21 U.S.C. § 360bbb–3c — Expedited development and review of medical products for emergency uses

(1) In general If there's a military emergency — or a real potential for one — involving a specific and immediate life-threatening risk of attack on U.S. military forces, the Secretary of Defense can ask the FDA Commissioner, through the HHS Secretary, to speed things up. This applies to developing a medical product, reviewing investigational new drug applications under section 355(i), reviewing investigational device exemptions under section 360j(g), and reviewing applications to approve or clear medical products under sections 355, 360(k), and 360e, and under section 262 of title 42 — including vaccine and blood biologic license applications and regenerative medicine advanced therapy reviews under section 356(g). This only applies if the product could reasonably help diagnose, prevent, treat, or lessen that specific life-threatening risk. (2) Actions Once the Secretary of Defense makes that request, HHS — acting through the FDA Commissioner — must take steps to speed up development and review. Those steps can include: (A) holding meetings with the sponsor and review team throughout development; (B) giving the sponsor timely, interactive advice so the studies needed for approval are as efficient as possible; (C) bringing in senior managers and experienced reviewers for a collaborative, cross-disciplinary review; (D) assigning one cross-disciplinary lead to guide the review and act as the sponsor's contact; (E) designing clinical trials as efficiently as scientifically appropriate — for example, limiting how many patients get a less effective treatment; (F) using any existing FDA program meant to speed up development and review; and (G) when appropriate, allowing expanded access to the product while it's still being studied. (3) Enhanced collaboration and communication To keep in step with the Defense Department's current priorities: (A) the FDA must meet with the Department of Defense and other development partners, such as the Biomedical Advanced Research and Development Authority, twice a year to fully review the relevant products in Defense's portfolio; and (B) the Director of the Center for Biologics Evaluation and Research must meet with Defense every quarter to discuss the status of regenerative therapy, blood, and vaccine products that are Defense's top priorities — which can include freeze-dried plasma and platelet alternatives — unless the Secretary of Defense says such meetings aren't needed. (4) Medical product In this section, "medical product" means a drug, as section 321 defines it, a device, also under section 321, or a biological product, as defined in section 262 of title 42.