[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.

                          ____________________