21 U.S.C. § 360bbb–3c: Expedited development…

Summary

The Secretary of Defense can ask the Secretary of Health and Human Services, through the FDA, to speed up the development and review of drug, device, and biological product applications when there is a military emergency, or a likely one, that poses an immediate, life‑threatening risk to U.S. forces from an attack and the product would likely help diagnose, prevent, treat, or reduce that risk. This covers early research and approval filings for medicines, medical devices, vaccines, blood products, and similar items. When asked, the FDA must act to move the review faster. That can include regular meetings with the developer and reviewers, quick and interactive advice, using senior and cross‑disciplinary staff, assigning a project lead, making clinical trials as efficient as possible, using any FDA fast‑track programs, and sometimes allowing expanded access while the product is still being studied. The FDA must also meet with the Department of Defense and partners twice a year to review priority products, and the Center for Biologics Evaluation and Research director must meet quarterly with DoD about top vaccine, blood, and regenerative‑medicine priorities (which may include freeze‑dried plasma and platelet alternatives), unless DoD says the meetings are not needed. Medical product = drug (medicine), device (instrument), or biological product (like vaccines or blood).

Title 21, §360bbb–3c

Food and Drugs, Source: USLM XML via OLRC

(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 355(i) of this title, review of investigational device exemptions under section 360j(g) of this title, and review of applications for approval and clearance of medical products under section 355, 360(k), and 360e of this title and section 262 of title 42, including applications for licensing of vaccines or blood as biological products under such section 262 of title 42, or applications for review of regenerative medicine advanced therapy products under section 356(g) of this title, 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 321 of this title), a device (as defined in such section 321 of this title), or a biological product (as defined in section 262 of title 42).

Editorial Notes

Codification Section was enacted as part of Pub. L. 115–92, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

§360bbb–3c Expedited Development and Review of Medical Products for Emergency Uses

Summary

Title 21, §360bbb–3c

Notes & Related Subsidiaries

Editorial Notes

Citations & Metadata