[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
EXAMINING THE IMPLEMENTATION OF THE TOBACCO CONTROL ACT
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
__________
APRIL 8, 2014
__________
Serial No. 113-139
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 FRANK PALLONE, Jr., New Jersey
JOHN SHIMKUS, Illinois BOBBY L. RUSH, Illinois
JOSEPH R. PITTS, Pennsylvania ANNA G. ESHOO, California
GREG WALDEN, Oregon ELIOT L. ENGEL, New York
LEE TERRY, Nebraska GENE GREEN, Texas
MIKE ROGERS, Michigan DIANA DeGETTE, Colorado
TIM MURPHY, Pennsylvania LOIS CAPPS, California
MICHAEL C. BURGESS, Texas MICHAEL F. DOYLE, Pennsylvania
MARSHA BLACKBURN, Tennessee JANICE D. SCHAKOWSKY, Illinois
Vice Chairman JIM MATHESON, Utah
PHIL GINGREY, Georgia G.K. BUTTERFIELD, North Carolina
STEVE SCALISE, Louisiana JOHN BARROW, Georgia
ROBERT E. LATTA, Ohio DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington DONNA M. CHRISTENSEN, Virgin
GREGG HARPER, Mississippi Islands
LEONARD LANCE, New Jersey KATHY CASTOR, Florida
BILL CASSIDY, Louisiana JOHN P. SARBANES, Maryland
BRETT GUTHRIE, Kentucky JERRY McNERNEY, California
PETE OLSON, Texas BRUCE L. BRALEY, Iowa
DAVID B. McKINLEY, West Virginia PETER WELCH, Vermont
CORY GARDNER, Colorado BEN RAY LUJAN, New Mexico
MIKE POMPEO, Kansas PAUL TONKO, New York
ADAM KINZINGER, Illinois JOHN A. YARMUTH, Kentucky
H. MORGAN GRIFFITH, Virginia
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Ohio
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)
(ii)
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........................................... 2
Hon. Brett Guthrie, a Representative in Congress from the
Commonwealth of Kentucky, opening statement.................... 2
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 3
Hon. Eliot L. Engel, a Representative in Congress from the State
of New York, opening statement................................. 5
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, opening statement.................................... 5
Prepared statement........................................... 6
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 6
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 8
Hon. Kathy Castor, a Representative in Congress from the State of
Florida, prepared statement.................................... 53
Witnesses
Marcia Crosse, Director, Health Care, Government Accountability
Office......................................................... 9
Prepared statement........................................... 12
Answers to submitted questions............................... 59
Submitted Material
H.R. 389, the Transparency in Tobacco User Fees Act of 2013,
submitted by Mr. Pitts......................................... 55
EXAMINING THE IMPLEMENTATION OF THE TOBACCO CONTROL ACT
----------
TUESDAY, APRIL 8, 2014
House of Representatives,
Subcommittee on Energy and Commerce,
Committee on Health,
Washington, DC.
The subcommittee met, pursuant to call, at 10:17 a.m., in
room 2322 of the Rayburn House Office Building, Hon. Joe Pitts
(chairman of the subcommittee) presiding.
Members present: Representatives Pitts, Burgess, Shimkus,
Murphy, Lance, Cassidy, Guthrie, Griffith, Bilirakis, Ellmers,
Upton (ex officio), Pallone, Engel, Capps, Green, Barrow,
Christensen, Castor, and Waxman (ex officio).
Staff present: Gary Andres, Staff Director; Noelle
Clemente, Press Secretary; Paul Edattel, Professional Staff
Member, Health; Sydne Harwick, Legislative Clerk; Carly
McWilliams, Professional Staff Member, Health; Charlotte
Savercool, Legislative Coordinator; Heidi Stirrup, Policy
Coordinator, Health; John Stone, Counsel, Health; Ziky Ababiya,
Democratic Staff Assistant; Karen Lightfoot, Democratic
Communications Director and Senior Policy Advisor; Karen
Nelson, Democratic Deputy Staff Director, Health; Anne Morris
Reid, Democratic Senior Professional Staff Member; and Matt
Siegler, Democratic Counsel.
Mr. Pitts. The subcommittee will come to order. Chair will
recognize himself for an opening statement.
OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
The Tobacco Control Act, TCA, was signed into the law on
June 22, 2009. The TCA established the Center for Tobacco
Products, the CTP, within FDA, and gave FDA authority over the
regulation of tobacco products, including restricting their
sale, distribution, advertising and promotion. In addition, FDA
has the authority to require changes in the design and
characteristics of current and future tobacco products, such as
the reduction or elimination of harmful ingredients and
additives. The sole funding source for CTP is user fees
assessed on tobacco manufacturers and importers.
GAO has conducted a comprehensive study on the law's
implementation, and in September 2013, it released a report
entitled ``New Tobacco Products: FDA Needs to Set Time Frames
for Its Review Process.'' The report examines CTP's review of
new tobacco product submissions, responses to meeting requests,
and use of its user fees. Among its findings, GAO reports that
CTP lacks basic performance measures ``like time frames for
reviews of submissions'' and that this ``limits CTP's ability
to evaluate policies, procedures and staffing resources in
relation to CTP's submission review process, and in turn limits
CTP's ability to reasonably assure efficient operations and
effective results.''
GAO concludes that ``an entity that is limited in its
ability to evaluate its performance will be hard-pressed to
determine what adjustments it should make to its operations, or
how to plan for the future.'' This report raises troubling
concerns about CTP's performance, and its ability to
effectively implement the Tobacco Control Act, and respond to
the thousands of new product submissions it has received in a
timely manner.
As the subcommittee with oversight of FDA and the Center
for Tobacco Products, we were hoping to hear directly from the
FDA, however, Dr. Marcia Crosse of GAO is here today to walk us
through the report and GAO's ongoing efforts to oversee
implementation of the act.
[The prepared statement of Mr. Pitts follows:]
Prepared statement of Hon. Joseph R. Pitts
The Tobacco Control Act (TCA) was signed into law on June
22, 2009.
The TCA established the Center for Tobacco Products (CTP)
within FDA and gave FDA authority over the regulation of
tobacco products, including restricting their sale,
distribution, advertising, and promotion. In addition, FDA has
the authority to require changes in the design and
characteristics of current and future tobacco products, such as
the reduction or elimination of harmful ingredients and
additives.
The sole funding source for CTP is user fees assessed on
tobacco manufacturers and importers.
GAO has conducted a comprehensive study on the law's
implementation, and, in September 2013, it released a report
entitled ``New Tobacco Products: FDA Needs to Set Time Frames
for Its Review Process.''
The report examines CTP's review of new tobacco product
submissions, responses to meeting requests, and use of its user
fees.
Among its findings, GAO reports that CTP lacks basic
performance measures ``like time frames for reviews of. . .
submissions'' and that this ``limit[s] CTP's ability to
evaluate policies, procedures, and staffing resources in
relation to CTP's submission review process and, in turn,
limit[s] CTP's ability to reasonably assure efficient
operations and effective results.''
GAO concludes that ``[a]n entity that is limited in its
ability to evaluate its performance will be hard-pressed to
determine what adjustments it should make to its operations or
how to plan for the future.''
This report raises troubling concerns about CTP's
performance and its ability to effectively implement the
Tobacco Control Act and respond to the thousands of new product
submissions it has received in a timely manner.
As the subcommittee with oversight of FDA and the Center
for Tobacco Products, Dr. Marcia Crosse of GAO is here today to
walk us through the report and GAO's ongoing efforts to oversee
implementation of the act.
Thank you.
Mr. Pitts. Yield the balance of my time to the gentleman
from Kentucky, Mr. Guthrie.
OPENING STATEMENT OF HON. BRETT GUTHRIE, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF KENTUCKY
Mr. Guthrie. Thank you, Mr. Chairman. Thank you for
yielding and holding this hearing today.
Congress granted the Center for Tobacco Products the
authority to regulate tobacco products, but unfortunately, the
process has been fraught with problems. I have heard from many
in the industry, including constituents, who have been stuck in
the dysfunctional CTP approval process.
As a result of CTP's inaction, many reduced risk or harm
reduction products are not being approved and are not available
to consumers. There are examples of ingredients that could be
potentially hazardous, and are removed from products sold in
other international markets, but because of the burdensome
process at the FDA, and the unlikelihood that their submission
would even be reviewed, they have to leave the ingredient in
their products sold in the U.S. So consumers overseas are
offered a potentially less harmful product than American
consumers have access to.
There are a number of examples like this, very minor tweaks
that require substantial equivalence or SE submissions, and
they just sit at CTP waiting approval. For March 2011 until
June 2013, CTP did not rule on one single filing, and at that
point, they ruled on six of nearly 4,000 submissions. To date,
I believe they have made only 12 determinations. It appears
that CTP is just not doing their job.
I have a bill, House Resolution 389, that would exercise
oversight over CTP, and require they submit a report to
Congress on their activity. It is a good-government,
commonsense approach to ensure that this agency of government
works, and is accountable to Congress and the committee that is
vested with its authority.
Tobacco user fees are not subject to reauthorization, so
there is little opportunity for the industry to enter into
discussions with FDA the way pharmaceutical companies or device
manufacturers can. As the oversight body, I believe we should
be able to see how these funds are being used, the number of
applications being reviewed or still pending, and get a clear
picture of the division's work.
Mr. Chairman, my--by its inaction, CTP is blocking
consumers from having access to less harmful products, with the
little sign of improvement, I encourage my colleagues to
support my bill, which would ensure we receive a clear picture
of CTP's activities moving forward.
I yield back.
Mr. Pitts. Chair thanks the gentleman.
Now recognizes the ranking member of the subcommittee, Mr.
Pallone, 5 minutes for an opening statement.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Mr. Chairman, and thank you for
calling today's important hearing on the implementation of the
Tobacco Control Act.
This year marks 5 years since the Tobacco Control Act
became law, which, for the first time, provided FDA the
authority to regulate tobacco products.
The Center for Tobacco Products was given an enormous but
critically overdue task to protect the public health from the
dangers of tobacco use, and many members of this committee,
including myself, led by Mr. Waxman, were proud to work on this
groundbreaking law.
We have known for 50 years about the terrible health
effects of smoking. Tobacco companies initiated and sustained
the Nation's tobacco epidemic, and for decades deliberately
misled the public about the risks of smoking. Meanwhile, new
findings in the latest Surgeon General's report indicated
cigarettes are even more hazardous and addictive than they
previously were known. Each year, 480,000 Americans die from
smoking-related causes, and smoking costs the country over $289
billion in health bills and lost productivity.
So I think we can all agree that the Center for Tobacco
Products has a lofty task moving forward, but I wanted to
highlight a few of the important benefits FDA has begun to
execute.
They have restricted the sale of and marketing of tobacco
products to children, they have set standards for companies who
make claims about the harms on their products, they have
implemented a new science-based public health standard for the
review of tobacco products, and they have begun to review these
new product applications. Of course, there is a lot more work
to be done. There are a number of regulatory actions that I
believe still need to occur to protect the public from the
dangers of other tobacco products, and this includes banning
candy-flavored cigars that appeal to our youth, and ending e-
cigarette marketing practices that target kids. We should also
raise taxes on all tobacco products, and close loopholes that
let tobacco companies avoid Federal taxes. In addition, I
believe we must remove barriers to quitting tobacco use by
making certain that tobacco cessation coverage is available to
all Americans through the Affordable Care Act.
Mr. Chairman, I hope this will be the first in a number of
oversight hearings on the tobacco law. For the past few years,
my colleagues and I have asked for tobacco hearings. In fact,
the most recent request would have examined the recent alarming
trends in the currently unregulated tobacco products like e-
cigarettes. Just last week, we learned that about--some data
came forward that reports of poisonings caused by accidental
ingestion of e-liquids, and that is the liquid containing
nicotine used to refill e-cigarette cartridges. That--the
incidents tripled from 2012 to 2013. And while I appreciate the
views of GAO and look forward to Ms. Crosse's testimony and
comments, today's hearing should have included the FDA. It is
important that we offer our administration some courteousness.
That includes allowing for sufficient time in scheduling
hearings. So I hope you will ensure that the Director of the
Center for Tobacco Products and the FDA have a legitimate
ability to update members on FDA's regulatory efforts.
I would like to yield the balance my time to the gentleman
from New York, Mr. Engel, if he would like to use it.
OPENING STATEMENT OF HON. ELIOT L. ENGEL, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF NEW YORK
Mr. Engel. Well, I thank my friend for yielding to me, and
I want to thank both the ranking member and the chairman for
holding this hearing.
I want to echo the comments of Ranking Member Pallone, and
then I also wish that this hearing could have been scheduled at
a time that would have allowed the FDA to participate. The
implementation of a Family Smoking Prevention and Tobacco
Control Act is critically important, and I think members of
this committee would have benefitted from hearing the FDA's
perspective.
That being said, however, I do appreciate the willingness
of GAO to come here today to testify about their oversight
efforts on the law.
My district includes parts of the Bronx, where over 100,000
people have asthma. I live in that borough. This borough has
some of the highest rates of asthma-related emergency room
visits in all of New York. This reality is due in no small part
to the prevalence of smoking and secondhand smoke exposure.
Just Friday, a report by New York State Comptroller, Thomas
DiNapoli, found that asthma-related medical expenses and lost
productivity are costing my State an estimated $1.3 billion a
year. Eliminating the use of tobacco products amongst children
and youth can play an important role in reducing these asthma-
related costs.
So I am pleased that we are holding hearings on this today,
and I look forward to the testimony.
And I yield back.
Mr. Pitts. The Chair thanks the gentleman.
Now recognizes the chairman of the full committee, Mr.
Upton, 5 minutes for an opening statement.
OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Upton. Well, thank you, Mr. Chairman.
You know, it has been 5 years since the Family Smoking
Prevention Tobacco Control Act was signed into law. We have a
collective responsibility as the FDA's authorizing committee to
ensure the Agency is implementing the law, and all laws, in a
fair, consistent and transparent manner. FDA's decision should
always be based on sound scientific evidence, with the health
of our Nation's citizens in mind.
The GAO has done a thorough job overseeing the
implementation efforts conducted by the Center for Tobacco
Products to date, and their work continues.
I want to thank Dr. Marcia Crosse from the outset for her
hard work on this front, and for her responsiveness to the
committee staff.
GAO has raised a number of concerning issues about the
efficiency and consistency of CTP's regulatory activities to
date. For instance, they issued a report in September of last
year noting that the center had yet to set any performance
measures or reviewed timelines to ensure accountability and
gauge progress. I am a firm believer that transparency does
breed accountability. Congressman Guthrie, as he noted, did
introduce The Transparency in Tobacco User Fees Act, H.R. 389,
which is a commonsense piece of legislation that would require
the FDA to submit annual reports to Congress on how those user
fees have been spent. FDA has such a statutory requirement for
user fee programs, such as PDUFA, and the insight gained from
such reports has led to improvements across the board.
And again, I welcome our witnesses.
[The prepared statement of Mr. Upton follows:]
Prepared statement of Hon. Fred Upton
It has been almost 5 years since the Family Smoking
Prevention and Tobacco Control Act was signed into law. We have
a collective responsibility as the FDA's authorizing committee
to ensure the agency is implementing this law- and all laws-in
a fair, consistent and transparent manner. FDA's decisions
should always be based on sound, scientific evidence with the
health of our Nation's citizens in mind.
The Government Accountability Office has done a thorough
job overseeing the implementation efforts conducted by the
Center for Tobacco Products (CTP) to date, and their work
continues. I would like to thank Dr. Marcia Crosse from the
outset for her hard work on this front and for her
responsiveness to committee staff.
GAO has raised a number of concerning issues about the
efficiency and consistency of CTP's regulatory activities to
date. For instance, they issued a report in September 2013,
noting that the center had yet to set any performance measures
or review timelines to ensure accountability and gauge
progress.
I am a firm believer that transparency breeds
accountability. Congressman Guthrie has introduced the
Transparency in Tobacco User Fees Act, H.R. 389, which is a
commonsense piece of legislation that would require FDA to
submit annual reports to Congress on how the user fees have
been spent. FDA has such a statutory requirement for user fee
programs such as PDUFA, and the insight gained from such
reports has led to improvements across the board.
I welcome the opportunity to examine these issues in
greater detail with today's hearing.
Mr. Upton. I yield the balance of my time to the vice chair
of the Health Subcommittee, Dr. Burgess.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. I thank the chairman for yielding.
The Chairman is correct; this subcommittee has an
obligation as the principle authorizing committee that allowed
the Center for Tobacco Products to be created in the first
place, we have a responsibility for its oversight. The fact of
the matter is, they have been up and running for 5 years, and
this is the first hearing and they are not here.
We need to know how the Agency is implementing the law. We
need to know what taxes are collecting and how they are
allocating the resources. We have asked these questions over
and over again for 5 years.
And here is the bottom line. Somebody already said it:
tobacco--when used as directed, tobacco products cause 580,000
deaths every year.
The Food and Drug Administration is charged with seeing
that medicines and devices are safe and effective. 480,000
deaths every year. You can't call that safe, but it darned sure
is effective.
The fact of the matter is, this Agency never belonged
within the Food and Drug Administration in the first place. I
argued against that when the bill passed 5 years ago. I will
continue to argue against it today, but the fact of the matter
is, they are in the same building, and as long as they are
housed in the same building, it is this committee's obligation
to require an accounting of how are the user fees collected,
how are they spent. My understanding is there is over $1
billion in user fees that have been collected in the 5 years
since this agency was created, and almost half of that remains
unspent.
To put that number in perspective, it is 5 times the amount
of user fees collected from medical device manufacturers, and
we don't have an accurate accounting as to how the money has
been spent and how it will be spent. We know there were
challenges about the graphic labels, and that is tied up in the
courts.
Stakeholders complain of the lack of any regulatory
guidance, despite the fact they were given statutory direction
by this committee.
Here is the bottom line. Since we approved this agency
within an agency, has it improved the health of Americans?
Every statistic tells us it is going in the wrong direction.
So this morning, where is the FDA? They could not find the
time to come here and testify. In fact, this is the third time
this year that they have been asked to come and testify before
this committee. This committee, both sides of the dais,
Republican and Democrat, should be seriously concerned about
the fact that the FDA, the head of the Center for Tobacco
Products, will not come to this committee and testify. They are
always traveling, they are always out of town. Make your other
directors available to us within that same agency. We don't
mind hearing from them. We don't always have to hear from the
same person, but at least make an effort to accommodate the
committee staff when they ask you to be here when we have these
hearings.
Mr. Waxman. The gentleman yield?
Mr. Burgess. I hope the GAO can shine light on these
actions.
Mr. Waxman. I would like the clarification about FDA not
being here, because as I understand it, they were notified last
week, a week. They said they needed more time, so it sounds
like we haven't accommodated them to be here, not that they
haven't accommodated us.
Mr. Burgess. Yes, but this--just reclaim my time, this is
the third time that we have asked Mr. Zeller to come here and
testify, and the third time that he has been traveling for a
speech or participating in another event. So after the FDA
staff informed the committee staff that Mr. Zeller could not
testify on April 7, committee staff informed the FDA that any
or all of the various office heads within the Center for
Tobacco Products could speak and testify to their regulatory
activities. Food and Drug Administration informed the committee
staff that there wasn't enough time to draft and clear formal
testimony by April 7. In response, the committee staff told FDA
that we would not require formal testimony be submitted, an
arrangement that we have previously agreed to in special
circumstances. The Food and Drug Administration decided they
did not want to participate without submitting formal
testimony, but they were open to testifying at some point in
the future. And I think this subcommittee should do everything
it can to ensure that that condition is met.
I yield back.
Mr. Pitts. The Chair now recognizes the ranking member of
the full committee, Mr. Waxman, 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.
I think we are making a big to-do about nothing. The FDA
has been offered a number of dates. We wouldn't accept their
request. I don't think we have accommodated them, and I think
this is a little silly. If we are going to have a hearing, FDA
ought to be here.
But let us look at the big picture. Twenty years ago, this
subcommittee held a famous hearing. Seven tobacco CEO
executives, seven tobacco CEOs testified at that hearing and
denied that cigarettes are harmful, that nicotine is addictive,
that they didn't manipulate nicotine, that they certainly
wouldn't go after kids, and their denials that day galvanized
the antismoking movement.
A lot has happened in the last 20 years. Smoking rates have
dropped, smoke-free laws have become widespread. In 2009,
Congress passed the Family Smoking Prevention Tobacco Control
Act on a bipartisan basis. The tobacco companies are trying to
circumvent this law. The law banned the sale of candy-flavored
cigarettes. So what did the tobacco companies do? They started
selling candy-flavored little cigars. The law restricted
marketing of cigarettes and smokeless tobacco to kids, but
companies are using the same tactics to promote e-cigarettes to
kids.
We have asked repeatedly for hearings in this committee to
examine these outrageous practices, but the committee has
refused to hold any hearings.
Today we are finally holding a hearing on that law that was
passed in 2009, which I authored, but we are focusing on a very
narrow issue. The timelines for reviewing applications
submitted by the tobacco companies, not the public health
issues that American families care about, and FDA is not able
to testify because the committee would not accommodate the
Agency's reasonable request for adequate time to prepare. This
is a missed opportunity.
In the 50 years since the first Surgeon General report on
smoking, we have made tremendous progress in reducing tobacco
use. We have cut adult and youth smoking rates in half or more,
we have prevented millions of premature smoking-related deaths.
Since the enactment of the Tobacco Control Act, FDA has
restricted the sale and marketing of cigarettes and smokeless
tobacco to youths. FDA has set standards for companies that
assert their products reduce harms, and the Agency has
undertaken reviews of new tobacco product applications using a
new public health standard, marking the first time this
industry has been regulated. But our work is far from done.
These are the things we ought to be looking at. More than
480,000 Americans die each year from smoking. Each day,
thousands of children try their first cigarette. Cigarette use
has declined, but we have seen an alarming increase in the use
of candy-flavored little cigars and e-cigarettes by our kids.
That should concern us, but not at today's hearing.
There is a long list of things we need to do. First, FDA
must continue implementation of the Tobacco Control Act, and
take full advantage of its authorities. That is why I and other
members have repeatedly called on FDA to issue deeming
regulations that will stop companies from marketing e-
cigarettes to kids, and using candy-like flavors to entice our
kids to smoke.
Secondly, we must take coverage--we must make coverage of
tobacco cessation more accessible to current smokers through
the Affordable Care Act.
Third, we must raise the taxes on all tobacco products, and
close the loopholes that let companies avoid Federal taxes,
like the lower tax rates for pipe tobacco.
Fourth, we must support effective public health campaigns
and tobacco control programs that discourage smoking.
And fifth, we must encourage other nations to adopt strong
tobacco control measures, and stop the tobacco companies using
trade agreements to challenge these policies.
We are unlikely to tackle these issues during today's
hearing, so I hope this will be the first of a series of
hearings into the tobacco industry's practices, and our
progress on tobacco control.
I appreciate GAO for testifying, and the work they have
done, but it just reminds me that after the series of hearings
that we had in 1994 which changed the tobacco issue forever, we
hadn't had a hearing in this committee for many, many years
after the Republicans took control, until one day we had a
hearing, not on all these health issues, but why we shouldn't
encourage people to use smokeless tobacco as a way to wean off
smoking. Trade one addiction for another. Of course, we never
invited anybody else to come in and testify about the other
public health measures that were in place to encourage people
and help people give up smoking.
So you sometimes wonder, is this committee concerned about
public health or are they concerned about special interests.
And I put that question out there for people to think about.
Yield back my time.
Mr. Pitts. The Chair thanks the gentleman.
That concludes the opening statements. As always, the
written opening statements of all members will be made part of
the record.
We have one panel today, one witness. I will invite our
witness to please come to the witness table and introduce her
at this time, Dr. Marcia Crosse, Director, Health Care, U.S.
Government Accountability Office. Your written testimony will
be made a part of the record, and you will be given 5 minutes
to summarize your testimony.
So at this time, Chair recognizes Dr. Crosse, 5 minutes for
an opening statement.
STATEMENT OF MARCIA CROSSE, DIRECTOR, HEALTH CARE, GOVERNMENT
ACCOUNTABILITY OFFICE
Ms. Crosse. Thank you. Chairman Pitts, Ranking Member
Pallone, and members of the subcommittee, I am pleased to be
here today as you examine implementation of the Family Smoking
Prevention and Tobacco Control Act, enacted almost 5 years ago
in June 2009.
The act represents the first time that FDA has had the
authority to regulate tobacco products. It requires that
tobacco manufacturers submit information to be reviewed by FDA
in order to market certain new tobacco products. FDA reviews
the products using a public health standard, taking into
account the risks and benefits of tobacco products on the
population as a whole, including users and non-users. The act
also established the Center for Tobacco Products, CTP, within
FDA. CTP implements the act by reviewing submissions for
marketing new tobacco products, enforcing prohibitions on the
sale of certain tobacco products, developing and issuing
regulations and guidance, and engaging in public education
about the risks associated with tobacco product use. The act
also authorizes FDA to assess and collect user fees from each
tobacco manufacturer and importer. All of CTP's activities are
funded exclusively through user fees, and unspent user fees may
be carried over from year to year.
My statement today will discuss the extent to which FDA has
spent its tobacco user fees, and the status of CTP's reviews of
new tobacco product submissions.
At the end of fiscal year 2012, just over 3 years after the
Tobacco Control Act was passed, CTP had spent less than half of
the user fees it had collected to that point. The time it took
to award contacts contributed to the center spending less than
it had planned.
In fiscal year 2013, CTP was able to award contracts for a
number of activities, including media campaigns to educate
youth on the dangers of tobacco use. By the end of last year,
CTP had spent over 80 percent of the approximately $1.75
billion in user fees collected by that time.
Turning to product reviews. It has taken FDA a number of
years to begin making decisions on submissions for new tobacco
products. Nearly all of the almost 4,500 submissions received
by CTP were made under the substantial equivalence, or SE,
pathway. Under the SE pathway, CTP determines whether the
product has the same characteristics as a predicate tobacco
product, or has different characteristics that do not raise
different questions of public health. About 80 percent of the
SE submissions FDA received were provisional SE submissions.
This means they were received by FDA prior to a statutory
deadline in March 2011, allowing the product to be marketed
unless CTP finds that they are not substantially equivalent. SE
submissions received after that deadline are called regular SE
submissions, and these products cannot be marketed until CTP
determines that they are substantially equivalent to predicate
products.
CTP made its first decisions on SE submissions in June
2013, and, as of December 31, 2013, CTP has made a final
decision on a total of 30 of the 4,490 SE submissions it had
received. All 30 final decisions, that is, substantially
equivalent or not substantially equivalent, were for regular SE
submissions.
In February 2014, CTP made its first decisions on
provisional SE submissions, finding products in 4 submissions
to be not substantially equivalent to predicate products, and
issued orders to stop the further sale and distribution of
these 4 products. CTP officials and manufacturers told us that
several factors increased the time it took CTP to review SE
submissions, such as CTP requests for additional information
from manufacturers, and having to hire and train staff.
However, we found that CTP has not had performance measures
that include time frames for making final decisions on SE
submissions. We reported last year that the lack of such
performance measures limits CTP's ability to reasonably assure
efficient operations and effective results. We recommended that
FDA establish such performance measures, and the Agency agreed
with our recommendation.
As of last week, FDA officials said that they expect to
identify performance measures that include time frames for some
types of submissions in spring 2014, and to implement the
measures by October 2014. However, the Agency has not
determined when it will establish performance measures for the
largest part of its backlog of submissions, the provisional SE
submissions for products that are currently on the market.
In addition, although FDA has increased its staff and
training for staff, tobacco industry stakeholders express
concerns about whether CTP will have a sufficient number of
qualified staff to review the current backlog, and also review
new submissions that may be made in the future, particularly if
FDA asserts jurisdiction over new types of tobacco products.
In summary, in the past year, FDA has taken a number of
steps, such as media campaigns and conducting product reviews,
that have begun to result in actions and final decisions.
However, there are many remaining challenges for the Agency,
particularly if it expands the scope of its authority to
include additional types of tobacco products.
Mr. Chairman, this completes my prepared statement. I would
be happy to respond to any questions that you or members of the
subcommittee may have.
[The prepared statement of Ms. Crosse follows:]
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Mr. Pitts. The Chair thanks the gentlelady.
I will begin the questioning. Recognize myself 5 minutes
for that purpose.
Dr. Crosse, GAO's September 2013 report recommended that
FDA establish performance measures that include time frames for
making decisions, and that the Agency monitor performance
relative to these time frames. What actions, if any, has FDA
taken in response to these recommendations?
Ms. Crosse. They agreed with the recommendations, and they
have told us that this spring, they will establish time frames
for 2 types of submissions, for the regular SE submissions and
for the exemption from SE submissions, but that is a subset of
the larger pool. They have not yet determined when they are
going to establish time frames for the larger portion of their
backlog, and that is the earlier submissions that were made
prior to the March 2011 deadline.
Mr. Pitts. These seem like general, good government
practices that FDA should have already implemented, without GAO
having to make such a recommendation. Are there not time frames
for review in the Tobacco Control Act?
Ms. Crosse. The Tobacco Control Act only established time
frames for review for one type of application, and that type of
application is one that requires more information to be
provided. It is one where there is no predicate product on the
market, and the act established a 180 day time frame for
decisions on those applications. It did not establish time
frames for the substantial equivalence submission, which have
made up the vast majority of submissions that FDA has received.
Mr. Pitts. How does FDA prioritize reviews of the
substantial equivalence submissions?
Ms. Crosse. Right now, the officials have told us that they
are prioritizing the regular SE submissions, and those are for
products that are not yet on the market, for products that need
approval by FDA before those products can be marketed. So they
are prioritizing ones for products that are not on the market.
Among the provisional SE submissions, they have divided those
submissions into 4 groups, 4 tiers, that they have assigned
risk levels to, and they are prioritizing those that they
believe pose the highest risk.
Mr. Pitts. Now, is it true that some of these submissions
are for products that actually have reduced levels of harmful
ingredients, and if so, would there be a way for FDA to
prioritize these types of submissions?
Ms. Crosse. It is possible, but there is another pathway,
the modified risk tobacco product submissions. FDA has received
only 7 submissions of that type, and that is where the
manufacturer is making a claim that it actually reduces the
risk, and none of those have had sufficient information for FDA
to proceed. So all of those submissions are at a halt at this
point, and withdrawn by the manufacturer.
The products that have come in through the regular SE
pathways are not making claims that they reduce the risk to
public health, although it is possible that they could.
Mr. Pitts. We have heard that one factor affecting the long
time frames for FDA review is the fact that it took them a
while to get the Center for Tobacco Products up and running.
They have had now 5 years. Have they gotten any faster over
time?
Ms. Crosse. They have gotten somewhat faster in the initial
steps that they go through in determining their jurisdiction,
and in determining the completeness of the application,
particularly for the regular submissions, they now feel that
they are at a point where they can establish some time frames
for those reviews. They haven't made enough decisions on the
provisional SE submissions for us to determine whether or not
they are getting any faster. There have only been just 4
decisions, all for a single type of product, from a single
manufacturer.
Mr. Pitts. All right, thank you.
The Chair recognizes the ranking member, Mr. Pallone, 5
minutes for questions.
Mr. Pallone. Thank you, Mr. Chairman.
Dr. Crosse, in April 2011, FDA indicated that it would
issue regulations asserting jurisdiction over additional
tobacco products like e-cigarettes, little cigars and pipe
tobacco, and as you testified in October, FDA submitted a
proposed deeming rule to OMB, but the rule has not yet been
issued by FDA.
Over the past few years, we have seen dramatic increases in
the use of e-cigarettes and flavored little cigars among youth,
and there is also evidence that manufacturer activity targeting
youth has driven this growth in alternative tobacco products,
and that FDA, in action, made it easier for manufacturers to do
so.
So I would like to find out more about FDA's proposed
regulations and the public health costs of delay. And my first
question, I have a lot, is last week, the Centers for Disease
Control and Prevention at CD--or Prevention--I am sorry. The
Centers for Disease Control and Prevention, or the CDC,
reported that the number of calls to poison centers involving
e-cigarette liquids rose from 1 per month in September 2010, to
215 per month as of February of this year.
Did you see this CDC report, and if so, what were your
impressions?
Ms. Crosse. Yes, I did see the CDC report, and I think it
is concerning because nicotine, in a liquid form like that, can
be a potent poison. With the growth of e-cigarettes, there are
more liquids being distributed, as I understand it, for refill
purposes, both to businesses and in some quantities for
purchase by individuals. And as with any poison, it is a
concern if children can have access to that.
Mr. Pallone. Well, in fact, members of this committee have
repeatedly written to FDA raising the alarm about the various
risks that e-cigarettes pose to children and adolescents. We
pointed out that e-cigarette makers are producing products with
kid-friendly flavors such as cookies and cream milkshake, and
we have called on FDA to issue deeming regulations to bring an
end to manufacturers targeting our youth through aggressive ad
campaigns, as well as event sponsorships and other tactics once
used by cigarette manufacturers.
So, Dr. Crosse, last September CDC reported that between
2011 and '12, the percentage of high school students who had
used e-cigarettes more than doubled. Are you aware of these
findings?
Ms. Crosse. I have seen the CDC statistics, yes.
Mr. Pallone. And are you also aware that CDC's Director,
Dr. Tom Frieden, and other experts, have raised concerns that
e-cigarettes could be a gateway product to conventional
cigarette and other tobacco products use?
Ms. Crosse. Yes, I have seen that statement.
Mr. Pallone. The importance of FDA issuing deeming
regulations extends beyond e-cigarettes. Flavored cigars, for
example, are also currently unregulated. In October, CDC
reported that sales of little cigars have skyrocketed over the
past decade, and more than 40 percent of middle and high school
students who smoke were reportedly using these flavored
products.
Dr. Crosse, I would like to ask you a series of questions
regarding FDA's ability to take specific actions if the Agency
asserts jurisdiction over e-cigarettes and flavored little
cigars.
First, could the Agency prohibit the sales of these
products to minors, and require age verification prior to
purchase?
Ms. Crosse. It is my understanding that they have that
authority.
Mr. Pallone. Could the Agency prohibit brand name
sponsorships of events that are widely attended by youth?
Ms. Crosse. Yes, I believe that they could extend that
current prohibition to new products that were deemed under
their control.
Mr. Pallone. Could FDA prohibit the use of characterizing
flavors that are attractive to kids?
Ms. Crosse. Yes, I believe that they have the authority.
Mr. Pallone. And finally, could FDA take steps to inform
the public about the harms of ingesting, inhaling or absorbing
e-cigarette nicotine cartridges through the skin or eyes?
Ms. Crosse. Yes, they have authority to conduct public
education campaigns.
Mr. Pallone. I just think it is crucial that FDA acts
quickly to deem additional tobacco products. In the absence of
regulation, manufacturers take advantage of regulatory
loopholes to target impressionable children and teens. The
recent Surgeon General's report reiterated what we have known
for a long time, that exposure to nicotine in youth increases
the risk of lifelong tobacco product use.
So do you have any insight into why release of the deeming
rule has been delayed?
Ms. Crosse. I don't have any information on that. FDA has
announced that its deeming regulation will include a number of
tobacco products that it does not currently regulate. I do not
know what the delays are for this deeming rule.
Mr. Pallone. I mean if, you know, obviously, Mr. Chairman,
if at any point Dr. Crosse could get us more information about,
you know, the delay or when this is going to come out, we would
appreciate you providing the committee with that and, you know,
and any written followup. If I could ask through the chairman.
Ms. Crosse. Yes. I have no information beyond the
Commissioner's statement last week at the Appropriations
hearing that it would be very soon.
Mr. Pallone. OK. So let me just say that evidence from GAO,
CDC, this committee and others has demonstrated that the use of
e-cigarettes, little cigars and other unregulated products has
increased dramatically, and this is due on part to inaction on
the deeming rule. So I just have to emphasize, Mr. Chairman,
that FDA has to act quickly to assert jurisdiction over all
these tobacco products.
Thank you.
Mr. Pitts. The Chair thanks the gentleman.
Now recognizes the gentleman from Kentucky, Mr. Guthrie, 5
minutes for questions.
Mr. Guthrie. Thank you, Mr. Chairman. And thank you for
coming today. I appreciate that, Dr. Crosse.
Do you have any more data on what the backlog at CTP looks
like, and can you let us know how many of the SE submissions
within the backlog relate to different--product changes, label
changes and name changes? It is not just product changes they
can regulate, it is label and name as well.
Ms. Crosse. I don't have information at the moment on that.
We are conducting further work, and we expect to issue a report
in late June, that was mandated by the Tobacco Control Act,
that actually will have some additional information.
Mr. Guthrie. OK, thanks. And it is my understanding, and
you said, that 99 percent of submissions to the FDA are SEs,
substantial equivalence, which in theory these should be
quicker to review than new products submission, and yet as you
note, it is taking years for them to be reviewed. And FDA has
similar pathways for other products in other FDA agencies. It
takes roughly 5 months to review a 510(k) for medical devices,
6 to 10 for new pharmaceutical drugs coming to market, and the
CTP is taking years for these steps, for these SEs.
Can you discuss the approval times at CTP compared to those
of drug and device centers at FDA, and in your opinion, why
does CTP have such a lag on decision-making when other centers
are able to turnaround products in a better manner?
Ms. Crosse. Well, CTP was starting from scratch, and they
indicated that they had a number of delays because they needed
to hire staff, they needed to develop a process, and they
needed to develop the science around tobacco products because
these products had not been previously regulated. They needed
to gain an understanding of the risks posed by different types
of tobacco products, the constituents within tobacco products,
and what risks might be posed by changes to tobacco products.
Mr. Guthrie. Are they beyond those points now, or are they
still----
Ms. Crosse. They still have a significant amount of
research underway, and, in fact, that has absorbed a lot of the
budget of the Office of Science, which is the office that makes
decisions about substantial equivalence. They say that they are
much further along that process. They clearly are much slower
than the Center for Drugs or the Center for Medical Devices,
although I will note that GAO reported in 1983, on the Center
for Devices that had been established in 1976, and we commented
at that time that they were being very slow to fulfill the
requirements of their authority. So I think----
Mr. Guthrie. But----
Ms. Crosse [continuing]. It is an issue when you are
starting up a center from scratch.
Mr. Guthrie. But there were some subsequent
reauthorizations the product manufacturers and FDA worked
through to try to find a way to work. Do you think that--in
your opinion, do you think that Congress should impose
statutory timelines?
Ms. Crosse. You know, I don't think I have enough
information to speak to that point at this point in time,
because I think they are still feeling their way through it,
and I think we haven't had enough information to base that
decision on. They have a concern--not my concern--their concern
is that when a product is approved through the SE pathway, it
then can become a predicate. And so they don't want to make
mistakes because they want to have an understanding of what the
likely public health impact would be of a new product, because
it then becomes a predicate that a subsequent product can use.
Mr. Guthrie. OK, and then my final question, my legislation
would require the CTP to provide annual reports to Congress,
all it does is outlining how their user fees are being spent,
the number of submissions received, the number of applications
approved or denied, and the number still pending and the number
of modified risk products. That is what this application does--
that is what this legislation I proposed does.
In your opinion, is this information that the CTP has
readily available? I mean if we pass this bill today, would
that information be available for the CTP to provide, or do you
think it would be a burden on the CTP to provide that
information?
Ms. Crosse. No, I believe this is information that they
have readily available. And, in fact, my understanding is that
the appropriators have put report language in to require
something similar.
Mr. Guthrie. Do you think that is helpful information for
Congress to have?
Ms. Crosse. I think it is appropriate for Congress to have
information on the operations of the center. There is already a
required report, but it does not require that those specifics
be included.
Mr. Guthrie. Well, and I thank you for coming. I think
you--all--every time you testify, you always do a good job, and
you do your job well and testify well. I appreciate it very
much.
Ms. Crosse. Thank you.
Mr. Guthrie. Thank you, and I yield back.
Mr. Pitts. The Chair thanks the gentleman.
Now recognize the gentlelady, Dr. Christensen, 5 minutes
for questions.
Mrs. Christensen. Thank you, Mr. Chairman. Good morning,
Dr. Crosse.
Ms. Crosse. Good morning.
Mrs. Christensen. Thank you for your testimony. I remember
when the law was being drafted, and one of the key issues for
the Congressional Black Caucus for many organizations and for
all of the living past HHS Secretaries was a menthol issue, and
I know that FDA was granted broad authority to address menthol
as an additive in cigarettes, ranging from doing nothing, to
reducing the concentration, to removing menthol altogether. And
I appreciate the approach the FDA has taking around the issue
of other flavorings and the sensitivity.
My question to you would be, are you able to provide an
update about where FDA is on the menthol issue, in particular,
what types of studies have been conducted, whether menthol--
have they been able to determine whether menthol exacerbates
directly or indirectly the incidence of lung cancer, et cetera,
and if there are any preliminary results?
Ms. Crosse. I am afraid I don't have that information. That
is specific to menthol.
Mrs. Christensen. OK. Well, my other question goes back to
the fees. Again, we thank you for your testimony on the fees.
My colleagues have commented on user fee carryover, and how the
user fees are being spent, and I want to make sure the record
is clear on a few points.
What portion of FDA's tobacco user fees have been spent as
of December 31, 2013?
Ms. Crosse. They have spent 81 percent of the user fees
they have received through that time.
Mrs. Christensen. Thank you. You mentioned that most of the
user fees were spent by 3 offices at FDA, one of which is the
Office of Health, Communication and Education, and as you
stated today, FDA devoted a portion of its fiscal year 2013
user fees on a public health education campaign. From your
review of FDA's user fee spending, can you tell the
subcommittee whether the Agency's user fee spending is
consistent with the purposes and authorities of the Tobacco
Control Act?
Ms. Crosse. Yes. We did not identify any spending that was
not consistent with their authorities, and the different
provisions of the Tobacco Control Act.
Mrs. Christensen. Thank you. Since the investment in the
Real Cost Campaign has come up this morning, I wanted to take a
moment to comment on the importance of this campaign.
It is an evidenced-based campaign that launched in
February, and will target millions of youth between the ages of
12 and 17 who are already experimenting with cigarettes, that
are open to smoking. So, Mr. Chairman, we know that the vast
majority of current smokers started when they were kids. Every
day in the U.S., more than 3,200 kids smoke their first
cigarettes, and more than 700 youth aged under 18 become daily
smokers. So these statistics underscore the need for targeted
youth tobacco prevention efforts, particularly when you put
this investment in context. The amount FDA spent on the Real
Cost Campaign for the entire year was less than the amount the
tobacco industry spends on marketing and promotional efforts
for a single week.
Well, I have some more time. Yes. So the GAO makes clear
that FDA review of new products must become more efficient and
effective. I am concerned that they are not placing enough
priority on requiring changes to products that are already on
the market to make them less harmful or addictive. The most
recent Surgeon General's report found that cigarettes are more
dangerous today than they were when the first Surgeon General's
report on smoking was issued 50 years ago. Remarkably,
cigarette smokers today have a higher risk for lung cancer than
smokers in 1964, despite smoking fewer cigarettes. The Surgeon
General report also found that some, if not all, of this
increased risk is likely caused by changes in the composition
and design of cigarettes. Fortunately, FDA now has the
authority to set product standards that require changes to
products to make them less harmful or addictive.
Do you know if FDA plans to respond to the alarming
findings in the more recent Surgeon General's report, and if
there are any plans underway for FDA to use its authority to
set product standards?
Ms. Crosse. I am not aware of specific regulatory actions
that FDA may have underway, but they do have a number of
different studies, scientific studies, to try to understand, I
think, the impact and the risks posed by different constituents
in tobacco products.
Mrs. Christensen. Thank you.
And, Mr. Chairman, I yield back the balance of my time.
Thank you.
Mr. Pitts. The Chair thanks the gentlelady.
Now recognizes the gentleman from Pennsylvania, Dr. Murphy,
5 minutes for questions.
Mr. Murphy. Hello, Doctor. Good to have you here today.
Ms. Crosse. Thank you.
Mr. Murphy. You say in your report CTP is limited in its
ability to evaluate policies, procedures and staffing resources
in relation to its substantial equivalence review process, and
in turn is limited in its ability to reasonably assure
efficiency and effectiveness.
So in your conversations with the Agency, did you get a
feel for how the approval process would be affected if FDA
proposes deeming regulations for other products that it doesn't
currently regulate?
Ms. Crosse. Well, certainly, industry expressed concerns to
us that, if the number of products to be regulated is greatly
expanded, that FDA will not have sufficient resources, will not
have sufficient staff to be able to review those applications.
FDA assured us that they believe that the challenges of
initially staffing the office are behind them, and that they
believe they could go through routine processes if they need to
hire or train additional staff, and that additional products
under their regulatory authority would not pose new challenges.
Mr. Murphy. Will that fulfill all the things that they need
to do prior to issuing deeming regulations to make sure the
backlog isn't made worse?
Ms. Crosse. I don't believe that it is required that they
complete those steps prior to issuing deeming regulations. You
know, we think that it is important that they get their
processes under control with routine procedures and time frames
established for staff so that they can better determine how
many staff they need. We think that without having those kinds
of benchmarks in place, it is difficult for them to determine
for themselves whether they have the essential resources, and
whether there are bottlenecks in certain parts of their
process.
Mr. Murphy. OK, thank you. Is it fair to say that reviewing
new tobacco product submissions, and approving or denying them
for entrance into the marketplace, is one of the core functions
to the Center for Tobacco Products under the Tobacco Control
Act?
Ms. Crosse. Yes, it is one of the core functions.
Mr. Murphy. And is it also fair to say that reviewing
substantial equivalence applications is one of the three main
determinations that CTP has in carrying out this core function
of reviewing new tobacco products for marketplace suitability?
Ms. Crosse. That is part of their authority, yes.
Mr. Murphy. You state in your study CTP is ``limited in its
ability to evaluate policies, procedures and staffing resources
in relation to its substantial equivalence review process, and
in turn, is limited in its ability to reasonably assure
efficiency and effectiveness.''
So given your review that CTP is limited in its ability to
reasonably assure efficiency and effectiveness, in this core
function of reviewing SC or premarket applications, do you
believe CTP is presently capable of handling even more
responsibilities and a much greater volume of applications
which would result from the new deeming rule CTP and FDA plan
to propose to dramatically expand its scope of authorities
under the Tobacco Control Act?
Ms. Crosse. You know, I don't think I have sufficient
insight into that, but even if FDA proposes this deeming, I
believe it will be a number of years before such regulations
would go into effect in the normal course of how long it takes
to get a regulation in place, so there may be a number of years
further before any new products would actually begin to be
regulated by FDA. So I can't speak to what may happen in the
future in terms of----
Mr. Murphy. Sure.
Ms. Crosse [continuing]. Them dealing with their backlog.
Mr. Murphy. Well, we want to work you in this, but I am
trying to find out if you have confidence that CTP can at this
time, given its backlog it already has of SE applications,
efficiently and effectively process a whole new onslaught of
applications that would rise from a new deeming rule.
Ms. Crosse. I think were they to arrive today, that would
pose a problem. As I say, I can't predict how soon new product
applications might arrive, and what the status would be of
their backlog at that point in time.
Mr. Murphy. Well, what do you infer from the fact that--I
understand there is zero premarket tobacco product applications
have been submitted. There is no statutory--do you have any
thoughts on that?
Ms. Crosse. Actually, there were--I believe that there were
four that were submitted----
Mr. Murphy. OK.
Ms. Crosse [continuing]. But none were found to have all of
the information that FDA required.
You know, it is a different standard. It is not unlike with
medical devices where there are many more products that go
through the 510(k) process, as opposed to the PMA process.
Here, this is for products where there is no predicate product
that they can point to, so there is not a similar prior product
on the market before February 15, 2007, that they can point to
and say this product is like that, or like an approved product
through the SE process to say that that is a predicate. So, you
know, as more products get approved through the SE----
Mr. Murphy. Um-hum.
Ms. Crosse [continuing]. Process, there may be predicates
available that could continue to allow products----
Mr. Murphy. Well, is it----
Ms. Crosse [continuing]. To go in that pathway. The PMTA
process requires a lot of different information than
manufacturers may have yet developed.
Mr. Murphy. I hope one of the questions you can answer in
writing later on is about a new product review being more
complex than a substantial equivalence review, and help us with
that information.
Thank you very much. I yield back.
Mr. Pitts. The Chair thanks the gentleman.
And now recognizes the vice chairman of the subcommittee,
Dr. Burgess, 5 minutes for questions.
Mr. Burgess. Thank you, Mr. Chairman, and Dr. Crosse,
welcome to our subcommittee again.
Ms. Crosse. Thank you.
Mr. Burgess. I am sorry I had to step out for a moment, but
just tell me if you have already--and I apologize if you have
already addressed this, but what is the average time that a
substantial equivalence has been sitting at the Center for
Tobacco Products?
Ms. Crosse. The bulk of the applications have been sitting
there since March of 2011. They received over 3,000
applications in the first 3 weeks of March 2011, just prior to
the deadline for a provisional SE product, and so that those
products can be marketed until FDA makes a decision. And so the
bulk of the backlog has been sitting there for now more than 3
years.
Mr. Burgess. So you evaluate other agencies that have a
substantial equivalence pathway, do you not?
Ms. Crosse. Yes, well, the medical devices at FDA.
Mr. Burgess. So is this an unusual backlog, given your
experience with other substantial equivalence pathways?
Ms. Crosse. I do think it is an unusual backlog. I think it
was a bit of an unusual circumstance because of the deadline
that resulted in this bolus of applications all in a very short
period of time, rather than a growing steady stream.
Mr. Burgess. OK. Given that, the way the information was
delivered, does it seem to be that they are accommodating at
the Center for Tobacco Products now, accommodating this bolus
that they received?
Ms. Crosse. They have, as of yet, only made four decisions.
So they still have that bolus sitting there. They have made
some progress in sorting through it, but they have not yet
reached decisions.
Mr. Burgess. And the 4 decisions that they have reached,
were those positive or negative decisions?
Ms. Crosse. Those were negative decisions. They ordered
four products off the market.
Mr. Burgess. Can you give the committee--and maybe I should
know this, but can you give the committee an idea of what were
those products?
Ms. Crosse. They were four products that are called bidis,
I believe. They are an Indian type of cigarette, and FDA said
that sufficient information on a predicate had not been
supplied by the manufacturer in order to meet the standard for
a determination of substantial equivalence.
Mr. Burgess. So was that a product that was already on the
shelves prior to the passage of the CTP?
Ms. Crosse. No. If it required a provisional SE
application, it would have been a product that came onto the
market in the United States after February 15, 2007, but before
March 22, 2011. So in that window of time, products that came
onto the market were required to submit these provisional SE
applications.
Mr. Burgess. Well, what is your opinion on why the Center
for Tobacco Products has this lag in their decision-making,
when other centers are able to turn things around in a more
timely fashion?
Ms. Crosse. Well, they did have to staff up from scratch.
They had to develop their procedures. They have taken a lot of
time, they tell us, to try to understand the science of
tobacco, which they did not have sufficient information on
before, and they have now engaged both in contracts with CDC
and with NIH, and with universities, to try to gain a better
understanding of the risks posed by different types of tobacco
products and constituents in tobacco products.
Mr. Burgess. Dr. Crosse, I believe I could help them there.
When used as directed, 480,000 deaths a year. What is there to
the science that they don't understand? It is a dangerous
product.
Ms. Crosse. Well, the standard requires that they determine
whether or not the new product is any more dangerous, poses
different dangers to public health than the existing products,
because the existing products are allowed to continue to be
marketed.
Mr. Burgess. So what if Congress were to establish a
timeline of 90 days for substantial equivalence applications,
and 180 days for new tobacco product applications, would that
be helpful or hurtful?
Ms. Crosse. I don't know whether or not they could meet
that standard at the current time. There may come a point in
time where they have regular procedures and where they do not
have such a backlog, but I don't know if that would help them
or not. I just don't have the information to say.
Mr. Burgess. Well, it can't be a resource or a revenue
issue, correct?
Ms. Crosse. That is correct. They tell us that they now
have over 500 staff, and they believe that that is a fairly
steady state for them, and they have resources, they have not
expended all their user fees.
Mr. Burgess. 500 staff in an agency that didn't even exist
5 years ago, and a surplus of user fees. You know, I just have
to say I am mystified as to why we are having to study this. It
shouldn't even be a problem.
Thank you, Mr. Chairman. I yield back.
Mr. Pitts. The Chair thanks the gentleman.
Now recognize the gentleman from Texas, Mr. Green, 5
minutes for questions.
Mr. Green. Thank you, Mr. Chairman, and the Ranking Member
for having the hearing today, and, Dr. Crosse, for your
testimony.
The 2009 Tobacco Control Act was historic in saving
legislation representing the first time the FDA was granted the
authority to regulate tobacco products, and I hope this is just
the first series of hearings on implementation of the Tobacco
Control Act. And I agree with my Texas colleague that this was
the first new center in the FDA in 20 years. Is that correct?
Ms. Crosse. Yes, actually, and that was when the Center for
Drugs and Biologics was divided into two centers. So, even in
that situation, it was not creating a center from scratch.
Mr. Green. OK. Well, and I guess I am concerned like he is,
we have that number of staff members and yet we are not moving
as quick as we could.
The law is necessary. The next step is addressing tobacco
use, which is is initiated and sustained by the aggressive and
sometimes dubious strategies of the tobacco industry. Its
continued effective implication would allow the FDA to reduce
tobacco product addictiveness and harm, and take other
necessary actions. According to the GAO report, tobacco
product, FDA needs to set time frames for review process. The
FDA Center for Tobacco Products created by the Tobacco Control
Act has gotten off to a slow start, and I want a better
understanding what is the issue.
I understand it is conducting your reviews to the tobacco
products submissions, and the Agency is using a new public
health standard, one that is different than the safe and
effective standard used for medical products. Can you describe
that standard that the FDA must be using in reviewing these
submissions?
Ms. Crosse. Yes. They need to understand whether or not the
product is going to pose any different risks to public health
than currently legal tobacco products, and by that, that means
to the public health in general, both to the users of those
products, but also to non-users, to people who may be exposed
in other ways, either to fumes or in some other way to the
constituents of that product.
Mr. Green. The GAO report focused on the need for the FDA
to establish time frames for making decisions on submissions as
a performance measure to improve the CTP review process. I want
to ask you more about GAO's recommendation. In making its
recommendation, did GAO consider other performance measures
besides established timelines that could be helpful in
reviewing the SE submissions in a more timely manner?
Ms. Crosse. Well, in part, we particularly focused on the
time frames because it was clear that this was taking
substantial amounts of time, and that they had not established
any benchmarks either for individual staff performance or for
the performance of the center as a whole.
We certainly think it is important that they understand
what kinds of guidances are necessary, and what kind of
communications with industry may be helpful, but also what
kinds of information is most important to share with the
public. And it is only in the last year that they have put out
those major contracts for media campaigns to try to address
their responsibility for reducing the use of tobacco products
by youth.
Mr. Green. OK. Mr. Chairman, I appreciate this hearing, and
hopefully, we will have someone from the FDA because they have
come to our hearings pretty often, and to come back and explain
what they are doing 5 years later.
I also want to remind my colleagues that, according to the
GAO, the vast majority of substantial equivalence backlog for
products that can remain on the market while the FDA reviews
their applications, the majority of the substantial equivalence
applications submitted to FDA were incomplete, slowing down the
review process as the Agency had to request additional
information and await responses from tobacco companies.
Last week the FDA announced \1/4\ of the regular
substantial equivalence applications had already been resolved,
and FDA has stated the Agency is ready to initiate review of
any newly submitted applications.
Even as the FDA becomes more efficient in its review
process, it is important to make sure that the new products
coming on the market through the substantial equivalence
pathway are not causing greater harm to the public health. And
I would hope our subcommittee would continue to monitor this to
see just how the Tobacco Control Act is being enforced, because
a lot have supported it and feel like the FDA needs to do their
job.
So I yield back my time.
Mr. Burgess [presiding]. Gentleman yields back.
The Chair recognizes the gentlelady from North Carolina, 5
minutes for questions, please.
Mrs. Ellmers. Thank you, Mr. Chairman, and thank you, Dr.
Crosse, for being with us today on this issue.
I too was hopeful that a representative from the FDA would
be with us. I know it is difficult for you to be able to answer
some of the questions simply based on the study and report that
was put forward, and I know that you can see, and I think you
share with us the questions of why this hasn't moved quicker
than it should. I think you have identified a few things. One,
because they collect the user fees, there is plenty of revenue,
they have got their staff in place. What is left? What is left
to keep them from moving forward in a more timely fashion?
Ms. Crosse. Well, one thing that they have told us that
they continue to try to determine is exactly what information
they may need in applications. Representative Green was correct
in that a number of the initial applications did not contain
information that FDA determined subsequently----
Mrs. Ellmers. Um-hum.
Ms. Crosse [continuing]. That they needed in order to reach
decisions. Now, some of those deadlines required that
applications come in----
Mrs. Ellmers. Um-hum.
Ms. Crosse [continuing]. Prior to FDA putting out guidance
on what was needed. And so there has been a lot of back-and-
forth. At this point in time though, certainly, you know, there
has been sufficient time, I believe, for them to have----
Mrs. Ellmers. That they should have----
Ms. Crosse [continuing]. For them to have identified what
kinds of information they need in an application.
Mrs. Ellmers. So at what point did the FDA put out the
guidance for those application requests?
Ms. Crosse. I don't have a date in my head. I'm sorry. We
can find out----
Mrs. Ellmers. Well, if you can get that----
Ms. Crosse. We can find out----
Mrs. Ellmers [continuing]. I would like to know.
Ms. Crosse. Yes.
Mrs. Ellmers. I want to make sure that there are guidelines
in place, first of all. But there again, I am kind of stumped,
and I realize that much of what we do and the government can be
very bureaucratic and not necessarily move as quickly as the
private marketplace, but as you can see, this is affecting the
private marketplace. I mean, obviously, there are products that
can't move forward and get on the market as a result of this,
and one of the things that I have been thinking about in
relation to this is how does this particular situation with the
Tobacco Control Act differ from other user-fee industry-
related--what is missing? One of the things that I support my
colleague Brett Guthrie for his legislation, and I also
associate myself to Dr. Burgess' comments on setting a timeline
in place as well, but one of the things that I realize is
missing is this can just go on into perpetuity. There is no
sundown, there is no re-evaluation or need for reauthorization
of this particular act.
In your opinion, would this be helpful for us to be able to
help enforce what the CTP is doing?
Ms. Crosse. You know, I don't think I am in a position to
weigh in on whether or not it would be helpful to have it
sunset. The user fee structure is quite different. The
responsibilities assigned to FDA----
Mrs. Ellmers. Um-hum.
Ms. Crosse [continuing]. Under this act are quite
different.
Mrs. Ellmers. Um-hum.
Ms. Crosse. The user fees are intended to fund not only the
reviews of the product applications as they are for devices or
for drugs, for example, but also to fund the research, the
media campaigns and the enforcement of----
Mrs. Ellmers. Um-hum.
Ms. Crosse [continuing]. The requirements of the Tobacco
Control Act, and FDA has undertaken a lot of enforcement
actions to try to ensure that teenagers are prevented from
having access to purchase tobacco products.
Mrs. Ellmers. But at the same time, I mean, there is
obviously, as you can see, and I know you agree, there is just
this incredible backlog.
So, I mean, are there other situations like this where we
have user fees that are being shared, where there isn't a
sundown provision, or there isn't reauthorization in place?
Ms. Crosse. You know, I am not qualified to speak to user
fees across the Federal Government. I don't believe there are
similar circumstances at FDA, but there may be user fee
programs in other government agencies that are similar, that I
just am not aware of.
Mrs. Ellmers. OK. Well, there again, I think this is just
one of those issues that we are all kind of baffled by why this
is, and it almost seems as if it is not an organized effort to
keep products from moving forward. And I do think that this is
something that I would like to continue to work on, and there
again--I am out of time.
Thank you very much for coming today, and helping us to
understand this issue.
And, Mr. Chairman, I yield back the remainder of my time.
Mr. Burgess. Gentlelady yields back.
The Chair now recognizes the distinguished gentleman from
Louisiana, the Honorable Bill Cassidy, 5 minutes for questions,
please.
Mr. Cassidy. Thank you.
The increase in sales of pipe tobacco. People aren't buying
a lot more pipes, so I presume they are rolling this in some
sort of paper and making their own cigarettes?
Ms. Crosse. GAO put out a report last year, or 2012,
rather, that pointed out a huge shift in the use of pipe
tobacco for roll-your-own cigarettes, subsequent to the changes
in taxation on different types of tobacco products in the
Children's Health Insurance Program Reauthorization Act,
CHIPRA, in 2009, when taxes were greatly increased on certain
types of tobacco products. There was a tremendous shift so that
consumers were no longer using roll-your-own tobacco, but
rather using pipe tobacco for roll-your-own cigarettes. And we
have substantial data pointing to a huge shift in that market,
and a huge loss of revenue to the Federal Government because of
that shift.
Mr. Cassidy. Can you make a guestimate as to whether or not
there has been any discouragement--let me start over. If we
know that there is a certain amount of regular cigarettes which
are purchased, and then there is the roll-your-own, we have
raised taxes on the regular cigarettes, does it not look like
it is the same amount of tobacco being consumed, or is there a
decrease in the per capita use of tobacco?
Ms. Crosse. The data in that report did not point to any
decrease in the overall use of tobacco but rather to a shift in
order to avoid taxes.
Mr. Cassidy. So we shifted, if you will, from something
which is at least filtered to something that is unfiltered,
arguably which has more health implications by using it
unfiltered.
Ms. Crosse. You know, some roll-your-owns, I believe,
actually can attach a filter from some machines, and I can't
speak to what the proportion is of the different types of roll-
your-own tobacco cigarettes that are made in these tobacco
shops now using pipe tobacco instead of roll-your-own tobacco.
Mr. Cassidy. Now, under the Family Smoking Prevention
Tobacco Control Act, roll-your-own tobacco is any tobacco
product which, I am reading here, because of its appearance,
type, packaging, labeling, is suitable for use or likely to be
offered to or purchased by consumers of tobacco for making
cigarettes. Cigarette tobacco is defined as a product
consisting of loose tobacco intended for use by consumers in a
cigarette.
In your opinion, does the product labeled as pipe tobacco,
about which you reported in April of '12, meet either or both
of these definitions?
Ms. Crosse. You know, the Treasury, which imposes the
taxes, indicated that it was difficult for them to make that
distinction between the roll-your-own tobacco and the pipe
tobacco that's sold in tobacco shops.
Mr. Cassidy. So related to that then, let me just ask
specifically, are there any provisions in the Tobacco Control
Act which permit a manufacturer product which meets either
definition, to exempt themselves from the act simply by
labeling their product something other than roll-your-own?
Could it be the exact same tobacco, in this bag it is called
roll-your-own, taxed, and here it is pipe tobacco, not taxed?
Ms. Crosse. I can't speak to that. I know that the pipe
tobacco is allowed to be flavored, so that if it is a flavored
product, it could not currently be labeled as roll-your-own,
because that is currently regulated by FDA and flavorings are
prohibited. But in terms of the constituents or, you know, the
extent to which the tobacco has been finely chopped or requires
a certain blend, I don't know if that could be the same.
Mr. Cassidy. OK, thank you.
I will yield the remainder of my time to Mr. Guthrie.
Mr. Guthrie. Thank you. One of my colleagues on the other
side did mention that last week, right before this hearing, CTP
put out that they are working to get rid of the backlog, and it
is a massive move to get rid of the backlog. But as I
understand it, there are two lines. There is one line you get
into to say, if you get in this line, we are going to tell you
to go to that line, and that line is the one that matters, and
all they did was say we are not going to make you go through
two lines now, you are going to have to go to the back of the
other line.
So there was no--the announcement that they made, it is my
understanding, did not improve the determinations whether it is
safe or unsafe, or can be sold or not sold. All it did was say,
we are just going to make one line longer by getting rid of the
other line. Is that an accurate description?
Ms. Crosse. You know, that is not my understanding of the
announcement that they made. I believe that the announcement
focused on the regular SE submissions, and the line for
products that are not currently allowed to be on the market,
you know, those provisional SEs--I would restate, the large
bolus of applications that are sitting there waiting in the
queue, those products are currently on the market. They do not
have to await an FDA decision to enter the market, they are on
the market. They are waiting for a decision about whether or
not they can remain on the market or have to be removed.
So FDA is focusing on working at the backlog of
applications for products that cannot enter the market until
they have reached a decision. That is a smaller group. They
received something over 900 applications for those products,
and they have reached 30 decisions. So that is the backlog--my
understanding of their announcement is that is the backlog that
they are focusing on right now.
Mr. Burgess. OK----
Mr. Guthrie. Thank you.
Mr. Burgess [continuing]. Well, the gentleman's time has
expired.
The Chair now recognizes the gentlelady from California, 5
minutes for questions, please.
Mrs. Capps. Thank you, Mr. Chairman. And, Dr. Crosse, thank
you for your testimony.
As a public health nurse, the issue of tobacco use and our
Nation's wellbeing and healthcare expenditures is one that we
cannot ignore. Thanks to the Tobacco Control Act, tobacco
companies can no longer mark ``light'' or ``low-tar''
cigarettes, misleading smokers who may otherwise have quit, but
we do know there is much more we need to do to hold tobacco
companies accountable for their marketing, and I urge the
chairman to hold a hearing on the many issues that Ranking
Member Waxman pointed out, but especially on e-cigarettes and
the other products that continue to be targeted at our young
people.
We should not lose sight of why the Tobacco Control Act
requires tobacco companies to receive authorization to market
their products in the first place, and I encourage the
subcommittee to hold hearings on the continual efforts by
tobacco companies to skirt the rules, as opposed to a hearing
like this, based on the business concerns of these same
companies.
Dr. Crosse, I understand that there were some initial
roadblocks that slowed down the review process for substantial
equivalence, or SE submissions, and are being addressed by FDA.
Ms. Crosse. That is my understanding.
Mrs. Capps. OK. Could you please comment on the extent to
which incomplete submissions from manufacturers has been a
roadblock to the review process?
Ms. Crosse. Yes. Both FDA and manufacturers told us that
incomplete submissions did slow down the review, that
manufacturers did not have a good understanding of what
information was required, and FDA itself was still developing
its understanding of what information it might need in order to
reach a decision. And so virtually every application that has
come in has required some communication with the manufacturer
to try to either understand part of the application, or to
obtain additional information to supplement the application.
Mrs. Capps. So this clearly needs to be addressed.
And could you elaborate on the steps FDA has taken to
improve its review process?
Ms. Crosse. Well, they have undertaken a lot of research to
understand the science behind different tobacco products, they
have organized their staff and their procedures in order to
have a number of routine steps that an application goes
through, so that there now is a jurisdictional review
initially, and then a completeness review that takes place
before a product enters actually the scientific review for the
merits of the product.
And so they have organized a process, they have developed
steps, they have identified staff who are responsible for the
different steps of the process, but they have yet to complete
the process for very many of the applications.
Mrs. Capps. In September of last year, the GAO recommended
that FDA establish time frames for making decisions on new
tobacco product submissions.
You indicated in your testimony today that FDA agreed with
GAO's recommendations, and plans to identify time frames for
decision-making on new tobacco products submission. And the
agency, is it still on track to identify these time frames this
spring?
Ms. Crosse. Yes, it is on track to identify time frames for
the regular SE submissions. They have not yet decided when they
will have time frames in place for the provisional SE
submissions because they tell us they do not yet have enough
experience themselves with getting something through the
complete process to know what time frames to establish.
Mrs. Capps. Well, it is helpful for the subcommittee to
hear that FDA has already agreed to establish and implement
performance measures, including decision-making time frames,
for regular SE submissions. Excuse me.
Once these standards are in place, we can better monitor
FDA's progress. As FDA has focused on regular SE submissions,
and continues to undertake these reviews, have the review times
improved?
Ms. Crosse. The review times have improved, we understand,
for the regular SE submissions. It is not clear that they have
improved for the provisional SE submissions because they
haven't made very many decisions yet, so we can't see any kind
of trend.
Mrs. Capps. I see. For decades, tobacco companies
deliberately misled the public about the risks of smoking, and
there is evidence that today's products are perhaps even more
harmful and addictive than those from past decades.
My colleagues on the other side of the aisle have talked
about setting time frames for review of these SE submissions.
Mr. Chairman, we need to hear from FDA about the wisdom of this
approach. We should be incentivizing tobacco companies to
manufacture products that reduce harmfulness, not delay that
process further.
And I yield back the balance of my time.
Mr. Burgess. Gentlelady yields back.
Now recognize the gentleman from Virginia, Mr. Griffith, 5
minutes. Your questions, please.
Mr. Griffith. Thank you very much, Mr. Chairman. Thank you,
Dr. Crosse, for being here today. Appreciate that.
I was a little concerned with some of the folks who said,
on the other side of the aisle, that we needed to be more
accommodating. I was pleased that the acting chairman went
through the list of things that we did to accommodate the FDA.
Not only did we say that other people could show up, as opposed
to the head of this particular department, but that they didn't
have to have a written statement that had to be approved in
advance, we are just trying to get to the information.
And, you know, I had to make the comment to the acting
chair that when I ran for election, I thought I was being
elected to the United States Congress, not to a discussion
committee to accommodate every whim of bureaucracy. And so I am
a little disturbed that the FDA didn't bother to send somebody
here to testify today, particularly in light of the fact of the
accommodations that were made to say, OK, you don't have to
have a written statement, you can send somebody who is, you
know, a deputy. We understand they might say, ``I don't know
the answer to that question, that is a little bit outside of my
realm, but I will get you an answer.'' Sometimes those things
happen, but it is interesting that, you know, with all the busy
schedules that so many of us are keeping, we were able to have
this hearing, but nobody from the--how many employees did you
say there were, over 500, with this particular division of the
FDA?
Ms. Crosse. Yes.
Mr. Griffith. That none of those 500-and-some people could
accommodate the United States Congress.
That being said, I will say that the Agency, you know, as
it states, is responsible for advancing the public health by
helping to speed innovations. Further, they state the Agency
protects, promotes the health and safety of all Americans by
promoting innovation that addresses public health needs.
Ms. Crosse, is it your opinion that the FDA is able to keep
pace with the advances in science and product technology, not
only for the Center for Tobacco Products, but for other
industries it regulates? And before you answer, let me tell you
one of the concerns I have is working on the mobile apps that
are out there, and I have talked to the FDA about this, but you
can do all kinds of things on your cell phone today that you
didn't used to be able to do, and I related to them on one
occasion that, in Africa, a team of doctors were able to put
together a $8 hack that would send pictures back of parasites
found in children's stool, and get it immediately analyzed by
somebody in the United States. And I said can we use that in
our country if somebody comes up with that, or does it have to
first go through your regulatory process, and the answer was
basically, well, if they are using it to diagnose what type of
parasite it is, that makes it diagnostic, it would have to be
regulated. Sometimes it seems they are just not, my opinion,
they are just not able to keep up.
If you can answer that question, both in regard to the
Center for Tobacco Products and in other areas from your
observation, to the best of your ability.
Ms. Crosse. Well, I can't speak directly to the mobile
apps, but we have previously examined activities at FDA, and
raised some concerns certainly in the Center for Devices about
their ability to have staff with all of the technical expertise
for the rapidly changing technologies, and for the software
that is included in medical devices, for example. That has been
a concern that we have identified in the past, and that FDA has
acknowledged is a challenge for them.
Mr. Griffith. I appreciate that.
I would say in regard to the tobacco products, and I don't
know the answer, we all want to know what is in the products,
what the health effects are of those products, and we certainly
want them to get that done in a timely fashion. I will say
that, you know, when I was in the fourth grade, growing up in
Virginia, they used to teach us the history that one of the
first times that somebody was smoking a cigar, walking down the
streets of London, somebody ran into a local store where they
all kept water buckets in case a fire broke out, and threw
water on the man because he was on fire, he had smoke coming
out of his mouth.
So it would seem to me that if we could get to some more of
these smokeless products, it would probably help folks. That is
the gut reaction. I would like to see the science on it.
Do you think that they are going to be able to give us some
of that, and reduce this backlog dramatically in the next
couple of years?
Ms. Crosse. Well, with regard to smokeless products, I
think that that depends upon the applications that are
submitted to them. That is dependent upon the industry. Some of
those products are currently not deemed to be subject to FDA
regulation, and so products of those types can enter the market
right now. I think that there is not currently a sufficient
understanding, though, of the risks posed by those products,
and whether or not they simply allow someone who smokes to co-
use those types of products, or use those products in
situations where they can't use a cigarette because of
restrictions on where they can smoke, or whether or not it
allows them to cease use of tobacco products, which we do know
is dangerous to their health.
Mr. Griffith. Yes. And we certainly need to get the answers
to these questions because, you know, even a number of
healthcare individuals have indicated that there is a good
possibility that things like the e-cigarette may be a step in
between smoking the smoke tobacco and moving away from using
the product at all.
Ms. Crosse. Yes, of course, if they are making smoking
cessation claims, then they would be subject to regulation as a
drug, and subject to regulation in a different part of FDA. So,
you know, I think the concern is whether or not they become a
gateway product to allow young people to then begin smoking
cigarettes, and I think the science is just not there yet to
know.
Mr. Griffith. Yes, ma'am. I appreciate that, and I hope
that the center will get to work and get it done.
Thank you so much, and I yield back.
Mr. Burgess. The gentleman's time has expired.
The Chair now recognizes the gentleman from Illinois, Mr.
Shimkus, 5 minutes for your questions, please.
Mr. Shimkus. Thank you, Mr. Chairman. If I can get the
staffer to move. Mike Bilirakis. Thank you.
Mr. Bilirakis. Gus Bilirakis.
Mr. Shimkus. Yes, yes, yes. Well, anyway, your staffer, get
him to move. Thanks. Mike's dad.
Mr. Bilirakis. Yes.
Mr. Shimkus. That is his dad, former committee member, it
is an easy mistake.
So welcome. And actually, I am following a lot of Morgan's
comments, and a lot of comments all other folks have made, but
I want to start with--I was going to flip the questions around,
but you ended up with this whole, if there is a statement of
smoking cessation claimed, it goes into another part or another
area of regulation, versus just tobacco use product, is that
correct?
Ms. Crosse. That is my understanding, yes.
Mr. Shimkus. And because another former colleague, not Mike
Bilirakis, but Steve Buyer, when we passed this bill in 2009,
kept trying to address these issues of nicotine gum, snuff, and
now you could make some debate about e-cigarettes, that, yes,
do provide nicotine to the individual consumer, but you could
also argue, especially with e-cigarettes, that in the vaporized
form versus a burning form, and all those issues, there may be
some health benefits over a burned tobacco product is kind of
the debate, and so, in this process, we need to get the FDA to
move in the direction of evaluating this, right? Or shouldn't
the FDA, in essence, be like the referee on the court in making
judgments?
Ms. Crosse. Well, I think that the statute gives them that
authority and that responsibility, and that they have announced
that they intend to deem additional tobacco products, and as I
understand it, virtually all additional tobacco products, as
subject to their regulation.
Mr. Shimkus. And so intent to deem, I guess that is part of
the reason why we are here, right? How long does it take to
have an intent to deem, and how long should it?
Ms. Crosse. Well, rulemaking, as I am sure you are aware,
is typically a years-long process. They first announced their
intent to deem in 2010, but it was not clear whether they at
that time intended to deem all products at once, or product
after product individually. My understanding is that they now
have made a determination to deem multiple products at one
time, and so, therefore, needed to develop the information to
support that rulemaking. We had other work that had examined
rulemaking at FDA that had a range of 1 year to 14 years, so
this is still in that range.
Mr. Shimkus. Yes, but the importance of the intent to deem
is to provide information to the consuming public, the adult
consuming public, correct?
Ms. Crosse. Well, yes, and to make determinations about the
safety and controls that might be required for different types
of products.
Mr. Shimkus. Because they should be using science and
evidence in this decisionmaking process, correct?
Ms. Crosse. That is what they are saying that they are
trying to develop, is a scientific base to understand the risks
posed by different types of tobacco products.
Mr. Shimkus. And we would hope that they will do that
sooner rather than later for all of us involved. I would think
that would be the argument.
And then on the--my time is running short, but also
following up on Morgan's comments is technology and moving
rapidly, bureaucracy does not, we fight that issue across the
board in the telecom world. And you talk about apps, but is the
FDA's ability to keep up with the innovation and science and
product technology for the Center for Tobacco Products, have
you seen that that is lagging also?
Ms. Crosse. Well, I think it is too soon to say whether it
is lagging. I think they have just been mounting it in the last
several years. And so----
Mr. Shimkus. You know, I think that is what frustrates a
lot of us here, and I know people--there is a role for
government, but in the private sector, you can't mount
something for years. You would never have a product, you would
never have a return on investment, and your competitors would
move right past you. So we would wish that they would move
expeditiously.
And thank you, Mr. Chairman, I yield back.
Mr. Burgess. Gentleman yields back.
That being all the members of the subcommittee, the Chair
now recognizes Mr. Bilirakis, 5 minutes for questions, please.
Voice. Is that Mike or Gus?
Mr. Bilirakis. Yes. Either one. I can get Mike----
Mr. Burgess. Either one.
Mr. Bilirakis [continuing]. In short notice if you want
him. Thank you, but I am a member of the subcommittee as well,
but turning to--thank you very much for appearing today. I
appreciate it very much, Doctor.
Turning to staffing levels at the Center for Tobacco
Products, how many FTEs are currently in the various offices?
Ms. Crosse. My understanding is that they currently have a
total of about 511 staff, and the figures I have are that the
Office of Science, which is the office that makes the decisions
on product reviews, they have 194 staff, and that the Office of
Health Communications has 44 staff, and the Office of
Compliance and Enforcement has 116 staff.
Mr. Bilirakis. Thank you. Do most of these employees have
previous experience regulating tobacco products in other
government agencies?
Ms. Crosse. No, because tobacco products weren't regulated
previously, and so they may have experience in regulating
products, but not necessarily tobacco products. They did bring
in a number of scientists who had done research on tobacco
products, but not for purposes of regulation.
Mr. Bilirakis. Thank you.
Next question. Has FDA implemented the small business
provisions included in the statute, including the establishment
of the office to assist small tobacco manufacturers for the
provision of technical assistance, and has the Agency issued
any small business guidance?
Ms. Crosse. You know, I am not certain. We can get back to
you on that. I know that they have had some implementation in
that area, but we did hear concerns from manufacturers that
that was an issue for them in terms of being able to get the
information that they needed.
Mr. Bilirakis. You are not sure about the small business
guidance?
Ms. Crosse. I am just not sure. I don't think that we
looked at it explicitly.
Mr. Bilirakis. OK, you will get back to me?
Ms. Crosse. Yes, we will.
Mr. Bilirakis. All right, thank you very much.
Anybody like some time here?
Thank you. I yield back, Mr. Chairman.
Mr. Burgess. The gentleman yields back.
That concludes the questions by the members of the
subcommittee. I would remind all members they have 10 business
days to submit questions for the record, and ask the witness to
respond to the questions promptly. Members should submit their
questions by the close of business on Tuesday, April 22.
Without objection, the subcommittee is adjourned. Thank the
witness.
[Whereupon, at 11:49 a.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
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