H.R. 4374House115th Congress (2017-2019)Enacted

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.

Introduced November 13, 2017

AI-Generated Summary

Updated April 15, 2026 at 7:04 PM UTC

The bill amends the Federal Food, Drug, and Cosmetic Act to let the Secretary of Defense request emergency use of medical products when U.S. forces face a military emergency involving biological, chemical, radiological, nuclear, or other life‑threatening agents. It requires the FDA to expedite development, review, and possible expanded access for drugs, devices, and biologics that could help diagnose, prevent, treat, or mitigate those threats. The changes also set up regular coordination meetings between the Department of Defense and the FDA and repeal a related provision from the 2018 National Defense Authorization Act.

Key Provisions

  • Defines a "military emergency" and authorizes the Secretary of Defense to request expedited FDA actions for medical products needed in such emergencies.
  • Requires the FDA, within 45 days of a Defense determination, to decide whether to make an emergency use declaration and to accelerate review processes for relevant applications.
  • Mandates the FDA to hold meetings, assign project leads, and use existing fast‑track programs to speed development and allow expanded access during the investigational phase.
  • Establishes semi‑annual and quarterly coordination meetings between the FDA and the Department of Defense (and partners) to review high‑priority products.
  • Repeals a specific subsection added by the 2018 National Defense Authorization Act that previously addressed similar emergency use provisions.

Legislative Activity

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14 earlier actions
Became Law Latest Action

Became Public Law No: 115-92.

December 12, 2017

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HouseIntro Referral

Introduced in House

November 13, 2017

HouseIntro Referral

Referred to the Committee on Energy and Commerce, and in addition to the Committee on Armed Services, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

November 13, 2017

HouseCommittee

Referred to the Subcommittee on Military Personnel.

November 14, 2017

HouseFloor

Mr. Walden moved to suspend the rules and pass the bill.

November 15, 2017 • 3:56 PM

HouseFloor

Considered under suspension of the rules. (consideration: CR H9297-9300)

November 15, 2017 • 3:56 PM

HouseFloor

DEBATE - The House proceeded with forty minutes of debate on H.R. 4374.

November 15, 2017 • 3:56 PM

HouseFloor

Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H9297-9298)

November 15, 2017 • 4:16 PM

HouseFloor

On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H9297-9298)

November 15, 2017 • 4:16 PM

HouseFloor

Motion to reconsider laid on the table Agreed to without objection.

November 15, 2017 • 4:16 PM

SenateIntro Referral

Received in the Senate, read twice.

November 15, 2017

SenateFloor

Passed Senate without amendment by Unanimous Consent. (consideration: CR S7270)

November 16, 2017

SenateFloor

Message on Senate action sent to the House.

November 16, 2017

President

Presented to President.

November 30, 2017

Became Law

Signed by President.

December 12, 2017

Became Law

Became Public Law No: 115-92.

December 12, 2017

Floor Debate

19 members

What members said about H.R. 4374 on the floor

13 Republicans6 Democrats
Bradley Byrne
Rep. Bradley ByrneR-AL-1 · Nov 14, 2017

Mr. Speaker, by direction of the Committee on Rules, I call up House Resolution 616 and ask for its immediate consideration. Mr. Speaker, for the purpose of debate only, I yield the customary 30…

Greg Walden
Rep. Greg WaldenR-OR-2 · Nov 15, 2017

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…

Louise McIntosh Slaughter
Rep. Louise McIntosh SlaughterD-NY-25 · Nov 14, 2017

Mr. Speaker, I want to thank the gentleman from Alabama for yielding me the customary 30 minutes, and I yield myself such time as I may consume. Mr. Speaker, H.R. 2810, the Fiscal Year 2018 National…

Sean P. Duffy
Rep. Sean P. DuffyR-WI-7 · Nov 14, 2017

Mr. Speaker, I want to thank the gentleman from Alabama for yielding. First, I want to make a comment about how this process has gone in coming up with this compromise with the amendment on the flood…

Liz Cheney
Rep. Liz CheneyR-WY · Nov 14, 2017

Mr. Speaker, I would also like to thank my colleague, Mr. Byrne, for his hard work, both on the Armed Services Committee and on the Rules Committee, on this important rule. Mr. Speaker, I rise today…

Show 8 more
Frank Pallone, Jr.
Rep. Frank Pallone, Jr.D-NJ-6 · Nov 15, 2017

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…

Dennis A. Ross
Rep. Dennis A. RossR-FL-15 · Nov 14, 2017

Mr. Speaker, I am proud to rise in support of the rule and the underlying bill, H.R. 2874. Homeowners deserve choice; they deserve competition; and, above all, they need to know the true risk their…

Garret Graves
Rep. Garret GravesR-LA-6 · Nov 14, 2017

Mr. Speaker, I want to thank the gentleman from Alabama for yielding. Mr. Speaker, there are fundamental problems with flood insurance. We all know that. The program, by some estimates, has a debt,…

Frank Pallone, Jr.
Rep. Frank Pallone, Jr.D-NJ-6 · Nov 14, 2017

Mr. Speaker, I want to thank my colleague from New York, the ranking member of the Rules Committee, for yielding. Mr. Speaker, I rise today in opposition to the bill and also to the rule. Just a few…

Eliot L. Engel
Rep. Eliot L. EngelD-NY-16 · Nov 14, 2017

Mr. Speaker, I thank the ranking member for yielding. I rise in opposition to this record-breaking closed rule, the 50th closed rule in a year, which is more than any time in any yearly period…

Earl Blumenauer
Rep. Earl BlumenauerD-OR-3 · Nov 14, 2017

Mr. Speaker, I appreciate the gentlewoman's courtesy. I was listening to our friend from Louisiana, and I sympathize with much of what he was saying. I have been working on flood insurance reform for…

John Shimkus
Rep. John ShimkusR-IL-15 · Nov 15, 2017

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…

Ralph Norman
Rep. Ralph NormanR-SC-5 · Nov 14, 2017

Mr. Speaker, I rise today to speak in favor of H.R. 2874, the 21st Century Flood Reform Act. This act is near and dear to my heart. That is how I make my livelihood. I am a real estate developer. We…

Show 7 more
Brad R. Wenstrup
Rep. Brad R. WenstrupR-OH-2 · Nov 15, 2017

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…

Barbara Lee
Rep. Barbara LeeD-CA-13 · Nov 14, 2017

Mr. Speaker, I want to thank Ranking Member Slaughter for her tremendous leadership on so many of these very critical issues. Mr. Speaker, I rise in strong opposition to this rule and to H.R. 2810,…

David P. Roe
Rep. David P. RoeR-TN-1 · Nov 15, 2017

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…

Adriano Espaillat
Rep. Adriano EspaillatD-NY-13 · Nov 14, 2017

Mr. Speaker, I thank the gentlewoman from New York for yielding. Mr. Speaker, there are 2,400 DACA recipients in my district. ``We are not one,'' ``no somos uno.'' There are 30,000 DACA recipients in…

Mike Coffman
Rep. Mike CoffmanR-CO-6 · Nov 15, 2017

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…

Mitch McConnell
Sen. Mitch McConnellR-KY · Nov 16, 2017

Mr. President, as in legislative session, I ask unanimous consent that, notwithstanding rule XXII, the Senate proceed to the immediate consideration of H.R. 4374, which was received from the House. I…

George Holding
Rep. George HoldingR-NC-2 · Nov 14, 2017

Mr. Speaker, I was unavoidably detained. Had I been present, I would have voted ``yea'' on rollcall No. 627.

Bill Text

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One Hundred Fifteenth Congress of the United States of America

At the First Session

Begun and held at the City of Washington on Tuesday, the third day of January, two thousand and seventeen

H. R. 4374

AN ACT

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.

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, 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.

Speaker of the House of Representatives.

Vice President of the United States and President of the Senate.