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.

August 2, 2001

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

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.'.

END