[Senate Hearing 114-568]
[From the U.S. Government Publishing Office]
S. Hrg. 114-568
MEDICAL AND PUBLIC HEALTH PREPAREDNESS AND RESPONSE: ARE WE READY FOR
FUTURE THREATS?
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HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED FOURTEENTH CONGRESS
FIRST SESSION
ON
EXAMINING MEDICAL AND PUBLIC HEALTH PREPAREDNESS AND RESPONSE, FOCUSING
ON FUTURE THREATS
__________
FEBRUARY 26, 2015
__________
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming PATTY MURRAY, Washington
RICHARD BURR, North Carolina BARBARA A. MIKULSKI, Maryland
JOHNNY ISAKSON, Georgia BERNARD SANDERS (I), Vermont
RAND PAUL, Kentucky ROBERT P. CASEY, JR., Pennsylvania
SUSAN COLLINS, Maine AL FRANKEN, Minnesota
LISA MURKOWSKI, Alaska MICHAEL F. BENNET, Colorado
MARK KIRK, Illinois SHELDON WHITEHOUSE, Rhode Island
TIM SCOTT, South Carolina TAMMY BALDWIN, Wisconsin
ORRIN G. HATCH, Utah CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas ELIZABETH WARREN, Massachusetts
BILL CASSIDY, M.D., Louisiana
David P. Cleary, Republican Staff Director
Evan Schatz, Minority Staff Director
John Righter, Minority Deputy Staff Director
(ii)
C O N T E N T S
__________
STATEMENTS
THURSDAY, FEBRUARY 26, 2015
Page
Committee Members
Burr, Hon. Richard, a U.S. Senator from the State of North
Carolina....................................................... 1
Murray, Hon. Patty, a U.S. Senator from the State of Washington.. 3
Alexander, Hon. Lamar, Chairman, Committee on Health, Education,
Labor, and Pensions, opening statement......................... 4
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of
Pennsylvania................................................... 4
Warren, Hon. Elizabeth, a U.S. Senator from the State of
Massachusetts.................................................. 32
Cassidy, Hon. Bill, M.D., a U.S. Senator from the State of
Louisiana...................................................... 34
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode
Island......................................................... 45
Witnesses
Lurie, Nicole, M.D., MSPH, Assistant Secretary for Preparedness
and Response, U.S. Department of Health and Human Services,
Washington, DC................................................. 6
Prepared statement........................................... 8
Robinson, Robin A., Ph.D., Director, Biomedical Advanced Research
and Development Authority, Deputy Assistant Secretary for
Preparedness and Response, Washington, DC...................... 11
Prepared statement........................................... 13
Redd, Stephen C., RADM, M.D., Director, Office of Public Health
Preparedness and Response, Centers for Disease Control and
Prevention, Atlanta, GA........................................ 17
Prepared statement........................................... 18
Borio, Luciana, M.D., Assistant Commissioner for Counterterrorism
Policy, Director of the Office of Counterterrorism and Emerging
Threats, Deputy Chief Scientist (Acting), U.S. Food and Drug
Administration, Silver Spring, MD.............................. 21
Prepared statement........................................... 23
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
Response by Nicole Lurie, M.D., MSPH, to questions of:
Senator Alexander........................................ 48
Senator Burr............................................. 51
Senator Isakson.......................................... 55
Senator Kirk............................................. 56
Senator Scott............................................ 56
Senator Roberts.......................................... 58
Senator Murray........................................... 59
Senator Mikulski......................................... 60
Senator Casey............................................ 62
Senator Franken.......................................... 64
Senator Baldwin.......................................... 65
Senator Warren........................................... 66
(iii)
MEDICAL AND PUBLIC HEALTH PREPAREDNESS AND RESPONSE: ARE WE READY FOR
FUTURE THREATS?
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THURSDAY, FEBRUARY 26, 2015
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 10:05 a.m., in
room SD-430, Dirksen Senate Office Building, Hon. Richard Burr
presiding.
Present: Senators Burr, Alexander, Cassidy, Casey, Murray,
Franken, Whitehouse, and Warren.
Opening Statement of Senator Burr
Senator Burr. The Senate Committee on Health, Education,
Labor, and Pensions will come to order. I'm delighted to steal
the gavel this morning from the chair, and I apologize to my
colleagues. I clearly was the only one that had people that
were late for their appointments this morning, so it threw me
back about 5 minutes. I apologize to our witnesses.
I thank the chairman and Ranking Member Murray, and I want
to thank my good friend, Bob Casey, for his willingness to work
with me on this hearing, as well as a number of other
initiatives that he and I have joined together on. Once we've
made some opening statements, I'll have an opportunity to
introduce formally our witnesses today.
I'm pleased to have the opportunity to chair today's
hearing on such an important topic that is a key aspect of our
national security. Our work to strengthen our Nation's medical
and public health preparedness and response has always been
bipartisan. It's fitting that Senator Casey, who has been a
strong partner on these issues over the years, is serving as
the Ranking Member of today's hearing.
The American people expect us to do all that we can do to
protect them from the full range of threats that we face,
whether they're naturally occurring, as we've seen with the
emergence of novel influenza strains, or are deliberate man-
made attacks. Regardless of the source of these threats, we
must be well-prepared to respond and to protect the American
people.
In the aftermath of Katrina, Congress, through the Pandemic
and All Hazards Preparedness Act, established the position of
the Assistant Secretary for Preparedness and Response. The ASPR
position was created to clearly answer the question of who is
in charge during a public health emergency. The statute is
clear, and there should be no confusion at this point.
We need to examine why, in the midst of the Ebola response,
there was uncertainty at this point. This was exactly one of
the issues that we were trying to avoid by speaking clearly to
who was in charge in PAHPA and strengthening the role of the
ASPR in the 2013 reauthorization of the law.
Today's hearing asks a very simple but critical question:
Are we ready for future threats? Our recent experience with
Ebola suggests that there's still room for improvement to make
sure that we're as prepared as possible. Our healthcare system
was not fully stressed in those response efforts.
As with each public health emergency before, we must apply
what we've learned from our response to Ebola to strengthen our
overall medical and public health preparedness and response
efforts so that we are better prepared for the next threat we
face. We cannot put off taking the steps that we must today to
be better prepared tomorrow.
We need consistent and strong leadership and support at all
levels in carrying out our medical and public health
preparedness and response efforts. There must be a daily focus
and urgency to this work, not just when we're in the midst of
responding to a crisis at hand. These efforts must be
prioritized. That is how we ensure that we're better prepared
to respond to the full range of threats we may face.
Ebola underscores the importance of having medical
countermeasures as part of our response arsenal. Today, the
Biomedical Advanced Research and Development Authority not only
manages the BioShield Special Reserve Fund, our medical
countermeasure procurement fund, but BARDA is also actively
helping innovators bridge the advanced research and development
Valley of Death to bring forward innovative medical products
and platform technologies that will play a critical role in
protecting the American people.
While these efforts have resulted in the development,
approval, and stockpiling of medical countermeasures that we
didn't have a decade ago, we know that we cannot let up on
these efforts because there's much work left to be done. We
still do not have any vaccines or therapeutics for some of the
most serious identified threats. We must be prepared for what
we have already identified while also having the capabilities
to quickly pivot and execute the development of vaccines and
treatments for novel and emerging threats.
The ASPR, BARDA, FDA, and CDC are all before the committee
today because of the critical coordination that must occur
between each of these agencies in bringing forward medical
countermeasures to the strategic national stockpile as well as
the coordination between all facets of our medical and public
health preparedness and response efforts, including critical
partnerships with States and local public health officials and
our Nation's healthcare providers. Their efforts together with
the important work of the National Institutes of Health is
critical for ensuring that we are as prepared as possible.
There's been improvement in the coordination across these
agencies. We must ensure that these efforts are as timely and
seamless as possible. I look forward to hearing from our
witnesses today on what is working well, where there are still
areas for improvement, and how Congress and the Administration
can work together to ensure that we are as prepared as possible
for the future threats we face.
Almost 2 years ago, Congress passed with overwhelming
bipartisan support the Pandemic and All Hazards Preparedness
Reauthorization Act, legislation I authored with my colleagues
on this committee and which the President signed into law.
Today's hearing provides a good opportunity to look at the
aspects of PAHPA that have not gotten as much attention in
recent months and years but are very important. I want to take
this opportunity to underscore that each provision of the law
was very carefully and intentionally crafted the way that it
was.
While the administration has leveraged some provisions in
the law, such as the FDA utilizing the authorized use
authorities to more quickly respond to H7N9 and MERS and Ebola,
including an authorization on another Ebola diagnostic just
this week, other requirements remain outstanding. The
deliverables required by PAHPA are not optional.
Unfortunately, it took moving forward with this hearing for
a long awaited 5-year medical countermeasure budget plan and
the latest strategy and implementation plan to be sent to
Congress. If it's going to take the scheduling of regular
oversight hearings to ensure timely action and response in
these areas, then that's something that I am more than happy to
chair on behalf of you, Chairman Alexander, because the urgency
of this work cannot be overstated.
Our actions and inactions in this area impact the health of
the American people and our Nation's overall security. Medical
and public health preparedness and response is a matter of
national security.
I want to thank each of our witnesses for being here today,
for taking the time to be here, for the efforts that you put
into your work, and for your expertise. I look forward to the
hearing and to your thoughts on how we ensure that we're
prepared for the future threats.
I will recognize Senator Casey.
Senator Casey. I will yield to my senior member.
Opening Statement of Senator Murray
Senator Murray. Let me just say quickly that I really want
to thank you, Senator Burr and Senator Casey, for spearheading
this conversation. I really appreciate all of our witnesses who
are here today.
As we heard, 2 years ago, the President signed the Pandemic
and All-Hazards Preparedness Reauthorization Act into law, and
it was a very important step forward in terms of advancing our
national health preparedness, from providing support for States
and local communities facing public health emergencies to
promoting a very robust pipeline of medical countermeasures
including drugs and vaccines that help us combat threats to
public health.
I'm really pleased that today, we have an opportunity to
look to the lessons learned over the past few years and talk
about what we need to do going forward to prevent and, when
necessary, respond quickly and effectively to public health
emergencies. As events like the Ebola cases last fall and the
difficult flu season we've had made clear, this is a very
important time for a discussion about protecting communities'
health and having effective systems in place when risks do
emerge.
I want to thank all of our witnesses who are here today.
I'm very delighted that Senator Casey is running this committee
for us on this side and is going to do a great job on these and
many issues, and I want to thank him for that. I just want to
let the committee know that I have several hearings today,
including one in the V.A. that's very important on our budget.
Senator Casey is taking the lead on our side today, and I will
turn it over to him.
Senator Casey. Senator Alexander, do you want to go next?
Statement of Senator Alexander
The Chairman. Thank you, Senator Casey. I'll just reiterate
what Senator Murray said. This committee has a long reputation
for bipartisan commitment to ensuring that our country is
prepared for any and all threats.
Senator Burr has been a real leader in that. He was the
author of the Pandemic and All-Hazards Preparedness Act of 2006
and its 2013 reauthorization, which is why I asked him to chair
this hearing. He and Senator Casey have worked together very
effectively, and I thank both of them for their leadership.
I look forward to being a part of the hearing today and to
continuing with whatever oversight is necessary to make sure
that we do our job.
Thank you, Senator Casey.
Statement of Senator Casey
Senator Casey. Mr. Chairman, thank you, and I want to thank
Ranking Member Murray for this opportunity, and I certainly
want to commend and salute the work of Senator Burr on these
issues over many years in our working together. I'll be brief
because I want to get to our witnesses.
I do want to say a word of thanks to our witnesses for your
testimony, for your presence here today, for the expertise that
you bring to bear on these issues, and, of course, for your
public service.
We've convened today, not just a panel of witnesses but a
panel of expert witnesses to examine the progress we've made
since the passage of the Pandemic All Hazards Preparedness
Reauthorization Act known as PAHPRA. I'll try to call it the
Preparedness Act so we don't get too caught up in a lot of
acronyms; I wonder if people listening are always following
them. I'll call it the Preparedness Act to make it easier.
As we look ahead to challenges that confront the country,
at the same time we have to learn from experience that we've
derived over the last decade. I think it's safe to say that we
cannot hope to adequately be prepared for medical or public
health emergencies if we lurch from crisis to crisis, piecing
and patching together a response when we're already in the
middle of an emergency. I think we all agree on that.
Public health preparedness requires a sustained commitment
and investment at the Federal, State, and, indeed, at the local
level as well. We should also acknowledge that public health
preparedness does not exist in a vacuum separate from the rest
of our public health and medical infrastructure.
The healthcare providers and hospitals that provide care
for us and the public officials working with us to keep us safe
are the same ones who would be providing care for us and
working to respond in the case of a public health emergency.
Ensuring a basic level of access to care and supporting efforts
that help Americans be healthier every day will also help us to
be more resilient in the face of a pandemic, a natural
disaster, or a terrorist attack.
The public health challenges our Nation must prepare for
are considerable and diverse, as we've seen. In only the last
several months, we've seen concerns about antibiotic-resistant
superbugs, Ebola, and a worse than usual flu season.
The Preparedness Act is a framework for our medical and
public health preparedness infrastructure which addresses the
need for a coordinated response from multiple Federal agencies
and also State and local governments as well as community
partners. The law also recognizes and addresses the challenges
in developing medical countermeasures and ensuring we are able
to deploy those resources as needed.
With our witnesses here today, I hope to learn more about
the progress we've made, and there has been lots to be positive
about. We also have to make sure we're checking and ensuring
that that progress continues. We must ensure our Nation is
prepared for all medical and public health threats.
I want to thank Chairman Burr for this hearing.
Senator Burr. Thank you, Senator Casey.
At this time, I'd like to introduce our witnesses and
welcome them. First is Dr. Nikki Lurie. She is the Assistant
Secretary for Preparedness and Response with the Department of
Health and Human Services. In this capacity, she serves as the
Secretary's principal advisor on matters related to
bioterrorism and other public health emergencies.
Her office is the lead agency for Federal public health and
medical preparedness and response, helping the Nation prepare
for, respond to, and recover from disasters. She has also
served with HHS as the Principal Deputy Assistant Secretary of
Health.
Prior to her work at the Department, Dr. Lurie was a senior
natural scientist and a professor of health policy at the Rand
Corporation and served in Minnesota State government. Dr. Lurie
attended college and medical school at the University of
Pennsylvania and completed her residency and master's at UCLA.
She continues to practice medicine in Washington, DC.
We welcome you, Dr. Lurie.
Let me introduce all of you, and then I'll come back to Dr.
Lurie and let her start.
Dr. Robin Robinson is the first and current Director of the
Biomedical Advanced Research and Development Authority and the
Deputy Assistant Secretary in the Office of the Assistant
Secretary for Preparedness and Response at HHS. Dr. Robinson
has vaccine and private sector experience and joined HHS in
2004 to establish the medical countermeasures policy for the
national strategy for pandemic influenza.
Dr. Robinson received his bachelor's degree from Millsaps
College and a doctoral degree from the University of
Mississippi Medical School in medical microbiology. He
completed an NIH post-doctoral fellowship with the State
University of New York at Stony Brook in molecular oncology.
Robin, welcome.
Dr. Stephen Redd, Rear Admiral Stephen Redd, is with us
today--welcome--from the Centers for Disease Control and
Prevention, where he serves as the Director of the Office of
Public Health Preparedness and Response. Before this role, Dr.
Redd was the Director of Influenza Coordination Unit and served
as the Incident Commander during the H1N1 pandemic.
He has served as a commissioned officer for 29 years. Dr.
Redd is a graduate of Princeton and Emory Universities, and he
received his medical degree and trained in medicine at Johns
Hopkins. He has received numerous awards, including the Public
Health Distinguished Service Medal and Meritorious Service
Medal.
Again, welcome, Rear Admiral.
Dr. Luciana Borio--am I close?
Dr. Borio. Lu Borio.
Senator Burr. Lu Borio joined the FDA in 2008 and is the
Assistant Commissioner for Counterterrorism Policy and Director
of Food and Drug Administration's Office of Counterterrorism
and Emerging Threats. She heads the FDA medical countermeasures
initiative and is the acting Deputy Chief Scientist.
Dr. Borio--correct? I thought you stuck another part in
there, but--also serves at HHS as the advisor on biodefense
programs. In addition to her various roles at FDA and HHS, Dr.
Borio was also a senior associate at the UPMC Center for
Biosecurity and assistant professor of medicine at the
University of Pittsburgh.
She received her M.D. from George Washington University and
completed her residency at New York Presbyterian Hospital
Cornell Medical Center. She continues to practice medicine at
Johns Hopkins Hospital.
Doctor, welcome.
With that, I'll turn to you, Dr. Lurie, for any opening
statement you might want to make.
STATEMENT OF NICOLE LURIE, M.D., MSPH, ASSISTANT SECRETARY FOR
PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF HEALTH AND HUMAN
SERVICES, WASHINGTON, DC
Dr. Lurie. Thank you and good morning, Senator Burr and
Ranking Member Murray and acting Ranking Member Casey and other
distinguished members of the committee.
I'm Dr. Nicole Lurie, the Assistant Secretary for
Preparedness and Response, or ASPR, at HHS. As you know, I'm
joined by my colleagues today from BARDA, CDC, and FDA. I
appreciate the opportunity to talk to you today about our
Nation's preparedness and ASPR's successful implementation of
the Pandemic and All Hazards Preparedness Acts.
These critical pieces of legislation arose from lessons
learned following several disasters and created ASPR, providing
the Federal Government with better mechanisms to coordinate
preparedness and response activities and support State and
local authorities throughout the disaster cycle. ASPR has
successfully executed its responsibilities, leveraging the
authorities that you have provided.
We've improved the Federal personnel and logistical
capabilities deployed in responses, expanded training for our
responders, and changed the way we conduct drills and exercises
to ensure we're coordinated when disaster strikes. We've also
spearheaded new coordination among Federal preparedness grant
programs, formally incorporated mental health into response,
built regional preparedness coalitions, and developed new
guidance to give States flexibility in deploying their human
resources in emergencies.
We've dramatically enhanced our focus on children and other
potentially at-risk populations, including through a novel
collaboration with CMS to better identify and prepare for the
needs of electricity dependent and dialysis patients.
To advance the development and procurement of new medical
countermeasures, ASPR created an interagency body called the
Public Health Emergency Medical Countermeasures Enterprise--
it's a mouthful, so I say PHEMCE--developed a multiyear medical
countermeasure budget, and used critical authorities to
encourage strong partnerships with industry. As you will hear
from Drs. Robinson and Borio, these flexibilities have made a
tremendous difference.
The National Health Security Strategy provides strategic
direction to ensure that efforts to improve the Nation's health
security are guided by a common vision, based on sound
evidence, and carried out in an efficient and collaborative
manner. In ASPR, we believe that strong day-to-day systems are
the backbone of strong preparedness and response.
We have reoriented the Hospital Preparedness Program so our
programs better link public health and healthcare and encourage
healthcare entities in every community to work together through
healthcare coalitions. Healthcare coalitions now include nearly
three-quarters of the hospitals in the United States as well as
EMS providers, emergency management organizations, long-term
care facilities, behavioral health, public health agencies, et
cetera.
We've witnessed the benefits of these coalitions time and
time again, with community responses in Joplin after the
tornado, in North Carolina after Hurricane Irene, in West, TX
after a chemical plant fire, and along the East Coast after
Hurricane Sandy, to name a few. We need to look back no further
than Ebola to see how critical it is that public health and
medical care work closely together while at the same time
recognizing the unique capabilities that each system
contributes.
We recognize, however, that communities can be quickly
overwhelmed, and when that happens, they need to count on their
Federal partners to come through. To that end, we revamped the
National Disaster Medical System, and our teams are now on the
ground within hours, not days, of requests for help. Over the
past 9 years, our operation centers coordinated 120 Federal
public health and medical responses.
PAHPA also authorized programs to develop and make
available new countermeasures. I will say that 2010 marked an
important turning point. Our review of the entire Medical
Countermeasures Enterprise resulted in improvements across the
entire PHEMCE in the way partners work together and get things
done.
The PHEMCE strategy and implementation plan lays out
priorities, and the first ever PHEMCE multiyear budget was
recently provided to Congress. Together, PHEMCE agencies have
over 160 product candidates in the pipeline, and we've added a
dozen products to the strategic national stockpile. Eight
products have been approved by FDA since 2012. As you'll hear,
new capabilities we have up and running have been central to
getting Ebola countermeasures into West Africa for clinical
trials now underway.
In the years since the passage of PAHPA, we've learned many
things about how to become more prepared, how to respond more
effectively, how to help communities recover faster and better.
However, the most important lesson is that there is no end
point to preparedness, no point at which we can dust off our
hands, stand back, let down our guard, and say we're done. Our
nation's health security requires continuous improvement and
constant vigilance. PAHPA and PAHPRA have been critical to
these advances in our preparedness.
Before I close, I just want to say a special thank you to
you, Mr. Burr, the poppa and grandpoppa of all of these
efforts. Thank you, and I'm happy to answer any questions that
you might have.
[The prepared statement of Dr. Lurie follows:]
Prepared Statement of Nicole Lurie, M.D., MSPH
Good morning Senator Burr, Ranking Member Casey, and other
distinguished members of the committee. I am Dr. Nicole Lurie and I
serve as the Assistant Secretary for Preparedness and Response at the
Department of Health and Human Services (HHS).
I appreciate the opportunity to talk to you today about the Office
of the Assistant Secretary for Preparedness and Response (ASPR) and its
accomplishments in moving the country forward in preparing for,
responding to, and recovering from the adverse health effects of
emergencies and disasters. Recognizing lessons learned from disasters
including the terrorist attacks on 9/11, the anthrax attacks in 2001,
and Hurricane Katrina, ASPR and its predecessor agency were established
to improve coordination and direction across the spectrum of HHS
preparedness and response activities. Under the Public Health Service
Act, as amended by the Pandemic and All-Hazards Preparedness Act of
2006 (PAHPA) and the Pandemic and All-Hazards Reauthorization Act of
2013 (PAHPRA), ASPR was established as the lead for HHS emergency
preparedness and response and serves as the principal advisor to the
Secretary regarding Federal public health and medical preparedness and
response to public health emergencies.
introduction
Over the past 6 years, ASPR has significantly advanced the Nation's
preparedness, contributing to enhanced response and more resilient
communities that are better prepared to recover from an emergency or
natural disaster. We have found innovative ways to identify and protect
vulnerable populations, including targeted approaches for children,
pregnant women, and people with special medical needs, like those who
need dialysis or electrically dependent durable medical equipment. We
restructured the National Disaster Medical System teams so they are
more flexible, are pediatrics capable, and can provide other
specialized capabilities to assist communities after disasters. We
developed and now use innovative approaches to stimulate private sector
interest in partnering with us to develop medical countermeasures to
protect against threats to health. ASPR and the Centers for Disease
Control and Prevention (CDC) aligned preparedness grants to State and
Local partners to reduce their administrative burden and maximize the
return on investment and are building new tools to assist hospitals and
other healthcare coalition members in meeting the medical and public
health needs of their communities. Today, we integrate behavioral
health into our response to every disaster, recognizing that community-
level recovery depends on individual ability to cope with the impacts
of disasters. We are galvanizing the scientific community to be ready
to conduct research quickly to answer the tough questions your
constituents will have for you about their health after disasters.
These advances--vital to our Nation's health security--have been
supported and made possible by the authorities provided in PAHPA and
PAHPRA and an incredible team of men and women who comprise ASPR. Under
these authorities, ASPR's responsibilities are broad, and include:
overseeing advanced research, development, and procurement of resulting
medical countermeasures, coordinating with health care systems, and
providing integrated policy and strategic direction under the National
Response Framework. In addition, ASPR directs medical and, with CDC,
public health grants and cooperative agreements, provides leadership in
international programs and policies with global impact, and has
developed and submitted a 5-year budget plan for countermeasure
priorities. ASPR oversees the National Disaster Medical System (NDMS),
the Hospital Preparedness Cooperative Agreement Program (HPP), and the
Biomedical Advanced Research and Development Authority (BARDA). Through
guidance documents like the National Health Security Strategy (NHSS)
and Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)
Strategy and Implementation Plan (SIP), ASPR leads the path forward for
our partners and stakeholders.
Since PAHPRA was passed in 2013, ASPR has provided to the Congress
critical requested deliverables including a new National Health
Security Strategy for 2015 to 2018, and a National Health Security
Review for 2010 to 2014. In addition, ASPR provided a 5-year Medical
Countermeasure budget plan, a new PHEMCE SIP, an Interagency
Coordination Plan with the Department of Defense regarding medical
countermeasures, established a new National Advisory Committee on
Children and Disasters, and issued guidelines for temporary
reassignment of State and tribal public health personnel, State
pandemic influenza plans, a public health and medical situational
awareness strategy, and an annual review of the Strategic National
Stockpile (SNS).
improving the medical countermeasure enterprise
Recently, my office released the 2014 PHEMCE SIP, which guides
medical countermeasure priorities for short, middle, and long-term
projections. The PHEMCE is one of many great examples of ASPR's whole-
of-government approach. In 2006, ASPR established the PHEMCE to be the
single Federal coordinating body that oversees the entire medical
countermeasure lifecycle across the various Federal departments and
agencies. My office manages the PHEMCE in partnership with other HHS
agencies including the National Institutes of Health (NIH), the Food
and Drug Administration (FDA), CDC, and BARDA, along with interagency
partners such as the Department of Defense (DoD), the Department of
Homeland Security (DHS), the Department of Agriculture (USDA), and the
Department of Veterans Affairs (VA). Prior to the PHEMCE, Federal
efforts were fragmented, and collaboration with our industry partners
was limited. With a variety of potential threats requiring substantial
investment, we needed a method to make sure we were not wasting
resources on duplicative ventures. The resulting governance process and
decision framework provides means to coordinate across government,
prioritize investments, and get results.
As you know, HHS recently provided estimated funding requirements
for HHS PHEMCE agencies, including NIH, ASPR/BARDA, FDA, and CDC, in
the first-ever PHEMCE multi-year budget. The multi-year budget
describes a plan for funding BARDA's Advanced Research and Development
programs and Project BioShield over 5 years; to maintain the current
level of preparedness at the SNS; to continue the NIH investments in
biodefense basic research and development; and to sustain FDA's Medical
Countermeasure Initiative, initially recommended by the 2010 PHEMCE
Enterprise Review. It is a critical companion to the PHEMCE SIP in
accurately projecting the resource estimates required for end-to-end
medical countermeasure life-cycle management as a product, or candidate
product, moves through development, licensure, acquisition, and
stockpiling.
the biomedical advanced research and development authority
Coordination made possible through the PHEMCE continues to drive
progress and success in making medical countermeasures available. BARDA
has made great progress, from a time when there were almost no medical
countermeasures in the pipeline, to a robust pipeline with over 160
candidate medical countermeasures for chemical, biological,
radiological, and nuclear (CBRN) threats and pandemic influenza. Eight
of these products have received FDA approval in the last 3 years
including countermeasures for anthrax, botulinum and pandemic
influenza. Moreover, BARDA procured 12 novel medical countermeasures
for the SNS through Project BioShield, including those for smallpox,
anthrax, botulinum, radiologic/nuclear emergencies and chemical events.
Since 2007, BARDA has supported the development of 18 influenza medical
countermeasures, including those used during the 2009 H1N1 pandemic and
others stockpiled for potential avian influenza H5N1 and H7N9
outbreaks.
We are on a trajectory to make available 12 new medical
countermeasures through Project BioShield procurements in the next 5
years. These medical countermeasures include next generation anthrax
vaccines, new smallpox vaccines, biodosimetry diagnostic devices,
thermal burn radiation drug and skin replacement therapies, radiation
cell therapies, new antibiotics to counter the ever growing public
health threat from antimicrobial resistance, and new chemical
antidotes.
We have moved from a one-bug, one-drug approach in countermeasure
development, to a capabilities-based approach in which we are able to
make novel medical countermeasures when they are most needed during an
emergency. With the establishment of the three Centers for Innovation
in Advanced Development and Manufacturing in 2012 and a Fill Finish
Manufacturing Network comprised of four aseptic filling manufacturers
in 2013, we are developing, manufacturing, and filling medical
countermeasures for CBRN threats like anthrax, for emergency situations
like pandemic influenza like the H7N9 vaccines in 2013, and for
emerging infectious diseases. In keeping with the parameters of our
public-private partnership, these state-of-the-art facilities may also
be used by our private sector partners to develop new vaccines and
drugs for the open market.
We've also made huge progress in pandemic influenza preparedness.
In 2004, the Nation had a single domestic influenza vaccine
manufacturer. Due to planning, foresight and support across the Federal
Government, and robust public-private partnerships, we now have robust
and rapid domestic manufacturing capacity for pandemic influenza
vaccines, capable of rapidly producing vaccines and other biologics
against pandemic influenza and other emerging threats.
emergency preparedness and response
HHS is the coordinator and primary agency for the Public Health and
Medical Services Emergency Support Function of the National Response
Framework. Our day-to-day work involves supporting local and State
partners to build stronger, more resilient communities. Ultimately,
communities should be able to respond to a wide-range of threats to
public and medical health emergencies on their own, limiting the need
for Federal assets to augment response. Critical to this effort is the
National Hospital Preparedness Program--or HPP, which strengthens the
day-to-day activities necessary to maintain readiness by providing
resources to State, territorial, and local awardees.
Over the last few years, ASPR has shifted the focus of HPP from
preparing one hospital at a time to preparing all of the healthcare
entities in a community through Health Care Coalitions. Health Care
Coalitions are formal, collaborative networks of hospitals, health care
organizations, public health providers, emergency management, emergency
medical services, and other public and private sector health care
partners within a defined region. We saw the importance of this first-
hand, during Hurricane Sandy, when nursing homes and hospitals needed
to evacuate, and mobile satellite emergency units funded in part by HPP
were used to relieve pressure on the remaining facilities. Further,
hospitals can now communicate with other responders through
interoperable communications systems; track bed and resource
availability using electronic systems; protect health care workers with
proper equipment; train health care workers on how to handle medical
crises and surges; develop fatality management, hospital evacuation,
and alternate care plans; and coordinate regional training exercises.
There are many more examples of how HPP has demonstrated a return on
investment, notably during the outbreak of fungal meningitis in
Michigan; the ammonium nitrate explosion at a fertilizer facility in
West, TX; and during the bombings at the Boston Marathon.
aspr has foucused on the needs of at-risk populations
The underlying goal of my office is to make sure our Nation is
secure and resilient when confronting diverse incidents with
challenging health consequences. The National Health Security Strategy
guides the Nation in achieving that goal. The first NHSS was submitted
to the Congress in 2009. The second quadrennial report builds on the
lessons of the first 4 years, and was submitted to the Congress, on
time, in December 2014.
Central to the NHSS is the understanding that resilient communities
include healthy individuals and families with access to health care,
both physical and psychological, during routine and emergency
situations. Enhanced resilience is critical to mitigating
vulnerabilities, reducing negative health consequences, and rapidly
restoring community functioning. ASPR provides subject matter
expertise, education, and coordination to make sure the functional and
access needs of at-risk individuals and behavioral health issues are
integrated with national public health and medical emergency
preparedness, response, and recovery activities, as required by PAHPA
and PAHPRA.
ASPR works to promote strategies for building individual and
community resilience that are inclusive of both behavioral health and
the functional needs of at-risk individuals. Such strategies will
improve communities' ability to maximize resources, meet needs, and
recover from the adverse health consequences of public health
emergencies and disasters at the individual and community levels.
PAHPRA provided my office with the tools necessary to strengthen our
capabilities and highlighted the need to address the risks and
challenges faced by children during emergencies and disasters. Just
this past year, we established the National Advisory Committee on
Children and Disasters to further address the public health needs of
children affected by disasters, a critically important component of our
response efforts.
conclusion
In the past 6 years, we have learned many things about how to
become more prepared, how to respond more effectively, and how to
recover faster. However, it is critical that we recognize that there is
no end point in preparedness--and that maintaining a strong, steady
State of preparedness is our new normal. Our objective has been to
create a system of flexible and nimble capabilities which can be used
in response to the range of threats we face. PAHPA and PAHPRA have
given us many of the tools we need, from programs like HPP and BARDA to
authorities like emergency use authority (EUA) flexibility. We have
used each and every one of them, including in the Ebola crisis. We
appreciate the support and partnership we have had with this committee
and with the Congress and look forward to continuing to work together
to enhance our Nation's health security.
Senator Burr. Thank you, Dr. Lurie.
Dr. Robinson.
STATEMENT OF ROBIN A. ROBINSON, Ph.D., DIRECTOR, BIOMEDICAL
ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY, DEPUTY ASSISTANT
SECRETARY FOR PREPAREDNESS AND RESPONSE, WASHINGTON, DC
Ms. Robinson. Good morning, Chairman Alexander, Ranking
Member Casey, Senator Burr, and other distinguished members of
the committee. First, thank you for your continued support in
our mission to make the Nation better prepared and for the
opportunity to update you today on medical countermeasures for
public health preparedness and response.
I'm Dr. Robin Robinson, Director of the Biomedical Advanced
Research and Development Authority, or BARDA, the Deputy
Assistant Secretary for the ASPR, Dr. Lurie, as well as a
former vaccine developer in industry. BARDA is the full-time
Federal Government agency created in 2006 by the Pandemic and
All Hazards Preparedness Act to support advanced research and
development and procurement of novel and innovative medical
countermeasures that address the needs of the entire Nation for
man-made threats and emerging infectious diseases, like the
2009 H1N1 pandemic and the current Ebola epidemic.
Medical countermeasure development is risky, lengthy, and
expensive, with many inexperienced developers failing, and, in
the past, many larger pharmaceutical companies avoiding the
sector completely. BARDA serves as a bridge over a critical gap
referred to as the Valley of Death in medical countermeasure
development by transitioning product candidates from early
development at NIH to advanced development toward FDA approval
and potential procurement through direct funding, public-
private partnerships, and technical core service assistance
programs.
Seven years ago, I agreed to take up the mantle as BARDA's
first director because I believed that the country needed
medical countermeasures for protection against bioterrorism and
pandemic diseases. I also believed that PAHPA's creation of
BARDA was the appropriate course adjustment for the long
journey to win this fight. Last, I believed that BARDA's
talented and dedicated scientist staff and I could succeed in
this mission.
Today, I am pleased to report to you that BARDA is living
up to PAHPA's vision of making our country better prepared and
secure against these threats with the right medical
countermeasures. I'll briefly walk you through what we have
done pre- and post-PAHPA and what we plan to do going forward.
PAHPA directed BARDA to promote countermeasure advanced
research and development. Before PAHPA, our medical
countermeasure product development pipeline was very small,
primarily for anthrax, smallpox, and pandemic influenza. Now
there are more than 160 medical countermeasures for all known
CBRN threats and pandemic influenza, including those for
special populations.
Nearly 20 of these medical countermeasures have been
approved by the FDA since 2007 with many more products expected
to receive approval in the next several years. Before PAHPA,
only three BioShield products were in the strategic national
stockpile. Now there are 12 products for biothreats, chemical
threat agents, radiation illnesses, and 12 more new products
expected within the next several years.
Under the national strategy for pandemic influenza and
using PAHPA authority, BARDA expanded domestic pandemic
influenza vaccine manufacturing capacity multifold, stockpiled
H5N1 and H7N9 vaccines, and provided influenza medical
countermeasures for the 2009 H1N1 pandemic. Today, BARDA is
supporting development and manufacturing of promising Ebola
vaccine and therapeutic candidates.
For the future, we are launching major new initiatives to
address antimicrobial drug resistance and biothreats primarily,
with secondary benefits for high-priority public health
pathogens and to enhance pandemic preparedness with new
universal influenza vaccines and immunotherapeutics that will
also benefit seasonal influenza.
PAHPA directed BARDA to promote innovation to reduce the
time and cost of countermeasure advanced research and
development. Prior to PAHPA, there were no innovation
investments under Project BioShield. Since PAHPA, we have
stimulated innovations like synthetic biology in the
development and manufacturing of vaccine and therapeutic
candidates and helped modernize the vaccine industry.
Going forward, we will work with our partners on a
transformative and cost-saving innovation called continuous
manufacturing that may change how and where and how much we
spend for medical countermeasures.
PAHPA directed BARDA to facilitate collaboration with
respect to medical countermeasure advanced research and
development. Under PAHPA, BARDA has collaborated closely with
our Federal partners in both medical countermeasure
preparedness and response. Further, BARDA has made public-
private partnerships with industry a standard business practice
by partnering with more than 90 companies, large and small, and
more than 25 academic institutions.
Cost-sharing public-private partnership examples include
the utilization of the other transactional authority authorized
under PAHPA to create a novel model for the development of new
antibiotics and the establishment of three Centers for
Innovation in Advanced Development and Manufacturing. The
centers are part of our overall core service assistance
programs that help medical countermeasures daily and provide a
national medical countermeasure response.
In conclusion, State- and terrorist-sponsored actors using
CBRN agents of mass destruction and recurring infectious
diseases like pandemic influenza and Ebola are real threats to
our national health security. BARDA's progress in medical
countermeasure preparedness and response to these threats
through our product development acumen, public-private
partnerships, and commitment to innovation may also serve as a
model to help make Americans healthier.
However, the job is not yet done. Continued and more
vigorous investment into BARDA's mission will ensure that our
partners and we are able to better prepare the Nation for the
next known and unknown threat.
Thank you.
[The prepared statement of Ms. Robinson follows:]
Prepared Statement of Robin A. Robinson, Ph.D.
Good morning, Senator Burr, Ranking Member Casey, and distinguished
members of the committee. Thank you for the opportunity to speak with
you today about our Government's public health preparedness and
response medical countermeasure efforts and challenges. I am Dr. Robin
Robinson, Director of the Biomedical Advanced Research and Development
Authority (BARDA) and Deputy Assistant Secretary for Preparedness and
Response (ASPR). I am happy to testify today with the ASPR, Dr. Nicole
Lurie, and my other HHS colleagues.
BARDA is the Federal Government agency, within the Office of the
Assistant Secretary for Preparedness and Response (ASPR), created in
2006 by the Pandemic and All-Hazards Preparedness Act (PAHPA) and
reauthorized by the Pandemic and All-Hazards Preparedness
Reauthorization Act of 2013 (PAHPRA) to support advanced research and
development and procurement of novel and innovative medical
countermeasures. These medical countermeasures--vaccines, therapeutics,
antiviral and antimicrobial drugs, diagnostics, and medical devices--
address the needs of the entire nation to mitigate the medical
consequences of man-made chemical, biological, radiological, and
nuclear (CBRN) agents of terrorism and naturally occurring and emerging
threats like the 2009 H1N1 pandemic, the 2013 H7N9 influenza outbreak,
and the current Ebola epidemic.
Medical countermeasure development is risky, lengthy, and costly
with many inexperienced developers failing and many larger
pharmaceutical companies avoiding the sector completely. BARDA serves
as a bridge over a critical gap in medical countermeasure development.
BARDA transitions product candidates from early development into
advanced development toward potential Food and Drug Administration
(FDA) approval and stockpile procurement through direct support,
public-private partnerships, and technical core service assistance
programs.
The Public Health Emergency Medical Countermeasure Enterprise
(PHEMCE) establishes product specific requirements for CBRN medical
countermeasures based on threat scenarios and Material Threat
Assessments performed by the Department of Homeland Security (DHS). The
National Institutes of Health (NIH) launch discovery and early stage
development of product candidates from academic and industry partners
for transition to BARDA. In turn, BARDA supports and assists these
product candidates through advanced research and development toward FDA
approval, until they are sufficiently mature to be acquired and
potentially stockpiled under Project BioShield at the Centers for
Disease Control and Prevention's (CDC) Strategic National Stockpile
(SNS) or at commercial vendors. Upon FDA approval, the financial
responsibility of purchasing medical countermeasures transfers from
BARDA under Project BioShield to the CDC/SNS for the stockpile and
delivery phases. Finally, in public health emergencies, like we saw in
the H1N1 influenza pandemic and today during the Ebola epidemic, BARDA,
under the emergency management authorities of ASPR, assumes a response
posture, interfacing with other Federal agencies and manufacturers to
develop, produce, and test products for FDA review and approval and
distribution by CDC to State and local providers.
BARDA is the only Federal Agency that operates in the advanced
development space of product development. Advanced development includes
critical steps needed to transform a candidate to a product that is
ready to use. These steps include: optimizing and validating
manufacturing processes such that products can be made at commercial
scale; optimizing product formulations, storage, and product longevity
and effectiveness; creating, optimizing, and validating assays to
assure product integrity; conducting late-stage clinical safety and
efficacy studies; and carrying out pivotal animal efficacy studies that
are often required for approval of CBRN medical countermeasures.
PAHPA directed BARDA to promote countermeasure and product advanced
research and development. Since its creation, BARDA has built a
comprehensive and formidable advanced development product pipeline
comprised of more than 160 medical countermeasures for CBRN threats and
pandemic influenza. Eight of these products from influenza vaccines to
anthrax antitoxins have received FDA approval in the last 3 years
alone; a total of nearly 20 have been approved since 2007. The anthrax
and botulinum antitoxin products were the first Project BioShield
products approved by FDA under the Animal Rule. Twelve of these
products, ranging from anthrax and smallpox vaccines to anti-
neutropenia cytokine therapeutics for radiation illness have been
procured under Project BioShield with another 12 ready for Project
BioShield procurement between now and the end of fiscal year (FY) 2018.
Many of these Project BioShield medical countermeasures were made
possible through use of Advanced and Milestone Payment Authorities
designed by PAHPA to provide small companies with greater financial
stability. Further BARDA has supported the development and
manufacturing of 18 influenza vaccines, antiviral drugs, and
diagnostics that were used in the 2009 H1N1 pandemic and stockpiled for
avian influenza H5N1 and H7N9 outbreaks; a set of industry and academic
partnerships enhanced through our PAHPA authorities (e.g., antitrust
exemption). To better serve the needs of special populations, BARDA has
led the development of many medical countermeasure candidate
formulations for children, like Prussian Blue, a treatment for internal
radiation contamination, and solithromycin, a new antibiotic, as well
as a smallpox Modified Vaccinia Ankara vaccine for immuno-
compromised individuals, which was transitioned from the National
Institute of Allergy and Infectious Diseases. BARDA is currently
supporting development and manufacturing of several Ebola vaccine and
therapeutic candidates destined for clinical trials in West Africa.
BARDA's work on Ebola medical countermeasures has marked a milestone,
as the medical countermeasure development pipeline now includes at
least one product candidate for each of the DHS's Material Threat
Determinations and pandemic influenza.
PAHPA directed BARDA to promote innovation to reduce the time and
cost of countermeasure and product advanced research and development.
BARDA has stimulated innovation in the development and manufacturing of
vaccine and therapeutic candidates across the pharmaceutical industry.
Innovation investments have transitioned a platform technology using a
novel bacterial expression system into a next generation anthrax
vaccine candidate by coupling that expression system with rational
genetic design technology; the objective of which is an anthrax vaccine
with increased stability and production yields, and thus a lower
overall product cost. BARDA partnered with industry to use synthetic
biology technology to generate influenza vaccine seed strains. In 2013,
this technology was pivotal in making pre-pandemic H7N9 bulk vaccine
for stockpiling in record time by cutting several weeks off the usual
timeframe to make influenza vaccines. BARDA began working with industry
partners last fall to develop new Ebola monoclonal antibodies rapidly
using the latest innovations in monoclonal antibody development; now we
are testing these new Ebola antibody candidates in non-human primate
challenge studies; if these studies are successful, these products will
move into clinical trials later this year. BARDA has kept a keen eye on
and supported innovative technologies that may enhance existing medical
countermeasures or generate new transformative medical countermeasures
at lower costs and with longer shelf lives.
PAHPA directed BARDA to facilitate collaboration between the
Department of Health and Human Services and other Federal agencies,
relevant industries, academia, and others, with respect to such
advanced research and development. BARDA has established its medical
countermeasure development pipeline by collaborating with Federal
partners, primarily NIH, CDC, FDA, and the Department of Defense, and
by making many public-private partnerships with industry and academia.
BARDA partnerships have included nearly 90 pharmaceutical and
biotechnology companies, both large and small, and more than 25
academic and other institutions since 2006. BARDA, with vaccine
manufacturers, has established the first and largest pre-pandemic
influenza vaccine stockpile in the world, one that could, if necessary,
vaccinate tens of millions of Americans against potential H5N1 and H7N9
pandemics. BARDA utilized the Other Transaction Authority authorized
under PAHPA to create a novel cost-sharing public-private partnership
with industry for the simultaneous development of multiple new classes
of antibiotics for biothreats and high-priority public health
pathogens. Further, BARDA, industry, and academia have entered into
partnerships designated as the Centers for Innovation in Advanced
Development and Manufacturing (CIADM) to assist inexperienced medical
countermeasure developers, expand modernized domestic pandemic
influenza vaccine manufacturing capacity, ensure nimble and flexible
manufacturing capabilities for emerging infectious threats in public
health emergencies, and provide workforce training to the next
generation of vaccine developers and manufacturers. Today the CIADMs
are working on anthrax and Ebola medical countermeasures.
Building on the National Strategy for Pandemic Influenza, BARDA has
collaborated with industry and Federal partners to: (1) support
advanced development of new influenza vaccines, antiviral drugs, and
diagnostic devices leading to multiple FDA approvals for the U.S.
market; (2) improve influenza vaccine manufacturing resulting in
greater vaccine production yields and availability sooner; (3) build
and maintain stockpiles of pre-pandemic influenza vaccines for the
critical workforce and antiviral drugs at the Federal and State levels;
and (4) expand domestic and global pandemic influenza vaccine
manufacturing infrastructure and capacity multifold.
To save cost and time in product development and manufacturing,
BARDA has established a medical countermeasure infrastructure comprised
of core service assistance programs to assist product developers on a
daily basis while ensuring rapid and nimble response in a public health
emergency. BARDA has employed this medical countermeasure
infrastructure for development of CBRN medical countermeasures on a
routine basis and is now using them in the current Ebola response by
supporting the development and manufacturing of several Ebola
therapeutics and vaccines. BARDA's Nonclinical Studies Network (NCSN),
which was established in 2010 and is comprised of 17 high-
biocontainment laboratories in the United States and the United
Kingdom, has developed qualified animal models for CBRN threats,
performed animal-challenge studies for CBRN medical countermeasures,
and evaluated potential CBRN medical countermeasure candidates in these
animal models prior to BARDA investment. Today NCSN is conducting
critical animal challenge studies for promising Ebola monoclonal and
antiviral drug therapeutic candidates. BARDA's three CIADMs are helping
to develop anthrax vaccines and are expanding the production of new and
existing Ebola monoclonal antibodies similar to ZMapp in mammalian
cells. BARDA's Fill Finish Manufacturing Network, established in 2013
with four contract manufacturing organizations having aseptic filling
capabilities in the United States, is now being used to formulate and
fill multiple Ebola antibody and vaccine candidates into vials for
clinical efficacy studies in West Africa. Two contract research
organizations among the five members of our clinical studies network
are working with BARDA scientists and with CDC in-country to conduct
Ebola vaccine clinical trials in Sierra Leone. BARDA's modeling unit,
which routinely provides medical consequence modeling of CBRN threats
to inform medical-countermeasure requirements, generated key models and
forecasts on the impacts of medical-countermeasure intervention on the
epidemiology of the 2009 H1N1 pandemic, the 2013 H7N9 outbreaks, and
the current Ebola epidemic in West Africa. The investments that BARDA
has made in our national medical-countermeasure infrastructure since
2010 are playing a major role in the Nation's response to the current
Ebola epidemic and will become even more vital for medical-
countermeasure responses to public health and national security
emergencies in the coming years.
Since PAHPA, FDA and BARDA have greater scientific and regulatory
engagement, both in regard to the requirements for Emergency Usage
Authorization and Animal Rule, as well as all aspects of regulatory
approval throughout the medical countermeasure development pipeline.
Currently BARDA and FDA are working together to implement a framework
for selection of medical countermeasure candidates needing Regulatory
Development Plans as required in PAHPRA.
BARDA has developed multiple opportunities for government,
industry, and academic stakeholders to engage us with regard to medical
countermeasure research, development, innovation, and stockpiling. The
PHEMCE's website,\1\ managed by BARDA, serves as a portal for updated
information on medical countermeasure goals, priorities, programs,
funding opportunities, meetings, and procurement policies and
processes. Through this portal, stakeholders can arrange meetings with
BARDA and other PHEMCE partners via the BARDA-coordinated Tech Watch
program that enables companies and others to discuss product candidates
in detail and to understand PHEMCE goals, priorities, and procurement
processes. Through the TechWatch program, BARDA has met with an average
of more than 150 stakeholders each year on CBRN and pandemic influenza
medical countermeasures; in the last year, we've met with an additional
130+ stakeholders on Ebola medical countermeasures. Data have shown
that those companies that visit BARDA through the Tech Watch program
have a much greater chance of success than those not meeting with BARDA
for assistance on technical issues and procurement processes.
Additionally, BARDA hosts Industry Day, an annual 3-day event in
Washington, DC, where BARDA presents to 700+ stakeholders a status
report on the BARDA-funded medical countermeasure portfolio, new
programmatic initiatives and funding priorities. Industry Day also
offers a concentrated series of TechWatch-like sessions to meet
individually with stakeholders. ASPR's contracting office also provides
presentations on current procurement policies and processes and
provides assistance on contracting issues. BARDA also meets regularly
with medical associations, industry alliances, State and local health
department associations, and first-line end users across the United
States to seek their input on BARDA medical countermeasure programs and
initiatives. BARDA's stakeholder outreach demonstrates further our
commitment to partnerships with many different sectors and fulfills
PAHPA's directive to facilitate collaboration on medical countermeasure
development.
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\1\ medicalcountermeasures.gov.
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PAHPRA extended, reauthorized, or amended many of the authorities
that were initially enacted in PAHPA and that BARDA has utilized
successfully to establish an advance-development medical-countermeasure
pipeline, invigorate Project BioShield with new products, and enable
BARDA to meet pandemic influenza medical countermeasure goals. More
importantly, PAHPRA reauthorized funding for BARDA Advanced Research
and Development programs and the Special Reserve Fund for Project
BioShield through fiscal year 2018. The recently released PHEMCE Multi-
Year budget details BARDA's plan for utilizing these resources.
However, substantial returns on investment seen already in medical
countermeasure candidate development and innovative technologies are
leading to mature and FDA-approved products and national medical
countermeasure infrastructure assets are becoming mature. Major new
initiatives in the coming years will include development of products
that address our core mission space--man-made and emerging infectious-
disease threats--that also will pay dividends in everyday public
healthcare. Specifically, BARDA's focus will expand toward development
of new classes of antibiotics and new diagnostics to combat
antimicrobial drug resistance primarily for biothreats but also public
health pathogens, as appropriate; universal influenza vaccines to
afford more effective control of seasonal influenza and better
preparedness for pandemic influenza; influenza immunotherapeutics to
mitigate the emergence of drug resistance to the present classes of
influenza antiviral drugs; and continuous manufacturing of
pharmaceutical products that may transform where and how we make
medical countermeasures in the next 20 years. These new initiatives and
the lessons learned from Ebola coupled with BARDA's medical
countermeasure advances provide a compelling argument for BARDA to
create a new Emerging Infectious Disease program in the coming year.
conclusions
State- or terrorist-sponsored actors using chemical, biological,
nuclear and radiological agents of mass destruction, and recurring
natural events including pandemic influenza and emerging infectious
diseases like Ebola present real and present health threats to the
Nation. BARDA has made significant progress in developing and acquiring
medical countermeasures that can address the catastrophic medical
consequences of many of these threats. BARDA's progress has been not
just in medical countermeasure preparedness, but in the establishment
of a rapid and nimble response national infrastructure to develop,
manufacture, and test in animals and humans new medical countermeasures
for known and unknown emerging infectious diseases. Authorities and
responsibilities created by the Project BioShield Act, PAHPA, and
PAHPRA including the establishment of BARDA have demonstrated a
successful model to address market failures and high priority USG
needs.
Going forward, it is important that we maintain our medical
countermeasure preparedness in areas where we have succeeded against
key threats, continue medical countermeasure development and
manufacturing where we are not yet finished, and reach forward toward
transformational medical countermeasure innovations that may bring both
more rapid and better preparedness and response capabilities at less
expense to these threats. Advancing BARDA's mission will help ensure
that we are prepared to face the next Ebola epidemic, influenza
pandemic, anthrax attack, or unknown pathogen. BARDA is prepared to
meet those challenges and provide resources, expertise, and technical
assistance for promising and transforming vaccine, therapeutic and
diagnostic candidates.
Senator Burr. Thank you, Dr. Robinson.
Dr. Redd.
STATEMENT OF STEPHEN C. REDD, RADM, M.D., DIRECTOR, OFFICE OF
PUBLIC HEALTH PREPAREDNESS AND RESPONSE, CENTERS FOR DISEASE
CONTROL AND PREVENTION, ATLANTA, GA
Dr. Redd. Good morning, Senator Burr, Senator Casey, and
Senator Alexander. It's a pleasure to be here today to talk
with you about our efforts to improve the state of public
health preparedness. I am Rear Admiral Stephen Redd. I'm
Director of CDC's Office of Public Health Preparedness and
Response.
I'll focus my remarks on two programs this morning. The
first is the support to State and local governments, and the
second is the strategic national stockpile. I'll also focus on
mechanisms or processes that we use to coordinate those
activities.
The terrorist attacks of September 11th and the anthrax
attacks that followed shortly thereafter brought to light key
weaknesses in the U.S. public health infrastructure. In
response, the U.S. Government increased efforts to ensure that
public health was part of emergency responses and also part of
planning and preparing for those responses.
Since 2002, CDC has awarded more than $9 billion to improve
preparedness at the State and local level through a cooperative
agreement program known as the Public Health Emergency
Preparedness program, and that's commonly known by its acronym
of PHEP, but I will limit my use of that acronym. This program
supports 62 awardees, all 50 States, 8 territories, and 4
directly funded cities. The funds support staff, they support
planning, exercises, training, and the procurement of
equipment.
I'm going to now talk about what else these grantees do.
They're required to conduct at least one exercise per year and
evaluate their performance with an after-action review. They
also use real world events to test their operational readiness.
I'll give an example of how this process has led to an
intervention through PAHPRA. In the H1N1 influenza pandemic,
State governments recognized that they had people working for
them that were funded by Health and Human Services but in
programs that weren't related to response, and they couldn't
move them from those activities to the higher priority.
Through PAHPRA, this problem was corrected, and now when
there's a federally declared public health emergency, it's
possible to move people from the work that they were doing to
respond to public health emergencies with the appropriate
oversight.
I'll turn now to the strategic national stockpile. As you
know, this is a Federal asset that manages and delivers
lifesaving medical countermeasures. It contains
pharmaceuticals, critical medical supplies, Federal medical
stations, and medical equipment. It's currently valued at $6.3
billion, and we work closely within the Public Health Emergency
Medical Countermeasure Enterprise to prioritize investments in
the strategic national stockpile as well as in the upstream of
development and production.
We also offer training and technical assistance to State
health departments which are the recipients of these materials
when they're deployed. We make sure that the knowledge and the
skills are available at the State and local level to actually
use these products when there is a need.
To conclude, public health threats are everywhere, from the
reemergence of measles, which was eliminated from the United
States in the year 2000, to Ebola, a threat from the other side
of the world, to an earthquake that can strike suddenly. The
public health system must be ready to respond.
Due to investments made by Congress, the Nation is better
prepared to prevent and respond to public health emergencies
now than before September 11th. As you've heard from the other
speakers, preparedness requires ongoing work. We have to learn
from our responses and adapt and be ready to adapt as we face
new threats.
CDC will continue to work in this system, coordinating with
State, tribal, and local health departments and within the
Federal family to keep the public safe. I look forward to our
continuing to work together in this important area, and I'd be
glad to answer any questions.
Thank you.
[The prepared statement of Dr. Redd follows:]
Prepared Statement of Stephen C. Redd, RADM, M.D.
Good morning Chairman Burr, Senator Casey, and members of the
committee. I am Rear Admiral Stephen Redd, Director of CDC's Office of
Public Health Preparedness and Response. I am pleased to appear before
the committee today to discuss the state of public health preparedness
in the United States and the role that the Pandemic and All-Hazards
Preparedness Reauthorization Act of 2013 (PAHPRA) and other legislation
play in improving the health security of the Nation.
CDC advances the health security of the Nation by helping
communities prepare for, respond to, and recover from all hazards,
including chemical, biological, radiological, and nuclear threats;
natural disasters; and epidemics (Influenza). Whether the hazard is
naturally occurring (Ebola, Middle East Respiratory Syndrome, and
hurricanes), accidental (the 2014 West Virginia chemical spill) or
intentional (Boston Marathon bombings and anthrax attacks), effective
public health emergency response depends on building, maintaining and
constantly improving the capability of State and local health
departments to prepare for and respond to public health emergencies.
The all-hazards approach to public health preparedness and response
fosters development of emergency-ready public health departments that
are flexible and adaptable to the needs of a particular event.
In support of the National Strategy to Combat Antibiotic Resistance
Bacteria (CARB) released in September 2014, CDC is also working with
other HHS agencies and executive branch departments to address the
growing threat of antibiotic resistance. Without rapid and coordinated
action, antibiotic resistance threatens public health progress made
over the last century from the discovery and development of antibiotic
drugs, thereby threatening patient care, economic growth, public
health, agriculture, economic security, and national security. The
President's fiscal year 2016 budget supports implementation of the
National Strategy by nearly doubling the amount of Federal funding for
combating and preventing antibiotic resistance to more than $1.2
billion. The funding will improve antibiotic stewardship; strengthen
antibiotic resistance surveillance and prevention capacity; and drive
research innovation in the human health and agricultural sectors.
role of state and local public health agencies
State and local public health agencies are the lead entities in
public health preparedness and response. CDC provides ongoing technical
assistance and, if requested, will provide on-the-ground personnel to
assist with a state's response effort. For example, CDC personnel are
providing laboratory capacity and communications support to California
public health agencies in response to the current measles outbreak.
Investments in preparedness since 2001 have greatly increased the
Nation's public health preparedness for all hazards. One of the lessons
learned as a result of responding to the 9/11 and anthrax attacks was
that State and local health departments lacked critical capabilities
needed to mount an emergency response, and the Nation's public health
system also was unable to provide essential public health services
during an emergency. Health departments lacked laboratory networks,
electronic disease surveillance systems, risk communication networks,
and emergency operations centers.
Successful State and local response to public health emergencies
depends upon many factors, including a capable State and local public
health and healthcare system. Since 2002, CDC has awarded more than $9
billion to improve preparedness at the State and local level, first
through the Cooperative Agreement for Preparedness and Response to
Bioterrorism, and then through the Public Health Emergency Preparedness
(PHEP) cooperative agreement authorized by the Pandemic and All-Hazards
Preparedness Act of 2006 (PAHPA) and reauthorized as PAHPRA in 2013.
PHEP currently supports 62 awardees--including all 50 States, 8
territories and freely associated States, and directly funded cities
(New York City; Washington, DC; Chicago; and Los Angeles)--according to
a base-plus population formula prescribed by statute, which ensures a
minimum amount of funding to each awardee. These funds support staff,
enable exercises, provide for training, pay for equipment, and provide
other services essential to maintaining preparedness. In addition, CDC
personnel help PHEP awardees improve their performance by sharing
knowledge, useful practices and lessons learned along with the tools
and resources needed to identify and address gaps in preparedness
capabilities. Congress appropriated $571 million to CDC to enhance
domestic preparedness and response for Ebola including State and local
preparedness, laboratory capacity, and expanded entry screening.
Cooperative agreements under CDC's PHEP program and the Hospital
Preparedness Program (HPP), overseen by the Assistant Secretary for
Preparedness and Response (ASPR), are managed through a joint funding
opportunity announcement. This collaboration reduces the administrative
burden on the awardees through a single application process for both
cooperative agreements.
In 2011, CDC published the Public Health Preparedness Capabilities:
National Standards for State and Local Planning to better focus the
preparedness activities of State and local health departments.\1\ The
15 capabilities serve as national public health preparedness standards
and help ensure Federal preparedness funds are directed to priority
areas. State, local and territorial health departments allocate PHEP
funds based upon their strategic priorities. Awardees devote nearly 50
percent of their funding to building and sustaining Public Health
Surveillance and Epidemiological Investigation and Public Health
Laboratory Testing capabilities, core public health activities that
help protect their communities. Remaining funds are invested in the
other 13 capabilities--Community Preparedness, Community Recovery,
Emergency Operations Coordination, Emergency Public Information and
Warning, Fatality Management, Information Sharing, Mass Care, Medical
Countermeasure Dispensing, Medical Materiel Management and
Distribution, Medical Surge, Non-Pharmaceutical Interventions,
Responder Safety and Health, and Volunteer Management.
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\1\ http://www.cdc.gov/phpr/capabilities/index.htm.
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Each year the 62 PHEP awardees report data on their current status
for each capability. The data and supporting documentation are
validated by CDC's Office of Public Health Preparedness and Response.
Aggregate awardee scores show increases in 14 of the 15 capabilities
over the past 3 years. The 2014 response to Ebola cases in the United
States illustrates one of the impacts of PHEP funding throughout the
past decade. Through that funding, State and local health departments
across the country built their capability to perform effective contact
tracing to help identify individuals who may have been at a higher risk
for infection due to contact with a person with Ebola or due to travel
from one of the highly affected countries in West Africa.
lessons learned from real-life events
While training and skill development are important, exercises and
real-life events provide opportunities to put those skills to work.
PHEP awardees are required to demonstrate their capabilities at least
once a year by conducting an exercise and evaluating their performance
through an after-action review process. Oftentimes, jurisdictions are
able to use real incidents in their communities to test operational
readiness to respond to public health emergencies. After-action reviews
collect data about successes and areas for improvement identified
during unexpected incidents, exercises, and planned events such as
festivals or concerts that draw large crowds. Data from these reviews
are used to identify strengths for sustainment and gaps for future
capability development. Use of this information is key to improving
performance for the next incident.
The review process following the 2009 national response to the H1N1
Influenza pandemic provides a good example of how identification of an
obstacle encountered during a response can be a catalyst for changes
that improve preparedness for future events. At the State and local
levels, employees supported through Department of Health and Human
Services (HHS) grants that were funded by non-influenza programs were
not able to assist in response to the flu outbreak due to restrictions
on performing tasks outside of the funding for their normal work. In
some areas where there were not enough staff for the H1N1 response,
this restriction prevented additional State and local staff from
performing surveillance or providing vaccinations. Federal and State
partners identified this issue, and the Congress provided new
authorization in PAHPRA in 2013 that provides a mechanism for States to
request that a worker at the State or local level who is funded under
programs authorized by the Public Health Service Act be allowed to
assist, based on specified criteria, in a response to a federally
declared public health emergency. This provides additional flexibility
and scalability to support quick and effective responses to public
health emergencies.
a strong laboratory network
Rapid identification of disease is critical to addressing public
health threats before they become a crisis. CDC's Laboratory Response
Network (LRN) maintains an integrated network of State and local public
health, Federal, and international laboratories that can respond to
biological, chemical, and other public health threats. The linking of
State and local public health laboratories, veterinary, agriculture,
and water- and food-testing laboratories is unprecedented and provides
for rapid testing, timely notification and secure messaging of
laboratory results. The LRN demonstrates a scalable and flexible asset
to address public health threats.
In response to the West Africa Ebola outbreak, CDC collaborated
with the Department of Defense (DoD) to equip select LRN laboratories
around the United States with the ability to quickly and accurately
test specimens for the outbreak strain of Ebola virus. Prior to the
current outbreak only two LRN laboratories were capable of performing
an Ebola test--DoD's U.S. Army Medical Research Institute of Infectious
Diseases and CDC laboratories. By August 1, 2014, CDC provided the FDA
emergency use authorized DoD assay to 13 LRN public health laboratories
in States chosen based on geography and the number of travelers
arriving from West Africa. Currently, 55 laboratories in 43 States have
completed proficiency testing with the DoD Ebola assay, and CDC
continues to work with LRN laboratories to acquire and maintain
capacity to handle Ebola specimens.
medical countermeasures for public health responses
CDC's Strategic National Stockpile (SNS) manages and delivers life-
saving medical countermeasures during a public health emergency. Valued
at approximately $6.3 billion, it is the largest federally owned
repository of pharmaceuticals, critical medical supplies, Federal
Medical Stations, and medical equipment available for rapid delivery to
support Federal, State, and local response to health security threats.
If a biological, chemical, radiological, or nuclear event occurred on
U.S. soil tomorrow, the SNS is the only Federal resource readily
available to respond once State and local medical countermeasure
supplies are depleted.
CDC works with ASPR and with other Federal agencies, through the
Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), to
prioritize Federal investments in medical countermeasures based on
analysis of risk and support of critical markets. SNS procurements and
the advanced development and procurement mechanisms managed through
ASPR are critical to maintaining production capacity for products with
no commercial market and products for which commercial supplies may be
insufficient to meet demands during an emergency.
Just as important as having the right medical countermeasure on the
shelf in the SNS is knowing our public health partners at the State and
local levels will be able to effectively and efficiently receive those
assets from the SNS and get them to the individuals in need of
treatment or protection in time. For this reason, CDC offers training
programs to ensure that our partners have the knowledge and skills they
need to distribute and dispense SNS assets in a timely manner, and CDC
supports exercises to test the skills of trained responders and
evaluate plans for possible improvements. These trainings and exercises
help our partners improve their preparedness and establish confidence
in their ability to respond.
Jurisdictions face ongoing challenges when planning to dispense
medical countermeasures to large populations. Whether it is the
availability of staff or infrastructure to support dispensing of
medical countermeasures to large populations, few State or local public
health agencies have the resources at their disposal to meet the
required dispensing timelines. For this reason, CDC engages with the
private sector to establish agreements for support of medical
countermeasure dispensing. These partners, who range from nationwide
retail, pharmacy and hospitality chains to faith-based and community
organizations, all make commitments to support dispensing of
countermeasures in the communities they serve. These partnerships, when
working with local public health officials, improve efficiency, provide
additional means to dispense medical countermeasures to populations
within the community and reduce the burden on local public health
responders during times of urgent need.
conclusion
Public health threats are everywhere. From the reemergence of
measles, which hadn't been a problem in the United States for years, to
the Ebola virus, a threat from the other side of the world, to an
earthquake that can strike without warning, the public health system
must remain vigilant to protect U.S. residents.
Preparedness is not a destination. It is a process of skill
development, using lessons learned to help us adapt to the current
environment and better prepare us to address future threats. CDC will
continue to work with our Federal, State, territorial, local and tribal
partners to ensure necessary capabilities are maintained to keep the
public safe. I look forward to our continued partnership with the
Congress and would be glad to answer any questions you may have.
Senator Burr. Thank you, Dr. Redd.
Dr. Borio.
STATEMENT OF LUCIANA BORIO, M.D., ASSISTANT COMMISSIONER FOR
COUNTERTERRORISM POLICY, DIRECTOR OF THE OFFICE OF
COUNTERTERRORISM AND EMERGING THREATS, DEPUTY CHIEF SCIENTIST
(ACTING), U.S. FOOD AND DRUG ADMINISTRATION, SILVER SPRING, MD
Dr. Borio. Good morning, Chairman Alexander, Senator Burr
and Senator Casey, and thank you for calling this hearing. I'm
grateful for the opportunity to appear before you today to
discuss FDA's preparedness and response efforts.
I can say with confidence that we are much better prepared
today because of this committee's actions and your leadership,
Senator Burr. PAHPRA established key legal authorities to
strengthen our Nation's readiness for public health
emergencies.
In 2010, FDA launched its Medical Countermeasures
Initiative to deepen our engagement in medical countermeasure
activities. This engagement and new authorities, both codified
in PAHPRA, have improved FDA's readiness and has allowed us to
mount an extraordinary response to the Ebola epidemic in West
Africa.
There are currently no treatments or vaccines that have
been shown to be safe and effective for Ebola. The FDA is
taking tremendous steps to speed the development, manufacture,
and availability of these medical products. We have established
continuous lines of communication with commercial developers
and U.S. Government agencies.
We are reviewing data as they are received. We have worked
with product sponsors, international regulators, and the NIH to
launch Ebola vaccine trials in record time. We are leveraging
our authorities under PAHPRA. We issued EUAs for eight Ebola
diagnostic tests, and as mentioned earlier, just 2 days ago, we
authorized the first point of care rapid diagnostic test for
Ebola.
We collaborated with the NIH on the design of innovative,
adaptive, and scientifically rigorous clinical trial protocol
to evaluate investigational drugs for Ebola. This clinical
trial, which will first test ZMapp, is now positioned in the
United States and in Liberia.
These accomplishments were made possible by the hundreds of
frontline FDA scientists and medical officers engaged in this
response. I would like to thank them for their tireless efforts
and unwavering commitment to service. Congressional investment
in our FDA program has also led to improved preparedness in a
broader way of threats. For example, under our EUA authority,
we authorized the use of diagnostic tests for the H7N9 avian
influenza virus and the Middle East Respiratory Syndrome
coronavirus. In this time period, FDA approved medical
countermeasures for anthrax, botulism, plague, seasonal and
pandemic influenza. I may add that virtually all of these also
carry a pediatric indication, thanks in part to regulatory
science.
Just yesterday, we approved an antibiotic drug combination
to treat some very serious infections that may involve bacteria
resistant to other drugs. Developing countermeasures is highly
complex, as you know, and the Ebola epidemic has demonstrated
how critical it is to respond with speed and flexibility, but
also how important it is to get it right.
When investigation of products are still in the early
stages of development, it is possible that some that at first
seemed promising may ultimately have little or no effect. The
fastest and most definitive way to determine whether a product
is safe and effective is through properly designed scientific
investigations and clinical trials. In emergencies like this,
the urgency to do something may be used as an excuse to conduct
studies that are not scientifically sound and may fail to
detect harm.
It must be remembered that investigational drugs can have
side effects that may harm patients. This is particularly
important for Ebola, where many patients survive with basic
medical care, and administering a drug that lacks activity and
that has significant side effects to vulnerable patients could
have disastrous and even fatal consequences.
It's very important that decisions about using
investigational products need to be carefully considered. It's
essential for safeguarding patient safety and also maintaining
the trust of affected populations.
I want to conclude by emphasizing that close cooperation
and coordination are essential, and the strong engagement that
is evident among the agencies here today is an example of
public health synergy at its best. There is still a tremendous
amount of work for us to do, and we are fully committed to
leveraging our deep expertise and all of our authorities to the
fullest extent to support our Nation's readiness for these
serious public health threats.
Thank you for making this happen.
[The prepared statement of Dr. Borio follows:]
Prepared Statement of Luciana Borio, M.D.
Good morning Mr. Chairman, Ranking Member, and members of the
committee. I am Dr. Luciana Borio, Assistant Commissioner for
Counterterrorism Policy, Director of the Office of Counterterrorism and
Emerging Threats, and Acting Deputy Chief Scientist at the Food and
Drug Administration (FDA or the Agency). Thank you for the opportunity
to appear today to discuss FDA's efforts to prepare our Nation to
mitigate chemical, biological, radiological, and nuclear (CBRN) threats
as well as threats from naturally emerging infectious diseases like
pandemic influenza and antimicrobial-resistant pathogens.
fda's medical countermeasures mission
FDA plays a critical role in facilitating the development and
availability of medical countermeasures to protect the United States
from CBRN and emerging infectious disease threats. FDA works closely
with its interagency partners through the Public Health Emergency
Medical Countermeasures Enterprise (the Enterprise) to build and
sustain the medical countermeasure programs necessary to respond
effectively to public health emergencies. We also work with the U.S.
Department of Defense (DoD) to facilitate the development and
availability of medical countermeasures to support the unique needs of
the military. The mission of my office is to facilitate the development
and availability of these lifesaving products.
In 2010, FDA launched its Medical Countermeasures Initiative (MCMi)
to focus increased resources on facilitating the development and
availability of medical countermeasures. FDA's scope of operations
within its medical countermeasures mission covers a broad range of
activities vital to facilitating the development of and access to safe
and effective medical countermeasures, including:
Reviewing medical countermeasure marketing applications
and approving those that meet applicable standards for safety and
efficacy;
Providing regulatory advice, guidance and--when
appropriate and needed--technical assistance to medical countermeasures
product sponsors, U.S. Government partners, international regulators,
and international organizations such as the World Health Organization
(WHO);
Supporting efforts to establish and sustain an adequate
supply of medical countermeasures, including averting supply
disruptions when feasible and, in certain situations, allowing products
to be used beyond their expiration dates when supported by our
scientific analyses;
Supporting the development of advanced manufacturing
technologies by collaborating with the Department of Health and Human
Services (HHS) Biomedical Advanced Research and Development Authority
(BARDA) on their Centers for Innovation in Advanced Development and
Manufacturing;
Facilitating access to medical countermeasures that are
not yet approved, licensed, or cleared for use, if circumstances
warrant, through an appropriate mechanism such as an Emergency Use
Authorization (EUA);
Ensuring that FDA regulations and policies adequately
support medical countermeasures development and enable preparedness and
response activities;
Fostering the professional development of our scientists
to ensure that FDA personnel maintain the skills and abilities to
support the medical countermeasures mission;
Proactively identifying and resolving regulatory
challenges associated with medical countermeasures; and
Supporting regulatory science to develop the tools,
standards, and approaches necessary to assess the safety and efficacy,
including quality and performance, of medical countermeasures.
measures of success
The additional resources that Congress provided to FDA for the MCMi
have enabled FDA to hire expert staff and become more deeply and
thoroughly engaged in medical countermeasure activities.
This increased engagement, along with new authorities gained under
the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA)
of 2013, which, for example, provided FDA greater flexibility in the
issuance of EUAs, has enabled FDA to better respond to emerging public
health threats. For example, FDA worked proactively with U.S.
Government partners, international partners, and product developers to
help facilitate the development and availability of medical
countermeasures to respond to the avian influenza A (H7N9) virus and
the Middle East Respiratory Syndrome coronavirus (MERS--CoV). FDA
authorized the use of three diagnostic tests for the H7N9 virus and one
diagnostic test for MERS-CoV, under its EUA authority.
FDA has also taken extraordinary steps to be proactive, flexible,
and highly responsive to the Ebola epidemic in West Africa, which has
presented a complex range of issues. FDA's efforts include:
Working to help expedite the development and availability
of medical products to detect, prevent, and treat Ebola virus disease,
by providing scientific and regulatory advice to commercial developers
and U.S. Government agencies that support medical product development;
Working with product sponsors, international regulators,
WHO, and the National Institutes of Health (NIH) to launch Ebola
vaccine trials in record time;
Collaborating with NIH to help with the design of an
innovative and robust common clinical trial protocol to evaluate
investigational treatments for Ebola;
Collaborating extensively with WHO and our international
regulatory counterparts to exchange information about investigational
products for Ebola in support of international response efforts and to
achieve regulatory harmonization, where possible;
Facilitating access to investigational medical products
for patients with Ebola, when requested by clinicians;
Authorizing the use of seven diagnostic tests for Ebola
under our EUA authority; and
Actively monitoring for fraudulent products that claim to
diagnose, prevent, or treat Ebola infection and taking action, as
warranted, to protect public health (for example, FDA issued Warning
Letters to six firms marketing products that claim to prevent, treat,
or cure infection with the Ebola virus).
FDA's increased engagement under the MCMi has also helped to
resolve many challenges and impediments associated with the U.S.
Government's medical countermeasures pipeline so that development
programs continue to move forward. For example, this has resulted in
the approval of several medical countermeasures, including a
therapeutic for inhalational anthrax, a botulism antitoxin, two
antibiotics for the treatment and prophylaxis of plague, and a next-
generation portable ventilator. Of note, FDA was able to approve the
anthrax therapeutic for use in children as well as adults, despite the
fact that pediatric patients were not studied due to ethical concerns
during the development of this product. This achievement was made
possible by the application of regulatory science.
FDA has also continued its efforts to support the establishment and
sustainment of an adequate supply of medical countermeasures. For
example, FDA supports the Shelf Life Extension Program (SLEP), a
Federal fee-for-service program, for extending the useful shelf life of
military-significant and contingency-use medical products, including
medical countermeasures that are owned by components of DoD or other
Federal program participants, such as the Strategic National Stockpile
(SNS).\1\ FDA laboratory personnel test and evaluate drugs submitted
for shelf-life extension to ensure stability and quality before a
shelf-life extension is approved.
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\1\ SLEP is designed to defer drug replacement costs for date-
sensitive stockpiles of drugs by extending their useful shelf life
beyond the manufacturer's original expiration date.
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In addition, FDA has continued to work to ensure that the U.S.
Government is as prepared as possible to rapidly deploy medical
countermeasures when necessary. For example, FDA has readied stockpiled
medical countermeasures for potential use under its EUA authorities
against a diverse array of threats including smallpox, anthrax, and
pandemic influenza.\2\
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\2\ To facilitate the issuance of EUAs, FDA has developed a pre-EUA
submission process. FDA works with product sponsors or government
agencies, such as CDC and DoD, to develop pre-EUA packages that will
form the basis of an EUA request and decision, when circumstances
justify. Pre-EUA packages contain data and information about the safety
and efficacy of the product, its intended use under an EUA, and
information about the potential emergency situation that might unfold.
---------------------------------------------------------------------------
In the area of pandemic influenza preparedness, FDA has approved
several influenza diagnostic tests, which can help facilitate an
effective response to an influenza pandemic by rapidly identifying
infected persons and facilitating appropriate containment measures and
clinical care. In addition, FDA has approved several seasonal influenza
vaccines, which helps increase and sustain pandemic influenza vaccine
production capacity, including the first seasonal influenza vaccine
licensed in the United States, produced using modern cell culture
techniques, and the first seasonal influenza vaccine made through
recombinant deoxyribonucleic acid (DNA) technology. Both of these
vaccines offer an alternative to the egg-based process and a potential
for a faster manufacturing startup in the event of a pandemic. FDA also
approved the first adjuvanted influenza vaccine for use in people 18
years of age and older, who are at increased risk of exposure to the
avian influenza H5N1 virus subtype contained in the vaccine. This
vaccine is not for commercial distribution but will be part of the
national stockpile in the event it is needed. Furthermore, FDA has
collaborated closely with BARDA, the National Institute of Allergy and
Infectious Diseases (NIAID), and CDC on developing avian influenza H7N9
virus vaccine candidates.
Additionally, FDA has approved the first intravenous antiviral drug
to treat acute, uncomplicated influenza infection in adults and has
expanded approval for use of an influenza antiviral, oseltamivir, to
treat children as young as 2 weeks of age. Prior to this action,
oseltamivir was only approved to treat influenza in children ages 1
year and older. FDA was able to expand the approved use of oseltamivir
in children younger than 1 year old based on the extrapolation of data
from previous studies of adults and older children, and additional
supporting studies sponsored by both industry and academic researchers.
Consistent with the President's September 18, 2014, Executive order
and the national strategy for combating antibiotic resistant bacteria,
FDA is working hard to help ensure the development of new products in
preparation for threats from naturally emerging infectious diseases
from antimicrobial-resistant pathogens. Toward this end, FDA will
evaluate new antibacterial drugs for patient treatments, streamline
clinical trials, help phaseout the use of medically important
antimicrobials in food-producing animals, develop better vaccines for
antibiotic resistant organisms, and strengthen capacities to detect
antibiotic resistance.
On the regulatory science front, FDA has established a broad and
robust portfolio of cutting-edge research under MCMi's Regulatory
Science Program to help develop the tools necessary to support
regulatory decisionmaking. A few examples of ongoing projects include
supporting the Wyss Institute for biologically inspired engineering at
Harvard University as it develops models to assess radiation damage in
lung, gut, and bone marrow, and then using these models to test
candidate medical countermeasures; collaborating with DoD and the
National Center for Biotechnology Information to establish a publicly
available, well-curated, high-quality, whole microbial genome sequence
reference data base from clinically important pathogens, which
diagnostic test manufacturers will be able to use to advance their
sequence-based test development programs; and examining the scientific
basis for the instability of the protective antigens that has hindered
efforts to develop next-generation anthrax vaccines and using protein
engineering to stabilize the antigen.
conclusion
Developing and enabling ready access to medical countermeasures to
mitigate CBRN and emerging infectious diseases is highly complex. Close
cooperation and collaboration within FDA and with U.S Government,
international, and private sector partners are essential, and without
this cooperation and collaboration, progress to address this growing
public health challenge would be very limited. The deep engagement that
is evident among the agencies represented here today is an example of
public health synergy at its best. FDA is fully committed to continuing
to work closely with our partners, using our authorities to the fullest
extent possible to protect and promote public health, both domestically
and abroad, in response to public health threats.
Thank you and I am happy to answer your questions.
Senator Burr. Thank you, Dr. Borio.
Let me say to all of our witnesses that as I look at the
response and our capabilities over this period of time that
we're looking at, we've gotten better every time. The level of
cooperation that exists interagency is remarkable compared to
where it was at the start.
I think that we have tried to work with every agency to
identify those impediments that either needed a push or a
legislative remedy to overcome, that stood in the way of either
further collaboration or a quicker response or a more effective
outcome. I plead with all of you if there are additional things
that you see, having just, hopefully, gone through the Ebola--
this version of the Ebola crisis--I don't want to be
presumptuous--that are further changes that we need to make,
then, by all means, make sure that we're fully briefed on what
they are.
Our attempt is to continue to refine the legislation so
that not only is it seamless, but it is the most expeditious
that we possibly can present. I understand, especially to Dr.
Borio, that there's a huge difference between your mission and
Dr. Robinson's mission from a standpoint of core
responsibilities of the agency. All of them have to work
together for us to maximize the outcome, and that's what we're
all after.
Dr. Lurie, one of ASPR's duties, as set forth by the law,
is to provide leadership in international programs,
initiatives, and policies that deal with public health and
medical emergency preparedness and response. Yet over the past
year as the Ebola outbreak grew in urgency and attention, the
question of who's in charge was once again raised.
I'll ask you what specific steps are you going to take to
make sure that the role of the ASPR is clear and fulfilled
consistent with the statutory intent so that there is no future
confusion on who is in charge?
Dr. Lurie. Thank you, Mr. Burr. I appreciate your question.
I also appreciate all of your letters over the last few months
to be sure that we, in fact, remembered our authorities and
were in a position to leverage every single one of them that we
needed to leverage for Ebola, and I believe that we did.
I'll answer your question in a couple of ways. To begin
with, within ASPR, we have a group that very specifically deals
with preparedness for international public health emergencies
of different kinds--our collaboration with other countries were
the focal point for the international health regulation
reporting and others. We are positioned very much at that
interface.
Within the department, as this unfolded, as I think you
know, it unfolded first as a global or an international event
in West Africa. I'll say for starters that if anyone ever
needed any reminding that what happens somewhere else is
important to U.S. domestic national health security, I hope
they need to look no further than this past year as any
reminder for that.
In a complex emergency where multiple departments and
agencies are involved, as you first know, the President is in
charge, and within the department, the Secretary is in charge.
Throughout this event, the Secretary took full advantage of all
of the different kinds of roles and expertise at CDC, at NIH,
at FDA and ASPR and BARDA and beyond, pulling together people
every day.
Senator Burr. Let me stop you there, if I can.
Dr. Lurie. Yes. Sure.
Senator Burr. Because there was tremendous thought put into
this as we constructed it originally. As a matter of fact, you
couldn't find anybody to raise their hand and say ``I'm in
charge'' when there's a problem.
Dr. Lurie. I'm in charge.
Senator Burr. We created the office specifically for this
purpose. Trust me, I get it. The President is in charge. When
you get past the President--do you remember the weeks and
months that we went through of the requests by the public and
people abroad and people in government going ``Who's in
charge?'' There was a point that the White House got to where
they appointed somebody who never made a public statement, and
they said, ``You're in charge.''
When I called the White House and asked who was in charge,
they told me another person. The statute of the law says you're
in charge, because you're ASPR. Why was that so difficult for
people to understand? One of the purposes of this whole
legislation was to map out what we do when something happens.
Quite frankly, we got from there down pretty good, and this is
not critical of you, individually.
I have raised this with the Secretary. I have raised it
with the chief of staff at the White House. I have raised it
with Lisa Monaco. We tried to recreate a wheel when we had an
architecture in legislation already in statute that says if
something happens, here's what we do--bam, bam, bam, bam, bam.
It disturbs me only from this standpoint, that every other
mechanism that we put in place worked almost seamlessly.
We could make the case, Robin, that maybe we should have
had some stuff in NIH at a more mature state so that there
could have already been a handoff.
I think, Dr. Fauci, you would probably agree with that. It
got put on a back burner.
It might be that CDC might have had more assets
prepositioned somewhere in the world, but they responded to it.
It may have been that maybe FDA had done further thought about
how do we expedite a review on things that are critical to
whether somebody lives or dies. They've done that.
I still get the impression that we're not sold on who's in
charge. What does it take?
Dr. Lurie. I take your point, and, as you know, we are not
totally through this event. We still have a lot of action going
on in West Africa. We hope we don't have more Ebola cases here,
but we are focused and vigilant and prepared.
Even though we're not yet through, we have already begun
both a series of in-process progress reviews as well as a
process for us to step back and look at lessons learned and
take corrective actions, both within the department, and I
think it's fair to say that every part of government that was
involved in Ebola is really looking at lessons learned and how
to do better the next time. I will look forward to sharing
those and discussing those with you as we move forward.
Senator Burr. Well, I hope you will also raise your hand
and say, ``You know what? I was supposed to do all this.'' As
you know----
Dr. Lurie. Absolutely. I hear you.
Senator Burr [continuing]. I think so much of the
Secretary. The Secretary, by design, wasn't put in charge,
because the Secretary has all sorts of other things. For this,
to at least be tried, we have to get to the point where we
execute what the statute of the law says. I thank you for the
work that you do.
Senator Casey.
Senator Casey. Thanks very much, Mr. Chairman.
I wanted to start with something that I could have
mentioned in my opening, but we've got two panel members that
have Pennsylvania connections. The committee, I'm sure, will
indulge me.
Dr. Lurie, as Senator Burr introduced you--both college and
medical school at the University of Pennsylvania. I want to
note that for the record.
Dr. Borio--senior associate at University of Pittsburgh
Medical Center for Biosecurity and assistant professor of
medicine at the University of Pittsburgh from 2003 to 2008.
I just had to say that, and I'm sure Dr. Robinson and Dr.
Redd would want to retire in Pennsylvania or have some
connection so we can mention it at a hearing.
[Laughter.]
I wanted to focus initially on one broad topic as it
relates to all of your mandated responsibilities and the
obligation you have to implement the Preparedness Act,
including both the original act and then the new reauthorized
act. I want to talk about children in a broad-based way.
A lot of great advocates for children over many years have
often said that children are not small adults, that we have to
often have different strategies, different approaches, and
different treatment regimens to deal with the impact on
children when we have a disaster or an outbreak. In particular,
I wanted to ask each of you--and maybe just starting with Dr.
Lurie and go from my left to right--to ask you how are you
ensuring in your work that the needs of children are being
met--and I know, Dr. Lurie, you mentioned children in the
opening part of your testimony and it's in your prepared
testimony.
How do you ensure that the needs of children are included
in both preparedness and in terms of response planning efforts?
Dr. Lurie. Great. I'm so glad you asked the question. I
came into this job, No. 1, as a mom, and No. 2, recognizing
that children are a quarter of the population, and they're a
very diverse population, and the area of children is an area
that I feel very, very proud of our progress.
Let me just give you a couple of examples. To start with,
we now have something we didn't have before, which is that all
of our national disaster medical teams are pediatric-equipped
and pediatric-capable. We took a look at where we were in terms
of mental health in response and realized that we really fell
short, in general, and fell short for children, and we've
remedied that situation.
With regard to countermeasures, we took----
Senator Casey. Let me just stop you there. Remedied in what
way?
Dr. Lurie. Well, first of all, we have a formal operational
plan now for how we do this, and we have formal components,
formal guidance, and staff that deal with children. We took a
good hard look at our countermeasure portfolio and both put
together an ongoing pediatrics-obstetrics group to look at
countermeasures, but, more importantly, made specific
countermeasures and formulations for children, both for the
stockpile and for products in development.
These are anywhere from kinds of flu vaccines to radio-
nuclear countermeasures and antibiotic formulations, all the
way to a portable ventilator that is suitable for neonates.
We have a children's advisory committee now that just got
up and running. One of the things I asked them to do first off
was take a look at the issue of children at large and help us
think about, No. 1, all the areas where children are not small
adults, but also areas in which children, particularly youth,
are poised to contribute to preparedness and response in a
variety of different ways, because, as you know, we have to
meet kids where they are along the whole developmental
spectrum.
And, finally, just let me say with regard to Ebola, one of
the things I went way out of my way to do was to be sure that
we had children's hospitals that were prepared and will be
funded as Ebola treatment centers. That's just a quick
smattering. I could go on with a long list. I'm happy to
provide more information.
Senator Casey. I appreciate that.
Dr. Robinson and the rest of the panel, you're left to
speak in sound bites now.
Ms. Robinson. In addition to the medical countermeasures
that Dr. Lurie mentioned, we actually have pediatricians on
staff that are able to help us with those medical
countermeasures and work with FDA and CDC and ASPR on that.
Senator Casey. Thanks.
Dr. Redd. In the strategic national stockpile, we include
formulations that are specific for children, for example,
oseltamivir suspension.
Senator Casey. Doctor, when you say formulations, explain
what that means.
Dr. Redd. It's essentially the form that the drug is stored
in. It's as a suspension so children don't have to be able to
take tablets or capsules. We have a children's team when we
respond in the emergency operation center, and that is linked
tightly with the American Academy of Pediatrics.
We also understand your question. In fact, we have a
monthly public health grand rounds, and the one in March, this
coming March, will be on issues for children. In fact, Dr.
Lurie will be a speaker at that grand rounds.
Senator Casey. Thank you.
Dr. Borio.
Dr. Borio. In addition to what was already previously said,
we also have a pediatric action team that works in tandem with
BARDA to provide input on these issues, and I think that in the
last 5 years, we've seen tremendous progress in the capability
to develop and make sure that new countermeasures that are
being approved today carry the pediatric indication. Even
sometimes when studies cannot be done in pediatric populations,
we'll use regulatory science to be able to extrapolate a dose,
given the important need of children during disasters.
Senator Casey. Thank you very much.
Thank you, Mr. Chairman.
Senator Burr. Chairman Alexander.
The Chairman. Thank you, Senator Burr.
To all the witnesses, we have an ongoing priority in this
committee, a project on innovation to try to identify how to
move treatments, cures, and devices from early stage
development into medicine cabinets, and to do that more rapidly
and still do it safely. We're doing that in a bipartisan way.
We're doing it in parallel with an effort in the House
called 21st Century Cures. President Obama is very interested
in it because of his interest in precision medicine. I've
talked with him about it.
What I'd like to say to the four of you and to your
agencies is that the train is moving through the station this
year. We expect to finish that work this year. We already have
a bipartisan working group of staff members that Senator Murray
and I have constituted.
If there are specific legislative things that you need us
to do, now is the time to do it. We need specific
recommendations.
For example, Dr. Borio, if you need new tools to develop
medical countermeasures that we've overlooked, I wouldn't wait
a year or two. I would offer suggestions within the next few
weeks.
I think we will succeed with this. There's no reason we
shouldn't because of the broad interest and support we have
both from the administration and from the Democrats and
Republicans on the committee.
I have two questions I want to ask, but I want to go back,
Dr. Lurie, to this ``who's in charge'' question. When I was a
Governor, I used to have a phrase, ``Who's on the flagpole?''
If nobody was on the flagpole, nothing got done. If somebody
was on the flagpole, usually we'd show up the next week and it
got done, because it would be that person's responsibility.
I think of Hyman Rickover, who would tell the captains of
the nuclear subs two things when they'd have a 7-minute
interview with him. One is, ``You're in charge of the ship.
You're in charge of the reactor. If anything happens to the
reactor, your career is over.'' We have never had a death as a
result of a Navy reactor problem in the last 60 years in this
country because of accountability.
We didn't have that with Ebola. Maybe it was our fault for
not seeing it. I expected someone to step up and say who was in
charge and maybe this is the President's fault. Somebody should
have said, ``Dr. Lurie is in charge here. She's on the
flagpole.'' If it had been a military operation, we would have
had a daily briefing.
We had a near panic in the United States over Ebola. I
thought for a while that if I had announced, or if you had
announced, that if you'd take your flu shot, you wouldn't get
Ebola, about 9,400 lives could have been saved, because people
would go take a flu shot, an Ebola shot, because people were so
afraid of Ebola.
In Tennessee, public health departments were turned upside
down because all they were doing was Ebola. In hospitals, they
were spending all their time and money buying personal
protective suits for Ebola. All that was good, and the reaction
was good. It needed to be put in perspective, and people were
afraid.
I think we should consider if the Assistant Secretary of
HHS can't be seen in an epidemic as in charge, then maybe we
should change the law. I know you have thought about this.
First, it was Dr. Frieden. Next it was NIH. Then the
President appointed a czar who became the phantom of the White
House and disappeared and was never seen again. Maybe he did a
good job, but none of us would know it. He wasn't available to
testify before this committee or any other committee because he
was a White House czar. This is something we should think about
before we have another incident like that.
Let me go to you, Dr. Robinson. I visited Dr. James Crowe
at Vanderbilt University. He's developing antibodies for
Ebola--one of the most advanced centers for that kind of work.
It was very, very impressive. He did some of the work with Mapp
Biopharmaceutical that has been mentioned.
He talked about the ``Valley of Death,'' and his antibodies
for Ebola are many years away from being available to help cure
someone. What else can we do about the so-called ``Valley of
Death,'' which is generally described as the space between
studies in the lab and human clinical trials? How can we
compress that, both for identified threats and emerging
threats, like--Dr. Crowe was working on something called
chikun.
Ms. Robinson. Chikungunya.
The Chairman. Yes. That's not an identified threat. That's
another one of these things that could come at us from out of
left field, and it's not even in line with an identified
threat. What else can we do about the ``Valley of Death?'' I'd
conclude by saying again if there are legislative things we
need to do, this year is the time to do it.
Ms. Robinson. Thank you for the question. There are two
things I would say. First is that BARDA has been able to mature
programs for CBRN and pandemic influenza. The third part of
what PAHPA put us in charge of doing was making medical
countermeasures for emergent infectious diseases.
We haven't until the Ebola epidemic actually been able to
really get into that space. We now are fully there with all our
response capabilities and everything that we've done for the
others. We are setting up an emergent infectious disease
division that will have response and preparedness
responsibilities, and we need to be able to afford to do that
and prioritize those high threats for emergent infectious
diseases to do that.
The second thing is our Centers for Innovation in Advanced
Development and Manufacturing were for advanced development.
What we had to do because candidates were so early in
development--we had to reach back very early. We realized
that's something that we do well and we can go forward with in
actually being able to take, with response capabilities, early
development, even almost discovery, and bring them forward.
We did this with Ebola monoclonal antibodies with several
companies starting from scratch, and they were able to do it in
4 or 5 months. Now we're being able to go into non-human
primate studies, and we'll be going into clinical studies
later. We can do that, but we need to be able to have the
resources to do so.
Senator Burr. Senator Warren.
Statement of Senator Warren
Senator Warren. Thank you, Mr. Chairman. Infectious
diseases pose an enormous threat to human health and to the
world economy. Each time a disease appears, Congress is great
about spending billions of dollars combating the immediate
crisis. But Congress is terrible about spending money to make
sure we're ready for these crises before they occur.
NIH funds the research that leads to the cures, but it has
lost nearly 25 percent of its purchasing power since 2005. The
CDC is responsible for keeping us safe from outbreaks, but
Congress gives CDC only about $20 per American to be prepared
for everything from a bad strain of the flu to food poisoning
to Ebola. Project BioShield, which ensures that we have medical
countermeasures for emergencies, is subject to the tumultuous
appropriations process.
What I'd like to ask is how do robust and stable
investments in basic research and development help us prepare
our Nation to deal with known and unknown contagious diseases?
Maybe I could start with you, Dr. Lurie. If we can, we'll try
to keep this short. I want to make sure we get this on the
record.
Dr. Lurie. Sure. Thank you so much for your question. It's
terribly important. One of the things that's so challenging is
that Americans forget quickly, and we do lurch from crisis to
crisis. The funding lurches from crisis to crisis.
We need to have sustainable funding that people can count
on year after year so they can hire employees, so they can make
investments, so they can continue to train and exercise. I know
that, initially, Project BioShield was a 5-year commitment.
We've moved to an annual appropriation. I understand that the
annual budget cycle sometimes is not exactly what people need
to have reliable, sustainable investments.
I think it's worth taking a look at how we fund
preparedness overall, both the research and development and
countermeasure parts, but also the routine public health
emergency preparedness, hospital preparedness, which has had
significant cutbacks as well, and to be sure that a workforce
coming up in this field who want to dedicate themselves to
America's health security know that this is a sustainable
career path and the rug isn't going to be pulled out from under
them as soon as they train.
Senator Warren. A very important point. Not just the
training of the current workforce but how we develop the people
who are going to do this work.
Would you like to add to that, Dr. Robinson?
Ms. Robinson. Yes. Thank you. I think that Project
BioShield with the addition of PAHPA made the advanced research
and development pipeline very robust, and now we're ready to go
forward and harvest some of that fruit. Without having
sustainable funding going forward, then our partners in
industry are really at a standstill as to whether they should
continue with their portion of the funding going forward.
Project BioShield was funded under the special reserve fund
originally under a special appropriations. Industry has asked
for that, and, certainly, we wanted that to begin with. We
understood budget austerity, but we still think that that's an
important message.
Senator Warren. If I can say it another way, we get maximum
leverage from the Federal dollars by getting the industry to
pick up much of this work. That happens better when there is
robust funding that's guaranteed over a much longer period of
time.
Ms. Robinson. I agree.
Senator Warren. Is that fair?
Ms. Robinson. I agree.
Senator Warren. Good.
Would you like to add to that, Dr. Redd?
Dr. Redd. Yes, ma'am. What we find in emergency response is
that the public health systems that are in place all the time
are the ones that are most able to adapt to be used for an
emergency response. I'll give you a quick example. During the
H1N1 pandemic, we distributed the monovalent vaccine through
the system that's used to send vaccines into the Vaccines for
Children Program. It worked very smoothly. Physicians were able
to order doses through their health departments.
In contrast, the system that was used to distribute
oseltamivir delivered it to States where there hadn't been the
same kind of planning and experience in distributing that drug
further down the line, and it didn't work as well.
Senator Warren. The short version is we've got to be ready
all the time. Right?
Dr. Redd. Yes, ma'am.
Senator Warren. All right. Good point, Dr. Redd.
Dr. Borio, would you like to add anything?
Dr. Borio. Thank you for the opportunity. Our resource
requirements are of a different magnitude because we are not
developing and purchasing products. For the health of the
pipeline, the FDA plays a very critical role. Our expert staff
and our regulatory science need to be supported to be able to
support the entire pipeline.
This staff that works in these areas are highly, highly
expert and experienced. We need to be able to hire and retain
them.
Senator Warren. All right. Thank you all very much. We're
falling behind in our preparation for known threats, and we're
not laying the intellectual and the scientific groundwork to
prepare for the next round of threats.
If Congress is truly concerned about the very real threat
of contagious diseases, then we need to start making some smart
decisions right now, and that means supporting basic research
at NIH. It means supporting preparation by CDC, and it means
supporting long-term planning by BARDA. We spent decades
building these agencies, and now it's time for Congress to step
up and make sure they have the resources that are necessary to
protect us from the next biological threat.
Thank you, Mr. Chairman.
Senator Burr. Thank you, Senator Warren.
Senator Cassidy.
Statement of Senator Cassidy
Senator Cassidy. Dr. Borio, during the Ebola outbreak,
several agencies, including USAID, the Defense Threat Reduction
Agency, issued broad agency announcements seeking proposals for
devices and diagnostics to respond to and contain the Ebola
outbreak. Did the FDA implement an expedited approval process
for these devices? How long would the expedited review process
take, if they did? And can the FDA trigger it with existing
authority, or do you need specific requests from another
Federal agency?
Dr. Borio. Well, our outreach in the diagnostics has been
one of the most active. As a result of PAHPRA authorities,
we've been able to issue EUAs for now eight diagnostic tests.
Senator Cassidy. So your existing authority is adequate?
Dr. Borio. Yes, and our staff basically stand ready to
review submissions as they are received. As an example, the
first test for Ebola that was authorized for use under an EUA
was a DoD developed test. We were able to authorize it within
24 hours. The most recent EUA was issued after staff on standby
worked through the weekend to review the application.
Senator Cassidy. Well, a hat tip to you all for being so
prompt. Thank you, and I mean that sincerely.
Dr. Borio. Thank you.
Senator Cassidy. Dr. Redd, March 2014, Guinea had
reported--as I review the literature, I think it was back in
Zaire long ago that there was an outbreak of Ebola that was
contained, and we knew how to contain it. In March 2014, Guinea
had reported 49 cases--which within weeks spread to Liberia.
I remember seeing an MMWR report on this, and sometime--I
couldn't dig it back up, but sometime early summer, CDC had
field workers in the affected countries. You all were aware of
this and were in the process of responding. It wasn't, though,
until the cases reached the thousands and Americans were
getting infected that we really triggered that huge response.
You all mentioned that you are doing kind of a postmortem.
I don't mean that in a grisly sense, but, a kind of after-the-
fact analysis of what's going on. It begs a question, though.
You've got trained public health there. You know how to stop
it, but you see the genie coming out of the bottle. Why did it
take this sort of dramatic increase before the hammer went down
and those resources were fully requested?
Dr. Redd. Yes, sir. The outbreak was identified in March
2014. A large team responded to that, a multinational team led
by the World Health Organization. The disease was brought under
some measure of control, but not enough. The entire team
redeployed in May-June, and----
Senator Cassidy. Wait, there's something you left out.
Redeployed--meaning they were yanked out?
Dr. Redd. They came back. Yes, sir.
Senator Cassidy. What was the incident rate, and what was
the geographic spread and the interval between when they were
pulled out and it began to spread once more?
Dr. Redd. I can get you the exact numbers. I don't have
those on hand right now, but I think I would take your main
point that that was a mistake.
Senator Cassidy. It's easy with a retrospective to look
back and say it was a mistake. Reasonably speaking--again, I'm
asking, because CDC--you're good. You're real good. You had--
no, wait a second. There's a case over here that previously has
not been contained. Maybe we should not pull out. Did you have
the ability to not pull out if World Health said ``yes'' but
you said ``no''?
Dr. Redd. I think in retrospect, we would not have pulled
out. Let me just continue on, because the emergency operations
center at CDC was activated at the beginning of July, and that
was as cases in Liberia and Sierra Leone were detected. We've
been activated since that time, our highest level of activation
since early July. Cases really--there was an exponential
increase that began in August and September.
Senator Cassidy. The exponential increase--just
intuitively, you know that there was a slope that began to
ascend, and this is a curvilinear slope, so it's going to begin
like that and then it's going to rocket-ship up. Right?
Dr. Redd. Yes, sir.
Senator Cassidy. I guess the question I come back to--
Senator Alexander has left--but it seems like there should have
been somebody on the ground, saying, ``Listen, we're seeing a
curvilinear increase in the number of cases. This thing is
about to take off.'' It shouldn't have taken an American
missionary to get infected. Do you follow what I'm saying?
Dr. Redd. I do. I do. Actually, I wanted to say that the
recognition of the problem did not coincide with the people
coming back with infections. It was before that----
Senator Cassidy. Well, believe me, I understand that. You
guys are so good. You saw that graph, that incident rate,
beginning to increase, and that begs the question, though: Did
it fall on deaf ears? Did people there make a mistake in not
asking for more help? Because there was a critical time where
you could have stopped it, and yet it took off.
Dr. Redd. I think that there was a period in May and June
when a more vigorous response could have made a big difference.
Senator Cassidy. Again, I come back to my question, and
maybe you can't answer it. Were the resources requested and not
given? Or were the resources not requested?
Dr. Redd. In July, when we went back in, we recognized that
there was a problem. The actual request for large resources--
and I think probably the full recognition of the problem--was
not until September. That was when, as you'll recall----
Senator Cassidy. August is when the exponential increase
began. Did I hear that correctly?
Dr. Redd. There was a lot of work trying to figure out what
was going on during that period of time.
Senator Cassidy. You're not answering my--I don't mean----
Dr. Redd. Well, I'd say that I think that the period when
the exponential increase was recognized was in early September,
and the resources were requested shortly thereafter.
Senator Cassidy. The American returned in August, and
that's when I think it started garnering a large amount of
attention. I assume there was a death rate. You could just look
at the Liberia version of an obituary and have a sense of the
death rate. It was so deadly.
I guess what I'm not fathoming is since your death rate is
such a ready indicator of something bad happening, your death
rates increasing--I don't understand the lag time between
requesting additional resources and the body bags filling up,
so to speak.
Dr. Redd. Well, all I can say is as soon as we recognized
the extent of the problem, we began to work harder and to try
to define what resources were going to be needed. As soon as
that request was formed, it was made.
Senator Cassidy. OK. I yield back.
Senator Burr. Thank you, Senator Cassidy. Let me--I'll wait
for Senator Franken to come back, but I'll take some time in
the interim.
In fact, to Senator Cassidy's answer, Dr. Frieden went in
August, and when Dr. Frieden came back, all of a sudden the
request was made.
Dr. Redd. Yes, sir.
Senator Burr. I mean, it triggered the director being on
the ground. It triggered somebody in that multiple leadership
level--and I'd go back to Dr. Lurie. That's why it is so
important that there be somebody driving the train.
I guess I would ask this, Robin. When did the vaccine alarm
bell go off?
Ms. Robinson. Last summer, probably the middle of the
summer, because we had been looking at a number of different
candidates at the NIH, also at DoD, and we went out and
immediately started looking at procuring those for development.
NIH and CDC were moving forward with putting together the
initial clinical trials with Walter Reed, which actually
started in September and in October, and we made investments at
that time, not only in vaccines, but also in August, in fact,
we went forward with ZMapp as a major investment for
countermeasures.
Senator Burr. I want to point out that this is why we know
what we had in place works, because the alarm bell went off for
vaccines before Dr. Frieden was on the ground, before the
request.
Dr. Lurie.
Dr. Lurie. Yes. Let me provide a little bit more
information about timeline and some activities.
Back in the spring, as we saw the epidemic unfolding in
Liberia, one of the things that I did was pull together all the
members of the Countermeasure Enterprise, including all of HHS,
DoD counterparts, DHS counterparts, others, and said, ``What do
we have anywhere in the pipeline? What's buried in there? Let's
talk to our international partners.''
Through that, we identified the two vaccine candidates. We
identified ZMapp and some other candidates, and we had a number
of Enterprise meetings and said, ``What is it going to take to
put our foot on the gas, pick who we think we can get--the
candidates we think we can get forward with faster? '' By the
time that we really sounded the alarm bell, there was already a
huge amount of work in progress, because now the Countermeasure
Enterprise is working together so well.
I will comment--I'm sorry Mr. Cassidy is not here to do
this. Throughout this whole Ebola episode, we have been racing
to catch up with FDA. They have been amazing in their speed and
their flexibility and their real outreach to work with
companies.
Similarly, back in the spring/early summer, as we looked at
the Ebola trajectory, we said, ``We need to start waking up our
U.S. healthcare system and preparing them,'' and began working
with CDC to develop and push out lots of guidance and
information. In fact, while this was still in Africa, and the
epidemic curve was still going up, Dr. Frieden was on the
ground.
We were taking many, many steps here in this country to
advance our preparedness and to get the countermeasure work
going. That's, in fact, why we've got two vaccines in clinical
trial right now in West Africa and a ZMapp trial which will
start any day.
Senator Burr. I'm not going to be as diplomatic as Senator
Cassidy was, because I think what he was alluding to--and I'm
not surprised you won't go there--was the WHO an impediment?
I'm not asking you. I don't want you to comment on it. The fact
was that the WHO was the lead on the ground, and CDC, even with
great insight as to what the potential was down the road,
wasn't in a position to make a decision to trump the World
Health Organization.
The reason I'm less diplomatic and go ahead and mention
those three letters--folks, this is something we have to think
about. I can't tell you how many times I was on the phone,
saying, ``Forget about them. Bypass them.''
When we see the threat as seriously as we did, then we have
an obligation to this country to do whatever we need to do in
conjunction--and I think this is where we ended up--with the
countries affected and not with some health architecture that
probably had never modeled something quite like this. I only
hope that this is one of the discussions internally that we
will have: How do we react next time if, in fact, we run up
against an impediment that looks like this?
Let me just move very quickly--Dr. Borio, as you know,
human efficacy studies are not feasible for some medical
countermeasures. Therefore, FDA's animal rule is particularly
important for such products. The 2013 PAHPA reauthorization
required FDA to finalize guidance on animal rules.
We're coming up on the 2-year anniversary of the enactment
of PAHPA, and this final guidance is already past due. When
will the animal rule guidance be finalized as required by law?
Dr. Borio. Senator Burr, first I'd like to thank you for
bringing this issue up, because I share your sense of priority
for the animal rule, and I sense the frustration for this
animal rule guidance not having been completed as of yet. We
did issue the revised guidance in May 2014. The comment period
closed in August 2014.
I don't mean this as an excuse, but we have been very
engaged with stakeholders on the guidance, as well as providing
some additional training, and the feedback we have received is
overwhelmingly positive. Having said that, I also requested a
timeline and additional action items that are required to bring
this to closure, because, again, I share your priority, and
I'll do everything I can to bring this to closure as soon as
possible.
Senator Burr. I appreciate that. Please carry the message
back that we are watching. My only regret here is that it
doesn't take EPA as long to promulgate rules and to put
authorizations out as it does at FDA.
Dr. Redd, less than 24 hours before today's hearing, CDC
updated its website to include information on the influenza
antiviral that was approved over 2 months ago and is
highlighted in FDA's testimony here today. This countermeasure
was supported by BARDA and played a role in the H1N1 response.
I'm concerned that in the midst of one of the worst flu seasons
in recent memory, it took CDC more than 2 months to update its
website. What took so long?
Dr. Redd. Sir, I can't answer that question directly. I can
get back to you with an answer. I think 2 months is a long
time.
Senator Burr. Well, let me say get back to us with an
answer and also what steps, if any, is CDC taking to ensure
that this type of delay in providing the most up-to-date and
complete information to healthcare practitioners, whether it's
in the midst of a flu season or not--it could be an emerging
threat like Ebola, and this would seem like it's a fairly easy
thing to try to accomplish. So please take that back.
Senator Casey.
Senator Casey. Thanks, Mr. Chairman. I wanted to get back
to a broader question, make a brief statement and then go to
some followup questions.
The urgency that Senator Burr is talking about is essential
and not just in the heat of the challenge or the crisis. We've
got to have a sense of urgency that's maintained month to
month, year to year, long before we face that challenge.
I was not at all satisfied in the initial weeks, of the
Ebola outbreak, with how the administration was communicating
about this. I just thought it wasn't where it needed to be.
That was unfortunate. I hope, not just this administration, but
a lot of folks can learn from some of the shortcomings of the
response.
Doctor Lurie, when you have a title like yours, Assistant
Secretary for Preparedness and Response, I think it's critical
that that be made known quickly, and that people in the
administration, or the next administration, or 20 years from
now--that they identify you as the point person, and that
that's very clear. I think the communication has to be much
clearer.
Having said that, there was a problem at the time this was
playing out, in my judgment. It is my opinion that because you
had the combination of some shortcomings on communication
combined with a political season, and then the third element,
unfortunately, was some irresponsible statements by folks here
in Washington--I won't say who, but a few Members of Congress--
that added to the problem. That's just my opinion.
I was asked at the time what should be the response from
Members of Congress in the midst of a crisis like that. Unlike
Senator Burr, some Members of Congress weren't looking at
science, and they weren't looking at constructive proposals. I
came up with a radical idea that Members of Congress should
make constructive proposals based on science. I hope we can do
that next time.
Along the way, Senator Warren's point about funding is very
important. I really am grateful for the way in which Senator
Burr has engaged with me on preparedness issues, and also with
other members over many years. I think we can all be better
prepared next time. Even though I think the results by and
large were positive, when you look at what happened here and
what could have happened, it could have been a lot worse than
it was.
Let me just ask you, Dr. Lurie, you don't have to agree
with my assessments--but if someone walked up to you, or to
me--let's say I'm walking down the street in Pennsylvania, and
someone says,
``Well, look, generally, I think we were pleased with
what happened, and that we didn't have the kind of
horror that we saw in West Africa, but I'm a little
concerned about how we dealt with it.''
What would you say to that constituent of mine when they
said,
``What did you learn? What did we do well? What needs
improvement, and what are the areas where Congress can
play a more constructive role?''
Dr. Lurie. Great. I appreciate you asking that question. I
would agree with your constituent that, certainly, early on, it
was pretty bumpy. There were some missteps. I think we were all
able to pivot and get ourselves on a good course. I think
that's just how it was.
We're still in the process of learning lessons. I think
there are a couple of things that are important to highlight
now. We already talked about our interconnected world, but I do
want to highlight that that's why funding for the global health
security agenda, which really strengthens our ability to have
good situational awareness and respond anywhere in the world,
has been part of the President's fiscal year 2016 budget.
The other thing I'll say is when we have an emergency that
doesn't invoke the Stafford Act, as we did with Ebola and as we
have many times before, there are a lot of questions about
where money comes from. We have not had----
Senator Casey. Can you explain that so people understand
what you mean.
Dr. Lurie. When the Stafford Act is invoked, then money is
available through FEMA to respond, both federally and at the
State and local level. When you have these other kinds of
emergencies, largely when something doesn't go boom or terrible
weather doesn't come through, we need to respond with the
current appropriation that we have on hand. Usually that's
already planned for and spoken for.
We don't have an emergency fund that we can turn to, to get
going. We saw this very much in this event. Congress was
terrific, you know, ultimately in providing this emergency
funding. As you know, we all needed to start to respond both in
West Africa and here long, long before that happened.
You'll see again in the President's fiscal year 2016 budget
that there's a request for a sizable emergency fund that I
think we all agree would sit there until there is the next
really bad crisis. Then we don't have to wait for lots and lots
of other processes to run their course to find the funds to get
going. That's important both at the Federal level and it's
critically important for our State and local partners, who get
asked to do a huge amount in these emergencies and, similarly,
don't have the funding to hire staff or turn on the apparatus.
As a place where I think we could make some immediate
improvements and from a policy perspective have a way to go
forward, for me, that's probably No. 1. I think there are some
other smaller things that you'll also find in the President's
budget.
For example, we couldn't send our national disaster medical
system responders into harm's way with Ebola because we had
never been able statutorily to solve this issue about
disability and death benefits should they get hurt or injured
in service. Again, you'll see a proposal and request to do that
in the President's budget.
I think at all three levels, the global level, how we
respond nationally with immediate funding, and then at the
smaller responder level, we all have identified already many
steps to take to improve going forward.
Senator Casey. I know we're over time, but does anyone else
want to weigh in on lessons learned and what you hope we'd be
able to do better together?
Dr. Redd. Just repeating Dr. Lurie's emphasis on the global
health security agenda. Working with these countries
bilaterally to develop the capability to detect, and once
detection occurs to respond effectively could have stopped this
problem long before it got to where it did.
Senator Casey. Thanks very much.
Senator Burr. I think it's only appropriate while we're
having this hearing that there is a news flash that an
Arlington County individual has been taken by EMS--a potential
Ebola case. We've been through that many times and found it to
be not the case.
Dr. Lurie. This is a place, though, where the system now
works extraordinarily well, and I want people to really
understand that.
Senator Burr. I'm convinced it is, and I think,
specifically, for you, I'll put this out as a thought. At some
point, we're going to have to explain exactly how we came up
with the hospitals designated to handle, because there are a
lot of institutions out there that felt they should have been
included in that. Maybe there are a lot that hoped that they'd
never been included in it--I think that's a question for
another day.
Given what we know today about the amount of contaminated
waste that had to be delicately taken care of, when we say this
hospital has the capacity for 10 Ebola patients or 10
infectious disease patients in the future, yet we look at the
capacity to dispose of the waste, meaning two patients, haven't
we done an injustice by suggesting we've got 10 beds when we've
only got 2 beds that we can fill and adequately take care of? I
know this is going to trigger a lot of things for you.
Dr. Lurie. It is, and I look forward to as wholesome a
discussion as you would like about the strategy, about
designation, and the way we've approached Congress' request to
have a regional strategy going forward. I actually feel that
it's quite sound.
Senator Casey really talked about the importance of
science-based decisions. Clearly, at the beginning of this,
there were some things we didn't know about the science. It
also got, as I think we've all pointed out, very confused with
the fear and other factors.
Yes, a hospital that is an Ebola treatment facility has to
be able to handle waste. We also know that there are facilities
in this country that handle waste all the time, including
things like deactivated chemical weapons from Syria or the
Middle East, that were unwilling to take incinerated, not
infectious ash from an Ebola patient.
We have to put some science behind this and some
rationality behind this as we solve the problem. It's an area
where my office has been working very closely with CDC, with
EPA, the Department of Transportation, and we'll have some good
solutions going forward.
Senator Burr. Well, I appreciate that, and let me just make
this comment that I was telling Senator Casey when others were
asking questions. I can still remember Senator Mikulski and I
going through table-top exercises prior to writing the
legislation and how many times we got to a point where you
looked around the table and the question was, ``Who's in
charge?'' Nobody had an answer to it. That's why most of what
went into BARDA was the direct result of going through and
gaming these things out and knowing the difficulty.
I hope that the after-action process that is initiated from
this exercise in Ebola, regardless of which agency it's at, is
that we're sitting down, taking those things that we now know
are difficult, those things we now know are inciting for the
public, and we're figuring out a way to structurally make sure
that we've either minimized them or eliminated them for the
next round of this, because that's absolutely important. I
would tell you it starts right at the top, that somebody is
securely in charge of the whole process right from the
beginning.
Dr. Lurie. Yes, and let me make two comments. No. 1, that
has already begun. I've taken responsibility for this review
process. We already have a long list. Some of these corrective
actions are already in progress, and I'm sure we will surface
more along the way.
Senator Burr. Good.
Dr. Lurie. I also don't want to leave you or anyone else
with an impression that this whole response hasn't been
coordinated. I mean, I want you to be really----
Senator Burr. I feel confident that it has been. Please do
understand----
Dr. Lurie. I understand.
Senator Burr [continuing]. That when I call six different
places, one of them being the White House, and nobody can
answer the question of who's in charge, I have every legitimate
reason to sit up here and question at what point was there one
person who was moving the pieces and making the requests. I'm
hopeful we won't have that problem again.
Dr. Lurie. Yes.
Senator Burr. That was my most recent experience, and it
became very personal, because I thought we did a very good job
of stating in the statutory language exactly how it was----
Dr. Lurie. Because you are the poppa and the grandpoppa,
yes.
Senator Burr. Robin, as you know, BARDA intentionally has a
very specific and targeted medical countermeasure mission, and
this is to ensure that BARDA is staying focused on bringing
forward the medical countermeasures we need to protect the
American people from a range of chemical, biological,
radiological, and nuclear threats. The statute that governs
BARDA is clear on the focus of this mission with all of BARDA's
work being tied to this threat context.
I understand the concerns about increasing resistance to
certain antibiotics. Just this week, there have been reports of
an antibiotic-resistant superbug surfacing in North Carolina.
Clearly, antibiotic resistance is a significant public health
concern. However, I want to take this opportunity to clarify
that BARDA's work in this area is tied to its overall work to
advance medical countermeasures against CBRN threats and not
outside of this context.
Would you please take a moment and explain why BARDA is
working to bring forward broad spectrum antibiotics to address
the CBRN threats we may face and why it's so important that
BARDA's mission not be diluted by matters or mandates that
would require BARDA to work on areas outside of those tied to
threats we have discussed here today?
Ms. Robinson. Certainly. We have a material threat
assessment and determination from the Department of Homeland
Security that says antimicrobial resistance could occur in
these biothreats, like anthrax. That is a threat for us, and
that was the impetus for us in 2010 moving forward toward
developing new classes of antibiotics that would be able to
address antimicrobial resistance in biothreats.
I want to make really clear where we are on this. Our
mission was primarily for biothreats. It will remain there with
this development of antibiotics. They will have benefits for
other high-priority community pathogens. In fact, we see one of
the drugs that we have been developing, plicamycin, that has
been working for a number of different biothreats, is actually
being used--can be used for CRE and may be actually being used
in the outbreak in UCLA hospitals.
Saying that, our funding for broad spectrum
antimicrobials--because there are a number of those different
pathogens that are biothreats--we want to make sure that we
have coverage for those. There are several burkholderia species
that cause glanders and melioidosis that--we have drugs, but
they certainly could be made much better, and we want to make
sure if they're wild type, not antimicrobial resistant--that we
can address those wild type pathogens and have better drugs for
that. That's the main impetus of this.
We certainly want to make sure that the benefits that we
have in those investments can be made for multiple indications
that can help public health, too.
Senator Burr. Dr. Redd, as you and your colleagues at CDC
and BARDA know, it's very important to make sure that BARDA and
CDC are coordinating on strategic national stockpile needs so
that we're bringing forward medical countermeasure candidates
that will meet the identified requirements. There are few
mechanisms by which HHS can produce countermeasures.
For example, BARDA is responsible for executing the
BioShield Special Reserve Fund, which is used to procure
security countermeasures in the strategic national stockpile,
and CDC also receives funding to manage the strategic national
stockpile, including replenishing expired products.
How is CDC transparent to stakeholders regarding what
opportunities may exist to be considered for the strategic
national stockpile outside of the BioShield procured product?
Dr. Redd. Yes, sir. There are a couple of ways that we do
that. First on the internal coordination, I mentioned the
Public Health Emergency Medical Countermeasure Enterprise,
where the strategic national stockpile budget is reviewed and
recommendations are made. There's internal coordination,
particularly between BARDA and CDC.
The multiyear budget that I believe this committee
requested is part of making the future needs apparent, and I
think that was just released within the last few weeks. That
would be a way of forecasting what the future requirements
would be.
Senator Burr. Let me ask you, how does the handoff occur
for products that may have been procured or received from BARDA
in advanced research and develop funding but are not procured
by BioShield but could still be potential stockpile candidates?
Dr. Redd. I think, in general, when a product is licensed,
it moves into the strategic national stockpile responsibility,
and at that--there may be a first delivery through BioShield,
but then it's transferred to the strategic national stockpile
responsibility.
Senator Burr. Senator Casey.
Senator Casey. I wanted to just note something for the
record, but then ask one question about the Hospital
Preparedness Program. The three countries that have had the
most deaths from Ebola were, as everyone knows, Sierra Leone,
Liberia, and Guinea.
Total deaths as of February 21 are 9,556, a huge number,
and we are mindful of that today, especially in light of the
fact that our country had a capacity and an ability that those
countries didn't have.
Getting back to the circumstances here, one of the best
things that the Congress did over the years was to not only
authorize but fund the Hospital Preparedness Program.
Dr. Lurie, I meant to ask you earlier about the
announcement that was made with regard to both hospital
preparedness and the other program--the so-called PHEP, the
Public Health Emergency Preparedness Program. Can you talk
about the awards? I know that Pennsylvania got a little more
than $15 million allocated. Could you walk through that for us?
Dr. Lurie. Sure. The Public Health Emergency Preparedness
Program is a program that strengthens the capabilities of
health departments to do essential public health functions. It
is administered at CDC, and I think to Dr. Redd's point, it's
one of those things that builds the strong day-to-day system
that we have to count on during an emergency.
The Hospital Preparedness Program is the part that funds
the healthcare system administered through my office. We've
worked very closely together over the past couple of years to
align these administratively and in terms of the capabilities
that we require both from the public health system and the
healthcare system. They're very efficient programs.
Having said that, if you look at the funding for these
programs over the last decade and over the last X years, you'll
see a steady decrease, and that gets to our point about always
needing to be prepared and not having the sort of roller
coaster shape to this.
With regard to this most recent funding, States put out a
lot of money and need to continue to do lots of monitoring. The
Public Health Emergency Preparedness money funds that. Senator
Burr just talked about a suspected case in Virginia. That funds
the State and local capability to deal with that.
The Hospital Preparedness money funds the capability to be
sure that every hospital can recognize, detect, and safely
isolate somebody until they're transferred, that there are
hospitals that can assess these patients and decide if they
have Ebola or not, and to the extent that somebody has Ebola,
that those patients can be safely transferred to an Ebola
treatment center for treatment.
Both Congress and our stakeholders gave us very strong
advice about a regional strategy going forward. The
announcement that just came out basically calls for 10
regional--I almost want to call them supercenters--but regional
Ebola treatment centers, like Emory, like Nebraska, one in each
HHS region.
Underneath that, all of the hospitals that have been so
designated would be the surge capacity for those Ebola
treatment centers regionally, so that we really develop these
hospitals that are centers of excellence, so that if we have
more Ebola, we'll really have a lot of experience with it.
They'll be prepared to take care of more than one patient at a
time. They are super-prepared for other kinds of infectious
diseases, and they have to be ready within a matter of a few
hours to take a patient, not to then have to spend lots of time
tooling up to be ready.
I'm afraid Ebola could be with us for a very, very long
time, which means that we are at risk here for a very, very
long time, and we have to stay prepared and vigilant. We cannot
let our guard down.
Senator Casey. Well, I'll say just one thing in closing. I
complain loudly and frequently and will continue to complain
when you have an authorization level for hospital preparedness,
your program under your jurisdiction, when there's a huge gap
in the tens of millions of dollars between authorization and
appropriation. It made no sense, and we'll continue to monitor
that.
Dr. Lurie. I appreciate it.
Senator Casey. Thanks very much.
Senator Burr. Thank you, Senator Casey.
Let me just add to what Senator Casey said, because he read
the official death numbers. I don't think there's anybody at
the table that believes that that is an actual number of how
many deaths there were in West Africa, and the unfortunate
thing is we may never know exactly the extent of this outbreak.
I'm going to recognize Senator Whitehouse for no more than
5 minutes.
Statement of Senator Whitehouse
Senator Whitehouse. Thank you very much, Mr. Chairman. I
appreciate it.
I guess my question is twofold. I have heard that when a
biological agent is delivered in weaponized form at extremely
high dosage--more than would occur in a natural propagation of
the illness--the characteristics of the disease and the
characteristics of its propagation change, that it's dosage
sensitive in that sense. My first question is: Is that true?
The second thing is that I have heard that there are
strategies for developing countermeasures that are more cutting
edge than cooking them in batches, but that the technical
effort to get there is lagging a bit, and that there may be a
lot of incumbency pressure not to allow these disruptive
technologies to emerge. I'd love to hear the witnesses'
response to those two observations. Am I being given good info
on those?
Dr. Lurie. Well, certainly, we always worry about
weaponized forms of biothreats. That's, in fact, part of why we
exist, that's why BARDA exists, and we take those things very
seriously. It is very often the case that the more of something
you're exposed to, and get in your system, the sicker you get.
This is a really significant issue for us. We work on this
issue all the time.
In terms of the disruptive technologies in innovation, a
huge focus of our efforts is on innovation and on new and
better ways to do things--faster, better, cheaper. Since the
countermeasure review in 2010, we've moved away from one-bug-
one-drug to platforms, to new technologies that can make
countermeasures quickly, and we are always on the lookout for
these.
There's a whole part of BARDA that Robin can speak about
called Tech Watch, where innovators can come in at any time and
talk to us and propose those ideas, and we've been able to
support a whole number of those. BARDA has, frankly, been the
catalyst for a number of those new technologies that we're
seeing play out right in front of us with Ebola, in terms of
new ways to make monoclonal antibodies, and flu, in terms of
new ways to make vaccines that we just saw in H7N9.
Senator Whitehouse. Let me get a few other answers, if I
may, before my time expires, and I gather there'll be a firm
gavel.
Dr. Robinson.
Ms. Robinson. As we're going forward, we're actually
looking at influenza at what we call the holy grail, working
with NIH and our partners at CDC and FDA to actually have
universal influenza vaccines. We're also looking at
immunotherapeutics, these monoclonal antibodies that may work
against multiple strains of influenza and they're not
vulnerable to emergent drug resistance.
With our other drugs, for biothreats and radiation
illnesses, we are looking at stem cell therapies that one would
have never even thought about. We're looking also at pre-
symptomatic diagnostics going forward, so that before you
present with a disease, we actually have a way of looking at
people and knowing what direction they're going to go into and
if they're actually going to be in harm's way for that
particular disease. Again, we are at the cutting edge of
innovation.
Senator Whitehouse. Dr. Redd, 1 minute remaining.
Dr. Redd. Let me pass to Dr. Borio, then.
Dr. Borio. We love innovation in products as well as how we
approach the assessment of those products. Just to give you an
example, a couple of weeks ago, we hosted a colleague from
DARPA who came to socialize and began to engage with the FDA
scientists on ideas that were very innovative and
unprecedented. We are always looking forward to ways to engage
and to be able to support development of those products.
Senator Whitehouse. In my last 30 seconds, on the question
of there being a different illness response at high weaponized
doses that may require a different countermeasure, is that
factual?
Dr. Redd. I think that may be something that's particular
to each of the pathogens and exactly the way that it has been
weaponized. For example, if anthrax spores are made smaller,
they float around longer and, therefore, are easier to acquire.
I think it might be something that would be somewhat true, in
general, but there would be specific issues with each of the
possible pathogens.
Senator Burr. I thank Senator Whitehouse. Senator
Whitehouse has a deep interest in this, and we're working to
gather a number of initiatives, and we'll have further hearings
on some of those.
Robin, I did want to allow you 2 minutes, just if you want
to highlight anything for the record that you would point to
and say, ``Here's a success at BARDA that absolutely is the top
of the flagpole for us.''
Ms. Robinson. I think that having actually 12 new products
in the strategic national stockpile under Project BioShield,
when many people 5 or 6 years ago didn't think that we would
ever have more than three--I think that's extraordinary, and
it's not just for anthrax and smallpox, but against a number of
different threats and chemical and radiation illnesses. I think
that's one.
On my pandemic influenza side, we have created an
infrastructure in the United States that can provide a vaccine
for everyone that wants one and during a pandemic, unlike we
were able to do in 2009. We're able to do that now. I think
this is a major achievement and, certainly, the American people
can feel more secure about that. Again, as Dr. Lurie said, we
make those faster and in greater quantities and, hopefully, as
we go forward, even much better, not only in a pandemic, but
also for seasonal influenza.
I think we've now shown with emergent infectious diseases
that we can rapidly prepare and rapidly respond, and actually
doing things much earlier in the pipeline than we normally
would, and that we're capable of doing that and taking that
transition even earlier if need be. We look forward to, I
think, a very bright future, but we still have a long way to
go.
Senator Burr. Great. Thank you for that.
I just want to, for the record, say the hearing record will
remain open for 10 days so members can submit additional
information for the record, additional questions, within that
time if they'd like to.
Again, I thank all of our witnesses for being here. This
was educational and enlightening, and if there's a takeaway for
each one of you, it's that the committee is interested in this,
and we will continue to watch in hopes that we continue to
perfect the process even better.
Thank you.
The hearing is adjourned.
[Additional Material follows.]
ADDITIONAL MATERIAL
Response by Nicole Lurie, M.D., MSPH to Questions of Senator Alexander,
Senator Burr, Senator Isakson, Senator Kirk, Senator Scott, Senator
Roberts, Senator Murray, Senator Mikulski, Senator Casey, Senator
Franken, Senator Baldwin and Senator Warren
senator alexander
Question 1. We thought the United States was prepared for threats
like Ebola, but this fall showed us that we actually were not as ready
as we should be. Issues like how to handle infectious waste and the
type of health units capable of caring for and treating patients with
Ebola showed vulnerabilities in our public health system.
Has this prompted a review of the extent to which our preparedness
plans, scenarios, and drills truly do account for all-hazards, as is
called for by the Pandemic and All-Hazards Preparedness Reauthorization
Act? What has been the process for making sure we are prepared for
these types of emergencies?
Answer 1. As required by Presidential Policy Directive 8 (PPD-8),
the Department of Health and Human Services (HHS) participated in the
development of the National Preparedness Goal and National Preparedness
System. The National Preparedness Goal, released in September 2011,
defines what it means for the whole community--from individuals,
schools, businesses, and all levels of government--to be prepared for
disasters and emergencies. Specifically, the National Preparedness Goal
is defined as,
``A secure and resilient Nation with the capabilities
required across the whole community to prevent, protect
against, mitigate, respond to, and recover from the threats and
hazards that pose the greatest risk.''
In order to realize this goal, the National Preparedness System has
established an organized, systematic process for the whole community to
move forward in preparedness activities. All Federal partners are
utilizing the National Preparedness System to ensure that the Nation is
prepared for all emergencies and disasters. The National Preparedness
System ensures planning and preparedness initiatives to: identify and
assess risk at multiple levels; estimate the capabilities needed to
address such risks; build or sustain the required levels of capability;
develop and implement plans to deliver those capabilities; validate and
monitor progress; and review and update efforts to promote continuous
improvement.
Specific to all-hazards planning, development of an HHS all-hazards
plan started after the release of PPD-8 in September 2011. This plan
includes general assumptions for all types of emergencies and disasters
and ensures the Nation is prepared for all threats. The development of
the HHS all-hazards plan was done in conjunction with the development
of the National Response Framework and the Federal Interagency
Operational Plans to make sure the concepts did not conflict with each
other and to facilitate changes as planning documents were finalized.
The HHS all-hazards plan and functional appendices were completed in
April 2014.
HHS is also engaged in a number of other planning efforts to
further preparedness and response to public health and medical threats.
A number of efforts related to planning for both natural and
international infectious disease outbreaks have been completed or are
in progress. Specific efforts by HHS include:
A joint HHS and Federal Emergency Management Agency (FEMA)
interagency coordination plan for H7N9/MERS-CoV called the Interagency
Pandemic Operations Plan (PanCap). This plan was completed in November
2013.
Development of a Unified Coordination Group Plan to
address the surge in unaccompanied children. This included a medical
annex to address infectious disease detection, screening, and
monitoring.
A Biological Incident Annex to help planning for the
Response and Recovery Federal Interagency Operational Plans, an effort
HHS co-led with FEMA. The BIA will serve as a support document for the
Pandemic Crisis Action Plan and the Federal Medical Countermeasures
Plan, as well as existing regional, State, and local plans. A final
review is expected by the end of August 2015 with a target completion
date of the end of September 2015.
In collaboration with FEMA, the development of Federal
medical countermeasures (MCM) support plans for the Urban Area Security
Initiative. These plans enhance existing mass MCM dispensing plans and
support responses to naturally occurring pandemics and deliberate
biological outbreaks in these high-threat, high-density Urban Areas.
The Department of Defense Operation Vigilant Sentry
appendix which describes how ASPR collaborates with DHS to conduct
medical screening, triage, provide medical treatment, and implement
public health measures necessary to prevent the introduction or spread
of communicable diseases into the United States.
Related to Ebola planning:
HHS, in collaboration with its Federal Emergency Support
Function partners, is developing the U.S. Government Ebola Virus
Disease Plan. The purpose of the plan is to describe the integrated
concept of operations, processes, and organizational constructs that
the U.S. Government will utilize to prevent, protect against, mitigate,
respond to, and recover from EVD. The plan will guide the U.S.
Government in preparing to manage and contain Ebola domestically in
support of State, local, tribal and territorial governments, and
internationally in support of partner nations. It also will clarify the
roles and responsibilities of Federal interagency partners and other
supporting entities to establish clear lines of responsibility and
eliminate duplication of effort. This plan is scheduled to be completed
in fall 2015.
Participation in the interagency Latin America/Caribbean
EVD planning process to help foreign partners deter mass migration,
assist the Department of Homeland Security (DHS) Customs and Border
Protection in determining medical screening/processing support, and
assist the United States Coast Guard in determining maritime medical
screening and treatment guidance for para-professional medical
providers.
HHS Support Plan for the First Case of Ebola Diagnosed in
the United States in August 2014.
Question 2. After the failure to correctly diagnose Mr. Thomas
Duncan on his first visit to the emergency department in Texas, several
areas were identified for improvement to ensure that hospitals around
the Nation are prepared to recognize a potential case of Ebola, isolate
the individual, and provide a timely diagnosis. A key component is
awareness among health professionals about the importance of a travel
history to an Ebola epidemic country.
Please identify actions you took to improve awareness among health
professionals, including working with associations and professional
organizations.
Answer 2. An important lesson learned in the U.S. response to Ebola
was that the safety of health care workers, from clinicians and
laboratory workers to ancillary staff, must be a foremost
responsibility during health care system preparedness and response
activities. Health care worker safety is best achieved through the
implementation of infection control, appropriate use of personal
protective equipment (PPE), continuous training, demonstration of
competencies, and participation in frequent exercises. Moreover, we
must ensure that Ebola patients are safely and well cared for in the
U.S. health care system and that frontline health care workers are
trained to recognize and isolate a person with suspected Ebola. These
are the cornerstones of the Hospital Preparedness Program (HPP) Ebola
funding opportunity announcement (FOA): EP-U3R-15-002: HPP Ebola
Preparedness and Response Activities.
On April 15, 2014, the Office of the Assistant Secretary for
Preparedness and Response's (ASPR's) HPP program circulated frequently
asked questions concerning Ebola. These questions were developed by
physicians associated with HPP-supported health care coalitions and
U.S. health care professionals to improve outreach and awareness about
the Ebola virus. During the summer of 2014, in collaboration with the
Centers for Disease Control and Prevention (CDC), ASPR began developing
and disseminating checklists to prepare health care providers for
Ebola. These checklists provide practical and specific suggestions to
make sure health care workers, facilities, and health care coalitions
are able to detect possible Ebola cases, and that employers are able to
protect their employees, and respond appropriately. These checklists
are updated regularly and are available on both ASPR's and CDC's Web
sites.
Further, beginning in August 2014, ASPR coordinated, participated
in, and contributed to numerous webinars, conference calls, and
trainings with public health and health care professionals,
associations, professional organizations, and health care facility
leaders. Participating external stakeholder groups include State and
local public health departments, the Association of State and
Territorial Health Officials, the American Hospital Association, the
Association of American Medical Colleges, nursing professional
organizations, emergency medical service providers, and health care
coalitions. These direct outreach efforts reached over 160,000
individuals in the health care and public health fields.
ASPR has also promoted the use of National Standards for Culturally
and Linguistically Appropriate Services (CLAS Standards) in Health and
Health Care and in education to ensure language access and to avoid
stigma.\1\
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\1\ See https://www.thinkculturalhealth.hhs.gov/content/clas.asp
and https://www.thinkcult-
uralhealth.hhs.gov/Content/ContinuingEd.asp.
Question 3. How are you working with hospitals in the Hospital
Preparedness Program to review surge capacity for all-hazards? What are
the specific goals for setting up Ebola Treatment Centers and how does
this fit within an all-hazards framework?
Answer 3. In order to prepare the U.S. health care system to
respond to events in a coordinated and collaborative manner, rather
than facility-by-facility, ASPR has been providing resources to 62
State, territory, and local awardees through HPP. In 2012, HPP
transitioned from facility-based capacity building to coalition-based
capability development. This includes eight health care preparedness
capabilities: (1) healthcare system preparedness; (2) healthcare system
recovery; (3) emergency operations coordination; (4) fatality
management, (5) information sharing; (6) medical surge; (7) responder
safety and health; and (8) volunteer management. The medical-surge
capability is the ability to provide adequate medical evaluation and
care during incidents that exceed the limits of the normal medical
infrastructure within the community. This includes the ability of
health care organizations to survive an all-hazards incident and
maintain or rapidly recover operations that were compromised.
HPP awardees must maintain all-hazards public health emergency
preparedness and response plans as part of their cooperative agreement.
Awardee performance in regards to health care preparedness is evaluated
annually through annual program evaluations, progress reporting, and
site visits. Further, HPP awardees must ensure that hospitals have all-
hazards and hazard-specific preparedness and response plans, as well as
the space, staff, and supplies needed to provide immediate bed
availability. This is necessary to assure appropriate early medical
care for individuals affected by disasters and public health incidents.
To assist hospitals in their medical surge efforts, HPP released a
new hospital surge evaluation tool in December 2014 that was designed
to identify gaps in a hospital's preparedness and help assess its
ability to respond to a mass casualty event. The tool takes the form of
a no-notice drill and incorporates real-life health care considerations
in acute care settings. The tool is intended for use by hospital
emergency managers, hospital administrators, and clinical staff to
assess and improve their hospital's surge plans. Hospitals need to
exercise their preparedness for a mass casualty incident regularly.
This tool can help hospital emergency managers make recurring tabletop
exercises a reality by providing a fully developed tabletop exercise
that can be used at their facilities. In some respects, this tool can
be thought of as ``Surge Evaluation in a Box.'' HPP also is developing
a companion surge evaluation tool for health care coalitions.
A total of $194.5 million was awarded through the HPP Ebola FOA
(EP-U3R-15-002: HPP Ebola Preparedness and Response Activities) to
ensure our Nation's health care system is ready to safely and
successfully identify, isolate, assess, transport, and treat patients
with or under investigation for Ebola. While the primary focus is on
preparedness for Ebola, as required by Title VI of Division G of the
Consolidated and Continuing Appropriations Act, 2015, it is likely that
preparedness for other novel, highly pathogenic diseases will also be
enhanced through these activities.
In December 2014, HHS released its Interim Guidance for U.S.
Hospital Preparedness for Patients under Investigation or with
Confirmed Ebola Virus Disease: A Framework for a Tiered Approach, which
outlines the different roles U.S. acute health care facilities can
assume in preparing to identify, isolate, and evaluate or treat
patients with possible or confirmed Ebola. These responsibilities
include serving as Ebola treatment centers, assessment hospitals, and
frontline health care facilities. In addition to outlining the roles
these facilities can assume, the guidance provides minimum standards
each facility must meet in order to help State health officials assess
facilities and assist with the designation process. Building upon the
tiered State and jurisdiction based hospital approach and meeting
Congress' regional directive, HHS provided a portion of the total HPP
Ebola resources to establish a nationwide, regional treatment network
for Ebola and other infectious diseases. This regional treatment
network balances geographic need with differences in health care
institutional capabilities and accounts for the potential risk of
needing to care for an Ebola patient. This overall Ebola health care
treatment and assessment network currently consists of:
Nine regional Ebola and other special pathogen treatment
centers that can be ready within a few hours to receive a confirmed
Ebola patient from their region, across the United States, or medically
evacuated from outside of the United States, as necessary. These
hospitals will also have enhanced capacity to care for other highly
infectious diseases.
State or jurisdiction Ebola treatment centers (61 as of
July 21, 2015) that can safely care for patients with Ebola in the
event of a cluster of Ebola patients that overwhelm a regional Ebola
and other special pathogen treatment center. Clinical judgment,
available logistical resources, and patient preference may indicate the
patient should receive treatment at a state/jurisdiction Ebola
treatment center rather than be transferred to a regional Ebola and
other special pathogen treatment center.
Assessment hospitals that can safely receive and isolate a
person under investigation for Ebola and care for the person until an
Ebola diagnosis can be confirmed or ruled out, and until a discharge or
transfer has been completed.
Frontline health care facilities that can rapidly identify
and triage patients with relevant exposure history and have symptoms
compatible with Ebola. These facilities would then coordinate patient
transfer to an Ebola assessment hospital.
With funding provided in the HPP Ebola FOA, all HPP awardees will
develop and implement a health care system concept of operations
(CONOPS) for care of Ebola patients. This CONOPS must link State
activities related to the active monitoring of returning travelers to
designated assessment or treatment hospitals. From there, they would
ensure patients can be safely transported to a regional Ebola or
special pathogen treatment center and/or a State or jurisdiction Ebola
treatment center. Each awardee's health care system CONOPS for Ebola
will be maintained and exercised annually throughout the 5-year project
period.
Further, HPP Ebola FOA awardees will assure readiness of regional
Ebola and special pathogen treatment centers, State- and jurisdiction-
based Ebola treatment centers, assessment hospitals, and health care
coalitions (with, at a minimum, frontline health care facilities and
EMS) through quarterly or annual trainings and exercises, depending on
their respective roles. Exercises in the first year should be specific
to Ebola. If in subsequent years there are no global outbreaks of
Ebola, exercises may address other infectious diseases, such as MERS-
CoV and measles. The PPE trainings that health care facilities around
the Nation have been conducting for Ebola, such as training covering
donning and doffing of PPE, have relevance to other and more common
infections. While the PPE (e.g., Tyvek suits) might be different for
other infectious diseases, the actual process for removing the PPE,
such as gloves, without contaminating oneself is the same and will
assist with health care acquired infections and other pathogens.
senator burr
Question 1. PAHPRA set forth a new requirement for the ASPR to
brief the President's National Security Advisor on a periodic basis.
Since being confirmed to serve as the ASPR, how many times have you
briefed the National Security Advisor?
Answer 1. The Assistant Secretary for Preparedness and Response
(ASPR) annually updates the National Security Advisor, and the National
Security Staff on the status of the Strategic National Stockpile (SNS).
This is a report that is required both by statute\2\ and by Homeland
Security Presidential Directive (HSPD-21), which directs the HHS
Secretary, through the Public Health Emergency Medical Countermeasures
Enterprise (PHEMCE), to comprehensively examine the SNS formulary each
year to ensure the most effective use of the limited resources
available to stockpile those critical medical countermeasures that will
be required in an emergency. The recommendations, developed by subject
matter experts and senior policy leaders, inform resource management
and procurement policy for the most appropriate set of medical
countermeasures to acquire and maintain in the SNS.
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\2\ 42 U.S.C. 247d-6b(a).
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Furthermore, ASPR represents the HHS Office of the Secretary on a
variety of National Security Council Interagency Policy Committees,
which serve to inform the National Security Advisor and staff regarding
policy and technical issues related to naturally occurring as well as
deliberate public-health emergencies on a regular basis. The ASPR meets
regularly to update the Deputy National Security Advisor on any new or
potential event(s) that may present a risk to the health security,
including Middle East Respiratory Syndrome (MERS-CoV) and avian
influenza A (H7N9).
Question 2a. The ASPR is responsible for the hospital preparedness
program and our Nation's medical surge capacity. We have a handful of
special treatment units and beds that we have used to provide treatment
to Ebola patients in the United States. The experiences that these
facilities gained in providing care to these patients underscored the
significant challenges in providing treatment to patients with Ebola
and similar conditions, including the high volume of medical waste they
produced.
Is ASPR reexamining any facets of our medical surge capacity based
on our experiences with Ebola treatment?
Answer 2a. A few important lessons learned in the recent response
to Ebola include: health care worker safety from clinicians and
laboratory workers to ancillary staff, recognizing that care for Ebola
patients is clinically complex and demanding, and understanding that
early case recognition is critical for preventing spread and improving
outcomes. These lessons highlight the importance of adequate and
sustained preparedness funding and the need for a national network of
hospitals for treating highly pathogenic infectious diseases.
The Hospital Preparedness Program's (HPP) preparedness and response
strategy is concerned with making sure HPP awardees can meet eight
national health care preparedness capabilities. These capabilities
provide flexibility and address all-hazards, including: (1) health care
system preparedness, (2) health care system recovery, (3) emergency
operations coordination, (4) fatality management, (5) information
sharing, (6) medical surge, (7) responder safety and health, and (8)
volunteer management. Health care system preparedness, emergency
operations coordination, and health care system recovery address the
planning and preparation required to support efforts in all stages of
an incident (preparedness, response, recovery, and mitigation).
Fatality management and medical surge capabilities focus on rapid
health care coordination, the ability to scale up operations, and
resource allocation during an emergency. Information sharing highlights
the need for the health care system to share information during an
emergency with both system members and the public. Responder safety and
health identifies and procures resources needed to protect health care
workers. Volunteer management is the ability to coordinate and utilize
volunteers to augment incident operations.
Research and history demonstrate that if HPP awardees strengthen
their local health care preparedness capabilities, they will be ready
to respond to any given disaster or public health event. It is vital
that health care systems maintain a baseline level of preparedness on
all capabilities, so that for whatever the event (Ebola, terrorist
attack, or natural disaster) local systems can respond quickly and
effectively to save lives.
HPP awardees originally targeted all eight health care preparedness
capabilities when the program transitioned to a health care coalition-
based approach in 2012. As a result of funding reductions in 2014, many
awardees have had to prioritize their efforts by targeting five of the
eight capabilities. An HPP impact assessment of this reduction showed
that 68 percent of awardees were not able to sustain progress made
since 2012 on responder safety and health. Furthermore, 90 percent of
awardees reduced exercises, evaluations, and corrective actions.
Seventy percent reduced health care worker education and training.
Responder safety and health was not among the five prioritized
capabilities for many awardees and problems with health care worker
safety during the Ebola outbreak underscored the need to re-emphasize
responder safety.
To re-emphasize responder safety and health, funding from both the
Ebola emergency supplemental and the annual cooperative agreement
program will support activities to enhance this capability including
exercises, health care worker trainings, and optimizing the planning
and management of PPE for health care workers.
Additionally, strong regional coordination through health care
coalitions (HCCs) can mitigate challenges associated with scarce
supplies and resources during an outbreak or other public health event.
For example, if a regional health care system has extra PPE available
in some of its facilities, this equipment can be dispersed to local
health care providers in need. The need for a national network of
hospitals that are capable of treating highly pathogenic infectious
diseases is addressed through the HPP Ebola funding awarded in May and
June 2015. The capabilities and capacity of HPP awardees, and the
health facilities and HCCs they will support through the supplemental
Ebola funding, will be maintained for the full 5-year project period
through quarterly or annual exercises and trainings, according to their
respective roles. While the focus is on preparedness for Ebola, as
required under Title VI of Division G of the Consolidated and
Continuing Appropriations Act, 2015, it is likely that preparedness for
other novel, highly pathogenic diseases will also be enhanced through
these activities.
Question 2b. How is ASPR ensuring that our projected medical surge
capacity is sufficient for the threats we may face?
Answer 2b. HPP awardees must maintain all-hazards health care
system emergency preparedness and response plans to meet requirements
within the HPP cooperative agreement. Awardee performance on the health
care preparedness capabilities is evaluated annually through program
evaluations, progress reporting, and site visits. Further, HPP awardees
must make sure hospitals have all-hazards and hazard-specific
preparedness and response plans, as well as the space, staff, and
supplies needed to provide immediate bed availability and assure
appropriate early medical care for individuals affected by disasters
and public health incidents.
HPP annually collects planning information from awardees on eight
health care preparedness capabilities. Information sharing and medical
surge were ranked as the most important capabilities by HPP awardees in
each budget year 2012-15. Additionally, medical surge and health care
system preparedness, which includes health care coalition development,
were the most highly prioritized capabilities in awardees' funding
allocations in 2012-15.
To assist hospitals in their medical surge efforts, HPP released a
new Hospital Surge Evaluation Tool in December 2014 that was designed
to identify gaps in a hospital's preparedness and help assess its
ability to respond to a mass casualty event. The tool takes the form of
a no-notice drill and incorporates real-life considerations in acute
care settings. The tool is intended for use by hospital emergency
managers, hospital administrators, and clinical staff to assess and
improve their hospital's surge plans. Hospitals need to exercise their
preparedness for a mass casualty incident regularly. This tool can help
hospital emergency managers to make recurring tabletop exercises a
reality by providing a fully developed tabletop exercise that can be
used at their facilities. In some respects, this tool can be thought of
as ``Surge Evaluation in a Box.''
Question 2c. How is ASPR ensuring that the lessons we learn from
our experiences with Ebola are being taken into consideration and
reflected in our preparedness and response strategies? For example, how
do we ensure that the medical waste issues are not an issue in future
response efforts?
Answer 2c. While most of the Ebola outbreak has occurred in West
Africa, HHS and other critical public health preparedness stakeholders
have been working to strengthen domestic preparedness, should this or
another infectious disease become an epidemic domestically. Many
components of HHS have partnered together to support the response in
West Africa and strengthen domestic preparedness. Partners include: the
Centers for Disease Control and Prevention (CDC), the National
Institutes of Health (NIH), the Food and Drug Administration (FDA), and
operational divisions within the HHS Office of the Secretary such as
the Office of the Assistant Secretary for Preparedness and Response
(ASPR), the Office of the Assistant Secretary for Health, and the
Office of Global Affairs.
Representatives of these components recently met to discuss an
after action review and report process to identify successes and
identify any gaps in planning and response efforts. As this effort
moves forward, HHS will gather information, draft an after-action
document, and develop an improvement plan to strengthen preparedness
and response to not only Ebola but other potential infectious disease
outbreaks that have the potential to impact public health.
A few important lessons learned throughout the national health care
system in response to Ebola include health care worker safety from
clinicians and laboratory workers to ancillary staff, recognizing that
care of Ebola patients is clinically complex and demanding, and
understanding that early case recognition is critical for preventing
spread and improving outcomes. These lessons highlight the importance
of adequate and sustained preparedness funding and the need for a
national network of hospitals for treating highly pathogenic infectious
diseases.
HHS, in partnership with Federal and State partners, has made
significant advances in the safe removal and transport of medical waste
during the Ebola response, all of which can be applied in a future
event. ASPR, working closely with CDC and the Department of
Transportation, developed a mechanism that allowed for the safe removal
and legal transport of contaminated medical waste from civilian health
care facilities treating confirmed cases of Ebola. This led to the
Pipeline and Hazardous Materials Safety Administration issuing a
nonsite specific special permit (Special Permit DOT-SP 16279) to
certain waste haulers, which authorizes the transportation and disposal
of waste contaminated with or suspected of being contaminated with
Ebola.
As part of the HPP Ebola FOA (EP-U3R-15-002: HPP Ebola Preparedness
and Response Activities), awardees are directed to take a number of
steps that address infectious waste for the full 5 years of the Ebola
cooperative agreement project period. These include:
Assuring the readiness of all nine regional Ebola and
other special pathogen treatment centers, the 61 State or jurisdiction
Ebola treatment centers and assessment hospitals across the country by
making sure their capability to handle Ebola-contaminated or other
highly contaminated infectious waste. This can be done through contract
with a waste management facility within the State or jurisdiction
willing and able to incinerate and dispose of Ebola waste or by
purchasing an onsite, high-volume autoclave capable of sterilizing
hospital waste used in the care of a patient with Ebola. This can also
be done by having a written agreement with another State willing to
assume these responsibilities.
Ensuring that EMS and interfacility transport systems are
included in Ebola coalition planning. This includes making sure medical
waste generated through the care of Ebola patients for EMS is safely
managed through their own plans, a hospital's plan, or a separate
coalition plan.
While focus remains on preparedness for Ebola as required under
Title VI of Division G of the Consolidated and Continuing
Appropriations Act, 2015, it is likely that preparedness for other
novel, highly pathogenic diseases will also be enhanced through these
activities.
Further, the National Ebola Training and Education Center (NETEC),
which was awarded funding in July 2015 through a separate FOA (EP-U3R-
15-003) will offer expertise, training, technical assistance, peer
review, monitoring, and recognition to State health departments,
regional Ebola and other special pathogen treatment centers, State and
jurisdiction based Ebola treatment centers, and assessment hospitals.
The NETEC is a consortium of all three U.S. hospitals that successfully
and safely treated patients with Ebola: Emory University in Atlanta,
GA; University of Nebraska Medical Center/Nebraska Medicine in Omaha,
NE; and Bellevue Hospital Center in New York, NY. One of the activities
required of the NETEC is to create and maintain a comprehensive suite
of timely and relevant educational materials (e.g., curricula,
training, templates, train-the-trainer modules, tools, simulations,
online resources, webinars) for policies and procedures related to the
care of patients with possible Ebola and other special pathogens.
Resources must align with government guidance and evolving scientific
and clinical evidence bases. One topic they will address is handling
Ebola-contaminated or other highly contaminated infectious waste.
Question 3. How is the ASPR ensuring that the drills and exercises
the ASPR is leading are training to the most appropriate protocols and
across various threat scenarios so our Nation is better prepared for
the full range of threats we may face?
Answer 3. The Secretary of Homeland Security conducted a strategic
national risk assessment to help identify types of incidents that pose
the greatest threat to the Nation's homeland security. Representatives
from Federal interagency offices have supported this effort and
released the Strategic National Risk Assessment (SNRA) in December
2011. The SNRA describes a wide range of threats and hazards that
warrant national attention--threats include animal disease outbreaks,
earthquakes, floods, pandemic outbreaks, chemical spills, dam failures,
aircraft as a weapon, biological terrorists attacks, and explosive
terrorist attacks, to name a few.
ASPR's drills and exercises are based on the threats and hazards
identified in the SNRA. ASPR also bases current drills and exercises on
the findings contained within the Department of Homeland Security's
National Preparedness Report. The National Preparedness Report is
published annually and summarizes progress in building, sustaining, and
delivering the core capabilities outlined in the National Preparedness
Goal.
In order to ensure response teams are adequately prepared and
trained, the National Disaster Medical System (NDMS) utilizes the NDMS
Fundamentals 100 series course designed and administered in
collaboration with the Department of Homeland Security's Center for
Domestic Preparedness in Anniston, AL. This week-long course provides
didactic and hands-on, full-context training for response to a mass
casualty situation. Specifically, the course targets training in:
National Incident Management System (NIMS) command, control, and
coordination structures; health and safety hazard assessments;
dissemination of guidance and resources to support environmental health
and safety actions for response personnel; recognition of cache
equipment; and the capability of NDMS teams to provide medical care to
patients with access and/or functional needs. Current programmatic
resources enable approximately 20 percent of the NDMS workforce to
attend the Fundamentals courses annually.
Question 4a. Emergency Support Function #8 sets forth the
coordination of medical and public health services as part of the
National Response Framework, which was updated in May 2013. The
previous document ESF #8 clearly set forth that the Secretary of Health
and Human Services leads all Federal public health and medical response
to public health emergencies and incidents covered by the National
Response Framework and that the ASPR coordinates national ESF #8
preparedness, response, and recovery actions, which is also set forth
by PAHPA.
Was the office of the ASPR involved in updating this document? If
not, why considering the subject matter at hand?
Answer 4a. ASPR's Office of Emergency Management (OEM) was involved
in updating this document. OEM led a workgroup comprised of HHS
divisions to review and update the annex.
Question 4b. Why did this updated document remove the reference to
the ASPR?
Answer 4b. Ultimately, the content of all of the ESF Annexes to the
National Response Framework (NRF) were updated to reflect the direction
contained within the Presidential Policy Directive 8 (PPD-8)
Implementation Plan that:
1. The Planning Frameworks are intended to provide succinct
descriptions, at a high level, of the steps taken to prepare to deliver
the necessary capabilities, and;
2. The Planning Frameworks are not intended to be traditional
operations plans, concept of operations plans or detailed plans for
action.
Under these guidelines and in the process of aligning to the second
edition of the NRF, all internal departmental policies,
responsibilities, and procedures were removed from ESF Annexes.
Question 5. Since 2006, limited PREP Act declarations have been
issued for various threats. The current PREP Act declaration related to
anthrax, smallpox, and other threats is set to expire on October 1,
2015. What steps are being taken to renew these declarations to ensure
there is no gap in the PREP Act protections contained within the
current declaration?
Answer 5. PREP Act declarations covering medical countermeasures
against anthrax, smallpox, botulinum toxin, acute radiation syndrome,
and pandemic influenza A viruses expire on December 31, 2015, the PREP
Act declaration for certain vaccines against Ebola expires on December
3, 2015, and the PREP Act declaration for a therapeutic against Ebola
expires on April 8, 2016. This summer, HHS, through the PHEMCE, has
been reviewing options and will develop recommendations for the
Secretary regarding extension of PREP Act coverage under these
declarations past 2015.
Question 6. How is the 5-year medical countermeasure plan that was
recently submitted to Congress being shared with outside stakeholders?
Answer 6. ASPR's Biomedical and Advanced Research Development
Authority (BARDA) has provided briefings on the PHEMCE multiyear budget
on several occasions across various forums. BARDA Director Dr. Robin
Robinson has presented to biodefense organizations (e.g., Alliance for
Biosecurity), to industry conventions (e.g., BIO), at BARDA Industry
Day, at international biodefense meetings (e.g., chemical, biological,
radiological, nuclear, and explosives conferences), at congressional
staff briefings, and during other formal and informal speaking
engagements.
senator isakson
Question 1. Secretary Lurie, I was pleased to see that ASPR
released its FOA last Friday regarding the emergency funding allocated
in the CRomnibus. The FOA released $194 million to be channeled through
the State departments of public health for hospital preparedness.
This is less than half of the money that Congress provided for this
purpose. I hope that ASPR has plans to spend more of the remaining
funding, which I understand to be about $375 million, directly to our
hospitals that are on the front line.
Can you please outline your plan for this remaining funding that
Congress directed to hospital preparedness?
Answer 1. The Hospital Preparedness Program (HPP) is awarding
$201.5 million of the total funding appropriated to the Department of
Health and Human Services under Title VI of Division G of the
Consolidated and Continuing Appropriations Act of 2015. This includes:
$194.5 million through the HPP Ebola Preparedness and
Response Activities funding opportunity announcement (FOA), and
$7 million (together with $5 million from CDC for a total
of $12 million) for the National Ebola Training and Education Center
(NETEC) FOA.
The remaining funding is not allocated to specific activities
either in the statute or in report language. The language allows
resources to be used for Countermeasure Injury Compensation Program
expenses, reimbursement of domestic transportation and treatment costs
for individuals treated in the United States for Ebola, Ebola patient
treatment cost reimbursement, and other preparedness and response
needs. The statute also provides transfer authority of funds
appropriated under title VI to specific Departmental components to meet
critical needs that may arise rapidly. For example, resources could be
used to scale-up Ebola response efforts in Guinea, Sierra Leone, and
neighboring countries if the outbreak spreads or if the caseload
dramatically increases. As HHS continues its work to develop an Ebola
vaccine, these resources could also be used to scale-up production and
support initial activities for a potential vaccination campaign.
senator kirk
Question 1. Guidance from the National Strategy on Pandemic
Influenza recommends maintaining enough antivirals to treat 25 percent
of the U.S. population. Do you have plans to replace existing product
in the Strategic National Stockpile based on changes to its patent
exclusivity? Do you have plans to replenish existing stock that will
soon expire to maintain preparedness? How are you engaging the private
sector to address both issues?
Answer 1. By 2007, the Biomedical Advanced Research and Development
Authority (BARDA) in the Office of the Assistant Secretary for
Preparedness and Response (ASPR) met the domestic influenza antiviral
drug stockpile goals established in the National Strategy for Pandemic
Influenza (2005). Today, the Centers for Disease Control and
Prevention's (CDC) Strategic National Stockpile (SNS) maintains an
influenza antiviral drug stockpile that continues to address this
function in preparation for a potential influenza pandemic.
During 2009, the United States distributed more than 11 million
treatment courses of influenza antiviral drugs to the States,
replenished those products accordingly, and subsequently replenished
stockpiled products that had expired. In addition, the shelf life of
these products has been extended by the Food and Drug Administration
(FDA) in light of data from applicants supporting stability and
demonstrating longer shelf life (e.g., 5 to 10 year expiry dating for
Tamiflu). During annual reviews of the SNS formulary, as required by
the Pandemic and All-Hazards Preparedness Act (PAHPA), the inventory of
influenza antiviral drugs are assessed and adjusted as needed based on
strategic goals, product composition, expiring product, and general
population needs. SNS acts on these recommendations by acquiring
additional influenza antiviral drugs. CDC and BARDA have met with
companies that may have generic versions of influenza neuraminidase
inhibitor products and will consider them in replenishment procurement
plans if/when generics are approved by the FDA in coming years.
senator scott
Question 1. In December, it was announced that after less than 3
months on the job Ebola Czar Ron Klain would be leaving his post and
returning to the private sector. When Klain was first appointed to this
position I know everyone had serious questions as to whether the
Administration had picked the right man for the job, given the fact he
had zero public health experience. Dr. Lurie, given that you are the
Assistant Secretary for Preparedness and Response, and have the
credentials necessary for responding to an Ebola or any public health
crisis, did you have any input into this decision? Will you have a roll
in future appointments, should another public health crisis arise?
Answer 1. The Secretary of the Department of Health and Human
Services (HHS) convened daily (or more) meetings with a diverse team of
senior department leadership officials that included, but was not
limited to: the Assistant Secretary for Preparedness and Response
(ASPR), the Assistant Secretary for Health, the National Institutes of
Health (NIH), the Centers for Disease Control and Prevention (CDC), and
the Food and Drug Administration (FDA). This was done to make sure the
Department did everything possible to respond to Ebola both
domestically and in West Africa.
ASPR, as the principle advisor to the HHS Secretary, regularly met
with Ron Klain and continues to meet regularly with senior government
officials to support the government's comprehensive response to Ebola.
ASPR's operating divisions continue to provide leadership, expertise,
and support for the implementation of numerous preparedness, response,
and recovery activities. For example, throughout the Ebola response,
ASPR has led and supported the development of medical countermeasures
and policies pertaining to use and clinical trials; the development of
standards of care for Ebola patients and clinical guidance; the
advancement of domestic health care system preparedness; interagency
coordination for patient movement issues and repatriation; and
interagency and international coordination to support response efforts
in West Africa and to discuss and harmonize domestic response policies
with allied countries. ASPR also led a series of focused domestic
preparedness and response readiness, modeling, and science and budget
activities.
As you know, ASPR serves at the request and privilege of the
President of the United States and under the leadership of the
Secretary of HHS. Ebola required a multifaceted Government response and
the President chose Mr. Klain to coordinate this effort. Mr. Klain led
a successful response and has transitioned to a new endeavor. ASPR is a
leader in preparing our Nation and its communities to respond to and
recover from public health and medical disasters and emergencies. With
that in mind, ASPR stands ready to lead our Nation during the next
public health crisis and will remain available to the President and to
the Secretary for any advice and guidance they request.
Question 2. During the height of the Ebola outbreak, I'm proud to
say that South Carolina hospitals stepped up to the challenge and
quickly created a statewide response system that included Greenville
Health System, Spartanburg Regional Healthcare System, Palmetto Health,
and the Medical University of South Carolina. Our hospitals and their
staff went above and beyond to prepare, and remain prepared, for a
worst case scenario. Though the CDC has not officially designated any
hospital in South Carolina an official ``Ebola Treatment Center,'' I'm
confident our hospitals would be able to deliver the highest quality of
care should any public health crisis arise. However, I am concerned
about preparedness in the rural areas in our State, where providers
have fewer resources to prepare and local coordination is often more
difficult.
What is being done to assist these rural areas in their response
readiness? Related to this is the overall cost issues that arise during
a sudden public health crises. What is being done to ensure appropriate
reimbursement for large and rural hospitals, not only for rapid stepped
up preparation but also for the expensive treatment of patients?
Answer 2. The Hospital Preparedness Program (HPP) awarded $162
million in May 2015 through funds made available through the Ebola
supplemental appropriation. This funding was distributed via formula to
all 62 HPP awardees. This includes the 50 States, DC, select
metropolitan jurisdictions (Chicago, Los Angeles County, and New York
City), U.S. territories, and freely associated States to support health
care facilities that are capable of serving as Ebola treatment centers
and assessment hospitals for their States or jurisdictions. The funding
will also support health care coalitions (HCCs) to prepare frontline
hospitals (including those in rural areas), emergency medical services
agencies, and the overall health care system. The funding formula for
the HPP Ebola awards took into account Ebola risk, based on the travel
patterns of individuals coming from the affected countries. It also
reflected West African diaspora population centers and jurisdictions
with enhanced airport entrance screenings. This was done to make sure
those States and localities most likely to have a case of Ebola are
fully prepared.
For Part A of the HPP Ebola FOA (which includes the $162 million
described above), awardees must limit their direct costs (excluding
sub-awards to HCCs and health care facilities) to no more than 10
percent of their allocation. Of the funds for sub-awards, at least 30
percent was allocated to health care coalitions in their jurisdiction
and no more than 70 percent was used to provide funding directly to
Ebola treatment centers and/or assessment hospitals.
One of the required Part A activities is for awardees to develop
and implement a health care system concept of operations (CONOPS) for
the care of Ebola patients. This CONOPS links State activities related
to active and direct active monitoring of returning travelers to
designated assessment hospitals and treatment hospitals, and ensures
that patients can be safely transported to a regional Ebola and other
special pathogen treatment center and/or a State or jurisdiction Ebola
treatment center in the event that they are not the same or the
regional facility cannot accept patients. Each awardee's health care
system CONOPS for Ebola will be maintained and exercised annually
throughout the project period.
The 30 percent set aside for HCCs is intended to develop the
capabilities of HCCs and enable their members to care for Ebola
patients. HCCs incentivize diverse and often competitive health care
organizations with differing priorities and objectives to work
together. HCCs collaborate to ensure that each member has the necessary
medical equipment and supplies, real-time information, communication
systems, and trained health care personnel to respond to an emergency.
Nationwide, HCC membership is growing rapidly; between 2013 and 2014,
there was a 47 percent increase in membership and there are currently
about 24,000 health care and public health partners participating, from
local health departments to hospitals, EMS, and emergency management
agencies. Strong regional coordination through HCCs can mitigate
challenges associated with scarce supplies and resources during an
outbreak or other public health event and help each patient receive the
right care at the right place at the right time. For example, if a
regional health care system has extra PPE available in some of its
facilities, this equipment can be dispersed to local health care
providers who need it.
As part of the HPP Ebola FOA, HCCs will:
Ensure that all coalition partners have access to
personnel protective equipment (PPE), trainings, and exercises
according to their respective role in the health care system.
Purchase PPE or support facility purchase and stockpile,
preferably using vendor-managed inventories and mutual aid agreements
at the coalition, community, or regional level.
Rapidly distribute or re-distribute PPE to a facility
within their coalition as needed. At a minimum, coalitions will
coordinate with partners to obtain visibility of the PPE supplies
available at health care facilities in their communities and ensure it
can be moved rapidly as needed.
Ensure the competency of health care workers to identify,
assess, and treat suspected or confirmed patients with Ebola through
annual training.
Conduct annual coalition level exercises with, at a
minimum, frontline facilities and EMS. Exercises in the first year
should be specific to Ebola. If in subsequent years, there are no
global outbreaks of Ebola, exercises may address other infectious
diseases, such as MERS-CoV and measles.
Conduct training and assist coalition partners in final
preparations to assure State or jurisdiction Ebola treatment centers
and assessment hospitals are able to accept a patient (in the event of
a small cluster of cases) within 72 hours of accepting a confirmed
patient from the region's Ebola or other special pathogen treatment
center. This includes coordination with EMS and interfacility transport
agencies.
Ensure that EMS and interfacility transport systems and
911/Public Safety Answering Points are included in Ebola coalition
planning.
Provide funding, as necessary, to EMS agencies for Ebola
preparedness activities, such as purchasing PPE, training on PPE and
other Ebola-related protocols, and exercises.
Ensure that medical waste generated from the care of Ebola
patients by EMS is safely managed through their own plans, a hospital's
plan, or a separate coalition plan.
Integrate health care system preparedness and infection
control through health care coalition engagement with State Healthcare-
Associated Infection/Infection Control advisory groups, established
with funding and guidance from CDC's Epidemiology and Laboratory
Capacity for Infection Control program. This is also done to consider
how a regional emergency preparedness structure could support improved
infection control for coalition members.
Awardees can use their discretion to provide supplemental funds to
sub-recipient health care facilities and coalitions for previous Ebola
preparedness costs incurred since July 2014; however, awards may not be
used to reimburse health care facilities for direct patient treatment
costs. HPP seeks to build capabilities within the entire health care
system to better prepare communities for future outbreaks of Ebola and
other highly pathogenic diseases illnesses.
A separate process has been developed to reimburse health care
facilities for uncompensated costs associated with the domestic
treatment and transportation of confirmed patients with Ebola. Health
care facilities began submitting claims on April 15, 2015.
senator roberts
Question 1a. According to many of your industry partners, the move
in authority of BARDA contract's to ASPR's Office of Acquisitions
Management, Contracts and Grants (AMCG) has caused unnecessary delays
and uncertainty regarding the time sensitive review of BARDA's medical
countermeasures (MCM) development contracts.
Do you think BARDA should be allowed to negotiate and award its own
advanced R&D contracts as it has done in the past?
Answer 1a. The Biomedical Advanced Research and Development
Authority (BARDA) in the Office of the Assistant Secretary for
Preparedness and Response (ASPR) always seeks the best approaches for
preparing contracts, grants, cooperative agreements, and Other
Transaction Agreements (OTAs) with industrial and academic partners to
support advanced development, manufacturing, testing, and purchase of
medical countermeasure candidates and products for preparedness and
response to the medical consequences of chemical, biological,
radiological, and nuclear (CBRN) threats, pandemic influenza, and
emerging infectious diseases.
Question 1b. Would you be willing to examine the possibility of re-
instating BARDA's contracting authority as a means to accelerate the
development of critical MCM projects?
Answer 1b. ASPR and BARDA are constantly seeking ways to improve
the efficiency and quality of the procurement process and we welcome
any suggestions you have for improvement. Maintaining a separate
contracting office benefits ASPR as a whole, including BARDA and other
operating divisions. Thus far, it has been an effective process. From
the 2009-10 H1N1 pandemic influenza response through the current Ebola
outbreak, ASPR and BARDA has benefited from senior-level, experienced
contracting officers executing timely contract actions.
Question 2. When Project BioShield was created, OMB independently
reviewed all procurement contracts since the funds were derived from
DHS but the program was administered by HHS.
Now that BioShield funds are also housed at HHS, would you support
removing this additional step of OMB approval in an effort to
streamline the process and reduce wait times for these MCM contracts?
Answer 2. ASPR and BARDA are always looking for ways to improve our
efficiency and we welcome your suggestions. OMB provides valuable
oversight and helps maintain our quality and the whole of Government
approach to these important issues. Similarly, according to the Project
BioShield Act of 2004, DHS continues to play an important role in
reviewing and recommending use of these funds.
senator murray
Question 1. PAHPRA made critical advances in ensuring that the full
range of our national preparedness efforts take the unique needs of at-
risk populations into consideration--such as children, pregnant women,
seniors, and others who may need additional response assistance, in the
event of a public health emergency. I know a number of these advances
are addressed in strategy and implementation plans released recently.
Dr. Lurie, what are some areas of real progress with regards to at-
risk individuals and where do you think further advances are needed?
Answer 1. The Office of the Assistant Secretary for Preparedness
and Response (ASPR), in collaboration with the Centers for Medicare &
Medicaid Services (CMS), has utilized limited administrative claims
data to evaluate the impact of prolonged power outages on health care
delivery, and individuals that rely on electricity-dependent medical
equipment and health care services. In addition, ASPR and CMS are
creating maps to inform and support State and local health department
emergency planning and response. Pilot programs in the city of New
Orleans and in Broome County, NY successfully demonstrated that limited
administrative claims data can be securely disclosed to and used by a
health department to rapidly identify and conduct potentially
lifesaving outreach to at-risk individuals that live independently and
rely upon electricity-dependent oxygen medical devices. Building on
these successes, ASPR and CMS are launching the Department of Health
and Human Services (HHS) At-Risk Resiliency Initiative that will be
comprised of three national data and mapping capabilities that can
inform and support all U.S. territories, State, local, and community
partners in emergency planning for and/or assisting electricity-
dependent at-risk populations. Finally, ASPR is also collaborating with
CMS and other partners, to identify medications that may be needed by
at-risk populations prior to a disaster and explore mechanisms that can
expedite advance or rapid medication refills for those that may need
them after a disaster. In addition, ASPR has worked on the following
activities to address at-risk populations during disasters:
Publishing the 2012-2013 Report of the Children's HHS
Interagency Leadership on Disasters (CHILD) Working Group.\3\ This
report documents the significant progress HHS has made in addressing
the needs of children in disasters since 2011 and highlights three new
focus areas: pregnant and breast feeding women and newborns, children
at heightened risk, and interdepartmental and non-governmental
organization collaboration.
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\3\ http://www.phe.gov/Preparedness/planning/abc/Documents/child-
wg-report2012-2013.pdf.
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Developing the ``Guidance on Integrating People with
Access and Functional Needs into Disaster Preparedness Planning for
States and Local Governments.''
Developing the ``Pediatric Preparedness for Healthcare
Coalitions (Part I)'' Webinar and Resources, as well as a Part II
Webinar.
Developing the ``Disaster Preparedness Planning for Older
Adults Web page.''
Developing ``Promising Practices for Communication with
Persons with Access and Functional Needs'' Webinar with DHS.
Developing ``Disaster Preparedness for Family Caregivers''
Webinar.
Developing the ``2014 HHS Human Services Concept of
Operations.''
Launching the HHS Preparedness for Pregnant Women Working
Group. The goal of this working group is to integrate the needs of
pregnant women across all disaster and public health emergency
preparedness, response, and recovery activities. The working group will
focus on opportunities to identify, develop, and update tools and
resources within HHS including infographics, job aids, and other
actionable products that can easily be disseminated and utilized by
health care providers, public health practitioners, human services
agencies, advocacy groups, and emergency management officials.
Launching ASPR and the Administration for Community Living
Working Group to integrate the Aging Network into Public Health and
Medical Response (ESF #8). The goal of this working group is to
increase awareness of the Incident Command System and develop tools and
training to improve coordination of the Aging Network (long-term care,
home and community-based services, meal delivery services, etc.) with
ESF #8 and health care coalitions to ensure that the health and medical
needs of older adults who may be impacted by public health emergencies
and disasters are addressed.
Publishing the ``Disaster Response Guidance for Health
Care Providers: Identifying and Understanding the Health Care Needs of
Individuals Experiencing Homelessness.'' This HHS-led document is part
of a larger collaboration with the Department of Veterans Affairs, the
Department of Housing and Urban Development, and other Federal partners
to develop a Homeless Disaster Planning Toolkit.\4\
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\4\ http://www.vemec.org/assets/1/6/Toolkit_Project_One-Pager.pdf.
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Developing and publishing a website and fact sheet on
``Cultural and Linguistic Competency in Disaster Preparedness and
Response'' and development of the ``American Indian & Alaskan Native
Disaster Preparedness Resource.''
Coordinating and leading the Interagency Coordinating
Council on Emergency Preparedness and Individuals with Disabilities
(ICC) Health Subcommittee to promote the safety, security, and equal
access to services for people with disabilities during emergencies.
senator mikulski
Question 1. As you know, I authored the provision in the PAHPA
Reauthorization that created the HHS National Advisory Committee on
Children and Disasters (NACCD). I felt the creation of the NACCD was
important because of the continued need to ensure that our Federal
disaster preparedness and response programs are adequately addressing
the needs of our most vulnerable, children. This year marks 5 years
since the National Commission on Children and Disasters issued its
final report looking comprehensively at each of our Federal agencies,
States, and non-governmental entities to make recommendations for ways
each can improve its readiness to meet children's unique medical and
mental health needs during and in the aftermath of a disaster. While
much progress has been made, many gaps remain in our level of
preparedness for children. We can and should be doing all we can to
ensure we as a nation are prepared to meet the needs of children, who
represent 25 percent of the population.
I want to commend you for selecting such a distinguished group of
experts from inside and outside the Federal Government for the NACCD
including its Chair, Dr. Michael Anderson, a pediatric critical care
medicine doctor from Cleveland, OH, and Linda MacIntyre, the Chief
Nurse at the American Red Cross. I have high hopes and expectations for
the NACCD and I look forward to receiving their recommendations and
guidance.
Can you tell me how you are utilizing the expertise of the NACCD as
HHS, ASPR and CDC respond to outbreaks and threats such as Ebola,
Enterovirus D-68, and now measles?
Answer 1. The NACCD was tasked with examining the current State of
readiness to address the ability of the pediatric healthcare system to
surge in the case of an outbreak of an infectious disease. This surge
capacity task examines the current state of readiness across the Nation
for a surge of pediatric patients in the event of an infectious disease
outbreak such as influenza, measles, or Enterovirus D-68. Crises such
as these could overwhelm local pediatric capabilities and the NACCD has
been asked to focus on how health care organizations would cope in the
near-term with large numbers of ill or infectious pediatric patients.
To date, committee members working on this task have gathered pertinent
information from several pediatric health care experts around the
country. This includes insight and understanding of the issues
concerning pediatric surge capacity as well as local and national
readiness gaps for a large number of infectiously ill children. The
members are synthesizing this information in a report with
recommendations for improving pediatric transport, children's and non-
children's hospital capacities, as well as tools to strengthen
pediatric health care coalitions. The NACCD Surge Capacity Report
(Near-Term Strategies to Improve Pediatric Surge Capacity During
Infectious Disease Outbreaks) was considered at a public meeting on
April 30, 2015.\5\
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\5\ The report can be found at: http://www.phe.gov/Preparedness/
legal/boards/naccd/Pages/recommendations.
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The Health Care Preparedness Task looks across the broad health
care system to care for large numbers of ill or injured children in the
aftermath of public health threats, medical disasters, and mass-trauma/
casualty emergencies. Topic areas that the committee members will
examine include the current State of facility preparedness, quality
control programs, granting structures, innovation, communication
streams, and medical counter measures. The members will propose
strategies for mitigating identified gaps and suggest best practices
and tools for increasing pediatric health care readiness. Members are
finalizing the framework for a report of recommendations, as well as
identifying subject matter experts to engage and gather insights that
will inform the report's content. The NACCD plans to provide a report
of its findings in October 2015.
Question 2. Can you describe how you are best utilizing the
existing Federal funding mechanisms through the Hospital Preparedness
Program (HPP) and the Public Health Emergency Program (PHEP) to ensure
grantees are prepared to meet the needs of children?
Answer 2. As aligned cooperative agreements, ASPR's Hospital
Preparedness Program (HPP) and CDC's Public Health Emergency
Preparedness (PHEP) program include a number of joint and specific
program requirements that address the particular needs of at-risk
individuals and those with special medical needs, including children,
in public health and medical emergencies. Awardees must:
Complete jurisdictional risk assessments to identify
potential hazards, vulnerabilities, and risks within the community,
including interjurisdictional (e.g., cross-border) risks that
specifically relate to public health, medical, and behavioral health
systems and the functional needs of at-risk individuals, including
children.
Conduct an annual public health and medical preparedness
exercise or drill that includes the access and functional needs of at-
risk individuals, including children. Awardees must also provide a
report in the following year's funding application on the strengths and
weaknesses identified and corrective actions taken to address material
weaknesses. HPP awardees were required to consider the access and
functional needs of at-risk individuals, including children, and engage
these populations as they planned for Budget Period 4 (July 2015-June
2016) health care coalition-based exercises.
Maintain updated plans describing activities they will
conduct with respect to pandemic influenza as required by Sections
319C-1 and 319C-2 of the Public Health Service Act. This also includes
efforts to address the needs of at-risk individuals, including
children.
Describe the structures or processes in place to ensure
that access and functional needs of at-risk individuals, including
children, are included in public health/health care and behavioral
health response strategies and are identified and addressed in
operational work plans.
Obtain public comment and input on public health emergency
preparedness and response plans and implementation using existing
advisory committees, or similar mechanisms, to ensure continuous input
from other State, local, tribal stakeholders, and the general public.
This includes those with an understanding of at-risk individuals,
including children, and their needs.
Coordinate emergency preparedness and response with
designated educational agencies and lead child care agencies in their
jurisdictions.
Include the ``Pediatric Preparedness for Healthcare
Coalitions (Part II)'' Webinar in Budget Period Four HPP Supporting
Documents. This two-part webinar describes resources, partnerships and
strategies that HPP Directors and Healthcare Coalitions have
implemented to strengthen pediatric components within their
jurisdiction's healthcare preparedness capabilities. Topics discussed
include Federal policy and efforts to address the needs of children in
disasters; Superstorm Sandy lessons learned; putting the pieces
together on pediatric response planning; Los Angeles County pediatric
surge plan; and pediatric lessons learned (Alaska Shield/Hale Borealis
2014 National Capstone Exercise).
senator casey
Question 1. This year is the fifth anniversary of the National
Commission on Children and Disasters. What progress has been on the
Commission's recommendations from 2010?
Answer 1. In February 2015, ASPR published the 2012-2013 Report of
the Children's HHS Interagency Leadership on Disasters (CHILD) Working
Group.\6\ This 82-page report documents the progress HHS has made in
addressing the needs of children in disasters since 2011 and highlights
three new focus areas: pregnant and breast feeding women and newborns;
children at heightened risk; and interdepartmental and non-governmental
organization collaboration.
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\6\ http://www.phe.gov/Preparedness/planning/abc/Documents/child-
wg-report2012-2013.pdf.
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The first chapter of the report provides a descriptive list of
departmental activities supported by CHILD Working group member
agencies since 2011. All activities are grouped into the following
categories: behavioral health; medical countermeasures; child physical
health, emergency medical services, and pediatric transport; and child
care, child welfare, and human services.
These four categories were created by the 2010-2011 CHILD Working
Group members upon careful review of the NCCD's recommendations and
internal policy and programmatic initiatives already begun across HHS.
In order to demonstrate continued progress, HHS will continue to
monitor and report all HHS activities related to children and
disasters. For example, in August 2015, HHS launched a new data call
for the 2014-2015 Report of the CHILD Working Group.
Question 2. How are BARDA, CDC and FDA working together to ensure
smooth transitions of products under development, through FDA review,
and into the Strategic National Stockpile?
Answer 2. The Biomedical Advanced Research and Development
Authority (BARDA) in the Office of the Assistant Secretary for
Preparedness and Response has transitioned more than 85 medical
countermeasure (MCM) candidates for chemical, biological, radiological,
and nuclear (CBRN) threats from early development at the National
Institutes of Health (NIH), the Department of Defense (DoD), and
industry into advanced development toward Food and Drug Administration
(FDA) approval and potential acquisition under Project BioShield.
Twelve of these MCMs have been purchased since 2005 under Project
BioShield and another 12 will become mature enough for purchase by
2018. Four Project BioShield MCMs [Raxibacumab anthrax antitoxin
(2012), HBAT botulinum antitoxin (2013), Neupogen for ARS (2015), and
AIG anthrax antitoxin (2015)] have been approved by the FDA under the
Animal Rule. The Public Health Emergency Medical Countermeasures
Enterprise (PHEMCE) governance structure includes: Integrated Program
Teams, the Enterprise Executive Committee, Enterprise Senior Council
oversight bodies, MCM portfolio reviews, a multiyear budget process,
joint MCM projects, and monthly meetings between leadership and staff
from BARDA, the Centers for Disease Control and Prevention (CDC), and
NIH's National Institute of Allergy and Infectious Diseases (NIAID) to
ensure continuous coordinated communication and seamless transition
among these HHS agencies.
Question 3. CDC has ranked CRE and Clostridium difficile as urgent
antibiotic resistance threats, the highest level of resistance threat,
but these organisms are not on PHEMCE's list of high priority threats.
How does PHEMCE determine which organisms to include on the list?
Should these resistant organisms be added?
Answer 3. The PHEMCE addresses high priority threats, determined by
the Secretary of Homeland Security, that pose a material threat
sufficient to affect national security. This includes a material threat
determination (MTD) issued by the Secretary of Homeland Security and/or
a threat that PHEMCE leadership has determined has the potential to
seriously threaten national health security.
The PHEMCE recognizes the threat posed by naturally occurring and
accidental threats to national health security that are outside the
realm of the Department of Homeland Security (DHS) threat and risk
assessment processes. For example, pandemic influenza was included in
the PHEMCE high priority threat list based on PHEMCE leadership's
consensus that it posed a serious threat to national health security
and warranted investment in targeted MCM-related planning and response.
To better standardize the process by which such decisions are made
for particular naturally occurring threats, including antibiotic
resistant organisms, the PHEMCE is currently developing a risk
assessment methodology and process to examine emerging infectious
diseases (EIDs). This process, anticipated for completion in fiscal
year 2016, will inform PHEMCE leadership decisions on which EID threats
require PHEMCE response at the research and development, requirement,
advanced research and development, large-scale production, stockpiling,
and/or utilization planning levels. While the intention of this
framework is to review EIDs, it will be designed in a way that allows
for the evaluation of a wide variety of organisms including health care
associated infections such as Clostridium difficile and CRE.
In the meantime, the PHEMCE will continue efforts to combat drug-
resistant bacteria in general. As noted in the 2014 PHEMCE Strategy and
Implementation Plan, it is a PHEMCE programmatic priority to support
Executive Order 13676, ``Combating Antibiotic-Resistant Bacteria,''
which calls for, among other actions, development of new and next-
generation MCMs that target antibiotic-resistant bacteria that present
a serious or urgent threat to public health.
Question 4. The amount that has been spent on the development of
rapid diagnostics is small compared to the antimicrobial development
budget. Since there is evidence that we can conserve our antibiotics if
we are able to rapidly diagnose an infection, should we focus more
resources on the development of rapid diagnostics? What are some of the
barriers to the development of rapid diagnostics?
Answer 4. BARDA values and supports development in diagnostics for
biothreats, radiation exposure (i.e., biodosimetry), influenza, drug-
resistant bacteria and viruses, and EIDs. BARDA is currently supporting
the development of multiple diagnostic candidates in these areas: four
for biothreats (e.g., anthrax); five for biodosimetry; four for
influenza and antiviral drug resistance; and one for Ebola. In fiscal
year 2016, as funds become available, BARDA plans to add diagnostic
candidates for antimicrobial drug resistance. BARDA's support focuses
on rapid diagnostics for point-of-care throughout institutional usage.
BARDA partners with CDC to set strategic diagnostic goals and plans,
and to support development for many of these diagnostic candidates.
Thus far, BARDA support has led to FDA clearance and marketing of five
diagnostic assays for detection of influenza.
Primary barriers to the development of rapid diagnostics for
pathogenic bacteria include the following:
poor clinical sample collection methods;
availability of validated reference reagents and samples;
assays with high enough specificity for reliable and
reproducible clinical diagnoses;
acceptance and widespread usage by the medical community;
and
limited commercial marketplace.
Question 5a. I understand that HHS is working with the Department
of Homeland Security to conduct a reassessment of certain material
threat assessments and, by extension, the medical countermeasures
requirements for threats such as anthrax and smallpox.
Could you please provide a timeline of this threat reassessment
process?
Answer 5a. On January 20, 2004, the Department of Homeland Security
(DHS) issued a Material Threat Determination (MTD for Bacillus
anthracis (anthrax). Subsequently, Material Threat Assessment (MTA) 1.0
for Anthrax was published in April 2005.
On September 23, 2004, DHS issued a MTD for smallpox. The most
recent Smallpox MTA was published February 2012.
MTA 2.0 for Anthrax began fall of 2013 with the development of a
working group comprised of interagency subject matter experts to frame
the approach. Modeling efforts began August 2014. While weather
selection, indoor transit, and integrated modeling efforts have already
concluded, outdoor modeling, Intelligence Community elicitation, and
development of the illustrative scenario matrix are concurrent
activities. A draft report for MTA 2.0 is expected to be ready for HHS
review by July 2015 with finalization by the end of 2015.
Upon receipt, BARDA's modeling unit will utilize these assessments
(anthrax being the first threat for analysis), develop scenario-based
computer models on the medical consequences of these threats, and
determine their impacts relative to non-medical and MCM interventions.
Results from these analyses will inform PHEMCE product-specific
requirements, MCM development, and product procurement for stockpiles.
Discussions focused on prioritization and planning for future MTA
efforts are ongoing.
Question 5b. When do you expect this process to be complete?
Answer 5b. DHS draft MTA 2.0 became available in July 2015 for HHS
review for anthrax medical consequence modeling and analysis. The final
version should be completed by the end of 2015. Others like smallpox,
ionizing radiation, and chemical agents will follow upon receipt of
MTAs from DHS.
Question 5c. Would these reassessments have the potential to change
BARDA's plans for anthrax and smallpox MCM advanced research and
development or stockpiling?
Answer 5c. Potentially, the MTAs may change and thus impact
development and procurement of CBRN MCMs by PHEMCE partners at NIAID,
BARDA, and CDC.
senator franken
Question. When news of the Ebola outbreak spread, hospitals in
Minnesota responded quickly and took key steps to ensure that they were
prepared to screen, diagnose, and treat affected patients. These
hospitals incurred significant expenses for things like personal
protective equipment and staff training--most of which they have not
been compensated for up to this point. Congress provided HHS with the
authority to use Ebola emergency funding to reimburse hospitals
directly for care that they provided to Ebola patients.
Given all the resources that hospitals in Minnesota and elsewhere
expended to make sure that they were prepared to treat Ebola patients,
my question is, how you are determining eligibility for reimbursement
under this authority?
Answer. The Hospital Preparedness Program (HPP) provided $162
million in Ebola preparedness and response funds through a funding
formula to all HPP awardees in May 2015. These awardees are the public
health departments in all 50 States, DC, select metropolitan
jurisdictions (Chicago, Los Angeles County, and New York City), U.S.
territories, and freely associated States. The majority of the funds
will be further sub-awarded to support health care facilities that are
capable of serving as Ebola treatment centers and assessment hospitals
for their States or jurisdictions. The funding will also support health
care coalitions prepare frontline hospitals, emergency medical services
agencies, and the overall health care system. The funding formula for
the HPP Ebola FOA takes into account Ebola risk, which is based on the
travel patterns of individuals coming from the affected countries. It
also reflects West African diaspora population centers and
jurisdictions with enhanced airport entrance screenings to ensure that
the States and localities most likely to have a case of Ebola are fully
prepared. As a high risk State for Ebola, Minnesota's allocation was
among the largest at $5,513,716. Hospitals designated as Ebola
treatment centers by State health officials as of February 14, 2015
will receive no less than $500,000 through this FOA, including four in
Minnesota: Allina Health's Unity Hospital, Fridley, MN; Children's
Hospitals and Clinics of Minnesota--St. Paul Campus, St. Paul, MN; Mayo
Clinic Hospital--Rochester, St. Mary's Campus, Rochester, MN; and
University of Minnesota Medical Center, West Bank Campus, Minneapolis,
MN.
State awardees have the discretion to provide additional funding to
the Ebola treatment centers as their allocation allows.
In addition, nine State or local health departments, along with
their health facility partners, were awarded funding on June 12, 2015
to establish regional Ebola and other special pathogen treatment
centers (1 in 9 of the 10 HHS regions). As necessary, these centers can
be ready within a few hours to receive a confirmed Ebola patient from
their region, across the United States, or medically evacuated from
outside of the United States. These hospitals will also have enhanced
capacity to care for other highly infectious diseases. The Minnesota
Department of Health, in partnership with the University of Minnesota
Medical Center, Minneapolis, MN, was one of the recipients of these
competitively awarded funds, to serve as the regional Ebola and other
special pathogen treatment center for HHS Region Five. Funding will be
distributed to these awardees incrementally over the full 5-year
project period in order to sustain and maintain readiness for Ebola and
other highly pathogenic infectious diseases. The total funding to
establish regional Ebola and special pathogen treatment centers across
the country is $32.5 million.
Awardees can use their discretion when providing supplemental funds
to sub-recipient health care facilities and coalitions for previous
Ebola preparedness costs incurred since July 2014. However, awards may
not be used to reimburse health care facilities for direct patient
treatment costs. HPP seeks to build capabilities within the entire
health care system to better prepare communities for future outbreaks
of Ebola and other novel, highly pathogenic diseases.
The office of the Assistant Secretary for Preparedness and Response
(ASPR) has established a program to reimburse hospitals and other
health care providers for direct and uncompensated treatment and
domestic transportation costs accrued while caring for a confirmed
Ebola patient in the United States. This program reimburses care
provided to patients treated since the start of the Ebola response and
remain in place should additional patients require treatment during the
5-year funding period, as set forth in the Consolidated and Further
Continuing Appropriations Act, 2015. Health care facilities began
submitting claims on April 15.
senator baldwin
In the House of Representatives, I worked to include language in
the Pandemic All-Hazards Preparedness Reauthorization Act of 2013 that
added the critical care system to the Federal Government's medical
preparedness and surge capacity goals to ensure that critical care is
included in emergency planning efforts. I also recently introduced the
bipartisan Critical Care Assessment and Improvement Act to evaluate our
critical care infrastructure, as the recent Ebola outbreak and severe
flu season has underscored the importance of critical care systems.
Question 1. Dr. Lurie, what methods are currently being used by the
Department of Health and Human Services to identify and deploy surge
medical providers with critical care expertise, like intensivists,
nurses and respiratory therapists, as well as those that are able to
care for children and infants in need of critical care?
Answer 1. The Office of the Assistant Secretary for Preparedness
and Response (ASPR), in collaboration with the Centers for Medicare &
Medicaid Services (CMS), has utilized limited administrative claims
data to evaluate the impact of prolonged power outages on health care
delivery, and individuals that rely on electricity-dependent medical
equipment and health care services, such as dialysis. Following
Hurricane Sandy, dialysis studies have allowed us to see how dialysis-
dependent Medicare beneficiaries were adversely impacted and have
identified clinical preparedness practices which can help us better
anticipate, plan for, and respond to needs in a disaster.\7\ For
example, our studies provided evidence that Medicare dialysis-dependent
patients who received early dialysis in anticipation of Sandy's
landfall had their odds of an emergency department visit reduced by 20
percent, hospitalization in the week of the storm reduced by 21
percent, and 30-day mortality reduced by 28 percent.\8\ ASPR, in
collaboration with CMS, is actively disseminating these important
findings across the dialysis community as well as encouraging
healthcare and public health officials to encourage and prioritize
early dialysis, where appropriate, in advance of a notice emergency
such as a hurricane or blizzard.
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\7\ http://www.ncbi.nlm.nih.gov/pubmed/25156306.
\8\ http://www.ncbi.nlm.nih.gov/pubmed/26120039.
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ASPR and CMS have also established the HHS emPOWER Initiative, a
data and mapping collaboration to help inform and support Federal,
State, local, and community emergency planning and response activities
for those in need of electricity-dependent medical and assistive
equipment and oxygen, home health, and dialysis healthcare services.
This information is made available to State and local health
departments and the community partners and appropriately balances the
need to support emergency planning and response with the need to
protect privacy. One component is the HHS emPOWER Map,\9\ a publicly
available and interactive map that provides de-identified and
aggregated population data down to the zip code level for Medicare
beneficiaries that rely upon electricity-dependent medical and
assistive equipment. Another component provides State and local health
public health authorities with more de-identified and granular data
(e.g., type of medical equipment, home health services, oxygen-tank
use, dialysis-dependence) that can support more detailed emergency
planning and response activities. Public health authorities that meet
certain Health Insurance Portability and Accountability Act
requirements can also request secure access to more detailed
information, such as addresses, to facilitate life-saving assistance
and outreach as part of an emergency response. Finally, ASPR is also
collaborating with CMS and other partners, to identify medications that
may be needed by at-risk populations prior to a disaster and explore
mechanisms that can expedite advance or rapid medication refills for
those that may need them after a disaster.
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\9\ http://www.phe.gov/empowermap/.
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Specific activities include:
Publishing the 2012-2013 Report of the Children's HHS
Interagency Leadership on Disasters (CHILD) Working Group.\10\ This 82-
page report documents the significant progress HHS has made in
addressing the needs of children in disasters since 2011 and highlights
three new focus areas: pregnant and breast feeding women and newborns,
children at heightened risk, and interdepartmental and non-governmental
organization collaboration. A comprehensive summary of HHS activities
related to medical countermeasures, child physical health, emergency
medical services, and pediatric transport is found on pages 11 through
20 of the report.
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\10\ http://www.phe.gov/Preparedness/planning/abc/Documents/child-
wg-report2012-2013.pdf.
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Developing the ``Pediatric Preparedness for Healthcare
Coalitions (Part I)'' Webinar and Resources, as well as a Part II
Webinar.
Question 2. In response to the Ebola outbreak last year, Wisconsin
designated three Wisconsin health systems to care for patients who may
be diagnosed with the Ebola virus. These hospitals have invested a
significant amount of staff and financial resources to ensure that they
are ready to provide the best and safest care in the event that
Wisconsin must care for a patient with Ebola. It is critical that our
Federal efforts support these important investments.
How much of the $162 million in emergency funding being provided to
States for Ebola preparedness will be provided directly to hospitals,
and how will such funds prioritize State-designated treatment centers,
such as the three in Wisconsin?
Answer 2. The Hospital Preparedness Program (HPP) provided $162
million in Ebola funding through a funding formula to all HPP awardees
in May 2015. These awardees are in all 50 States, DC, select
metropolitan jurisdictions (Chicago, Los Angeles County, and New York
City), U.S. territories, and freely associated States to support health
care facilities that are capable of serving as Ebola treatment centers
and assessment hospitals for their States or jurisdictions. The funding
will also support health care coalitions (HCCs) to prepare frontline
hospitals, emergency medical services agencies, and the overall health
care system.
Awardees must limit their direct costs (excluding sub-awards to
HCCs and health care facilities) to no more than 10 percent of their
allocation. Of the funds for sub-awards:
At least 30 percent must be allocated to health care
coalitions in the jurisdiction (Wisconsin has eight health care
coalitions across the State).
No more than 70 percent may be used to provide funding
directly to Ebola treatment centers and/or assessment hospitals.
Hospitals that have been designated by State health officials as
Ebola treatment centers as of February 14, 2015 will receive no less
than $500,000 through the HPP awards, including three in Wisconsin: UW
Health--University of Wisconsin Hospital, Madison and the American
Family Children's Hospital, Madison, WI; Froedtert and the Medical
College of Wisconsin--Froedtert Hospital, Milwaukee, WI; and Children's
Hospital of Wisconsin, Milwaukee, WI. States and awardees have the
discretion to provide additional funding to the Ebola treatment centers
as their allocation allows.
senator warren
Question 1a. The Ebola outbreak in West Africa has raised questions
about whose responsibility it is to lead, coordinate, and finance
international infectious disease response efforts, especially when
local governments are ill-equipped to handle a crisis alone. There are
many international groups, including the World Health Organization,
non-governmental organizations like the Gates Foundation and Doctors
Without Borders, and initiatives like the Global Health Security Agenda
which brings together U.S. Government agencies and partner nations to
make strategic investments to develop a better system of preventing,
detecting, and responding to disease threats worldwide.
Who do you think is ultimately responsible for the coordinating and
financing international outbreak response efforts?
Answer 1a. International-Level Coordination.--The United Nations
(UN) Cluster Approach was established in June 1992 by the U.N. Inter-
Agency Standing Committee to strengthen humanitarian assistance during
complex, multi-sectoral responses. More specifically, it strengthens
response to situations where humanitarian needs are of sufficient scale
and complexity and require the coordination and engagement of a wide
range of international stakeholders. Within the U.N. Cluster Approach,
the World Health Organization (WHO) leads the Health Cluster and has
the ultimate responsibility for coordinating response efforts to
international emergencies with a public health component, including
efforts among WHO Member States, other U.N. Agencies, and non-
governmental organizations.
Additionally, WHO has a leading role under the 2005 International
Health Regulations (IHR), which includes determining whether particular
events constitute a public health emergency of international concern
(PHEIC). Other WHO responsibilities include disseminating information
to State Parties, building and strengthening core public health
capacities for surveillance and response to PHEIC, developing and
recommending measures for surveillance, and the prevention and control
of public health emergencies of international concern. WHO's leading
role in emergencies was strengthened by Article 2(d) of WHO's
Constitution and World Health Assembly Resolutions 34.26, 46.6, 48.2,
58.1, 59.22, 64.10, and 65.20.
WHO has also established an Emergency Response Framework\11\ and a
Global Emergency Management Team to provide overall policy, strategy,
and management guidance. This is important to coordinate an effective
health sector response as the Health Cluster Lead Agency and in line
with responsibilities under the 2005 IHR. In this role, WHO has the
responsibility for coordinating global financing and resources
contributed to public health responses (direct funding and in kind
support). A proposal to establish a contingency fund to support public
health emergency responses will be considered by the Sixty-eighth World
Health Assembly. When this happens, the WHO Director-General will be
asked about options regarding the size, scope, sustainability,
operations and sources of financing for such a fund. In addition, the
Director-General will be asked about accountability mechanisms
including possible internal sources of funding from within WHO's
existing program budget. This is done taking into account other
relevant financing mechanisms and emergency funds already in operation
or being considered, at regional and global levels.
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\11\ http://www.who.int/hac/about/erf_.pdf.
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In addition to HHS's full support of the implementation of the IHR
(2005) through numerous public health emergency and response capacity
building arrangements and public health activities internationally, HHS
participates in a number of specific international partnerships that
serve to strengthen global capacity to prevent, detect, respond, and
recover from international public health emergencies, as well as to
foster technical and policy coordination among key stakeholders prior
to and during a response. Among others, these partnerships include the
Global Health Security Agenda, the Global Health Security Initiative
(which consists of the G7 countries, Mexico, and the European
Commission, as well as the WHO as an expert advisor), the North
American Plan for Animal and Pandemic Influenza (NAPAPI), and the
United States-Canada Beyond the Border Initiative.
U.S.-Government-Level Coordination.--In accordance with the
Presidential Policy Directive (PPD)-1 process for coordinating
executive departments and agencies as they develop, integrate, and
implement national security policy, the National Security Council (NSC)
typically convenes Interagency Policy Committees as the U.S.
Government-wide policy coordination structure. This is done to support
the response to public health emergencies. A number of recent
frameworks were recently developed to coordinate the provision of
international assistance in response to international emergencies that
pose a risk to the United States including for chemical, biological,
radiological, and nuclear (CBRN) incidents, and pandemic influenza.
These frameworks specifically address the deployment of medical
countermeasures and personnel in response to a request for assistance
from another government or the WHO/international organizational.
However, no U.S. Government policy framework outlines the respective
roles and responsibilities of U.S. Government departments and agencies
in response to public health events of international concern that
require full-spectrum public health intervention (i.e., epidemiologic
investigation, healthcare services, risk communication, community
coordination, environmental services and international border controls)
to prevent regional and global spread.
The National Response Framework establishes the U.S. Department of
Health and Human Services (HHS) as the leader for coordinating response
to domestic public health and medical emergencies under Emergency
Support Function #8 (ESF-8). Within HHS, the Pandemic and All-Hazards
Preparedness Act (PAHPA) provides the Assistant Secretary for
Preparedness and Response (ASPR) with a mandate to ``provide leadership
in international programs, initiatives, and policies that deal with
public health and medical emergency preparedness and response.''
Additionally, other U.S. agencies, such as the U.S. Agency for
International Development and the Department of Defense, have legal
authorities and funding to lead, coordinate, or implement international
assistance and disaster response. However, there is no overarching U.S.
Government coordination framework that describes the roles,
responsibilities, or the legal and funding authorities of all relevant
U.S. Government stakeholders during such an international response with
potential domestic implications not covered by a Stafford Act
declaration.
Question 1b. What changes need to occur to empower such a system?
Answer 1b. International-Level Coordination.--Based on lessons
learned from the Ebola response, efforts are underway to strengthen
global preparedness and ensure that WHO has the capacity to prepare for
and respond to future large-scale outbreaks and health emergencies.
Accordingly, a number of reform proposals were brought before and
adopted by the Sixty-eighth World Health Assembly in May 2015. Areas of
focus include reaffirming WHO's role and leadership as the Global
Health Cluster Lead Agency, improving surveillance and information
sharing, calling for WHO and Member States to further efforts to
strengthen health systems establish capacities for public health
preparedness and response under the 2005 IHR, establishing mechanisms
for rapid medical assistance (including establishment and deployment of
foreign medical teams), and strengthening efforts to ensure access to
drugs and vaccines and developing a WHO-managed $100-million
contingency fund to provide financing for in-field operations for up to
3 months.
U.S. Government-Level Coordination.--The USG should consider the
development of a generic USG-wide framework that contemplates a variety
of scenarios and describes the roles, responsibilities, funding, and
legal authorities of relevant stakeholders during the different phases
of a response to public health and medical emergencies with a domestic-
international interface. This framework should include triggers
allowing responsibilities and leadership to shift from one U.S.
Department or Agency to another depending on their specific mission and
authorities. This includes events caused by CBRN threats, pandemic
influenza, emerging or re-emerging infectious diseases, and natural
disasters that originate abroad but potentially impact U.S. national
health security.
Under the role and authorities given to ASPR by PAHPRA, ASPR, in
collaboration with key HHS stakeholders, should also develop an
overarching HHS framework for responding to public health emergencies
with a domestic-international interface. The Framework should highlight
the leading role of HHS and specifically ASPR in coordinating the
public-health aspects of emergencies abroad that can have an impact in
U.S. health security. It should also clarify the roles and
responsibilities of the different HHS offices during a response and
(e.g., CDC, NIH, FDA) align these roles with existing roles during
domestic responses.
Question 2. In order for the United States to have the capacity to
respond to outbreaks at home and abroad, we need to have individuals
who are trained and experienced in handling infectious agents.
Biosafety training programs are essential to prepare both governmental
and nongovernmental personal to effectively respond to epidemics. Do
ASPR and CDC currently, or have plans to, leverage nongovernment
physicians and researchers, capabilities, and infrastructure to enhance
the Nation's clinical and research capacities for future outbreaks?
Answer 2. To reduce cost and save time in product development and
manufacturing, the Biomedical Advanced Research and Development
Authority (BARDA) in the Office of the Assistant Secretary for
Preparedness and Response (ASPR) has established a National Medical
Countermeasure Response Infrastructure comprised of core service
assistance programs to assist product developers on a daily basis while
ensuring rapid and nimble response in a public health emergency. BARDA
has employed this medical countermeasure (MCM) infrastructure for
development of CBRN MCMs on a routine basis and is now utilizing them
in the current Ebola response by supporting the development and
manufacturing of several Ebola therapeutics and vaccines. BARDA's
Nonclinical Studies Network (NCSN), which was established in 2010 and
is composed of 17 high-biocontainment laboratories in the United States
and the United Kingdom, has developed qualified animal models for CBRN
threats, performed animal challenge studies for CBRN MCMs, and
evaluated potential CBRN MCM candidates in these animal models prior to
BARDA investment. Today, the NCSN is conducting critical animal
challenge studies for promising Ebola monoclonal and antiviral drug
therapeutic candidates.
BARDA's three Centers for Innovation in Advanced Development and
Manufacturing are helping to develop anthrax vaccines and are expanding
the production of new and existing Ebola monoclonal antibodies similar
to ZMapp in mammalian cells. BARDA's Fill Finish Manufacturing Network,
established in 2013 with four Contract Manufacturing Organizations
having aseptic filling capabilities in the United States, is now being
used to formulate and fill multiple Ebola antibody and vaccine
candidates into vials for clinical efficacy studies in West Africa. Two
Contract Research Organizations among the five members of BARDA's
Clinical Studies Network are working with BARDA scientists and CDC to
conduct Ebola vaccine clinical trials in Sierra Leone. BARDA's modeling
unit, which routinely provides medical consequence modeling of CBRN
threats to inform MCM requirements, generated key models and forecasts
on the impacts of MCM intervention on the epidemiology of the 2009 H1N1
pandemic, 2013 H7N9 outbreaks, and of the current Ebola epidemic in
West Africa. All together, these programs constitute an active and
seasoned infrastructure able to respond to known and unknown emerging
infectious diseases. BARDA investments to our national MCM
infrastructure since 2010 have played a major role in our national
response to the current Ebola epidemic. Moreover, these investments
will become even more vital for MCM response to public health and
national security emergencies in the coming years.
In 2012, ASPR established a science preparedness initiative to
develop a framework for the integration of scientific research and to
mobilize clinical and scientific research responders during HHS
disaster-response efforts.\12\ Once fully developed, the science
preparedness framework will include a network of pre-identified
scientists, including those with expertise in biosafety, applied
biosafety research, and infection control training, who can rapidly
initiate research in response to all hazards. The framework will also
establish procedures for rapid institutional review of clinical
research involving human subjects, and the development of pre-scripted
clinical and scientific research protocols.
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\12\ http://www.phe.gov/Preparedness/planning/science.
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ASPR is also managing the S3 (Science, Safety, and Security)
program, which addresses biosafety, biosecurity, biocontainment, and
bio-risk management. The S3 program promotes transparency and broader
awareness about the evolving nature of biological agents that can be
hazardous and instructs how to handle and use these agents safely and
securely. Resources provided on the program's website\13\ are directed
toward laboratory personnel who work with potentially hazardous
biological agents, their supervisors, management personnel at their
institutions of employment, policymakers, and the public.
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\13\ http://www.phe.gov/s3.
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Recognizing a need to prepare the U.S. health care system to safely
assess and care for patients with suspected and confirmed cases of
Ebola, ASPR and CDC jointly awarded $12 million on July 1, 2015, to
establish a National Ebola Training and Education Center (NETEC). While
the focus of this funding is on preparedness for Ebola, as required in
the appropriations language, it is likely that preparedness for other
novel, highly pathogenic diseases will also be enhanced through these
activities. The NETEC is a consortium of all three U.S. hospitals that
successfully and safely treated patients with Ebola: Emory University
in Atlanta, GA; University of Nebraska Medical Center/Nebraska Medicine
in Omaha, NE; and Bellevue Hospital Center in New York, NY. NETEC will
offer expertise, training, technical assistance, peer review,
monitoring, and recognition, to State health departments, regional
Ebola and other special pathogen treatment centers, State and
jurisdiction-based Ebola treatment centers, and assessment hospitals.
However, recipients may not use funds for research or clinical care.
More specifically, NETEC will build a comprehensive set of
activities and deliverables for public health departments, U.S. health
care providers, and facilities to safely and successfully identify,
isolate, assess, transport, and treat patients with Ebola, or persons
under investigation for Ebola. In addition, it will develop and lead a
national peer review and recognition program for the regional Ebola and
other special pathogen treatment centers. Throughout the 5-year project
period, NETEC will modify materials developed (e.g., curricula and
templates) as the Ebola outbreak evolves and the science advances.
NETEC will develop metrics to measure facility and health care
worker readiness (including health care worker training). Using these
metrics, NETEC will conduct peer review assessments, monitoring, and
recognition reporting. These metrics should complement and build from
the capabilities detailed in CDC's Interim Guidance for Hospital
Preparedness, and other additional capabilities necessary for NETEC.
Regional Ebola and other special pathogen treatment centers will be
assessed annually while the State and jurisdiction Ebola treatment
centers and assessment hospitals will be assessed as mutually agreeable
over the 5-year project period. ASPR and CDC will assist NETEC with
prioritizing requests from health departments and hospitals, in the
event that requests are unmanageable. In order to address gaps, NETEC
will provide HHS with detailed reports concerning each facility's
assessment results, including a summary of all NETEC-provided
assistance.
NETEC will develop a training curriculum and will continuously
update a comprehensive set of educational materials, resources, and
tools to build and maintain health care worker readiness for Ebola-
virus diseases and other novel, highly pathogenic diseases. Under this
capacity, NETEC will focus on the knowledge, skills, and abilities
needed to safely and successfully identify, isolate, assess, transport,
and clinically treat a suspected Ebola patient in accordance with U.S.
Government guidelines.
More specifically, NETEC will provide technical support to train
staff at public health departments and health care workers at regional
Ebola and other special pathogen treatment centers, State and
jurisdiction designated treatment centers, and assessment hospitals.
The NETEC will facilitate the planning and observation of facility and
regionally based exercises through a variety of methods, including but
not limited to:
Full immersion training at the NETEC or requesting
facility location;
Exercises at an NETEC or requesting facility location on a
regular basis (e.g., annually);
Clinical consults and technical assistance via secure
video or telemedicine information technology;
Onsite and virtual clinical simulation training; and
Subject matter expert technical assistance visits (e.g.,
conference calls, webinars), training courses, and exercise templates.
[Whereupon, at 11:57 a.m., the hearing was adjourned.]
[all]