PRIA, Government Policy, Made Personal

Summary

Allows the Secretary of Defense to ask HHS, through the FDA Commissioner, to speed up the development and review of a drug, device, or biological product when there is a military emergency or a likely military emergency that creates a specific, immediate, life‑threatening risk to U.S. forces, and the product is reasonably likely to help diagnose, prevent, treat, or lessen that risk. When asked, HHS/FDA must work to hurry development and review. This can include meeting often with the developer and reviewers, giving fast and interactive advice, using senior and cross‑disciplinary staff, picking a project lead to coordinate the review, designing clinical trials to be as efficient as possible, using any FDA fast‑track programs, and, when appropriate, allowing expanded access during trials under FDA rules. The FDA must meet with the Defense Department (and partners like BARDA) on a semi‑annual basis to review DoD priorities, and the Director of the Center for Biologics Evaluation and Research must meet quarterly with DoD about top regenerative, blood, and vaccine projects (which may include freeze‑dried plasma products and platelet alternatives). Medical product means a drug, a device, or a biological product.

Title 21, §360bbb–3c

Food and Drugs, Source: USLM XML via OLRC

(1)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)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)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),

(4)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