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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 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

JOE BARTON, Texas 

Chairman Emeritus 

CLIFF STEARNS, Florida 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

Vice Chairman 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

BRIAN P. BILBRAY, California 

CHARLES F. BASS, New Hampshire 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

SUBCOMMITTEE ON HEALTH

JOSEPH R. PITTS, Pennsylvania 

Chairman 

MICHAEL C. BURGESS, Texas 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

TIM MURPHY, Pennsylvania 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

JOHN D. DINGELL, Michigan 

EDOLPHUS TOWNS, New York 

ELIOT L. ENGEL, New York 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

JIM MATHESON, Utah 

HENRY A. WAXMAN, California (ex officio) 

(II) 

(III) 

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 

Page

IV 

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 

(1) 

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. 

2 

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. 

21 

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 outVerDate Nov 24 2008 08:59 May 03, 2012 Jkt 037690 PO 00000 Frm 00030 Fmt 6633 Sfmt 6633 F:\112-079 HEALTH ISSUES-SUBMIT FOR OK 4-25\112-79 HEALTH ISSUES WORKING
27 

breaks, 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 diseasespecific 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:] 

28 

29 

30 

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 

31 

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. 

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[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 AuthorizaVerDate Nov 24 2008 08:59 May 03, 2012 Jkt 037690 PO 00000 Frm 00042 Fmt 6633 Sfmt 6633 F:\112-079 HEALTH ISSUES-SUBMIT FOR OK 4-25\112-79 HEALTH ISSUES WORKING
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tions, 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 atrisk 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. 

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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. 

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have seen some results accomplished that would not have been posVerDate Nov 24 2008 08:59 May 03, 2012 Jkt 037690 PO 00000 Frm 00066 Fmt 6633 Sfmt 6633 F:\112-079 HEALTH ISSUES-SUBMIT FOR OK 4-25\112-79 HEALTH ISSUES WORKING
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sible 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 

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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 AllHazard 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 

75 

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 

76 

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 

77 

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 

78 

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 threatappropriate 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 

79 

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 singlemost 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 

89 

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 effecVerDate Nov 24 2008 08:59 May 03, 2012 Jkt 037690 PO 00000 Frm 00093 Fmt 6633 Sfmt 6633 F:\112-079 HEALTH ISSUES-SUBMIT FOR OK 4-25\112-79 HEALTH ISSUES WORKING
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tive. 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? 

91 

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 constituVerDate Nov 24 2008 08:59 May 03, 2012 Jkt 037690 PO 00000 Frm 00095 Fmt 6633 Sfmt 6633 F:\112-079 HEALTH ISSUES-SUBMIT FOR OK 4-25\112-79 HEALTH ISSUES WORKING
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ents 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. 

93 

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 

94 

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. 

95 

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 handin-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. 

96 

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 

97 

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 

98 

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. 

99 

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 

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ever. 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 

101 

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 

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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 

103 

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 

104 

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. 

105 

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, 

106 

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. 

107 

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 parttime, and right now it is often only money that is coming through 

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lance 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 

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they have 10 business days to submit questions for the record, and 

I ask the witnesses to respond promptly to the questions. Members 

should submit their questions by the close of business on August 

4. 

This subcommittee is adjourned. 

[Whereupon, at 12:06 p.m., the subcommittee was adjourned.] 

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Æ