[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]



 
                  EXAMINING THE REAUTHORIZATION OF THE
               PANDEMIC AND ALL-HAZARDS PREPAREDNESS ACT

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

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED FIFTEENTH CONGRESS

                             SECOND SESSION

                               __________

                              JUNE 6, 2018

                               __________

                           Serial No. 115-136
                           
                           
                           
                           
 [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]                          
 
 
 
 
 


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov
                        
                        
                        
                            _________ 

                U.S. GOVERNMENT PUBLISHING OFFICE
                   
34-016                 WASHINGTON : 2019                             
                        
                        
                        
                    COMMITTEE ON ENERGY AND COMMERCE

                          GREG WALDEN, Oregon
                                 Chairman
JOE BARTON, Texas                    FRANK PALLONE, Jr., New Jersey
  Vice Chairman                        Ranking Member
FRED UPTON, Michigan                 BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
MICHAEL C. BURGESS, Texas            ELIOT L. ENGEL, New York
MARSHA BLACKBURN, Tennessee          GENE GREEN, Texas
STEVE SCALISE, Louisiana             DIANA DeGETTE, Colorado
ROBERT E. LATTA, Ohio                MICHAEL F. DOYLE, Pennsylvania
CATHY McMORRIS RODGERS, Washington   JANICE D. SCHAKOWSKY, Illinois
GREGG HARPER, Mississippi            G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey            DORIS O. MATSUI, California
BRETT GUTHRIE, Kentucky              KATHY CASTOR, Florida
PETE OLSON, Texas                    JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia     JERRY McNERNEY, California
ADAM KINZINGER, Illinois             PETER WELCH, Vermont
H. MORGAN GRIFFITH, Virginia         BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida            PAUL TONKO, New York
BILL JOHNSON, Ohio                   YVETTE D. CLARKE, New York
BILLY LONG, Missouri                 DAVID LOEBSACK, Iowa
LARRY BUCSHON, Indiana               KURT SCHRADER, Oregon
BILL FLORES, Texas                   JOSEPH P. KENNEDY, III, 
SUSAN W. BROOKS, Indiana                 Massachusetts
MARKWAYNE MULLIN, Oklahoma           TONY CARDENAS, California
RICHARD HUDSON, North Carolina       RAUL RUIZ, California
CHRIS COLLINS, New York              SCOTT H. PETERS, California
KEVIN CRAMER, North Dakota           DEBBIE DINGELL, Michigan
TIM WALBERG, Michigan
MIMI WALTERS, California
RYAN A. COSTELLO, Pennsylvania
EARL L. ``BUDDY'' CARTER, Georgia
JEFF DUNCAN, South Carolina
                         Subcommittee on Health


                       MICHAEL C. BURGESS, Texas
                                 Chairman
BRETT GUTHRIE, Kentucky              GENE GREEN, Texas
  Vice Chairman                        Ranking Member
JOE BARTON, Texas                    ELIOT L. ENGEL, New York
FRED UPTON, Michigan                 JANICE D. SCHAKOWSKY, Illinois
JOHN SHIMKUS, Illinois               G.K. BUTTERFIELD, North Carolina
MARSHA BLACKBURN, Tennessee          DORIS O. MATSUI, California
ROBERT E. LATTA, Ohio                KATHY CASTOR, Florida
CATHY McMORRIS RODGERS, Washington   JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey            BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia         KURT SCHRADER, Oregon
GUS M. BILIRAKIS, Florida            JOSEPH P. KENNEDY, III, 
BILLY LONG, Missouri                     Massachusetts
LARRY BUCSHON, Indiana               TONY CARDENAS, California
SUSAN W. BROOKS, Indiana             ANNA G. ESHOO, California
MARKWAYNE MULLIN, Oklahoma           DIANA DeGETTE, Colorado
RICHARD HUDSON, North Carolina       FRANK PALLONE, Jr., New Jersey (ex 
CHRIS COLLINS, New York                  officio)
EARL L. ``BUDDY'' CARTER, Georgia
GREG WALDEN, Oregon (ex officio)
  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     1
    Prepared statement...........................................     3
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................     4
    Prepared statement...........................................     5
Hon. Greg Walden, a Representative in Congress from the State of 
  Oregon, opening statement......................................     7
    Prepared statement...........................................     8
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     9
    Prepared statement...........................................    11

                               Witnesses

Robert Kadlec, Assistant Secretary for Preparedness And Response, 
  U.S. Department of Health and Human Services...................    13
    Prepared statement...........................................    15
    Answers to submitted questions...............................   169
Stephen Redd, Director, Centers for Disease Control and 
  Prevention.....................................................    27
    Prepared statement...........................................    29
    Answers to submitted questions...............................   193
Anna Abram, Deputy Commissioner for Policy, Planning, 
  Legislation, and Analysis, U.S. Food and Drug Administration...    39
    Prepared statement...........................................    42
    Answers to submitted questions...............................   208
Umair Shah, Executive Director, Harris County Public Health......    84
    Prepared statement...........................................    87
    Answers to submitted questions...............................   217
Dr. Michelle Berrey, President and CEO, Chimerix, Inc............    96
    Prepared statement...........................................    98
    Answers to submitted questions...............................   228
Erik Decker, Chief Security and Privacy Officer, University of 
  Chicago Medicine...............................................   107
    Prepared statement...........................................   109
    Answers to submitted questions...............................   232

                           Submitted Material

Burgess documents
    Shattuck Lecture, given by Bill Gates, New England Journal of 
      Medicine, May 31, 2018.....................................   129
    Statement of the American Academy of Pediatrics..............   133
    Statement of the American Hospital Association...............   135
    Statement of the American Society for Microbiology...........   140
    Statement of America's Essential Hospitals...................   143
    Statement of the Global Health Technologies Coalition........   145
    Statement of the Healthcare Leadership Council...............   148
    Statement of the Infectious Disease Society of America.......   152
    Statement of the International Safety Equipment Association..   160
    Statement of the Trust for America's Health..................   165


     EXAMINING THE REAUTHORIZATION OF THE PANDEMIC AND ALL-HAZARDS 
                            PREPAREDNESS ACT

                              ----------                              


                        WEDNESDAY, JUNE 6, 2018

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:00 a.m., in 
room 2123 Rayburn House Office Building, Hon. Michael Burgess 
(chairman of the subcommittee) presiding.
    Members present: Representatives Burgess, Guthrie, Barton, 
Shimkus, Blackburn, Latta, Lance, Griffith, Long, Brooks, 
Mullin, Hudson, Collins, Carter, Walden (ex officio), Green, 
Engel, Schakowsky, Matsui, Castor, Eshoo, DeGette, and Pallone 
(ex officio).
    Staff present: Karen Christian, General Counsel; Paul 
Eddatel, Chief Counsel, Health; Margaret Tucker Fogarty, Staff 
Assistant; Ali Fulling, Legislative Clerk, Oversight & 
Investigations, Digital Commerce and Consumer Protection; Ed 
Kim, Policy Coordinator, Health; Ryan Long, Deputy Staff 
Director; Kristen Shatynski, Professional Staff Member, Health; 
Alan Slobodin, Chief Investigative Counsel, Oversight & 
Investigations; Danielle Steele, Counsel, Health; John Stone, 
Senior Counsel, Health; Austin Stonebraker, Press Assistant; 
Josh Trent, Deputy Chief Health Counsel, Health; Hamlin Wade, 
Special Advisor, External Affairs; Jessica Wilkerson, 
Professional Staff, Oversight & Investigations; Jeff Carroll, 
Minority Staff Director; Tiffany Guarascio, Minority Deputy 
Staff Director and Chief Health Advisor; Samantha Satchell, 
Minority Policy Analyst; Andrew Souvall, Minority Director of 
Communications, Outreach and Member Services; Kimberlee 
Trzeciak, Minority Senior Health Policy Advisor; and C.J. 
Young, Minority Press Secretary.

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

    Mr. Burgess. Let me just ask all of our guests to please 
take their seats. The Subcommittee on Health will now come to 
order. The chair recognizes himself for 5 minutes for an 
opening statement.
    But first, as auspicious as we gather today it is a day 
that is so steeped in history. Last night was the California 
primary election. We all remember 50 years ago after the 
California elections when the country lost Senator Robert 
Kennedy.
    This is also the 74th anniversary of the landing in 
Normandy and D-Day. This is the 100-year anniversary of the 
battle of Belleau Woods when the Marines basically initiated 
World War I for the United States of America, and it is 100 
years since the Spanish Flu ravaged not just our country but 
the world.
    So it's appropriate that we convene today to authorize the 
Pandemic All-Hazardous Preparedness Act. Again, a century ago, 
our country was in the worst pandemic in its history, claiming 
the lives of almost 700,000 Americans and killing more than 50 
million people worldwide. We have elicited testimony and we 
will discuss this critical legislation. It is paramount that we 
remember the significance of this centennial anniversary. 
Sporadic flu activity had been spreading through the United 
States, Europe, and Asia. In the months following, the country 
and our soldiers faced an illness that we were not prepared to 
handle. In that October over a hundred years ago, more than 
100,000 Americans died as a result of the Spanish flu.
    It goes without saying that we have indeed come a long way. 
A century later we were substantially more prepared. As we 
consider this legislation, we must remember that there is more 
to be done to support America's public health security.
    The creation of the Assistant Secretary of Preparedness and 
Response under the original legislation in 2006 has helped us 
to make monumental strides in preparedness, coordination, and 
response. Close collaboration and efforts between the Centers 
for Disease Control, the Food and Drug Administration, our 
local, state, and tribal and territorial health partners has 
been vital in making progress in this regard.
    Much like politics, public health is local and it is 
executed on the ground by our hospitals, by our health 
departments, and our emergency responders who are our front 
lines addressing infectious diseases, disasters, and threats.
    I do want to thank my fellow Texan on our second panel, Dr. 
Umair Shah, for being here today and to share his testimony and 
for his leadership in protecting the health of Harris County, 
Texas. Recently, Dr. Shah and his team responded on the front 
lines for Hurricane Harvey, which caused such catastrophic 
damage in the Houston metropolitan area and did require a large 
coordinated response from all of the organizations that we have 
before us today.
    You'll hear more about critical issues that must be 
addressed to continue and strengthen the nation's preparedness 
and response capabilities.
    We will talk about proposals to strengthen the Strategic 
National Stockpile, our cache of life-saving medications and 
supplies for public health emergencies. We also must address 
the policies that affect our regional disaster response system. 
It is essential the program continues to integrate and 
coordinate at the local level. Additionally, we must provide 
assurances to protect those who respond to our health 
emergencies.
    We will also discuss sustaining the robust and reliable 
security capabilities such as disease surveillance, 
containment, risk, and countermeasure distribution. We must 
evaluate the domestic biologic surveillance systems such as 
BioWatch, taking a closer look at what can be done to bring 
these programs up to date so that they are operating with the 
most efficient technologies and capabilities. I believe we must 
look for innovative ways to continue to advance medical 
countermeasures, ensuring that Americans can access medications 
that will provide critical protection in the future. As we 
consider the problem of antimicrobial resistance in this 
country, we must address new methods to curb this growing 
problem.
    Frontline facilities and responders in Dallas, Texas 
experienced this firsthand in 2014 when a patient presented 
with Ebola in a DFW emergency department. We must remember that 
infectious diseases are a mere plane ride away and we must 
continue to ensure that we are prepared and ready to respond.
    This Pandemic All-Hazards Preparedness Reauthorization is 
critical in protecting the lives of all Americans and providing 
the necessary tools and infrastructure to ensure that they are 
in place when disaster strikes. I want to thank both 
Representative Susan Brooks and Anna Eshoo for working on this 
draft legislation which is being considered today.
    Lastly, I want to thank all of our witnesses for testifying 
before us this morning. I do look forward to a productive 
discussion on a broad array of issues that will be the focus of 
this authorization.
    And will yield the balance of my time to the gentlelady 
from Tennessee, who I believe is celebrating a birthday on this 
day rich in history.
    [The prepared statement of Mr. Burgess follows:]

             Prepared statement of Hon. Michael C. Burgess

    Today, we convene to consider legislation to reauthorize 
the Pandemic and All-Hazards Preparedness Act (PAHPA). One 
century ago our country was in the midst of the worst pandemic 
in its history, claiming the lives of almost 700,000 Americans 
and killing more than 50 million people worldwide. As we listen 
to testimony and discuss this critical legislation, it is 
paramount that we remember the significance of the centennial 
anniversary of the 1918 influenza pandemic. On this very day, 
in 1918, the first large-scale battle of World War I had begun, 
and hundreds of thousands of soldiers traveled across the 
Atlantic to be deployed for war. At the same time, sporadic flu 
activity was spreading throughout the United States, Europe, 
and Asia. In the months following, the country and our soldiers 
faced an illness that we were not prepared to handle. In that 
October alone, more than 100,000 Americans died as a result of 
the Spanish flu.
    It goes without saying that we have come a long way. A 
century later, we are substantially more prepared. As we 
consider this legislation, we must remember that there is more 
to be done to bolster America's public health security.
    The creation of the Assistant Secretary of Preparedness and 
Response under the original legislation in 2006 has helped us 
to make monumental strides in preparedness, coordination, and 
response. Close collaboration and efforts between the Centers 
for Disease Control and Prevention, Food and Drug 
Administration, and our state, local, tribal, and territorial 
public health partners has been vital in making this progress.
    Much like politics, much of public health is local and 
executed on the ground by our hospitals, health departments, 
and emergency responders who are our front lines addressing 
infectious diseases, disasters, and threats.
    I want to thank my fellow Texan, Dr. Umair Shah, for being 
here today to share his testimony and for his leadership 
protecting the health of Harris County. Recently, Dr. Shah and 
his team responded on the front lines of Hurricane Harvey, 
which caused catastrophic damages in the Houston metropolitan 
area and required a large coordinated response from all of the 
organizations before you today.
    We will hear more about the critical issues that must be 
addressed to continue to strengthen the nation's preparedness 
and response capabilities.
    We will talk about proposals to strengthen the Strategic 
National Stockpile, our cache of life-saving medications and 
supplies for public health emergencies. We also must address 
the policies that affect our Regional Disaster Response System. 
It is essential that the program continues to integrate and 
coordinate at the local level. Additionally, we must provide 
assurances to protect those who respond to health emergencies.
    We also will discuss sustaining robust and reliable 
security capabilities such as disease surveillance, 
containment, risk, and countermeasure distribution. We must 
evaluate the domestic biological surveillance systems such as 
BioWatch. We must also take a closer look at what can be done 
to bring these programs up to date, so that they are operating 
with the most efficient capabilities and technologies. Finally, 
we must look for innovative ways to continue to advance medical 
countermeasures, ensuring that Americans can access the 
medications that will provide critical protection in the 
future. As we consider the problem antimicrobial resistance in 
this country, we must discuss new methods to curb this growing 
problem.
    Frontline facilities and responders in Dallas experienced 
this firsthand in 2014 when a patient presented with Ebola in a 
DFW emergency department. We must remember that infectious 
diseases are a mere plane ride away, and we must continue to 
ensure we are prepared and ready to respond.
    This Pandemic All-Hazards Preparedness Reauthorization is 
critical in protecting the lives of all Americans, and 
providing the necessary tools and infrastructure are in place 
when disaster strikes. I want to thank both Representatives 
Susan Brooks and Anna Eshoo for their work on the draft 
legislation being considered today.
    Lastly, I thank all of our witnesses for testifying before 
us this morning. I look forward to a productive discussion on 
the broad array of issues that will be the focus of this 
reauthorization.

    Mrs. Blackburn. I am indeed celebrating a birthday and I 
thank you for yielding.
    Thank you all for being with us to discuss this. We have 
focused on how the response ought to be to address our national 
disasters and our natural disasters, and this has been a 
process.
    We have worked with our friends in the Senate, our friends 
here. As you know, this is something we have done in a 
bipartisan manner so we thank you for your time, and I yield 
back to the gentleman.
    Mr. Burgess. Chair thanks the gentlelady. The gentlelady 
yields back.
    The chair recognizes the gentleman from Texas, the ranking 
member of the subcommittee, Mr. Green, 5 minutes for an opening 
statement, please.

   OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Green. Thank you, Mr. Chairman, and again I'd like to 
welcome the panels--both the first panel and I particularly 
want to thank Umair Shah, the executive director of Harris 
County Public Health, for joining us this morning on the second 
panel. They help keep my constituents healthy.
    Events in recent years including natural disasters, cyber 
terrorism, influenza epidemic has posed a threat to our public 
health systems and our national security. PAHPA provides a 
framework that allows us to address in a coordinated way 
various threats both natural and manmade. As a founding member 
of the Congressional Public Health Caucus and a long-time 
advocate for public health, I hope our committee will look at 
the very real threat that antimicrobial resistance poses.
    Antibiotics and antimicrobial agents have been used for the 
last 70 years to treat patients who have infectious diseases. 
These drugs greatly reduce illnesses and death from infectious 
diseases. However, these drugs are being used so widely and for 
so long that the infectious organisms that the antibiotics are 
designed to kill have adapted to them and make the drugs less 
effective. Each year in our country at least 2 million people 
become infected with bacteria that are resistant to antibiotics 
and at least 23,000 people die annually as a result of these 
infections.
    In the past years, the Generating Antibiotic Incentives 
Act--GAIN--and the Antibiotic Development of Advanced Patient 
treatment--ADAPT--have sought to address both the economic 
hurdles and the regulatory barriers to the development of new 
antibiotics. Through the reauthorization of PAHPA we need to 
ensure that the proper incentives are in place that will lead 
to investment in the development of new antibiotics and 
antimicrobial agents.
    I believe the creation of a market entry reward program 
that incentivize the manufacturers to develop novel antibiotics 
would provide the best bang for our buck in this space.
    I'd like to work with my colleagues and I have over the 
years with Congressman Phil Gingrey recently on our committee 
and also currently with Congressman Shimkus. It's such a 
critical issue.
    In addition to addressing antimicrobial resistance, we also 
need to further consider the proposal to move the Strategic 
National Stockpile--SNS--from CDC to the office of Assistant 
Secretary for Preparedness and Response.
    My home state and our district was heavily impacted by 
Hurricane Harvey last year in response to the flooding. The SNS 
was deployed to Houston and provided needed material to help 
local and state health departments respond to the overwhelming 
needs of the community.
    SNS had been deployed countless times since its inception. 
It was placed in CDC over the years. CDC has worked closely 
with state and local health departments to respond to public 
health emergencies.
    Before our committee codifies any change in the SNS, we 
must learn whether it's the best policy to advance human 
health. Additionally, as we have discussed the move of the 
stockpile from CDC to ASPR we have to ensure that the systems 
and networks which have been in place are not disrupted in 
order that the stockpile may be deployed successfully when 
needed.
    Mr. Chairman, I yield the remainder of my time to my 
colleague from California and co-sponsor of the bill, 
Congresswoman Eshoo.
    [The prepared statement of Mr. Green follows:]

                 Prepared statement of Hon. Gene Green

    Thank you, Mr. Chairman, for holding today's hearing on the 
reauthorization of the Pandemic and All-Hazards Preparedness 
Act (PAHPA). I also thank our witnesses, particularly Umair 
Shah, Executive Director of Harris County Public Health, for 
joining us this morning.
    Events in recent years, including natural disasters, 
cyberterrorism and the influenza epidemic have posed a threat 
to our public health systems and our national security. PAHPA 
provides a framework that allows us to address in a coordinated 
way various threats both natural and man-made.
    As a founding member of the Congressional Public Health 
Caucus and longtime advocate for public health, I hope our 
committee will look at the very real threat that antimicrobial 
resistance poses.
    Antibiotics and antimicrobial agents have been used for the 
last 70 years to treat patients who have infectious diseases. 
These drugs have greatly reduced illness and death from 
infectious diseases. However, these drugs have been used so 
widely and for so long that the infectious organisms the 
antibiotics are designed to kill have adapted to them, making 
the drugs less effective.
    Each year in our country, at least 2 million people become 
infected with bacteria that are resistant to antibiotics and at 
least 23,000 people die annually as a direct result of these 
infections.
    In past years, the Generating Antibiotic Incentives Now 
(GAIN) and the Antibiotic Development to Advance Patient 
Treatment Act (ADAPT) have sought to address both the economic 
hurdles and the regulatory barriers to the development of new 
antibiotics.
    Through the reauthorization of PAHPA, we need to ensure 
that the proper incentives are in place that will lead to 
investment in the development of new antibiotics and 
antimicrobial agents.
    I believe the creation of a market entry reward program 
that incentivizes manufacturers to develop novel antibiotics 
would provide the best bang-for-your-buck in this space. I 
would like to work with my colleagues on this critical issue.
    In addition to addressing antimicrobial resistance, we also 
need to further consider the proposal to move the Strategic 
National Stockpile (SNS) from the CDC to the Office of the 
Assistant Secretary for Preparedness and Response. My home 
state and my district were heavily impacted by Hurricane Harvey 
last year. In response to the flooding, the SNS was deployed to 
Houston to provide needed materiel to help local and state 
health departments respond to the overwhelming needs of the 
community.
    The SNS been deployed countless times. Since its inception, 
it was placed in the CDC. Over the years, the CDC has worked 
closely with state and local health departments, to respond to 
public health emergencies.
    Before our committee codifies any changes to the SNS, we 
must learn whether this is the best policy and will advance 
human health. Additionally, as we discuss the move of the 
stockpile from the CDC to the ASPR, we have to ensure that the 
systems and networks which have been put in place are not 
disrupted in order that the stockpile may be deployed 
successfully when needed.
    Thank you, Mr. Chairman. I yield the remainder of my time 
to my colleague, Congresswoman Eshoo of California.

    Ms. Eshoo. I thank the gentleman for yielding, and welcome 
to the witnesses. And Mr. Chairman, thank you for your opening 
remarks, especially about the 50th anniversary of Senator 
Robert Kennedy.
    In 2001, our nation endured the attacks of September 11th 
and the anthrax attacks shortly after that. It was one of the 
most grueling times, I think, in the modern history of our 
country.
    Congress realized that our country was not prepared to 
coordinate responses to mass casualty events or chemical 
attacks. I authored legislation with then Representative 
Richard Burr, who was a member of the Committee, that 
established the Office of the Assistant Secretary for 
Preparedness and Response--we refer to it as ASPR--to be 
responsible for coordinating federal responses and the 
Biomedical Advanced Research and Development Authority we call 
BARDA to be responsible for developing the needed medical 
countermeasures for chemical, biologic, radiological, and 
nuclear threats. That important bipartisan legislation, the 
Pandemic All-Hazards Preparedness Act, or PAHPA, was signed 
into law in 2006.
    The threats we faced in 2001 have not gone away. They have 
evolved and new threats have emerged and that's why it's 
important that this committee work to reauthorize PAHPA in a 
timely manner before it expires at the end of this fiscal year.
    We need to give the agency the tools that they need and the 
resources they need to respond to the threats that confront us.
    This is the discussion today and I think all members need 
to keep that in mind because stakeholders and others have not 
seen their suggestions come into a draft yet.
    So I think all members need to keep that in mind and I'd 
like to compliment Congresswoman Brooks. I couldn't have a 
better partner in this.
    So thank you, Mr. Chairman. I yield back.
    Mr. Burgess. The chair thanks the gentlelady. The 
gentlelady yields back.
    The chair recognizes the gentleman from Oregon, the 
chairman of the full committee, Mr. Walden, 5 minutes for an 
opening statement, please.

  OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF OREGON

    Mr. Walden. Well, thank you, Mr. Chairman. Thanks for your 
leadership on this issue and that of Ms. Eshoo and Mrs. Brooks 
as well. I know we will be hearing from both of them even more 
during this process.
    I appreciate their work together on this. They've been the 
team leaders for this for our committee.
    Since the terrorist attacks of September 11th, 2001, our 
country has taken important steps to fortify our health 
preparedness and response infrastructure. The Federal 
Government has recognized that we must foster development of 
important medical countermeasures in the event of a potential 
chemical, biological, radioactive, or nuclear attack.
    Preparing for and responding to these kinds of incidents 
and mass casualty events requires the collaboration of all 
levels of government with hospitals, biotech firms, community 
leaders, members, and other partners both public and private 
all across the country.
    Recent diverse threats illustrate the importance of our 
country having an effective and an efficient emergency 
preparedness system in place. In the last few years alone, we 
have seen the arrival of the Zika virus, last year's 
devastating hurricane season, the WannaCry malware outbreak, 
and looking ahead, I can think about other prospects including 
the projected devastating earthquake of Cascade event that they 
predict could hit the Oregon coast as it did hundreds and 
hundreds of years ago.
    In 2004, Congress authorized Project BioShield. I was here 
when that happened, and later in 2006 enacted the Pandemic and 
All-Hazards Preparedness Act. In addition to establishing a 
strategic plan to direct research, development, and procurement 
of medical countermeasures, PAHPA also created the Assistant 
Secretary for Preparedness and Response--ASPR--and the 
Biodefense Advanced Research and Development Authority--BARDA--
within the Department of Health and Human Services.
    So today's hearing really will take a closer look at this 
bipartisan discussion draft led by our colleagues, Susan Brooks 
and Anna Eshoo. Thank you both for your leadership on this 
bill.
    This bipartisan bill builds upon our previous work to 
modernize our health preparedness and response systems, 
ensuring that we are well equipped across all levels and 
government agencies to handle current emergency--emergent bio 
threats, chemical attacks, radiological emergencies, 
cybersecurity instances, and mass casualty events.
    This is an important conversation. It's an important issue. 
We will move forward. We will move forward expeditiously.
    We realize there is a deadline ahead for reauthorization 
and so we look forward to getting your feedback as we put this 
legislation into final form and move it through this committee.
    With that, I'd yield the balance of my time to the 
gentlelady from Indiana, Mrs. Brooks.
    [The prepared statement of Mr. Walden follows:]

                 Prepared statement of Hon. Greg Walden

    Since the terrorist attacks on September 11, 2001, the 
Nation has taken important steps to fortify our health 
preparedness and response infrastructure. The federal 
government has recognized that we must foster development of 
important medical countermeasures in the event of a potential 
chemical, biological, radioactive, or nuclear attack.
    Preparing for and responding to these kinds of incidents 
and mass casualty events requires the collaboration of all 
levels of government with hospitals, biotech firms, community 
members, and other partners--both public and private--across 
the country.
    Recent, diverse threats illustrate the importance of our 
country having an effective and efficient emergency 
preparedness system in place. In the last few years alone, we 
saw the arrival of the Zika virus, last year's devastating 
hurricane season, and the WannaCry malware outbreak. Looking 
ahead, I think about the prospect of a devastating earthquake 
``Cascadia'' predicted to hit my home state of Oregon.
    In 2004, Congress authorized Project Bioshield, and later 
in 2006, enacted the Pandemic and All-Hazards Preparedness Act 
(PAHPA). In addition to establishing a strategic plan to direct 
research, development and procurement of medical 
countermeasures, PAHPA also created the Assistant Secretary for 
Preparedness and Response (ASPR) and the Biodefense Advanced 
Research and Development Authority (BARDA) within the 
Department of Health and Human Services.
    Today's hearing will take a closer look at a bipartisan 
discussion draft lead by our Energy and Commerce Committee 
colleagues, Reps. Susan Brooks (R-IN) and Anna Eshoo (D-CA). 
Thank you both for your leadership on this critical bill.
    This bipartisan bill builds upon our previous work to 
modernize our health preparedness and response systems, 
ensuring that we are well-equipped across all levels and 
government agencies to handle current and emerging biothreats, 
chemical attacks, radiological emergencies, cybersecurity 
incidents, and mass casualty events.
    It's an important conversation, and I look forward to 
continuing our work today. Lastly, I'd like to thank our 
witnesses for being with us today. We look forward to gaining 
your feedback. This is a critical reauthorization that can have 
a tremendous impact on our country, and it's imperative we get 
it right.

    Mrs. Brooks. Thank you, Mr. Chairman, and thank you for 
holding this hearing today to examine the issues surrounding 
the reauthorization of PAHPA.
    I am proud to be working on this important bill with my 
good friend, Representative Eshoo, who was one of the authors 
of the first PAHPA bill in 2006, as well as the lead author of 
the last reauthorization in 2013.
    As everyone here knows, this is not a question of if we 
will face a threat. It is more of a question of when we will 
face the threat. The threat of chemical, biological, 
radiological, or nuclear incidents continues to grow. Every day 
our adversaries are looking for more effective and faster ways 
to produce a threat. We have already faced threats from 
naturally occurring outbreaks such as Ebola and Zika as well as 
from hurricanes. In addition, cyber-attacks like the WannaCry 
incident illustrate the vulnerability of our public health 
system. Reauthorizing PAHPA is an important public health and 
national security issue and I look forward to working with all 
members of the committee on this bipartisan effort.
    The discussion draft bill that we have written creates a 
PAHPA--a Public Health Emergency Response Fund for the HHS 
secretary to use as a funding bridge when we face an outbreak 
like Ebola so that immediate funding is available so that we 
can supplement them with an emergency appropriation bill. The 
bill strengthens the hospital preparedness program to improve 
surge capacity by allowing grantees to use federal funding for 
health care surge capacity response activities in addition to 
the preparedness activities. It establishes a pandemic 
influenza program as well as an emerging infectious disease 
program at BARDA. Our bill includes and this draft includes 
requests from CDC, ASPR, HHS, and FDA, and we look forward to 
working with everyone to improve the bill and ensure that it's 
ready for introduction later this month.
    Thank the PAHPA, already we have seen 14 products placed in 
the Strategic National Stockpile to be used in an emergency. 
Our bill increases funding for the Strategic National Stockpile 
to $610 million per year in order to keep the authorized level 
consistent with what we have currently appropriated.
    In addition, the bill codifies moving the SNS from the CDC 
to ASPR but, really, it's more an appropriate realignment of 
the responsibilities and it's a move that the administration is 
already making. And so it seems as members of Congress it's 
important that we provide that oversight and the guardrails for 
any move or any changes.
    PAHPA reauthorization is a unique opportunity to examine 
our response to all threats and ensure we look forward to the 
future, that we have the procedures, the resources, and the 
support in place to protect ourselves and our citizens, and I 
look forward to hearing from our witnesses this morning.
    I yield back.
    Mr. Burgess. And the chair thanks the gentlelady. The 
gentlelady yields back.
    The chair now would like to recognize the ranking member of 
the full committee, Mr. Pallone of New Jersey, 5 minutes for an 
opening statement, please.

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

    Mr. Pallone. Thank you, Mr. Chairman.
    Today, we will examine the reauthorization of a critical 
law known as the Pandemic All-Hazards Preparedness 
Reauthorization Act, or PAHPA. It's designed to prepare for and 
respond to health security events and emergencies that 
unfortunately are all too common, and these include 
bioterrorism acts, the spread of emerging infectious diseases, 
and natural disasters.
    In order to effectively prepare for and respond to these 
types of events, we must have extensive coordination between 
Federal, State, local, and tribal governments and the private 
sector organizations, and the critical programs included in 
this law help to accomplish that goal.
    That's why I am disappointed that on a bill of such 
magnitude my staff and our witnesses including the 
administration did not receive the draft legislation until late 
last week. This has been a very broken legislative process to 
date, and now the administration is limited in the feedback it 
can provide on the specific provisions of the bill. And I hope, 
moving forward, we will work together to ensure that these 
policies are fully understood.
    Federal funding and support for local, State, and tribal 
public health activities is critical to saving lives. This 
existing public health infrastructure is how we respond to all 
types of hazards. Unfortunately, our public health capacity and 
infrastructure is not as strong as it could be. Public dollars 
have been depleted and the workforce has shrunk. Public funding 
is also not stable or reliable from year to year, making 
planning across all levels of government difficult.
    I am worried that there is a lack of public health funding 
at a time when communities are facing increased need. For 
example, climate change is creating conditions for increased 
extreme weather events. Last year, hurricanes in Texas, 
Florida, Puerto Rico, and the U.S. Virgin Islands placed 
significant stress on our public health system and we need to 
increase public health funding including to programs authorized 
by this bill to bolster both our ability to prepare for and 
respond to these threats.
    While I am generally supportive of the draft bill, I'd like 
to outline some specific concerns and questions. First, the 
public health emergency response fund is funded under transfer 
authority, and this is short-sighted. We witnessed the downside 
of this approach firsthand during the Zika outbreak when the 
Republican Congress forced the administration to fund our 
initial Zika efforts through transfers of existing 
appropriations. As a result, a state like Michigan, which was 
confronting its own public health emergency--the Flint water 
crisis--had some of its public health funding sent to states at 
high risk of local Zika transmission. Michigan lost funding 
that it could have used to address its own crisis in Flint and 
we shouldn't have to pick one crisis over another. New real 
funding should be put in this fund.
    Second, I have yet to hear a strong argument for moving the 
Strategic National Stockpile--or SNS--from the Centers for 
Disease Control and Prevention to the Assistant Secretary of 
Preparedness and Response--or ASPR--in statute. The Secretary 
of HHS has already started the process of moving the SNS under 
existing law and I see no reason to codify this move before we 
know the consequences. We must make certain that placing the 
SNS in ASPR instead of CDC does not weaken our current 
preparedness and response capabilities before making such a 
move permanent. From what I can tell, we are trading some 
debatable improvements and procurement efficiency on the front 
end for the ability to more effectively reach communities and 
individuals with the materials they need in case of a public 
health emergency, and I would argue that ensuring that we can 
reach people with potentially lifesaving drugs and medical 
supplies in the event of a public health emergency must be our 
top priority. CDC has the relationships and expertise that make 
the most sense managing and operationalizing the stockpile as 
well as the record of successful stewardship of the SNS.
    And third, I have numerous questions regarding the intent 
of the cybersecurity language in this draft. As many are aware, 
the Oversight and Investigations Subcommittee has been working 
on this issue and has discovered challenges regarding internal 
and external cybersecurity preparedness within HHS. I agree we 
need to do more to protect our health system from cyber-attacks 
and the potential interruptions of care because of these 
attacks. However, we need to make certain that placing 
increased cybersecurity authorities within ASPR as part of 
other emergency preparedness and response programs is the 
optimal solution, and if it is, that we authorize the resources 
to support any new authorities. Simply adding the word 
cybersecurity to certain programs within the Public Health 
Service Act and FDA's emergency use authorities will do little 
to boost our preparedness and response for cybersecurity 
threats unless it is done thoughtfully and with consideration 
for the problems we are trying to solve.
    So I look forward to learning what exactly the role of the 
Assistant Secretary for preparedness and response would play 
under this legislation in the event of a cybersecurity attack 
on the health care system.
    I believe we should evaluate this legislation, Mr. 
Chairman, based on whether Americans in all corners of the 
country will be safer or not, and I look forward to continuing 
our work on this bill.
    So thank you, Mr. Chairman.
    [The prepared statement of Mr. Pallone follows:]

             Prepared statement of Hon. Frank Pallone, Jr.

    Today we will examine the reauthorization of a critical law 
known as the Pandemic All- Hazards Preparedness Reauthorization 
Act or PAHPA. It is designed to prepare for and respond to 
health security events and emergencies that unfortunately are 
all too common. These include bioterrorism acts, the spread of 
emerging infectious diseases, and natural disasters.
    In order to effectively prepare for and respond to these 
types of events, we must have extensive coordination between 
federal, state, local, tribal governments and private sector 
organizations. The critical programs included in this law help 
to accomplish that goal.
    That is why I am disappointed that on a bill of such 
magnitude my staff and our witnesses, including the 
Administration, did not receive the draft legislation until 
late last week. This has been a very broken legislative process 
to date. And now the Administration is limited in the feedback 
it can provide on the specific provisions of the bill. I hope 
moving forward we will work together to ensure that these 
policies are fully understood.
    Federal funding and support for local, state, and tribal 
public health activities is critical to saving lives. This 
existing public health infrastructure is how we respond to all 
types of hazards. Unfortunately, our public health capacity and 
infrastructure is not as strong as it could be. Public dollars 
have been depleted and the workforce has shrunk. Public funding 
is also not stable or reliable from year to year, making 
planning across all levels of government difficult.
    I am worried that there is a lack of public health funding 
at a time when communities are facing increased need. For 
example, climate change is creating conditions for increased 
extreme weather events. Last year, hurricanes in Texas, 
Florida, Puerto Rico and the U.S. Virgin Islands placed 
significant stress on our public health system. We need to 
increase public health funding, including to programs 
authorized by this bill, to bolster both our ability to prepare 
for and respond to these threats.
    While I am generally supportive of the draft bill - I'd 
like to outline some specific concerns and questions. First, 
the Public Health Emergency Response Fund is funded using 
transfer authority. This is short sighted. We witnessed the 
downside of this approach firsthand during the Zika outbreak 
when the Republican Congress forced the Administration to fund 
our initial Zika efforts through transfers of existing 
appropriations. As a result, a state like Michigan, which was 
confronting its own public health emergency, the Flint water 
crisis, had some of its public health funding sent to states at 
high risk of local Zika transmission.Michigan lost funding that 
it could have used to address its own crisis in Flint. We 
shouldn't have to pick one crisis over another. New, real 
funding should be put in this fund.
    Second, I have yet to hear a strong argument for moving the 
Strategic National Stockpile (SNS) from the Centers for Disease 
Control and Prevention (CDC) to the Assistant Secretary of 
Preparedness and Response (ASPR) in statute. The Secretary of 
HHS can and has already started the process of moving the SNS 
under existing law, and I see no reason to codify this move 
before we know the consequences. We must make certain that 
placing the SNS in ASPR instead of CDC does not weaken our 
current preparedness and response capabilities before making 
such a move permanent. From what I can tell, we are trading 
some debatable improvements in procurement efficiency on the 
front end for the ability to more effectively reach communities 
and individuals with the materials they need in case of a 
public health emergency. I would argue that ensuring that we 
can reach people with potentially life-saving drugs and medical 
supplies in the event of a public health emergency must be our 
top priority. CDC has the relationships and expertise that make 
the most sense for managing and operationalizing the stockpile, 
as well as a record of successful stewardship of the SNS.
    Third, I have numerous questions regarding the intent of 
the cybersecurity language in this draft. As many are aware, 
the Oversight and Investigations Subcommittee has been working 
on this issue, and has discovered challenges regarding internal 
and external cybersecurity preparedness within HHS. I agree we 
need to do more to protect our health system from cyberattacks 
and the potential interruptions of care because of those 
attacks. However, we need to make certain that placing 
increased cybersecurity authorities within ASPR and as part of 
other emergency preparedness and response programs is the 
optimal solution. And if it is, that we authorize the resources 
to support any new authorities. Simply adding the word 
``cybersecurity'' to certain programs within the Public Health 
Service Act and FDA's emergency use authorities will do little 
to boost our preparedness and response for cybersecurity 
threats unless it is done thoughtfully and with consideration 
for the problem we are trying to solve. I look forward to 
learning what exactly the role the Assistant Secretary for 
Preparedness and Response would play, under this legislation, 
in the event of a cybersecurity attack on the health care 
system.
    I believe we should evaluate this legislation based on 
whether Americans in all corners of the country will be safer 
or not. I look forward to continuing our work on this bill.
    Thank you, I yield the remainder of my time.

    Mr. Burgess. The Chair thanks the gentleman. The gentleman 
yields back.
    This concludes member opening statements and the Chair 
would remind members that pursuant to committee rules all 
members' opening statements will be made part of the record.
    And we do want to thank our witnesses for being here this 
morning and taking the time to testify before the subcommittee. 
Each witness will have the opportunity to give an opening 
statement followed by questions from members.
    Our first panel this morning we will hear from Dr. Robert 
Kadlec, Assistant Secretary for Preparedness and Response from 
the United States Department of Health and Human Services. We 
will also hear from Rear Admiral Stephen Redd, Director of the 
Office of Public Health Preparedness and Response, Center for 
Disease Control and Prevention, and Ms. Anna Abram, Deputy 
Commissioner for Policy Planning, Legislation, and Analysis at 
the United States Food and Drug Administration.
    We appreciate each of you being here today and, Dr. Kadlec, 
you're now recognized for 5 minutes to summarize your opening 
statement, please.

   STATEMENTS OF DR. ROBERT KADLEC, ASSISTANT SECRETARY FOR 
PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF HEALTH AND HUMAN 
   SERVICES; REAR ADMIRAL UPPER HALF STEPHEN REDD, DIRECTOR, 
CENTERS FOR DISEASE CONTROL AND PREVENTION; ANNA ABRAM, DEPUTY 
 COMMISSIONER FOR POLICY, PLANNING, LEGISLATION, AND ANALYSIS, 
               U.S. FOOD AND DRUG ADMINISTRATION

                   STATEMENT OF ROBERT KADLEC

    Dr. Kadlec. Thank you. Good morning, Chairman Burgess, 
Ranking Member Green, and distinguished members of the 
committee.
    I am Dr. Bob Kadlec, the Assistant Secretary for 
Preparedness and Response--ASPR. Thank you for this opportunity 
to appear before you today as you consider the second 
reauthorization of the Pandemic All-Hazards Preparedness Act.
    This committee championed the drafting and passage of PAHPA 
more than a decade ago and I want to acknowledge the original 
vision and leadership of Representative Mike Rogers and Anna 
Eshoo, now under the stewardship of Representative Brooks and 
Representative Eshoo as well. Thank you again for your hard 
efforts in this work.
    One of our Constitution's sacred obligations to our 
citizens is to provide for the common defense, to protect the 
American people, our homeland, and our way of life. The ability 
of our nation's public health and medical infrastructure to 
quickly mobilize a coordinated national response to 21st 
century threats like pandemics, deliberate attacks, and natural 
disasters is a national security imperative and is at the heart 
of my efforts at the ASPR.
    When ASPR was originally established by PAHPA, the 
objective was to answer a very simple question: who's in charge 
of federal public health and medical preparedness and response 
functions. The approach adopted was modeled on the Goldwater-
Nichols Act that created the unity of effort at the Department 
of Defense. My goal is to ensure that we can mobilize the 
capabilities of the federal government to support state, local, 
tribal, and territorial health authorities to save lives and 
protect Americans.
    I have four key priorities: provide strong leadership; 
develop a regional disaster health response system; advocate 
for CDC sustainment of robust responsive public health security 
capabilities; and advance an innovative medical countermeasure 
enterprise. I will elaborate on two of these. The importance of 
national health care readiness and medical surge capacity was 
highlighted during the last hurricane season when ASPR led 
Federal medical and public health response and recovery 
activities under the national response framework. We worked 
closely with FEMA and state and territorial health officials to 
augment health care with HHS disaster medical assistant teams, 
many of whom are your constituents who are health care 
providers, and public health commission core officers as well 
as physicians and health care providers from the VA, Department 
of Homeland Security, and the Department of Defense.
    As we speak, we are implementing many lessons learned from 
the hurricanes and from the 2014 Ebola outbreak two work with 
our colleagues across HHS and the Federal interagency to better 
coordinate our national preparedness and response to the 
current Ebola outbreak in the Democratic Republic of Congo as 
well as actively monitoring the dynamic global national 
security landscape as well as the weather landscape.
    As we look forward, we are actively engaging our public and 
private partners in health care delivery to understand how we 
can most effectively improve their readiness for potential 
catastrophic threats. I believe we need to modernize our 
existing programs to build a tiered regional system utilizing 
local health care coalitions and trauma center systems that 
integrates all medical response capabilities, expands specialty 
care expertise in trauma and other related disciplines such as 
burn and radiation treatment, and incentivize the health care 
system to integrate measures of preparedness into daily 
standards of care. I call this the foundation of a regional 
disaster health response system.
    The second area to highlight is our medical countermeasure 
enterprise. PAHPA established the Biomedical Advanced Research 
and Development Authority, or BARDA, which is the component of 
ASPR to bridge the so-called valley of death in the late stage 
of development of vaccines, drugs, and diagnostics where many 
products historically languished or failed. By using flexible 
nimble authorities, multi-year advance funding, strong public-
private partnerships, and cutting-edge expertise, BARDA has 
achieved a remarkable 35 FDA approvals.
    Just yesterday, we announced an exciting new public-private 
engagement model called DRIVe--the Division for Research, 
Innovation, and Ventures--which is designed to accelerate 
innovation, address some of the Nation's most pressing health 
security challenges and potentially affect major health care 
markets.
    It is the brainchild of this committee in the 21st Century 
Cures Act. At a time when synthetic biology and personalized 
medicine are not just conceivable but attainable, the time is 
right to apply an innovative approach to some of the most 
daunting far-reaching health security problems such as sepsis 
and early diagnosis of infectious disease.
    We are opening our doors to more innovators and, most 
importantly, investors to better leverage advances in science 
and technology.
    Thank you again for your bipartisan commitment to this 
national security imperative. I am happy to answer any 
questions you may have.
    Thank you.
    [The prepared statement of Dr. Kadlec follows:]
    
    
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    Mr. Burgess. The chair thanks the gentleman.
    The chair now recognizes Rear Admiral Redd. Dr. Redd, 
you're recognized for 5 minutes, please.

                   STATEMENT OF STEPHEN REDD

    Admiral Redd. Chairman Burgess, Ranking Member Green, and 
members of the subcommittee, I am Rear Admiral Stephen Redd, 
director of CDC's Office of Public Health Preparedness and 
Response.
    Thank you for the opportunity to testify before you today 
to describe the role that CDC plays in public health 
preparedness and response including those responsibilities 
under the Pandemic and All-Hazards Preparedness Reauthorization 
Act.
    Today, I will highlight CDC's role in protecting the Nation 
against health threats and I will describe that in three areas: 
preparedness, protection, and response. Within that discussion, 
there are three themes that I would like you to appreciate: 
first, the work that CDC does every day in public health lays 
the foundation for responding to emergencies; second, CDC's 
world-class scientific and medical expertise ensures we are 
ready to respond to any threat; and third, our longstanding 
connection to state and local health departments ensures that 
public health systems function effectively both day to day and 
during emergency responses.
    Let me first address the issue of preparing for 
emergencies. CDC works every day with state and local health 
departments. In fact, we have 590 staff assigned to state and 
local health departments. We fund the public health emergency 
preparedness cooperative agreement program and the Cities 
Readiness Initiative.
    Our public health emergency preparedness grants go to every 
State, eight territories, and four cities. These funds support 
staff, enable exercises to test and validate capabilities and 
pay for laboratory and communications equipment. Cities 
Readiness Initiative funds the Nation's 72 largest cities to 
develop and test plans to receive and dispense medical 
countermeasures from the Strategic National Stockpile.
    Turning now to detecting threats, CDC's laboratories and 
surveillance systems are able to detect and identify agents 
causing illness, whether that cause is microbial or from 
chemical or radiation exposure. Every year, laboratories from 
all over the world send several hundred thousands of specimens 
to CDC because they know that we will be able to identify 
pathogens other laboratories cannot.
    Rapid identification of disease permits intervention before 
a health threat becomes a crisis. CDC's laboratory response 
network maintains an integrated, scalable, and flexible system 
of 153 Federal, State, and local laboratories. The development 
of this network over the past 15 years has provided a larger 
capacity to test and report more quickly than was possible 
before. For example, during the Zika outbreak, CDC and other 
laboratory response network laboratories processed over 207,000 
specimens.
    Now, turning to response, when there's a crisis, CDC 
responds. We are able to deploy scientific and medical experts 
anywhere in the world. For example, by the end of the 21-month 
Ebola response, 3,700 CDC staff, more than a quarter of our 
workforce, shifted from their day-to-day duties to assist in 
the response. Fifteen hundred staff deployed to West Africa, 
accounting for over 2,000 trips. Today, we are responding to 
the much smaller outbreak in the Democratic Republic of Congo.
    During health emergencies, CDC communicates. For example, 
during the 2009 H1N1 response, CDC held 39 press conferences 
and 21 telebriefings. During the Zika response, CDC published 
51 morbidity and mortality weekly report articles ensuring that 
the public and health professionals had the latest and best 
information. Being able to prepare for, detect, and respond to 
public health threats is a top priority for CDC. Our 
preparedness and response capabilities are built on a broad and 
deep scientific medical and program expertise. Our longstanding 
partnerships with State, local, and public health authorities 
assured an integrated approach wherever that approach is 
needed, resulting in better responses and better public health 
outcomes.
    Thank you for the opportunity to testify here today. I look 
forward to answering your questions.
    [The prepared statement of Admiral Redd follows:]
    
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    Mr. Burgess. Thank you, Dr. Redd.
    Ms. Abram, you're recognized for 5 minutes, please.

                    STATEMENT OF ANNA ABRAM

    Ms. Abram. Thank you.
    Chairman Burgess, Ranking Member Green, and the other 
members of the committee, thank you for the opportunity to 
appear today and discuss reauthorization of the Pandemic and 
All-Hazards Act, or PAHPA.
    Medical and public health preparedness and response is of 
critical importance to the health and security of our nation 
and I am pleased to be here today to share how FDA is working 
toward the shared goal of making sure we have the medical 
products we need to protect Americans from a range of public 
health threats, whether naturally occurring, like a pandemic, 
or the result of a deliberate attack.
    We are reminded of the urgency and need to remain ever 
vigilant against identified and emerging public health threats 
as we carefully monitor the current outbreak of Ebola virus 
disease, this time in the Democratic Republic of Congo. I can 
assure you that FDA is dedicated to helping end this outbreak 
as quickly as possible and we are actively engaged with our 
Federal colleagues testifying here with me today, as well as 
with medical product developers, international organizations 
including the World Health Organization, to support 
international response efforts. This most recent Ebola outbreak 
accentuates the continuing threat posed by emerging infectious 
diseases, which can and often do emerge with little to no 
warning and the need for us to continue to optimize our 
preparedness and response capabilities.
    PAHPA, which was passed in 2006 and reauthorized in 2013, 
in addition to other key pieces of legislation that has served 
to significantly strengthen our nation's preparedness and 
response capabilities to respond to public health emergencies 
involving chemical, biological, radiological and nuclear--or 
CBRN--threats as well as emerging infectious disease threats 
such as the Zika virus, Ebola virus, and pandemic influenza.
    Prior to joining FDA, I worked for more than a decade on 
health care policy with your colleagues in the United States 
Senate, serving as a health policy director to U.S. Senator 
Richard Burr from North Carolina on the Health, Education, 
Labor, and Pensions Committee for many years. In that capacity, 
I collaborated with colleagues serving in the United States 
House of Representatives, including this committee, and it's 
nice to see some of those colleagues here today. I was actively 
involved in working on a range of health care issues and my 
tenure was very much highlighted by my work on medical and 
public health preparedness and response issues including the 
bipartisan 2013 PAHPA Reauthorization ACT, or PAHPA, and more 
recently the 21st Century Cures Act.
    PAHPA recognized the key role FDA plays in emergency 
preparedness and response and codified and built on FDA's 
ongoing efforts to augment our review processes and advance 
regulatory science to enable better response to public health 
emergencies and emerging health threats. The provisions in 
PAHPRA have been critical to FDA's efforts to drive innovation 
in the medical countermeasure space and have provided FDA with 
essential tools that continue to support our mission to protect 
and promote public health.
    At FDA we've made it a priority to utilize these 
authorities to proactively work with our private sector and 
government partners to help facilitate the translation of 
discoveries in science and technology into safe and effective 
medical countermeasures as part of advancing public health and 
strengthening our national security.
    We share Congress' goal to have safe and effective medical 
countermeasures available in the event they are needed and we 
have made key progress towards this important goal. As of the 
end of fiscal year 2017, FDA has approved, licensed, or cleared 
121 medical countermeasures including supplementals to 
approvals, licensures, and cleared medical products. We have 
issued more than 60 emergency-use authorizations since 2005, 
including about 40 since 2013, including for Ebola and Zika. 
Medical countermeasures can face unique development challenges 
that require medical product sponsors to rely on animal models 
because even efficacy trials would not be ethical.
    PAHPRA required FDA to issue final guidance regarding the 
development of animal models to support the approval and 
clearance of medical countermeasures. FDA finalized this 
guidance in October 2015 and to date, 13 medical 
countermeasures have been approved under the animal rule, 
including the approval of a new indication for a medical 
countermeasure to increase survival of adult and pediatric 
patients acutely exposed to myeloid suppressive doses of 
radiation as could occur after a radiological or a nuclear 
event. This is the third FDA-approved medical countermeasure 
that is indicated to increase survival in patients exposed to 
myeloid suppressive doses of radiation.
    Other approvals under the animal rule include inhalational 
anthrax therapeutics of botulism antitoxin, antibiotics for the 
treatment and prophylaxis of plague, prophylaxis against the 
lethal effects of some nerve agent poisoning and treatment of 
known or suspected cyanide poisoning.
    We have been actively implementing the new authorities 
within our medical countermeasures initiative, specific to our 
engagements with the Department of Defense as well. In January 
of 2018, the agency launched enhanced engagements with the 
Department of Defense under a joint program to prioritize the 
efficient development of safe and effective medical projects 
intended for our U.S. military personnel.
    We are fully committed to working with our colleagues at 
the Department of Defense to support the needs of our U.S. 
military personnel and look forward to continue to enhance 
collaborations in these endeavors.
    Finally, I am pleased to share that today we are releasing 
our medical countermeasures initiative program update which 
highlights the many notable achievements the agency has made to 
advance the development and availability of safe and effective 
medical countermeasures in fiscal year 2017. This report 
provides an in-depth insight into the breadth of activities and 
the progress FDA has contributed to our nation's medical 
countermeasure assets.
    FDA remains deeply committed to working closely with its 
partners and fully using the authorities and resources Congress 
provides us to advance this mission.
    We look forward to partnering with this committee and the 
Senate in the reauthorization of PAHPA. Thank you again for the 
opportunity to testify today and I would be happy to answer any 
questions.
    [The prepared statement of Ms. Abram follows:]
    
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    Mr. Burgess. Well, I thank you for your testimony. I thank 
all of our witnesses for their testimony. We will proceed to 
the question and answer portion of the hearing.
    Let me recognize myself for 5 minutes for questions and, as 
always, I will run out of time before I finish questions. So we 
will be submitting some for the record.
    Ms. Abram, let me just ask you, several years ago in the 
middle of a flu epidemic in Fort Worth, Texas, I came home one 
Thursday night to the Channel 8 news and they said the FDA was 
making available expired Tamiflu to the area hospitals.
    So, as you can imagine, Dr. Hamburg and I had a call the 
next morning, and she assured me that expired Tamiflu would in 
fact be just as efficacious. But as far as the Strategic 
National Stockpile goes, do you try to rotate stock in and out 
so we don't end up with an expired national stockpile?
    Ms. Abram. So FDA supports the Strategic National Stockpile 
very much from a technical and regulatory perspective. Congress 
has given us the authorities to help to extend the shelf life 
of products.
    So we will look at products to see if--even if they have a 
certain expiration date that they've been assigned whether or 
not it would be appropriate and they could still convey a 
therapeutic benefit if they were used.
    And I don't know if my colleague would like to add anything 
further to that.
    Admiral Redd. That's exactly right. The products are maybe 
labeled expired but they're tested to assure that they haven't 
expired.
    Mr. Burgess. So, Dr. Kadlec, let me just ask you--of 
course, we had Ebola in Dallas, Texas, a few years ago and 
recognized the unified response was certainly necessary in that 
public health emergency and all systems need to be able to 
coordinate their efforts at the Federal, State, and local 
level.
    So can you perhaps enlighten us further how ASPR would 
identify partners who would be involved in this collaboration 
and enhance our medical surge capacity?
    Dr. Kadlec. Yes, sir. In fact, during this Ebola outbreak 
we've--the secretary asked me to basically lead the 
coordination across the department. So we've been holding 
regular conversations with HHS partners as well as other 
Federal interagency partners to do two things.
    One is establish whatever is needed to support the response 
overseas, keep the disease over there rather than over here, 
and the second one is making sure that our capabilities 
domestically are prepared.
    We do have the National Ebola Treatment Network that was 
created with supplemental funding that runs out in fiscal year 
2019 that created three national centers for the treatment of 
Ebola patients as well as 10 regional centers in addition to 
the NIH clinical facility here in Bethesda. So it was basically 
assuring that the training, the equipping, and the requirements 
were all up to date in terms of if their case should show up on 
our soil how would we respond.
    Second is mobilizing the assets that were funded largely by 
BARDA, though NIH had some significant capabilities to include 
diagnostics that were basically made available and donated by 
the company to DRC as well as vaccines that BARDA supported 
with Merck that was deployed and has immunized and the folks 
down there, the responders, have immunized 1,100 folks so far 
in vaccination.
    So there have been a number of activities that we've 
monitored, coordinated on, and just ensured that we had 
everything ready to go should this outbreak take a different 
turn than it has so far shown.
    Mr. Burgess. What we discovered 2 \1/2\ years ago, whenever 
the previous outbreak occurred, is a state like Texas, where 
you have got some big distances between communities, hospitals 
did form networks and were agreeable to helping each other at 
the same time. If you had a car show up with a group of folks 
where high index of suspicion for a problem, all of the assets 
in a local area could be consumed very quickly.
    Are you looking at how to deal with that?
    Dr. Kadlec. Yes, sir. And beyond those 10 regional 
treatment centers we've also had 60 designated state Ebola 
treatment centers and 178 Ebola assessment hospitals. So we've 
really focused on the concentration of those skills and 
supplies necessary for those leading edge hospitals or clinics 
to basically initially evaluate patients, safely do so for 
themselves and for their patients and then make the referrals 
up the chain to higher levels of care and treatment.
    Mr. Burgess. Let me ask you this. You stressed strong 
leadership several times in your testimony. I am grateful that 
you are where you are. I want you to be there.
    But just in general, as far as your position is concerned, 
there are some jurisdictional issues. There are some 
Interagency issues. There has been some discussion about 
designating the office of the vice president as part of that 
central command. What are your thoughts about that?
    Dr. Kadlec. Sir, in an operational sense, I think the ASPR 
performs a function as part of the national response plan. In 
terms of orchestrating probably beyond the operational levels 
of the strategic levels, particularly for resourcing, having a 
friend or an ally at senior levels in the White House is a good 
thing.
    Having served as a special assistant to the President 
during the Bush administration--the second tour--I can only say 
that having support by the vice president or someone of stature 
like his would be exceptional and very force multiplying in 
terms of having the support to get the resources to support 
what we need to do at the operational or at the tactical level.
    Mr. Burgess. Thank you, and my time expired. I will 
recognize the gentleman from Texas, Mr. Green, 5 minutes for 
questions, please.
    Mr. Green. Thank you, Mr. Chairman.
    Dr. Kadlec, antibiotic resistance is a real and growing 
problem. I think we all agree to that, that in occurring 
pandemics, chemical, biological, radiological, and nuclear 
attack medical counter measures need to be able to treat the 
initial injury from these attacks.
    But, as you know, these patients may be suffering from 
burns and wounds, for example, that are susceptible to 
secondary bacterial infections. Antibiotics are an integral 
part of that with the growing threat of antibiotic resistance 
in public health as well as preparedness and response efforts.
    Can you tell us what role you see BARDA playing in shoring 
up this pipeline of new antibiotics?
    Dr. Kadlec. Well, thank you for the question, sir, and 
BARDA has been very active in this area. They set up a program 
called CARB-X which is an active program, which is interesting 
because it really forms as a model for what we believe the 
DRIVe program will look like.
    It's the idea of creating public-private partnerships and 
in this case CARB-X and BARDA has basically interactions with 
28 different companies who make novel anti-bacterial drugs, 
vaccines, or diagnostics, and as a result of that, there have 
been identified eight new classes of antibiotics. So that's 
important. But, significantly, for the taxpayer, $70 million of 
Federal investment by CARB-X has resulted in about $485 million 
in private equity following that investment.
    So not only are we trying to create new avenues and 
interest in this area which, quite frankly doesn't have a large 
commercial market for the drug companies, but we've worked 
effectively with the private sector to build, I think, the 
requisite investment to identify promising candidates that we 
can move through the developmental cycle and pathway to 
ultimate licensure.
    Mr. Green. There are not enough new antibiotics in the 
pipeline. Almost 75 percent of those products in clinical 
development are based on previously-approved classes of 
antibiotics. Novel structures and approaches are needed to stay 
ahead of the resistance--innovative preclinical antibiotic 
approaches.
    CARB-X is a global public-private partnership with BARDA 
and NIAID and other global partners ensure that a robust 
pipeline of preclinical innovation candidates that a product 
protect human health from the most serious bacterial infection.
    Can you describe how BARDA, CARB-X, and NIAID are working 
to ensure that there are enough preclinical products moving on 
to clinical trials?
    Dr. Kadlec. Well, sir, they do so by a variety of methods. 
Part of it is active--I want to say query which is part of it. 
And again, I will just use the example that we hope to build on 
is using innovation accelerators around the country to 
basically identify promising candidates that could be 
antibiotics or antimicrobials that would be part of this CARB-X 
program or part of the larger innovation program.
    So the thing is is that we work closely with NIAID on this. 
We do work with the Wellcome Trust as other organizations as 
well as with companies to basically identify these.
    Obviously, it's going to take long-term constant vigilance 
and, again creating new drugs is just part of the challenge, as 
Dr. Burgess would identify. Part of it is basically monitoring 
the environment and I think Dr. Redd can highlight on those 
pieces as well as practices by physicians in prescribing 
antibiotics. Dr. Redd.
    Admiral Redd. Yes. First of all, I want to acknowledge the 
significance of the problem, that if we run out of antibiotics, 
not just treatment of infects but things like cancer therapy 
and surgery are going to be much more difficult than they are 
today.
    In addition to developing new products, there are steps 
that need to be undertaken and are being undertaken in the 
public health domain. First is just preventing infections in 
hospitals--that bacteria in hospitals is where real resistance 
is bred.
    Secondly is tracking and identifying infections when they 
occur with resistant organisms so that intensive infection 
control measures can be undertaken to prevent the spread of 
those organisms to other individuals.
    And then thirdly, improving the prescribing of 
antimicrobial--that if these drugs can be limited to the people 
who really need them, that will also slow the development of 
resistance.
    Mr. Green. Is there any overlap between the CDC's 
investment in antibiotic resistance laboratory network and what 
ASPR does?
    Admiral Redd. There's not. We are funding laboratory 
testing as part of the surveillance system to identify 
resistant organisms so that those interventions can be 
undertaken to prevent their spread.
    Mr. Green. Well, and I want to thank the CDC because in 
2005, after Hurricane Katrina in Louisiana, Houston, Texas got 
about a quarter of a million people from south Louisiana, and 
CDC was there bringing in the medications and also the public 
health officers to help our local medical schools and our 
hospital system.
    So CDC is very valuable, and I yield back my time, Mr. 
Chairman.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentlelady from Tennessee, Mrs. 
Blackburn, 5 minutes for questions, please.
    Mrs. Blackburn. Thank you, Mr. Chairman.
    Ms. Abram, I want to come to you for just a minute and talk 
a little bit about the stockpile and the definition that is 
there. It is in statute, defined to include drugs, biological 
products, or devices.
    And until 2016, when we passed 21st Century Cures and 
included in that the Software Act, which deals with medical 
technology, medical software had been included in that 
definition of medical devices. And what happened or what we did 
in that was to remove some classifications of medical software 
from FDA oversight, and I know that you're familiar with the 
legislation and familiar that FDA is still in the process of 
implementing that law and making those determinations which 
products are going to go where. And we recently--I think it was 
the end of December--received more guidance documents to that 
fact.
    So what I wanted to know from you is are there any types of 
medical software or applications currently in the stockpile 
that no longer fall under the device definition?
    Ms. Abram. Thank you so much for the question. You alluded 
to this and mentioned it in your remarks. Yes, we are actively 
implementing a number of the provisions that were enacted as 
part of Cures including delineating in a risk-based manner the 
regulation of various devices and the software kind of 
components that get into that.
    Traditionally, much of what has been procured into the 
stockpile has focused more on vaccines, therapeutics, 
diagnostics, and some of the other materiel--for example, I 
believe, like, personal protective equipment would be something 
purchased there.
    And I would like to acknowledge that one of the additions 
to the draft that was released over the past week includes the 
concept of cyber security, which is, of course, a very 
important matter.
    Mrs. Blackburn. OK. Let me ask you this. Would you 
recommend that we amend the definition of security 
countermeasures to include medical software in applications 
when there is a clear need that some of these products may need 
to be procured?
    Ms. Abram. So the addition of the cybersecurity references 
and the context of where that may interface here with the 
software considerations and device considerations has raised 
some novel questions and considerations.
    And having just recently received the text we are having 
our subject matter experts look at it quickly because we 
understand this is an area of interest for the committee and we 
want to make sure we are providing very thorough and thoughtful 
input on these points because, as I mentioned, cybersecurity 
is, obviously, a very serious concern and we want to be 
responsive to it. We have looked at it in the context of 
devices form a total produce life cycle approach. At the same 
time, much of the framework that you're referencing has 
traditionally been looked at in a CBRN context.
    So this does raise some new questions for us. But we look 
forward to working with the committee and providing technical 
assistance.
    Mrs. Blackburn. Well, I think that--and probably Ms. Eshoo 
and Mrs. Brooks would agree with me--when you all conduct that 
oversight and look at this and formulate an opinion, I think we 
would like to have that----
    Ms. Abram. Absolutely.
    Mrs. Blackburn [continuing]. And include it in the 
information from this hearing.
    Ms. Abram. Absolutely. We'd be happy to follow up.
    Mrs. Blackburn. OK. That would be great.
    Kadlec, let me ask you a little bit about--we've had a bill 
here, the Good Samaritan Act, and of course, there is part of 
the language included in the Senate HELP's version of PAHPA, 
and I have worked on this for several years and I am 
appreciative that it is included. Part of that language is 
included here.
    But I am interested to hear your thoughts on how we can 
truly harness the services of health care professionals who are 
willing to volunteer their skills during emergencies.
    And, after Katrina we saw the need to get people into the 
area. After the Boston Marathon bombing, we saw the need to get 
people in.
    So I would love a quick response on that.
    Dr. Kadlec. Well, thank you, ma'am, for the question. And, 
clearly, there's a real significant role for volunteers in this 
situation. I think the best case scenario is when they identify 
before the crisis or the disaster happens and there are two 
programs that allow that--Medical Reserve Corps and ESAR-VHP, 
which is a volunteer program to allow people to enroll so they 
can be identified.
    I think the key thing is is, as many know, that sometimes 
even though volunteers come forward, their ability to help is 
going to be based on their knowledge and training. And so we 
would prefer that those people would be identified before an 
event and then we have confidence what to do and the right 
things to do so they do not cause any further injury or harm.
    We are very supportive of volunteers. They're a critical 
part of the response as we've seen historically and we know in 
the future they'll be there as we witnessed in the cases of 
several events recently. So very supportive of this notion.
    Mrs. Blackburn. I yield back.
    Mr. Burgess. The gentlelady's time has expired.
    The chair now needs to recognize the gentleman from New 
York, Mr. Engel, 5 minutes for questions, please.
    Mr. Engel. Thank you, Chairman Burgess and Ranking Member 
Green, for holding this very important hearing.
    I don't think we'll have properly considered pandemic 
preparedness without discussing the threat of antimicrobial 
resistance, a serious international drug crisis wherein 
diseases are able to resist the very drugs meant to destroy 
them.
    To underscore the seriousness of antimicrobial resistance, 
I want to talk about tuberculosis, or TB, not only because 
Ranking Member Green and I are two of the co-chairs of the 
House TB Elimination Caucus, because TB and airborne infection 
kills more people worldwide than any other infectious disease, 
and drug resistant TB is the most common and deadly airborne 
antimicrobial resistant disease.
    Cases of anti-resistant TB cost much more to treat than 
drug-sensitive TB in cases of multi-drug resistant TB, and 
extensively drug-resistant TB unfortunately becoming much more 
frequent. While we may typically think drug resistance is 
caused by inappropriate treatment, most drug resistant TB cases 
are now caused by transmission from person to person, making it 
much easier for drug resistant TB to spread to new parts of the 
world.
    History has shown us that we cannot stop infectious threats 
with isolationist policies. We need to invest in new tools to 
keep Americans safe and the growing threat of antimicrobial 
resistance and the very real possibility that one day, 
unfortunately, there might be a drug-resistant outbreak in the 
United States.
    So Dr. Kadlec, let me ask you what more can BARDA do to 
spur the development of novel antimicrobials and ensure that we 
have the tools we need to address antimicrobial resistance and 
improve health security in this country?
    Dr. Kadlec. Thank you, sir, for the question and, again, I 
would just, again, like to reemphasize the role that BARDA does 
have in this area, working closely with NIAID and with foreign 
activities Wellcome Trust to basically create CARB-X, which is 
really the opportunity to pool resources to promote research 
into a variety of different potential candidates.
    I mentioned the possibility of eight new classes of 
antibiotics. To this date, 30 potential high-quality 
antibacterial products have been identified and are being 
evaluated for this. So I think part of this is is realizing 
that there is an ongoing activity that BARDA is working with 
NIAID on. It's informed by CDC in terms of its role subject to 
monitoring the environment and identifying those cases and 
evaluating the sensitivities of those organisms, whether it be 
TB or anything else, quite frankly, and the ability to evaluate 
what we can do to promote renewed interest and research and 
commitment not only by the government but also by the private 
sector into these areas.
    Mr. Engel. Thank you very much.
    Let me also say, to truly protect Americans from health 
threats I believe we, obviously, cannot limit our focus to 
threats within the United States itself.
    So Dr. Redd, you know from your years of service, including 
during the 2009 H1N1 pandemic and the 2014 West Africa Ebola 
outbreak, the disease that knows no borders, do you think it's 
important for the U.S. to evaluate the global threats to health 
security to ensure that we are prepared to face these threats?
    Admiral Redd. Yes, sir. The work that has been done to 
strengthen global health security since 2014 is very important 
and needs to continue.
    I think our work in the Democratic Republic of Congo is 
emblematic of the kinds of threats that we need to be able to 
detect and, working with host countries, contain at the source.
    Mr. Engel. Thank you.
    Ms. Abram, would you like to comment on any of the things 
that I've mentioned?
    Ms. Abram. I would just further add to some of the comments 
that my colleagues have made is that FDA is also actively 
involved in helping to foster and bring forward next-generation 
of antibiotic products.
    We've been implementing the GAIN Act provisions and we've 
also been actively implementing the break points provisions 
that were included as part of the Cures Act, which are very 
helpful in helping to inform providers of proper utilization of 
the antibiotics that are available to treat.
    Mr. Engel. Thank you.
    Thank you, Mr. Chairman. I yield back.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    The chair recognizes the gentleman from Illinois, Mr. 
Shimkus, 5 minutes for your questions, please.
    Mr. Shimkus. Thank you, Mr. Chairman. It's great to have 
you all. Thanks for your work.
    Anyone who's followed this committee knows that I've been 
working on the antimicrobial resistance front for many, many 
years. Good to see folks who have been in this battle.
    You probably heard me say that we need to develop products 
we hope we never has to use. The fact is we are in a race, you 
all know, against antibiotic resistance by bacterial and fungal 
pathogens and we are losing because these diseases are 
developing resistance faster than our efforts can develop new 
agents. And BARDA is very valuable to these efforts, but it's 
clear that BARDA's work, even combined with commercial 
potential, isn't enough.
    FDA Janet Woodcock, CDC's Tom Frieden, and the National 
Institute of Allergy and Infectious Diseases, and NIAID's 
director, Tony Fauci, have joined every major country's 
assessment, acknowledging that there is simply very little 
incentive for biopharma companies to do the necessary R&D.
    I want to first go to Dr. Kadlec but others can chime in if 
they'd like. Can you comment on why antibiotics are a focal 
point of BARDA's work?
    Dr. Kadlec. For two reasons. As you defined, it is a public 
health challenge but, quite frankly, it's inextricably linked 
to the issues that relate to other threats that may happen--
emerging infectious disease as well as deliberate threats.
    So it would be a circumstance that you could anticipate I 
think as highlighted before either in cases of radiation 
exposure where the immune system is depressed or burns where 
the immune system is compromised. Infection becomes a 
significant consideration as well as if you had the intentional 
use of infectious diseases.
    Mr. Shimkus. Would you agree that the situation is dire?
    Dr. Kadlec. Sir, it's difficult and, depending on the agent 
or organism you're talking about, it can be dire, and for the 
individual who's afflicted by it, it is dire, quite honestly.
    Mr. Shimkus. Can you commit or will you work with my office 
and this committee on solutions that spur the proper level of 
critically-needed antimicrobial development?
    Dr. Kadlec. Yes, sir.
    Mr. Shimkus. Mr. Green and I have been trying to deal with 
this over the past couple years. He did touch on this issue and 
you mentioned the ongoing activities.
    But it's my understanding that these efforts may fall short 
when it comes to incentivizing development. Anyone want to 
comment on that observation? Admiral.
    Admiral Redd. I think the point I was going to make is that 
these products are used in a system and the detection and 
infection control procedures and assessment of effectiveness 
are all part of to ensure that these products are used to 
obtain the greatest effect.
    More products are, clearly, needed but we also need to do 
better in who is prescribed antimicrobials, making sure that 
there is as narrow a spectrum as is possible and, hopefully, 
that race we can kind of slow down the spread and evolution of 
resistance so that as new products develop they'll be effective 
for longer periods of time.
    Mr. Shimkus. Go ahead.
    Ms. Abram. Yes, I was just going to add, there's another 
facet to this that I think is important and you actually 
touched upon this in the opening of your question, which is 
around the development of products that you hope to never have 
to use but you may need to use.
    And so one of the aspects of actually being able to capture 
some of this data and real-world experience with the 
utilization of antibiotics and these other naturally occurring 
circumstances helps to add to our data set for understanding 
how these products might be used in the event of a bioterrorism 
event.
    Mr. Shimkus. And I've always been concerned. My observation 
is that they're too small. I always talk about raising capital, 
assuming risk and a return. Now you want to raise capital, 
assume risk, hoping never to get a return.
    And even though there's attempts being made to encourage 
that we just--I still think it's too small, based upon the risk 
out there.
    So go ahead.
    Dr. Kadlec. Sir, I think you're kind of highlighting the 
issue of kind of two kind of categories of incentives. One is 
the push--what can we do to help companies be successful in 
their endeavor to bring new antibiotics or class of antibiotics 
to the table, and then what's the pull--what's the incentive on 
the other side that would kind of somehow offset the cost, 
either opportunity or real, to execute that.
    We are actively looking at that. I think in the past 
Congress has responded in terms of the priority review 
vouchers, obviously, the incentives in terms of investments 
into this are.
    But we are trying to evaluate what is the road to success 
and what's a sustainable road to success, which is another 
story here in terms of looking at incentives over time that 
make sense as well as are affordable.
    Mr. Shimkus. Excellent. Thank you very much.
    Yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentlelady from Illinois, Ms. 
Schakowsky, 5 minutes.
    Ms. Schakowsky. Thank you, Mr. Chairman, and I want to 
thank our panelists all for being here.
    One absolutely essentially part of disaster preparedness is 
having the workforce in place to respond to public health 
emergencies and the workforce is, of course, the backbone of 
disaster preparedness, in my view, and that's why I am proud 
I've introduced H.R. 5998, which is the Securing Experts to 
Control, Understand, and Respond to Emergencies--or the SECURE 
Act--to support and build a robust disaster preparedness 
workforce and the bill would actually simply reauthorize the 
education loan repayment program for the Epidemic Intelligence 
Service--EIS--at the Centers for Disease Control.
    So I am hopeful that this program can be reauthorized and 
make it a part of the underlying bill. EIS officers are health 
professionals who serve on the front lines of public health 
emergencies as boots on the ground, disaster detectives who 
investigate outbreaks and assist during natural disasters. And 
since its creation in 1951, the EIS program has trained more 
than 3,600 officers and based in state and local public health 
departments across the country. EIS officers are deployed more 
than 200 times every year, responding to public health 
emergencies at home and abroad.
    So Dr. Redd, I wanted to ask you how important in our 
ability to recruit this workforce is this program, the loan 
repayment program?
    Admiral Redd. So I agree with you that the Epidemic 
Intelligence Service, or the EIS, is a major asset for CDC and 
the country. It's a major vehicle to recruit health 
professionals and, in particular, physicians to public service.
    I was actually an EIS officer quite a few years ago. The 
proportion of physicians that have been included has decreased 
over the years and I think that probably--that is a part of 
that.
    I am not going to specifically address your bill but I can 
say that for myself when I came to the EIS program I did have 
student loans and it would have been an incentive to have some 
method to have those loans repaid.
    I think it is really critical that we continue and 
strengthen the EIS program.
    Ms. Schakowsky. So why don't you tell us all what EIS 
officers--how they protect the public's health, what kind of 
events do they respond to, and what role do they play in 
responding to those events?
    Admiral Redd. Sure. So Epidemic Intelligence Service 
officers either have doctorate degrees in public health 
sciences or in medicine, generally finish their training, come 
to CDC for post-graduate training. So the EIS program is a 2-
year experiential training program.
    Officers are assigned either within CDC or with state and 
local health departments and the experience part is 
investigating outbreaks. For example, I investigated a 
Legionnaire's disease outbreak in California as part of my EIS 
experience, working with state health departments and local 
health departments to identify risk factors and implement 
control measures.
    It's a great lead-in to public service and to public 
health----
    Ms. Schakowsky. That's really what I wanted to get at. 
After the EIS 2-year training period, 85 percent of EIS 
graduates enter the public health workforce.
    So I think what I am hearing you say and I would agree that 
EIS acts as a pipeline for the next generation of health care 
leaders and contributes to a strong workforce. Would you agree?
    Admiral Redd. Absolutely. As a personal matter, I am pretty 
sure I wouldn't be here today if I hadn't done the EIS program 
a number of years ago.
    Ms. Schakowsky. Well, thank you. I know you can't comment 
on the legislation but I am going to really try and make sure 
that this incentive to get more people into this program is 
part of the legislation.
    Thank you so much for your service.
    Mr. Burgess. The gentlelady yields back. The chair thanks 
the gentlelady.
    The chair recognizes the gentleman from New Jersey, Mr. 
Lance, for 5 minutes.
    Mr. Lance. Thank you, Mr. Chairman.
    Good morning to the distinguished panel. Dr. Kadlec, 
scientists and drug companies are looking to discover and 
develop approaches other than traditional antibiotics to combat 
bacterial infections and these can range from using viruses to 
attack the bacteria, creating vaccines to prevent hospital-
acquired infections, applying known successful interventions in 
treating cancer by changing the way the human immune system 
responds to infections.
    Scientists harness cutting-edge science that will combat 
bacteria in new ways and potentially reduce risk of resistance. 
Would you please talk about BARDA's role in fostering the 
discovery and development of non-traditional approaches?
    Dr. Kadlec. Sir, BARDA is very interested in those kinds of 
approaches and, quite frankly, I think it's part of the 
innovation side that was required through 21st Century Cures 
Act is now building a program to actually look for those kind 
of innovative ideas.
    To your point about viruses to beat bacteria, that's phage 
technology, which BARDA is actively investigating and actually 
looking at different programs that exist that could be relevant 
in terms of addressing--again, a novel way of addressing 
antimicrobial resistance.
    Every bacteria has a counter virus that effectively can 
either disarm it, kill it, or potentially change its antibiotic 
resistance patterns. And so those are things that are actively 
being investigated right now. It is, I think, one of the areas 
that probably deserves more consideration. We welcome the 
opportunity through the 21st Century Cures Act to open these 
new doors to innovative approaches and to maybe non-traditional 
approaches and we look forward to Congress' continued support 
to do more of that, going forward.
    Mr. Lance. Thank you very much, Doctor.
    To the panel in general, the Presidential Advisory Council 
on combatting antibiotic-resistant bacteria was created under 
an executive order in 2014 and has twice been continued, most 
recently in 2017.
    The Advisory Council is set to expire on September 20th, 
2019, unless there is another continuation by executive order. 
Considering the danger posed by antibiotic-resistant bacterial 
infections, the fact that this remains quite high, is there any 
reason why the Advisory Council should not be extended to 
continue its mission to produce reports and recommendations 
that influence Federal combating antibiotic-resistant bacteria 
activities both here and abroad?
    Admiral Redd. Well, I think this problem is going to be 
with us for the foreseeable future. So I think that, regardless 
of the exact structure used to organize our response to that, 
this will be a problem that we'll be facing for years and years 
to come.
    Mr. Lance. So that means, I assume, that looking in the 
future we probably should extend this beyond the current 
deadline?
    Admiral Redd. I think that's a decision that won't be mine 
to make. I think we'll have to look at what progress we've made 
and how that panel had encouraged that progress.
    Mr. Lance. Thank you.
    Would anyone else on the panel like to comment?
    Yes. Go ahead.
    Ms. Abram. I was just going to add, there's, 
understandably, a considerable amount of interest in the 
antimicrobial-resistant issues and one point I haven't made, be 
remiss if I didn't, is also the importance of regulatory 
certainty when it comes to bringing forward the next generation 
of antibiotics products and they, like other medical 
countermeasures, can face unique development challenges.
    And so one thing that FDA has also been very focused on is 
putting out product-specific guidance. For example, we've 
issued guidance on the clinical trial design for specific 
diseases including prophylaxis of inhalational anthrax.
    And so we are trying to do our part, what we can to help 
make the pathway as clear as possible, recognizing that there 
are some inherent challenges that have been discussed at length 
at the hearing.
    Mr. Lance. Thank you very much, and please keep up the good 
work--a very distinguished panel.
    I yield back 37 seconds, Mr. Chairman.
    Mr. Burgess. The chair is overjoyed and thanks the 
gentleman for yielding back.
    The chair now recognizes the ranking member of the full 
committee, Mr. Pallone, 5 minutes for questions, please.
    Mr. Pallone. Thank you, Mr. Chairman. I am trying to get in 
some questions about the Strategic National Stockpile and also 
the priority review vouchers. So try to be quick in answering 
the questions.
    Dr. Redd, I am interested in learning more about CDC's past 
work in leading the Strategic National Stockpile. Can you 
describe the range and type of deployments as well as the types 
of products CDC has delivered through the SNS program?
    Admiral Redd. Thank you for that question.
    There have been in the neighborhood of a hundred 
deployments since the formation of the Strategic National 
Stockpile. Many of these are very small deployments, for 
example, for treatment of adverse reaction to smallpox 
vaccine--vaccinia immune globulin--also for containing or for 
treating people who've been involved in a botulism outbreak 
with the antitoxin.
    The largest deployment of the stockpile was during the H1N1 
pandemic. A quarter of the stockpile of antiviral drugs--about 
12 million treatment courses--were distributed to states. Also, 
personal protective equipment was distributed.
    Another product that is frequently distributed--it's called 
Federal medical stations. These are basically hospitals but 
without the building. They've been deployed for the hurricanes.
    About every other year there's a significant deployment of 
Federal medical stations.
    Mr. Pallone. OK. How does CDC help ensure that State and 
local health departments are ready for the last-mile deployment 
of the SNS in which items are dispensed to the public in the 
event of a public health emergency?
    Admiral Redd. Well, the state and locals have a very 
important responsibility to assure that products are dispensed 
quickly and in accordance with guidelines.
    So we've been working through really two different parts of 
our state and local program. The Cities Readiness Initiate 
funds states to develop those systems.
    We also have an assessment process called the medical 
countermeasure operational readiness review where we have 
worked with each of the grantees and, in fact, the grantees 
have worked with their subgrantees and local departments--
around 500 assessments of state and local capability. The 
things that we found in that are that there are some areas 
where we need to improve.
    The capability to dispense from a manpower standpoint, the 
staffing and then also staffing for security areas that are not 
universally but pretty general challenges that state and local 
health departments face.
    Mr. Pallone. All right. Thanks.
    I understand that some of these training activities are 
funded through the SNS program appropriations. So, Dr. Kadlec, 
will SNS funding continue to be used to pay for these important 
training activities?
    Dr. Kadlec. Yes, sir. I think the key thing is 
understanding in this transition of oversight that nothing, and 
nobody's moving, if you want to call it that, and we are 
leveraging all the resources and expertise that CDC has offered 
in the past.
    And, again, to highlight one thing that Dr. Redd talked 
about is in a recent preparedness summit that was held in 
Atlanta, we did an informal survey of state and local 
authorities about what kind of help they need. And so what we 
found out is true to his characterization they need more people 
to help deploy and dispense these kinds of things, particularly 
if they were interested in the opportunity for residential 
delivery or potentially capitalizing on retail distributors 
that could be used to distribute some of these products in the 
event of an emergency and that's maybe the one, if you will, 
new area that we are hoping to work with CDC, going forward, is 
using our state representatives from ASPR to basically work 
together to help more on the sense of what can we do nationally 
to help state and local authorities do that. Part of it may be 
mobilizing the Federal workforce, which has been considered 
before. Part of it may be looking at alternative means to help 
with residential delivery. People have suggested even Amazon.
    And then the third area is really about what can we do with 
retail outlets that could basically facilitate for this. And so 
in the end, I think what we hope to build is a stronger 
partnership with our state and local authorities, realizing if 
they're not successful, no one is successful, and that is our 
intent is to basically build on the past success of the 
programs and basically further extend them to support state and 
local authorities.
    Mr. Pallone. All right. Thank you. I wanted to ask about 
priority review voucher but I think I've run out of time. So I 
will have to get back to you on that. Thank you.
    Mr. Burgess. Gentleman yields back. The chair thanks the 
gentleman.
    The chair recognizes the gentleman from Ohio, Mr. Latta, 5 
minutes for your questions, please.
    Will the gentleman suspend? I didn't realize Mr. Barton had 
come on the end of the dais. The gentleman----
    Mr. Barton. I will only take 2 or 3 minutes.
    Mr. Burgess. The gentleman is recognized for 5 minutes.
    Mr. Barton. Normally, I would yield to Mr. Latta but I've 
got to leave and go to another meeting. So I am just going to 
be real quick.
    First, thank our panel, especially Dr. Kadlec. It says that 
you used to work for Senator Burr and Senator Kennedy. The 
senator doesn't talk about it but he used to be a congressman 
on this committee and he and I worked on what's now Medicare 
Part D, the prescription drug benefit, way back when and, of 
course, Senator Kennedy helped me tremendously on what was the 
reauthorization of the National Institute of Health.
    Senator Kennedy has passed away but Senator Burr is still 
over there and they're both good men.
    So you were trained right, or maybe you trained them right. 
I don't know.
    Dr. Kadlec. Well, sir, Anna Abram was also trained by him 
so you got a pair of us here, bookends.
    Mr. Barton. Oh, well, that's good. Well, apparently, the 
big controversy in the pending reauthorization is the transfer 
of the stockpile from CDC to APR whatever.
    I am going to start with you, Admiral. You're the one who 
controls it now. Why should we keep it with you?
    Admiral Redd. Well, we are implementing the transfer and so 
that is a process that's underway. We've worked--been working 
closely with ASPR. We've actually formed a number of committees 
to make sure that the transition doesn't result in any 
degradation----
    Mr. Barton. So you don't oppose the transfer?
    Admiral Redd. Well, I will say that we are working to make 
sure that when we make the transfer it doesn't result in any 
loss of capability.
    Mr. Barton. It's obvious your Navy training is kicking in. 
You have been giving a directive and I thought I would get a 
little different answer.
    Well, I will go to you, Dr.----
    Admiral Redd. Let me mention a couple of areas that we are 
working closely with--that in these five committees the two 
areas that I think are really essential to sustain are the 
linkage with subject matter expertise at CDC in the stockpile 
and in the decision making process, and the other was the 
question earlier about the state and local capabilities in our 
work to strengthen or assure that the state health departments 
are able to dispense.
    That's something that we are working very closely on, I 
would say, on a more than weekly basis.
    Mr. Barton. OK. Well, that's a great answer.
    Dr. Kadlec, why should we transfer it to your agency?
    Dr. Kadlec. Well, sir, we are all in the business about 
preparedness and response. I think the secretary, when he made 
his decisions, thought about three things in particular--
integrating with the other operational assets that exist within 
the national medical system.
    There's another logistics system within HHS that supports 
disaster response. The second thing is is how do we streamline 
the medical countermeasure enterprise to make sure what we have 
in it can be sustained and replenished over time efficiently as 
well.
    And then the last thing is, is to this point is how can we 
better support state and local authorities in the last mile.
    Mr. Barton. It sounds like your two groups are working well 
together. Would you both agree with that?
    Dr. Kadlec. Yes, sir.
    Mr. Barton. OK. And Ms. Abram, since you don't have a dog 
in this hunt, does the FDA have a position on where it should 
go and if so, what is it?
    Ms. Abram. The FDA stands ready to support the Strategic 
National Stockpile wherever it ends up being housed.
    Mr. Barton. It's a very politically correct answer.
    With that, Mr. Chairman. I yield back.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    The chair recognizes the gentlelady from California, Ms. 
Matsui, 5 minutes for questions, please.
    Ms. Matsui. Thank you, Mr. Chairman. I want to thank the 
witnesses for being with us today.
    Some of the scariest potential attacks that the world is 
vulnerable to today are now posed by chemical and biological 
weapons as well as cyber-attacks. We made so much progress with 
the innovation of new drugs and treatments as well as 
technology. But those new advancements come with new 
vulnerabilities.
    We also continue to see damage from ever-increasing natural 
disasters. We want our health system to be prepared to respond 
to hurricanes, fires, and earthquakes as well as things like 
Ebola and anthrax.
    PAHPA is critical to our success in both responding to 
public health emergencies including minimizing harm of any 
attacks and this field is constantly changing. So we need to 
keep up. I am pleased that we are working on the 
reauthorization in a bipartisan manner on this committee. I 
look forward to working with my colleagues, Representatives 
Eshoo and Brooks, to advance their legislation.
    One of the main issues that we are discussing today is the 
Strategic National Stockpile supplies that can be deployed in 
case of a variety of types of emergencies under discussions 
which you have all been talking about with your last--in the 
last witness here is the--whether it's appropriate and 
necessary to transfer some SNS functions from CDC to assistant 
secretary.
    I am interested in hearing more of your thoughts on this. 
But I want to ask a specific question related to safety of 
products stored in a stockpile.
    I understand that vaccines and other injectable drugs can 
be contaminated by glass because the glass containers may 
break, crack, delaminate, or contain glass particles.
    In some cases, glass failure is a result of recalls because 
they pose a potential threat to patient safety. Dr. Redd, do 
you have any concerns about the impact of glass failures on the 
safety, security, or sterility of counter measures in the 
stockpile?
    Admiral Redd. So I think the issue of assuring the safety 
of the material that is stored in the stockpile is a very 
important issue. The products are stored at undisclosed 
locations.
    There is a standard monitoring of those materials. As Ms. 
Abram noted earlier, there's a process for products for which 
the shelf life extension program is appropriate to test them 
and make sure that they retain their capability. For products 
that need to be stored at certain temperatures there is quite a 
system----
    Ms. Matsui. Right. How about glass in particular? Dr. 
Kadlec or Ms. Abram, would you like to comment on the issue of 
glass contamination?
    Ms. Abram. Yes. I would be happy to take that one and thank 
you for the question.
    The agency, FDA, did put out information specific to some 
of the analysis we have been looking at in recent years. You're 
touching upon the phenomenon that can occur with glass vials. 
Glass affords many advantages as a packaging. However, there 
can be this phenomenon where you have these thin flexible 
fragments that break off.
    Ms. Matsui. Right.
    Ms. Abram [continuing]. And that's something that we've 
been studying to look at.
    We issued an advisory in 2011 and went back and did some 
pretty extensive surveillance of products on market that had 
these type of vials, going back to fiscal year 2008 through 
fiscal year 2017.
    We've actually seen a decrease in the number of recalls 
associated with particulates and so we recently shared. Based 
on that analysis, we didn't see a new or emerging safety signal 
or trend. We chose not to update the analysis at that time.
    There's been particular interest around new glass design 
and how that compares to the more traditional borosilicate 
glass vials, and in that regard our studies demonstrated that 
the novel glass vials exhibited improved performance in terms 
of withstanding mechanical stress and scratching relative to 
type one borosilicate glass vials in the study.
    But we also looked at this from the standpoint of chemical 
durability because, under certain stress conditions such as a 
more basic environment, the novel glass vials exhibited an 
improvement over one of the borosilicate glass vials. But there 
was no definitive difference in performance relative to the 
other borosilicate vials.
    Ms. Matsui. So are you continuing to follow up on this to 
ensure that, you look at the glass, ensure----
    Ms. Abram. Yes.
    Ms. Matsui. OK.
    Ms. Abram. Absolutely.
    Ms. Matsui. OK. Thank you, and I am running out of time 
already. I have further questions and I will submit them.
    Thank you. I yield back.
    Mr. Burgess. The gentlelady yields back. The chair thanks 
the gentlelady.
    The chair now recognizes the gentleman from Ohio 5 minutes 
for questions, please.
    Mr. Latta. I thank the chairman very much and I also want 
to thank our witnesses for being with us today on this very 
important topic.
    And Dr. Kadlec, if I could pose my questions to you right 
off the bat. First of all, I want to thank you very much for 
your service to our country in the Air Force for your 20 years 
of service.
    And as we talk about cybersecurity, I think it's really 
important because this committee has been involved in very--not 
only involved but concerned about what's going on out there, 
and I've served on a cybersecurity task force in the past and 
in the hearings that we've had so it's a huge issue.
    I represent a very unique district--that I have more 
community hospitals than anybody else in the state of Ohio, and 
when I am out one of the things I hear from my community 
hospitals is on the cybersecurity and cybersecurity threats 
that they're under.
    In the last Congress, Mr. Welch from this committee--from 
Vermont--and I did the Internet of Things Working Group and we 
heard from folks, especially when we are dealing with 
telehealth and when you look at electronic medical records and 
the Internet of Things what's happening on the great things 
there. But then again, on the cyber side it's always a concern.
    So the question I have is as I've seen in your testimony 
that the healthcare sector very nearly suffered a severe cyber-
attack last year due because of WannaCry. In fact, while the 
United States was spared the worst of the damage, the U.K. had 
34 percent of its hospitals affected and there are numerous 
other examples of recent and growing cybersecurity threats to 
the healthcare sector.
    All that being said, I notice that cybersecurity isn't 
listed in one of your key priorities. Does this mean that 
cybersecurity isn't a key priority at ASPR and, if not, is 
there a part of HHS that does consider healthcare cybersecurity 
be a priority?
    Dr. Kadlec. Thank you for your question, sir, and I just 
want to reiterate the importance of this issue as it relates to 
our health care systems because they can range from hospitals 
to actually individual devices that may be at risk and I think 
it's important to note that in the Department of HHS that the 
deputy secretary basically manages the overall cybersecurity of 
the department.
    And so from that standpoint, each operation and staff 
division has its own cybersecurity piece of this but it's 
managed and if you will--overseen at that level to ensure that 
there is uniformity of policy as well as oversight and 
capabilities.
    Mr. Latta. Well, let me follow up then because you say the 
Deputy Secretary is there, because in their report to this 
committee last spring the previous HHS secretary had designated 
your office as the health care sector specific agency to lead 
the health care cybersecurity.
    Did you agree with that designation?
    Dr. Kadlec. Sir, I don't disagree with it. I think one of 
the things that happened as a result of the WannaCry event is 
that because the potential impacts are much greater than just 
simply ASPR that they can affect CMS, FDA, CDC, all of OpDivs 
and StaffDivs that I think it was the decision at that point in 
time.
    But to be fair to your question, sir, I will be very happy 
to provide an answer for the record, if you'd like.
    Mr. Latta. OK. Let me just follow up, though.
    So, with the deputy secretary then because are you saying 
then that you think that that--the specific and the proper 
position would be having that cybersecurity control for the 
HHS, then?
    Dr. Kadlec. Sir, I think the fact is is that the only 
person higher than the deputy secretary is the secretary to 
manage the issue and I think the issue here is is that the 
deputy secretary I think performs a vital function to ensure 
that it remains on the forefront of everyone's consideration 
for the different staff and operational divisions of HHS.
    Mr. Latta. Well, if you could follow up again on that with 
me I would greatly appreciate it.
    Dr. Kadlec. I would be happy to, sir.
    Mr. Latta. And we look forward to that.
    Mr. Chairman, I am going to yield back the balance of my 
time.
    Mr. Guthrie [presiding]. The gentleman yields back his 
time.
    The chair recognizes the gentlelady from California, Ms. 
Eshoo, 5 minutes for questions.
    Ms. Eshoo. Thank you, Mr. Chairman, and thank you to the 
witnesses for your testimony.
    Just a couple of comments before I get to my questions. I 
wish Dr. Bright were here today, who heads up BARDA. He 
couldn't. I think there was a conflict relative to his 
schedule. But I want the members to have a deep appreciation of 
what BARDA has accomplished--35 approved measures in 10 years. 
I don't know of a pharmaceutical company that has produced 10 
major drugs in a decade. And so that really is an outstanding 
record. Many members have raised the issue of the whole issue 
of antimicrobial infections. Now, God forbid there's an anthrax 
attack and we have something for that but you're in the 
hospital and you contract a terrible infection and I think that 
we are all worried about that. I don't know of conversation 
with friends of mine where someone doesn't mention someone 
having been in the hospital and contracted an infection.
    So I want members to know that Dr. Bright is all over this. 
He truly is, even in the meeting that Congresswoman Brooks and 
I had just recently over at BARDA.
    Admiral, you described in detail how the CDC is responding 
today, and I know that we just heard Congressman Barton raise 
the issue of CDC, the stockpile. I think it's important for all 
members to know that the stockpile isn't moving anywhere. It's 
going to remain with the CDC.
    There is an administrative change here. With the shift 
from--what's in the legislation from CDC to ASPR, what actually 
changes for you? Do you have to get permission from ASPR to do 
something? Is it that you and ASPR are going to coordinate? In 
a very clear way, can you just set down in a sentence or two 
what is going to change?
    Admiral Redd. So thanks for that question, and you're 
correct. The people----
    Ms. Eshoo. Well, I know that. But just tell us what it is.
    Admiral Redd. Sure.
    [Laughter.]
    Ms. Eshoo. You don't have to thank me.
    Admiral Redd. The stockpile provides funding within CDC and 
that's one of the things that we are talking about with ASPR is 
what things in that mission----
    Ms. Eshoo. So it's not decided yet, you're saying?
    Admiral Redd. Well, some areas are, some aren't. But we are 
still working on the details.
    Ms. Eshoo. Well, that's interesting. All right. Thank you.
    To Dr. Kadlec, always good to see you. In your opening 
statement, you used the term in terms of responsibilities, one 
of them territorial responsibility. It's very important.
    The official government death count for Hurricane Maria, 
relative to Puerto Rico, was 64. Now the New England Journal of 
Medicine last week, one of the most prestigious publications in 
our country, they concluded that the death toll was 70 times 
higher than the official estimate.
    What is ASPR doing in Puerto Rico? I think that even in the 
meeting that we had we came over to the agency, you sensed my 
lack of confidence in what ASPR is doing.
    Dr. Kadlec. Yes, ma'am.
    Let me first just comment on the New England Journal 
article because I think it's important to realize----
    Ms. Eshoo. Well, do you accept that?
    Dr. Kadlec. I accept it that it's an estimate. I accept it 
that----
    Ms. Eshoo. Look, there are two and there's a chasm between 
the two. So tell the committee what you're doing on the----
    Dr. Kadlec. Sure, ma'am.
    On the issue of the mortality rates, I've been working 
this----
    Ms. Eshoo. Tell us what you're doing in Puerto Rico right 
now. Who's on the ground, what's being used, are people being 
inoculated?
    Dr. Kadlec. I just wanted to differentiate between 
mortality for sure. We have 40 personnel down in Puerto Rico 
right now working with the Puerto Rican Department of Health 
looking how to basically make their system more resilient and 
that goes to the issue of not only the hospitals, which are 
both private and public, as well as federally qualified 
health----
    Ms. Eshoo. So you're having discussions with their public 
health people. Do you have people that are administering 
anything to the Puerto Rican people?
    Dr. Kadlec. Based on the requests from the Puerto Rican 
Department of Health, no, ma'am, at this point in time. We 
basically extended our emergency prescription assistance 
program that was basically providing 30 days of prescriptions 
free to people.
    We've left 13 DMAT caches there, which is a host of medical 
supplies that we----
    Ms. Eshoo. Well, my time is--my time has run out. But I 
really would like a full report from you on it.
    Dr. Kadlec. Sure. Be happy to. We can do that, ma'am.
    Ms. Eshoo. Yes.
    Dr. Kadlec. I would just add we are also maintaining or 
taking care of about a hundred or so people who were evacuated 
from the Virgin Islands and Puerto Rico who are dialysis 
dependent until they can go home and receive their care at 
home. But we'll be happy to provide a more fulsome picture for 
you and for the record.
    Ms. Eshoo. Thank you. Yield back.
    Mr. Burgess [presiding]. The gentlelady's time has expired.
    The chair is pleased to recognize the gentleman from 
Virginia, Mr. Griffith, 5 minutes for your questions, please.
    Mr. Griffith. Thank you very much.
    Let's continue with Puerto Rico for a minute, and I 
appreciate what you all are doing down there. But Admiral Redd, 
were any of the stockpiles that we've talked about today used 
in Puerto Rico?
    Dr. Kadlec. Yes, sir. We deployed both our DMAT, or 
disaster medical assistant team caches, actually 13 of them, as 
well as field medical stations, which are these kind of like 
hospitals in a box kind of thing.
    Mr. Griffith. Right. So here's my question. Back to you, 
Ms. Abram.
    When we start talking about the vials and the delamination 
and whether or not there's a better product, you indicated that 
the new novel product does better under stress but it was one 
product was better than the other in chemical situations or 
more normal situations it was pretty much the same.
    My question is, though, isn't the stockpile for emergency 
situations and wouldn't the stress be greater if you're sending 
something in either before or immediately after a hurricane or 
other natural disaster and so wouldn't we want to have the 
better product in those situations?
    Ms. Abram. We want to make sure that we have high quality 
safe and effective medical countermeasures in the event they 
need to be used and there's a number of steps that go into 
making sure that the products that we have are what we are 
expecting them to do in terms of safety efficacy and being 
effective.
     Mr. Griffith. And my concern is just this.
    Ms. Abram. Yes.
    Mr. Griffith. If they're just sitting on the shelf and we 
go in one day into the back storage room and say we need these, 
I get it. The current glass works.
    But if there's a risk of delamination, which we've seen in 
the past, and there's a product that takes care of that, at 
least with the stockpile wouldn't we be better off using the 
glass that's less likely to have glass fragments floating 
around in what we are trying to then use in an emergency 
situation? Because when people are trying to get something in 
there in a hurry, whether before or after the storm, they're 
not necessarily handling it with kid gloves. Wouldn't you agree 
they're not handling it with kid gloves under those 
circumstances?
    Ms. Abram. The handling is a matter of importance to the 
product, depending upon if it's something that has to be 
temperature controlled. That's one of the issues that is at 
play with the Ebola response efforts right now.
    So depending upon the countermeasure, depending upon how 
it's going to be used, it could bring unique handling and care 
instructions.
    Mr. Griffith. I appreciate that. Thank you.
    I do want to ask about and I've heard a lot and I am 
stepping a little bit outside of my comfort zone. I've heard a 
lot about the antimicrobials and the antibiotics and the 
concerns there. I am just wondering is BARDA looking at some 
interesting and new novel approaches?
    I recently toured a facility in my district--a very small 
start-up group, Techulon, and they have a platform technology 
for gene targeting. So I asked my team to find out what that is 
and here's what I got back, so I don't get it wrong.
    It is an anti-sense approach. It knocks down gene 
expressions. That kills the pathogen--basically, disrupts gene 
functions, which means there's no way for the pathogen to adapt 
because basically you're going in and knocking out part of 
their genes and they die. Are we looking at some of that kind 
of new novel approach?
    Dr. Kadlec. Sir, I would like to hear more about it, quite 
frankly. I haven't heard of that particular approach but I 
would be welcome to the idea that we would hear about it and 
understanding how we could learn more and potentially see it in 
the future of our efforts.
    Mr. Griffith. But it's fair to say for both you and the 
rear admiral that there's a lot of interesting things going on 
out there and it's hard to keep track of it. I will make sure 
you get some of the info on this.
    Dr. Kadlec. Sir, and again, compliments to the committee 
with the creation of the Medical Countermeasure Innovation 
Partnership because that's one of the things we hope to do with 
this program called DRIVe is to basically set up the 
opportunity for great ideas to come in.
    We've identified so far as of yesterday eight accelerators 
in your different states around the country to basically be 
these receptive points for these great ideas so that we can 
make sure to sweep them up and don't miss them.
    Mr. Griffith. Thank you. I appreciate that.
    I would be remiss--and I appreciate the chairman bringing 
this up in his opening remarks--if I didn't mention the 
historic nature of today's date.
    Being the representative on this committee from Virginia, 
we have a national D-Day memorial in Bedford because, per 
capita, they lost more boys on D-Day than any other part of the 
country, and I had the opportunity to meet the sister of one of 
the boys who was part of the D-Day boys of Bedford and knew Bob 
Slaughter, who pushed for the memorial and had the great thrill 
about 12 years ago before he passed away to introduce my 
daughter to him in a local cafeteria.
    He was just there, as humble as he could be, but these were 
true heroes and they really did save the possibility of a 
vibrant world with democratic principles in place and it all 
came down to that one morning on this day 74 years ago.
    So I yield back.
    Mr. Burgess. Gentleman yields back. The chair thanks the 
gentleman.
    The chair recognizes the gentlelady from Colorado, Ms. 
DeGette, 5 minutes for questions, please.
    Ms. DeGette. Thank you, Mr, Chairman.
    I want to thank Representatives Eshoo and Brooks for their 
leadership on this important draft that we are discussing 
today. Medical countermeasures are really an important element 
of preparing for pandemics.
    Several of our witnesses have mentioned the 21st Century 
Cures Act, which Fred Upton and I authored but which everybody 
on this committee had input into, and Representatives Eshoo and 
Brooks were really instrumental in helping us put some of the 
medical countermeasures into that bill. They included 
encouragement of complex, adaptive, and other novel trial and 
medical advice designs, fostering potential use of real-world 
evidence for the development of drugs, and harmonizing FDA 
human subject protections with the common rule, otherwise known 
as the Federal policy for protection of human subjects.
    And in addition, Cures includes provisions that would waive 
certain paperwork requirements during a public health emergency 
along with streamlining BARDA procurement process and allowing 
BARDA to enter into agreements with independent non-profit 
entities to support medical countermeasure development.
    Now, Commissioner Abram, you spoke a little bit earlier 
about the recent Ebola outbreak in the Democratic Republic of 
the Congo. I am wondering if you can talk for a minute about 
exactly how the lessons learned in the 2014 Ebola outbreak are 
being used to help contain the recent outbreak.
    Ms. Abram. Absolutely, and I will likely ask my colleague 
from CDC to join as well.
    Ms. DeGette. Great.
    Ms. Abram. We've been very much supporting the efforts and 
helping to facilitate the export of vaccine that's being used 
overseas as part of the outbreak control measures.
    We've also continued to engage with our international 
collaborators and conversations with developers around 
diagnostics and therapeutics. And so I think one of the 
continual lessons learned and actually that PAHPRA was very 
effective in doing is helping to make some accommodations and 
adjustments in our authorities so that we can be even better 
prepared in prepositioning which helps us then when we do have 
these emergent situations to be even more timely in the 
response effort.
    Ms. DeGette. That's good to hear. Yes?
    Admiral Redd. So I think one of the lessons of 2014 is that 
when an outbreak like what is happening in the Democratic 
Republic of Congo occurs you really have to pursue it until 
there are no more cases.
    Ms. DeGette. That's right.
    Admiral Redd. There was an opportunity to do that in West 
Africa in the spring and that opportunity was lost, resulting 
in the outbreak over the summer and fall.
    In the Democratic Republic of Congo, CDC has had a long-
standing presence. There are actually 33 staff there----
    Ms. DeGette. Excuse me. I don't have a lot of time and so 
my question really was what, from the 2014 outbreak, helped us 
now. If you can address that.
    Admiral Redd. Sure. I think there is a much more intense 
focus on contact tracing, making sure that our partnership with 
WHO and the country ministry of health is solid and that things 
are slipping through the cracks.
    So there's much more intense follow-up, identification of 
cases. Laboratory testing is in place now. We are working on 
measures of exit screening with the ministry. So all the things 
that we should have done in 2014 are happening now.
    Ms. DeGette. Mr. Kadlec, do you want to add on?
    Dr. Kadlec. Yes, ma'am. May I just insert that we have two 
candidate vaccines, one that's actually being used for ring 
vaccination.
    We have a point of care diagnostic that has been deployed, 
donated by the companies, as well as those vaccines, as well as 
three different monoclonal antibody therapies that could be 
used. The one from NIH is actually deployed down there right 
now.
    Ms. DeGette. Right. OK. Thank you.
    While I've got you on the hot seat, you indicate that 
increasing BARDA's authorization levels would increase BARDA to 
implement new innovation authorities that the 21st Century 
Cures Act provided.
    Can you talk about those new authorities and how additional 
funding would actually help increase the goals of BARDA?
    Dr. Kadlec. Yes, ma'am. We announced yesterday, with the 
creation of DRIVe--the Division for Research, Innovation, and 
Ventures--with the intent that right now $25 million will be 
spent on two areas, which will be one is on the treatment of 
sepsis.
    Sepsis basically afflicts 1.5 million Americans a year, 
kills 250,000, costs the health care system $24 billion, and so 
we think that's an area ripe for an opportunity to find things 
that could either prevent or mitigate that.
    The second area is actually identifying or finding 
diagnostics that would identify people who have been exposed 
who are not yet sick so that you can institute treatment or 
therapies to actually prevent them becoming ill or potentially 
dying.
    Ms. DeGette. Thank you.
    Thank you very much, Mr. Chairman.
    Mr. Burgess. Gentlelady yields back. The chair thanks the 
gentlelady.
    The chair recognizes the gentlelady from Indiana, Mrs. 
Brooks, 5 minutes for your questions, please.
    Mrs. Brooks. Thank you, Mr. Chairman, and thank you all so 
very much for your testimony and for your important work.
    I think there continues to be a little bit of confusion 
that has come up with the various members regarding what I 
think the word that might be causing confusion is the word 
moving the Strategic National Stockpile, which is in our draft 
text of the bill from CDC to ASPR.
    But as I understand it, discussions and things are still 
taking place relative to what the roles will be and I think we 
all have the same goal and that is to ensure that all medical 
countermeasures get to our citizens in the appropriate time and 
as fast and as efficient as possible.
    And so for our sake, maybe starting with Dr. Kadlec and 
then going to Admiral Redd, if we could please talk about where 
that stands right now and are there tools or resources you need 
to effectively carry out the execution of the Strategic 
National Stockpile for our citizens who expect it to work.
    Dr. Kadlec and then Admiral Redd.
    Dr. Kadlec. Yes, ma'am. Thank you, ma'am. I need----
    Mrs. Brooks. We just need to clarify and make sure we 
understand.
    Dr. Kadlec. Sure. Sure. As Dr. Redd identified earlier, 
there are a number of working groups. I think the key thing is 
some of them dealt with contracts and particularly how would 
the contracts that have been previously administered by CDC be 
administered by ASPR.
    And so part of that is kind of--I think the word is 
novate--contracts to ASPR so that in terms of replenishing the 
stockpile in the future so you'd have single oversight of how 
you would basically develop, procure, and resupply this, the 
Strategic National Stockpile.
    There are issues around personnel, how many people would 
be, basically, transferred to the ASPR and would be the 
responsibility of ASPR to basically pay for or provide services 
to. And then, lastly, one of the areas that's still under 
negotiation is what percentage, if any, of those people who are 
working with the state and locals would be transferred to ASPR 
as well.
    And so that is an area that is further under discussion. 
The intent is to meet with senior CDC officials later this 
month to basically hopefully finalize that.
    But as to this date, there has been no requirement for any 
legislative language--the facility to transfer is within the 
secretary's purview and authorities to do so.
    Mrs. Brooks. And I think that's what the greatest concern 
is is that local and state authorities--and one of our next 
witnesses in the next panel expresses that as well and so we 
need to make sure that that relationship with whomever is 
responsible.
    And I think what I am hearing you say, though, and I would 
like, Admiral Redd, you to talk about what you believe the role 
is and is going to be because we want to make sure that there 
is no problem working with state and local officials that 
actually do the work on the ground.
    Admiral Redd. Yes, ma'am. I think actually Dr. Kadlec 
summarized the current situation quite well. The areas that I 
think are critical to just make sure we've got good clarity on 
are the role that subject matter experts at CDC will have both 
whether or not they're funded by the stockpile now or not--that 
that linkage with the stockpile and with planning, for example, 
in clinical guidance, how the product should be used, under 
what circumstances to control or to respond to emerging events, 
that we've got that part nailed down and then similarly work 
that we have been doing partly funded by the stockpile, partly 
by the state and local program that we've got very good 
agreement on the work that we are going to continue in that 
domain to make sure that state and locals are able to dispense 
products.
    I think the overall medical countermeasure structure is now 
more completely under the ASPR but that state and local role--
we think we have a role to support both state and locals and 
the mission of the ASPR.
    Mrs. Brooks. And would you agree with that, Dr. Kadlec?
    Dr. Kadlec. Yes, ma'am, and we also have a role at the 
state and local level and we look to figure out how we can best 
integrate that to provide the best support in state and locals.
    Mrs. Brooks. Well, and I think integration is the key here 
and it is trying to ensure that everyone is clear as to what 
CDC's role is with state and local partnership and what ASPR's 
role is. But it sounds as if the contracting piece and the 
management of the product, so to speak, and mostly the 
vaccines, the diagnostic testing, is what would move to ASPR 
but yet both agencies will be or both parts of--will be working 
with state and local health officials. Is that correct? Fair to 
say?
    Dr. Kadlec. I think that's the overall intent.
    Mrs. Brooks. And very briefly, Ms. Abram, a very quick 
question relative to diagnostic tests and so forth, and can you 
speak to the role of diagnostic tests including point of care 
tests and influence in infectious disease detection and 
management and how FDA ensures that we have what we need for 
diagnostic testing because it's not just about vaccines. It's 
also about the diagnostic.
    Ms. Abram. Right. When we think about medical 
countermeasures it runs the full gamut of medical products from 
vaccines, therapeutics, and, of course, diagnostics, and rapid 
point of care of diagnostics is something that also colleagues 
at BARDA and ASPR are working on.
    It's absolutely critical and it's not just critical in the 
context of emergency response as a public health emergency. 
It's critical as part of good routine care. The sooner you can 
pinpoint what a patient is dealing with the faster you can 
provide optimal care.
    Mrs. Brooks. Thank you. My time is up. I yield back.
    Mr. Burgess. The gentlelady yields back. The chair thanks 
the gentlelady.
    The chair recognizes the gentlelady from Florida 5 minutes 
for questions, please.
    Ms. Castor. Thank you, and thank you to the witnesses for 
everything you do to strengthen America's public health 
infrastructure, especially when we are talking about medical 
emergencies and preparedness and response.
    And I want to thank the authors for their bipartisan work 
on PAHPA. I am very pleased that we are going to codify what 
CDC is doing relating to the children's preparedness unit into 
this bill because when we are talking about public health 
emergencies, children have very special needs and we have to 
ensure that they're not overlooked, and for many years CDC has 
had a group of experts working through their children's 
preparedness unit.
    Just think about the Zika emergency. Child development was 
the issue. Think about Flint and the water crisis--lead in the 
water. That had a direct impact on babies and children. So it's 
very important that we do.
    So, Dr. Redd, does this codification language--does it do 
what we need to do? Is there anything that's left out here?
    Admiral Redd. I think we recognize the importance of 
children in emergencies and we'll work on that. Whether or 
not----
    Ms. Castor. Yes. So this is actually Senate language that 
we need to bring into this version because this version just 
has kind of the national advisory committee.
    Admiral Redd. Well, I think that both in preparing for and 
then responding to almost any emergency, children are going to 
be an important part of that and there are particular 
considerations that need to be taken into account.
    And as you noted, we have, within CDC, a children's 
preparedness unit. That unit mobilizes when we have a response. 
For example, in the Ebola response there was work on reopening 
schools that unit played an important--in West Africa--that 
that unit played an important role in.
    Ms. Castor. So I hope the authors can look at what the 
Senate language is and make sure that we are carrying over this 
very important initiative where they bring in the 
pediatricians, the psychologists, everyone, at the table to 
make sure that it's properly recognized, funded, and 
structured.
    Dr. Redd, the draft legislation also would allow the 
secretary to transfer 1 percent of any appropriation to the 
public health emergency response fund. The emergency response 
fund would supplement the response of local and state 
authorities during any number of public health emergencies.
    Previously, this has been an issue and it's been a problem 
because transfers during emergency situations resulted in 
automatic cuts elsewhere in funding in critical areas for state 
and local governments. They were kind of left in the lurch--
created a lot of uncertainty for communities back home.
    For example, during the height of the Zika crisis in 2016 
funds were pulled from emergency preparedness and public health 
grants across the country, despite the fact that those 
communities needed to prepare, they needed to respond, and they 
were hamstrung at that time.
    Probably the most troubling example--and I am glad Mrs. 
Dingell is here because she worked so hard on this--was the 
fact that during that Zika crisis we had a terrible crisis in 
Flint, Michigan, and when they had to go take funds to address 
Zika, they swept some of the grants back in Flint and in 
Michigan that they needed for their public health emergency.
    In a Washington Post article, the president of the 
Association of State and Territorial Health Officials said it 
is short-sighted to fund the Zika response by weakening all 
states' ability to respond to future public health crises.
    So based on your experience with the Zika response, could 
you describe how state and local public health departments were 
impacted when the funds were taken and drained from the public 
health emergency prepared cooperative agreement?
    Admiral Redd. Yes, ma'am.
    Ms. Castor. Go into a little detail for us on that.
    Admiral Redd. So, first of all, this is a real problem. In 
the H1N1 response there was a 54-day interval between the 
request for funding and the appropriation. For Ebola there was 
a 4-month interval and for Zika 190 days. So this is a 
significant problem that is inhibiting the best response.
    I am not going to speak directly to the bill but I will say 
that during the Zika response the PHEP award overall was cut by 
about 8 percent and we heard from states that that was causing 
problems with staffing. There was sort of a payback about 6 
months later but there was a period of uncertainty and I think 
that uncertainty really is not helpful to the preparedness 
interval.
    Ms. Castor. And I think congressional members have a lot of 
responsibility for those. When you get into government 
shutdowns and you can't work together when we are talking about 
emergency situations in Flint, Michigan, or Zika or flu we 
simply cannot be caught up in these partisan fights. There has 
to be a pot of money where we can adequately respond to public 
health emergencies without getting into the partisan food 
fights, not in times of emergency.
    So I would hope that the authors would work on that with 
all of us as we move forward. Thank you, and I yield back.
    Mr. Burgess. The gentlelady's time has expired.
    The chair recognizes the gentleman from North Carolina, Mr. 
Hudson, 5 minutes for questions, please.
    Mr. Hudson. Thank you, Mr. Chairman, and thank you to each 
member of the panel for what you do on behalf of our country. 
Thank you for being here with us today.
    Every time there is a disaster or an infectious disease 
outbreak I hear from my constituents back home. Hurricane 
Matthew, Zika, and Ebola outbreaks are all recent events that 
have quickened the pulses of my constituents. Understandably, 
they're concerned and want to know what we are doing to ensure 
their communities have the resources they need and these 
outbreaks are contained.
    One thing I've heard from physicians, emergency medical 
responders, and hospitals is that there are continuing drug 
shortages, particularly essential emergency medications. These 
providers are concerned that they're not prepared to respond to 
a massive public health emergency.
    Dr. Kadlec, you mentioned in your testimony that the 
strength of our nation's public health and medical 
infrastructure and the capabilities necessary to respond to 
emergencies and disasters are foundational to the quality of 
life of our citizens and I completely agree with you. But I 
believe these drug shortages hamstring our ability to properly 
respond. So I want to see how we can work tighter to best fix 
these problems.
    So, Dr. Kadlec and Ms. Abram, can you share your thoughts 
from both the FDA and ASPR's perspective on assuring the 
availability of emergency medications in a public health 
emergency and are there options Congress should be considering 
as part of PAHPA and beyond?
    Ms. Abram. I will go ahead and jump in and take it first 
and then turn it over to my colleague. Drug shortages is a 
serious concern.
    It's a serious concern not just in routine everyday 
clinical care but also in the context of what a particularly 
lifesaving product--the shortage of a lifesaving product at a 
time of a public health emergency might mean. We've got medical 
countermeasures and we've also got other products that would 
certainly go toward patients and be part of care, perhaps 
supportive care.
    And we've also recognized that even though we have a very 
dedicated team that is focused on this at the agency among our 
CDER colleagues, we continue to see some challenges persist. 
The agency is doing everything that we can to mitigate and 
prevent. Particularly, we've been very forthcoming about some 
of our work in the IV saline solution shortages and our work to 
work with developers.
    We encourage manufacturers to try to build in capacity. 
It's not something that we can require. But we do encourage 
that they try to do that to help to mitigate.
    We've also worked in a discreet manner to help to import 
product to supplement where there have been shortages. But it's 
a continual challenge and it's something we continue to look at 
and would welcome the opportunity to have dialogue with the 
committee around what other solutions might be brought to bear 
as part of this.
    Mr. Hudson. Thank you.
    Dr. Kadlec. Sir, for the purposes of time, I would probably 
want to get back to you on the record on this. But I just want 
to highlight as--I think it was alluded to by Ms. Abram and 
that is the subject to the events in Puerto Rico and how that 
impacted on several critical supplies of critical medicines--
not only saline solution but also pediatric oncology drugs and 
the like. And we have an interest in that in terms of how do 
you basically make sure that that critical infrastructure is 
more resilient. I will just highlight that there is some 
interesting legislation in the House subject to the Disaster 
Recovery Reform Act of 2017. I think it's being considered with 
the FAA Act as well, and that is subject to how we can use some 
of our disaster relief funding in advance of an event to 
basically make things more resilient.
    I think there's a couple of pieces here as to how can you 
make your production supply chain more resilient before a 
disaster and then what to do with the events, as Ms. Abram had 
mentioned about what can we do to make sure that there is an 
uninterrupted supply of these critical supplies.
    But we'll be happy to get back to you with further details.
    Mr. Hudson. Great. Well, I appreciate that and appreciate 
the commitment to work with us on it.
    Just changing topics, Dr. Kadlec, I have become aware of 
the time-intensive process involved in producing a vaccine 
through egg-based production. Oftentimes, this manufacturing 
can take up to 6 months, which is a lifetime in the ever-
changing world of infectious disease. I've recently become 
aware of the new flexible platform techniques--technologies 
that have the potential to reduce production time for vaccines 
from months to weeks.
    I understand BARDA's primary mission is to support products 
that are being tested in clinical trials of which I know of one 
product in phase three. But there are also products in 
preclinical testing. I understand ASPR and BARDA are examining 
these innovative platform technologies. But I want to get some 
clarification from you.
    How would these rapid response platform technologies 
benefit BARDA and its mission and can BARDA play a more 
proactive role in fostering the plug-and-play platforms that 
are beyond basic research but not yet at the clinical trial 
stage?
    Dr. Kadlec. Sir, I think just two things to echo what your 
comments are, our dependence on egg production, which provides 
more than 70 percent of our vaccine for flu, and eggs are not 
very flexible and they're not very fast. The only other vaccine 
you can produce from an egg is yellow fever. So the idea of 
having flexible and fast capabilities which are platform 
technologies is either cell or recombinant production that is 
going to be critical, going forward.
    So we see that as an essence and there's also been the 
situation we experienced this past seasonal flu season where 
some of the vaccine strains drifted a little bit from egg 
production and so that's another liability.
    So there's several reasons why we are relooking at what we 
are doing. But we really owe you and this committee probably a 
detailed brief on not only the situation we experienced in the 
past but what may be a strategy to address how to avoid those 
limitations and get us the most flexibility and speed in the 
future. I will turn to Anna.
    Ms. Abram. Yes. I was just going to quickly add we'd be 
happy to follow up with some of the work that we've been doing 
to advance continuing manufacturing and innovations. We think 
that this could be responsive in terms of helping to foster a 
more nimble flexible responsive framework.
    Mr. Hudson. I agree. Thank you, Chair.
    Mr. Burgess. And the gentleman's time has expired.
    The chair recognizes the gentleman from Kentucky, Mr. 
Guthrie, 5 minutes for questions.
    Mr. Guthrie. Thank you, Mr. Chairman. I thank the panel for 
being here today.
    And so this kind of follows on what he's saying about new 
platforms. There's a company in my district, Kentucky 
BioProcessing, in Owensboro that actually uses a plant-based 
platform to more efficiently produce recombinant protein 
products.
    In fact, applying their platform technology they rapidly 
developed an experimental antibody and used it to successfully 
treat an American doctor who contracted Ebola while treating 
patients in Africa.
    I understand a major goal of BARDA is to identify new 
approaches and capabilities that allow for better preparedness 
and response to multiple public threats by serving as platform 
technologies.
    So, Dr. Kadlec, how can BARDA interact with and support 
companies which have developed such technologies but do not 
have a specific medical countermeasure in clinical development?
    Dr. Kadlec. Well, I think that's an issue that we probably 
need to follow up with on the notion of this flexible and agile 
kind of production capacity and how do we basically nurture 
that and promote that in a way that to this date hasn't been 
fully actualized.
    So I think it's an area that I think we'd be very welcome 
to work with you and our colleagues at FDA who are also 
evaluating these kinds of innovative ideas and how do we do 
that.
    We think that the DRIVe program that was--we just announced 
yesterday could be one of those venues to basically evaluate 
that as well as promote those kinds of concepts.
    Mr. Guthrie. Thank you. I would encourage BARDA to use its 
current authorities to support preclinical platform 
technologies--planned technology which has demonstrated its 
ability to deliver BARDA's needs in one-third of the time of 
traditional platforms.
    So that follows up what he just said so I appreciate that. 
Matter of fact, the plant they used for Ebola was tobacco. So 
it's nice that we have a use for one of our plants that's 
positive in that direction. So we appreciate that very much.
    And also, Dr. Kadlec, kind of switching gears a little bit, 
could you speak to how the discussion draft can further empower 
ASPR to be the vital coordinating agency for both planning and 
responding to a biological threat?
    Dr. Kadlec. Well, sir, I think just reauthorizing the 
language that already exists is critical. I think there's some 
areas in there in terms of effectively improving our ability to 
respond in terms of direct hiring for national disaster medical 
personnel will be very important. That was one of the critical 
shortfalls during the last hurricane season. We only had less 
than half of the number of intermittent Federal employees who 
basically service our disaster medical assistant teams.
    We also believe that what you have in your discussion draft 
is so important in terms of providing, if you will, life 
benefits to those people who would lose their lives in an event 
of a response to make sure that they get the equal 
consideration as to public safety officers.
    So there are several areas. There's also mention about in 
your draft about the PHEMCE, or the Public Health Emergency 
Medical Countermeasure Enterprise. We think the idea of 
basically having that role to ensure that, as Dr. Redd said, 
that we use the expertise within the department and CDC, FDA, 
NIH to basically ensure that whatever we are trying to develop 
and produce is not only useable but safe and efficacious to use 
in our population, both children and adults and elderly.
    So those are all positive things that I think just off--in 
the little time that I have. I would be happy to follow up on 
the record if you'd like.
    Mr. Guthrie. Thank you very much. We appreciate that and 
look forward to, hopefully, a briefing as you talked about and 
schedule that sometime in the future.
    That concludes my questions and I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentleman from Missouri, Mr. Long, 
5 minutes for questions, please.
    Mr. Long. Thank you, Mr. Chairman, and Dr. Kadlec, as you 
may be aware, I've introduced legislation along with Ms. Matsui 
to allow the HHS secretary to reorganize HHS cybersecurity 
offices as the secretary thinks best.
    One of the motivations for this legislation is the 
recognition that many organizations including HHS are using the 
cybersecurity organizational strategies that were originally 
designed in the early 2000s and my not be suited for modern-day 
threats.
    I think you would agree with me--I will ask you if you do--
that the nature and severity of cybersecurity threats to 
healthcare have significantly changed over the last 20 years. I 
don't think your mic is on.
    Dr. Kadlec. Yes, sir. They have.
    Mr. Long. Do you think the evolution of cybersecurity 
threats may require organizations like HHS to evolve their 
cybersecurity strategies including the way they organize their 
cybersecurity offices and officials to manage?
    Dr. Kadlec. Sir, I believe giving the secretary that 
flexibility and the authority would be appropriate.
    Mr. Long. And how has HHS addressed its cybersecurity 
strategies to confront the changing cyber threats and what more 
needs to be done, in your recommendations?
    Dr. Kadlec. Sir, thank you for that question. As I outlined 
earlier, the center of gravity for the department is in the 
deputy secretary's office at the present time.
    I think we probably owe you a full and fulsome response to 
that question. If you don't mind I will take it for the record 
and provide you a complete outline of what is ongoing and 
anticipated for the department in these areas that could help 
guide your future actions.
    Mr. Long. OK. Thank you.
    And Mr. Chairman, I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back and the chair is aware that Dr. Kadlec has another 
engagement at HHS. But we'll now recognize the gentlelady from 
Michigan, who's not on the subcommittee, 5 minutes for 
questions, please.
    Mrs. Dingell. I will be brief. Thank you, Mr. Chairman and 
Mr. Green, for holding this hearing.
    I do have a concern, like everybody else has. We've asked a 
lot of questions but not gotten as much into the long-term care 
and hospital preparation when we have these hurricane 
emergencies.
    So, Dr. Kadlec, I am going to go right to you and ask you. 
You have said that a regional disaster health response system 
would incentivize the health care system to integrate measures 
of preparedness into daily standards of care.
    Would this include an important sector of the health care 
system, the long-term care facilities, which in these most 
recent hurricanes have really suffered some tragedies?
    Dr. Kadlec. Yes, ma'am, and I just want to annotate two 
things really quickly. In Puerto Rico, we evaluated in an acute 
situation about 1,900 adult senior living facilities of varying 
different types in terms of their resilience and their 
functioning during that terrible period of time there, and 
certainly we know the events in Florida and I just acknowledge 
that Florida has established new guidelines for its hospitals 
and skilled nursing facilities. So I think we have to have 
greater sensitivity to these areas as they take care of some of 
the most vulnerable populations in our society.
    Mrs. Dingell. Thank you.
    In an effort to improve our understanding involved with 
threats hospitals and long-term care facilities face I have a 
bipartisan bill that directs HHS to engage with the National 
Academy of Medicine to conduct a comprehensive study into the 
assessment of future threats impacting emergency preparedness 
policies and procedures across the health care system.
    In your opinion, would a study of this kind be helpful as 
you establish a regional disaster health response system?
    Dr. Kadlec. I am always having very bright and experienced 
people consider these efforts and to do a deep study would 
always be beneficial and, obviously, the National Academy of 
Sciences is the place to do it.
    Mrs. Dingell. Thank you.
    So we talked briefly a minute ago about the tragedies in 
Florida where one home lost 12 residents who eventually died. 
Following the disaster of this kind, how do we best ensure that 
long-term care facilities that lose power are prioritized as 
hospitals are and back up and running fast? Because that was 
part of the problem.
    Dr. Kadlec. Part of the practical situation is is that in 
terms of our approach to these events, a pre-event to identify 
those facilities--I don't know if you're familiar with the 
Empower program that we have in the department, but I think 
it's the idea of identifying those places where people of 
particular vulnerability are housed and how quickly you can 
make sure that they have the capacity and capabilities and are 
identified early so that you can connect with them and that was 
an issue that, quite frankly, in Puerto Rico we did on foot, 
place by place, because the nature of their facilities was very 
different than what you'd find in places like Florida.
    Mrs. Dingell. We do need to worry about it.
    My colleagues, Debbie Wasserman Shultz, Ms. Eshoo, and I 
have a bill that would, among other things, require states to 
prioritize nursing homes in the same manner as hospitals are 
prioritized in all-hazards public health emergency preparedness 
and response plans and would include in those plans information 
on how utilities plan to ensure that nursing homes return to 
operating as soon as practical following a disaster.
    I would urge all of my colleagues to support that. We are 
down to 1 minute so, Deputy Commissioner Abram, some have 
advocated that as a part of the reauthorization of PAHPA that 
we should make the MCM PRV program permanent.
    Can you comment on FDA's viewpoint regarding whether or not 
this program should be permanent at this time?
    Ms. Abram. We think it's premature to determine how 
effective the program has been. I think Congress had good 
foresight when enacting the MCM PRV program and reauthorizing 
the pediatric PRV program to charge GAO with looking at this.
    One of the dynamics with the priority review voucher 
programs--and we now have three programs: one for neglected 
tropical diseases, one focused on peds, one focused on security 
medical countermeasures, which I would point out are those 
which are linked to material threat determinations.
    So these are pretty serious--is the more vouchers you have, 
it diminishes then the incentive and the value of the voucher. 
And so I think Congress had good foresight to consider that 
this would need to be looked at as how many vouchers are out 
there--is the program having the intended effect.
    There has always, throughout the journey of these issues, 
been a consistent threshold question, which is have we 
optimized the incentives for bringing forward the medical 
countermeasures we need to protect the American people and I 
think if you look at the bipartisan history of these issues 
from BioShield to the creation of BARDA to the innovation 
collaboration that Dr. Kadlec has talked about today to the MCM 
PRV, this continues to be a threshold question.
    Mrs. Dingell. Thank you.
    Mr. Burgess. The gentlelady's time has expired.
    Dr. Kadlec, we know you're needing to depart and I think 
all the members now asked questions. I do want to just note for 
the record that you were part of a bipartisan Energy and 
Commerce delegation to the island of Puerto Rico last--late 
last year and were very much a part of our work in assessing 
the damage there.
    Also, you mentioned in your prepared testimony about the 
BioWatch program and I will note that the Shattuck Lecture that 
was published in this week's New England Journal of Medicine 
given by Bill Gates, the subject innovation for pandemics also 
talks about an early detection system. I will probably be 
submitting a question for the record for you on that because I 
believe that should be part of our work here.
    Dr. Kadlec. Thank you, sir. I look forward to it.
    Mr. Burgess. Mr. Green, any parting comments?
    Mr. Green. No.
    Mr. Burgess. Bye. All right. We will excuse this panel and 
Dr. Kadlec, again, thank you for your forbearance and we 
appreciate all of you being here today.
    And we will transition immediately to our second panel.
    [Pause.]
    I will ask all of our participants to take their seats and 
the subcommittee will continue. We are pleased to have our 
second panel here today.
    Just as a housekeeping detail there is likely to be a 
series of votes on the floor. If that does occur we will recess 
briefly to attend to those votes and then immediately resume 
activities here.
    But I do want to thank our second panel of witnesses for 
being here today. You each have a chance to give an opening 
statement followed by questions from members.
    We are pleased today to welcome Dr. Umair Shah, Executive 
Director of Harris County Public Health; Dr. Michelle Berrey, 
President and CEO, Chimerix, Incorporated; and Mr. Erik Decker, 
Chief Security and Privacy Officer, University of Chicago 
School of Medicine.
    We appreciate each of you being here today and we 
appreciate you sticking with us through the first panel.
    Dr. Shah, you are now recognized 5 minutes for an opening 
statement.

STATEMENTS OF DR. UMAIR SHAH, EXECUTIVE DIRECTOR, HARRIS COUNTY 
    PUBLIC HEALTH; DR. MICHELLE BERREY, PRESIDENT AND CEO, 
    CHIMERIX, INC.; ERIK DECKER, CHIEF SECURITY AND PRIVACY 
            OFFICER, UNIVERSITY OF CHICAGO MEDICINE

                    STATEMENT OF UMAIR SHAH

    Dr. Shah. Thank you, Chairman Burgess and Ranking Member 
Green. A pleasure to see you, Representative Barton. As fellow 
Texans, it's always great to have a conversation with you as 
well.
    To members of the House Energy and Commerce Health 
Subcommittee, thank you for inviting me to testify this morning 
on this very important topic.
    My name is Dr. Umair Shah. I am the Executive Director of 
Harris County Public Health, the county health department in 
Houston, Texas, the third largest county in the U.S. with 4.7 
million people.
    I am also the local health authority of Harris County, 
Texas. I am also here as the President of NACCHO, the National 
Association of County and City Health Officials, representing 
the Nation's nearly 3,000 local health departments.
    I refer you to my full written testimony today. In the 
interest of time, I will touch on three main points. One, that 
public health truly matters, especially at the local level and 
in emergencies. The PAHPA reauthorization, number two, is 
extremely important to support our work. Number three, CDC and 
ASPR must appropriately be funded and getting dollars to local 
communities.
    So public health is vital to the health of our communities. 
This is especially true in emergencies. Public health does all 
the behind-the-scenes work and is truly boots on the ground, 
performing disease surveillance, ensuring the safety of our 
environment, spraying for mosquitoes, providing immunizations, 
picking up dangerous animals, supporting chronic disease and 
mental health efforts. These are just some of what public 
health departments do to keep our communities healthy, 
protected, and safe.
    I can tell you firsthand how important these roles are 
because I am from an impacted community. Dating back to 
Tropical Storm Allison in 2001, the Nation's first BioWatch had 
Hurricanes Katrina, Rita, and Ike, H1N1 pandemic, Ebola, and 
Zika and, most recently, 300-plus year floods in 3 years 
including Hurricane Harvey with its 1 trillion gallons of water 
that were dumped on Harris County.
    Emergencies abound. But our story is one of a community of 
resilience, one that has invested in our health and response 
systems and understands the importance of working together to 
prepare, respond, and recover and that's what Texans do.
    Truly, our strong response to Harvey was built on the 
responses to Tropical Storm Allison on forward. Indeed, you can 
learn from previous emergencies and investments can and do pay 
off. Harvey was just one storm, though.
    In the last year, our nation has seen severe weather 
events, ice storms, floods, hurricanes, wildfires, acts of 
violence, a severe flu season. This doesn't even include the 
issue of opioids or global health challenges that impact 
domestic health. Truly, two things are certain. Emergencies can 
and will be lurking around the next corner and public health 
agencies will be there to respond in kind. But we cannot do our 
job without the adequate resourcing and support that both 
public health emergency preparedness and the hospital 
preparedness program funding streams--PHEP and HPP--provide.
    That's why, number two, the PAHPA reauthorization bill is 
so critically important for our work. Let me now speak briefly 
to some of the proposed provisions.
    First, we strongly support the reauthorization of the PHEP 
and HPP programs through 2023. These are complementary programs 
that work hand in hand to enable health departments and health 
care systems alike to prepare and respond to emergencies.
    Secondly, the Medical Reserve Corps program strengthens our 
ability to respond by deploying an army of volunteers. We urge 
you to maintain the authorization level under the current law.
    Thirdly, with respect to the public health emergency fund, 
we are concerned about the 1 percent transfer authority to 
infuse the fund when a public health emergency is declared. The 
transfer authority would take vital dollars away from other 
public health programs in the midst of a funding cycle and we 
recognize that multiple emergencies can be happening at one 
time.
    Finally, the SNS plays a critical role in preparedness 
regardless of its structure or location. With the proposed 
authority from CDC to ASPR legislative language must assure 
maintenance of appropriate coordination and support of state 
and local health departments. Public health response 
capabilities cannot get lost in the sea of other health care 
system capability needs.
    Number three, we feel strongly that CDC and ASPR are 
agencies that are critical to support what we do on the ground. 
They provide not just funding and resources, technical 
expertise, and advice, but they often are the response agencies 
that deploy at a moment's notice when necessary. We must ensure 
that the authorization levels of both agencies are maintained.
    Truly, as we do our work in public health we remain hidden 
from the public's eye. We have a visibility crisis in public 
health and it impacts our ability to be appropriately 
resourced.
    I think of public health as the offensive line of a 
football team. Of course, it is Texas so I must say football. 
Whether it is Tom Brady or Aaron Rodgers, everyone knows the 
quarterback but very few know members of the offensive line, 
yet they are critical to the success of that line. Just like 
the behind-the-scenes offensive line absolutely critical to the 
wellbeing of our communities.
    Since we don't invest appropriately in public health 
capacity, we find ourselves reactively scrambling to act when 
the next emergency is upon us. Decreased investment in public 
health leaves us more vulnerable and forces us to rob Peter to 
pay Paul by taking from elsewhere, and funding fluctuations 
also take a toll. If funding for public health is cut by 10 
percent, for example, the expectations of our communities do 
not decrease by 10 percent in kind. We must have adequate 
resources to do our job appropriately.
    Let me close by saying I am honored to represent the strong 
dedicated public health workforce that give it their all as 
first responders in emergencies just like fire, EMS, law 
enforcement, et cetera, even when themselves personally 
impacted.
    This proposed bill helps support our work. More is needed, 
of course, especially to support the values of innovation, 
engagement, equity of collaborative multi-disciplinary linking 
of one health, global domestic health, and all-hazards 
preparedness with ongoing public health capacity building, 
ensuring funds get equitably to jurisdictions based on both 
need and risk. This reauthorization is an important step in 
that direction.
    Thank you, and I look forward to taking your questions.
    [The prepared statement of Dr. Shah follows:]
    
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    Mr. Burgess. Thank you, Dr. Shah.
    Dr. Berrey, you're recognized for 5 minutes, please.

                  STATEMENT OF MICHELLE BERREY

    Dr. Berrey. Good morning. My name is Michelle Berrey. I 
would like to thank Chairman Burgess and Ranking Member Green, 
other members of the committee, for the opportunity to speak to 
you today.
    I am here in support of reauthorization of PAHPA and to 
highlight the important components of successful public-private 
relationships to develop medical countermeasures from the 
perspective of a small biotechnology company.
    I am a board-certified infectious disease and public health 
physician. I spent the last 20 years developing new drugs for 
viral diseases. I currently serve as CEO of Chimerix, a small 
publicly-traded biotech of 85 employees in Durham, North 
Carolina. We are one of many companies currently collaborating 
with BARDA in development of medical countermeasures against 
CBRN threats.
    We are here today as members of the Alliance for 
Biosecurity as a strong supporter of reauthorization of PAHPA. 
Our lead candidate, brincidofovir, or brinci for short, is an 
anti-viral with activity against a broad range of viruses. It 
is in late stage development for treatment of small pox. Brinci 
is one of a handful of dual-use agents, meaning it is in 
development both as a medical countermeasure for protection of 
the public health and to address some of the most common 
viruses in patients with urgent needs for new treatments. For 
brinci, this is for children undergoing bone marrow 
transplants. It was Federal funding that allowed us to 
jumpstart our smallpox program and to progress to full 
development and our currently collaboration with BARDA.
    When smallpox was eradicated in the 1970s, routine 
vaccinations ceased. Without broad immunity, weaponized 
smallpox could be devastating to the global population and thus 
it became an appealing potential biological weapon. It is a 
highly infectious easily transmitted airborne virus with at 
least a 30 percent mortality date. As the first lien of defence 
for smallpox exposure, vaccines are stockpiled by BARDA for 
every American including the one in five Americans who would 
require a next-generation or attenuated vaccine.
    So why did the Institute of Medicine also recommend that 
the U.S. stockpile two different smallpox antivirals with 
different mechanisms of action? The reason that antivirals are 
critical is for three separate populations: one, those who 
remain ineligible for vaccine; two, patients with severe side 
effects from the vaccine; and three, those with symptomatic 
smallpox.
    Like the flu, once symptoms begin it is too late for a 
vaccine. Specifically for brinci, we have completed over a 
dozen efficacy studies for the treatment of smallpox under the 
FDA's animal rule. In our largest rabbit pox study, we 
demonstrated 100 percent survival in animals that we began 
dosing at the time we confirmed infection. Our studies have 
also shown that brinci may also reduce transmission of smallpox 
by accelerating clearance of virus. This point could be 
critical in stopping an outbreak.
    Chimerix has worked closely with our colleagues at the 
Division of Antivirals at the FDA to progress this challenging 
program. Just this morning, we received orphan drug designation 
from the FDA, which provides a waiver for FDUFA fees and will 
thus provide further savings for BARDA. Developing 
countermeasures as dual-use compounds allows us to stretch 
precious federal resources and to ensure sustainability of the 
enterprise.
    We've also seen that brinci's development for the treatment 
of life-threatening antivirus infections has provided 
innovations for drug formulations that are paid for fully by 
private sector dollars and this has reaped additional benefits 
for compounds that are included in the medical countermeasures 
and the stockpile.
    The passage of Project BioShield and PAHPA created a market 
for medical countermeasures where one did not previously exist. 
Knowing that there is a fund dedicated to support stockpiling 
provides for our common defense. This is critical. We are 
developing a solution for a problem that we all hope never 
presents itself.
    But not being prepared for a smallpox event is not an 
option. We commend the Committee for the bipartisan 
collaboration on PAHPA reauthorization and in particular for 
the 10-year advance appropriation for the Project BioShield 
special reserve fund.
    Companies like Chimerix rely on the existence of a 
government market for medical countermeasures in order to 
sustain the long-term investment in research and development 
for these critical.
    I will be happy to welcome any your questions.
    [The prepared statement of Dr. Berrey follows:]
    
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    Mr. Burgess. Thank you, Dr. Berrey.
    Mr. Decker, you're recognized for 5 minutes, please.

                    STATEMENT OF ERIK DECKER

    Mr. Decker. Thank you, Chairman Burgess, Ranking Member 
Green, and members of the subcommittee. It's an honor to 
testify concerning the reauthorization of PAHPA.
    I am the Chief Security and Privacy Officer for the 
University of Chicago Medicine. I also serve as the Chairman of 
the Advisory Board for the Associations of Executives and 
Health Care Information Security, otherwise known as AHIS.
    AHIS is an association that represents more than 850 senior 
security leaders within health care. Lastly, I serve as the 
Industry Lead and Co-chair of a public private partnership task 
group sponsored by the Department of Health and Human Services 
for establishing cybersecurity best practices within the health 
care sector. This group is the result of a legislative 
imperative of the Cybersecurity Act of 2015, Section 405(d) and 
authorized under the National Infrastructure Protection Plan.
    We are organized under the joint cybersecurity working 
group within the Healthcare Sector Coordinating Council and the 
Government Coordinating Council. We support the reauthorization 
of PAHPA. Specifically, we support the inclusion of 
cybersecurity as an identified hazard and the need to designate 
a sector-specific agency such as ASPR to interface with the 
health care industry.
    Over the last decade, the health care sector has witnessed 
the evolution of cyber-attacks against our health systems. 
Today's cyber-attacks have become more numerous and 
sophisticated from the establishment of underground markets for 
the exchange of stolen sensitive information to the creation of 
a ``hacking as a service industry.'' In the hyper-connected 
world of health care, the digital footprint has exploded, 
creating more points of entry than ever for attacks to be 
successful.
    As was evidenced by the WannaCry ransomware attack that was 
launched in May of 2017, we must recognize that cyber-attacks 
are a real and present danger. What the recent WannaCry 
incident has signaled to the industry that attacks are no 
longer localized to one particular health system or another but 
can impact us locally, regionally, and nationally.
    We need a system of prevention and response that is similar 
to the disease prevention and infection control practices 
within the health care industry. This system should encourage 
and incentivize the adoption of standard cyber hygiene 
practices, as our clinicians do with washing their hands, and 
that is capable of coordinating large-scale emergency response 
to cyber threats as HHS has done with the Ebola and Zika 
outbreaks.
    We feel that this is the perfect moment to introduce the 
inclusion of cybersecurity to PAHPA and strengthen the 
partnership with the Federal Government. Specifically, we feel 
that ASPR, in combination with the right cybersecurity 
expertise, capabilities, and funding will serve as an impartial 
partner to help bolster the industry's cyber capabilities.
    I would like to offer a few methods that ASPR could deploy 
to achieve these outcomes. Number one, encourage the adoption 
of a cybersecurity framework and a soon to be released top ten 
cybersecurity best practices within health care.
    Number two, bolster the importance of cybersecurity 
technical--of sharing technical cybersecurity threat 
intelligence information through the use of a national 
healthcare ISAC, otherwise called NHISAC. Ensure that this 
information is protected from regulators.
    Number three, offer enforcement relief for organizations 
that demonstrate the adoption of the cyber framework--the 
aforementioned best practices and participation within NHISAC.
    And number four, establish a national response program in 
partnership with NHISAC and potentially DHS that is capable of 
facilitating a response to the national threat.
    I sincerely thank the committee for allowing me to speak on 
this important topic and I look forward to answering your 
questions.
    [The prepared statement of Mr. Decker follows:]
    
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    Mr. Burgess. And I thank all of our witnesses for their 
testimony. We will proceed into the question and answer portion 
of the hearing. I will recognize myself 5 minutes for 
questions.
    And Dr. Shah, again, thank you. Before I go to you, Dr. 
Shah, I wanted to introduce the Shattuck Lecture that was 
printed in the New England Journal of Medicine given by Bill 
Gates, specifically the comments about the early detection 
system and BioWatch.
    So I will be asking unanimous consent to make that as part 
of the record. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    So now, Dr. Shah, again, I appreciate you being here today. 
Appreciate all the work that you have done for the county of 
Harris where I lived for a while while I was in medical school. 
So I am very familiar with the issues that you elucidated in 
your testimony.
    We talked a little bit about BioWatch. I think Dr. Kadlec 
mentioned that in his testimony. So do you see a need to update 
the technology currently used in the BioWatch program and is 
the guidance provided by Health and Human Services and 
Department of Homeland Security appropriate for our local 
responses?
    Dr. Shah. Thank you, Mr. Chairman.
    So let me answer that with going back a little bit in the 
history. So as the first BioWatch hit that we had in Houston in 
our community and then over the years having multiple BioWatch 
actionable results at the bars. What we've seen over the years 
is that there has been a shift in the way BioWatch was actually 
looked at.
    Initially, it was you have a hit, it is an act of intent 
and you have to launch an all public health response to it. 
That has now shifted, fortunately, in a way that it is a 
laboratory confirmation--a sensor positive that doesn't 
necessarily mean that it's a public health positive, and this 
is the difference between the science of public health and the 
art of public health where we have to put all the other 
epidemiologic data, all the other environmental health data, 
all of the other factors in so we can make a determination 
whether this is truly a terrorist attack or a terrorist threat, 
and that, I think, is the way to go. But what that really 
implies is that we have to make sure that the technology is as 
strong as it can be, it's as certain as possible to give us the 
right result.
    And so we, certainly at the local level and even really 
thinking about this more from a physician standpoint, we really 
want to make sure that if you ask for a test that you know what 
you're going to do with the result and that's the first adage 
in medicine and that's what applies here is that we want to 
make sure that the technology is certain, gives us the right 
results, and then we can use all of the other information that 
we have at our disposal to make a determination. So we support 
better technology. We also support better guidance because 
continuation of changing shifting guidance over the years means 
that we have to relook at what kind of guidance has been given 
to local health departments and state health departments so we 
could relook at this program and make sure that it really meets 
the needs of today and not just yesterday.
    Mr. Burgess. So if I could ask, what is the state of the 
art? The level of precision that is now technically available 
is--obviously, you can work with that at the local level?
    Dr. Shah. Yes, we can. There are some challenges with the 
proposed some technologies that were there.
    The initial technology would allow for more information 
about what the results were and how there was some move toward 
saying it was, more or less, for all intents and purposes, a 
positive or a negative and not giving you all the factors that 
were in play.
    And, fortunately, DHS has moved away from that. But that 
was a challenge and so we are really recognizing that it's 
really important to work with Federal, state, and local 
partners in a transparent way so that we can actually 
understand the science because we too can interpret information 
and we are partners as part of that system.
    Mr. Burgess. Thank you for that answer.
    Dr. Berrey, I referenced I went to medical school in 
Houston. It was a number of years ago. The New England Journal 
of Medicine back in 1974 or 1975 or 1976 talked about the fact 
that smallpox was going to be eradicated from the face of the 
earth. As I sat in my study cubicle that day in the mid-1970s I 
thought it was until I arrived here a number of years later as 
a member of Congress and found out that it wasn't.
    But I just want to mention that as a thanks to you and your 
company for working on those agents. Right after 9/11 when 
people were concerned about biologic agents there was really an 
open question as to whether or not we were prepared because of 
the nonvaccination of the population and the lack of a 
substantial stockpile to deal with what could have been a 
significant attack.
    So you're welcome to respond to that but I just wanted to 
thank you for the work that your company has done.
    Dr. Berrey. Thank you, Chairman Burgess, and we appreciate 
the opportunity to speak here today. We do believe the 
eradication of naturally-occurring smallpox remains probably 
the greatest contribution of medicine to humankind on the 
planet.
    It is unfortunate that the technologies available to would-
be attackers have kept a step ahead and we are hoping that we 
are keeping in lockstep with them.
    I really commend BARDA for their foresight in moving 
forward not just with vaccination and being at the ready but 
their close work with CDC to be prepared to implement ring 
vaccination, to be able to control another outbreak that could 
begin from either naturally occurring or more likely from an 
attack of smallpox.
    Some of the more recent information available about the 
likelihood of being able to implement synthetic smallpox is 
something we've had a lot of discussions about with our 
colleagues at BARDA and really hope to, by having multiple 
therapeutics available within the stockpile, to be prepared in 
the event to face whatever form that that smallpox could take.
    Mr. Burgess. Thank you for that.
    My time has expired. I will recognize the gentleman from 
Texas, Mr. Green, 5 minutes for questions, please.
    Mr. Green. Thank you, Mr. Chairman, and again, Dr. Shah, 
and our whole panel, thank you for being here.
    I know in the Houston areas that I represent we have a 
coordinated effort. Both our county judge, Ed Emmett in the 
city of Houston and Harris County and some of the responses 
that we've had necessitate the deployment of the national 
strategic stockpile.
    In your statement, you made reference, Dr. Shah, to the 
fact that the response to Hurricane Harvey was more than an 
acute response but was instead the result of years of planning 
and coordination.
    With the likely transfer of SNS from CDC to ASPR, do you 
foresee any possible disruptions to the planning, coordination, 
and development of the SNS in future events, given that 
frequency, intensity of weather-related events will only 
increase?
    Dr. Shah. First of all, Congressman Green, thank you so 
much for your service and for the continued partnership that 
you have given to our health department and our community in 
general.
    What I would say is that Hurricane Harvey was the 
culmination and the continuation of a lot of the lessons that 
we have learned over the decade plus since Tropical Storm 
Allison. And, fortunately, we have learned those lessons and 
there has been an incredible amount of investment in both 
public health and health care. With respect to the SNS, as you 
heard from the earlier panel, there certainly are challenges as 
we think about a transfer and there's some uncertainty at least 
at the local level of what exactly this means when they say 
it's being moved from the CDC to ASPR.
    The biggest concern that I would put out there is the fact 
that we know that ASPR is responsible for hospital readiness 
and health care readiness, and we also know that oftentimes 
public health gets drowned out by the hospitals and healthcare 
system. And so one of the biggest challenges we would have as 
moving SNS over to ASPR is to ensure that it does not get lost 
in all the public health activities that we at the local level 
and the state level, that we require from an SNS as well--from 
our Federal partners. And so ensuring that the legislation has 
that built in is absolutely critical. The other aspect of this 
is the federal medical station that was deployed during SNS for 
Hurricane Harvey response was very much about really having a 
field hospital that we were able to rely on.
    Unfortunately, Florida and Hurricane Irma happened right 
afterwards and it started to move. And so one of our big 
challenges is to ensure that when we have multiple emergencies 
happening how do we really try to figure out what those Federal 
assets are and how we can use them locally as well as across 
the system. I think that's another challenge.
    Mr. Green. Well, I appreciate it, because I know the 
response with Hurricane Harvey and Katrina--when the CDC came 
in we were treating a lot of our visitors, who are now Texans, 
from Louisiana. CDC can bring other resources, including the 
public health service, and I just didn't want to disrupt some 
of the good things we had.
    If you have any suggestions on how we may make sure that 
that process will not lose the success we have now, I would be 
glad to see what we can do when we are marking up the bill, 
because that's my concern--the change from CDC to ASPR, which 
is a great agency, but I don't want to lose that effort.
    Dr. Shah, one of the other concerns I have is we spent some 
today discussing the importance of well-funded public health 
infrastructure for preparedness and response.
    A related discussion in the provision of the bill would 
allow the secretary to transfer 1 percent of any appropriation 
to the public health emergency response fund. The intent of the 
fund is to provide a source of extra funding for responding to 
public emergencies like Katrina or Harvey.
    However, in your written testimony, you indicated that you 
had significant concerns about the transfer authority. 
Specifically, you mentioned that the authority will take away 
vital dollars from other public health programs.
    And my question is from the perspective of the local public 
health officials on the ground can you describe the challenges 
that would occur from allowing the secretary to transfer 1 
percent of HHS funding to the public health emergency response 
in case of a public health emergency declaration?
    Dr. Shah. Thank you again for that question.
    What I would say is that we recognize the importance of 
having a fund because in the midst of an emergency you have to 
have that funding ready right then. You cannot waits months or 
some period of time to get those dollars back into the system.
    The challenge that we have is that while we were looking at 
what happened during Zika, we started to go back and pull 
dollars from Ebola. But Ebola was still a threat while we were 
also trying to find the dollars over to Zika.
    And at our own health department, for example, we had hired 
a physician for chronic disease prevention for diabetes and 
high blood pressure and immediately because we did not have 
those funds we had to move that physician over to be part of 
the response system for Zika.
    And so I think it's a real challenge that we have to 
remember that there are multiple challenges and issues the 
public health departments at the local level are facing all the 
time. What we don't want to have happen is in mid-cycle dollars 
are shifted from one place to another and you now start to lose 
infrastructure in that existing area that is equally important.
    And we also have to remember that multiple emergencies can 
happen at the same time. So yes, those are our concerns, 
Congressman, that we are interested in discussing.
    Mr. Green. Thank you. I know I am out of time but that's 
another issue we'll look at because I still have my 
constituents waiting for FEMA assistance 10 months now since 
Harvey and I would not like to have our public health have to 
wait that long because then we could end up with epidemics.
    Thank you, Mr. Chairman.
    Dr. Shah. When you wait for dollars that can cost lives, 
and so that's very important. Thank you.
    Mr. Burgess. The chair thanks the gentleman.
    The chair recognizes the gentlelady from Indiana 5 minutes 
for questions, please.
    Mrs. Brooks. Thank you, Mr. Chairman.
    Dr. Berrey, in 2004 Congress passed the Project BioShield 
Act, which created the special reserve fund of $5.6 billion 
made available over a 10-year period to help create stability 
and ease concerns from companies about the likelihood of--help 
them decide about whether or not to get into the market for 
medical countermeasures. That has traditionally been 
unprofitable, and once this initial funding expired, Congress 
reverted to appropriating for the program on an annual basis, 
which I understand has created less long-term certainty.
    Do you agree that recommitting to a multi-year funding 
approach for medical countermeasures development and 
procurement would help strengthen our nation against biological 
threats and could you please talk about whether or not it's 
incentives or how can we better prioritize our existing funding 
for medical countermeasures?
    Dr. Berrey. Absolutely. Thank you, Congresswoman Brooks, 
and I want to thank both you and Congresswoman Eshoo for 
sponsoring this bill.
    I will say without question that having Federal moneys 
available for support of these long-term research and 
development projects is absolutely critical. We know that the 
private sector does not establish the same value--does not 
support those programs, especially these longer-term programs, 
and thus it is critical that we have federal moneys available.
    We've seen the impact in other small and large companies 
that are committed to this space. But without a multi-year 
authorization have seen the dollar value and the size of those 
procurement contracts decrease because BARDA does not have that 
capability of having the security of a longer-term multi-year 
commitment there. Having that dedicated fund is absolutely 
critical. We believe in dual use and both the economic and the 
medical benefits that dual-use compounds can bring.
    We've seen benefits to our medical countermeasure program 
that have been exclusively paid for through our private sector 
dollars. One specific example is optimization of our pediatric 
suspension. We now have a suspension that has no need for 
refrigeration, which is ideal for the SNS, and because we are 
treating children through our clinical program for adenovirus, 
we have real-world data that can support the dosing information 
specific for pediatric use in the event of a smallpox outbreak.
    I believe that both the long-term funding and continued 
support through PAHPA reauthorization are critical for that 
but, secondly, I wanted to make the point that I do believe 
dual-use compounds, even though they do bring additional 
challenges, have additional economic benefits.
    Mrs. Brooks. Thank you.
    Mr. Decker, the Blue Ribbon Study Panel on Biodefense 
called for the development and implementation of a government-
wide security strategy for stored pathogen data that 
incorporates deterrent and enforcement measures, oversight, and 
inspection.
    Would you be willing or interested in contributing to such 
a process and do you believe a strategy like this would improve 
the security of sensitive public health information?
    Mr. Decker. Well, certainly, I think that focusing any 
amount of preparation and effort on securing sensitive 
information is going to be important.
    I am not familiar with that particular provision so I am 
happy to take that back and provide an answer to you, if you'd 
like.
    Mrs. Brooks. Are you familiar with the Blue Ribbon Study 
Panel on Biodefense and recommendations they made?
    Mr. Decker. No, I am not.
    Mrs. Brooks. OK. Well, we would welcome the opportunity to 
work with you on that and to get your further thoughts on what 
they recommended.
    And finally, Dr. Shah, if we could just go in a little bit 
with respect--can you help us understand the role that CDC--
we've certainly had quite a debate and discussion this morning 
about CDC's role and what would you say?
    Are there any additional tools CDC needs that--or resources 
that they need that we ought to be providing as we explore what 
their role is, going forward, relative to ASPR's?
    Dr. Shah. Yes, that's a tough one. Thank you for that 
question.
    That's a tough one only because there are a number of needs 
that public health in general has at the Federal, state, and 
local level. And so I could reall have a nice----
    Mrs. Brooks. That's a huge lecture. I understand that.
    Dr. Shah. Yes. Yes. Exactly. Exactly.
    That said, I do think that outside of supply chain 
logistics and those kinds of things that, obviously, and ASPR 
would be very good at doing, there would be an opportunity 
really to be looking at the real consultation and the technical 
assistance----
    Mrs. Brooks. Right.
    Dr. Shah [continuing]. And the support that's given to 
local and state health departments. Really, that's what CDC is 
really, really good at--technical assistance and really being 
able to pick up a phone and call and/or even deploy in if you 
need help and assistance and want to make sure that that 
consultation piece is available.
    But also the real piece about the support that is given to 
local health departments as they're doing their work. If this 
shifts over to ASPR and that piece is not so strong then at the 
end of the day the last mile is really the most important piece 
about SNS is how do you get medications into the mouths of 
people and you want to make sure that local health departments 
have the support to be able to get that done well and that, 
obviously, would mean that we would continue to have that 
support from whomever is going to be providing it.
    So those guardrails really need to be in place.
    Mrs. Brooks. Thank you. I agree. I yield back.
    Mr. Guthrie [presiding]. The gentlelady yields back and I 
will recognize myself for 5 minutes to ask questions, and thank 
you all for being here today.
    And Dr. Shah, this is for you. During an Ebola outbreak in 
West Africa--the Ebola outbreak in 2014, much was made about 
the lack of standards and guidelines for the use of personal 
protective equipment in hospitals that were treating infected 
patients.
    What are your thoughts on establishing reasonable personal 
protective equipment guidelines and requirements for emergency 
medical service personnel in advance of a biological event 
based on existing research and lessons learned?
    Dr. Shah. Thank you for that question.
    I would say, first of all, there are a few things about 
Ebola. I think Ebola and Zika and H1N1, the pandemic, teach us 
that global health is very much connected with domestic health 
and we have to keep that in mind.
    So, really, the way to be able to interrupt the 
transmission or get to zero risk for the American people is to 
be able to interrupt transmission in global communities, for 
example, in West Africa in 2014 or in the case of Zika in Latin 
American and Caribbean countries.
    That also, obviously, is a concern now with the Democratic 
Republic of Congo with DRC because the concern now is does this 
get into an urban environment that potentially you could get 
spread and get on a plane and you can now get to North America 
and here we are, we are back and playing for years later a very 
similar situation.
    So we work very closely with our environmental health 
folks. The environmental health field is amazing when it comes 
to really helping us as well as the occupational health field 
when it comes to those personal protective equipment and those 
environment changes that need to be made and we really believe 
with a disease like Ebola, because it's so meticulous that you 
have to use personal protective equipment every single time, we 
have to recognize the absolute importance of ensuring that we 
are working with our private sector that are designing these 
suits, designing those gloves, designing those masks, designing 
all those materials but we also train local practitioners so 
they know what they're doing, how they're doing it, how they're 
putting it on, how they're using it so they are meticulous.
    One example I will give you is from Hurricane Harvey. We 
have J.R. Atkins, who was an EMS responder, who volunteered. He 
was meticulous about using personal protective equipment except 
one time where he was bitten by a mosquito--it was a spider, 
most likely, and he wound up having necrotizing fasciitis, a 
flesh-eating bacteria, and we wound up going to the operating 
room three to five times.
    So we have to be meticulous when it comes to infectious 
disease control and we certainly support that.
    Mr. Guthrie. OK. Thank you very much.
    And this for you but anybody on the panel that would like 
to address it--the public health emergency preparedness 
cooperative agreement is an annual source of direct funding for 
state and local public health systems.
    Can you speak about the importance of these agreements in 
terms of capability to address biological threats and how do 
state, local, and territorial public officials leverage the 
Federal support and how does it help prepare the country for 
the next outbreak?
    Dr. Shah. Thank you again for that question.
    What I would say is that we recognize that there is a lot 
of capacity already at the local and state level. There is a 
lot that's already being done with the resources that we have 
in state and local communities.
    But it would be important to say that public health 
emergency preparedness funding--that 55 percent of local health 
departments are actually relying on those dollars for their 
preparedness work. It is so critical to many of our local 
health departments, especially the smaller local health 
departments, the more frontier local health departments. We 
have to make sure that those dollars are available and that 
they can support and really augment what's already happening at 
the local level.
    The other piece around the biologics is that we want to 
make sure that there is improved recognition of quicker digital 
systems and recognition of surveillance systems that really 
allow us to do disease pattern recognition.
    The final point that I would make in the interest of time 
is the fact that we have to really be thinking about where the 
risk is, where the threats are, and really ensuring that those 
dollars are going not just to certain areas of a community but 
all of a community to make sure that those dollars are really 
reaching those local health agencies that are boots on the 
ground to ensure that they can do the work that they're doing.
    Mr. Guthrie. Thank you.
    Anybody comment? I know that's more his area but anybody 
want to comment on that as well?
    Dr. Berrey. The only additional point that I would make is 
as we look back on smallpox and as Chairman Burgess noted 
earlier that we haven't seen smallpox since the 1970s. So when 
you think about the physicians that are currently staffing 
emergency rooms, it's very unlikely that any of the physicians 
who are currently serving in those first response settings have 
actually seen smallpox.
    So a big component not just in diagnosis is first to think 
about this could be a bioweapon, could be a chemical weapon, 
reflect recently on coverage of the nurses who was treating the 
Russian spy and his daughter who entered into the emergency 
room considered it was mostly likely an opioid overdose, and 
only an hour later as the police officer was brought in with 
similar symptoms did they realize that this was not in fact an 
opioid overdose.
    So we really have to go back to thinking about those 
zebras. When you hear hoof beats, don't always think of zebras, 
but today might be the day for us to begin remembering those 
zebras. We can be educating our physicians to think about early 
diagnosis and give them the tools to make sure that diagnosis 
can occur rapidly.
    Mr. Guthrie. Thank you. My time is expired.
    I will recognize the gentleman from Missouri, Mr. Long, for 
5 minutes for questions.
    Mr. Long. Thank you, Mr. Chairman.
    Mr. Decker, did you participate in the industry calls that 
HHS led during the WannaCry cyber-attack?
    Mr. Decker. Yes, I did.
    Mr. Long. Did you find them valuable?
    Mr. Decker. Yes, I did. What was valuable was getting the 
information out to all the health systems so that we could 
understand what was happening--if we were being impacted. 
Having a sort of a pulse on what was going on in Europe and the 
U.K. at the time and if that was coming over across the pond 
was important.
    There was some confusion on some of the calls--some 
information that came out of those calls that was technical in 
nature and it was not necessarily related to the actual 
technical nature of the attack that was occurring. But the 
coordinated and facilitation effort of what those calls were 
doing was highly useful.
    Mr. Long. So I am assuming that you did find it valuable to 
interact with HHS in real time?
    Mr. Decker. Absolutely.
    Mr. Long. Do you think that if another WannaCry attack took 
place today HHS would be able to serve a similar kind of 
function?
    Mr. Decker. I think they would stand up a similar type of 
activity--an incident response function like that. I think it 
would be beneficial for the preparedness of that response to be 
a little more coordinated.
    The means by which HHS is facilitating the process versus 
the means by which information sharing and analysis centers 
facilitate technical and distribute technical information down 
to the health systems, I think there's some better coordination 
that could occur there as well as some further monitoring of 
the other critical infrastructures that's occurring.
    But, ultimately, you know, having HHS serve as the focal 
point and facilitation point and the coordination point for a 
national response so that we can have an open line of 
communication with them in case we need help is, I think, 
incredibly important.
    Mr. Long. If another cybersecurity incident like WannaCry 
were to take place, would you want to contact HHS for guidance 
and additional information?
    Mr. Decker. Personally, yes. I think there's also a bit of 
hesitancy from some of our constituents on HHS being a 
regulator as well as an office that provides support and 
resources.
    I think there's a hesitancy for some to not open up the 
lines of communication. So I think that further bolstering the 
knowledge of who that sector-specific agency is, what the 
protection is----
    Mr. Long. Knowledge of what? I am sorry.
    Mr. Decker. Of who the sector-specific agency is and how we 
can communicate with them under protection is something that 
would help with disseminating that information.
    Mr. Long. If it did happen again, who would you want to 
contact at HHS and how do you know that that would be the right 
person to contact?
    Mr. Decker. Yes. So contacting ASPR would be on the list as 
well--now, ASPR would probably be the main focus point, or the 
MCIC within the Department of Health and Human--or DHS.
    Mr. Long. You mentioned some people might have concerns 
about sharing information with HHS since HHS is your 
regulator----
    Mr. Decker. Yes.
    Mr. Long [continuing]. In addition to your sector-specific 
agency. You said other people had that concern. Do you share 
that concern?
    Mr. Decker. Do I share that concern?
    I think there is a clear line between which operating 
division is responsible for interfacing with industry and which 
is responsible for regulating the industry.
    But I don't think that is common knowledge throughout all 
the healthcare industry. I think people see HHS as the 
regulator. They don't understand the intricacies inside of HHS.
    So though I understand the difference between what ASPR is, 
what OCR, what ONC, CMS, et cetera, are, I think it's not 
common knowledge.
    Mr. Long. What steps could HHS take to address some of the 
concerns that you detail?
    Mr. Decker. A lot of focused education and awareness I 
think would be important. Designating a very specific agency 
that's going to be responsible for coordinating with the 
industry is, I think, very important.
    Being able to facilitate the various guidance between OCR, 
FDA, ONC, CMS, et cetera, because all of those operating 
divisions produce guidance for cybersecurity for the health 
care industry.
    But it's potentially in conflicting matters and so 
deconflicting the guidance that comes out and being able to 
really lower the barrier of entry to the cyber space I think is 
going to be important, especially for the smaller practice 
organizations like small practices, one- or two-physician 
practices, critical access hospitals, community hospitals where 
they're resource strapped and every dollar that they have, if 
they spend it on cyber or if they spend it on public health, or 
they spend it on something is something they have to consider.
    Mr. Long. With all the players involved in the soup it 
sounds like acronymology to me.
    Mr. Decker. It is a little bit.
    [Laughter.]
    Mr. Long. Thank you, Mr. Chairman. I yield back.
    Mr. Burgess [presiding]. The chair thanks the gentleman. 
The gentleman yields back. We are just about to have votes on 
the floor so it looks like there are no further members wishing 
to ask questions.
    So I want to thank our witnesses for being here with us 
today. Pursuant to committee rules, I will remind members they 
have 10 business days to submit additional questions for the 
record. I am going to ask witnesses to submit their response 
within 10 business days upon receipt of those questions.
    I would also like to submit documents from the following, 
for the record: American Academy of Pediatrics, the American 
Hospital Association, the American Society for Microbiology, 
America's Essential Hospitals, Global Health Technologies 
Coalition, Healthcare Leadership Council, Infectious Disease 
Society of America, International Safety Equipment Association, 
and the Trust for America's Health statement.
    Again, members have 10 business days to submit additional 
questions. I ask the witnesses to submit their responses within 
10 business days of the receipt of those questions.
    Without objection, the subcommittee is adjourned.
    [Whereupon, at 1:13 p.m., the committee was adjourned.]
    [Material submitted for inclusion in the record follows:]
    
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