Title: 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.
Policy area: Health

Summary:
This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to authorize the emergency use of an otherwise unapproved medical product if the Department of Defense (DOD) determines that there is a military emergency involving an agent that may cause imminently life-threatening and specific risk to U.S. forces. If a military emergency is determined to exist, the bill allows DOD to request that the FDA expedite certain procedures for approving medical products that would be reasonably likely to diagnose, prevent, treat, or mitigate such risk. The FDA must take specified actions to facilitate such a request by DOD.
The bill repeals provisions of the National Defense Authorization Act for Fiscal Year 2018 that allow DOD, rather than the FDA, to authorize the emergency use of an unapproved product under similar circumstances.
Unless DOD determines such meetings to be unnecessary, the FDA shall meet with DOD: (1) semi-annually to conduct a full review of relevant medical products in the DOD portfolio; and (2) quarterly to discuss the development status of regenerative medicine advanced therapy, blood, and vaccine medical products and projects that DOD prioritizes.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4374 Introduced in House (IH)]

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115th CONGRESS
  1st Session
                                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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           November 13, 2017

  Mr. Walden introduced the following bill; which was 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

_______________________________________________________________________

                                 A BILL


 
    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.

    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, 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.
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