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Re: FDApproved post# 8357

Friday, 11/17/2017 1:01:13 PM

Friday, November 17, 2017 1:01:13 PM

Post# of 44784
That article is not accurate. Here is the version with the ammended SEC. 716


SEC. 716. ADDITIONAL EMERGENCY USES FOR MEDICAL PRODUCTS TO REDUCE DEATHS AND SEVERITY OF INJURIES CAUSED BY AGENTS OF WAR.
Section 1107a of title 10, United States Code, is amended by adding at the end the following new subsection:


“(d) Additional Authority To Reduce Deaths And Severity Of Injuries Caused By Agents Of War.— (1) In a case in which an emergency use of an unapproved product or an emergency unapproved use of an approved product cannot be authorized under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) because the emergency does not involve an actual or threatened attack with a biological, chemical, radiological, or nuclear agent or agents, the Secretary of Defense may authorize an emergency use outside the United States of the product to reduce the number of deaths or the severity of harm to members of the armed forces (or individuals associated with deployed members of the armed forces) caused by a risk or agent of war.

“(2) Except as otherwise provided in this subsection, an authorization by the Secretary under paragraph (1) shall have the same effect with respect to the armed forces as an emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3).

“(3) The Secretary may issue an authorization under paragraph (1) with respect to the emergency use of an unapproved product or the emergency unapproved use of an approved product only if—

“(A) the committee established under paragraph (5) has recommended that the Secretary issue the authorization; and

“(B) the Assistant Secretary of Defense for Health Affairs makes a written determination, after consultation with the Commissioner of Food and Drugs, that, based on the totality of scientific evidence available to the Assistant Secretary, criteria comparable to those specified in section 564(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3(c)) have been met.

“(4) With respect to the emergency use of an unapproved product or the emergency unapproved use of an approved product under this subsection, the Secretary of Defense shall establish such scope, conditions, and terms under this subsection as the Secretary considers appropriate, including scope, conditions, and terms comparable to those specified in section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3).

“(5) (A) There is established in the Department of Defense a Department of Defense Emergency Use Authorization Committee (in this paragraph referred to as the ‘Committee’) to advise the Assistant Secretary of Defense for Health Affairs on proposed authorizations under this subsection.

“(B) Members of the Committee shall be appointed by the Secretary of Defense and shall consist of prominent health care professionals who are not employees of the Department of Defense (other than for purposes of serving as a member of the Committee).

“(C) The Committee may be established as a subcommittee of another Federal advisory committee.

“(6) In this subsection:

“(A) The term ‘biological product’ has the meaning given that term in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)).

“(B) The terms ‘device’ and ‘drug’ have the meanings given those terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).

“(C) The term ‘product’ means a drug, device, or biological product.

“(D) The terms ‘unapproved product’ and ‘unapproved use of an approved product’ have the meanings given those terms in section 564(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3(a)(4)).”.



SEC. 716 ammended