[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4035 Introduced in House (IH)]







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) introduced the following bill; which was 
referred to the Committee on Commerce, and in addition to the Committee 
on National Security, for a period to be subsequently determined by the 
  Speaker, in each case for consideration of such provisions as fall 
           within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
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.

    Be it enacted by the Senate and House of Representatives 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 REQUIREMENT OF INFORMED CONSENT 
              FOR ADMINISTRATION OF CERTAIN DRUGS TO MEMBERS OF ARMED 
              FORCES.

    (a) Requirement of Concurrence of President in Determination of 
Food and Drug Administration 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 requirement under such paragraph for prior consent be 
waived, any determination under such paragraph by the Secretary that 
obtaining consent is not feasible, or is contrary 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 Affected Members Regarding 
Drugs Involved.--Section 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 section 505(i)(5) of the Federal Food, 
        Drug, and Cosmetic Act to request or require a member'';
            (2) in subsection (b), by striking ``first administered to 
        the member, if practicable'' and all that follows and inserting 
        ``first administered to the member.''; and
            (3) in subsection (c), by striking ``provided in writing 
        unless'' and all that follows and inserting ``provided in 
        writing.''.
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