[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]

BIOTERRORISM, CONTROLLED SUBSTANCES, AND PUBLIC HEALTH ISSUES

=======================================================================

HEARING

BEFORE THE

SUBCOMMITTEE ON HEALTH

OF THE

COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES

ONE HUNDRED TWELFTH CONGRESS

FIRST SESSION

__________

JULY 21, 2011

__________

Serial No. 112-79

Printed for the use of the Committee on Energy and Commerce

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COMMITTEE ON ENERGY AND COMMERCE

FRED UPTON, Michigan
Chairman

JOE BARTON, Texas HENRY A. WAXMAN, California
Chairman Emeritus Ranking Member
CLIFF STEARNS, Florida JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky Chairman Emeritus
JOHN SHIMKUS, Illinois EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania EDOLPHUS TOWNS, New York
MARY BONO MACK, California FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska ANNA G. ESHOO, California
MIKE ROGERS, Michigan ELIOT L. ENGEL, New York
SUE WILKINS MYRICK, North Carolina GENE GREEN, Texas
Vice Chairman DIANA DeGETTE, Colorado
JOHN SULLIVAN, Oklahoma LOIS CAPPS, California
TIM MURPHY, Pennsylvania MICHAEL F. DOYLE, Pennsylvania
MICHAEL C. BURGESS, Texas JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee CHARLES A. GONZALEZ, Texas
BRIAN P. BILBRAY, California JAY INSLEE, Washington
CHARLES F. BASS, New Hampshire TAMMY BALDWIN, Wisconsin
PHIL GINGREY, Georgia MIKE ROSS, Arkansas
STEVE SCALISE, Louisiana JIM MATHESON, Utah
ROBERT E. LATTA, Ohio G.K. BUTTERFIELD, North Carolina
CATHY McMORRIS RODGERS, Washington JOHN BARROW, Georgia
GREGG HARPER, Mississippi DORIS O. MATSUI, California
LEONARD LANCE, New Jersey DONNA M. CHRISTENSEN, Virgin
BILL CASSIDY, Louisiana Islands
BRETT GUTHRIE, Kentucky KATHY CASTOR, Florida
PETE OLSON, Texas
DAVID B. McKINLEY, West Virginia
CORY GARDNER, Colorado
MIKE POMPEO, Kansas
ADAM KINZINGER, Illinois
H. MORGAN GRIFFITH, Virginia

7_____

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 EDOLPHUS TOWNS, New York
MIKE ROGERS, Michigan ELIOT L. ENGEL, New York
SUE WILKINS MYRICK, North Carolina LOIS CAPPS, California
TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee CHARLES A. GONZALEZ, Texas
PHIL GINGREY, Georgia TAMMY BALDWIN, Wisconsin
ROBERT E. LATTA, Ohio MIKE ROSS, Arkansas
CATHY McMORRIS RODGERS, Washington JIM MATHESON, Utah
LEONARD LANCE, New Jersey HENRY A. WAXMAN, California (ex
BILL CASSIDY, Louisiana officio)
BRETT GUTHRIE, Kentucky
JOE BARTON, Texas
FRED UPTON, Michigan (ex officio)

(ii)

C O N T E N T S

----------
Page
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 3
Hon. Mike Rogers, a Representative in Congress from the State of
Michigan, opening statement.................................... 5
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 20
Hon. Tammy Baldwin, a Representative in Congress from the State
of Wisconsin, opening statement................................ 21
Prepared statement........................................... 22
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, opening statement.................................... 23
Prepared statement........................................... 24
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 26
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 26
Prepared statement........................................... 28
Hon. Joe Barton, a Representative in Congress from the State of
Texas, prepared statement...................................... 110
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, prepared statement................................ 111

Witnesses

Hon. Charles W. Dent, a Representative in Congress from the
Commonwealth of Pennsylvania................................... 30
Prepared statement........................................... 33
Nicole Lurie, Assistant Secretary for Preparedness and Response,
Department of Health and Human Services........................ 38
Prepared statement........................................... 41
Howard K. Koh, Assistant Secretary for Health, Department of
Health and Human Services...................................... 62
Prepared statement........................................... 65

Submitted Material

Statement, dated July 21, 2011, of Joseph T. Rannazzisi, Deputy
Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration, Department of Justice, submitted by
Mr. Pitts...................................................... 6
Letter, dated July 8, 2010, from Mr. Barton and Mr. Burgess to
Greg Burel, Director, Division of Strategic National Stockpile,
Office of Public Health Preparedness and Response, Centers for
Disease Control and Prevention, submitted by Mr. Burgess....... 80
Letter, dated August 18, 2010, from Thomas R. Frieden, Director,
CDC, and Administrator, Agency for Toxic Substances and Disease
Registry, Department of Health and Human Services, to Mr.
Burgess, submitted by Mr. Burgess.............................. 82
Discussion Draft of H.R. --------, A Bill to improve the
coordination of research and other activities conducted by the
Department of Health and Human Services that are specific to a
disease or condition, and for other purposes, submitted by Mr.
Pitts.......................................................... 112
H.R. 1254, A Bill to amend the Controlled Substances Act to place
synthetic drugs in Schedule I, submitted by Mr. Pitts.......... 122
H.R. 2405, A Bill to reauthorize certain provisions of the Public
Health Services Act and the Federal Food, Drug, and Cosmetic
Act relating to public health preparedness and counter-measure
development, and for other purposes, submitted by Mr. Pitts.... 128

BIOTERRORISM, CONTROLLED SUBSTANCES, AND PUBLIC HEALTH ISSUES

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THURSDAY, JULY 21, 2011

House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:03 a.m., in
room 2123 of the Rayburn House Office Building, Hon. Joseph
Pitts (chairman of the subcommittee) presiding.
Members present: Representatives Pitts, Burgess, Shimkus,
Rogers, Myrick, Murphy, Gingrey, Latta, McMorris Rodgers,
Cassidy, Guthrie, Upton (ex officio), Pallone, Dingell, Towns,
Capps, Baldwin, Green, and Waxman (ex officio).
Staff present: Clay Alspach, Counsel, Health; Gary Andres,
Staff Director; Jim Barnette, General Counsel; Sean Bonyun,
Deputy Communications Director; Brenda Destro, Professional
Staff Member, Health; Andy Duberstein, Special Assistant to
Chairman Upton; Debbee Keller, Press Secretary; Ryan Long,
Chief Counsel, Health; Carly McWilliams, Legislative Clerk;
Andrew Powaleny, Press Assistant; Chris Sarley, Policy
Coordinator, Environment and Economy; Heidi Stirrup, Health
Policy Coordinator; Phil Barnett, Democratic Staff Director;
Stephen Cha, Democratic Senior Professional Staff Member; Alli
Corr, Democratic Policy Analyst; Eric Flamm, FDA Detailee; Ruth
Katz, Democratic Chief Public Health Counsel; Karen Lightfoot,
Democratic Communications Director and Senior Policy Advisor;
and Karen Nelson, Democratic Deputy Committee Staff Director
for Health.
Mr. Pitts. The subcommittee will come to order. The chair
will recognize himself for 5 minutes for an opening statement.

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

Today's legislative hearing will focus on H.R. 2405, the
Pandemic and All-Hazards Preparedness Act of 2011; H.R. 1254,
the Synthetic Drug Control Act of 2011; and the Enhancing
Disease Coordination Activities Act of 2011.
Our witness for the first panel will be my friend and
fellow Pennsylvanian, Representative Charlie Dent. His bill,
H.R. 1254, the Synthetic Drug Control Act, addresses a growing
problem in many States and gives law enforcement additional
tools to deal with the very real dangers of synthetic drugs.
H.R. 1254 would prohibit the sale of synthetic drugs that
imitate the hallucinogenic and stimulant properties of drugs
like marijuana, cocaine, and methamphetamines. While these
drugs are synthetic, they are just as dangerous as the real
thing, but they are not illegal.
Along with banning these synthetic drugs, the bill would
also allow the Drug Enforcement Administration (DEA) to
temporarily schedule a new substance for up to 3 years instead
of the current standard of up to 18 months.
Next, the subcommittee will examine Representative Rogers'
bill, H.R. 2405, the Pandemic and All-Hazards Preparedness Act
of 2011, which would reauthorize certain provisions of the
Project Bioshield Act of 2004 and Pandemic and All-Hazards
Preparedness Act of 2006 (PAHPA). These laws help protect our
country against pandemics and attacks from chemical,
biological, radiological, and nuclear weapons.
Among the reauthorizations in the bill are the Biomedical
Advanced Research and Development Authority (BARDA), which
helps to ensure that early-stage research leads to tangible
medical countermeasures that can be used to save lives in an
emergency, and the reauthorization of Project Bioshield's
Special Reserve Fund, which helps procure medical
countermeasures against anthrax, smallpox, botulism, and other
threats for the Strategic National Stockpile.
Finally, the Enhancing Disease Coordination Activities Act
of 2011 would allow the Secretary of Health and Human Services
to establish committees based on existing interagency
coordinating models that will help coordinate disease-specific
research and other activities currently spread across the
department.
[The information appears at the conclusion of the hearing.]
I would like to thank all of our witnesses today, and I
would like to yield the remainder of my time to Representative
Rogers.
[The prepared statement of Mr. Pitts follows:]

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OPENING STATEMENT OF HON. MIKE ROGERS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN

Mr. Rogers. Thank you, Mr. Chairman, for holding this very
important hearing.
Last month, I introduced H.R. 2405, legislation to
reauthorize the Pandemic All-Hazards Preparedness Act. I want
to thank Gene Green and Sue Myrick for being original
cosponsors on this bill, which will also reauthorize Project
Bioshield's Special Reserve Fund.
It has been almost 10 years since 9/11 and the anthrax
attacks that followed, and while they haven't had a successful
terrorist attack on U.S. soil, our enemies are still working
every single day to kill innocent Americans. Bioterrorism
remains a very real threat to our country, which is why I think
this bipartisan legislation is so important.
Over the last 10 years, we have made significant progress
in our ability to protect the public from CBRN threats.
Congress created Project Bioshield in 2004, creating a market
guarantee that prompted the private sector to develop
countermeasures for the Federal Government. In 2006, we also
created the Biomedical Advanced Research and Development
Authority (BARDA), which helped bridge the ``valley of death''
that prevented many countermeasure developers from being
successful.
Today, we have numerous vaccines and treatments in the
Strategic National Stockpile that will save lives in the event
of an attack. And while we hope that we never have to use these
medical countermeasures, they are essential to protecting the
public health from a bioterrorism attack. Simply put, we must
always be prepared.
I would also like to thank Mr. Pallone and Mr. Waxman for
working with us on this bipartisan basis to move this
legislation through the committee. The issue has always been a
bipartisan effort, and I appreciate their willingness to
partner with us. I also look forward to hearing from Dr. Nicole
Lurie, the HHS Assistant Secretary for Preparedness and
Response who oversees the entire medical countermeasure
enterprise. It is an important role in protecting the country
and I am pleased that they have also worked with us on this
critical legislation.
Thank you again for holding this hearing, Mr. Chairman, and
I yield back my time.
Mr. Pitts. The chair thanks the gentleman and asks
unanimous consent to enter the statement of Joe Rannazzisi of
the Drug Enforcement Administration into the record. Without
objection, so ordered.
[The information follows:]

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Mr. Pitts. The chair recognizes the ranking member of the
subcommittee, Mr. Pallone, for 5 minutes for opening statement.

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY

Mr. Pallone. Thank you, Chairman Pitts, and thank you for
holding today's hearing on these important health bills. I am
encouraged that this hearing marks two bipartisan hearings in a
row for this subcommittee and I support all three bills under
consideration. And I thank our witnesses for joining us today.
Over the past 10 years, this Congress--rightfully so--has
placed a high priority on biodefense. In 2004, we passed the
Project Bioshield Act with tremendous bipartisan support.
Democrats and Republicans worked together to establish a
process that would help our Nation respond to bioterrorism
threats and attacks. This goal was to encourage the development
of new bioterrorism countermeasures.
Unfortunately, at first the program had limited success.
This committee recognized its shortfalls and in 2006 worked to
amend the program to help fix some of the problems.
Specifically, it provided the Department of Health and Human
Services with the additional authorities and resources
necessary to rapidly develop drugs and vaccines to protect
citizens from deliberate, accidental, and natural medical
incidents involving biological pathogens, as well as chemical
and radiological agents. It also helped to build the Nation's
health infrastructure.
In addition, a single point of authority within HHS was
created for the advanced research and development of medical
countermeasures to quickly make important procurement
decisions. The new position of assistant secretary for
preparedness and response (ASPR) has since led the Federal
Government's effort.
And today we consider H.R. 2405, the Pandemic and All-
Hazards Preparedness Act of 2011, which attempts to further
strengthen these programs. Specifically, it clarifies ASPR's
role in these efforts and attempts to improve coordination and
accountability.
We have worked very closely with the Republicans on this
bill, and while there are still some minor outstanding issues,
I am confident they can be settled. I know some of my
colleagues also have issues they would like to see addressed--
specifically, the ways in which we can enhance the Nation's
ability to care for pediatric populations and the critically
ill or injured in the event of a public health emergency, and I
hope we can incorporate these important ideas in some way into
the reauthorization bill.
Another bill we are considering today is the Synthetic Drug
Control Act introduced by Representative Charles Dent, who
joins us today. It is quite alarming to hear some of the
stories you have shared, as well as other members, whose
constituents have been able to utilize these products to the
detriment of their mental and physical health, and in some
cases, costing them their lives. It appears these imitation
drugs are not illegal and I support strengthening the Federal
Government's ability to keep these harmful and dangerous drugs
off the street.
Lastly, we are discussing the Enhancing Disease
Coordination Activities Act of 2011. This year, HHS is devoting
over $900 million and 72,000 full-time employees to carrying
out their mission ``to help provide the building blocks that
Americans need to live healthy, successful lives.'' As such,
tackling the countless diseases we face is a major component of
their work. For a large and complex organization with an even
greater charge, the flexibility to form coordinating bodies to
better organize research and public health activities is ideal.
The committee recently considered the Combating Autism
Reauthorization Act of 2011, a bill that seeks to address
autism spectrum disorders, a major public health problem in New
Jersey and across the Nation. The original program created the
interagency Autism Coordinating Committee, which, as we heard
last week, has been largely successful. So I am encouraged that
it can and should serve as a model for the creation of other
disease-specific coordinating committees. The Enhancing Disease
Coordination Activities Act of 2011 will give the secretary
explicit authority to create committees that would not only
streamline activities within the Department but also would
stimulate partnerships between public and private
organizations. Especially at a time when we are faced with such
limited resources, coordinating activities across public and
private sectors is critical.
So I look forward to working with you, Chairman Pitts, as
we move on these critical pieces of legislation through this
committee and onto the House Floor.
And I now would like to yield what time I have left to Ms.
Baldwin.

OPENING STATEMENT OF HON. TAMMY BALDWIN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF WISCONSIN

Ms. Baldwin. Thank you. I want to thank you, Mr. Chairman
and Ranking Member Pallone, for holding this important hearing
on bipartisan measures that focus on our Nation's public health
preparedness. I am not going to be able to offer my entire
opening statement, so I ask unanimous consent to insert that
for the record in its entirety.
Mr. Pitts. Without objection, so ordered.
Ms. Baldwin. Thank you. But I did want to point out that
earlier this year I introduced a bipartisan bill called the
Critical Care Assessment and Improvement Act with my colleague
from Minnesota Erik Paulsen. The bill seeks to identify gaps in
the current critical care delivery model and bolster our
capabilities to meet future demands. I am hopeful that we will
be able to incorporate some of the relevant provisions of that
act into the Pandemic and All-Hazards Preparedness Act as we
look towards that reauthorization. And in that vein I look
forward to working with my colleagues on both sides of the
aisle to do so as this legislation moves forward.
Again, Mr. Chairman and Mr. Pallone, thank you so much for
holding this bipartisan hearing. I yield back.
[The prepared statement of Ms. Baldwin follows:]

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Mr. Pitts. The chair thanks the gentlelady and now
recognizes the chairman of the full committee, Mr. Upton, for 5
minutes.

OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN

Mr. Upton. Well, thank you, Mr. Chairman. And first I want
to congratulate you and your wife on 50 years of bliss
tomorrow. Formally, 50 years. Yes. I also want to thank you for
holding today's hearing on bioterrorism, controlled substances,
and public health legislation. I look forward to hearing from
the witnesses on these important pieces of legislation,
particularly our good friend, Mr. Dent of Pennsylvania.
Congressman Mike Rogers--the good Mike Rogers--recently
introduced H.R. 2405, the Pandemic and All-Hazards Preparedness
Act of 2011. This bill reauthorizes provisions of the Project
Bioshield Act of '04 and Pandemic and All-Hazards Preparedness
Act of '06, laws we passed in the wake of September 11 to build
the Nation's health infrastructure and foster the development
of medical countermeasures so the Nation could better respond
to terrorist attack.
Congressman Dent introduced H.R. 1254, the Synthetic Drug
Control Act, to prohibit the sale of synthetic drugs that
imitate the effects of drugs like marijuana, cocaine, and other
methamphetamines. These synthetic drugs are certainly just as
harmful and dangerous as those drugs, but due to a loophole in
the law they are not illegal. This bill solves that problem.
Finally, the Enhancing Disease Coordination Activities Act
of 2011 would improve the coordination of research and other
activities conducted or supported by HHS. Inspired by the
success of the Interagency Autism Coordinating Committee, the
bill would allow the HHS secretary to establish committees that
coordinate research and other activities on specific diseases
and conditions. The bill also would enable the HHS secretary to
conduct a review of existing, disease-specific committees at
HHS to determine the benefits of maintaining them. So as I said
at last week's hearing, we must find a way to have our agencies
work better together with a common strategic vision, and I
think these bills do that.
I yield the balance of my time to Dr. Burgess.
[The prepared statement of Mr. Upton follows:]

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OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS

Mr. Burgess. I thank the chairman for yielding.
I appreciate the fact that we are having a legislative
hearing, and certainly I hope the committee will move
expeditiously on all three.
Let me comment, because of the briefness of the time, on
the Pandemic and All-Hazards Preparedness Act of 2011. This
program was launched after the terrorist attacks in 2001 and
set the framework for new medical countermeasures to respond to
any attacks in the future. This program encourages and spurs
market entry and competition and ingenuity into the private
market. In the aftermath of an attack, we need to be assured
that there is an adequate supply of countermeasures for the
Strategic National Stockpile, and this program helps to
accomplish that goal.
I certainly want to thank Congressman Rogers from Michigan
for his hard work on this legislation, for his willingness to
walk through the shallow of the valley of death, literally, and
move this bill along. I also want to thank him for his
inclusion of H.R. 570, the Dental Emergency Responders Act,
which provides clear authority for dental professionals to
participate in supporting medical and public health measures in
response to disasters.
So I certainly look forward to working with the chairman
and to Mr. Rogers on this bill and see to the passage of H.R.
2405 as well as the other bills before us. I will be happy to
yield any time I have remaining to any other member on the
Republican side who wishes to comment or an opening statement.
If not, Mr. Chairman, I will yield back to you.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the ranking member of the full committee, Mr.
Waxman, for 5 minutes.

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA

Mr. Waxman. Thank you, Mr. Chairman, for holding today's
hearing on three important pieces of public health legislation,
H.R. 2405, the Pandemic and All-Hazards Preparedness
Reauthorization Act of 2011; H.R. 1254, the Synthetic Control
Drug Act of 2011; and the soon-to-be-introduced Enhancing
Disease Coordination Activities Act of 2011. I am pleased that
we have once again come together on a bipartisan basis to move
forward with these bills. Although our work is not quite
complete, I feel confident that we will work out the substance
of these bills for further discussion.
I want to thank you, Mr. Chairman, and your staff, as well
as all the members of the subcommittee for working with us to
make this happen. This bipartisan approach has been the
foundation upon which each of the proposals we will discuss
today has been developed.
The Pandemic and All-Hazards Preparedness Reauthorization
Act reauthorizes programs and activities first established in
the 2004 Project Bioshield Act. These programs are critically
important to help ensure that our Nation is well prepared to
successfully manage the effects of natural disasters,
infectious disease outbreaks, and acts of bioterrorism. In
reauthorizing these programs and activities, there are a number
of issues we are exploring and would like to hear about during
today's hearing. In my view, surge capacity, the ability of our
healthcare system to respond to mass casualty emergencies and
biosurveillance--the ability to detect natural or manmade
hazardous or disastrous events as soon as possible--deserve
special attention. So does the State and local public health
infrastructure needed to support these kinds of efforts.
The role of the FDA in dealing with various public health
emergencies of great enormity is especially critical. I have
concerns about the new Regulatory Management Plan that is
proposed in 2405, but I believe we can achieve the balance
necessary to make certain that the communications process
functions as it should--on the one hand, allowing FDA the
flexibility it needs to deal with regulatory science issues of
great complexity; on the other, we should also consider the
idea of allocating some of the Bioshield funds to FDA in
support of its countermeasure review process. This approach
would allow FDA's work to complement the efforts of both NIH
and BARDA. Clearly, we cannot permit resource constraints to
stand in the way of FDA's ability to complete its reviews,
putting in potential jeopardy the entire Bioshield enterprise.
Other subjects we would want to look at include the unique
needs of children in disasters, an issue that Congresswoman
Eshoo has been championing, and the administration's strategic
investor proposal. And like the other issues I have just
mentioned, I am confident that all these matters will be
resolved in a bipartisan negotiation.
Let me now speak briefly about the two other bills in our
hearing today. The Synthetic Drug Control Act adds specified
synthetic versions of drugs of abuse to Schedule 1. These
designer drugs can be very unsafe causing convulsions, anxiety
attacks, and dangerously elevated heart rates, among other
conditions. This bill would enable the Drug Enforcement Agency
to take appropriate enforcement actions to get them off the
street and away from our Nation's youth.
Finally, the Enhancing Disease Coordination Activities Act
provides direct authority to the Secretary of HHS to establish
disease-specific interagency coordination committees and lays
out the parameters for these committees. This will be modeled
on the highly successful Interagency Autism Coordinating
Committee, which we learned about in last week's hearing.
Again, I want to thank you, Mr. Chairman and the members of
the subcommittee for the cooperation with which we have worked
on all three bills under consideration. I look forward to the
hearing today and to working out our issues. And I have less
than a minute if anybody on our side would like a minute? If
not, I yield back the time.
[The prepared statement of Mr. Waxman follows:]

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Mr. Pitts. The chair thanks the gentleman. That concludes
the members' opening statements. I would like to thank all the
witnesses on both panels for agreeing to appear before the
committee today. We will go to Panel 1. Congressman Charlie
Dent represents Pennsylvania's 15th Congressional District. He
is the author of H.R. 1254, the Synthetic Drug Control Act.
Representative Dent, you may begin your prepared testimony.

STATEMENT OF HON. CHARLES W. DENT

Mr. Dent. First, I want to thank the committee and the
subcommittee. Thank you, Chairman Pitts, Ranking Member
Pallone, Chairman Upton, Ranking Member Waxman, for this
opportunity to talk to you today about this very important
issue.
Now, it was a little under a year ago at this time that the
issue of synthetic drugs or designer drugs was first brought to
my attention by a constituent named Alana Marshall, whose son
had been abusing legal substitutes for marijuana. And in fact,
just a couple of months ago I went to the Children's Hospital
of Philadelphia where they had seen very little of this issues
in synthetic drugs, bath salts, et cetera, and now they are
seeing a case every single day. That is how prevalent this has
become in such a very short period of time.
These synthetic cannabinoids affect the brain in a manner
similar to marijuana, but they can actually be much more
harmful. Synthetic marijuana or cannabinoids are just one
category of designer drugs. Even more potent substances have
properties similar to cocaine, methamphetamine, LSD, and other
hard street drugs. These substances are marketed as innocent
products like bath salts, plant food, incense, and they are
sold under brand names familiar to their users such as K2
Spice, Vanilla Sky, Ivory Wave, but these are total misnomers.
They are designed to facilitate their legal sale. These drugs
have really no legitimate purpose. And these bath salts, by the
way, are things you would never put in your tub. Some people
are confused by that that actually think they are what people
put in their tub. That is not the case at all.
Over the past year, there has been a sharp increase in the
number of reports detailing horrific stories of individuals
high on synthetic drugs. A man in Scranton, Pennsylvania,
stabbed a priest and another jumped out a three-story window.
Both were high on bath salts. Several deaths from West Virginia
to Florida have been attributed to overdoses of synthetic
drugs. Senator Grassley of Iowa has introduced a bill with
provisions similar to the one in this one, H.R. 1254, named
after one of his young constituents who tragically took his own
life while high on synthetic marijuana. A man in my district
was arrested this past May for firing a gun out of a window in
a university neighborhood. The police charges indicate that the
individual injected himself with bath salts and he later told
the police he thought there were people on the roof watching
him.
Finally, you know, I was approached by another distraught
mother from my district whose son was hospitalized for over 2
weeks after suffering liver failure and other complications
after injecting himself with bath salts. These substances pose
a substantial risk both to the physical health of the user as
well as to the safety of those around them when these drugs
contribute to dangerous psychotic behavior, suicide, and public
endangerment. The fact that these drugs are legal in many
States contributes to the misconception that they are safe and
the use of these easily recognizable brand names and logos on
the packaging promotes the concept of a consistent product.
Significant variation of potency from one unit to the next has
led recurrent users to inadvertently overdose.
You know, and one of the major difficulties in combating
these designer drugs is the ability of the producers to skirt
the law with different chemical variations. You know, by
modifying the formula in some minor way, producers can generate
a new compound which circumvents legal prohibitions but has
similar narcotic events. And that is why we have H.R. 1254,
this Synthetic Drug Control Act of 2011, and we drafted this in
consultation with other law enforcement officials, particularly
the DEA, and this legislation has three principle components:
prohibition of broad structural classes of synthetic marijuana
or the cannabinoids; prohibition of other designer drugs such
as bath salts--that is methylenedioxypyrovalerone (MDPV) and
others--and there is an expansion of the DEA's existing
authority temporary ban of substance from 1-1/2 to 3 years. And
that is very, very significant, that additional time.
Under current law, if the DEA and the Department of HHS can
prove that a substance is dangerous, that is important, but
they also are lacking in legitimate value while it is
temporarily banned. So the prohibition becomes extremely
important. I can't emphasize this enough, this authority for
DEA. You know, I should mention, too, that there are a lot of
States out there right now to pass laws. Pennsylvania, my
State, just passed a law last month that had banned many forms
of these synthetic drugs, but Federal action is certainly
necessary to prevent these drugs from being obtained by simply
crossing State lines or increasingly ordering them over the
internet.
And I think every State representative on this panel--
except Ohio, but Representative Latta will fix that--has
enacted laws restricting some synthetic drugs in one form or
another. So all your States have already taken some action, and
that I think you should be commended. So Texas, Michigan,
Kentucky, New Jersey, Illinois, New York, North Carolina,
Georgia, Wisconsin, Washington State, you know, they are all
really taking some action--Louisiana, Arkansas, Utah. So State-
by-State differences in which individual substances are
controlled and how strongly makes for a confusing legal
patchwork, and this bill will provide for a national ban on
these dangerous drugs.
You know, as we speak, the Senate Judiciary Committee right
now is marking up a companion synthetic drug legislation, and
so I really would encourage this subcommittee, then the full
committee to take up H.R. 1254 as soon as possible and report
it. I do really appreciate this. This is a very serious public
health issue and it is just getting worse by the day. These
drugs come into this country usually by Europe, start in Asia,
head to Europe, so we usually have a good idea of what is
coming here. The DEA is on top of this but they really do need
this additional authority. And again, I appreciate your
consideration.
Thank you again, Chairman Pitts, Ranking Member Pallone.
[The prepared statement of Mr. Dent follows:]

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Mr. Pitts. The chair thanks the gentleman for his testimony
and thanks him for his leadership on the issue. We look forward
to working with you on the legislation. And you may be excused
at this time.
And we will call Panel 2 to the witness table. Our second
panel consists of two witnesses. Dr. Nicole Lurie is the
Assistant Secretary for Preparedness and Response of the
Department of Health and Human Services; and our second
witness, Dr. Howard Koh, is the Assistant Secretary for Health
of the Department of Health and Human Services. Thank you for
coming this morning. Dr. Lurie, you may begin your testimony.

STATEMENTS OF NICOLE LURIE, ASSISTANT SECRETARY FOR
PREPAREDNESS AND RESPONSE, DEPARTMENT OF HEALTH AND HUMAN
SERVICES; AND HOWARD K. KOH, ASSISTANT SECRETARY FOR HEALTH,
DEPARTMENT OF HEALTH AND HUMAN SERVICES

STATEMENT OF NICOLE LURIE

Ms. Lurie. Good morning, Chairman Pitts and Ranking Member
Pallone and distinguished members of the subcommittee.
In 2006, the Congress understood the critical need to
strengthen our public health and medical preparedness
activities enacting the Pandemic and All-Hazards Preparedness
Act, or PAHPA as it is affectionately known. Recent events
remind us of the significant challenges that we continue to
face from ever-present and always-evolving terrorist threats to
unprecedented natural emergencies and how quickly and
unpredictably the call comes to respond and support the
American people.
Within HHS, PAHPA established the Assistant Secretary for
Preparedness and Response as the lead in coordinating Federal
health response to disasters. In 2009, I had the privilege of
being asked to lead ASPR, a still-young organization with a
vital mission to lead the country in preparing for, responding
to, and recovering from the adverse health effects of
emergencies and disasters. And since that time, ASPR has risen
to the challenge in the face of unprecedented events. As we
responded, capturing lessons learned along the way, we kept
careful note of where legislative changes would enhance our
response to efforts in the future. I would like to take a few
minutes now to walk you through some of them.
The H1N1 pandemic tested our ability to adapt and respond
to a novel influenza strain and required all parts of the
healthcare, public health, and response systems to work
together and to innovate. One of the most important lessons
learned came from seeing that at every step along the way we
needed to be able to rapidly get resources to where they needed
to go. Consequently, we are interested in authority to
temporarily allow States to reassign certain HHS-funded
personnel to critical areas of need during a public health
emergency.
Both H1N1 and the Japanese nuclear crisis demonstrated the
importance of getting countermeasures to those who need them as
quickly as possible. Often the speed with which countermeasures
are administered is the difference between life and death, and
so we would like the authority to issue Emergency Use
Authorizations, or EUAs, prior to an event. This would minimize
delays in making critical countermeasures available when
needed.
In addition, clarifying FDA's authorities to extend the
timeline for safe and effective products through the Shelf-Life
Extension Program will facilitate using these products when
needed and will make investments go further helping save
taxpayer dollars on replacement costs and stockpiling
practices.
We have been successful in developing promising safe and
effective medical countermeasures and the Bioshield Program has
indeed been a critical tool. As demonstrated by the language
included in H.R. 2405, your continued support to this program
is a clear commitment to the Nation's preparedness.
I would want to highlight that we embrace the whole-
community approach articulated by FEMA, particularly in
planning for all at-risk individuals. In the countermeasure
arena, we have become very aggressive about pursuing medical
countermeasure products for children.
The secretary's Medical Countermeasure Enterprise Review
recognized that to achieve a modern and flexible enterprise
that can quickly develop and produce safe and effective
products, we must strengthen each of the enterprise's major
components. One recommendation, the Strategic Investor
Initiative, will support and accelerate the activities of
companies that have innovative products while reducing the
probability that the companies will fail because of their
inability to manage their business risks.
H.R. 2405 reauthorizes two critical elements of our
preparedness enterprise: the Hospital Preparedness and the
Public Health Emergency Preparedness Cooperative Agreement
Programs. When I visited Missouri after Joplin and witnessed
the ongoing response and recover efforts from the tornadoes in
May and similarly with the tornadoes in the South before that,
it was again clear to me why we need both medical care and
public health capabilities.
A central priority for me is the alignment of these two
programs, as well as similar grant programs throughout the
government to efficiently use limited resources, eliminate
duplicative or conflicting programmatic guidance, and reduce
the administrative burden for grantees. We anticipate that the
PHEP and HPP programs will be aligned in time for the 2012
Grant Guidance. Reauthorizing other programs, including BARDA,
the Medical Reserve Corps, the National Disaster Medical
System, and the Emergency System for the Advanced Registration
of Volunteer Healthcare Personnel will ensure investments
continue to support and foster resilient communities.
As identified in the original PAHPA legislation, HHS and
specifically ASPR has the lead for coordinating the Federal
health response efforts during public health emergencies. In my
time as serving as assistant secretary, ASPR has strengthened
its leadership role within HHS as well as nationally. Along
with our Federal partners, we have improved our coordination of
preparedness and response operations, and we have also gotten
better at how we coordinate. Our continued progress and
improvements along with clarifying and strengthening
authorities that I have talked about today will ensure ASPR and
HHS have the tools necessary to protect the Nation against
public health threats.
We applaud Congress' leadership and vision for enacting
PAHPA as the foundation for effective response and recovery to
public health emergencies, and I look forward to working with
you as PAHPA is reauthorized in this congressional session.
Thank you.
[The prepared statement of Ms. Lurie follows:]

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Mr. Pitts. The chair thanks the gentlelady.
Dr. Koh, you are recognized for your opening statement.

STATEMENT OF HOWARD K. KOH

Mr. Koh. Thank you very much, Chairman Pitts, Ranking
Member Pallone, and distinguished members of the committee. I
am Dr. Howard Koh, the Assistant Secretary for Health for HHS
and I am very pleased to be here to testify on the legislation
entitled ``Enhancing Disease Coordination Activities Act of
2011.''
As the Assistant Secretary for Health, I have the honor of
overseeing some 14 core public health offices, 10 regional
health administrators and their staffs, and 10 secretarial and
presidential advisory committees. Collectively, our Office of
the Assistant Secretary for Health implements an array of
interdisciplinary programs relating to ensuring the Nation's
public health. And in fact our portfolio includes programs in
many areas such as disease prevention, health promotion,
women's health, minority health, adolescent health, vaccines,
fitness, sports, and nutrition, human research protection,
among other areas. The mission statement of our offices in fact
is ``Mobilizing leadership in science and prevention for a
healthier Nation.'' We are very proud of this mission and we
are very proud of the efforts of the Department all public
health colleagues in fact in helping all Americans reach their
highest attainable standard of health.
So in that context, I am very pleased to add some comments
about the draft legislation here before us to improve the
coordination of research and other activities conducted or
supported by HHS that are specific to a disease or condition. I
thought it would be useful to share our experience in
coordination efforts at HHS because over recent months, our
office has helped put forward strategic plans in coordination
in a number of areas including tobacco, HIV, racial-ethnic
disparities, viral hepatitis, vaccines, multiple chronic
conditions, health literacy, and other areas.
I would like to focus on one particular plan as an example
of our coordination efforts at the Department and that has to
do with tobacco. As you all know, tobacco addiction is one of
the most troubling public health challenges of our time, and in
fact in the 21st Century it is forecast that tobacco use
globally will cause some one billion preventable deaths. And
that is a stunning fact that demands our attention and our
action.
So to address this public health challenge, the Department
last year released its first-ever comprehensive tobacco control
strategy called ``Ending the Tobacco Epidemic: A Tobacco
Control Strategic Plan.'' This process in fact began in the
spring of 2010 when the secretary charged me to convene a
coordinating committee across the Department consisting of
leaders from every agency to inventory the activities and
efforts that were underway and then leverage them together to
have maximum impact with our current resources. And we were
very pleased to unveil that plan last fall with activities
focused on four pillars: engaging the public, supporting State
and local efforts, advancing research, and having HHS lead by
example.
I am very pleased to report to this committee that already
we have seen some results accomplished that would not have been
possible without this high level of coordination and
collaboration. For example, just several weeks ago on July 1,
the secretary announced that HHS was now completely tobacco-
free. And also in recent weeks our Centers for Medicare and
Medicaid Services (CMS) has released formal guidance on the
Affordable Care Act's expansion of smoking cessation benefits
for pregnant women enrolled in Medicaid. Also, CMS has formally
announced new options for Medicaid beneficiaries such that
administrative reimbursement for quit lines could be put
forward. So that is a very important resource to help smokers
quit.
We are also pleased to report that this action plan has
garnered a lot of support from the general community. For
example, just last week, there was a scientific report released
showing a significant decrease in smoking in the movies, which
contributes to changing the social norm about this very
important public health issue. That report cited the HHS
tobacco action plan as an example of bringing more attention to
mass media efforts around tobacco control as well. So we look
forward to presenting more progress on plans like tobacco and
many others as an example of our commitment to collaboration
and coordination.
The draft legislation here today--``Enhancing Disease
Coordination Activities of 2011''--recognizes that important
role of cross-departmental coordination and collaboration, and
we want to thank the committee for your thoughtfulness and
insight in putting that effort forward. I should note, however,
that Section 222 of the Public Health Services Act already has
the secretary with the authority to create advisory councils
and committees and appoint members to those groups. So with
that authority, the Department has established a number of
advisory committees which allow the Department to get input
from external experts and then also allows for the public to
engage in the work and policy-development process that occurs
at the Department.
The proposed legislation supports very strongly the efforts
of coordination collaboration and that spirit, but I do want to
note that it may introduce some unintended redundancies. For
example, the legislation requires that each coordination
committee have a strategic plan every 2 years and update that
plan every 2 years. And under the current structure, we have
our advisory committees establishing their own priorities and
updating plans on a flexible schedule, so the bill's
requirement for an every-2-year timetable could take away time
and resources that could be better used for implementation.
Another area I do want to mention is potential costs to the
Department that could be associated with this legislation. The
Department already commits significant resources to existing
advisory committees and having to spend even more funds on many
more committees could potentially take away dollars from other
important endeavors and potentially represent duplication of
efforts.
So in closing, I want to thank the committee for its
recognition and promotion of the important role that cross-
agency collaboration and coordination play in developing strong
policy. I would urge the committee to take into account the
current system that exists and I believe works well at HHS for
establishing and managing advisory groups. And as always, we at
the Department look forward to working closely with you on
many, many important areas in public health. Thank you very
much and, of course, I am happy to take any questions on these
issues.
[The prepared statement of Mr. Koh follows:]

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Mr. Pitts. The chair thanks the gentleman and thanks both
of our witnesses for your testimony. I will now begin the
questioning and recognize myself for 5 minutes for that
purpose.
We begin, Dr. Lurie, with you. Congress enacted the Project
Bioshield Act of 2004 and the Preparedness and All-Hazards
Preparedness Act of 2006 to build the Nation's preparedness
infrastructure and foster the development of chemical,
biological, radioactive, and nuclear medical countermeasures so
the Nation could better respond to attacks. Would you please
expand on your comments on how these laws have helped prepare
our Nation?
Ms. Lurie. Certainly. Thanks for that question.
As I think we know, the development of medical
countermeasures has been a particularly vexing problem because
there is by and large not a commercial market for these
products. So through these laws, we have a) provided funding to
develop these countermeasures, b) provided the assurance that
the Federal Government will be a good partner and will purchase
these products if in fact private companies come to make them.
In doing all of this work and through the enterprise, over time
we have continued to strengthen our efforts both to identify
what needs to be developed, to identify how it is developed, to
strengthen our work with developers and companies, and now to
move forward to coordinate the efforts with BARDA in the lead,
with FDA, CDC, NIH, and BARDA so that we now have a much more
seamless process for countermeasure development.
At the end of the day, however, this stuff takes a long
time, it is really expensive, and we have an obligation to the
American people to be sure we are prepared. When we started all
of this and when you all decided to help cross this so-called
``valley of death,'' we had almost no products in the
development pipeline. Now, I am proud to say we have over 70
CBRM products in development and a slue more in the flu area
and we have moved forward to procure a number of
countermeasures for the Strategic National Stockpile for
smallpox, anthrax, botulism, red nuke threats, et cetera. I
could go on and on.
Mr. Pitts. Thank you. Your position, the Assistant
Secretary for Preparedness and Response, was created in the
Pandemic and All-Hazard Preparedness Act of 2006 to lead the
oversight and coordination of the entire medical countermeasure
enterprise through HHS. Would you give us your insight on the
challenges you have faced in leading this enterprise, what we
can do to help you in your position, and in the aftermath of
the natural disasters and pandemics of the past few years, can
you describe some of the challenges that you and your staff
have faced, especially related to coordination, flexibility,
and communication?
Ms. Lurie. Great. No, I very much appreciate that question
as well. You know, I came into this position early on in H1N1
and the importance of coordinating across all of HHS was
terribly important, whether it was our public health response
or our healthcare response or our countermeasure response, all
of those things kneaded together. So through my office and
because of the authorities of my office, we have been able in a
very regular way to pull together all of the parties end to end
on the countermeasures side and through the response side to be
sure everybody is working together.
You know, as do we all, some of the programs are at CDC,
some of the programs are at HRSA, some of the programs are at
NIH or FDA, and we all meet together under my leadership to
identify gaps and to solve problems. I do sit on the
secretary's Budget Council. I do have the opportunity to review
and provide input into the budget process through that
mechanism.
An area that has worked particularly well has been the
PHEMCE, or the Public Health Emergency Countermeasures
Enterprise, which I lead and chair. And again, through the
Medical Countermeasure Review, we have really enhanced the
coordination of all of the parties so that now everybody sits
at the table and sits at the table with product developers at
the beginning, identifies the plan, identifies the gaps, and
works together going forward. I would also comment that DOD and
DHS participate in this, so our role coordinating there is much
broader in fact than just at HHS.
Similarly, on the healthcare delivery system side where we
have responsibilities as Mr. Waxman pointed out for medical
surge and for working through issues in the emergency care
system, we coordinate and work closely with our colleagues at
CDC and HRSA and CMS, the National Disaster Medical System and
Hospital Preparedness Programs, you know, being two major
centerpieces of those.
Mr. Pitts. Thank you. My time has expired. I yield to the
ranking member of the subcommittee, Mr. Pallone, for 5 minutes
for questions.
Mr. Pallone. Thank you, Mr. Chairman.
Dr. Koh, if I could start with you, you noted in your
testimony that under Section 222 of the Public Health Service
Act, the secretary already has the authority to create advisory
councils and other committees and to appoint members. As I
understand it, the intent of the Enhancing Disease Coordination
Activities Act, which is before us today, is not to duplicate
that authority but rather to outline the structure and
functions of committees' focus on coordinating a specific
disease or health condition. The provisions of that bill are
modeled on those in the Autism Coordinating Committee, and as
we heard in our hearing last week, that has been very
successful.
So as we consider this new bill, I wanted to be sure that
if and when the secretary elects to establish another disease-
related coordinating committee that it operates in an effective
and productive way. So based on the experiences you shared in
your testimony, are there certain elements of success that have
gone into these efforts that should be reflected in the
legislation?
Mr. Koh. Well, thank you for that question, Congressman,
and also thank you for your commitment to public health in
general.
So as I mentioned, we always review the landscape in terms
of evolving public health challenges in a magnitude of new
issues and then assess the resources and the responsibilities
of the various parts of HHS and see how we can coordinate that
to the best of our ability. In the examples I cited, many of
these had strategic plans which were very, very valuable
because it explicitly put forward the resources we had agency
by agency and also put forward common goals and measures by
which we would work together and measure success. So that is an
effort that I think has been very, very valuable in many of the
areas that I have pointed out. And in the interagency Autism
Committee, there is an excellent strategic plan that has also
been developed with goals and targets that is being followed.
So I think the more explicit the coordination and the goal-
setting is, that is a major element of success moving forward.
Mr. Pallone. Now, let me ask Dr. Lurie, my colleagues on
the subcommittee--most notably Representative Eshoo--have some
concerns that the current programs do not adequately address
the needs of the pediatric population and would like to see
some enhancements that would assist in the Nation's ability to
care for kids in the event of a public health emergency. Kids
make up 25 percent of the Nation's population, so it only seems
natural to me that we should prepare for their unique needs in
the case of an emergency or disaster. So in that regard, I
would like to issue some questions.
First, is the Strategic National Stockpile adequately
stocked for pediatric populations? If not, how can the Pandemic
and All-Hazards Preparedness Act before us today be
strengthened to ensure that the SNS has adequate supplies for
pediatric populations? And we will start with that, but I have
got three questions.
Ms. Lurie. Sure. I think those are great questions. And you
know, when I came into this position, I came in facing a
pandemic that a) was primarily killing children, and b) I came
into it as a mom and looked at this set of issues that relate
to strengthening our ability to respond to pediatric issues in
all areas. Since this experience, we have done a number of
things to strengthen our pediatric footprint. We have hired
pediatricians within BARDA and we have also hired and brought
on a chief medical officer to really pay attention to the
countermeasure development needs. In addition, we have
developed a pediatric NOB, interagency workgroup that advises
now each stage of development for countermeasure requirement-
setting all the way through development and procurement so that
we strengthen the pediatric footprint there.
And finally, I have directed my staff to look at every new
contract we let to be sure that the development of pediatric
countermeasures is there from the get-go so we now have a
smallpox antiviral contract that supports pediatric
formulation, the new advanced research and development
contracts for new broad-spectrum antimicrobials, support
pediatric populations. We have funded the development of the
palatability studies so that we can----
Mr. Pallone. Well, let me finish this because my time is
almost up.
Ms. Lurie. Yes.
Mr. Pallone. Is there anything that we don't have in the
law that would prevent you from integrating kids into the
national preparedness goals? Is there something that we need in
the law?
Ms. Lurie. I tried to think hard about that because I am
always a big fan of getting the authorities we need. My view
right now is that we have made enormous progress with the
authorities we have and there doesn't seem to be anything in
the way for me of us continuing to make more progress in these
areas. At the end of the day, I will point out that pediatric
countermeasures are expensive to develop and test and the
market issues there are like the market issues in the rest of
the countermeasures sphere but more profound. So from an
authorization perspective, I feel like I have what I need.
Mr. Pallone. Mr. Chairman, I know that time has run out but
just when she was saying she was hiring those pediatricians,
all I kept thinking was that we better pass our bill with the
Graduate Medical, the GMEs, otherwise there won't be any
physicians to hire.
Mr. Pitts. I was thinking the same thing.
Ms. Lurie. There we go.
Mr. Pitts. The chair thanks the gentleman and recognizes
the vice chairman of the committee, Dr. Burgess, for 5 minutes
for questioning.
Mr. Burgess. Thank you, Mr. Chairman. And Dr. Lurie, thank
you for being here. Thank you for helping our office when you
first took your position and the H1N1 was clearly making its
presence felt in the State of Texas. We felt it acutely.
Appreciate the efforts from your office to help us discuss that
with the Fort Worth Independent School District during the
summer. You were concerned about kids; I was concerned about
pregnant women, schoolteachers in particular who would be
exposed to large numbers of children during the beginning of
the next school year. And it is one thing to close down the
schools in May; it is another thing to close them down in
September where so much instructional time could be lost in the
year going forward. And although, certainly, I know there have
been criticisms about how all of that was handled. I think it
certainly could have been much more disruptive than it was, and
I think that is largely due to your efforts.
The issue of pediatric dosages being available was
something I became acutely aware of when contacted by the
Tarrant County Health Department that they did not have
antivirals available in children's doses and were simply having
to make it up as they went along, and that is clearly
uncomfortable.
I have got some questions for you about the National
Strategic Stockpile. I need to set it up a little bit so bear
with me. In July of 2010, I sent a letter to the National
Strategic Stockpile, myself and Joe Barton as the ranking
member of the full committee and Subcommittee on Oversight and
Investigations talking about the preparedness through the
National Strategic Stockpile. Ten items were in that letter.
Number five was dealing with the stockpile's ability to deliver
threat-appropriate materials in the event of something that
required national activation. So we were interested in the
methods to secure delivery of threat-appropriate materials from
both domestic and foreign manufacturing sites in the stockpile
activation. The material provided back to me by Dr. Friedan of
the CDC on issue number five detailed some of the things that
they were doing.
As part of that response, Dr. Friedan referenced the
Executive Order 12919, that HHS with the approval of DHS and
FEMA may utilize the Defense Production Act authority with
respect to health resources. That is pretty broad authority.
Essentially, the Federal Government could take over those
things if necessary at the time of a national emergency. But
then the question comes up, you know, we have authority over
foreign manufacturers and we do rely on foreign manufacturers
for materials, masks, gloves, active pharmaceutical ingredients
for some of these materials. So, again, the question, then, can
you give us a description of how your office coordinates the
movement and delivery of special medical countermeasures to
ensure the delivery of threat-appropriate materials in the
event of a National Stockpile activation? That is one.
And the second is in the event of a global pandemic, can
you assure the committee that there are the resources available
to ensure threat-appropriate materials will be able to be
disseminated among the population?
Ms. Lurie. Great. Well, thank you for both the set up and
for the question. But first, let me also thank you for your
leadership during the pandemic and your leadership both with
the pediatric and the OB community. I think largely because of
your efforts in highlighting this issue, we now have record
numbers of pregnant women vaccinated for influenza. I think it
has made a huge difference. It also led us to think very hard
about including OB issues in this pediatric interagency working
group so that we are sure that we really nail those issues for
both the pregnant women and children as we develop
countermeasures moving forward.
Mr. Burgess. Mr. Chairman, let me just ask unanimous
consent. I would like to make copies of Ranking Member Barton's
and my letter available to the record as well as the response
we got from Dr. Frieden. Let me get this material to you, Dr.
Lurie, because this requires some thought and perhaps some
research in delivering an answer. But it is important. And
really the essential issue is how do we assure that we are
going to be able to deliver threat-appropriate materials to the
correct places? Yes, we can have broad authority in this
country----
Ms. Lurie. Yes.
Mr. Burgess [continuing]. But what do we do if we are
getting that stuff from Mexico, the Philippines, China--fill in
the blanks? And that is really my main consideration.
Ms. Lurie. It is an important question. It is something
that I think we have a number of answers to and we are
continuing to work on, but I think it might use up an awful lot
of time.
Mr. Burgess. All right. We will get that to you in writing.
Ms. Lurie. So if you want to get that to us, we will be
happy to get back to you on it.
Mr. Burgess. Dr. Koh, let me just briefly ask you. You
referenced quit lines in your testimony. Is that like a 1-800
number?
Mr. Koh. I think the number is 1-800-QUIT-NOW and it is a
coordinated national effort.
Mr. Burgess. Have you done any studies to see the efficacy
of a quit line as opposed to, perhaps, a medically supervised
program of Chantix, Wellbutrin, or even medical hypnosis in
regards to smoking cessation? I appreciate your leading by
example. I think that is great that HHS is smoke-free. We need
to work on the White House and the U.S. House, but those are
separate considerations of leading by example. I would
appreciate you helping me with that. But I would also
appreciate if you could give us some information about what
research you have done as to the efficacy of the quit lines as
opposed to medical therapy. I was always disturbed in my
practice and I was never reimbursed for helping someone with
smoking cessation, and yet it might be the single-most thing
that you could do to help with their future health if you could
get them to quit smoking.
So thank you, Mr. Chairman, for your indulgence. I will
yield back.
Mr. Koh. Thank you, Congressman. You raise many good points
in your question. And first, I should say that we are very
pleased at the increasing attention on prevention in general in
the country and with the passage of the Affordable Care Act,
there are many preventative benefits that are begin afforded to
people, especially in the area of tobacco cessation and tobacco
counseling.
Smoking quit lines have been studied very, very carefully
and in excellent randomized trials, and those studies showed
the benefit have led to the expansion of quit lines across the
country. And this 1-800-QUIT-NOW number that is available to
anybody in the U.S., and in general, we support using all these
measures together--quit line services, counseling, medications
when appropriate. We want prevention to be a multi-dimensional
effort so we can move people to a tobacco-free future.
Mr. Pitts. The chair thanks the gentleman. Without
objection, the letters that you have submitted will be entered
into the record. So ordered.
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Mr. Pitts. And the chair now recognizes the ranking member
emeritus, Mr. Dingell, for 5 minutes for questions.
Mr. Dingell. Mr. Chairman, thank you for your courtesy. I
will be focusing my questions today on the Pandemic and All-
Hazards Preparedness Act. My questions will be directed to Dr.
Lurie, and I would like a yes or no response if that be
possible.
We have made progress but we know from recent events such
as the H1N1 pandemic that more must be done to ensure our
Nation's readiness to respond and recognize such events. It is
also important to note, as Secretary Napolitano recently did,
that one of the evolving threats to our Nation is the use of
chemical, biological, or radiological devices.
Now, first question, in your role as Assistant Secretary
for Preparedness and Response, you have a responsibility for
the preparations to address the threat of bioterrorism. Do you
believe that a bioterrorism even from a biological weapon
remains at or near the top of the Nation's most serious
threats? Yes or no?
Ms. Lurie. Yes.
Mr. Dingell. Next question, do you believe that we
currently have the necessary medical countermeasures stockpiled
to respond to a bioterrorist event? Yes or no?
Ms. Lurie. Not completely.
Mr. Dingell. OK. Would you submit to us a statement showing
where you feel we need to have more of these kinds of agents
stockpiled?
Do you believe that the U.S. is now in a position to
recognize and respond to threats such as a bioterrorist event
or an emerging infectious disease outbreak similar to H1N1? Yes
or no?
Ms. Lurie. I think we have made a lot of progress. We have
more ground to cover.
Mr. Dingell. But the answer is no?
Ms. Lurie. The answer is no.
Mr. Dingell. Do you believe that the Congress has allocated
sufficient funding to develop and procure proper medical
countermeasures? Yes or no?
Ms. Lurie. I think we have made a lot of progress. We have
more to----
Mr. Dingell. The answer is still no?
Ms. Lurie. The answer is still no.
Mr. Dingell. One of the greatest problems we faced during
the H1N1 pandemic was delays and interruptions in the
production of a vaccine, which has been an ongoing and
continuing problem for many reasons. Your testimony mentions
the Centers for Innovation in Advanced Development and
Manufacturing as one way to increase domestic manufacturing and
surge capacity for medical countermeasures. ASPR put out a
request for proposals in March. How many centers will ASPR
support?
Ms. Lurie. Well, I should tell you that the deadline for
submission is today. We have already been receiving
submissions.
Mr. Dingell. Would you give us, then, for the record an
answer to that question?
Ms. Lurie. Sure.
Mr. Dingell. Now, you state in your testimony that the
centers will also be available to manufacture vaccines in the
event of a pandemic. Given this, will you take into
consideration geographic questions when choosing where to
establish these centers? Yes or no? In other words, are you
going to consider geographic questions as to where you are
going to locate the centers?
Ms. Lurie. I think the most important factor to consider is
whether the proposers can do the job.
Mr. Dingell. Of course. Now, do you believe that the
centers will help reduce U.S. reliance on vaccine manufacturers
based overseas? Yes or no?
Ms. Lurie. Yes.
Mr. Dingell. Would you submit for the record a little
monograph as to why you feel that would be so?
Ms. Lurie. Certainly.
Mr. Dingell. Do you believe that these centers will have a
role in supporting small companies who have developed or are
currently developing medical countermeasures? Yes or no?
Ms. Lurie. Yes.
Mr. Dingell. And in the case of places like the University
of Michigan or other universities where they have substantial
spinoffs, this would be a very big help. Do you agree?
Ms. Lurie. Yes.
Mr. Dingell. Now, Doctor, as you know, the Department of
Defense has put out a request for proposals for advanced
development and manufacturing of medical countermeasures. Have
you been working closely with DOD to minimize any potential
duplication between these centers? Yes or no?
Ms. Lurie. Yes. We have been working very closely from the
very beginning, they with our proposal and us with them.
Mr. Dingell. Would you submit to us, please, a brief
statement as to what you are doing and how you expect this to
assist you and DOD in avoiding duplications----
Ms. Lurie. Sure.
Mr. Dingell [continuing]. And other kinds of unfortunate
events, please?
Mr. Chairman, I thank you for your courtesy. I yield back
the balance of my time.
Mr. Pitts. The chair thanks the gentleman and recognizes
the gentleman from Illinois, Representative Shimkus, for 5
minutes.
Mr. Shimkus. Thank you, Mr. Chairman. Thank you for
attending. I am going to kind of stay on my focus on Dr. Lurie
also.
And my first question deals with your proposal to extend
the shelf life on NCMs. Why is that important and can you go in
a little bit more detail?
Ms. Lurie. Sure. Well, right now----
Mr. Shimkus. And I think for those who aren't physicians,
shelf life, there is an issue there and we don't know really
much about the details.
Ms. Lurie. Right. Well, first, let me say that in all of
this our primary concern is continuing to make available safe
and effective medical products and countermeasures for the
American people in an emergency. Particularly with some of the
newer countermeasures that have developed, as well as
antibiotics and other things that have been around for a long
time, if they are stored properly and according to standards,
they remain safe and effective. It turns out that many of them
remain safe and effective and maintain their potency beyond the
initial date at which everyone thought that they could
guarantee their safety and effectiveness. As long as they still
work, as long as they are still tested----
Mr. Shimkus. And we know that by pulling them all randomly
and checking----
Ms. Lurie. We know by them pulling them off randomly. We
know them by testing. And there is a very extensive testing
process that goes on.
Mr. Shimkus. And the stored agents are basically the ones
that we most assume we will need readily available.
Ms. Lurie. So they might be vaccines, they might
antimicrobials, they might be antitoxins. So we test all of
these regularly as part of our stockpile maintenance.
Mr. Shimkus. Let me go to a lot of concerns is what you
have on hand and may be used that is not on hand, and the ramp-
up of something not expected. And in your testimony you talked
about the idea of a strategic investor.
Ms. Lurie. Um-hum.
Mr. Shimkus. How does that differ from--well, what is that
by definition? Because it is a little vague. And is that
similar to a private venture capital firm or are you proposing
that the government take the role of a venture capitalist in
this and that is what this strategic investor is?
Ms. Lurie. So the strategic investor is a nongovernment,
private, not-for-profit entity that does some of the things
that venture capital companies do but focuses strategically to
meet the Federal Government's needs in areas that is not met
now. You know, these Centers for Advanced Development help us
with the technical problems companies face.
It is also the case as we have looked at our experiments
that a lot of companies fail for business reasons or because
they can't leverage other resources that accelerate really
great ideas. You know, the intelligence community uses this
kind of mechanism to get things that it needs. NASA uses this
to get what it needs. And we have researched, I think, this
very carefully and think that as one of the components of the
Medical Countermeasure Review, making sure the companies
succeed or helping companies succeed for business reasons is
terribly important. Now, this is envisioned as a private, not-
for-profit entity not run by the Federal Government. It is not
like the Federal Government is going to get into the VC
business.
Mr. Shimkus. And that is why we ask these questions----
Ms. Lurie. Yes.
Mr. Shimkus [continuing]. Because I think if I was going
down and trying to figure out who is this? Who manages this?
How is this controlled? And I think you answered that question.
Ms. Lurie. OK.
Mr. Shimkus. And I appreciate it.
The last question I have is on the Medical Reserve Corps.
How effective has that been in current disasters and how does
the Emergency System for Advanced Registration of Volunteer
Health Professionals--is that segued into that? Is it fully
complementary? And are we seeing some positive results from
that?
Ms. Lurie. Sure. So the Medical Reserve Corps is a
volunteer cadre of people who sign up in their communities to
volunteer in case of emergencies, and they have training and
they meet regularly and they are rostered and they are
available when something happens. They are not a Federal asset.
They are a State and local asset.
Mr. Shimkus. And the question is have we seen them called
out? I mean is it 5 years old.
Ms. Lurie. They respond a lot to local events----
Mr. Shimkus. Right.
Ms. Lurie [continuing]. And in fact make it often so States
and locals can handle things on their own and don't need the
Federal Government. So yes.
Mr. Shimkus. And then how does the Emergency System for
Advanced Registration and Volunteer Health Professionals segue
into that?
Ms. Lurie. So you know that whenever either a State or the
Federal Government calls people up, we want to be sure that
their credentialed, they are who they say they are, they have
got the skills and the credentials for who they say they are.
In an emergency, it is not the time to figure that out. You
really want to figure that out beforehand.
You know, I will just point to our experience during Haiti
where we have thousands of people who wanted to help. They were
all well intentioned. Many of them were extremely well
qualified, but we couldn't process and certify all of those
people in the middle of a disaster. You have to do that in
advance so that you are ready to go when you have a disaster.
Mr. Shimkus. I know my time has expired, but the question
is is it working? Are we doing it? I know what the real world
we want it to be but is it working?
Ms. Lurie. So some States have very, very strong advanced
registration credentialing programs, and those are working
quite well. We are continuing to provide technical assistance
and supports to other States to get up to speed.
Mr. Pitts. The chair thanks the gentleman and recognizes
the gentlelady from California, Mrs. Capps, for 5 minutes for
questions.
Mrs. Capps. Thank you, Chairman Pitts and Ranking Member
Pallone for holding this very important hearing.
All too often, disaster preparedness is addressed in
hindsight once a disaster has already taken place rather than
before when it could have been more effective. I am proud of
the work that this committee has done to ensure that we are
better prepared today and look forward to reauthorizing PAHPA
to ensure that we are even more ready if and when disaster
strikes.
Today, we are here working together to ensure that
important safeguards are in place and that as the result of
this work communities will be able to better respond to and
recover from public health emergencies. Dr. Lurie, as you might
be aware, my district is home to one of two nuclear power
plants that the Nuclear Regulatory Commission recently
confirmed are located in the highest seismic-risk areas in the
country. In Japan, an earthquake and tsunami breached all the
safeguards at Fukushima Power Plant and put numerous
communities at risk. Needless to say, my constituents are very
concerned about a similar potential threat in their backyards.
And even the NRC has a recent report pointing out numerous
safety deficiencies in nuclear plant oversight.
So my concern and question for you is what is the current
status of our country's preparedness from your vantage point to
adequately address radiation exposure? Are there some
particular steps we should be taking that we are not and just
your general response?
Ms. Lurie. You know, it is a great question, and I think
you know that as a Federal Government we did a nuclear power
plant accident exercise a couple of months before the Japan
event confirming that nothing is really unthinkable. Since both
of those events, we have gone back and we are in the middle of
a systematic review of all of our public health gaps in
radiologic preparedness. So that is right now underway. That is
including an assessment of whether we need to be stockpiling
potassium iodide for children and going back and reviewing all
of the science related to that.
At the same time, we are very aggressively developing a set
of countermeasures for radiologic emergencies not only for the
blood and bone marrow suppression but for lung, for the
intestinal system, and for skin.
Mrs. Capps. Well, I am going to be very interested in what
you come up with and I would like to ask if it would be OK with
the chairman if we ask for that report to be made available to
this committee as soon as it is completed.
Ms. Lurie. We would be delighted to come and brief you
about what we have learned----
Mrs. Capps. That would even be better.
Ms. Lurie. Yes.
Mrs. Capps. You know, just in one general area, potassium
iodide tablets have been available to my community members in
the surrounding region, but since we saw the markers of mild
considered exposed in Japan to have increased dramatically.
That is one question that I think is certainly in the minds of
my constituents as they will also look forward to the results
of your study and hope that it will be completed at the
earliest possible time.
Ms. Lurie. Right.
Mrs. Capps. There is another related but not necessarily
just confined to nuclear exposure but surge capacity is another
topic that is very much on my mind. I have a background in
healthcare and that, of course, is the ability to respond in
case of a mass casualty event, whether that be a tornado, a
bombing, an outbreak of an infectious disease. The ability of
any community to respond to a massive influx of casualties'
capacity depends on care across the system, including
ambulatory care, hospital care, critical care, trauma and
emergency care. Some mass casualty events takes weeks or months
to develop such as a pandemic flu or a biologic attack, but
many events provide no such warning, as you know.
After a terrorist bomb explosion or a natural disaster such
as an earthquake, hospitals and the community would have to be
able to respond without any assistance in the immediate minutes
and hours without any assistance from State or Federal
authorities. Such assistance cannot arrive in time, and that is
why I believe surge capacity is so critical to response
capabilities.
So there is not enough time to go into this in depth, but
could you talk a little bit about the Hospital Preparedness
Program and anything else you want to bring up?
Ms. Lurie. Sure. No, thank you. So the Hospital
Preparedness Program has been central to getting hospitals
prepared to surge in case of emergencies. We also recognize two
things that are really important. It is not about only the
individual hospital. It is about all the entities in the
community being able to do this. And at the end of the day, if
we are going to be able to have the surge capacity we need, it
has to be built on the back of strong day-to-day systems,
especially for those no-notice events you talk about.
So dealing with issues like emergency department boarding
and crowding, which I know this committee has had hearings on
in the past, central issue here, getting people to the next-
lowest level of safe and appropriate care in an emergency,
something else that is really central. So as we are moving with
the next generation of the HPP program, that set of issues
about surge capacity is front and center, being sure that we
have the ability to work within the HPP program to innovate and
be flexible and test some new models, and that is also really
critical.
Mrs. Capps. Thank you. And Mr. Chairman, if I could just
beg for one follow-up that anything you could do to help our
communities just as you had an evaluation or training of
facilities, I think our communities would like to train and go
through some preparations to be prepared.
Ms. Lurie. That is a great comment and in the program we do
continue to support training and exercising all the time.
I would make one last comment. As I have looked at the no-
notice disasters that have struck this country since I have
been in this, there are many times when States and communities
have not needed to call the National Disaster Medical System to
provide medical care. They surged and handled it on their own.
And I continue to hear it was the Hospital Preparedness Program
that got us ready. It was that training and exercising that I
really didn't want to do but we did anyone and it really
helped.
Most recently in Joplin, you know, we saw them be able to
stand up a temporary hospital extremely rapidly after a
disaster. And that was done with a lot of support as a result
of the kinds of things that HPP does. Similarly, with a lot of
the flooding events and others that have happened. So in all of
the major events that I have been here to see, I hear from
emergency doctors, hospital administrators, State and local
public health about this very issue. We did it because.
Mrs. Capps. Excellent. Thank you very much. Thank you, Mr.
Chairman.
Mr. Pitts. Thank you. The chair thanks the gentlelady and
recognizes the gentleman from Michigan, Mr. Rogers, for 5
minutes for questions.
Mr. Rogers. Thank you, Dr. Lurie, and thanks for working
with us on this piece of legislation. Hopefully, we can
continue to work together to perfect it in a way that we can
here in Congress if there is such a thing.
And I just want to follow up on Mrs. Capps' line of
questioning. There is a point of issue that I hope you can help
us with is during an emergency from a terrorist attack or, as
we saw with H1N1, it is critical that there is a point person,
somebody that makes the decision, somebody that is absolutely
in charge. It is not CDC, it is not NIH, it is not the FDA or
anyone else. It is you.
Ms. Lurie. That is right.
Mr. Rogers. How can we improve the functions at HHS to
ensure that you are, in fact, in charge of the preparedness
efforts? And we understand HHS does work on a consensus model
brought by peer review and other things, but in this particular
case, I think it is incredibly important that there is a person
in charge or it takes longer, as you know. How can we help you
clarify that?
Ms. Lurie. Thank you. And I very much appreciate the
question. The original intent of the legislation was to do just
that. And I have found through this experience that indeed I
have the authorities that I need to be in charge. We have
strengthened our policy coordination and our preparedness
planning with all of the entities involved. So, you know, being
in charge during a response also requires sort of being in
charge and providing that policy direction in all of the
preparations so that when the balloon goes up, you are really
ready.
Mr. Rogers. And do you find you have that?
Ms. Lurie. And I find that the collaboration with the
sister agencies and HHS, I don't think it has ever been better.
We are working extremely closely together. I think they
recognize and respect the fact that we provide policy direction
and are in charge. And I think all of the efforts that we have
undertaken to coordinate across HHS have done that.
You know, during response, you know, it is really the
secretary's operations center run by the Office of Preparedness
and Emergency Operations in my office that is the bellybutton
for those activities, the central coordinating point for our
operational response, and it is my office as well that is the
central coordinating point for the strategic and policy
response. And that has all become increasingly recognized with
each of the events that we have dealt with this year. And I
very much understand that I am in charge that I am accountable
and I think I have the authorities that I need to do that.
Mr. Rogers. Well, I am not so interested if you know you
are in charge because I think you do. It is the other folks at
the table I want to understand that you are----
Ms. Lurie. Right. Right. Right. I appreciate that.
Mr. Rogers. Yes, thank you. I am going to move to the FDA
here for a minute. Last year the HHS conducted a comprehensive
medical countermeasure review. In that review you identified
the need to improve regulatory science at the FDA to ensure
medical countermeasures are given a priority. Specifically, you
said the FDA needs ``to work with sponsors to identify and help
resolve scientific issues as early and efficiently as
possible.'' And I couldn't agree more with that statement. And
I think that is absolutely critical. Countermeasures are
different than the next generation of--you know, they are
different from Viagra. They are different from--clearly. And so
having the FDA involved early, to me, is incredibly important.
Can you explain why improving regulatory science at the FDA
is so important in your view?
Ms. Lurie. Sure.
Mr. Rogers. And why early intervention may be different and
is important in countermeasures as it is different from other
drugs?
Ms. Lurie. Let me do the early intervention part first if I
can because I think it will help explain better the regulatory
science piece.
You know, if a company is developing a product and gets
either hung up scientifically or has a pathway to regulation
that is not as clear as it could be, it is really hard for that
company to go forward. We have--as I think you know or have
heard--really transformed the way in which we work with
companies so that now, at the beginning, at the get-go, we do
what I affectionately as a primary-care doctor call ``case
management.'' We sit down with scientists from FDA, NIH, CDC,
BARDA. We look at what the plan is, we provide scientific input
and expertise and then now on a very regular basis, we sit
down, review the process and the progress with those companies
and try to troubleshoot. And FDA is now at the table and a very
active participant. It has been very welcomed by companies and
I get feedback about that all the time.
Now, if in fact you are moving along on a plan to develop a
product and to get it approved or authorized by the FDA and,
for example, you don't have the tests necessary to know how
effective it is going to be, the time to develop those tests
isn't when the company is ready to submit a dossier to the FDA.
The time is very early on in the development process. A great
example of that has been, you know, the sterility testing for a
flu vaccine, which hadn't changed for 30 or 40 years. Now, you
know, we are doing things early on to work with FDA and
companies to change that process.
So what you need are the tools. You need the scientific
tools to evaluate whether a product is going to be safe and
effective, and the science has changed so rapidly that we need
to be able and we have to ask FDA to use new science, not
antiquated science, to do its job. That means that it has to be
at least at the pace of or a step or two ahead of where all of
these companies are so that when the companies are ready to
have their products evaluated, the science is there to do that.
Animal models are another great example. We are working
hand-in-glove with NIH and FDA on developing those kinds of
animal models so that at the end of the day if an animal model
is an appropriate way to move forward, we could do it. So
regulatory science becomes central to being able to get a
product approved and to clarifying and I think speeding up a
regulatory pathway.
Mr. Rogers. And early intervention with those folks is----
Ms. Lurie. Much earlier intervention. And we have been
doing that, as I said, since the secretary's countermeasure
review. It seems to be working quite well. In that early
intervention, we sort of make a plan. On the vaccine front, we
have moved forward with also working on some timelines so that
we and the BARDA, the sponsor, FDA agree on the plan, agree on
timelines, and we manage to those.
Mr. Rogers. Good. Thank you.
Mr. Pitts. The chair thanks the gentleman and recognizes
the gentleman from Louisiana, Dr. Cassidy, for 5 minutes for
questions.
Mr. Cassidy. I thought I was third in line.
So Dr. Koh, I appreciate the anti-tobacco efforts, but let
me just be a contrarian for a second. We just raised taxes
tremendously on tobacco. Do we know that the effects of this
taskforce, which I am sure consume a fair amount of resources--
are they responsible for our decrease in tobacco usage or would
it just be the fact that we are taxing the heck out of it and
that it making it less affordable for people to smoke?
Mr. Koh. Well, there are many parts to tobacco control,
Congressman, and the plan that we have put together really
accomplishes a multi-pronged approach. So you mentioned one,
which is raising the price and just about every State has done
that in the last 10-plus years.
Mr. Cassidy. So let me ask you, has there been any sort of,
for example, regression and analysis to see if there is a
secular trend that is just continuing downward usage as we
increase taxes versus this kind of significant commitment of
Federal resources which, frankly, I like, but I am wondering
could we redirect those resources if taxes are doing it all for
us?
Mr. Koh. Well, Congressman, this is one area in public
health that we have tremendous science; we have tremendous
data. We know what works. We know raising the price works. We
know that community-based interventions work. We know that quit
lines work. We know that providing cessation services to
smokers who want to quit is extremely helpful. So the challenge
is to put it all together so that we can have a country where
we are reducing the suffering here. We do know that tobacco
usage, which was declining for many years has stalled over the
last 7 or 8 years, and that is actually why the secretary asked
me to convene this group. And so we hope we can----
Mr. Cassidy. Well, let me ask you because, again, I think
as part of the CHIP reauthorization last year, there was a
dollar a pack placed. Now, was there any sort of downtick in
tobacco usage with that dollar-a-pack tax? And did that precede
the efforts of your interagency----
Mr. Koh. It preceded the efforts of our group. And the
economics of raising tobacco prices has been extremely well
studied. In fact, we know that raising the price about 10
percent decreases consumption 4 percent for adults and even
higher for children. So that was a Federal effort from several
years ago. I think you are referring also to State efforts. And
each governor of both parties actually in just about every
State has raised taxes over the last decade or so.
But I do want to stress again, Congressman, that is an
important and well studied intervention, but it is only one
intervention.
Mr. Cassidy. I guess but what I am wondering is does that
overwhelm the efficacy of all the others?
Mr. Koh. We need all the efforts. I am a physician. I----
Mr. Cassidy. No, I accept that, but I am just wondering,
again, as we have scarce resources, I guess I am asking is
there a secular trend whereby all others pale in significance.
Sure, if taxes are not raised, then we need the others, but if
taxes are raised, the others are obviated?
Mr. Koh. The price can increase can help to some degree and
I have presented the numbers to you, but we also know that
tobacco addiction is a really tough addiction. I know you know
that as a health professional, Congressman. And so do I. I am a
physician who has cared for patients for over 30 years. So when
you see people who are hooked and they want to quit and they
haven't been able to, you need every resource and you also need
additional resources to prevent the next generation from taking
up----
Mr. Cassidy. I am just asking is there statistical data to
show that these other interventions help over and above----
Mr. Koh. Absolutely.
Mr. Cassidy [continuing]. But I am also out of time, so let
me just kind of try----
Mr. Koh. Yes, and let me just say, Congressman, this area
has been extremely well studied. I would be glad to provide you
more materials, but we need many approaches here to tackle this
problem.
Mr. Cassidy. That would be good if you could. And again, I
am not saying we shouldn't do it. I am just saying if we have
got limited resources, where do we spend it sort of thing.
Let me ask you also, just broadly, as long as I have you--
and either of you can answer--but I am struck that sometimes it
seems--as perhaps you know, I am a doctor that treats diseases
of the liver----
Mr. Koh. Right.
Mr. Cassidy [continuing]. And societal and economic impact
is tremendous, and yet the amount of funding from the Federal
Government kind of pales in significant to some other illnesses
which, arguably, don't cost more if you will. Is there any sort
of metric as we do funding for Federal activities that I can
imagine a metric named morbidity, mortality, years of life
lost, potential--because smallpox clearly doesn't kill anybody
now but the potential death is tremendous--is there any sort of
metric applied to this or is it more or less historical funding
moving forward?
Mr. Koh. I can start and, Congressman, I really appreciate
your support of the Viral Hepatitis Strategic Plan. I remember
when you testified and presented in front of our congressional
briefing, and I know you have spent much of your career caring
for patients with hepatitis, so we really appreciate that.
And you all know that if you intervene on hepatitis, you
can prevent liver cancer and prevent liver transplant, all of
which drives up healthcare costs in this country.
So with respect to your question, obviously, these are very
challenging budget times. We have launched this plan to address
a rising public health need. We do need to bring in as many
resources on the table from many parts of our----
Mr. Cassidy. Well, let me ask you because I am frankly out
of time but I am asking do we have any sort of metric by which
Federal funding for addressing illnesses applied or it
historical funding that kind of continues for it? Is it active
politicians determining how we spend our dollars or is there a
metric that is applied that scientifically says we should put X
number of dollars here, Y there, and Z here?
Mr. Koh. Well, those metrics have been well defined for
tobacco. For hepatitis less so.
Mr. Cassidy. Well, I am just saying globally. OK, we have
this death rate from HIV, this from breast cancer, this from
prostate, this from hepatitis, this from smallpox----
Mr. Koh. Right.
Mr. Cassidy. And do we have a metric that then determines
how we do our spending?
Mr. Koh. Again, they are State-by-State guidelines for
spending on tobacco that are very well defined from scientific
data but on hepatitis there is less so.
Mr. Cassidy. OK. I yield back. I think I know what the
answer is.
Mr. Pitts. The chair thanks the gentleman and recognizes
the gentleman from Georgia, Dr. Gingrey, for 5 minutes for
questions.
Mr. Gingrey. Mr. Chairman, thank you so very much. And I
was going to direct my question to Dr. Koh, but as usual, my
good friend and colleague from Louisiana stole all my thunder
and I will have to then direct my question--I will let you take
a breath, Dr. Koh, and I will direct mine to Dr. Lurie.
Dr. Lurie, you mentioned in your testimony about the
Emergency Medical Countermeasures Enterprise Review, MCM Review
in August of last year that articulated ``a vision for a
nimble, flexible infrastructure to produce MCMs rapidly in the
face of an attack or threat, including a novel, previously
unrecognized naturally occurring emerging infectious
disease''--that terrorists or hostile governments might use a
drug-resistant form of bacteria or other infectious disease as
a weapon against us, against the United States?
Ms. Lurie. Well, one of the great things is that the
scientific methods and tools to do all kinds of things we call
synthetic biology has progressed tremendously. One of the very
scary things is it has become a lot more automated and a lot
easier--I don't know if you have seen these articles about the
DIY, the do-it-yourself, you know, garage manufacturing of----
Mr. Gingrey. Yes, we actually heard a little bit about that
activity from our first witness, our colleague, Charlie Dent,
in regard to some of these----
Ms. Lurie. Good point.
Mr. Gingrey [continuing]. Synthetic drugs----
Ms. Lurie. And so, you know, the technology to genetically
engineer all kinds of deadly organisms is there. It is
available. It is becoming more available and we have to be very
prepared for those kinds of things.
Mr. Gingrey. So a real threat.
Ms. Lurie. Yes, it is a real threat.
Mr. Gingrey. Well, look, let me ask you this, then. If we
ever meet these emerging threats, we need more novel
antibiotics, yet our current development is not as robust as it
needs to be. And you mentioned in your testimony that MCM
Review had identified choke points where product development
was--and I will quote you--``stalling or failing.''
Ms. Lurie. Yes.
Mr. Gingrey. Can you take a moment and describe some of
these choke points and disincentives in the current antibiotic
development pipeline? Because I think you know I had some real
interest in this area.
Ms. Lurie. Right. No, I appreciate that and I am glad you
have interest in this area because antimicrobial resistance is
terribly, terribly important.
In the medical countermeasure arena, we focus on
antimicrobial resistance for two reasons. One is because of the
genetically engineered set of issues. The other, quite honestly
is because antimicrobial resistance complicates our ability to
treat and save lives from trauma, from H1N1 where something
like 40 percent of kids died from methicillin-resistant staph
complicating their H1N1 infection, et cetera. So if we are
going to meet our mission in the countermeasure arena and in
the preparedness arena, we have to have novel antibiotics. Now,
to the sets of issues about the choke points----
Mr. Gingrey. It might be little off the subject matter of
the day, but I mean it would be true, too, in cancer to
chemotherapy patients, you know, whose immune system is beaten
down, they have no platelets, they have no T-cell lymphocytes
and then all of a sudden their own enteric bacteria is a
tremendous threat to them and they need more than just the
usual off-the-shelf, third-generation wonder drugs.
Ms. Lurie. But one of the things that I think is not as
appreciated about this whole medical countermeasure enterprise
that we are embarked on is that an awful lot of the
developments that are coming through this pipeline, whether it
is novel antimicrobials or a next-generation ventilator,
actually have benefits to a broader population in this country
even if we are never attacked, for example, or don't have a new
kind of threat. And a goal is for us to do those multi-use and
dual-use things as much as we can.
Mr. Gingrey. Sure. Absolutely.
Ms. Lurie. Our primary mission is to meet our
counterterrorism and biological----
Mr. Gingrey. I have got 30 seconds left so I am going to
shift just for a second. Mr. Shimkus was asking you a little
bit about our preparedness for a disaster of any kind. And I am
thinking Katrina because I remember jumping on a plane. I had
been out of the practice of medicine for a couple of 3 years
and flying down to Louisiana and just say here I am, I have got
my white coat, my stethoscope, and here is my medical license.
It is still active. Let me help out. I don't think the Red
Cross had any way, shape, or form of checking on me to see if
anything had been suspended or whether I truly was an OB/GYN or
maybe somebody with a criminal background indeed.
But in any regard, I think what he was trying to get at was
at the Federal level--you said the States and I think the
States are indeed doing a good job in regard to that, hopefully
all of them will--but we need to get that data, don't you
think, at the Federal level where somebody on the ground when
the next--Mrs. Capps talked about if another--obviously, we all
know another disaster is going to occur in some shape or form,
be it an earthquake or whatever. But we need that information
and if you could just comment very quickly.
Mr. Chairman, if you will let her do that and then I will
yield back.
Ms. Lurie. First, I just want to comment that when Katrina
hit and people came here, I walked into the armory with a
stethoscope around my neck. They said are you a doctor? I said
yes, and they set me loose. I didn't even show a license. So I
do think that we have to protect people and let them know--you
know, be sure that they are who they say they are and they are
really qualified to practice whatever their profession is.
I do think we need a national system to be able to rapidly
look at somebody's credentials and give them the OK. You know,
we also have a set of challenges that we continue to face
because State by State, you know, there is not license
reciprocity across all States. So a governor can, you know, use
their--I think we talked about it in another meeting--the
metric smoke stick and say in an emergency, you know, situation
I will accept licensed providers from another State and do
that, but everybody needs, then, that mechanism to know are
they licensed providers and to have that work in a hurry.
On a Federal level, we credential everybody you know in
advance through the National Disaster Medical System and we
have been working very aggressively since the Haiti earthquake
to be able to credential people in other specialties,
particularly in the critical care area and some of the
specialty surgical areas and trauma areas where we don't
necessarily have a full cadre of people on each team so that
when a disaster happens, we can pull those volunteers from
anywhere in the country and put them to work joining our NDMS
teams. And that is actively underway.
Mr. Pitts. The chair thanks the gentleman and recognizes
the gentlelady from North Carolina, Mrs. Myrick, for 5 minutes
for questions.
Mrs. Myrick. Thank you. I appreciate it. And thank you both
for being here. I am sorry I have to leave for a few minutes. I
understand that there are like 44 million doses of the first-
generation anthrax vaccine for the Strategic National Stockpile
for civilian use. Is that roughly about right?
Ms. Lurie. I would have to check on exactly what the number
of doses in the stockpile is now but we are continuing to add
to it.
Mrs. Myrick. Well, I know that is a lot of the budget
obviously.
Ms. Lurie. Yes. Right.
Mrs. Myrick. And I know back in 2004, HHS issued a
requirement to purchase 75 million doses of a second-generation
anthrax vaccine. How are you going to move forward on that? Do
you know? I mean is that something you have looked into?
Ms. Lurie. Well, so issuing the requirement, you know,
really means that we have a public health and preparedness need
for that.
Mrs. Myrick. Um-hum.
Ms. Lurie. Sometimes when we issue a requirement, there is
something kind of off the shelf already licensed that we can go
buy. Sometimes when we issue a requirement, that product
doesn't exist and we have to make it. That is what the advanced
development piece is really about.
Mrs. Myrick. Um-hum.
Ms. Lurie. And so we have invested in the advanced
development of a next-generation anthrax vaccine largely
because the current vaccine, you know, really takes multiple
doses----
Mrs. Myrick. Yes.
Ms. Lurie [continuing]. To develop immunity and isn't ideal
from the perspective of needing to respond to a public health
emergency involving millions of people.
Mrs. Myrick. But a second generation that is being
developed, is that----
Ms. Lurie. We are seeking next-generation vaccines that
would, you know, when they are developed--and the requirements
is that they have to meet certain, you know, specifications so
that ideally we would like something, you know, that is one
shot and works quickly. We are not there yet in the development
process. This is a great example of where science is hard. The
development process is cumbersome and it takes really all the
best scientific minds and the creativity of many of our
industry partners to do that.
Mrs. Myrick. Well, is this another area where you have to
have investors that are willing to do this? I mean I know all
of this, if you produce these countermeasures, is very
expensive. What kind of tools do you have at your disposal?
Ms. Lurie. It is a great question. So right now we use
advanced research and development funds to be able to do that.
And as you probably recall, PAHPA gave us the authority to
spend money on these advanced research and develop purposes,
and that is what we need to do.
The strategic investor seeks to do two other things that
are really important to think about. One is that, you know,
some of these companies have great scientific ideas but not a
lot of business expertise and so fail not for scientific
reasons but for business reasons. And so the strategic
investor, first of all, seeks to help them with those business
issues. And secondly, it seeks to identify companies that might
be working on something for a commercial application. They
don't want to work on anthrax because there is not a good
market for it, but they could say you have got a really great
idea and something innovative. And we are going to take us in
our venture-capital-like state, we are going to sort of take a
risk, invest in you, and working with us say we want you to
take this platform, this idea and apply it to the anthrax
problem. That is exactly what it is intended to do.
Mrs. Myrick. Yes, you have answered some of this while I
was gone, I apologize. I can always look at your testimony. But
the strategic investor is actually working with HHS or for HHS?
Is that what I understand?
Ms. Lurie. The strategic investor, as I explained to Mr.
Rogers and I am happy to again would be a private, nonprofit
entity that exists outside of government.
Mrs. Myrick. OK.
Ms. Lurie. But what we have to do is say here are the kinds
of things that we need you to invest in. We have a requirement
for a next-generation vaccine whether it is for anthrax or
purple spots and please, you know, go stimulate the development
of those things through the ways in which you work as a
strategic investor.
Mrs. Myrick. And maybe he asked the same question, but
about the strategic investor----
Ms. Lurie. Yes.
Mrs. Myrick [continuing]. Is that someone that is actually
like a consultant to HHS or something? Is that----
Ms. Lurie. No, it is not.
Mrs. Myrick. It is a volunteer or a----
Ms. Lurie. No, I think it would be a private, not-for-
profit company ideally, and it would act in many ways like
venture capital companies act----
Mrs. Myrick. Right.
Ms. Lurie [continuing]. But also act to invest
strategically. So one of the things I explained is that the
intelligence community does that now. NASA has done that in the
past.
Mrs. Myrick. Right.
Ms. Lurie. There are a number of examples across government
where that has been very successful. We didn't dream it up
ourselves.
Mrs. Myrick. Is that the type of thing that you would be
looking at, then, on the----
Ms. Lurie. Yes. We are looking for the authority to start a
strategic investor so that we can use this additional tool to
get the kinds of products we need.
Mrs. Myrick. Thank you very much.
Ms. Lurie. Yes.
Mrs. Myrick. Thank you, Mr. Chairman.
Mr. Burgess. [Presiding] The gentlelady yields back.
The gentlelady from Washington State is recognized for 5
minutes for the purposes of questions.
Mrs. McMorris Rodgers. Thank you, Mr. Chairman.
My questions relate to the Enhancing Disease Coordination
Activities Act of 2011, and I wanted to ask how the committees
for specific diseases and conditions will be established and
then how the bill changes the current process.
Mr. Koh. Well, first of all, Congresswoman, thank you for
your interest in the support of public health. I know you have
been a leader in many areas, and we appreciate that. In my
testimony, I did review a number of areas where we have
strategic plans and implementation efforts and then also did
review that we have actually many advisory committees up and
running. So the proposed legislation supports that general
theme, which we applaud. And in fact the mission of my office,
the Secretary for Health's office is to advance that
coordination on behalf of the Department and the country.
The provisions in the proposed legislation that require a
strategic plan update every 2 years might hold us to a level
where we are perhaps spending too much time on that effort and
not enough on implementation. So that current status that we
have offers us more flexibility.
And then I did review and mention that the unintended
consequences of a legislation like this might be to drive up
cost because putting together committees and running them adds
to our budget issues. So those are some of the areas that we
reviewed for you.
Mrs. McMorris Rodgers. In our experience in developing a
strategic plan for Down syndrome, the patient advocacy
organizations and private research foundations provide critical
insight into what is needed to move a research agenda forward.
And for example, as we speak, the Down syndrome community is in
the process of working with the National Institute of Child
Health and Human Development to establish a consortium that
includes patient advocacy organizations and researchers. This
interaction is critical to furthering one agenda. And I have a
little bit of a concern that the draft bill we are discussing
today keeps too much authority with the Federal agencies with
respect to the development of a research strategy, possibly to
the detriment of the collective goal of finding a cure or
treatment. And I just wanted to ask you to comment and could
the legislation be strengthened by including a role for
stakeholders?
Mr. Koh. Well, thank you for raising attention to that
particular issue. And we are pleased to report the evolution of
that consortium as you just mentioned, and there is a very
concerted effort at NIH to have a cross-trans-NIH coordinating
committee on Down syndrome, which I understand is up and
running and moving very, very well. In all these efforts,
current and proposed, we make special efforts to bring in the
best experts in the country so that we can do our work really
informed by people who are learned and have spent their career
studying these issues. And then we want the portfolio and the
public health areas addressed to focus not just on research but
on services and public health dimensions in the broadest sense.
So that is what we try to do. Currently, I think the proposed
legislation really resonates with that theme as well.
Mrs. McMorris Rodgers. OK. Thank you. I appreciate you
answering those questions.
Mr. Koh. Thank you.
Mr. Burgess. I am sorry. I didn't see you. You came in so
quietly.
The chair now recognizes Mr. Green from Texas for the
purposes of questions.
Mr. Green. Thank you, Mr. Chairman, and I know it is
unusual for a Texan to sit quietly but I want to thank each of
you for being here. This is my first term in Congress at least
on the Energy and Commerce Committee. I haven't been on the
Health Subcommittee and I appreciate the opportunity to weigh
in on the hearing on H.R. 2405 introduced by both Congressman
Rogers, a number of members, and myself. I am an original
cosponsor of the legislation. I am pleased it is a bipartisan
piece of legislation. It appears there are a few issues germane
that need to be worked about before this bill moves to
subcommittee markup. I know there is an interest in the sharing
special considerations given to children during national
emergencies, and I hope we will resolve this issue before the
markup.
The University of Texas Medical Branch's Galveston National
Lab is one of the two national biocontainment labs constructed
under grants awarded by the National Institute of Allergy and
Infectious Disease and the National Institute of Health and I
am proud much of this research is literally performed in the
backyard of my district in Houston. And I was happy during
Hurricane Ike that there was lots of damage but the lab was
very safe.
At this BSL-4 lab research is conducted to develop
therapies and vaccines and tests for diseases like anthrax,
Avian flu, the bubonic plague, hemorrhagic fever such as Ebola,
typhus, West Nile virus, influenza, and drug-resistant
tuberculosis.
I have a personal interest in this legislation because my
daughter was actually at UTMB during her fellowship and did
some work there in studies at the BSL lab, and believe me, when
you talk about my concern from our colleague from Georgia, Dr.
Gingrey, about--I was at the Astrodome when we evacuated a
quarter of a million people from New Orleans, and you are
right, Doctor, there were folks running around everywhere
because the medical community in Houston literally came
together, and I was amazed at what happened. And as we know,
medical facilities, nonprofits, and profits sometimes compete
with each other and their neighbors, but I watched them that
doing such a great job on triaging these folks who literally
were picked up in New Orleans and had no medication, no medical
records unless they were veterans. In those cases we were very
lucky.
But my concern today is that Texas A&M, University of
Texas, and Baylor College of Medicine, along with Texas
Children's Hospital in Houston, along with GlaxoSmithKline,
along with many other distinguished partners in a newly
established and developed National Center for Innovation and
Advanced Development and Manufacturing in Texas. The purpose of
the center will be to develop medical countermeasures to ensure
domestic vaccine manufacturing serve capacity for emerging and
infectious diseases, pandemic, influenza, and other threats
during public health emergencies utilizing flexible and multi-
product technologies. These public and private partnerships
along with academic research institutions are vitally important
both in the Federal Government and the private companies as we
work to develop novel bioterrorism measures. Solicitations for
these efforts were issued by HHS on March 30 of 2011.
My first question is can you discuss the Center for
Innovation and Advanced Development and Manufacturing and the
process going forward for these important institutions, Dr.
Lurie? And I believe these centers will be at the forefront of
developing medical countermeasures needed by our country in the
event of a bioterrorism event.
Ms. Lurie. Thanks so much for your question and for your
recognition of Advanced Development and Manufacturing
facilities. You know, they were another critical piece of the
recommendations of the secretary's Medical Countermeasure
Review, and they are intended to provide technical expertise
and core services to the small companies that get into the
countermeasures space and need help. You are right, we did
issue the request for proposals, and the deadline for proposals
is today. We are receiving applications and we are very excited
about that. And we will be reviewing those applications over
the course of the year working to be sure that we can identify
the very best entities to do that job and then after that hope
to make one or more awards.
Mr. Green. One of the concerns I have is BARDA has issued
contracts that are fulfilled by international companies with
production facilities in Europe. This leaves open the question
of supply security and job creation in our own country. Is
BARDA committed to allowing contract modifications for pandemic
flu vaccine development that will bring some of those jobs back
to the U.S. so you can supply us with these contract
modifications?
Ms. Lurie. We are very focused on domestic manufacturing of
our critical countermeasures, including pandemic vaccines. And
that has been the focus of much of our work.
Mr. Green. OK.
Ms. Lurie. And I think certainly what happened in the
pandemic very much showed us the criticality of domestic
manufacturing.
Mr. Green. OK. Thank you.
Mr. Chairman, thank you.
Mr. Pitts. The chair thanks the gentleman. That concludes
our first round of questioning. We will go to one follow-up on
each side. Dr. Burgess is recognized for a follow-up.
Mr. Burgess. Thank you, Mr. Chairman.
Dr. Lurie, Representative Markey of this committee amended
the Public Health Security and Bioterrorism Preparedness
Response Act in 2002 to make potassium iodide available to
State and local governments to meet the needs of all persons
living within a 20-mile radius of a nuclear power plant.
However, the Nuclear Regulatory Commission in both the previous
administration and in this administration has not enforced this
provision. Have there been any studies done on the health
effects of the difference on health effects done at different
differences and will we have a large enough supply of potassium
iodide to provide for us in a 20-mile radius?
Ms. Lurie. Thank you for that question and I think it is a
question that has been on everybody's minds since Fukushima.
And certainly planning for a radiologic disaster is part of our
all-hazards preparedness. You know, that disaster has caused us
to go back and try to look at what all of our public health
gaps are and to try to look at, you know, should there be a
requirement for potassium iodide, particularly for children in
the stockpile? And then how much should we stockpile? How much
should that be? So because we in public health like to apply
the best available science that we can, you know, going back we
have been reviewing all that. We are doing a lot of modeling
right now to determine is there a requirement and how big it
should be so that we can protect children. It is fair to say, I
think, that Fukushima sort of challenged a number of our
assumptions about an event.
Mr. Burgess. Sure, well, let me ask you this. I mean
apparently it is my understanding that you have the authority
to purchase the potassium iodide. Is that correct?
Ms. Lurie. We have the authority.
Mr. Burgess. And you have the money? The money has been
appropriated in previous Congresses. Is that correct?
Ms. Lurie. That is right.
Mr. Burgess. But the money has not been spent.
Ms. Lurie. So right now we are in the process of figuring
out--so we had pediatric potassium iodide in the stockpile, you
know, and that is now set to expire over the next year or two.
And so what we need to figure out right now is how much do we
need to have in the stockpile to adequately protect the
American people? And that is what we are doing right now. And
once we figure that out, assuming that we agree that there
needs to be potassium iodide in the stockpile, I think that we
will act on that requirement.
Mr. Burgess. Are you looking at larger radiuses than a 20-
mile radius as was outlined in Mr. Markey's amendment? Has the
experience in Japan taught us anything there?
Ms. Lurie. You know, I think what we are doing is, you
know, taking all of the science into account and taking what we
have learned from the recent event and trying to figure out
what does it best take to protect the population, whether it is
going to be what the exact radius is that we are going to
settle on, you know, I think that is going to really depend on
what the science shows us.
Mr. Burgess. The potassium iodide itself is a relatively
stable compound. Does it really go bad?
Ms. Lurie. You know, we just had that discussion as we
looked at shelf-life extension for the pediatric potassium
iodide that is in the stockpile. And FDA was really a terrific
partner with us in rapidly testing the liquid to try to look at
its stability over time. I think the stability of the liquid
version and the tablet version are different but we do need to
sort out what the shelf life of it is and when it is, you know,
safe to do the shelf-life extension. It sort of highlights the
need for some of the shelf-life extension authorities
potentially.
Mr. Burgess. Well, I remember in my district in the H1N1
crisis the FDA released all kinds of outdated antiviral
medication and I was assured by Dr. Hamburg that it was just as
good as the day it was minted and that they were revising some
of those shelf-life expiration dates on a much more complex
molecule than potassium iodide, which is relatively
straightforward.
Let me just ask you a question. Do you have any concern
about the availability of potassium iodide? As I understand it,
it is the only treatment that is currently available for
prevention of uptake of radioactive iodine by the thyroid and
particularly in young populations. Are you concerned about the
availability of potassium iodide?
Ms. Lurie. Well, I think what one of the things that we
said during the Fukushima event was this incredible epidemic of
fear in the United States and there was a huge run on the
companies. And so people bought up short-term the available----
Mr. Burgess. Yes, that is kind of the point.
Ms. Lurie [continuing]. Supply.
Mr. Burgess. That is kind of the point.
Ms. Lurie. Yes.
Mr. Burgess. We assure people that we have----
Ms. Lurie. What we need to do is be sure that we have it
where we need it, that it is stockpiled where we need it. You
know, there have been plans to stockpile it around nuclear
power plants. It is exercised differently in different States.
That is one of the things that we looked at.
Mr. Burgess. My understanding is that Janet Napolitano just
today released information that was gathered in the Osama bin
Laden compound about al-Qaeda's desiring to infiltrate nuclear
power plants in this country and reek some sort of damage. So
this is not just a theoretic concern. If the Secretary of
Homeland Security is out there talking about this, then our
National Strategic Stockpile should reflect that level of
concern. And really I urge you to spend some energy on doing
that.
Ms. Lurie. No, I appreciate that. And I think we all very
much appreciate the concern and that is why we are in the
midst, I think, almost a closure on coming up with, you know,
the recommendations about how much we should stockpile. I don't
think any of us has any question that this is a concern and I
don't think any of us have any question that we need to protect
the American people in this way.
Mr. Burgess. Thanks, Mr. Chairman. I will yield back.
Mr. Pitts. The chair thanks the gentleman and yields to Mr.
Pallone for follow-up.
Mr. Pallone. Thank you, Mr. Chairman.
Dr. Lurie, I was going to ask you this before so I didn't
have a chance. I wanted to ask about our current efforts on
biosurveillance. As you know, in many cases of bioterrorism or
natural disease outbreaks the first clue is that people seek
medical care for their condition. And sometimes the condition
may appear like other common conditions and could be missed
unless there is a system to detect unique features of an
outbreak. And biosurveillance is the ability of our system to
detect these ongoing outbreaks whether natural or manmade. I am
concerned because there was a recent GAO report in December
that suggests that HHS should be doing more to provide a
strategic plan for situational awareness.
So I have two questions. I will mention both. In your
professional opinion, do we have adequate capabilities for
biosurveillance and what are we doing to enhance these
capabilities? And can you tell us how the public health
infrastructure relates to the biosurveillance infrastructure?
Ms. Lurie. Sure. Great questions and issues that I think
are very much on my mind all the time. I appreciate that.
You know, surveillance and recognition of outbreaks is most
often something that happens locally. Sometimes it happens
through an astute clinician who happens to see something more
than once. Sometimes it happens through other surveillance
systems that are in place in health departments and hospitals
throughout the country. At the end of the day, our preparedness
in this country, particularly in this area is built on the back
of strong day-to-day systems. We see around the country right
now, because of the economic situation, real threats to public
heath, an erosion of public health capabilities. So something
like 40,000 jobs in the State and local level in public health
have been compromised over the past couple of years. They have
either been lost or been cut back drastically.
Mr. Pallone. They lost their jobs, then.
Ms. Lurie. So people have lost their jobs, they are working
part-time, and right now it is often only money that is coming
through a public health preparedness vehicle that is holding
that surveillance capability together at the State and local
level. So when you say do we have biosurveillance capability
and how good is it? We know the techniques, we have the tools,
and we know what to do, but we have to make it work and be sure
it works day to day on a State and local level and doesn't get
eroded as we are falling on hard times because this erosion at
the end of the day compromises our national security.
Mr. Pallone. I mean it is true, you know, I mean it is a
long time since I was a councilman, but I was at one time, and
I remember going over the budget and it was often the case
that, you know, somebody that would say let us cut back on, you
know, the health department because, you know, nobody really
knew what they did and also, you know, if you are talking about
something that may happen in the future, it is easy to say,
well, I don't know if that is going to happen so why should I
deal with the preparedness? I mean I see that that is a
significant problem.
But Chairman Pitts and I were talking about how important
this hearing is and how interesting it was because, you know,
you can't take that attitude. You have to take the attitude
that, you know, we need to prepare. But it is hard. It is hard
from a political point of view because people, you know, they
don't want to prepare for contingencies that may never occur
and it is easy to think that they never will occur.
And, you know, this is of course after the fact, but one of
the things that we have in my district is we have one of the 9/
11 clinics, you know, mostly first responders who sustained all
kinds of health problems from 9/11. And, you know, I talk to
the people that are in charge of the clinic from time to time
and even today, you know, they are still coming up with
diseases and disorders that, you know, are unforeseen or that,
you know, manifest themselves years later. So it is just so
important. But it is difficult, you know, to deal with this
issue and to be prepared. I mean I am only looking at it after
the fact but obviously when you talk about it before the fact,
I think it is even more difficult.
Ms. Lurie. And, you know, I think this reluctance of people
to always want to think about the unthinkable even though it
has happened an awful lot since I have been here is in part
human nature and it is part something we have to work against.
But it also, I think, shows us the importance of being sure
that the day-to-day systems are really strong so that the
systems that detect your foodborne outbreaks, the systems that
detect seasonal flu, the systems that do these other things and
function in the background day-to-day to prevent us from
infectious diseases and do that kind of surveillance have to be
strong if we are going to be able to detect a bioterror event
or a new emerging disease. We are working, you know, again
through BARDA on the diagnostics end of this, but there is that
whole local infrastructure that has to be on the ground to make
this work.
Mr. Pallone. Thank you. Thank you, Mr. Chairman.
Mr. Pitts. The chair thanks the gentleman, also thanks the
witnesses. Excellent panel, great testimony. Thank you very
much for answering our questions.
In conclusion, I would like to thank the witnesses and the
members for participating in today's hearing. I remind members
that they have 10 business days to submit questions for the
record, and I ask the witnesses to respond promptly to the
questions. Members should submit their questions by the close
of business on August 4.
This subcommittee is adjourned.
[Whereupon, at 12:06 p.m., the subcommittee was adjourned.]
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