage issues, but, no, we have no real
oversight of that right now. That is not the scheme that is in
place. That is regulated primarily by the State boards of
pharmacy.
Mrs. Blackburn. OK. On the ANDAs, you said you prioritize
those applications. How long does it take to get one of those
through the process?
Dr. Woodcock. Well, it varies tremendously, whether or not
the application is in good shape. If there are multiple foreign
facilities involved in production of the drug that we haven't
inspected before, we may have to go to other countries and
inspect those facilities. So that sometimes can be a rate
limiting step.
Mrs. Blackburn. On average.
Dr. Woodcock. I could get back to you on that. I don't have
it.
Mrs. Blackburn. OK. I would love that. I think that it
would be instructive to us.
Mr. Griffith mentioned something about limitations. I
understand that many States have used some form of volume
limitation for anticipatory compounding to determine whether an
entity is acting within the scope of their license.
So do you think that a volume limitation in conjunction
with other factors from 503(a) could help distinguish between
entities that are engaged in large-scale compounding similar to
manufacturing or in traditional compounding?
Dr. Woodcock. It is possible. The States have a patchwork
of laws which are different. Some allow anticipatory
compounding; some allow office stock. So there are a variety of
interpretations or laws across the different States.
Clearly, volume is another proxy for risk. And the larger
the volume of the batch or lot you are making, the higher the
risk that is imposed if you are not using good manufacturing
practices.
So that is possible, but we have struggled with this, and
we have had a very difficult time coming up with a coherent
scheme that would use volume. And then that would have to be
usually enforced by the States, because it would apply to all
the compounding pharmacies. It wouldn't be a uniform Federal
standard, or it would be very difficult for us to enforce it
even if it were, because, as the testimony shows, there may be
23,000 pharmacies or something that are doing compounding of
different types.
Mrs. Blackburn. OK. Thank you for that. I would think that
volume could be one of those indicators that may be a bit more
illuminating as you try to work through this process. It would
seem it would be a key indicator.
With that, I will yield back.
Mr. Pitts. The chair thanks the gentlelady and now
recognizes the gentlelady from the Virgin Islands, Dr.
Christensen, for 5 minutes for her questions.
Mrs. Christensen. Thank you, Mr. Chairman.
And welcome back, Dr. Woodcock.
Dr. Woodcock. Thank you.
Mrs. Christensen. Some of these questions have been asked
one way or another, but I want to just to be clear. And I would
like to talk about one of the concerns we have been hearing a
lot about, having to do with the proposed statutory framework.
As has been said, FDA has suggested that Congress should
revise its statute to clearly delineate which compounding
entities should be subject to Federal oversight and which ones
should remain the purview of States. Specifically, you have
recommended that facilities be subject to FDA oversight if they
conduct sterile compounding, which you said is the highest
risk; second, whether they compound medicines in advance of or
without a prescription, which I don't understand; or if they
ship compound medicines across State lines.
One of the problems, according to some of the stakeholders,
is that this construct would prevent doctors' offices from
obtaining limited amounts of compounded medication without a
prescription that would be kept as office stock. So they feel
that these medicines need to be in their office so that they
can be given to a patient who needs them right then.
It is my understanding from your answers that FDA doesn't
support this. So could you explain the rationale for not
allowing some limited amount of office stock to be exempt from
the triad of requirements?
Dr. Woodcock. Certainly.
We are not--we aren't wedded to anything. We need to find a
workable scheme, right? Each doctor's office or clinic may say,
as I said, they may say, we only use 25 of these vials a week.
OK? But if the compounding pharmacy has 1,000 customers, right,
then that is 25,000 vials. And would you say that is too many?
So if you simply use that and allow a certain amount of
anticipatory office stock, that is what you could end up with.
And so you just have to kind of play out this scenario in your
mind and what this would look like. And I don't know, maybe you
think that them making 25,000 sterile vials is OK, is not
manufacturing, right?
Mrs. Christensen. I think that anything that goes beyond a
specific compound for a specific patient is too much, trust me.
And----
Dr. Woodcock. Could I say one more thing?
Mrs. Christensen. Sure.
Dr. Woodcock. We are not proposing that this be prohibited.
We are saying that it should go into a category that involves
good manufacturing practices so that there would be oversight
of the aseptic processing so that we would be assured it would
be done correctly and at least these products would not be
contaminated.
Mrs. Christensen. Got it. And are there certain types of
compounded drugs for which some limited amount would not be
subject to the limitation? Are there specific drugs that you
could conceive of that could be compounded without--for which
some limited amount should not be subject to the extra
oversight?
Dr. Woodcock. Well, we have proposed that the category of
federally regulated would be, you know, interstate commerce
without a prescription of sterile drugs, right? And that leaves
a large variety of other things to the States, including
intrastate sterile drugs, which still, arguably, can be of high
risk, and all other compounded products, which would be the
oral, the creams, the lotions, all those sorts of things.
Now we have proposed that there be a floor that you should
not be able to compound drugs, say, that FDA pulled off the
market because they weren't safe, OK, and that you shouldn't
compound drugs from a monograph, you know, from a appropriate
source OK, and so forth. So we had certain criteria we think
should apply to all pharmacies who compound. However that vast
majority of nonsterile, non-injectables so we really are not
proposing to have under this broad scheme, this new scheme that
we were talking about.
Mrs. Christensen. And are there any exemptions to the
across State line borders for pharmacies that are close to
State borders or that routinely operate across State borders
today?
Dr. Woodcock. Right, well that is, I think, the question
that we just heard that that creates some unfairness like any
scheme we are going to apply there would be some disparities.
We weren't proposing that there would be that exemption for
States that were close by or four corners or whatever.
Mrs. Christensen. The question has been raised that you all
had a lot of authority that you hadn't exercised before so, and
you said that FDA took some aggressive action and when you have
taken that aggressive action, is it that FDA has gone over out
on a limb in the interests of public health risking court
challenges? Or did you find some authority that you didn't
think you had before?
Dr. Woodcock. Well, as I said, we, I think we may get court
challenges. I think in some cases, the States have taken action
because we have brought this to their attention, and they are
the holders of the, you know, they issue the pharmacy licenses.
And so although we have even inspected 61 pharmacies, now if
you think of the universe that we are talking about, it is a
much larger universe, and new ones can grow up all the time.
So although we are taking aggressive action, the fact that
we do have to think through the judicial consequences and so
forth meaning each of these actions, as I would call them
pretty lawyer intensive, all right, and we don't have unlimited
legal resources.
Mrs. Christensen. I have gone over my time, thank you.
Mr. Pitts. The chair thanks the gentlelady and now
recognizes the gentlelady from North Carolina, Mrs. Ellmers,
for 5 minutes for questions.
Mrs. Ellmers. Thank you, Mr. Chairman, and thank you, Dr.
Woodcock, for being with us again.
To the best of my knowledge this is about the fourth
hearing that we have had in the subcommittee on this issue,
especially in relation to the New England Compounding Center,
and I think there are still some questions out there that many
of us have about how that process is moving forward.
It seems to me, after looking at all the information that
the FDA did have some authority at that point to shut down
NECC, and of course, that is not the possess that went forward
and we obviously need to clarify, of course, the FDA authority
as been discussed many times here already today.
Dr. Woodcock, in your opinion, would you agree with my
statement and might you have anything to add? What can we do to
bridge this? Because as we are having this conversation, there
are many times that you say that we did have authority, we did
not have authority, but we have got to fix this problem. So
what is your solution? What do you want to see done?
Dr. Woodcock. Well, what FDA has proposed is that we have
different legislation, I won't say it is quote, that the large
scale industry that has grown up especially that is making
sterile products be subject to Federal regulation. It is
basically a new type of industry, the scale, the fact that it
is sterile and so forth, and it is not the traditional corner
drugstore making----
Mrs. Ellmers. And that, I guess at that point is now where
we have the question of the amount that is being compounded,
meaning each individual vial, or, you know, sterile unit, I
know I have heard shelf life be discussed, and of course, I
think that does have more to do with the actual make-up of the
compounded prescription, which leads me again to the question,
I know when we have a traditional pharmacy, we have a
prescription, and that is filled for the patient. Then we, as
you pointed, out have this situation where we have hospitals
and different, you know, maybe outpatient surgery clinics that
use those compounded products as well.
Why can't--I guess my question is rather than concentrating
so much on the number, obviously there is a safety issue there,
we want to make sure we are producing a sterile product, but
when it comes to going to a hospital or an outpatient surgery
center, why can it not stay under the same category that it is
right now rather than moving into a larger manufacturing label
or status?
Dr. Woodcock. Because they make--the people who supply
these outpatient clinics like NECC, OK, make large scale
volume, which Dr. Burgess has said, well, that clearly is
manufacturing, we know it when we see it, right, the question
is how do you distinguish that.
Mrs. Ellmers. Well, and that leads me to my next thought,
and I realize that we are talking about legislation that is
already being proposed, but if we know that an outpatient
clinic does a number, a particularly an average number of cases
every month, and they were to receive that compounding product
for that amount, would that not essentially be kind of a large-
scale prescription when you think about it? Is there not
another avenue we can take here rather than just add more
regulation and more costs, but at the same time, continue to
produce a very safe product?
Dr. Woodcock. Well, that is the issue, continuing to
produce a safe product. As I said, we have had another outbreak
since the last time this body had a hearing, all right.
Mrs. Ellmers. I am going to stop you there, thank you, I do
have about 50 seconds which leads me to my next question. At
the time of the outbreak, the NECC outbreak, there was a
compliance policy guide that the FDA was preparing, but I think
that had been put on hold.
Has that now been, has that policy been evaluated? And what
is the FDA doing?
Dr. Woodcock. We have learned since then, and as I told Dr.
Burgess we are aggressively applying our existing authorities
under the law to these pharmacies. Existing authorities require
prescriptions.
Mrs. Ellmers. So the question, again, is has the agency
evaluated the compliance policy guide? Has that been----
Dr. Woodcock. Yes.
Mrs. Ellmers. Is that being implemented now as this
authority?
Dr. Woodcock. No, we feel that parts of that are actually
unfeasible based on what we have learned. We have learnt a lot
since the NECC outbreak all right and we have revised our
approach to be more practical.
Mrs. Ellmers. Thank you and my time has run out thank you.
Mr. Pitts. The chair thanks the gentlelady. I recognize the
gentlelady from Illinois, Ms. Schakowsky 5 minutes for
questions.
Ms. Schakowsky. I am over here, Dr. Woodcock.
Dr. Woodcock. I am sorry.
Ms. Schakowsky. Did I hear you at some point say that there
ought to be labels of dates certain and information for the
consumer on compounded products?
Dr. Woodcock. Yes, after this NECC outbreak, many of the
FDA staff who had to go in the hospital they said, well, we
don't even know what products we are getting that are
compounded when they are having a procedure or something. There
is no label that is required now that identifies a product as a
compounded product.
Ms. Schakowsky. Here is my question problem, that I began
my activism decades ago to get expiration dates on products
sold in the supermarket. I am for consumer information. But
when it comes to prescription drug, particularly if you are in
the hospital, are you suggesting that in some way, we leave
this up to an informed consumer to be able to make decisions on
whether or not they want that or that it be suitable for them?
Dr. Woodcock. Not really. We think that this simply raises
awareness about the use of compounded drugs. The use of, there
are beyond use dates on compounded products now. Our issue with
them is that they aren't based on evidence, based on
experiments that are done on that compounded product from what
we have seen in our inspection.
Ms. Schakowsky. Well, let me ask you about all the
prescriptions that we get. They all now have a date on them and
I regularly go through my shelf and dispose of----
Dr. Woodcock. Excellent.
Ms. Schakowsky. Outdated drugs. Are all of those, do we
know that those are accurate?
Dr. Woodcock. Absolutely. They have to perform experiments
on stability and dating period and submit all that information
to FDA and we have to agree with it.
Ms. Schakowsky. OK, so that is not part of the requirement
and something that you would need the authority to require
that?
Dr. Woodcock. Performing stability testing, so forth, on
products is part of good manufacturing practices.
Ms. Schakowsky. And so that would, under your new
categories, would be required of these compounders?
Dr. Woodcock. We are proposing that for the highest risk
facilities that make sterile drug products and ship them inter
State.
Ms. Schakowsky. So if we are not doing it by quantity, what
are we doing it by? What do you recommend we do it by?
Dr. Woodcock. We propose by risk and simply pulling off the
highest risk class of products which is the sterile products
that are shipped inter State so they are going, causing multi
State outbreaks, and that are without a prescription and the
prescription--without a prescription is a proxy for mass
production, OK, because it is not one pharmacy making one
sterile product for a person, say, in another State. They are
making large batches and then shipping them all around.
Ms. Schakowsky. So the FDA has talked a lot about medical
need as a condition for compounding a product. So how should we
incorporate this concept into legislation?
Dr. Woodcock. We feel that is a fundamental concept for
compounding. It is the reason--why else would you give people
products that didn't go through the system that Congress has
established for drugs, right, which is they are tested for
safety and efficacy, and they have applications and everything,
and the reason is there is a medical need that is not met by
existing products. And so we feel to raise practitioners'
awareness that they would indicate that there was a medical
need for this product, and why are we doing this? Because when
we talk to people who bought products from NECC, the
practitioners, what they said, well, there was just the order
form online, and we just ordered like any other order that you
would make. And so there was no awareness, there was no
practitioner awareness that this was a higher risk product.
Ms. Schakowsky. I see. In your testimony, you explain that
certain products with limited exceptions are not appropriate
for compounding under any circumstances. Would you include this
situation that we are just talking about, that, you know, the
practitioner just went online, found this to be available?
Should those products not have been compounded under any
circumstances?
Dr. Woodcock. No, we have very specific criteria for what
we think shouldn't be compounded under any circumstances, and
that would be, for example, the drugs that FDA has pulled off
the market because they dangerous. We don't think they should
be compounded. Very complex dosage forms, our, the
pharmaceutical manufacturers have trouble making certain dosage
forms right. For example, extended release may cause dose
dumping and get all the dose in the body at once and could kill
you, for example, and they have to do extensive testing on
their products to make sure they have been manufactured
correctly. So we don't think some of these very risky products
should be compounded either.
Ms. Schakowsky. Thank you. I appreciate it. I yield back.
Mr. Pitts. The chair thanks the gentlelady and now
recognizes the gentleman from Florida, Mr. Bilirakis, 5 minutes
for questioning.
Mr. Bilirakis. Thank you, Mr. Chairman I appreciate it very
much. Thank you for your testimony. Dr. Woodcock, you mentioned
that copies of FDA-approved drugs should never be compounded.
What about the drug progesterone, which, for years, was
compounded by pharmacists for pregnant women to prevent
premature births? In 2011, FDA approved Makena, which is a
manufactured form of progesterone. The manufacturer sent a
cease and desist letter to compound pharmacies, and FDA weighed
in and said pharmacies could continue to compound this drug
even though a more expensive manufactured drug is available.
If we explicitly prevent compound pharmacies from making
copies of FDA-approved drugs, what will happen to pregnant
women's access to achieve drugs, affordable medication to
prevent premature births?
Dr. Woodcock. You know, I can't comment specifically on
that instance because of ongoing litigation issues. However, I
think in general, Congress set up a system that required new
drugs to go through the FDA review process, and that was
because of the many abuses and many deaths and many problems
there were long ago when there wasn't a system to make sure
drugs are safe and effective. So there were many outbreaks in
the past as well as like the thalidomide crisis and so forth,
all of which led Congress to do this.
Now, if we feel, in general, if there is a safe and
effective drug available to the public, people should not be
exposed to drugs that are of lower quality unless there is a
medical need for that other product.
Mr. Bilirakis. Next question, you mentioned needing the
power to access pharmacy records. Are you looking for the
authority over pharmacy records in general, or just the
nontraditional compound pharmacies?
Dr. Woodcock. Well, we would like to, so to speak, be able
to distinguish, more or less, the sheep from the goats. We need
to know, people have said, well, why don't you act on this or
that or other, haven't we acted if we can't demonstrate that a
pharmacy is shipping large quantities of drugs that violate
whatever scheme Congress comes up with, right, then we won't
have the power to use our authorities. And the way we do that,
you look at their shipping records and say if there is a
requirement for names or prescriptions, we would need to be
able to verify that, otherwise we--there are bad actors out
there and there are people who say oh get all that stuff or we
don't do this, and if we can't verify that then it really ties
our hands.
Mr. Bilirakis. How about, you mentioned using the
administrative warrants to compel access to records.
Can you explain what this process is and how do you go
about getting the records, the warrants?
Dr. Woodcock. Well, I am not a lawyer, all right. But my
understanding, I have asked the lawyers and we have to go to a
court and we have to ask the court. And sometimes it can be
done rapidly, but often it averages about 2 weeks. And we are
concerned, first of all, of course, if there is an outbreak,
that is too long because lives are at stake.
Another thing, a problem we can have is that people can
clean up and destroy their records in the time that it takes
for us, and, of course, we don't have evidence that they have
destroyed records because they may be destroyed, but when our
investigators are in some of these firms, they have had a very
strong smell of bleach which we think means that the mold has
been bleached off of the counters and so forth, and that there
was a lot of cleanup during the time we went and tried to get a
warrant to get in.
Mr. Bilirakis. Thank you. We all, of course, want to ensure
the safety and sterility of compounded drugs. We must also not
lose the sight of the important role that compounded drugs play
in patient care. Some physicians keep a supply of compounded
drugs available for anticipatory office use because in waiting
for the drug to get compounded for the patient, that waiting
period could endanger the patient's health. I know we touched
about upon this, but some of the bills we are reviewing today
include patient specific prescription requirements for certain
compounded drugs.
Do these prescription requirements really address and
improve the safety and sterility of compounded drugs? Are there
other measures that can be taken to improve the safety of these
products that also ensure physician and patient access to
compounded drugs for use in the office setting?
Dr. Woodcock. Well, our proposal doesn't preclude lack of
prescriptions in the anticipatory compounding. What we are
saying is when you do that for sterile products, you should
make the products under good manufacturing practices, proper
aseptic processing so you don't contaminate them. Now, that is
one way to deal with this. That is what we are proposing is if
you wish to ship products, sterile products around and not get
prescriptions, then you should make them under good
manufacturing practices because you are likely to be making
batches of sterile products, and that really doesn't look like
compounding, it looks more like manufacturing when you are
making batches.
Mr. Bilirakis. Thank you, Mr. Chairman. I yield back.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the gentlelady from Florida, Ms. Castor, 5 minutes
for questions.
Ms. Castor. Thank you, Mr. Chairman, and thank you Dr.
Woodcock for being here. The last time you were here you were
kind of to allow me to change the subject and ask you about one
of the serious drug shortages facing our country, and that
involves the injectables, injectable nutrition that primarily
affects premature infants and our children's hospitals continue
to raise the issue and practitioners and scared parents across
the country. I know at the end of May, FDA acted to allow some
imports of those nutrition elements.
Can you give us an update on how it is going? Is the
situation improving? Have you hit any roadblocks.
Dr. Woodcock. It took longer than we had hoped and when I
talk to you last, I thought it was imminent and it took longer
than what we hoped to get those products in. We believe we are
alleviating these shortages, but we are not out of the woods
yet. We do not have a U.S. manufacturer online to my knowledge
that can give us a stable supply but we are working on that.
Ms. Castor. Are there prospects for U.S. manufacturers to
come online?
Dr. Woodcock. That is what we believe, yes.
Ms. Castor. And what would that time frame would be?
Dr. Woodcock. Pardon me.
Ms. Castor. What do you think the time frame would be?
Dr. Woodcock. I don't know. We can get back to you with
details if you would like.
Ms. Castor. Good. I look forward to that, thank you very
much. And you really have clarified over the number of hearings
that we have had back on this topic on reforming drug
compounding, we have had a series of hearings, and your message
is sinking in, I believe. We now have three bills that are out
there, you have got a Senate bill by Senator Harkin, you have
got one that is kind of on the other end of the spectrum by
former Representative Markey, you have Mr. Griffith's bill now
that he is working on.
When you look at the three bills that have been drafted,
can you point to a section of any of those bills that you say
boy, that is really the most important thing that could be
accomplished here or that would be one of our priorities going
forward for FDA and protection of the public health?
Dr. Woodcock. Well, we do feel the Senate bill has the
right framework. There is still issues about, but you know it
does provide registration so we can find out who the people
are, it provides reporting of adverse events so that if any
compounding pharmacy starts getting into trouble, we can react
quickly. It does have a user fee program, it does carve out a
section of a sterile manufacturers who would be subject to
higher standards and it does provide some other Federal
standards. So we feel that is a good start, but all--this is a
very difficult issue to draw these lines correctly and they are
trade-offs that have to be made, and we recognize that everyone
is struggling with this and we want to work with you all.
Ms. Castor. In that Senate bill, is it clear to you when
you read it that the traditional neighborhood pharmacist that
are not in the, not making thousands of batches or even
hundreds of batches are clearly exempt.
Dr. Woodcock. Yes, the Senate bill has State law prevail on
the traditional pharmacy compounding, and we feel,
unfortunately, there is a bit of a patchwork there because each
State has a different set of laws, so your two pharmacies are
20 miles apart in different States may be operating under
totally different frameworks, and we think that will be
difficult for us to enforce, pending one might be regulated by
us, and the other on the other State regulated by the State,
and that is very difficult.
Ms. Castor. Well, thank you very much. I was thinking about
this earlier today reading over the testimonies and I think if
we just put ourselves in the shoes of the average American
consumer, I think what they want most of all is to be assured
that especially the highest-risk drugs, the ones that are being
injected, like you said, are being manufactured in a way that
is safe and that the government at least has the authority to
know who they are, where they are, so that we can ensure that
no one is harmed to the extent of what happened with NECC. So
thank you very much. I yield back.
Dr. Woodcock. Thank you.
Mr. Pitts. The chair thanks the gentlelady and recognizes
the gentleman from New Jersey, Mr. Lance, for 5 minutes for
questions.
Mr. Lance. Thank you, Mr. Chairman.
Dr. Woodcock, your opinion should entities making
nonsterile products in advance of prescription shipping
interstate be regulated by the FDA as traditional manufacturers
or by States as traditional compounders?
Dr. Woodcock. So should traditional, should manufacturers
who are making nonsterile products and shipping them
interstate.
Mr. Lance. Interstate?
Dr. Woodcock. Interstate, perhaps in very large quantities
be regulated as manufacturers or.
Mr. Lance. Or as traditional compounders.
Dr. Woodcock. I think that is a policy call. There are
trade-offs there; there are is far more of that. These are
lower risk products, and what we have proposed is other
restrictions like not copying FDA-approved product and only
working from certain bulk product, API's and so forth, that
would put some boundaries on these practices but I think there
is some danger of folks going into business as a kind of shadow
generic company without FDA oversight, if they could ship
broadly.
Mr. Lance. If they were regulated under the FDA what would
the proposed framework be? As opposed to being regulated by the
States.
Dr. Woodcock. Well, we haven't proposed anything for that
group. Generally speaking, doing those practices, you would
have to, right now under the current law, which we have been
talking about, you have to file an application for every single
form that you are shipping, and often, of course, these are
customized to different doctors' preferences and so forth, and
these groups make thousands of different dosage forms, they
would have to file an application for each one with extensive
documentation and pay user fees.
Mr. Lance. Thank you. I know that you have recently
conducted a series of inspections compounding pharmacies and as
I understand it, you have done that in conjunction with State
officials; is that accurate, Dr. Woodcock?
Dr. Woodcock. Yes, in almost all cases, we have gone in
with the State.
Mr. Lance. And you have stated that the agency needs full
record inspections authority for every pharmacy in the country
and in that, if you are conducting these inspections with State
Pharmacy Board officials, do you believe as well that you need
independent authority independent from the State boards?
Dr. Woodcock. We have had some cases where the State
officials, due to resource constraints, have not been able to
go in with us and we are concerned that might be even more
happen more often in emergency where we feel that we really
need the ability to get in there. We do always try to have the
State officials come with us because they have we have joint
authorities.
Mr. Lance. Are some States better at this than others
traditionally, or does it just vary based upon State resources
at the moment.
Dr. Woodcock. I don't think we have a large enough sample
size to say which States, you know, we know some States as the
Board of Pharmacy Association has testified, some States are
better staffed and so forth than others for their board of
pharmacy operations.
Mr. Lance. Thank you. I would be happy to yield to any
other member who wishes to speak.
Mr. Green. If I could, we are looking, and I think I share
it with my colleague, Congressman Griffith, we are looking at
multiple things that gives the FDA the authority to do it,
because we don't want this to happen again, and I have to admit
having served there a good while, that first hearing we had
neither the FDA nor the compounders nor the State agencies
showed that they were actually do the doing the job, so we want
to make sure you have the tools, so it will be multiple and I
would be glad to my colleague from New Jersey to yield to my
colleague, Mr. Griffith.
Mr. Griffith. If I could have a minute of that time I would
appreciate it, and one of the things we are also working on in
the bill that I think is helpful and I think you would agree is
that we set up a facilitating process where there are
complaints from the State where they can work a little more
efficiently with the FDA, and likewise, if you hear something
go on from State A that the FDA can then communicate that it to
that to State B and C, that this particular group may be having
a problem.
Dr. Woodcock. Yes, we would like to have, perhaps, a
message board or something but we don't want to turn into the
telephone operator.
Mr. Griffith. I understand that, but anything we can do to
facilitate, because one of the problems is those who were here
for the hearings know is that we had a couple of States that
were blowing the whistle, and no action was taken, so we want
to try to make sure we facilitate in making sure that the next
time when Colorado or Ohio or some other State is, in fact,
raising red flags that that message is getting through, and I
do appreciate and yield back to----
Mr. Lance. Thank you very much.
Mr. Pitts. The chair thanks the gentlemen. That concludes
questions from the members. I am sure they will have written
questions. We ask that you please respond promptly. Dr.
Woodcock, as always, you have been a very excellent witness.
Thank you for your testimony.
Dr. Woodcock. Thank you. I am pleased to respond.
Mr. Pitts. Thank you. I will call the second panel up at
this time and introduce them as they come forward. In this
order they will testify: Dr. Doug Hoey, chief executive
officer, National Community Pharmacists Association; Dr. Kasey
Thompson, vice president, American Society of Health-System
Pharmacists; Mr. Jeffrey Francer, assistant general counsel,
Pharmaceutical Research and Manufacturers of America; Dr. David
Gaugh, Senior Vice President for Sciences and Regulatory
Affairs, Generic Pharmaceutical Association; Mr. Allan Coukell,
Senior Director Medical Programs, the Pew Charitable Trust; Dr.
David Miller, Executive Vice President and CEO, International
Academy of Compounding Pharmacists; and, finally, Dr. Carmen
Catizone, Executive Director, National Association of Boards of
Pharmacy.
Thank you all for coming.
You will each have 5 minutes to summarize your testimony.
Your written testimony will be placed in the record.
Dr. Hoey, we will start with you for an opening statement.
STATEMENTS OF B. DOUGLAS HOEY, CHIEF EXECUTIVE OFFICER,
NATIONAL COMMUNITY PHARMACISTS ASSOCIATION; KASEY THOMPSON,
VICE PRESIDENT, AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS;
JEFFREY FRANCER, ASSISTANT GENERAL COUNSEL, PHARMACEUTICAL
RESEARCH AND MANUFACTURERS OF AMERICA; DAVID GAUGH, SENIOR VICE
PRESIDENT FOR SCIENCES AND REGULATORY AFFAIRS, GENERIC
PHARMACEUTICAL ASSOCIATION; ALLAN COUKELL, SENIOR DIRECTOR,
DRUG AND MEDICAL DEVICES, THE PEW CHARITABLE TRUSTS; DAVID G.
MILLER, EXECUTIVE VICE PRESIDENT AND CEO, INTERNATIONAL ACADEMY
OF COMPOUNDING PHARMACISTS; AND CARMEN CATIZONE, EXECUTIVE
DIRECTOR, NATIONAL ASSOCIATION OF BOARDS OF PHARMACY
STATEMENT OF B. DOUGLAS HOEY
Mr. Hoey. Thank you and good afternoon, Chairman Pitts and
Vice Chairman Burgess and Ranking Member Pallone, members of
the subcommittee, the National Community Pharmacists
Association greatly appreciates the opportunity to testify
today and share the community pharmacy perspective on
legislation addressing pharmacy compounding.
NCPA represents the interests of America's community
pharmacists, including the small business owners of more than
23,000 independent community pharmacies.
Almost 86 percent of independent community pharmacies
compound medications. Our members perform a wide variety of
compounding services, including working with physicians to
create medications to help patients needing hormone replacement
medications, help pediatric patients, and those with severe
nausea and vomiting where commercially available medications
are unresponsive or unavailable to give just a few examples.
NCPA commends members of this committee for taking a closer
look at what actions and inactions led to the tragic NECC
event. We believe this committee has taken the proper steps by
focusing on investigations into clarifying existing oversight
to ensure that the appropriate regulatory bodies are exercising
their full authority.
NCPA is also grateful to Congressman Griffith for the
tireless efforts to prevent a tragedy like NECC from occurring
again. NCPA supports the approach of Representative Griffith's
discussion draft as it is not a broad expansion of FDA power
over historically State regulated pharmaceutical compounding.
To the contrary, the draft strikes the proper balance of making
certain that future tragedies are avoided while also preserving
patients' access to vital compounds.
In addition, NCPA fully supports the discussion draft to
preserve State Board of Pharmacy oversight of pharmacy
compounding. NCPA has historically, and continues to advocate
that pharmacy compounding is best regulated by the State Boards
of Pharmacy. Conversely, manufacturing is overseen by the FDA.
If the FDA has a concern about an appropriately licensed
pharmacy, then the FDA currently has the authority to ask the
State Board of Pharmacy to work with them to address the issue.
NCPA also strongly supports efforts by Representative
Griffith's discussion draft to preserve office use and
anticipatory compounding where State laws allow such practices.
In order to preserve access to compounds, the discussion
draft acknowledges that pharmacies should not be hindered in
their ability to engage in anticipatory compounding as long as
it is reasonable and based on a historical pattern of
prescriptions, or for specific patients served by that
pharmacy.
Furthermore, NCPA strongly supports the efforts of the
discussion draft in recognizing that strengthening
communication between FDA and State Boards of Pharmacy is
essential.
NCPA believes one of the leading contributors to the NECC
tragedy was the failure of the FDA to exert its existing
authority to oversee entities going beyond pharmacy
compounding. Communication and coordination between State
Boards of Pharmacy and the FDA is imperative.
While NCPA appreciates all efforts on this very important
issue, we do have strong concerns with other legislative
proposals, including granting FDA additional authority to
create ``do not compound'' lists.
Contrary to the discussion draft, other legislative
proposals grant the FDA unrestricted authority to designate
drugs or specific categories of drugs to a ``do not compound''
list. This would be an unnecessary expansion of FDA authority
over the practice of pharmaceutical compounding while doing
nothing to prevent another tragedy like NECC.
A second concern is requiring community pharmacies to
notify FDA when compounding short supply medications. While the
discussion draft adequately addresses the concern that
shortages of prescription drugs have tripled during the last 5
years, other legislative proposals place burdensome FDA
notification requirements on compounding pharmacies.
Mandating all compounding pharmacies to bypass their State
Board of Pharmacy does nothing to prevent another NECC.
And, third, exempting pharmacies within health systems from
compounding standards, while the discussion draft holds all
compounding pharmacies to the same compounding standards, other
legislative proposals exempt all pharmacies within health
systems from the proposed compounding requirements.
A recent OIG report found that almost half of hospitals
stated that cost and space limitations would be major
challenges to achieve USP 797 compliance. Thus, as Congress
addresses this very important issue, the intent should be to
ensure all patients receive safe and quality compounded
medications.
In conclusion, NCPA is committed to working with Members of
Congress in order to make certain that a tragedy such as the
New England Compounding Center does not occur in the future,
while also preserving patients' access to customized and safe
compounded medications.
Thank you for inviting NCPA to testify and to share the
view points of independent community pharmacy owners and
operators across the country on compounding. I look forward to
answering any questions you may have. Thank you.
Mr. Pitts. Thank you, Dr. Hoey.
[The prepared statement of Mr. Hoey follows:]
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Mr. Pitts. Dr. Thompson, you are recognized for 5 minutes
for an opening statement.
STATEMENT OF KASEY THOMPSON
Mr. Thompson. Good afternoon, and thank you, Chairman Pitts
and distinguished members of the committee for holding this
hearing. I am here today to provide ASHP's perspective as a
professional society that represents over 42,000 pharmacists
who practice in hospitals, health systems and ambulatory
clinics, and has been a recognized leader for over 20 years in
the development of guidelines on sterile compounding,
nonsterile compounding and guidelines on working with
outsourcers. The event caused by the New England Compounding
Center resulted in 61 unnecessary deaths and more than 700
meningitis cases.
ASHP strongly believes that the authority and
accountability between the FDA and State Boards of Pharmacy
needs to be clarified. We believe that compounding outsourcers
that prepare customized sterile preparations that are not
commercially available should be held to the highest standards
for quality, including relevant current good manufacturing
practices and should be required to be registered with and
routinely inspected by the FDA.
Further, we believe that these entities should not copy
commercially available products except in the cases of drug
shortages or to make a medically necessary variation that meets
patient specific needs. The drug approval process in the United
States is the gold standard and should be maintained as such.
However, it is important to recognize that there are many
legitimate and medically necessary compounded sterile
preparations that simply are not available from a brand or
generic manufacturer in the strength or dosage forms that
patients need.
U.S. hospitals prepare a vast array of compounded sterile
preparations from FDA-approved products every day in order to
meet patient-specific needs. The compounded medications that
hospitalized patients need range from simple intravenous
admixtures to complex customized medications that are not
available off the shelf, such as multi-ingredient cardioplegia
solutions for heart surgery, epidural pain medications for
women in labor and delivery, concentrated pain medications for
cancer patients, and adult medications prepared in
concentrations that can be safely administered to babies and
children.
Where necessary, hospitals enlist the services of qualified
compounding outsourcers for some preparations for several
reasons. For example, some hospitals may not have the necessary
equipment or facilities to prepare some high risk sterile
preparations, which is sometimes the case in small and rural
hospitals. Or they may face medication shortages for commercial
products that can only be replicated by outside suppliers that
provide customized compounded sterile preparations. They may
also enlist the help of outsourcers to prepare FDA-approved
sterile products in ready-to-administer packages in the
strength and dosage forms they need.
The evolution of the compounding outsourcing industry over
the past decade has outpaced the ability of State and Federal
laws to keep up, creating legal and regulatory gray areas
between State and Federal Government.
Unfortunately, it just isn't as simple as calling these
large scale anticipatory compounding entities a pharmacy, a
repackager or a pharmaceutical manufacturer. They are something
in between each of these but no one category fits them
perfectly.
Recent bipartisan Senate legislation addresses the need for
clarity and distinguishing between compounding by a pharmacy
and the activities of a compounding outsourcer. It assigns
responsibility and accountability to the FDA for regulating
compounding manufacturers while preserving the accountability
for pharmacy compounding to State Boards of Pharmacy. It also
establishes a user fee program to help ensure that the FDA has
the resources it needs to effectively regulate compounding
manufacturers.
Because of the potential nationwide scale of these
operations, we are concerned that State Boards of Pharmacy may
not be able to provide adequate oversight of these facilities.
Many State boards may not have the resources or expertise to
evaluate whether a pharmacy has crossed the line and become a
manufacturer.
With respect to the regulatory framework proposed in the
draft legislation by Representative Griffith, ASHP is concerned
that the regulatory environment that allowed the New England
Compounding Center to operate as a pharmacy would remain
intact. In other words, if authority between State Boards of
Pharmacy and FDA is unclear due to lack of accountability, we
would be concerned that neither FDA nor State boards could be
held accountable if an entity were licensed as a pharmacy, but
was also preparing sterile compounded preparations without a
prescription and selling across State lines.
In addition, our understanding of the draft legislation is
that FDA would only be permitted to inspect a pharmacy that may
be operating as a large scale compounding entity if FDA has
received a submission from the State Board of Pharmacy.
This ability for FDA to have the necessary access to
records and inspect a compounding entity would be contingent
upon State boards being properly equipped with trained
personnel to determine if an activity appears to approach
manufacturing. We are concerned that FDA may not be fully
accountable if the State board does not notify the agency.
Further, this approach would imply that State boards would
inspect all prescription records and sales transactions of each
licensed pharmacy in their State to identify those entities
that may be acting outside the scope of traditional pharmacy
compounding. Therefore, it would be referred to the FDA. We do
not see that as realistic for many State boards, and therefore
believe that these types of compounding outsourcers would be
more appropriately regulated by FDA.
In conclusion, ASHP remains completely committed to working
with Congress, the FDA and other stakeholders in developing a
reformed regulatory framework for pharmacy compounding. Thank
you, Chairman Pitts, for holding this hearing on this very
important public health topic.
Mr. Pitts. The chair thanks the gentleman.
[The prepared statement of Mr. Thompson follows:]
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Mr. Pitts. Mr. Francer, you are recognized 5 minutes for an
opening statement.
STATEMENT OF JEFFREY FRANCER
Mr. Francer. Thank you, Mr. Chairman and members of the
subcommittee. I am Jeff Francer, I serve as assistant general
counsel of the Pharmaceutical Research and Manufacturers of
America. Thank you for the opportunity to present our views
this afternoon.
PhRMA is a voluntary, nonprofit association that represents
the country's leading pharmaceutical research and biotechnology
companies. In 2012, PhRMA's members alone invested nearly $50
billion in discovering and developing new medicines. PhRMA
shares the committee's goal of advancing public health and
protecting patient safety by ensuring that FDA's statutory
authority and safety standards for pharmacy compounding are
strong enough to protect patients against the risks
demonstrated over the past year.
There is no higher priority for biopharmaceutical companies
than patient safety. We commend the committee's diligence in
investigating the causes of the recent tragedies and examining
potential solutions.
PhRMA believes that medicines manufactured by our member
companies as well as those manufactured by nontraditional
pharmacies and manufacturers should be regulated by FDA using a
consistent, risk-based approach. This approach best serves
public health because products that present similar risks
should be regulated in a similar manner.
In light of the incidents surrounding the New England
Compounding Center, it is clearly appropriate for Congress to
revisit the FDA's authority to regulate compounding of
prescription drugs. And consistent with the goals of clarifying
FDA's authority and protecting patient safety, PhRMA would
support legislation that would include the following seven
attributes:
First, clarify that FDA retains its strong existing
authority to regulate as a new drug any medicine that is
compounded outside of traditional compounding. Large-scale,
commercial manufacturing of prescription medicine should be
governed by the same high standards, whether the commercial
producer is designated as a pharmacy or as a manufacturer.
Second, the legislation would provide express inspection
and registration authority for nontraditional compounders as
manufacturers, including to the extent that such authority is
not clear the ability to inspect records to determine whether
pharmacies are actually engaging in nontraditional compounding.
Third, provide user fee authority which we believe already
exists, to ensure that FDA has adequate resources to regulate
nontraditional compounders as manufacturers.
Fourth, ensure that nontraditional compounders may not
compound copies of marketed drugs and thus subvert FDA's
generic and bio similar approval processes.
Fifth, prohibit the compounding of specific drugs or drug
categories for safety reasons.
Sixth, appropriately limit the channels of distribution of
compounded drugs, including through a prohibition on wholesale
distribution.
And finally, any new legislation should resolve any
ambiguity in FDA's current authority by deleting the section of
the Federal Food, Drug, and Cosmetic Act at issue in the
Western States case.
Within this framework, FDA could and should take a risk-
based approach to the regulation of nontraditional compounding
using the same approach that FDA now takes to pharmaceutical
manufacturing. However, complex legislation that creates a
whole new classification of compounder, so-called compounding
manufacturers, is unnecessary. Such an approach could result in
regulatory confusion and the application of different
regulatory standards for similar types of manufacturing. In
fact, such a third class would actually decrease FDA's current
statutory standards for regulating nontraditional compounders.
Finally, PhRMA is concerned about risks to patient safety
that could result from proposals to allow compounding of copies
of marketed pharmaceuticals in the event of a drug shortage.
This potential exception could expose patients to unsafe drugs
because the compounder need not establish that the compounded
version has a safety and efficacy profile equivalent to the
FDA-approved product.
In conclusion, Mr. Chairman, PhRMA thanks the subcommittee
for the opportunity to provide testimony this afternoon
regarding how to clarify FDA's existing authority to regulate
nontraditional compounding. Biopharmaceutical companies are
committed to patient safety. The same safety standards that
govern pharmaceutical manufacturing should also protect
patients who are treated with medicines manufactured by large-
scale compounders. And we look forward to continuing the work
with the subcommittee as it continues this important task.
Mr. Pitts. The chair thanks the gentleman.
[The prepared statement of Mr. Francer follows:]
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Mr. Pitts. Dr. Gaugh, you are recognized for 5 minutes for
opening statement.
STATEMENT OF DAVID GAUGH
Mr. Gaugh. Thank you, Chairman Pitts and members of the
House Energy Subcommittee on Health, and thank you for inviting
me to testify before the subcommittee on this very important
topic of drug compounding.
My name is David Gaugh. I am senior vice president for
Sciences and Regulatory Affairs at the Generic Pharmaceutical
Association and a licensed pharmacist.
GPhA represents the manufacturers and distributors of
finished dose generic pharmaceuticals, bulk pharmaceuticals and
suppliers of other goods and services to the generic industry.
The quality and affordability of generic medicines is vital
to the public health and sustainability to the health care
system. Prior to joining GPhA, I was general manager of a
generic injectable manufacturing company. I also served a
leadership role in a major group purchasing organization and
was assistant director of pharmacy in a hospital system in the
Midwest where one of my responsibilities was oversight of
traditional compounding performed by my staff.
GPhA supports the goal of clarifying the FDA's authority
over compounding in order to protect patient safety and prevent
another health care crisis like the fungal meningitis outbreak
that was caused by the substandard compounded drugs.
Traditional compounding plays a vital role for patients and
any new regulation should maintain that role. GPhA firmly
believes that pharmacy compounding should adhere to the
standard of one patient, one prescription, one drug. Patient
safety is the highest priority for approved pharmaceutical
manufacturers who comply with quality and sterile manufacturing
processes and procedures as defined by the current good
manufacturing practices, or cGMP. These regulations and
associated guidances apply to all prescription drugs approved
by the FDA for sale in the U.S.
The FDA's regulations and guidance are based on the
fundamental principles that quality cannot be inspected or
tested into a finished product, but quality must be designed
into the product and the manufacturing process.
The large-scale manufacturing of sterile medicines, no
matter who performs the functions, must involve similar
activities as they have similar potential risks. In order to
ensure the safety of the American public, the large-scale
manufacturer of these sterile medicines should be regulated by
the FDA in a consistent risk-based manner at the same high
standards, including submitting documentation to the FDA and
submitting to both preapproval and routine risk-based cGMP
inspections.
A sterile injectable drug should not be the object of
compounding unless these aforementioned regulations and
guidances are enforced by the FDA or if the product is
compounded for an individual patient by an individual
prescriber.
GPhA strongly supports established standards for the
quality of bulk substances used in compounding. We believe it
is critical that these standards should include a requirement
to the bulk substance used in compounding be from FDA inspected
cGMP-compliant facilities, and that should be done prior to the
compounding. GPhA recognizes that many in Congress believe that
there should be an exemption to these requirements for certain
medically necessary sterile products and shortage. We believe
that the requirements for any category of large-scale
compounding of sterile products should be the same FDA
standards that apply to pharmaceutical manufacturers.
To solve a drug shortage of sterile injectable marketed
drugs by lowering oversight, safety and quality standards is
not in the best interests of the American public.
GPhA believes any drug substance exemption should include
explicit language clarifying that the large scale compounder
that is compounding marketable products on the FDA drug
shortage list must immediately stop both the compounding and
the distribution once notified by the FDA through established
processes that the shortage has ended.
GPhA strongly supports the requirement for large scale
compounding pharmacies or compounding manufacturers that plan
to compound a marketed drug on the official FDA drug shortage
list notify the FDA prior to starting that compounding.
We do not believe it is appropriate for notification only
after initial large scale compounding has started.
Additionally, the FDA should be given the authority to deny the
request for compounding of a drug on the drug shortage list.
GPhA strongly supports providing the FDA with the
additional resources needed to conduct inspections and do
effective oversight through the fees on large-scale
compounders. These fees should be sufficient to ensure that
resources are not diverted from other areas within the agency.
In the interest of providing health care professionals and
patients with complete information, any product compounded
outside of the institution in which it is administered should
be appropriately labeled as determined by the FDA and
identified as a compounded product.
GPhA believes large-scale compounding pharmacies should be
held to same adverse events reporting requirements as
pharmaceutical manufacturers to allow the FDA ability to
earlier identify and prevent any future health crisis.
In conclusion, Mr. Chairman, GPhA and our member companies
are committed to ensuring both the role of the traditional
compounders for patients, that need these patients are used and
are safe for the patients and we look forward to working with
the committee on this very important factor. Thank you.
Mr. Pitts. The chair thanks the gentleman.
[The prepared statement of Mr. Gaugh follows:]
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Mr. Pitts. Mr. Coukell, you are recognized for 5 minutes
for an opening statement.
STATEMENT OF ALLAN COUKELL
Mr. Coukell. Chairman Pitts and members of the
subcommittee, thank you for the opportunity to testify on
pharmacy compounding and the need for legislation to protect
patients.
My name is Allan Coukell. I am a pharmacist and director of
drug and medical device work at the Pew Charitable Trust,
independent research and policy organization with a
longstanding focus on drug quality issues.
This subcommittee has heard previously about the risks of
substandard compounded medicines and I won't reiterate those
today, except to say that the recent fungal meningitis outbreak
was far from an isolated incident, and even now, FDA
inspections reveal alarming ongoing quality problems.
Today, I would like to propose ways for Congress to reduce
these risks, and at the same time, ensure that patients have
access to the medicines they need. Current law is inadequate
for this purpose both because the courts have created
uncertainty about the status of section 503A of the FDCA and
because 503A does not recognize the emergence ofa large scale
compounding industry that is far removed from traditional
pharmacy practice.
So let me begin with two points that I think all
stakeholders should endorse. First, patients, doctors and
pharmacists should prefer FDA-approved drugs over compounded
medicines whenever possible. Only FDA-approved drugs have
demonstrated their safety, efficacy and bioequivalence and have
preapproved manufacturing facilities and methods. New
legislation must not encourage compounding at the expense of
traditional manufacturing.
Second, the preparation of customized medicines in response
to a prescription for an individual patient is an established
part of State-regulated pharmacy practice. But now let me make
a third point, which is that there is a large-scale compounding
sector that fits neither of the above categories. Instead, it
does batch production of products, often high risk sterile
products and admixtures of FDA-approved drugs for use in
hospitals and clinics.
And the Inspector General recently reported that 85 percent
of hospitals, hospitals of all sizes, large and small,
purchased some intravenous drugs from outside pharmacies,
sometimes thousands of doses a day. Together with the American
Hospital Association and ASHP, Pew recently convened a pharmacy
sterile compounding summit that brought together hospitals,
purchasing organizations, compounders, regulators and pharmacy
associations.
It also included experts on pharmacy and manufacturing who
emphasized the enormous differences between the standards
developed for pharmacy practice and the good manufacturing
practices that apply to manufacturing. These experts stressed
that only GMPs are adequate to ensure the safety of large
scale, standardized production.
Oversight of such standards is a role for the FDA and not
for State boards of pharmacy. Section 503A already recognizes
FDA's responsibility to oversee some compounding, but merely
reinstating the section would leave a lack of clarity about
which facilities were subject to FDA oversight, and it would
not clearly give FDA the ability to ensure that large-scale
compounders comply with applicable GMPs. And shutting down a
facility or requiring the filing of an NDA may not always be in
the public interest.
So which facilities should be subject to FDA oversight?
There is no single ideal solution, but a potential framework
could include some of the following: Volume of production.
Clearly larger scale operations expose more patients to risks.
Those risks are not mitigated by an after the fact
prescription. Large-scale operations should be subject to GMP.
The nature of the products, manipulating a sterile product is a
high-risk activity. Sterile drugs made from nonsterile raw
ingredients are especially high risk.
Expiration dates. The longer a product sits before use, the
more likely it is to degrade or sustain bacterial or fungal
growth. Longer beyond use dating calls for higher quality
standards and may also serve as a mechanism to distinguish
between traditional pharmacy and this new compounding sector.
My written testimony contains additional recommendations
for a practical and enforceable framework. In particular,
facilities under FDA oversight must be required to register and
to avoid an unfunded mandate to pay a fee. Compounded drugs
should be clearly labeled as such and wholesale distribution
prohibited. Current law gives FDA the authority to create a
list of drugs that may not be compounded and to inspect
pharmacies as necessary, and these authorities must be
maintained.
I thank you for your leadership on this important issue. It
is time to update the FDCA to remove ambiguities and create a
clear, workable framework for patient safety. And I welcome
your questions.
Mr. Pitts. The chair thanks the gentleman.
[The prepared statement of Mr. Coukell follows:]
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Mr. Pitts. Dr. Miller, you are recognized for 5 minutes for
your opening statement.
STATEMENT OF DAVID G. MILLER
Mr. Miller. Good afternoon, Chairman Pitts, ladies and
gentlemen of the committee, it is a pleasure on behalf of the
International Academy of Compounding Pharmacists to appear
before you today to talk about a situation that started with
one pharmacy in Framingham, Massachusetts, but fundamentally
has uncovered a real gap in our laws.
Now, I have been listening this afternoon to testimony, and
you have the written testimony of my colleagues and myself, but
I have heard six different terms used to define this thing that
we are attempting to address and regulate.
Members of the International Academy of Compounding
Pharmacists are pharmacists. We work in small drug stores, we
work in large chain drug stores, at CVS, at a Publix grocery
store in Florida, in hospitals.
Compounding is an essential core component of the filling
and care of prescription medications for patients throughout
this country. One of the challenges that we have found
ourselves in is that the core concept of filling a prescription
ordered by a physician either for the treatment of that patient
in his or her home, or the use of that medication in the
doctor's office for administration and treatment of a patient
on site has somehow been clouded by the evolution of this other
thing.
Tonight, this afternoon, we have heard that thing referred
to as repackagers, traditional compounders, nontraditional
compounders, outsourcing pharmacies, outsourcing admixture
pharmacies, manufacturers, compounding manufacturers, batch
production.
Now, again, I am a pharmacist. I look at this relatively
simple. I get a prescription from a physician to take care of
an individual patient, or I get a prescription to send a
medication to a doctor's office so he or she can take care of
that patient. IACP believes that currently section 503A is very
clear that the Food and Drug Administration does have authority
over the distribution of drugs in the United States, either
through manufacturing or wholesaler distribution, and that our
States have authority over the practice of pharmacy.
We believe at IACP that a great deal of confusion over this
other entity that appears to not want to be regulated either by
the FDA or falls within the gap of the regulation of the
States, that is a separate group from pharmacy. And one of the
things that we have seen as we have looked and worked with the
Senate HELP committee on S. 959 is the core concept of
preserving the integrity of the drug distribution system under
FDA oversight, and on that side of the body it has been deemed
a compounding manufacturer, unfortunately has gotten into the
day-to-day practice of pharmacy and practice of medicine.
For example, on the Senate side, we now know that one of
the things that we must have to ensure the protection, the
safety and access of medications for patients is quality
assurance. There is no language in S. 959 requiring all
pharmacies or these other things to adhere by the nationally
published standards of the United States pharmacopeia. There is
no quality assurance.
There are specific language that intrudes on the practice
of medicine and the practice of pharmacy. Most recently, the
version of S. 959 that was distributed now includes a
requirement that a pharmacist who fills a medication that may
be a medication that is in drug shortage must inform the Food
and Drug Administration within 3 days of filling that
prescription. And we believe that is a significantly
troublesome precedent.
There are also questions about whether or not all
pharmacies would be actually required to participate and be
overseen under this process and indeed within Senate 959 as my
colleague from NCPA said previously, all hospitals and health
system pharmacists are actually exempted from the Senate's new
approach to regulating this issue.
Fortunately, Congressman Griffith has introduced a draft
piece of legislation that we believe is really the closest
solution to solving the questions that arose because of NECC's
activities. We look forward to continuing to work with him and
with this body on helping craft legislation that does a few
most critical things: One, preserve patient access to
medication; two, assure the American public of the safety of
the medicines that they receive, that there are swift and
accountable actions by our regulators at both the State and the
Federal level to carry those laws out.
Thank you very much.
Mr. Pitts. The chair thanks the gentleman.
[The prepared statement of Mr. Miller follows:]
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Mr. Pitts. Dr. Catizone, you are recognized for 5 minutes
for your opening statement.
STATEMENT OF CARMEN CATIZONE
Mr. Catizone. Good afternoon, Chairman Pitts and members of
the subcommittee. On behalf of the National Association of
Boards of Pharmacy and the State boards across the country,
thank you for the opportunity to be here today.
NABP believes that the three legislative proposals provide
the regulatory framework for us to address the issue of
compounding manufacturing and to protect the public health. We
support the Senate HELP bill and support the provisions that
clearly distinguish traditional compounding, which should be
regulated by the States and remain the purview of the States,
and manufacturing, which should be the purview and remain the
purview of the FDA. And we support the new category of
compounding manufacturer that should fall within the purview
and under the regulation of the FDA.
We commend Mr. Griffith and the other authors of the House
bills for their diligence and concern for patient safety.
However, we must also caution that there are provisions in the
House bills that may not be intended to but could take us in
the wrong direction, in a direction different from the
legislative intent and a direction that could lead us to
another NECC tragedy.
In regard to a primary issue identified by the House bill,
NABP agrees that there is a bona fide but narrow need for
pharmacists to compound a limited amount of products for
administration to patients. The creation of the previously
referenced third category, compounding manufacturer, seems to
address the needs of the majority of patients. However, we are
also sensitive to the fact that some stakeholders do not
believe this is an appropriate category for this activity and
would like to place this activity under the domain of
traditional compounding and the purview of the State boards of
pharmacy.
To respond to these concerns, specifically those of patient
need, limiting the amounts of compounded products for direct
administration in order to avoid any masking of manufacturing
for compounding, we would support such an allowance provided
there are limitations and qualifiers to those activities.
Those qualifiers include: First, the State has to allow
such activity. Once that is allowed, the other limitations
follow. There must be a demonstrated medical need for the
compounded product. A non-patient-specific order must be
written by the practitioner who will be administering or is
directly responsible for administering the compounded product.
The total quantity provided at the clinic office or
healthcare setting per patient cannot exceed a 10-day supply.
The compounded medication cannot be resold. The compounded
medication must be prepared in accordance with applicable USP
standards or GMPs, depending upon the product, as determined by
the FDA.
There must be a limitation on the total quantity of
compounded products that the pharmacy can prepare. Such
quantity cannot exceed a certain percentage of or some other
measure of the pharmacy's total number of prescriptions
dispensed, dosage units, patient supply, or some other
measurable and comparable factor.
The pharmacy must notify the applicable State board or
boards of pharmacy and FDA of their involvement in this area in
accordance with an appropriate process and frame times to be
determined. And the FDA must have full legal access to all
records of the pharmacy engaged in this activity. And equally
as important, there can be no prohibitions on the sharing of
information between the States and the FDA on these activities,
as presently exists.
We want to note that these limitations and qualifiers for
this activity does not erode the distinction between
compounding manufacturing and compounding manufacturers created
by the Senate HELP bill. They simply allow for an exemption
with additional oversight under the category of traditional
compounder.
Generalizing to a large extent, if the Senate HELP bill is
used as a framework and modification from the House bills are
employed, we would have three broad categories for compounding
and manufacturing.
Traditional compounding: Per patient, patient-specific,
regulated by the States, and all requirements of the States and
USP standards in place. The FDA's current enforcement authority
and responsibilities would remain. And the FDA could act, as
they have been able to act, in the recent past.
Manufacturing and compound manufacturing: regulated by the
FDA, complete access to all of those records, all of the
requirements of the FDA, including GMPs.
And then this exemption, under traditional compounding: for
those activities for administration within a clinic, healthcare
setting, or hospital, shared authority between the FDA and the
States, access to those records, and communication between the
FDA and the States.
In closing, we appreciate the opportunity to be here today.
We respectfully request that action be taken to develop and
pass Federal legislation. We think it is important. We don't
want to lose the opportunity.
Thank you.
Mr. Pitts. The chair thanks the gentleman.
[The prepared statement of Mr. Catizone follows:]
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Mr. Pitts. Thanks to all the witnesses for your opening
statements.
We will now begin questioning. I will recognize myself for
5 minutes for that purpose.
Mr. Hoey, the meningitis outbreak was a clear example of a
communication breakdown between the FDA and the boards of
pharmacy. How does Mr. Griffith's draft address strong lines of
communication between boards of pharmacy and the FDA?
Mr. Hoey. Thank you, Chairman Pitts.
I think one of the key things that it does is that it
requires the FDA to respond within 60 days when the board of
pharmacy has sent a complaint or sent some kind of a warning to
the FDA.
Clearly, that did not happen in the NECC tragedy. Despite
numerous heads-up, numerous warning signs sent to the FDA,
there was not appropriate action taken. Representative
Griffith's bill would require that action be taken within that
60-day period.
Mr. Pitts. Mr. Francer, the Senate bill establishes a third
category: compounding manufacturers. Do you think establishing
a new category would provide clarity or confusion?
Mr. Francer. Chairman Pitts, we believe that a new
provision like that would provide confusion and that it is not
necessary. We believe that traditional compounding as it is now
should be regulated by the States. And when there is not a
prescription and we have a large-scale-type facility, it is
manufacturing. And the FDA is quite good at regulating
manufacturers.
Mr. Pitts. Mr. Gaugh, supporters of creating a compounding
manufacturing category argue that the growing market from
hospitals for outsourcers necessitates a need to exempt them
from the new drug requirements of the FDCA.
Wouldn't this change permanently preclude the FDA from
requiring pre-inspection of some facilities engaged in large-
scale manufacturing from bulk API?
Mr. Gaugh. It very well could. So it is not totally clear,
but, to your point, yes, it could blur those lines.
And even if you do outsource the product from a hospital to
another provider, you still have that capability in 21st-
century electronics to provide that prescription for the
patient to the compounding pharmacy to compound that product
one by one, patient to prescription.
Mr. Pitts. Now, in your testimony, you write about the
importance of the drug manufacturing control processes written
into the ANDA applications. Can you outline why this process
between FDA and an applicant is critical to ensure the safety
and efficacy of the product that will be ultimately marketed to
the public?
Mr. Gaugh. Yes. As I said earlier in my statement, the
fundamental principles of quality can't be inspected and tested
with the finished product. They need to be designed into that
product and into the manufacturing process. And so the NDA and
ANDA holders, as they develop these products, are designing
that in for both the product and for the manufacturing process.
That is not being done in compounding.
Additionally, the ANDAs and NDAs that are filed contain
specific specifications around stability, around impurities,
around container closure, other manufacturing processes that,
again, are not addressed by the compounding pharmacies.
Mr. Pitts. Dr. Miller, a couple of questions for you. Can
you explain the importance of traditional compounding in our
Nation's healthcare system? And then would you explain your
thoughts on the creation of an expanded do-not-compound
authority list for the FDA?
Mr. Miller. Yes. Thank you, Mr. Chairman.
I think the easiest way to understand why we need
compounded medications is just to look at all of us in the
room. We are all different sizes, we are all different ages, we
are all different sexes, and each one of us metabolizes and
uses drugs in different ways. One of the advantages of having
trained pharmacists and physicians who understand the use of
having medications customized to each one of us, it helps us
get the therapy that we need.
The U.S. drug system is phenomenal. The vast majority of
the products manufactured by my colleagues at PhRMA and the
Generic Pharmaceutical Association meet most of our needs. But
some of us require tweaks. So compounding pharmacists use
techniques, tools, skills, and training to prepare medicines
that are unique to a particular individual. Or, in some
instances, as we have heard repeatedly this afternoon and I
know that you will hear over and over again, compounding
pharmacists in the short term can step in to fulfill drug-
shortage or backorder situations. That is first and foremost
why we need compounds.
Your question was, the second one?
Mr. Pitts. Your thoughts on the creation of an expanded do-
not-compound authority list for the FDA.
Mr. Miller. IACP's position on this has been fairly
consistent, sir. The FDA has had the authority to create a do-
not-compound list based on a concern of safety or efficacy, and
that we would leave in and strongly support.
Unfortunately, the agency has not updated that list in more
than 10 years, and the provision of expanded authority to say,
well, we can add a drug based on that it is hard to compound,
or, you know, we think that you shouldn't use this particular
active pharmaceutical ingredient--there are some other clauses
on the Senate side--IACP strongly disagrees with that.
Because the fundamental reason for having a do-not-compound
list is the agency should simply say, this medication is not
safe, should not be used, is ineffective, it goes on the list.
Mr. Pitts. My time has expired.
The chair recognizes Mr. Green for 5 minutes for questions.
Mr. Green. Thank you, Mr. Chairman.
Dr. Thompson, in your testimony, you note that none of the
classifications of ``repackage'' or ``pharmacy'' or
``manufacturer'' fits neatly with the regulatory needs of the
large-scale compound or outsourcer.
Do you believe that asking the FDA to regulate these
operations as manufacturers but leaving these specifics on how
they are regulated up to the enforcement discretion of the FDA
is a good policy?
Mr. Thompson. Sir, you know, reflecting on the Senate bill
and how they have defined a compounding manufacturer, they
defined it as an entity that is not preparing product in
response to a prescription, is engaged in interstate commerce,
as a proxy for risk.
We think as this industry has evolved over the last decade
to provide necessary service to hospitals and clinics and
others that it has really created this gray area that there
isn't Federal legislation or regulation for. So we do think it
is necessary to help clarify what those entities do, which
provide very helpful services to healthcare organizations and
patients.
Mr. Green. Have you looked at the enforcement discretion
that is in Congressman Griffith's bill?
Mr. Thompson. Well, we don't think enforcement discretion
is a good policy. And that is the thing now, that there are
these companies out there that are selling products for
anticipatory use that, under the law, really isn't allowed. But
they do fill a need. They are doing it under, you know, under
good standards in many cases, but those need to be clarified.
What we think in the Griffith draft, that, you know, in
some ways, it creates a third category without calling it that.
It still allows entities to prepare large-scale products
without Federal oversight. It leaves it to State boards of
pharmacy--really, the same environment that exists now, that
caused NECC--it leaves it to the State boards to call the FDA
and identify something. The State boards are under-resourced,
they don't have the expertise, and they are not manufacturing-
level inspectors.
Mr. Green. And I agree, although I think the Griffith bill
also has some enforcement at FDA to respond to those State
boards when they just send a letter. Because we had a number of
letters in this situation that was done.
Mr. Miller, do you believe that using interstate commerce
of sterile compounds in advance of a prescription is an
adequate proxy to assess the highest-risk products?
Mr. Miller. We have to be very careful with that, because
as Congressman Griffith has pointed out in his own State and
even here within the Washington, D.C., metro area, where I grew
up in northern Maryland, the concept of interstate commerce as
the end-all-be-all definition of when something goes over that
line, we have to recognize that health care in the United
States is not limited to within State borders. So I would
challenge our thinking that just the movement of a medication
across a State line should be the trigger for FDA oversight.
Mr. Green. OK.
Mr. Miller. The other portion----
Mr. Green. I only have 2 minutes left. But I understand
that, because, you know, people in Beaumont, Texas, people come
from southeast Louisiana to buy from a pharmacy. But me, as an
individual, I can do it. But if you are selling across, there
may be an issue.
But let me go on to another question. Of your members, how
many are unquestionably small operations that would be caught
up in a regulatory net created by establishing a proxy of
interstate sterile and anticipatory compounding?
Mr. Miller. Quite honestly, sir, we don't know. And we
don't know because there is very little data on the amount of
prescription compounding that occurs not only in compounding
specialty pharmacies but hospitals, home infusion, long-term
care, others. That data is unknown. This could have significant
impact on practice.
Mr. Green. The goal of this legislation would be primarily
to protect the health and safety of our people and to also
respect the various State laws in providing regulatory
certainty to those who are regulated and to those who are
purchasing regulated products.
And I agree--some of us, I know the chairman has experience
in State legislature. And we dealt with ours in Texas just like
they dealt with in Pennsylvania. To me, our boards of pharmacy
are certainly best equipped to regulate State agencies and the
State-level activities.
However, don't you agree that engaging in interstate
commerce creates a regulatory gray area that justifies a
Federal response?
Mr. Miller. Well, you have to look at the model that has
already been created by my colleague at the National
Association of Boards of Pharmacy for the transfer of licenses
between pharmacists across State lines. There is certainly a
public-private partnership that can exist that currently shares
information back and forth as pharmacies, say, in Texas wish to
be licensed in the State of Louisiana.
We don't necessarily believe that a Federal response is the
only workable solution.
Mr. Green. Well, and I think you are right, that it has to
be a combination of State and Federal. But, you know, the
problem we had in Massachusetts wasn't going across into
Connecticut, necessarily. It was actually going across the
country. And, again, traditional compounding is something we
want to protect.
I know I am out of time, Mr. Chairman. Thank you.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the gentleman from Virginia, Mr. Griffith, for 5
minutes for questions.
Mr. Griffith. Thank you very much, Mr. Chairman.
I would say up front that I don't believe that our bill
would have allowed the NECC situation to have occurred. I think
the increased communications and the aspects that this bill has
in it would have prevented that.
I do think that there are some things that we left holes in
there and we are trying to sort out, and I think that is
important. I also want to make it clear that if there is any
indication, we can always tweak the language. That is why it is
a draft bill. We are not trying to take anything away from the
current FDA authority. If there is something that they
currently have, we are not trying to take anything away. But we
are trying to clarify, without going too far, what their
authority is and try to sort these things out.
Mr. Coukell, I think you have it; we just have to figure
out the combination. You listed in your testimony drawing the
line, and you said some of the things we could look at were
volume of production, nature of the products, percentage of
sales, expiration dates, and interstate commerce.
As you heard previously when I testified, I don't think
that interstate commerce alone necessarily does it, because it
creates problems in those border areas or where the States are
very close together or smaller. But some combination thereof is
probably the answer.
What I would ask each of you to think about--and you can
always get back to me later--is, what combination or which
number of those factors do you think might be most important in
figuring out that trigger to make that distinction? Because I
think we all recognize, that is one of the issues we are trying
to resolve.
And if we could start with you, Mr. Catizone, if you have
thoughts now, or just say, I will send them to you later.
Mr. Catizone. Sure. Distinctions we make are: patient-
specific, whether it is interstate or intrastate, it is
compounding. Non-patient-specific, inter- or intra-, quantity,
volume doesn't matter, it is manufacturing.
Mr. Griffith. Manufacturing. OK.
Mr. Miller. Congressman, our perspective is, you have to be
so careful with the issue of volume. It is an easy checkbox,
you know, very easy to define. But, unfortunately, in health
care, you can't usually rely upon easy----
Mr. Griffith. Let me ask you this, though. If we had
volume, plus maybe a percentage of the business crossing State
lines, if you threw two or three of them together, do you think
that gets us closer to where we need to be?
Mr. Miller. Yes. And I think you have some precedence
already in the Prescription Drug Marketing Act of 1987. That
actually sets limits on retail pharmacies of 5 percent of sales
to physician offices, hospitals, and clinics before they must
register as a wholesaler--precedent.
Mr. Griffith. All right. Let me keep moving down the line
so that we don't use up all the time.
Yes, sir?
Mr. Coukell. Congressman, first, thank you for your
leadership on that bill. We were heartened to see the
placeholder language and would like to work with you on that.
A couple of points just now. One is, you know, just to
emphasize, I think everybody agrees that if somebody is filling
a prescription for a patient, that is a traditional pharmacy
practice, and nobody is talking about that. So the question is,
how much product should people be able to make on spec ahead of
time?
And, you know, I mentioned the summit we held with ASHP and
AHA. One of the quality experts there said, if somebody is
starting with a non-sterile bulk ingredient, they are buying a
bottle of methylprednisolone over the Internet and making a
sterile product, that ought to be under GMP, no matter what. So
his threshold there was zero for that particular type of
product. For something that starts with a sterile precursor,
you would set a higher threshold.
So I think it would be--I will finish.
Mr. Griffith. Yes, I hate to--we are running out of time.
Mr. Coukell. I think it would be impossible to say,
basically, from a public health point of view, what is the
limit at which we would not want people putting product out
there.
Mr. Griffith. OK. And if we could, I hate to limit the
folks at the other end of the table, but we are running out of
time.
Mr. Gaugh. We would leave it at two categories: traditional
compounding and----
Mr. Griffith. Manufacturing.
Mr. Gaugh [continuing]. Pharmaceutical manufacturing, yes.
Pharmacists are trained to compound. They are not trained to
manufacture. It doesn't mean they can't learn, but they are not
trained to do that.
Mr. Griffith. Right.
Yes, sir?
Mr. Francer. Yes, Congressman Griffith, the touchstone
clearly is whether there is a prescription or not. However, the
FDA's current guidance in terms of its compliance lists a
number of criteria, including compounding finished drugs from
bulk active ingredients, using commercial-scale equipment. And
the FDA actually has a multiple-factor test that they use.
Mr. Griffith. All right.
Yes, sir?
Mr. Thompson. Sir, we appreciate that the bill is a working
draft, and we look forward to working with you to clarify key
aspects.
You know, the notion of percent of business might be a way
to look at it. You know, volume, as mentioned by others, is a
moving target. Risk level is a really key one, too. You know,
high-risk-level compounding, compounding from API, nonsterile
to sterile, is a very important area to focus on
Mr. Griffith. OK.
Mr. Thompson. And I will leave it at that, and we will
provide more----
Mr. Griffith. I appreciate that. Thank you.
Mr. Hoey. Thank you, Congressman.
A valid prescription, individual valid prescription, is
key. That is the starting point and possibly the ending point,
as well.
As far as interstate and percentage of prescriptions,
percentage of volumes, those are possible, but they can be a
slippery slope. And it is hard to have a one-size-fits-all in
those categories.
Mr. Griffith. Right.
Thank you all very much. And I look forward to working with
all of you in trying to sort this out at some point. We are
going to have to make the difficult decision and draw that line
somewhere. And I do appreciate it.
I yield back, Mr. Chairman.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the ranking member emeritus, Mr. Dingell, for 5
minutes for questions.
Mr. Dingell. Mr. Chairman, thank you for your courtesy.
One main reason for the NECC outbreak was much confusion
regarding FDA's authorities and the proper role of the States.
This question is for all of the witnesses, ``yes'' or ``no.''
Do you believe that it is important to have clear lines of
division between FDA and State boards of pharmacy when it comes
to regulating compounding pharmacies, yes or no?
Starting with you, Dr. Hoey.
Mr. Hoey. Yes.
Mr. Dingell. Next witness?
Mr. Thompson. Yes, sir.
Mr. Francer. Absolutely, yes.
Mr. Gaugh. Yes.
Mr. Dingell. Next witness?
Mr. Coukell. Yes.
Mr. Miller. Yes.
Mr. Catizone. Yes.
Mr. Dingell. Gentlemen, thank you.
Would you each submit, if you please, to the record how
that division of responsibility should be created in the
legislation.
Now, Section 503(a) of FDA Modernization Act of 1997 has
been subject to court challenges which have limited its
effectiveness. Since that time, our medical system has changed
drastically.
This question is for Kasey Thompson of the American Society
of Health-System Pharmacists.
Do you believe that our healthcare system has come to rely
on what you call compounding outsourcers, yes or no?
Mr. Thompson. To a greater extent, yes.
Mr. Dingell. Now, in your testimony, you mention that your
members also use compounded sterile preparations which are not
available in an appropriate form from a manufacturer. Is that
correct, yes or no?
Mr. Thompson. Yes.
Mr. Dingell. Now, can you please submit to the committee
for the record a list of examples of these kinds of products?
Mr. Thompson. Yes, sir.
Mr. Dingell. Now, do you believe that these compounding
outsourcers should be subject to current good manufacturing
practices and risk-based inspections by FDA, yes or no?
Mr. Thompson. Yes.
Mr. Dingell. Do you believe that State boards of pharmacy
could adequately regulate these compounding outsourcers, yes or
no?
Mr. Thompson. No.
Mr. Dingell. Now, these new compounding outsourcers are now
routinely used by hospitals across the country. Any legislation
must ensure that there are no unintended consequences which
could have a negative impact on patient care.
Now, these questions are for you, Mr. Coukell of Pew. How
is it correct that a recent study by the Inspector General at
HHS found that 85 percent of hospitals which administer IV
drugs purchased some of the products from outside the
pharmacies? Is that so, yes or no?
Mr. Coukell. Yes.
Mr. Dingell. Now, Mr. Coukell, does Section 503(a), as
currently drafted and interpreted, recognize the existence of
these compounding outsourcers and our reliance on them, yes or
no?
Mr. Coukell. It does not, not as such.
Mr. Dingell. Would you submit to us your thoughts on how
that matter should be addressed?
And if the other members of the panel would do the same
thing, it would be appreciated.
Now, do you believe that simply reinstating Section 503(a)
would result in sufficient clarity regarding FDA's authority
over compounding pharmacies, yes or no?
Mr. Coukell. No.
Mr. Dingell. Would you give us some comments for the
purpose of the record on that particular point, if you please?
Now, I want to thank you all.
It is clear that we need to update and to significantly
enhance FDA's authority in this area. I know there is
bipartisan support for this issue. And we need, I know, to
clearly define roles for the States and FDA concerning
compounding pharmacies.
This committee has done good bipartisan work on public
health in the past, and I believe that we can do it again. And
I am looking forward to continue working on this issue with my
colleagues on both sides of the aisle.
I want to commend each member of the panel for your
excellent testimony. Gentlemen, you have done a superb job, and
I want you to know how much I appreciate it.
And to you, Mr. Chairman, I thank you and yield back the
balance of my time.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the gentlelady from North Carolina, Mrs. Ellmers,
for 5 minutes for questions.
Mrs. Ellmers. Thank you, Mr. Chairman.
Dr. Thompson, a moment ago, one of my colleagues had asked
you about whether or not you felt that State boards could
actually continue to regulate any of the basically
nontraditional compounders. What is your reason? I mean,
keeping in mind, of course, safety and sterility and best
practices. Do you not feel that they have the capacity to do
so?
Mr. Thompson. I think it really comes down, ma'am, to
resources and expertise. You know, just like pharmacists, we
are not inspectors of pharmaceutical manufacturers, and----
Mrs. Ellmers. Right.
Mr. Thompson [continuing]. I don't think State boards tend
to have that capacity either.
Mrs. Ellmers. Right. I guess this gets to the--there again,
we seem to get hung up on volume, and, you know, it seems to
get back to the same things.
And, you know, to Dr. Woodcock I had posed a question of,
if the nontraditional compounder were to be providing to a
hospital or an outpatient surgery clinic, where the drugs would
be administered under the supervision, obviously, of a
physician to a patient within a reasonable timeframe and even
possibly with, you know, some certain guidelines, like on a
monthly basis, is it that they would be providing that to
multiple entities and the volume there would be too much to be
enforced?
Mr. Thompson. Well, I think the reason we think that some
version of CGMPs is important is because it would really get
into the specifics of sterility and stability tests in this per
FDA and compendial standards. And that would really determine
whether it had a 30-, 60-, 90-day, or 12-month beyond-use date
associated with it. And that would really determine the storage
conditions and when it needs to be administered.
But I think without, you know, a clearer process, whether
it is CGMPs or some other process, that you just don't have
that assurance in the current environment.
Mrs. Ellmers. Dr. Gaugh, shouldn't large-scale compounders
be required to prove that they can manufacture under GMP
conditions before patients are put at risk?
Mr. Gaugh. Yes, they should be.
Mrs. Ellmers. OK. In your testimony, you write about the
importance of the drug manufacturing control process. Can you
outline why this process between the FDA and applicant is
critical to ensure the safety and efficacy of the product that
will be ultimately marketed?
Mr. Gaugh. Again, it is all about the CGMP requirements
that exist between the FDA and the manufacturer. And those
requirements don't exist between the State boards of pharmacy
and the compounders to the same degree and the same level. And,
as Dr. Thompson stated, they are not typically trained to
inspect to that, whereas the FDA is. So it needs to fall into
that same category.
Mrs. Ellmers. So can you explain, the similar scope of risk
between ANDA holders manufacturing drugs and large-scale
compounders in relation to, you know, explaining and creating
two regulatory regimes for large-scale compounders and
manufacturers. So I am concerned I don't understand that
process.
Mr. Gaugh. So if I understand the question correctly, when
you look at what the ANDA and the NDA holders are required to
do, they have specifications they must meet around the potency
of the product, around potential impurities and impurity growth
around microbe growth. That doesn't exist currently in the
compounding structure, in the compounding review. It would
under CGMP requirements, but it doesn't under current
requirements.
Mrs. Ellmers. So it would under--OK, again----
Mr. Gaugh. It could, I should say.
Mrs. Ellmers. It could.
Mr. Gaugh. Yes.
Mrs. Ellmers. But it does not at this time?
Mr. Gaugh. It does not.
Mrs. Ellmers. OK. And so, again, expanding on that, do you
see risk in creating two more regulatory regimes? I mean,
essentially, would there be two separate regulatory processes
here or----
Mr. Gaugh. In our opinion, that would be creating two
different regulatory processes at the FDA, if they were the
ones controlling this. They would be controlling a manufacturer
process for CGMP----
Mrs. Ellmers. For compounding and manufacturing.
Mr. Gaugh [continuing]. To be different. And we don't see
the manufacturing processes being different, so, therefore, the
structure of control should not be different.
Mrs. Ellmers. OK.
I only have about 40 seconds left.
To Dr. Miller, again, getting back to just the importance
of the physician role in this, why is the anticipatory
compounding important to physicians?
Mr. Miller. Having medicine available. When the patient
comes to you, you don't want to send that patient--give them a
piece of paper, send them down to the compounding pharmacy,
where it may take 2 to 14 days to prepare and test that, then
come back to be treated.
Mrs. Ellmers. Yes.
Mr. Miller. Physicians want to treat you today. Pharmacists
want to treat you today. We have to be able to prepare
medicines in advance.
Mrs. Ellmers. Very good.
And I see that my time has run out, so thank you, Mr.
Chairman.
Thank you to the panel.
Mr. Pitts. The chair thanks the gentlelady and now
recognizes the gentlelady from the Virgin Islands, Dr.
Christensen, for 5 minutes for questions.
Mrs. Christensen. Thank you, Mr. Chairman.
Mr. Catizone, in your testimony, one of the limitations you
suggest on compounding in advance of a prescription for
traditional compounders is that the total quantity provided to
a healthcare provider not exceed a 10-day patient supply.
I am interested in NABP's views on an alternative or
additional approach to a limitation on compounding in advance
of or without a prescription, of something like a 10- or 14-day
expiration date from time of manufacture.
As I understand it, one of the aspects of traditional
pharmacy compounding that contributes to safety is that it
ordinarily is performed for an individual patient at a time the
patient needs and will use the drug. One of the problems with
allowing traditional compounders to make drugs in advance or
without a prescription is that the drugs can be made in
unlimited quantities and allowed to sit on a shelf, either in
the compounder's warehouse or in the healthcare provider's
offices, for extended periods of time. During that time, any
bacterial, fungal, or other biological contaminants have time
to grow and make the product more dangerous.
A relatively short expiration date from the time of
manufacture would presumably limit the amount of drug that
would be compounded in advance of an order, limit the size of
orders that healthcare providers would request, and limit the
amount of time any contaminants could grow.
So what are your thoughts about such an approach?
Mr. Catizone. Under the limitations we propose, there were
two factors: one, the patient supply, as well as the total
quantity the pharmacy would provide.
The 10- to 14-day expiration date is another variable that
we could support, provided that that expiration date coincides
with what the beyond-use dates are with the product so that we
didn't put a 10-day or a 14-day expiration when the product was
only good for 2 or 3 days. So coinciding those two factors
makes that another very viable factor to look at in this
process.
Mrs. Christensen. Does anyone else have an opinion or want
to comment on it?
Mr. Hoey. The USP requirement for a USP 797 standards would
also help to address some of the issues that you are talking
about.
I would also mention an example of the importance of
anticipatory compounding. There was a situation where there was
a shortage of injectable atropine for crash carts, for
emergency crash carts. And because that drug wasn't available,
a compounding pharmacy was able to make that. Well, if a
patient is crashing, you don't want to have to write a
prescription at that moment while your patient is coding. When
that patient has had the proper treatment from the nurses and
the physicians and the pharmacists, then you can write the
prescription. But not having that prescription available at the
time could cause someone to die.
So that is a situation where there is a shortage of the
drug, and because compounding pharmacists have made that drug,
it is available when the patient needs it immediately.
Mrs. Christensen. Yes. I think in a situation like that, as
I understood it from Dr. Woodcock's testimony, because it is an
emergency drug not available, that that would be something that
they would allow.
Mr. Hoey. And there would have to be a stock on those crash
carts that are on----
Mrs. Christensen. Absolutely.
Mr. Hoey [continuing]. Certain floors in the hospital.
Mrs. Christensen. Absolutely.
Mr. Hoey. And it wouldn't be just that drug. There would be
several drugs that are on those crash carts.
Mrs. Christensen. If there are no other comments, Mr.
Chairman, I don't have another question.
Mr. Pitts. The chair thanks the gentlelady and now
recognizes the gentleman from Pennsylvania, Dr. Murphy, for 5
minutes for questions.
Mr. Murphy. Thank you, Mr. Chairman. Thank the panel.
By the way, Mr. Chairman, I have an opening statement I
would like to submit for the record, too.
[The prepared statement of Mr. Murphy follows:]
Prepared statement of Hon. Tim Murphy
Thank you, Chairman Pitts, for holding this hearing to
further the discussion about FDA's authority over drug
compounding.
Soon after the fungal meningitis outbreak began in the fall
of 2012, the Oversight and Investigations Subcommittee
initiated a thorough investigation to determine whether this
tragic outbreak--which has now claimed the lives of over 60
people and sickened nearly 750 others--could have been
prevented.
The Subcommittee found that the New England Compounding
Center was not operating in the shadows; in fact, they were
operating right under FDA's investigative nose for a decade.
Our investigation highlighted several opportunities where the
agency confronted a choice in dealing with NECC and its sister
company, Ameridose. FDA repeatedly decided not to act.
Furthermore, as FDA has recently confirmed to the Committee,
not a single complaint the agency had independently received
about these companies over the past decade was forwarded to the
state pharmacy board.
It is very hard to legislate cultural change into a large
federal agency. However, Mr. Griffith's discussion draft makes
important changes to address the breakdowns that occurred at
FDA in the NECC case. His legislation is grounded in the facts
uncovered by our investigation and makes it clear when FDA
can--and must--put patients before process. I commend him for
his efforts, and look forward to continue working with my
colleagues to reform drug compounding rules so patients receive
safe and effective medications.
Mr. Murphy. All right. I am also the chairman of Oversight
and Investigations, and we had a number of hearings on this to
try and get the FDA to give us a straight answer. We didn't get
it from Dr. Hamburg. I am going to try and ask you folks.
If the FDA has reason to believe that a compounding
pharmacist is acting like a manufacturer, do you believe the
FDA should have the authority to inspect a facility to the
extent necessary to determine if that is the case?
Let's go down the panel. Dr. Hoey?
Mr. Hoey. In cooperation with the State board of pharmacy,
yes.
Mr. Murphy. Dr. Thompson?
Mr. Thompson. If they are truly acting as a manufacturer,
yes.
Mr. Murphy. Mr. Francer?
Mr. Francer. Yes.
Mr. Gaugh. Yes.
Mr. Murphy. Mr. Coukell?
Mr. Coukell. Yes, but of course they have to know that that
facility is out there.
Mr. Murphy. OK.
Dr. Miller?
Mr. Miller. Yes. And it already has that authority under
704(a).
Mr. Murphy. Thank you.
Mr. Catizone. Yes.
Mr. Murphy. OK.
So when we had our hearing before, I could not get an
answer from Dr. Hamburg on that, because what it appeared was
that they had, like, a 1-year moratorium against doing
inspections without cause, it was said, that had made the
medication that infected so many with meningitis.
And I asked several times, six or seven times, about this,
and her responses were--I said, ``For example, in terms of
dealing with the definition of a compounding pharmacy, who is
responsible for that?'' She said, ``Well, it is not the FDA, it
is Congress.'' I said, ``But who keeps that definition?'' She
said, ``Our chief counsel.'' ``So have you reviewed this
definition with your chief counsel?'' She said, ``I think
everyone agrees.'' And I said, ``I didn't ask you if you
agree.'' She said, ``The law is clear.'' And I said, ``I want
to know, have you reviewed with someone the definition of
'compounding' versus 'drug manufacturing'? Have you reviewed
that with someone? When did that take place?'' She said, ``You
know, we have had a lot of discussions.'' I frustratingly said,
``So has someone reviewed with you the definition of
'manufacturer' versus 'compounding'?'' She says, ``You know,
that is unfortunate. It is not clear.''
It went on. I said, ``Well, wait a minute. If you are
telling me you don't have the authority to inspect based upon
whether or not someone is a compounder versus a manufacturer,
someone must be advising the FDA on where you have jurisdiction
and where you do not.'' At that point, she said it was too
complex and we couldn't understand.
Now, all of you answered that question pretty
straightforward. You thought that there was authority with
regard to this. But this is a key part of this issue and one
that I want to find out. I mean, clearly, if we need more
jurisdiction, we need to review that, in terms of the safety of
patients and make sure people understand what is to be done
here. But the way you all responded to me, it sounds like it
already is there.
So I am going to go into a little more detail with this. Do
you all believe, yes or no, is there a clear definition of
``manufacturing'' that defines when the FDA can come in and
not?
Dr. Hoey?
Mr. Hoey. Yes, there is a clear definition of
``manufacturing.'' And the FDA, as my colleague from PhRMA
mentioned, the FDA does a good job of monitoring CGMP, and they
do a good job of regulating manufacturers.
Mr. Murphy. Dr. Thompson?
Mr. Thompson. I think there is, yes. But these large-scale
entities aren't behaving like manufacturers that have an NDA or
an ANDA.
Mr. Murphy. When you say a large-scale entity, meaning
what?
Mr. Thompson. Well, like the compounding-manufacturer-type
entities. I mean, they are really big compounding pharmacies.
They are registered as pharmacies in all 50 States. There are
nonresident license agreements.
Mr. Murphy. OK, so this is not a mom-and-pop. This is
someone who makes a lot of----
Mr. Thompson. Yes, but they are essentially compounding at
a very----
Mr. Murphy. On a large scale.
Mr. Thompson [continuing]. Large scale. They are not,
often, commercially available products, unless there is a
shortage, that are customized dosage forms. They are just
doing----
Mr. Murphy. I see. And the FDA has the authority to go into
those?
Mr. Thompson. I think they fall under the jurisdiction of
the State boards under the current construct. And I think that
is concerning for us, because these look more like
manufacturing entities, but they are not. And I don't think the
State boards have the capability to regulate them.
Mr. Murphy. Mr. Francer?
Mr. Francer. Congressman, I believe the FDA knows
manufacturing when the agency sees it and that, as a matter of
patient safety, they should be using their authority to the
maximum extent possible.
Mr. Murphy. Dr. Gaugh?
Mr. Gaugh. Yes. Once identified, I think they have the
authority to step in.
Mr. Murphy. Mr. Coukell?
Mr. Coukell. I think the authority to investigate after a
problem has been identified is not the same as having the
authority and the tools to proactively ensure quality. And that
is what we are missing.
Mr. Murphy. Yes, what we found in this case with NECC is
that they complaints from everybody--patients, doctors,
whistleblowers--who were all saying, there is a problem here,
and the FDA didn't act. So that is a question, and I still
think that is one of my concerns with this whole issue. Is it
that we need a bill or do we need an FDA that takes action
within that?
Dr. Miller?
Mr. Miller. I am going to answer backwards.
Mr. Murphy. Yes.
Mr. Miller. Yes, we believe they have adequate authority
and a definition.
However, the approach and the answers that you received
from Commissioner Hamburg implies that any one of us could go
into our garage, start an illegal drug company, put that
medication out into the marketplace, and the FDA would not be
able to shut me down? If that is indeed the case and that is
the confusion, when we address this legislation, we have to
make it very clear that illegal, inappropriate manufacturing
falls under the jurisdictional authority of the FDA.
Mr. Murphy. Thank you.
Mr. Catizone. There is not a clear definition.
Mr. Murphy. I see my time is up, and I am still seeking an
answer.
Thank you very much.
Mr. Pitts. The chair thanks the gentleman.
That concludes the questions from the Members who are here.
We will have follow-up questions. I am sure other Members will
have questions. We ask that you please respond promptly when we
submit them to you.
I will remind Members that they have 10 business days to
submit questions for the record. And so Members should submit
their questions by the close of business on Tuesday, July 30th.
Superb hearing. Excellent testimony. Thank you all so much
for coming.
Without objection, the subcommittee is adjourned.
[Whereupon, at 5:45 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
Prepared statement of Hon. Fred Upton
This legislative hearing is the product of the thorough,
thoughtful, and bipartisan investigation that the committee
launched in the wake of last fall's tragic meningitis outbreak.
We were deliberate in our efforts as we wanted to know what
went wrong and why before the committee acted legislatively.
Sadly, Michigan has been hit hardest by the outbreak--according
to CDC data last updated July 1, 2013, 264 of the 749 illnesses
caused by the outbreak were in Michigan and we have endured 17
of the 61 fatalities, including three from my own district.
During our committee's investigation, under the leadership
of Oversight and Investigations Subcommittee Chairman Tim
Murphy, we found that the meningitis outbreak and the loss of
innocent lives could have been prevented. The New England
Compounding Center was operating in an unacceptable and
unlawful manner for years. Yet, it took this outbreak and its
tragic consequences for the Food and Drug Administration (FDA)
to act. Although the facts demonstrate that the FDA had the
authority to regulate the bad actors who harmed patients with
unsafe products, we believe that clarifying FDA's regulatory
authority in this area through legislation is a prudent step
toward improving the safety of all Americans.
In May, this subcommittee held a hearing on the drug
compounding industry to understand its evolution and the
current role it plays in our health care system. We learned
that compounding is an integral part of our health care system
that helps patients receive the treatments necessary for their
unique medical needs. As we look to legislate in this area, we
want to ensure that patients can continue to receive compounded
drugs that are safe. I believe that everyone here today shares
that goal.
We also want to ensure that bad actors can no longer use
the good name of pharmacies to hide activity that is
essentially large-scale drug manufacturing. The FDA gold
standard for approval should give patients the assurance that
the drugs they use are safe and effective. Activities akin to
large-scale manufacturing must be regulated as such in order to
uphold the integrity of our nation's drug supply.
Our hearing today is a result of thorough and collaborative
investigative and policy work. While all of the bills before us
today include ideas that we should consider carefully, I would
like to thank Morgan Griffith for his dedication and leadership
throughout both the committee's investigative and legislative
process. The Griffith discussion draft before us today includes
key provisions that serve the important goals of clarifying
FDA's authority and protecting the role of traditional
compounding. As we continue to work in a bipartisan manner, it
is my belief that we will find common ground to advance
legislation that achieves these goals.
Thank you, Mr. Chairman. I yield my remaining time to ----
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