[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]


                     U.S. BIODEFENSE, PREPAREDNESS,
                          AND IMPLICATIONS OF
                        ANTIMICROBIAL RESISTANCE.
                         FOR NATIONAL SECURITY

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

                                HEARING

                               BEFORE THE

                   SUBCOMMITTEE ON NATIONAL SECURITY

                                 OF THE

                         COMMITTEE ON OVERSIGHT
                               AND REFORM

                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED SIXTEENTH CONGRESS

                             FIRST SESSION

                               __________

                             June 26, 2019

                               __________

                           Serial No. 116-41

                               __________

      Printed for the use of the Committee on Oversight and Reform
      
      
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                   COMMITTEE ON OVERSIGHT AND REFORM

                 ELIJAH E. CUMMINGS, Maryland, Chairman

Carolyn B. Maloney, New York         Jim Jordan, Ohio, Ranking Minority 
Eleanor Holmes Norton, District of       Member
    Columbia                         Justin Amash, Michigan
Wm. Lacy Clay, Missouri              Paul A. Gosar, Arizona
Stephen F. Lynch, Massachusetts      Virginia Foxx, North Carolina
Jim Cooper, Tennessee                Thomas Massie, Kentucky
Gerald E. Connolly, Virginia         Mark Meadows, North Carolina
Raja Krishnamoorthi, Illinois        Jody B. Hice, Georgia
Jamie Raskin, Maryland               Glenn Grothman, Wisconsin
Harley Rouda, California             James Comer, Kentucky
Katie Hill, California               Michael Cloud, Texas
Debbie Wasserman Schultz, Florida    Bob Gibbs, Ohio
John P. Sarbanes, Maryland           Ralph Norman, South Carolina
Peter Welch, Vermont                 Clay Higgins, Louisiana
Jackie Speier, California            Chip Roy, Texas
Robin L. Kelly, Illinois             Carol D. Miller, West Virginia
Mark DeSaulnier, California          Mark E. Green, Tennessee
Brenda L. Lawrence, Michigan         Kelly Armstrong, North Dakota
Stacey E. Plaskett, Virgin Islands   W. Gregory Steube, Florida
Ro Khanna, California
Jimmy Gomez, California
Alexandria Ocasio-Cortez, New York
Ayanna Pressley, Massachusetts
Rashida Tlaib, Michigan

                     David Rapallo, Staff Director
              Daniel Rebnord, Subcommittee Staff Director
                          Amy Stratton, Clerk

               Christopher Hixon, Minority Staff Director

                      Contact Number: 202-225-5051
                                
                                
                                ------                                

                   Subcommittee on National Security

               Stephen F. Lynch, Massachusetts, Chairman
Jim Cooper, Tennesse                 Jody Hice, Georgia, Ranking 
Peter Welch, Vermont                     Minority Member
Harley Rouda, California             Justin Amash, Michigan
Debbie Wasserman Schultz, Florida    Paul Gosar, Arizona
Robin L. Kelly, Illinois             Virginia Foxx, North Carolina
Mark DeSaulnier, California          Mark Meadows, North Carolina
Stacey E. Plaskett, Virgin Islands   Michael Cloud, Texas
Brenda L. Lawrence, Michigan         Mark E. Green, Tennessee
                         
                         
                         
                         C  O  N  T  E  N  T  S

                              ----------                              
                                                                   Page
Hearing held on June 26, 2019....................................     1

                               Witnesses

Dr. Helen Boucher, Director, Tufts Center for Integrated 
  Management of Antimicrobial Resistance, Tufts Medical Center
Oral Statement...................................................     4
Dr. Asha George, Executive Director, Blue Ribbon Study Panel on 
  Biodefense
Oral Statement...................................................     7
Mr. Chris Currie, Director, Emergency Management, Disaster 
  Recovery, and DHS Management Issues, Homeland Security and 
  Justice Team, U.S. Government Accountability Office
Oral Statement...................................................     9
Dr. Cham E. Dallas, University Professor and Director, Institute 
  for Disaster Management, University of Michigan
Oral Statement...................................................    11

Written opening statements and statements for the witnesses are 
  available on the U.S. House of Representatives Document 
  Repository at: https://docs.house.gov.

                           Index of Documents

                              ----------                              

Documents entered into the record for this hearing are listed 
  below, and are available at: https://docs.house.gov.

  * Statement by California Life Association; submitted by Rep. 
  Lynch on behalf of Rep. Rouda.


 
                     U.S. BIODEFENSE, PREPAREDNESS,
                          AND IMPLICATIONS OF
                        ANTIMICROBIAL RESISTANCE
                         FOR NATIONAL SECURITY
                         
                         
                              ----------                             
                              
                              
                              Wednesday, June 26, 2019




                   House of Representatives
                  Subcommittee on National Security
                          Committee on Oversight and Reform
                                                   Washington, D.C.

    The subcommittee met, pursuant to notice, at 4:11 p.m., in 
room 2247, Rayburn House Office Building, Hon. Stephen Lynch 
presiding. Present: Representatives Lynch, Hice, and Welch.
    Mr. Lynch. Good afternoon. This subcommittee will come to 
order, and without objection the chair is authorized to declare 
a recess of the committee at any time.
    This hearing is entitled, ``U.S. Biodefense, Preparedness, 
and Implications of Antimicrobial Resistance for National 
Security.'' And I want to apologize, first of all, to my 
witnesses, our witnesses, and to our guests. As you know, as I 
explained earlier, to most of our guests, there is rule in the 
house that a subcommittee hearing such as ours cannot convene 
while there is a full committee hearing ongoing, and so that is 
where my colleague, Mr. Hice, was. There is also a rule that a 
subcommittee cannot begin unless one Democrat and one 
Republican are present to constitute a quorum. So I have to say 
I have never been so happy to see a Republican in my life, so 
we will begin.
    Today's hearing will examine whether the United States is 
prepared to respond to various biological threats to our 
national security. These include natural pandemic outbreaks 
such as influenza, Ebola, or diseases yet unknown, as well as 
biological attacks which are perpetrated by foreign 
adversaries, terrorist organizations, and other non-State 
actors. We will also focus on the growing threat of 
antimicrobial resistance, which, according to the Center for 
Disease Control and Prevention already contributes to the 
deaths of about 23,000 Americans each year.
    In the two decades since September 11, 2001, amazing 
developments in biotech, including synthetic biology, gene 
editing, and genomic engineering have led to remarkable 
breakthroughs in health care, clean energy, and sustainable 
nutrition. However, actors with maligned intent can also 
exploit those same technologies to develop biological weapons 
or agents and deploy them across our Nation and the 
battlefield, with potentially devastating effect.
    Director of our National Intelligence, Dan Coats, 
underscored this risk in his 2019 Worldwide Threat Assessment, 
when he stated, and I quote, ``These technologies hold great 
promise for advances in precision medicine, agriculture, and 
manufacturing, but they also introduce risks, such as the 
potential for adversaries to develop novel biological warfare 
agents, threaten food security, and enhance or degrade human 
performance,'' close quote.
    A previous assessment issued by former Director of National 
Intelligence, James Clapper, identified gene editing as a 
potential weapon of mass destruction, the basic ingredients of 
which can be bought online today for as little as $60.
    Similarly, the nonpartisan Government Accountability Office 
has also highlighted the dangers posed by naturally occurring 
infectious disease that could easily become pandemics in view 
of global climate change and mass human migration. These 
official warnings demand our continued attention. Although we 
are fortunate not to have experienced a biological attack here 
in the United States since the anthrax attacks post September 
11th, the threat remains very real. Foreign adversaries have 
already demonstrated an interest in developing genetic and 
biological weaponry. According to official reports, North 
Korean leader Kim Jong-un is pursuing advanced bioweapons 
research and production capabilities.
    Andrew Weber, the Assistant Secretary for Nuclear, 
Chemical, and Biological Defense Programs under President Obama 
recently commented that ``North Korea is far more likely to use 
biological weapons than nuclear ones. The program is advanced, 
underestimated, and highly lethal.''
    Terrorist organizations and other non-state actors also 
have started to develop and deploy biological weapons. A laptop 
discovered from ISIS fighters in northern Idlib, Syria, in 
2014, reported contained a 19-page document with instructions 
on how to develop biological weapons and weaponize the bubonic 
plague from infected animals. It also highlighted the 
relatively low cost of biological weapons and their potential 
to inflict mass casualties.
    To their credit, both Democratic and Republican 
administrations have taken some steps to strengthen our 
national biodefense. Most recently, in September 2018, the 
Trump administration released the National Biodefense Strategy 
in compliance with a congressional directive, included in the 
Fiscal Year 2017 National Defense Authorization Act. The 
President has also established a multi-agency biodefense 
committee to be chaired by the Secretary of Health and Human 
Services.
    Congress has also sought to enhance our national biodefense 
and preparedness. Earlier this month, the House passed a 
bipartisan legislation that will reauthorize critical funds for 
bioterrorism and pandemic preparedness, including $7.1 billion 
for the BioShield Special Reserve Fund for the development of 
biothreat medical countermeasures. The bill, which the 
President has signed this week, also includes $685 million in 
annual grant funding to states and localities through 2023, to 
assist them in responding to infectious diseases, biological 
events, and other public health threats.
    Nevertheless, there are key gaps that remain. As reported 
by GAO, our national biodefense framework is still, and I 
quote, ``fragmented and lacks coordination among multiple 
agencies.'' Moreover, GAO has identified persistent challenges 
facing two primary biosurveillance programs operated by the 
Department of Homeland Security to detect and monitor 
biological threats. Both the BioWatch program and the National 
Biosurveillance Integration Center have been hampered by 
technical performance deficiencies in the absence of clearly 
stated mission.
    Our biodefense efforts must also adapt to the emergence of 
new biological threats, including deadly antimicrobial-
resistant diseases that render existing antibiotics, 
antifungal, or antiviral medications virtually useless. 
According to an April 2019 New York Times report, the spread of 
a resistant fungus known as Candida auris has led the CDC to 
designate it as a serious global health threat. The CDC has 
already documented nearly 700 cases of this life-threatening 
infection in the United States. American servicemembers in Iraq 
and Afghanistan have also contracted drug-resistant, superbug 
infections threatening overall troop readiness and morale.
    Robust and continued congressional oversight will be 
essential to enhancing our national biodefense going forward. 
To this end, I look forward to discussing these and other 
topics with today's witnesses, and I now yield to the ranking 
member of this subcommittee, the gentleman from Georgia, Mr. 
Hice, for five minutes for an opening statement.
    Mr. Hice. Thank you very much, Mr. Chairman, and I am 
honored to be the one Republican that you are very thrilled to 
see today, and the feeling is mutual toward you.
    I also want to take a moment to say thank you to our 
witnesses for your patience today, and all who are attending. 
Sometimes our schedules get turned upside down, and the fact 
that you have exhibited great patience with us and 
understanding, and that means a lot, so thank you for that.
    I also want to extend a very personal welcome to Dr. Dallas 
from the University of Georgia, a good friend and a wonderful 
family that you have. It is good to see you here. Dr. Dallas is 
recognized as a great leader on this topic as well as a 
phenomenal professor at the University of Georgia. And with 
there being about two months before football season we will 
just publicly say ``Go Dogs,'' and let's get that rolling.
    But we are here today to discuss how our country prepares 
for, responds to, and recovers from potential catastrophic 
biological incidents and naturally occurring pandemics. 
Historically, our country has faced a number of significant 
biological incidents. For example, shortly after 9/11, and the 
terrorist attacks then, envelopes containing infectious anthrax 
spores were deliberately mailed through the U.S. postal system. 
Many of you will remember that. Some 22 people were infected 
and five deaths occurred.
    In 2009, our country faced a pandemic virus that first 
emerged in the U.S., resulting in a worldwide death toll of 
between 150,000 to 575,000, according to the CDC. In 2014, 
there was an unprecedented Ebola outbreak in West Africa. The 
outbreak resulted in more than 28,000 cases and about 11,000 
deaths. Eleven individuals were treated in the U.S., one of 
which died.
    In September 2018, President Trump's administration 
released a comprehensive National Biodefense Strategy, as the 
chairman mentioned. It built on lessons learned from the past 
biological incidents, like the 2001 anthrax attacks and the 
2009 influenza pandemic and the 2014 Ebola outbreak. President 
Trump has also released a National Security Presidential 
Memorandum to support the National Biodefense Strategy. For 
instance, it established a Biodefense Steering Committee, which 
is chaired by the Secretary of Health and Human Services, to 
coordinate implementation of the strategy.
    These actions demonstrate the Administration's commitment 
to strengthen America's defense against biological threats to 
health and safety.
    So before us today, as I have already mentioned, each of 
you are experts in this field and we welcome you here to deal 
with the biodefense issue. We have a Blue Ribbon Study Panel 
representative, Government Accountability Office, and as I 
mentioned, representatives from both the University of Georgia 
and Tufts, and we are honored to have each of you here.
    So we look forward to hearing your testimony, and on this 
side of gaining some of your expertise on this topic. So again, 
we welcome you here, we thank you for being here, and with 
that, Mr. Chairman, I will yield back.
    Mr. Lynch. Thank you. Today we are joined by an all-star 
panel of witnesses, and very patient witnesses. Dr. Helen 
Boucher is the Director of--she is my homie, Massachusetts. She 
is the Director of the Tufts Center for Integrated Management 
of Antimicrobial Resistance at Tufts Medical Center. We also 
have Dr. Asha George, Executive Director of the Blue Ribbon 
Study Panel on Biodefense; Chris Currie, Director of Emergency 
Management, Disaster Recovery, and DHS Management Issues, 
Homeland Security and Justice Team, within the U.S. Government 
Accountability Office--his business cards are about this big--
and Dr. Cham Dallas, a Georgia native, University Professor and 
Director, Institute for Disaster Management at the University 
of Georgia.
    Mr. Hice. Go Dogs, if I failed to mention that earlier.
    Mr. Lynch. Go Dogs. On the record, without objection, Go 
Dogs is entered into the record.
    Mr. Hice. Thank you very much. Thank you, sir.
    Mr. Lynch. All right. Now, it is the custom of the 
committee to ask the witnesses to rise and be sworn in. Please 
raise your right hand.
    [Witnesses sworn.]
    Mr. Lynch. Let the record show that the witnesses answered 
in the affirmative.
    Thank you. Please be seated.
    The microphones are sensitive so please speak directly into 
them. Without objection, your written statements will be made 
part of the record, and with that I welcome Dr. Boucher. You 
are now recognized for five minutes to give an oral 
presentation of your testimony.

  STATEMENT OF DR. HELEN BOUCHER, DIRECTOR, TUFTS CENTER FOR 
INTEGRATED MANAGEMENT OF ANTIMICROBIAL RESISTANCE, ON BEHALF OF 
                      TUFTS MEDICAL CENTER

    Dr. Boucher. Good afternoon Chairman Lynch, Ranking Member 
Hice, and distinguished members of the subcommittee. On behalf 
of the Infectious Diseases Society of America, or IDSA, thank 
you for holding today's hearing and inviting me to testify.
    I am an infectious disease physician at Tufts Medical 
Center in Boston, director of the Tufts CIMAR that was 
mentioned, and the treasurer of IDSA. I also have the privilege 
to serve on the Presidential Advisory Council for Combatting 
Antibiotic-Resistant Bacteria. My comments today are my own and 
delivered on behalf of IDSA, and do not reflect the views of 
the U.S. Government.
    As I am a clinician, I would like to start by telling you 
about two patients we recently treated. The first is a young 
lady with a history of injection drug use, who had two prior 
heart valve infections related to opioid use. Over the course 
of two to three years, she had two separate heart valve 
infections, the second of which was due to methicillin-
resistant S. aureus, or MRSA, and involved her tricuspid valve 
that had been previously surgically repaired. Her treatment was 
complicated by kidney failure due to an antibiotic called 
vancomycin and prolonged hospitalization. Her course was 
further complicated with a chest wound infection, also due to 
MRSA.
    We saw her again when she was 22 weeks pregnant, and the 
MRS infection had extended from chest bone into her chest. She 
had to have several surgeries and received another long course 
of antibiotic therapy while she was pregnant. She had several 
more hospitalizations, including some time spent in the ICU, 
but ultimately delivered a healthy full-term baby. Her problems 
have continued, however, and she may require yet another heart 
valve replacement.
    Sadly, hers is not an isolated case. We, and most other 
health care facilities in the United States care for a large 
number of patients with drug-resistant infections related to 
opioid use.
    The second patient is a middle-aged lady I took care of in 
the hospital recently. She had undergone chemotherapy for 
leukemia and was in remission, so there was no cancer in her 
body. We were called when she developed pneumonia and a 
bloodstream infection due to a Gram-negative bacteria that was 
resistant to every drug tested by our lab. When I sat down to 
deliver this news to her she said, ``How can this be? Surely 
you are going to find something to treat this.''
    We did succeed in doing a lot of fancy testing in the lab 
and getting help from the FDA and collaborating with a company 
to get an investigational drug called cefiderocol, and gave her 
a combination of antibiotics, but she ultimately died 10 days 
later. So this lady, in the prime of her life, who had overcome 
cancer, died from an antibiotic-resistant infection.
    It is also important to point out that with our best 
efforts and help from many people around the country, including 
here in Washington at FDA, it took four days to get the 
emergency use antibiotic to her, and it sort of emphasizes how 
important it is for us to have effective drugs in our hospital 
pharmacies, ready to use when our patients need them.
    These and many other experiences motivate me and my 
colleagues to fight for solutions to this crisis. As many as 
162,000 people in the United States lose their lives every year 
to multidrug-resistant infections. CDC also estimates that 
antibiotic-resistant infections result in $20 billion in excess 
health care costs annually, due, in large part, to longer 
hospital stays for patients in whom these infections are not 
easily treated.
    Antibiotic-resistant infections pose a significant threat 
to our national security, as was mentioned. Resistant pathogens 
complicate our soldiers' combat wounds, increasing the risk of 
limb loss and death, and compromise our military's combat 
readiness and effectiveness. Between 2004 and 2009, over 3,300 
American soldiers in Iraq and Afghanistan became severely ill 
from a single resistant Gram-negative pathogen called 
Acinetobacter, which has become even more resistant to 
treatment over time.
    Alarmingly, as was also mentioned, resistant pathogens are 
a prime candidate for weaponization. The former Soviet Union 
successfully weaponized multidrug-resistant strains of both 
plague and anthrax. Studies have concluded that the aerosolized 
release of a weaponized, resistant pathogen in just a single 
incident of bioterrorism in the Washington, DC. area would 
result in a death toll of over 3 million. Any mass casualty 
event is likely to result in severe wounds and burns, which can 
quickly become infected and further complicated by resistance.
    Antibiotic resistance also puts our health security at 
risk, both in the U.S. and around the world. An outbreak of a 
serious resistant infection with limited or no treatment 
options could overwhelm health systems, harm economies, and 
even destabilize communities and countries.
    Antibiotic resistance importantly threatens to undo decades 
of medical progress. Many lifesaving procedures, like cancer 
chemotherapy, organ and bone marrow transplants, and other 
complex surgeries are only possible with the support of 
effective and safe antibiotics.
    While bacteria develop resistance in nature, the use of 
antibiotics places selective pressure on bacteria, leading them 
to develop resistance even faster. Antibiotic use in animals, 
agricultural settings, and the environment also contribute to 
resistance. We must curtail inappropriate antibiotic use to 
limit the development of resistance. But even appropriate 
antibiotic use causes resistance, so we must develop a robust, 
renewable pipeline of new antibiotics to address our current 
and future threats.
    Unfortunately, our toolbox of antibiotics is shrinking. 
Nearly all large pharmaceutical companies have left the 
antibiotic development field. The small companies that remain 
responsible for most of the antibiotic innovation are 
struggling to stay in business. In April, one small company, 
Achaogen, filed for bankruptcy, despite having received Federal 
support to develop and launch an important new antibiotic. 
Others have recently announced massive layoffs.
    There are currently 42 antibiotics in development. Of 
these, only 16 have the potential to treat our worst 
infections, the Gram-negative infections, and most drugs in 
clinical development do not ultimately achieve FDA approval.
    Factors very unique to antibiotics make it extremely 
difficult for companies to earn a return on investment in 
antibiotic R&D. Antibiotics are taken for a limited duration of 
time, and new antibiotics must be used judiciously to preserve 
their effectiveness. Incentives are needed to make antibiotic 
R&D feasible for companies.
    Congress and the Federal Government have taken many 
important steps to address antibiotic resistance and spurring 
antibiotic R&D, and we are very appreciative. Current efforts 
must be maintained and new policies are needed. The problems 
are complex and will require multifaceted solutions that cut 
across multiple congressional committees.
    We encourage you to support the DISARM Act, which will soon 
be introduced in the House. This bill will help stabilize the 
antibiotic market for companies and investors by boosting 
Medicare reimbursement for important new antibiotics. It will 
also help curb resistance by requiring hospitals to implement 
stewardship programs and report antibiotic use and resistance 
data to CDC.
    While reimbursement reform would be an important step 
forward, it alone is highly unlikely to deliver the antibiotic 
pipeline we need. A new incentive not linked to sales volume, 
to provide a predictable return on investment, is necessary. We 
also call for increased investments in research and public 
health interventions to address resistance.
    Once again, please accept my deepest thanks on behalf of my 
colleagues at IDSA, and most of all, our patients, to the 
subcommittee for holding this hearing and for inviting us to 
participate. We look forward to continued collaboration to 
address the problem of antibiotic resistance.
    Mr. Lynch. Thank you.
    Dr. George, you are now recognized for five minutes.

STATEMENT OF ASHA GEORGE, EXECUTIVE DIRECTOR, BLUE RIBBON STUDY 
                      PANEL ON BIODEFENSE

    Ms. George. Thank you, Mr. Chairman, Ranking Member Hice, 
and to the congressional staff, thank you for inviting us here 
today to talk about these issues.
    I am the Executive Director for the Blue Ribbon Study Panel 
on Biodefense. In addition to having a doctorate in public 
health and having spent 30 years in the biodefense arena, I am 
also a Desert Storm veteran, and I bring that up really only 
because I know what it feels like to be operating in an arena 
under the specter of biological warfare. I know what it feels 
like to be wearing chemical protective overgarments and wonder 
if they are going to protect me from a biological agent. I know 
what it feels like to be taking a vaccine that just the week 
before got emergency use authorization for me to take. And I 
know what it feels like to be standing on a battlefield 
wondering if antimicrobial-resistant anthrax or some other 
biological agent have been loaded into a Scud missile and are 
coming my way.
    I mention all of this because I don't want anybody in this 
country, particularly in this country, geographically, to ever 
have to feel any of those things, and I know that you don't 
either.
    I will just add one other point here, and that is while we 
haven't had any other biological attacks since the anthrax 
events of 2001, we still have all these white powder events. I 
believe it was today that the DeKalb County Courthouse had to 
evacuate for what seemed to be a rather significant white 
powder event that turned out not to be anthrax, from what I 
understand. But just imagine how all those people felt. That is 
a highly busy courthouse. There are a lot of people in there, 
all affected at once.
    I have submitted my longer written statement for the 
record, but I just want to make a few points here.
    The Blue Ribbon Study Panel on Biodefense addresses the 
entire spectrum of biodefense, so we are looking at prevention 
and deterrents in terms of the State Department and the Defense 
Department and the intelligence community, and then we look at 
everything beyond that as well--preparedness, detection, 
response, attribution, recovery, and mitigation.
    And when you hear that list you think about what that must 
mean in terms of the government. This is a huge governmental 
set of activities. All of the Federal departments, eight of our 
independent agencies, and one independent institution, that we 
know about, all contribute to biodefense. That makes 
jurisdiction and oversight here in the House and in the Senate, 
obviously, extremely difficult and challenging. But I think 
that it points very directly to this particular committee and 
the need to exert oversight from here, because you have the 
entire picture, and look at the entire government.
    We issued a report in 2015 called the Blueprint for 
Biodefense. In it we have 33 recommendations and 87 action 
items. And we assessed the state of biodefense here in the 
country looking at strengths and weaknesses and 
vulnerabilities. And the Nation remains vulnerable to this day. 
In short, the Nation is not prepared for biological outbreaks, 
acts of bioterrorism, biological warfare, or accidental 
releases, with catastrophic consequences, and I think that is 
where the national security issue comes into play, not to say 
that the onesy-twosy events are not worthy of our concern, but 
we are talking about catastrophic events that would affect the 
effective functioning of our entire society.
    The National Biodefense Strategy that was mentioned earlier 
is actually one of our recommendations from our blueprint, as 
was this Coordination Council, although you wanted to see both 
of those activities run out of the White House. When you have 
so many governmental agencies involved we believe you need 
somebody above them all to run them all.
    The strategy has come out, as you said, Mr. Chairman, but 
the implementation plan for that strategy is still pretty thin. 
The Department of Health and Human Services has been charged 
with working on that implementation plan, but they face the 
challenge of trying to get information out of all the other 
departments and agencies to inform that plan. I hope it doesn't 
take as long to produce that as it did to produce the 
implementation plan for the National Strategy for Pandemic 
Influenza. President Jimmy Carter issued that requirement to 
the Department of Health, Education, and Welfare for the 
strategy and the implementation plan, yet it was only released 
by President George W. Bush, however many decades later, and 
pulled away from the Department of Health and Human Services.
    Just quickly about antimicrobial resistance. The panel is 
very concerned about antimicrobial resistance. AMR would 
exacerbate all the types of threats that I mentioned earlier. 
Our national policy, which seems to focus quite a bit on 
hospitals and health care, looks at these individuals, these 
patients, and then says we have to get them out of the hospital 
as soon as we can, because we are trying to reduce their 
exposure to these resistant organisms within these hospitals.
    I would leave it to my colleagues to discuss how effective 
that actually is, but it is not a national security policy. It 
is not good national policy. If we were to be attacked or 
experience a naturally occurring disease that has become 
resistant, that affects a large population or populations here 
in the United States, we would have no place to discharge them 
to. There would be no place for them to go.
    So thank you very much for your time and letting me go over 
a minute, Mr. Chairman. I appreciate the opportunity.
    Mr. Lynch. Thank you very much, Doctor, and thank you for 
your service.
    Ms. George. Thank you.
    Mr. Lynch. Next up, Mr. Currie, you are now recognized for 
five minutes.

  STATEMENT OF CHRIS CURRIE, DIRECTOR, EMERGENCY MANAGEMENT, 
  DISASTER RECOVERY, AND DHS MANAGEMENT ISSUES, ON BEHALF OF 
          HOMELAND SECURITY AND JUSTICE TEAM, U.S. GAO

    Mr. Currie. Thank you, Chairman Lynch, Ranking Member Hice. 
It is an honor to be here today to talk about GAO's past work 
on biodefense. A lot of what I was going to talk about has been 
said, so I will try to alter this a little bit.
    Biodefense is a very unique threat, and biothreats are very 
unique in this country. We look at lots of different threats 
across the government at GAO. And I think unlike cyber threats 
and mass shootings and things that are in our face every day, 
it is very difficult because the perception is that these are 
low-likelihood events, and thus, it makes it very difficult to 
maintain focus and maintain resources on these types of events. 
But clearly it doesn't mean that these are not serious threats 
and very scary threats.
    The other challenge, that Dr. George mentioned, is 
fragmentation across the Federal Government and across all 
levels of government, and the private sector. We have 
identified, for almost a decade now, that fragmentation across 
large and small departments--DHS, USDA, Department of Defense--
I think we said before there are almost two dozen 
Presidentially appointed officials that have some sort of 
responsibility for biodefense. They make this very, very 
difficult to tackle, because departments cannot tell other 
departments what to do, and they can't tell them how to spend 
their money. They also can't tell them how much money to 
request. This also cuts across congressional committees of 
jurisdiction too. It just makes it a very big challenge.
    Because of this, for almost a decade, we have recommended 
that the Federal Government needs a large, overarching national 
strategy and focal point to address this issue, similar to what 
we have done in other areas, like cybersecurity.
    In addition to the strategy itself, at the high level, we 
have also done work at GAO on a number of more specific 
biodefense-related programs across the government, and I would 
like to talk about just a few of those things.
    In the area of biodetection, as was mentioned in the 
opening statement, we have done work looking at Department of 
Homeland Security's BioWatch program. This is the only system 
we have in this country that has a goal of detecting a 
biothreat that is released into the air. But frankly, the 
system has struggled since the very beginning to do what it was 
intended to do. It has never done what it was intended to do 
and never worked as well as we have wanted it to work.
    So we have made a number of recommendations over the years 
to try to address these issues, ultimately leading to the 
cancellation of this program in different ways. It is currently 
still in use but is going to be phased out by DHS, but the 
replacement situation is very uncertain and very unclear at 
this point, in terms of biodetection.
    In the area of situational awareness, which is extremely 
important, which is basically how do we know what threat we are 
facing, how quickly, and who knows it, DHS and HHS have both 
struggled. On the DHS side, we have found that the National 
Biosurveillance Integration Center has struggled to get the 
data it needs and the information it needs, frankly, to be 
useful to its partners. We heard from the people that use it 
that it doesn't provide new and useful information.
    And on the HHS side, it has been almost 13 years since 
there has been a requirement for a public health situational 
awareness network. That still has not been implemented. We have 
done work on it three or four different times in that 13 years, 
and recommended ways to try to implement that program. Most 
recently, in the recently passed legislation, required, set a 
deadline for its implementation again and required that HHS 
implement our recommendation. So HHS has just continued to 
struggle to implement that situational awareness program.
    Laboratory safety and security, another huge issue that we 
and many others have identified problems with. This is an area 
that we have identified problems across the biodefense 
enterprise with all of these departments. We looked at almost 
every department that oversees or has laboratories and we found 
widespread challenges in their policies and oversight. Some 
policies were out of date. Some suspicious incidents were not 
even being reported. So we made over 33 recommendations at that 
time, which is a huge number, across departments. Twenty-one 
are still open. So some departments have made progress; others 
are still lagging behind.
    I would also like to talk about what Dr. George mentioned, 
about the catastrophic incidents, and I will throw in there 
situations like Zika in 2016 and Ebola in 2014. What we see in 
these situations, and even those were not as severe as the ones 
we are really worried about, is it is not clear who is in 
charge when these situations happen, and it also not clear 
where the funding comes from.
    We have done some work in the past looking at development 
of a response fund. This would be similar to what FEMA has, for 
example, to handle disasters when they occur. I think people 
vary on their views of this issue, but some people thought 
there needed to be some sort of fund, so we deal with these 
issues when they come up, and we know exactly who is in charge 
of these situations, so we don't have to wait months for 
supplemental appropriations and things like that.
    So those are just a few of the issues. I have many more 
things to talk about but thank you for the invitation.
    Mr. Lynch. Thank you.
    Dr. Cham Dallas, you are now up for five minutes.

 STATEMENT OF CHAM DALLAS, UNIVERSITY PROFESSOR AND DIRECTOR, 
 INSTITUTE FOR DISASTER MANAGEMENT, ON BEHALF OF UNIVERSITY OF 
                            MICHIGAN

    Mr. Dallas. The potential for biological attacks and other 
naturally occurring pandemics is real, and of substantial 
national impact, and I applaud this subcommittee for addressing 
this issue, and thank you for inviting me here today.
    It seems appropriate for my testimony to address the area 
of biodefense preparedness at the local level, where an 
appreciation of the likely in-the-field response can be 
discussed.
    Over the last 20 years, the University of Georgia and the 
Medical College of Georgia--I am a professor in public health 
in the first and a professor of emergency medicine in the 
second--we have been active in research and training in 
biodefense emergency preparedness and response. As a result, we 
have had the unique experience of helping and evaluating over 
700 institutional stakeholders within the state of Georgia in 
their relative ability to respond to a biodefense challenge at 
the grassroots level.
    So this program in biodefense was ongoing at the turn of 
the century, and we got a CDC Center for Public Health 
Preparedness at UGA, and now is the Institute for Disaster 
Management that I direct.
    The last 13 years, this institute has had--we have led the 
planning, organization, and conduct of tabletop and full-scale 
exercises for virtually all the hospitals, 140 of them, and 
then, just as important, or maybe more important, the hundreds 
of additional supporting institutions--the nursing homes, law 
enforcement, public health departments.
    And so, how are we doing? One of the most important 
developments in this process, we have seen in Georgia, and is 
mimicked elsewhere in the country, is the development of health 
care coalitions to better coordinate biodefense response, 
between so many disparate institutions. It was very hospital-
based for so long and now we are getting all these support 
institutions involved. That has been a success story.
    And this was initially started in New York, quite frankly, 
and the success they have had there has been now duplicated in 
Georgia, and we hope elsewhere.
    For instance, there have been many epiphanies where we get 
these organizations, and for the first time they divulge their 
plans to each other. You have got to realize these people are 
in competition with each other, in most cases, and all of a 
sudden we discover they are depending on the same resources, 
and they are going to be fighting over them if these events 
ever occurred. And so we hopefully helped them work this out in 
advance.
    Starting in 2015, the Ebola crisis occurred, and Georgia 
received a lot of these patients from West Africa. And so we 
had to ramp up pretty quick, and we quickly realized, in our 
initial evaluations, that the 17 service providers, who 
volunteered to provide these services, were not ready. It is a 
pattern that expect would happen nationwide. It is just that we 
experienced it because we had these patients coming in.
    These EMTs and docs are very bold and they are willing to 
go in, but you have got to train them right. For instance, we 
just had a tabletop last week, at the Institute in Athens, 
where we had all the people from all around the state that 
would be the actual people that would respond. And there has 
been progress in that. It just shows that training can work.
    Now one of the most vulnerable populations in these 
anticipated biodefense scenarios we have found is increasing 
elderly populations, especially the ones in institutions, in 
nursing homes and assisted living facilities. There are 
thousands of them in Georgia alone. The vulnerabilities that 
have been seen in natural disasters, for vulnerable 
populations, very highly publicized in the recent hurricanes, 
as severe as they are, we can expect those to be exacerbated 
further, much further, when considering biodefense issues, and 
particularly with agents that are coming in that are 
microbially resistant.
    Now the current system is not robust in dealing with the 
background. If you have ever been to these institutions they 
have background problems with isolating infectious disease 
people. And then there is evacuation. The evacuation is a 
nightmare. We have designed evacuation plans for many of these 
facilities. Nationwide it is a big problem. In fact, in most 
cases they are just going to shelter in place, because of the 
complications in trying to get them out of there.
    We have researched new approaches. We have gone into the 
back of these ambulances and tried to ramp them up. A success 
story there is Georgia EMS, they were going to take three hours 
to transport a patient. Now we can do it in 30 minutes. That is 
a standard that should be expected nationwide. If we can do it 
in Georgia, certainly we can do it elsewhere.
    Now I will tell you, if you look at a top-flight problem, 
and that is going to be--and we are looking at it now, is the 
backup power for these long-term care facilities. There are 
some real nightmare stories with that. Efforts are greatly 
needed now to prioritize and close those gaps in power backup 
capabilities. They have been talking about it a long time and 
it hasn't happened. I will just tell you, I am really worried 
about that one.
    We have reviewed hundreds of after-action reports 
throughout the state, and we keep those at the Institute. Two 
common themes emerge--the need for additional research and 
training and incident command--Who is in charge? How are 
commands given out?--and the need for additional research in 
communication methodologies.
    I will close with just a couple of examples. For instance, 
emergency codes are coming out of all of these hospitals. We 
found, throughout the system, they don't know what they mean. 
They have no idea. It is unbelievable but they don't. And we 
have some plans to get off this color-code system and let's 
make the visitors and patients responders, instead of panicked 
people.
    And then I will close with the mortality issue. We wrote 
the mass fatality plan for the state. I tell you, these rural 
hospitals, for them, a morgue is a little room with an air 
conditioner, a window unit. A lot of these facilities only have 
maybe a couple of weeks of money on hand. They will collapse 
under this pressure. And I might point out that they are also 
the ones that are already hard hit. This will fall hardest on 
the vulnerable populations.
    So we have come a long way, and there is little doubt that 
with the increasing biological threat matrix we have a long, 
and I think difficult, work ahead of us.
    Thank you.
    Mr. Lynch. Thank you very much.
    I will now turn to questions and I yield myself five 
minutes for questions.
    So I think because of the anthrax attacks on September 
11th, I think our response was to that type of event, where 
terrorists or maligned actors might try to inject something 
like that into the population, but more recently--and I don't 
know, over time that has become sort of a low--there has been a 
probability bias that works against us focusing on that 
problem, because nothing has happened since 2001.
    The more recent manifestations, though, are, you know, this 
antimicrobial resistance that we have seen in some of the 
hospitals. Dr. Boucher, I think you mentioned that in your 
remarks.
    So there have been a number of assessments in terms of--the 
New York Times did a very, very good piece on that. It made my 
skin crawl--and we had a report from the Secretary-General of 
the United Nations that estimated that drug-resistant diseases 
cause at least 700,000 deaths worldwide each year, and the 
report noted that that figure, and I quote, ``could increase to 
10 million deaths per year by 2050.'' And all the reports say 
that the figures that they are putting out are very 
conservative assumptions.
    What is your assessment of the threat here? You know, we 
have heard about our preparedness, which is severely lacking, 
but in terms of trying to quantify the magnitude of the threat 
here, what are your thoughts?
    Dr. Boucher. Thank you very much, Mr. Chairman. I think the 
main message is that the crisis is here, so antibiotic 
resistance is real, it is at all of our hospitals, it is in the 
community, and it is no longer if it comes. It is here. So 
those patients I told you about, there are more, and all my 
colleagues across the country are treating patients like this, 
and we are having the sad duty to have to send people to 
hospice because we have infections we can't treat. This is 
happening all across the country.
    Mr. Lynch. Yes.
    Dr. Boucher. So I think that is one thing.
    In terms of our response, through at least, you know, my 
involvement with our society for the past 15 years and the 
Presidential Council now for the past five years, there 
certainly are efforts with the National Action Plan for 
Combating Antibiotic-Resistant Bacteria to coordinate the 
efforts across the U.S. Government, and I think there has been 
some progress. We certainly still have a ways to go, and, you 
know, the National Action Plan set out targets for what would 
happen by the year 2024, how resistance would decrease, how 
antibiotic overuse would decrease, you know, a number of hard 
targets, which we have not met.
    We have a meeting coming up in July and we will have 
another report released, sort of looking ahead to the next five 
years as to what are the big needs, and I think that we still 
have some really big needs. Probably the biggest need, if we 
had to pick one, would be to make stewardship programs for 
antibiotics a condition of participation for CMS, to finalize 
that rule. So that rule is under consideration. I think a week 
or so ago it was sort of continued for another year, but we are 
very, very hopeful that that will be finalized. The Joint 
Commission has mandated that, so all Joint Commission hospitals 
have to have stewardship programs, and we have seen great 
increase across the country in the presence of stewardship 
programs, and it is making a difference. We need to see more.
    We also have stewardship needs in the outpatient arena and 
CMS has a condition of participation for long-term care 
facilities, which are real breeding grounds for antibiotic 
resistance.
    So those a couple of high-level thoughts, in terms of where 
we are.
    Mr. Lynch. Well, let me ask you about the pipeline for 
antibiotics, because that has to be part of the answer here, 
right? You mentioned how even the 42 or 46 that are in the 
development now, a very small number of those might address our 
needs. How do we incentivize that? How do we, on our end, 
incentivize the research and development that needs to happen?
    Dr. Boucher. Great question. So it is true that the 
antibiotic pipeline is thin, and we have been making efforts 
for the last at least 10 years to work on, you know, 
resurrecting it a little bit. And while we had a little bit of 
good news and a few more antibiotics approved recently, we have 
this sort of terrible situation where the market really seems 
to be broken, and the bankruptcy of a company. So we are 
finding that the return on investment for antibiotics is just 
not what it needs to be, and some of the reasons are that 
antibiotics are given for short periods of time, we hold them--
people like me hold them as much as possible to be used only 
when we need them for the worst infections, and, you know, the 
societal sort of standards are that the cost is just not that 
high.
    So we, unfortunately, have come to the point where this 
company who developed an antibiotic that we really needed 
couldn't even afford to continue to manufacture it so we could 
have it on the shelf in our pharmacy for the time we need it. 
So that gets to incentives.
    We sort of break down incentives into two groups. Push 
incentives are those that happen before the drug is FDA 
approved, and we have a good example, I think, in CARB-X, which 
is a public-private partnership between BARDA and several other 
global partners, including the Wellcome Trust and some other 
academic and government groups. They have successfully funded a 
number that at the end of this year it will be over 60 
different medicines and diagnostics for antibiotic-resistant 
infections, and that is really great and that is helping that 
early phase.
    The other sort of part of the story are so-called pull 
incentives, which cover the time after a drug is approved by 
the FDA, and that is the area where we are seeing this big 
problem now, with the bankruptcy and maybe some more. And so 
there is where the DISARM Act comes in, and that is one idea of 
a pull incentive to carve out the cost of the new antibiotic 
from the diagnosis-related group, the kind of bundled payment 
that we get in the hospital, and could be a kind of short-term, 
small step in the right direction.
    Very importantly, that incentive is tied directly to 
antibiotic stewardship, so it has to be used in hospitals that 
have antibiotic stewardship programs, and takes it one step 
further, to actually requiring reporting on use of antibiotics 
back to the CDC, so that we will know that these drugs that are 
incentivized are used in the best way possible.
    Mr. Lynch. Yes.
    Dr. Boucher. We know that more is going to be needed in the 
pull side, and so the concept of delinkage, that is taking the 
return on investment away from the volume of sales, this 
concept has really gained traction in ideas like a market entry 
reward that might be awarded to the maker of a drug that 
targets a really great unmet need at the time of licensing and 
guarantees a certain amount of return on investment over a 
period of, say, five years, again, tied to good stewardship and 
appropriate use, could be enough to kind of help get this----
    Mr. Lynch. Yes, prime the pump.
    Dr. Boucher [continuing]. yes, get us back into a 
functional situation.
    Mr. Lynch. Yes. Okay. Thank you very much.
    I now yield five minutes to the ranking member for 
questions.
    Mr. Hice. Thank you very much, Mr. Chairman.
    Dr. Dallas, the biodefense preparedness, and then the 
defense management. How is that best coordinated on a local or 
state level?
    Mr. Dallas. The best thing for them to respond--and first, 
we have made a lot of progress. Exercises help a great deal. 
The one gap--I like to go back to gaps, how we improve 
further--is getting the physicians to come. It is hard to get 
them. They are busy. To get them involved in the exercise is a 
key factor for us. I think the key to that is through the CEOs 
of the hospitals. They can tell them what to do, and if they 
did, that would help a great deal.
    Like I said before, the infrastructure support--I didn't 
even mention it but these things that make everything worse--
the cyber vulnerability of the health care system is stunning. 
Just there in our local vicinity there, in your district, there 
have been a bunch of ransomware attacks that have taken down 
these health care institutions for millions of dollars. And all 
of this robs the infrastructure. So I would say bolstering the 
public health infrastructure is the answer to this, so that 
when it occurs--and I agree with my colleagues here that this 
is coming--we were talking about it before. When you say 
something is a low-likelihood event, it is not a straight line 
that we are talking about. It is low likelihood and then all of 
a sudden you are logarithmic and you are shooting up.
    Mr. Hice. Yes. When it happens you have got to be prepared 
at that point.
    Mr. Dallas. You have got to be ready.
    Mr. Hice. And you mentioned the health care coalitions. I 
am curious about that in reference to what you are talking 
about now, with the exercises, assuming that means not just the 
hospitals and doctors but the entire health care coalition that 
you are talking about, which would include enforcement and a 
host of others involved. Is that----
    Mr. Dallas. That is right, like volunteer groups, and how 
to mobilize people. They can't show up at the time and help. We 
have to train the people. Medical Reserve Corps units. There 
are all sorts of ways, but it has got to be the community 
working together.
    New York showed us the way on this, and it was really 
phenomenal, because it is a false multiplier of all your 
resources there, working together. We have seen--I saw it in 
Georgia, just in the last 10 years, it really explodes the 
capabilities, but in the end if we don't have the drugs, if we 
don't have the new antibiotics--I will add to the testimony 
that was just said, drug development is pretty big at the 
University of Georgia, and yet we are now telling the students 
coming up that the odds of you running a drug all the way 
through the system is 10 percent. And so these youngsters--they 
all look young to me now--are coming up and they are going, ``I 
am never going to run a drug through?'' And so there is just a 
lot of disincentivization with that, and that is a major issue.
    So on the pharmaceutical end we have got to fix it. On the 
health care coalition we have got to continue to build it, 
particularly the weak links, like the nursing homes and 
assisted living facilities and the power backup.
    Mr. Hice. And in addition to that I would think there would 
have to be partnership between Federal, state, and local. I 
mean, this is everyone working together.
    Mr. Dallas. Yes. Like we say, all disasters are local, and 
we sure appreciate the Federal Government's support, because 
the resources are massive and awesome and really impressive, 
although some of them, like you were describing, haven't been 
very efficient. But when it comes to being on the local level, 
it is all local, and we have to depend that they can meet these 
demands at the local level.
    Mr. Hice. All right. Mr. Currie, let me ask you real 
quickly, I am sure all of you are aware that DHS has determined 
that fentanyl poses a significant material threat to our 
security. Do you agree with that assessment, by the way?
    Mr. Currie. Yes, sir.
    Mr. Hice. All of you, I am assuming, would agree with that?
    So can something like fentanyl be used as a broader mass 
attack on the U.S.?
    Mr. Currie. Sir, I think--I am not sure I would be 
comfortable answering that in a public setting. We are not 
actually doing any work on that specifically, but the issue of 
fentanyl as a drug and some of the drug concerns versus its use 
as a weapon of mass destruction, those are kind of two separate 
issues and the latter gets into classified information pretty 
quickly.
    Mr. Hice. Okay. I totally respect that.
    And my last question for now, Dr. George, you mentioned the 
blueprint, with 33 recommendations. Who has received those 33 
recommendations, and ultimately, who is responsible to 
implement them?
    Ms. George. So we had distributed the report throughout 
Congress. We issued it in 2015, though, so it has been a while. 
We wrote recommendations for various Federal entities, for the 
Administration, meaning the White House specifically, and for 
Congress to execute. So it depends on the recommendation.
    But, you know, sir, it depends on what the topic is too. I 
don't think we should be leaving it to just one entity all by 
themselves. If the White House is not going to pick up on 
something, Congress certainly should. If Congress is not going 
to pick up on something, then the rest of the Federal 
Government can. You know, it is one of the beautiful things 
about our government. So that would be my----
    Mr. Hice. That is one of the messy things about our 
government. Like you said, Mr. Currie, we have got like 12 
different overlapping--nobody knows who is in charge, and it 
seems like this is something that needs to be addressed.
    Thank you, Mr. Chairman. I yield back.
    Mr. Lynch. Okay. Let me stay with you, Dr. George. I know 
that most nations, or most all have signed this, you know, 
Biological Weapons Convention, basically a treaty not to 
purchase these agents. However, it is a different story with 
some of these non-state actors. And the technology has really 
come down in terms of the cost of acquiring or developing 
yourself.
    What level of risk do you think that our military face, 
say, you know, we have got folks in Syria, we have got folks in 
Afghanistan, Iraq. What is the level of risk that you think is 
presented, for them to face what you faced in uniform?
    Ms. George. Yes, sir. I, of course, think it depends on the 
geographic area that they are located in, but I think that they 
are at great risk. I think these countries, and our troops, and 
everybody else's troops, are at enormous risk. When you look at 
Syria, for example, Syria had a vibrant biological weapons 
program. North Korea is suspected of engaging in biological 
weapons development as well. And al Qaeda, ISIL, and other 
terrorist organizations have been very vocal about their desire 
to obtain or produce and use biological weapons, and they are 
not talking about doing that, you know, out in the country 
somewhere where nobody is. You have to take their desires to 
use biological weapons and look at who they are fighting at the 
same time. That puts those populations at risk and it puts our 
troops at risk as well.
    Mr. Lynch. Let me ask, Mr. Currie, and also Dr. Dallas. So 
the response in its initial phase will be local, so that means 
my local community health center in my neighborhood, and in a 
lot rural communities it is probably a local community health 
center. It is our docs and nurses, EMS, first responders--that 
is the front line of the program we have right now.
    So how do we engineer our response so that we push out some 
of the countermeasures to that population, to our first 
responders, to our local health centers, to the people that are 
going to have to respond to this in the first instance?
    Mr. Currie. Well, I think one thing I would like to say, 
this is where I think health situational awareness becomes so 
important. So you are right, the nurses and docs are the ones 
that are going to see the information the fastest and right 
away, but at the Federal level this is why these information 
networks that DHS and HHS have been developing are so critical, 
because the idea is that we need to have them tied into all the 
state and local information, to get that information as quick 
as possible, not just to diagnose it and understand what is 
going on but then quickly communicate to everybody at all those 
levels that need to come in and help surge and respond. 
Otherwise it is going to remain localized for a long period of 
time before the word trickles up to whoever it needs to trickle 
up to, and then trickles down very slowly. And that is our 
concern about the lack of progress on these situational 
awareness networks.
    Mr. Lynch. So Dr. Boucher, you are at Tufts, and, you know, 
we have an event like this, and, you know, as Dr. Dallas points 
out and Mr. Currie, the initial impact is really on the street 
level. How well are we equipped to connect what you are doing 
and the resources that you have? Are there exercises that go on 
here that we coordinate, you know, the local community health 
center with, you know, Tufts or, you know, your research arm, 
and, you know, the labs that are working on this?
    Dr. Boucher. Well, I guess I can speak to what happens at 
the hospital. So we certainly have exercises that are ongoing 
and we work with the city and state Department of Public 
Health, which are tied into CDC. So I think we learned a lot 
from the Ebola experience, and it wasn't smooth when it 
started, but certainly I think that we have these tabletop 
exercises regularly and there is participation with community 
partners as well as a hospital like ours. You know, we are 
quaternary referral center, but we also communicate across 
town. And you know we have lots of different players in the 
medical world. But the state and local health departments 
really are the center and do a great job. And so both in sort 
of this really kind of dreaded disaster preparedness but also 
in things like the opioid epidemic, you know, we are working 
together in that way too.
    So I think that is the vision from our CDC colleagues, is 
that it works local, state, health departments up to CDC and 
back, at least for surveillance and initial response in that 
regard.
    Mr. Lynch. Can you comment on that? I mean, in your initial 
testimony, I meant to go back to that, where you talked about, 
you know, opioid use contributes to this vulnerability of 
antimicrobial resistance. What is the connection there? I 
missed that.
    Dr. Boucher. Okay. So people who inject opioids get 
infections because they are injecting through their skin. Even 
if their skin was clean they would have an increased risk of 
infection. And we know that patients who use opioids have a 16-
times-higher risk of having an MRSA infection, which is a 
resistant kind of bacterial infection.
    And so what we are seeing are patients like this, 
unfortunately----
    Mr. Lynch. Is that shared needles? Is that----
    Dr. Boucher. It is not even. I mean, it could be. It could 
be worse with shared needles, but just injecting. Every time 
you inject in your skin----
    Mr. Lynch. Okay.
    Dr. Boucher [continuing]. even if it is sterile there is 
still a risk. Skin is our most important barrier to infection. 
So these people are injecting over and over again, usually not 
in such a sterile way. But we know from good studies that these 
patients have a 16fold higher risk of MRSA, and that is just 
one kind of resistant bacteria.
    But our hospitals are full of these patients, and treating 
them is incredibly difficult. It is heart-wrenching. These are 
young, otherwise healthy people, and you are talking about 
doing a heart valve replacement and another one and another 
one. It is incredible, the burden of that morbidity and 
mortality that we see. And so our society now has a whole group 
dedicated to infections in people who inject drugs, because it 
is such a big problem. It is almost a little bit like at the 
beginning of the AIDS epidemic, in terms of what we are seeing, 
and the burden of it, the stigma of it, and the challenges, the 
sort of multidisciplinary challenges in treating it.
    Mr. Lynch. Great. All right. I want to yield to the 
gentleman from Georgia for five minutes.
    Mr. Hice. Thank you, Mr. Chairman.
    Dr. George, I know that the Blue Ribbon Panel has had some 
meetings and has published some stuff involving the private 
sector being involved in the preparedness efforts, and what Dr. 
Dallas was talking about. Just comment a little bit of how the 
partnership works between the private sector and government.
    Ms. George. So it depends, of course, on the topic, I 
guess, and I know I keep saying that.
    Mr. Hice. Just an example.
    Ms. George. Well, I think when it comes to pharmaceutical 
development, for example, the Federal Government has identified 
various threats, various biological threats that we would need 
antibiotics and other antimicrobials to address, and they need 
to fund those things that we don't have a market for. So that 
would be on the one hand.
    On the other hand, the U.S. Government is not in the 
business of producing antimicrobials by itself, so it has to 
work with the private sector, and together they have to produce 
what is needed for the country.
    Mr. Hice. Okay. So in that scenario you are talking private 
sector would be the corporate business sector.
    Ms. George. Mm-hmm.
    Mr. Hice. Okay. Coming back, Dr. Dallas, to you, the 
National Biodefense Structure that the President has come out 
with, do you see a pathway in that for better collaboration 
between the Federal Government, Federal agencies and state and 
local?
    Mr. Dallas. Yes, like what was said earlier, it was a good 
start and it was a long time coming, but it is a good start and 
I am encouraged by it, frankly. We have got to do something to 
bolster the private sector's incentivizations. For instance, 
vaccine development is a perfect example. We have almost chased 
the vaccine development out of the country, even when we 
provide incentivizations to these companies. Do you know what 
is their main objection? It is lawsuits. They say, ``Look, we 
can make Tylenol or some other agent and make lots of money. 
The liability here is too high.'' And we say, ``We will protect 
you,'' and they say, ``I don't believe you.'' And they have 
just withdrawn, even when offered what they say is legal 
protections.
    Yes, I am encouraged by it. I would like to see it move 
forward. Like was said in other testimonies here, there are 
often some real latent periods. Some of them go on a long time 
before we see a response. But yes, I am encouraged by it. I 
would really like to see us incentivize these companies to move 
forward, and I mean right away.
    Mr. Hice. Good suggestion.
    All right. I want to come back to earlier you mentioned one 
of the things--you didn't phrase it this way--that keeps you up 
at night is the vulnerabilities that we have, in particular 
with the elderly senior community.
    All right. So we have got all these facilities out here. We 
have got hundreds of thousands, millions of seniors living in 
them, and private homes, a host of different places. What is 
needed to bring these facilities up to standard? I mean, it 
sounds like an enormous task.
    Mr. Dallas. It helps that most of these facilities have 
isolation capabilities now, okay. It is just that they are 
operating on the edge. They are operating in a margin, and they 
don't have the incentives either to further develop these 
isolation capabilities. So we ought to take the isolation 
capabilities we have now and exercise them. Otherwise, what we 
will end up doing is if they get to the hospital, they will get 
care, and if they don't, they won't get care. And that is 
really dangerous.
    Mr. Hice. Okay. For my help, all right, what are we talking 
about, isolation capabilities?
    Mr. Dallas. Well, that usually means--they are laughing 
over here with me--that usually means we have a little room we 
stick them all in.
    Mr. Hice. All right. That is what I had pictured in my 
mind.
    Mr. Dallas. And we a $10-an-hour person that has no 
training that is expected to keep them from infecting the other 
people, and they don't succeed, and then it spreads, and then 
we can't move them, because if we move them we will then 
contamination the bus driver and who knows who else, the 
personnel.
    So, yes, it is to take that simplistic, very basic, almost 
19th century--I shouldn't have said that--system that we have 
and advance it. Let's bring it up to 21st century.
    Mr. Hice. Yes, I mean, and that has got to be an enormous 
thing. I think a little room as well. If you got an entire 
facility, a senior citizen facility where you have got 
something spreading, they are not all going to fit in one room. 
I mean, this is yet another disaster waiting to happen.
    Mr. Dallas. And the rural areas are where the real issues 
are, because they are on the edge. These are the vulnerable 
people. They are already on the edge, I mean, frankly, on the 
edge of health care access. And, boy, when this comes it is 
going to hit them the hardest, because they are on the edge. 
And then, like Mr. Currie was just saying, you know, we are the 
front-line people and we can't really tell what is going on. We 
have got to have a central organizing people to say, ``Look, 
there is the problem,'' and then they come back and tell us 
what to do.
    But I am telling you, these nursing home and assisted 
living facilities, particularly the ones that are on the edge 
now, there is where things are going to explode out of there.
    Mr. Hice. Well, we would appreciate if you would fix that 
problem real quickly. Thank you, Mr. Chairman.
    Mr. Dallas. We will do our best.
    Mr. Hice. All right.
    Mr. Lynch. I mean, that goes back to my question regarding 
the community health centers, because I know a lot of rural 
communities love their community health centers, but I am not 
sure that anybody on the ground within that health center is 
thinking about this problem, and I am not sure we have 
incentivized them to, you know, do that.
    Mr. Dallas. We have a lot of highly motivated people in 
public health departments, and people forget about them. And 
they are really motivated. They are just do-gooders par 
excellence.
    Mr. Lynch. Yes.
    Mr. Dallas. But they don't have the knowledge. Somebody at 
the central level has got to shoot information back to them and 
say, ``You have got to watch. You have got to isolate, or you 
have got to move them out.'' They have got to be told, and then 
somebody better get down there to help them, and we are going 
to have to force them to have evacuation plans, and then back 
them up.
    Mr. Lynch. Yes. Actually, you know, so we had a suicide 
cluster in my neighborhood, my local neighborhood. We lost 14 
young boys over about 18 months. And it was my local health 
center, it was the Massachusetts Department of Public Health, 
and then we reached out to CDC in Atlanta. So it was that whole 
network, sort of what you are describing, for a different type 
of problem, but it was very much a scramble until we got the 
right people in place and had an opportunity to address it.
    I want to ask each of you--so you each have got about a 
minute and 15 seconds--what else do you think is important for 
the ranking member and I to know, and members of the committee 
to know? What else do you think is very important for us to 
understand? And, I mean, we have your written statements so I 
know you have got your top five ideas, but what else is out 
there that you think is lacking that we might need to address, 
or something that might not have percolated up in our 
discussion already today?
    Dr. Boucher.
    Dr. Boucher. Thank you very much. I will comment on a 
couple of things quickly. We didn't really hit that much on 
diagnostics, but an area where we really are on the edge, I 
think, of making some big advances are on diagnostic tests. So 
that is the ability to know if a patient has a virus or a 
bacteria causing their infection, or if it is a bacteria, which 
bacteria? If we knew that we could impact this problem of 
resistance, we believe, in a really meaningful way.
    And so there are efforts going on in that public-private 
partnership I mentioned. It is funding some diagnostic 
companies. But there is still work to do on the path to 
approval and marketing and using them in our hospitals.
    Another area that I don't think we probably highlighted 
enough was the One Health approach. So we understand that the 
problem of antibiotic resistance really flows between humans, 
animals, and the environment, and we, in the United States, 
have made some good progress with our food animals, with the 
Veterinary Feed Directive that was passed sort of banning the 
use of antibiotics as growth promoters in food animals, but 
this problem, on a global scale is huge.
    The amount of people in the world who are going to be 
eating meat is going up and up and up, and we know that a lot 
of resistance comes from the developing world to us, so this 
interrelationship is very important in the way we address this 
problem, and this is something that we are focused on in our 
center, in terms of research.
    We are studying things like passing a resistance from your 
pet dog or cat to the family, and back and forth, and there are 
a number of issues here as well as in the environment. So I 
think we want to highlight that.
    And then the last thing I will mention is the work force. 
We need a robust work force to solve this problem. We need 
doctors, of course, which is my bias, but also we need nurses 
and pharmacists and others. So we at IDSA, and others are 
highly engaged in things that will help us recruit and retain 
the best and the brightest in this field and ensure that they 
are remunerated adequately to stay in the field.
    So thank you.
    Mr. Lynch. Excellent. Dr. George?
    Ms. George. Sir, I would just mention two things in 
particular. We talked about information flow earlier. I think 
it is important for you to realize that there is an 
intelligence issue here as well. The intelligence community has 
not dedicated a whole lot of resources to this particular 
threat since we shut down our own offensive biological weapons 
program back in the 1970's. They have to step up.
    But we are talking about diseases and activities that are 
occurring on the nonclassified side as well, so that 
information intelligence fusion has to happen and then 
information has to go up and down, so that it is usable by 
state and local folks.
    I would also mention that it is important for you to know, 
if you didn't already, that the public is actually very 
concerned about the biological threat. One of the reasons is 
almost everybody has had some issue with antimicrobial 
resistance, of course, but many know people who have received 
white powder letters and packages. And also, I think it is 
important to understand that Hollywood has picked up on this 
and they keep churning out these movies that put the biological 
threat front and center to the public, and keeps it on their 
minds.
    So we owe it to the constituents to actually do something 
about this and move, you know, the stick forward so that they 
feel better protected.
    Mr. Lynch. Very good.
    Mr. Currie?
    Mr. Currie. Yes, sir. I know we are running out of time so 
I will just limit it to----
    Mr. Lynch. No, no. You have got time.
    Mr. Currie. Okay. I have two things. So the first thing I 
will say, just for you as the chairman and the ranking member, 
you mentioned congressional oversight. I think Dr. George 
mentioned congressional oversight. We think the strategy--we 
are looking at it right now and we are going to report on it 
later this year. I think it is one of the best efforts we have 
seen so far, and we have been looking at this for a long time, 
to better coordinate biodefense.
    But consistent oversight is going to be critical to keep 
this moving forward. We see, across government, we look at 
everything there is in government, at GAO, and where there is 
heavy oversight and heavy emphasis, progress gets made. And I 
think the execution of the strategy is going to be critical.
    And there are going to be some really difficult things in 
that execution. I mentioned the prioritization of resources and 
budgets across so many departments. It is going to be a huge 
challenge to be able to look at that holistically.
    Mr. Lynch. Mr. Currie, you are actually--isn't the GAO 
currently reviewing the report that Dr. George referred to 
earlier?
    Mr. Currie. Yes, sir. We are currently reviewing the 
National Biodefense Strategy to both ensure that it met the 
legislative requirements and also to see if it is going to be 
successful when it is implemented.
    Mr. Lynch. Okay.
    Mr. Currie. And so that is exactly what I am talking about, 
is that, you know, it has got to be successful in the execution 
but it is going to be a major challenge, and it is not going to 
get implemented successively just by the departments without 
consistent congressional oversight.
    Mr. Lynch. Excellent. All right. Is that all you have got?
    Mr. Dallas. Yes, sir.
    Mr. Lynch. Okay. Dr. Dallas.
    Mr. Dallas. Yes. I want to jump right on that, along with 
Mr. Currie. He mentioned about congressional oversight. I will 
give you the perfect example, and the progress that we made in 
Georgia, you know, we had this influx of Ebola patients coming 
in, the way we were able to make progress was because there was 
congressional oversight language that we could get back to, 
that controlled how the Ebola funding was done.
    Now, as we all know in here, you know, when there is 
government appropriations people want to send it off in all 
sorts of directions. But since there was very firm 
congressional oversight language it really made a path for us, 
and that is probably more than any other single factor, other 
than our enthusiasm and running around in the back of 
ambulances, was the fact that there was congressional language, 
and every time we got lip service, ``No, the congressional 
language says this.'' And then that made us--and that is why I 
saw, in person, that is how we made the progress we did.
    Mr. Lynch. I do know that on the Ebola issue that we had 
asked a certain number of institutions to raise their hand and 
say, if we are in this situation, we are in. And so, you know, 
to those courageous institutions that volunteered their 
services and said, you know, ``we want to be part of this and 
we want to step up,'' the only problem was when it did happen 
many were unprepared. They were very willing but they were 
woefully unprepared. And that is sort of the gap between where 
we want to be and where we actually are.
    I also have a--I have got some housekeeping here.
    Mr. Hice. Do you have----
    Mr. Lynch. Yes, yes. Absolutely. Go right ahead. I yield to 
the gentleman for five minutes.
    Mr. Hice. I won't need five minutes. Dr. Boucher, I just 
have not been able to ask you the question, and I guess the one 
that I have remaining for you is how can we reduce the rate of 
unnecessary prescribed antibiotics?
    Dr. Boucher. That is a great question. So we believe that 
there are a number of ways to do this. And so antibiotic 
stewardship, this programmatic approach to the most optimal use 
of antibiotics, is a great way, and it involves, you know, a 
program that exists in a hospital or health care system to 
ensure that antibiotics are used appropriately, that is, they 
are not used when they are not needed, and used in the best way 
possible when they are needed. And that is really important 
because using them in the best way has better outcomes.
    We have learned a lot, I would say, in the first five years 
of the National Action Plan about what impacts behavior, why 
physicians give antibiotics to people with colds. We have 
learned that--good studies have shown that if a patient comes 
into the doctor's office late in the day, they are more likely 
to get an antibiotic than if they come early in the day. You 
know, there are a lot of issues at play.
    And so, actually, we have recommended, at the Presidential 
Advisory Council, more work on implementation science. How do 
you actually get it to happen? How do you get people to change 
their behavior? And I think we are making strides. There has 
been some good progress in pediatrics. There was just a study 
this week about emergency rooms, having stewardship programs in 
emergency rooms. That is a place where a lot of antibiotics are 
handed out, and then urgent care centers are other target 
places.
    So there is a lot of work to do, but I think that probably 
it is going to take a little bit of carrot and stick to make it 
actually work, and some better science to know what will not 
only work but be sustainable, because that is the other thing 
that we have observed, is that some programs and you get the 
numbers down for a while and then they trickle back up.
    So I think that clearly physicians, other prescribers, all 
of us have a role. And then every patient has a role. I 
encourage patients to ask, ``Do I need this antibiotic?'' If 
every patient asked that we would be a lot further along in the 
trajectory.
    Mr. Hice. Well, listen, I just want to personally, again, 
to every one of you say thank you for being here. This has been 
extremely informative to me, personally, and I am glad no one 
sneezed in here today. But this has been great and your 
expertise, bringing that here to Congress is very helpful. And, 
Mr. Chairman, to you as well, thank you for calling this 
hearing and putting this together. I appreciate it, and I yield 
back.
    Mr. Lynch. I thank the gentleman, and I would like to just 
followup on your excellent question.
    I spent a little time, a while ago, in Honduras and in 
Guatemala and in El Salvador, and it was on the immigration 
issue, but during my visit there I learned that many of the 
antibiotics that we use, the most popular ones here in the 
United States, penicillin and others, are available over the 
counter in those countries. So they sort of buy them like we 
buy aspirin. And so, you know, it provides a training ground 
for some of these germs, and it just reduces the efficacy of 
those antibiotics.
    Is there any sort of international or regional cooperation 
going on with some of those countries where we could work with 
their health departments and maybe try to educate everyone on 
our effort here and how they might sort of get on the same 
page, and maybe we can help them with some of their issues as 
well.
    Dr. Boucher. Huge issue, the over-the-counter availability 
of antibiotics, in much of the world. And I think the plan is 
the Global Action Plan for Combating Antibiotic-Resistant 
Bacteria. I came out of the U.N. meeting a couple of years ago. 
And the good news--and the WHO is sort of leading that charge, 
we are very much committed to, and part of that. The good news 
is that many countries now have an action plan. The challenges 
are that in many developing countries access to antibiotics is 
a much bigger problem than anything else. They have babies 
dying because they don't have access to antibiotics, and they 
don't have a health care infrastructure to have doctors, 
nurses, anybody prescribing.
    Mr. Lynch. I see.
    Dr. Boucher. So I think it is going to take a lot to change 
this. Certainly our efforts in every country as part of this 
action plan has to have some kind of a stewardship program. It 
is going to be very different, right, and for some countries it 
might be taking antibiotics away from over-the-counter status. 
But it is a huge issue, that access piece, globally, is very 
different than what we have here in the United States.
    Mr. Lynch. Right. More complicated than I thought.
    I have a little bit of housekeeping here. I want to ask 
unanimous consent to enter into the record a statement from the 
California Life Science Association that was offered by Mr. 
Rouda, right?
    Without objection, so ordered.
    Mr. Lynch. Last, I would like to thank you all for your 
patience and your very, very helpful testimony and the good 
work that you do on a regular basis in your official capacity.
    Without objection, all members will have five legislative 
days within which to submit additional written questions, for 
you, the witnesses, through the chair, which will be forwarded 
to the witnesses for responses. And I ask if you do receive any 
of these questions could you please respond as promptly as you 
are able.
    With that this hearing is now adjourned. Thank you.
    [Whereupon, at 5:32 p.m., the subcommittee was adjourned.]

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