[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2783 Introduced in House (IH)]







107th CONGRESS
  1st Session
                                H. R. 2783

   To amend the Federal Food, Drug, and Cosmetic Act to provide for 
research on whether drugs approved under such Act for human use affect 
          women differently than men, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             August 2, 2001

   Mrs. Maloney of New York introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to provide for 
research on whether drugs approved under such Act for human use affect 
          women differently than men, and for other purposes.

    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 ``Women's Health Drug Studies Act''.

SEC. 2. WOMEN'S-HEALTH STUDIES OF DRUGS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 505A the following 
section:

``SEC. 505B. WOMEN'S-HEALTH STUDIES OF DRUGS.

    ``(a) In General.--In the case of drugs for which applications 
under section 505(b)(1) are pending, and in the case of drugs for which 
applications under such section have been approved, the Secretary may 
by order require that the sponsors or holders of the applications 
involved conduct or support research to obtain information on whether 
the drugs affect females differently than males.
    ``(b) Design of Studies.--In providing for a study of a drug under 
subsection (a), the Secretary shall require that the study be designed 
and carried out in a manner sufficient to provide for a valid analysis 
(through one or more clinical investigations, as determined by the 
Secretary) of whether the drug affects females differently than males, 
taking into account biomedical and behavioral factors.''.
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