I
105TH CONGRESS
2D SESSION
H. R. 4035
To amend the Federal Food, Drug, and Cosmetic Act and title 10, United
States Code, with respect to the administration to members of the Armed
Forces of certain drugs without the informed consent of the members.
IN THE HOUSE OF REPRESENTATIVES
JUNE 11, 1998
Mr. SHAYS (for himself, Mr. TOWNS, Mr. SNOWBARGER, Mr. SANDERS, Mr.
GILMAN, Ms. NORTON, Mr. BURTON of Indiana, Mr. METCALF, Mr.
MCHUGH, Mr. ALLEN, Mr. LANTOS, Mr. BARRETT of Wisconsin, Mr.
CONDIT, Mr. MCINTOSH, Ms. STABENOW, Mr. MCGOVERN, Mr. PAPPAS,
Mr. SOUDER, Mr. KUCINICH, Mr. KENNEDY of Massachusetts, Mr.
DAVIS of Virginia, Mrs. JOHNSON of Connecticut, and Mr. UPTON) intro-
duced the following bill; which was referred to the Committee on Com-
merce, and in addition to the Committee on National Security, for a pe-
riod to be subsequently determined by the Speaker, in each case for con-
sideration of such provisions as fall within the jurisdiction of the commit-
tee concerned
A BILL
To amend the Federal Food, Drug, and Cosmetic Act and
title 10, United States Code, with respect to the adminis-
tration to members of the Armed Forces of certain drugs
without the informed consent of the members.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Drugs and Informed
Consent Armed Forces Protection Act of 1998’’.
SEC. 2. PROVISIONS REGARDING WAIVERS OF REQUIRE-
MENT OF INFORMED CONSENT FOR ADMINIS-
TRATION OF CERTAIN DRUGS TO MEMBERS
OF ARMED FORCES.
(a) REQUIREMENT OF CONCURRENCE OF PRESIDENT
IN DETERMINATION OF FOOD AND DRUG ADMINISTRA-
TION TO GRANT WAIVER.—Section 505(i) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)), as
amended by section 117 of Public Law 105–115 (111
Stat. 2315), is amended by adding at the end the following
paragraph:
‘‘(5) With respect to the administration under this
subsection of a drug to members of the Armed Forces for
investigational use, if the Secretary of Defense submits to
the Secretary a request under paragraph (4) that the re-
quirement under such paragraph for prior consent be
waived, any determination under such paragraph by the
Secretary that obtaining consent is not feasible, or is con-
trary to the best interests of the members involved, is not
effective unless the President provides to the Secretary a
written statement providing that the President concurs in
such determination.’’.
(b) WAIVER OF CONSENT; WRITTEN NOTICE TO AF-
FECTED MEMBERS REGARDING DRUGS INVOLVED.—Sec-
tion 1107 of title 10, United States Code, as added by
section 766(a) of Public Law 105–85 (111 Stat. 1827),
is amended—
(1) in subsection (a)(1), by striking ‘‘Whenever
the Secretary of Defense requests or requires a
member’’ and inserting the following: ‘‘Whenever the
Secretary of Defense is authorized pursuant to sec-
tion 505(i)(5) of the Federal Food, Drug, and Cos-
metic Act to request or require a member’’;
(2) in subsection (b), by striking ‘‘first adminis-
tered to the member, if practicable’’ and all that fol-
lows and inserting ‘‘first administered to the mem-
ber.’’; and
(3) in subsection (c), by striking ‘‘provided in
writing unless’’ and all that follows and inserting
‘‘provided in writing.’’.
Æ