[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

                              ----------                              


                        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.]
    [Material submitted for inclusion in the record follows:]

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