[Congressional Record Volume 163, Number 187 (Wednesday, November 15, 2017)]
[House]
[Pages H9297-H9300]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
AUTHORIZING ADDITIONAL EMERGENCY USES FOR MEDICAL PRODUCTS TO REDUCE
DEATHS AND SEVERITY OF INJURIES CAUSED BY AGENTS OF WAR
Mr. WALDEN. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 4374) to amend the Federal Food, Drug, and Cosmetic Act to
authorize additional emergency uses for medical products to reduce
deaths and severity of injuries caused by agents of war, and for other
purposes.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 4374
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. ADDITIONAL EMERGENCY USES FOR MEDICAL PRODUCTS TO
REDUCE DEATHS AND SEVERITY OF INJURIES CAUSED
BY AGENTS OF WAR.
(a) FDA Authorization for Medical Products for Use in
Emergencies.--Section 564 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-3) is amended--
(1) in subsection (b)--
(A) in paragraph (1), by amending subparagraph (B) to read
as follows:
``(B) a determination by the Secretary of Defense that
there is a military emergency, or a significant potential for
a military emergency, involving a heightened risk to United
States military forces, including personnel operating under
the authority of title 10 or title 50, United States Code, of
attack with--
``(i) a biological, chemical, radiological, or nuclear
agent or agents; or
``(ii) an agent or agents that may cause, or are otherwise
associated with, an imminently life-threatening and specific
risk to United States military forces;''; and
(B) by adding at the end the following:
``(6) Military emergencies.--In the case of a determination
described in paragraph (1)(B), the Secretary shall determine,
within 45 calendar days of such determination,
[[Page H9298]]
whether to make a declaration under paragraph (1), and, if
appropriate, shall promptly make such a declaration.''; and
(2) in subsection (c)--
(A) in paragraph (3), by striking ``; and'' and inserting
``;'';
(B) by redesignating paragraph (4) as paragraph (5); and
(C) by inserting after paragraph (3) the following:
``(4) in the case of a determination described in
subsection (b)(1)(B)(ii), that the request for emergency use
is made by the Secretary of Defense; and''.
(b) Emergency Uses for Medical Products.--
(1) In general.--The Secretary of Defense may request that
the Secretary of Health and Human Services, acting through
the Commissioner of Food and Drugs, take actions to expedite
the development of a medical product, review of
investigational new drug applications under section 505(i) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)),
review of investigational device exemptions under section
520(g) of such Act (21 U.S.C. 360j(g)), and review of
applications for approval and clearance of medical products
under sections 505, 510(k), and 515 of such Act (21 U.S.C.
355, 360(k), 360(e)) and section 351 of the Public Health
Service Act (42 U.S.C. 262), including applications for
licensing of vaccines or blood as biological products under
such section 351, or applications for review of regenerative
medicine advanced therapy products under section 506(g) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(g)),
if there is a military emergency, or significant potential
for a military emergency, involving a specific and imminently
life-threatening risk to United States military forces of
attack with an agent or agents, and the medical product that
is the subject of such application, submission, or
notification would be reasonably likely to diagnose, prevent,
treat, or mitigate such life-threatening risk.
(2) Actions.--Upon a request by the Secretary of Defense
under paragraph (1), the Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs,
shall take action to expedite the development and review of
an applicable application or notification with respect to a
medical product described in paragraph (1), which may
include, as appropriate--
(A) holding meetings with the sponsor and the review team
throughout the development of the medical product;
(B) providing timely advice to, and interactive
communication with, the sponsor regarding the development of
the medical product to ensure that the development program to
gather the nonclinical and clinical data necessary for
approval or clearance is as efficient as practicable;
(C) involving senior managers and experienced review staff,
as appropriate, in a collaborative, cross-disciplinary
review;
(D) assigning a cross-disciplinary project lead for the
review team to facilitate an efficient review of the
development program and to serve as a scientific liaison
between the review team and the sponsor;
(E) taking steps to ensure that the design of the clinical
trials is as efficient as practicable, when scientifically
appropriate, such as by minimizing the number of patients
exposed to a potentially less efficacious treatment;
(F) applying any applicable Food and Drug Administration
program intended to expedite the development and review of a
medical product; and
(G) in appropriate circumstances, permitting expanded
access to the medical product during the investigational
phase, in accordance with applicable requirements of the Food
and Drug Administration.
(3) Enhanced collaboration and communication.--In order to
facilitate enhanced collaboration and communication with
respect to the most current priorities of the Department of
Defense--
(A) the Food and Drug Administration shall meet with the
Department of Defense and any other appropriate development
partners, such as the Biomedical Advanced Research and
Development Authority, on a semi-annual basis for the
purposes of conducting a full review of the relevant products
in the Department of Defense portfolio; and
(B) the Director of the Center for Biologics Evaluation and
Research shall meet quarterly with the Department of Defense
to discuss the development status of regenerative medicine
advanced therapy, blood, and vaccine medical products and
projects that are the highest priorities to the Department of
Defense (which may include freeze dried plasma products and
platelet alternatives),
unless the Secretary of Defense determines that any such
meetings are not necessary.
(4) Medical product.--In this subsection, the term
``medical product'' means a drug (as defined in section 201
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)),
a device (as defined in such section 201), or a biological
product (as defined in section 351 of the Public Health
Service Act (42 U.S.C. 262)).
(c) Repeal.--Effective as of the enactment of the National
Defense Authorization Act for Fiscal Year 2018, subsection
(d) of section 1107a of title 10, United States Code, as
added by section 716 of the National Defense Authorization
Act for Fiscal Year 2018, is repealed.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Oregon (Mr. Walden) and the gentleman from New Jersey (Mr. Pallone)
each will control 20 minutes.
The Chair recognizes the gentleman from Oregon.
General Leave
Mr. WALDEN. Mr. Speaker, I ask unanimous consent that all Members may
have 5 legislative days within which to revise and extend their remarks
and insert extraneous material in the Record on the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Oregon?
There was no objection.
Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I include in the Record a letter to the Senate Committee
on Armed Services from the FDA Commissioner, Dr. Scott Gottlieb.
U.S. Food & Drug Administration,
Silver Spring, MD, November 14, 2017.
Senator John McCain,
Chairman, Senate Committee on Armed Services, Washington, DC.
Senator Jack Reed,
Ranking Member, Senate Committee on Armed Services,
Washington, DC.
Dear Chairman McCain and Ranking Member Reed: Thank you for
your commitment to our Nation's service members and for your
leadership in enhancing the Food and Drug Administration's
(FDA) medical countermeasure authorities and collaborations
with the Department of Defense (DoD). FDA shares your goal of
protecting our Nation's military service men and women by
advancing safe and effective medical products, strengthening
our partnerships with the DoD on behalf of our Nation's
warfighters, and ensuring that this critical work is
prioritized by the Agency.
Our Nation's troops face unique risks on the battlefield,
and my colleagues and I at the Agency are committed to
implementing a lasting framework that not only considers
these unique risks, but prioritizes the warfighters' needs by
expediting the development and review of medical
countermeasures needed in the face of emerging threats. The
bipartisan bill that will be considered alongside the
National Defense Authorization Act of 2018 would codify these
commitments to ensure that the warfighters' needs for safe
and effective medical countermeasures are met on a priority
basis and in strong partnerships with DoD.
For instance, I believe this new authority and enhanced
collaborations with DoD will help enable FDA to approve
freeze dried plasma as soon as 2018, addressing a key medical
priority. Further, it will put in place a permanent process
for strong engagement between FDA and DoD on any future
medical products DoD determines are necessary to address
military emergencies. Additionally, under these provisions,
FDA would be able to recognize military threats in advance
and provide an emergency use authorization for a fuller range
of medical products that could help save lives on the
battlefield.
Thank you again for your dedication to our Nation's service
members and for working with FDA on this meaningful framework
to better serve and protect our warfighters. Please be
assured that I am personally committed to this effort. I will
make it one of my highest priorities as Commissioner to
rapidly implement the framework that is called for under this
legislation and work with my colleagues at FDA and DoD to
create an enduring pathway for the efficient development and
prioritization of products intended to help save the lives of
military personnel on the battlefield. Please do not hesitate
to reach out to me as we implement these new authorities.
Sincerely,
Scott Gottlieb, M.D.,
Commissioner of Food and Drugs.
Mr. WALDEN. Mr. Speaker, our men and women in uniform have put their
lives on the line for this country, and they deserve to have the
earliest possible access to medical products that could save their
lives on the battlefield.
H.R. 4374 will establish important new authorities for the Food and
Drug Administration, the FDA, and the Department of Defense, DOD, to
ensure that our warfighters have the benefits of new treatments and new
devices.
Mr. Speaker, currently the FDA has the authority to authorize the
emergency use of an unapproved medical product for a specific set of
military emergencies. They have that authority. This emergency use
authority requires two things, though. First, the Secretary of Defense
must make a determination that there is a risk of attack on military
forces with a chemical, biological, radiological, or nuclear agent.
Next, the Secretary of Health and Human Services must make a
declaration that there is, in fact, an emergency or threat justifying
the emergency use authorization of a product.
To ensure there are no unnecessary delays in this process, this
legislation, H.R. 4374, establishes a deadline for the Secretary of
Health and Human Services. Once the Secretary of Defense
[[Page H9299]]
makes a declaration of an imminent risk of attack, the Secretary of
Health and Human Services has 45 days--that is the maximum--to make a
declaration that such a risk exists.
Limiting the threat under which an emergency use can be authorized to
chemical, biological, radiological, or nuclear agents, frankly, has
been too narrow to incorporate all the serious threats of harm to our
troops.
To address this problem, H.R. 4374 establishes a new category under
which the emergency use authorization process can be triggered. H.R.
4374 expands this authority to include situations where the Secretary
of Defense makes a determination that there is risk of attack with any
agent that may cause an imminently life-threatening and specific risk
to the United States military forces.
In addition to creating new pathways for emergency access to
unapproved medical devices, H.R. 4374 also creates a new breakthrough
designation to expedite actual FDA approval of medical products for
military emergencies.
Currently, the breakthrough pathway exists only for products intended
to treat serious, life-threatening conditions where the Secretary
determines such a product may demonstrate significant improvement over
existing therapies.
{time} 1600
Mr. Speaker, this expedited approval is based on the successful
breakthrough designation created by Congress back in 2012. This has
worked. It has accelerated oncology drug reviews by more than 2 years.
Now, in short, H.R. 4374 addresses the critical issue of military
access to the newest available products by expanding the circumstances
under which emergency use authorizations can be issued and by
establishing an expedited pathway to full approval of products that the
Secretary of Defense requests.
Mr. Speaker, policies in this bill are bipartisan. They were
developed with the input from the administration as well as the
authorizing committees in the House and the Senate. Additionally, CBO
has indicated that H.R. 4374 will have no impact on direct spending or
revenue. So, Mr. Speaker, this is not only a good bill, it is an
important bill for our men and women in uniform, and I urge my
colleagues to support H.R. 4374.
I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, today we are considering legislation that would
authorize additional emergency uses for medical products in response to
the needs of the Department of Defense in the instance of a military
emergency.
Like all of my colleagues, I want to ensure that our military
personnel who put their life in harm's way for our freedom have access
to the medical products that they need, and I have supported and will
continue to support policies that further the goal of protecting our
troops from life-threatening risks.
However, these policies also have to be balanced to ensure that, in
our effort to protect troops from harm, we are not inadvertently
exposing them to additional risk from unproven products. That is why I
was disappointed to learn that the National Defense Authorization Act
conference report included a policy supported by the Senate that would
have given the Secretary of Defense authority to authorize emergency
access to unapproved medical products, an authority that solely rests
within the Food and Drug Administration today.
This provision was not the subject of hearing and debate, did not
receive the congressional oversight it should have, and I believe
decisions of such consequence should go through regular order,
providing Members and stakeholders with the opportunity to learn fully
of the risks and benefits associated with transferring regulatory
oversight of medical products to an agency that is not equipped with
the expertise and medical product knowledge of the FDA.
While I am not pleased with the process and how it has unfolded, I do
support H.R. 4374 because I believe it will maintain emergency use
authority with the agency that has the resources and scientific
expertise needed to make decisions about access to unproven medical
products. It is solely the FDA that has been charged with weighing the
risks and benefits of medical products and making determinations as to
their safety and effectiveness, and this legislation maintains the
FDA's important role in that process.
Mr. Speaker, H.R. 4374 not only addresses the Department of Defense's
concerns about access to medical products in instances of military
emergencies, but it also goes further by providing them with additional
support, in this instance, to expedite the development and review of
medical products that are of priority to the Department. It also
commits FDA to regularly meeting with the Department of Defense to
discuss their priorities and product pipelines.
So I just want to thank FDA Commissioner Gottlieb, Chairman Walden,
Senate Health Committee Chairman Alexander, and Ranking Member Murray
for working to find a compromise that will maintain proper regulatory
oversight over emergency uses of unproved medical products, while also
ensuring that our Nation's military has access to the products that
they need in a military emergency situation.
I do urge my colleagues to vote in support of this legislation, and I
reserve the balance of my time.
Mr. WALDEN. Mr. Speaker, I appreciate the comments of the gentleman
from New Jersey as we work on this together.
I yield 3 minutes to the gentleman from Illinois (Mr. Shimkus),
chairman of our Subcommittee on Environment and a veteran himself.
(Mr. SHIMKUS asked and was given permission to revise and extend his
remarks.)
Mr. SHIMKUS. Mr. Speaker, it is great to be on the floor today.
It was an awesome opportunity to be a conferee on the National
Defense Authorization bill. As a veteran, 5 years active Army Infantry,
23 in the Reserves, I don't get a chance to do that very often because
I am on the best committee in Congress, which is Energy and Commerce.
But to be able to be in that process, I am very appreciative to you and
to the other conferees.
It was then that you learn what you learn, and the military had a
problem. They had a long-delayed issue on freeze-dried plasma that is
inexcusable, and they took action in the legislative language to
rectify that delay, and we would, too. But the legislative process
worked.
I also want to commend my colleagues on the minority side and Ranking
Member Pallone because what we want for our men and women in uniform,
we want them to get an expedited pathway to lifesaving devices and
drugs. But we also want to make sure that those things are safe, and
the premier institution for safety and efficacy is the Food and Drug
Administration.
Now, we have a new administration that probably wouldn't have had an
8-year delay on freeze-dried plasma, and we have a new administrator of
the FDA who has committed to reform these processes.
But good intentions are not all that we need. We need legislative
language. We need to enshrine these changes in the law, and this is a
good example, when I used to teach government history in high school,
of how government works: House bill, Senate bill, go t conference. Even
after a conference, it wasn't just right, so the legislative leaders
went to work to fix this.
The changes have been identified by both the ranking member and the
chairman, but the bottom line is the FDA needs to have the opportunity
to look and expedite the drug. And we actually give them a shot clock
for those people in harm's way, to make sure that drugs and devices are
available to our warfighters, that it is safe and secure and delivered
in a timely manner. This is the least we can do for our men and women
in uniform.
I thank my colleagues on both sides, and I thank Chairman Thornberry.
Mr. PALLONE. Mr. Speaker, I don't have any other speakers at this
time, and I reserve the balance of my time.
Mr. WALDEN. Mr. Speaker, I want to again thank the gentleman from
Illinois (Mr. Shimkus), who I believe is also a West Point graduate. We
appreciate his counsel, and I concur.
I appreciate working with the House Armed Services Committee and its
very able chairman, my friend, Mac Thornberry.
[[Page H9300]]
Mr. Speaker, I yield 3 minutes to the gentleman from Tennessee (Mr.
Roe), the chairman of the Veterans' Affairs Committee, a doctor himself
and a veteran.
Mr. ROE of Tennessee. Mr. Speaker, I rise today in support of H.R.
4374 because our Nation's servicemembers deserve the best and safest
medical treatments available, especially when they are in harm's way.
This bill fixes a provision in the FY 2018 NDAA which passed the
House overwhelmingly just yesterday, which would have allowed the
Secretary of Defense to approve the emergency use of medications that
have not yet received FDA approval.
Under today's legislation, we ensure the FDA will review any
emergency DOD request for the use of unapproved medical products on an
expedited basis while maintaining the FDA's critical role of evaluating
the safety and effectiveness of treatments. This new authorization will
include situations when the Secretary of Defense determines the risk of
attack with an agent that may cause an imminently life-threatening and
specific risk to the United States' military forces.
As a physician and a veteran myself and the chairman of the House
Veterans' Affairs Committee, I have worked tirelessly to ensure our
Nation's servicemembers have access to the best, safest, and most
effective medical treatments available while they are in service and
after.
While we all want these breakthrough treatments made available to our
Nation's men and women in service as quickly as possible, we need to
make sure that they are safe and effective before subjecting members of
our Armed Forces to unproven treatments in the interest of expedience.
I have personally spoken to the FDA Commissioner, Dr. Scott Gottlieb
on this issue, and he assures me that the FDA will work in a
collaborative way with DOD to ensure the processes work more
effectively for our troops.
Mr. PALLONE. Mr. Speaker, I reserve the balance of my time.
Mr. WALDEN. Mr. Speaker, I yield 2 minutes to the gentleman from
Colorado (Mr. Coffman), a great public servant who has served our
Nation, I think, in two different uniforms and is a terrific member of
the Armed Services Committee.
Mr. COFFMAN. Mr. Speaker, I rise today in support of H.R. 4374,
having served in the first Gulf war when military analysts were saying
or predicting that there could be 30,000 coalition casualties in a
ground war with Iraq.
We knew that Saddam Hussein had both chemical and biological
stockpiles, and, at that time, there was an experimental drug given for
the pretreatment to increase the survival after the exposure to nerve
gas. It was untested in terms of the FDA, did not go through their
lengthy bureaucratic process, but it was, I think, correctly assumed by
military leaders that the risk of giving this drug that didn't go
through all the bureaucratic processes that I think are important, that
the risk of nerve gas exposure outweighed those risks.
So I just want to commend the Energy and Commerce Committee as well
as the leadership of the Armed Services Committee, the leadership of
both committees, for working together with the Department of Defense
and the FDA to find that middle ground where the military can have
access to drugs and medical devices expeditiously in order to meet the
rapidly changing threats on the battlefield.
I again thank Chairman Thornberry for his unyielding support on this
issue. I also thank Chairman Walden for offering legislation that seeks
to put this process on the right path.
Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my
time.
Mr. WALDEN. Mr. Speaker, I yield 2 minutes to the gentleman from Ohio
(Mr. Wenstrup), a terrific member of our Conference and of the Armed
Services Committee, again, a practitioner of medicine, a saver of
wounded people, including our own whip of the House.
Mr. WENSTRUP. Mr. Speaker, I rise in support of H.R. 4374. This
provision would amend the Federal Food, Drug, and Cosmetic Act to
authorize additional emergency uses for medical products to reduce
deaths and severity of injuries caused by agents of war.
Having served as a combat surgeon in Iraq, I understand the
importance of being able to administer lifesaving treatments at a
moment's notice. Our servicemembers going into harm's way must be
confident that their corpsmen, medics, docs, and health professionals
are equipped with the latest technology to save lives every time.
Freeze-dried plasma is used during the initial resuscitation of
combat casualties. Since 2011, 24 severely injured U.S. troops have
been treated with freeze-dried plasma provided by the French, who have
used this successfully since 1994. Of those patients, 17 lives were
saved due to rapid treatment with freeze-dried plasma.
H.R. 4374 is important because it puts a process in place to broaden
the definition of military emergencies and provides the Department of
Defense with access to expedited FDA processes for the investigational
products like freeze-dried plasma.
I support Chairman Thornberry's unwavering leadership on this issue.
With rapidly developing medical technology, the FDA must be part of the
modernization and readiness of our Armed Forces. We are committed to
ensuring that the FDA does the best it can for our deployed forces, and
I hope that we can find a way to enable the FDA to consider approved
research and clinical studies from our allies in an effort to aid their
approval process.
The future will likely bring more medical devices and drugs that can
save lives. Having a process to approve and implement emerging medical
technologies is a matter of life and death, especially for our brave
troops.
Mr. PALLONE. Mr. Speaker, I continue to reserve the balance of my
time.
{time} 1615
Mr. WALDEN. Mr. Speaker, you have heard from my colleagues the
importance of this legislation. We found a good balance with our
friends in the Armed Services Committee and in working with the FDA and
with the leadership of the Pentagon to get this right. What matters
most to Americans is that we take care of our warriors on the field
when they are injured, and when they are in harm's way that we are
doing the best possible thing we can for them.
Mr. Speaker, I think this is important legislation. I encourage my
colleagues to vote for it, and I yield back the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I would urge my colleagues to vote in support of this
legislation. I do think it is a good compromise dealing with these
military emergencies, but at the same time making sure that the FDA,
which has responsibility for approving medical products, still retains
its authority.
Mr. Speaker, I would urge a ``yes'' vote, and I yield back the
balance of my time.
The SPEAKER pro tempore (Mr. Donovan). The question is on the motion
offered by the gentleman from Oregon (Mr. Walden) that the House
suspend the rules and pass the bill, H.R. 4374.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill was passed.
A motion to reconsider was laid on the table.
____________________