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Action Alert

Summer 1999

All interested parties, please fill out this form, and send it to the address below.

Please see related article "Gender Agenda" for related background and current information.

Consensus Statement

We demand that the Food and Drug Administration enact the clinical hold regulation and halt discrimination against women with life threatening illnesses based upon their reproductive potential.

On January 19, 1995, the National Task Force on AIDS Drug Development issued a series of recommendations to the FDA concerning women's participation in the drug development process. On December 8, 1995, the Presidential Advisory Council on HIV/AIDS adopted the Task Force's recommendation that the FDA amend its regulations to prevent the exclusion of women who have a life-threatening disease from clinical trials.

Pursuant to these recommendations, the FDA proposed amendments to its clinical hold regulations and published the proposed rule for comment in the Federal Register on September 24, 1997. The proposed regulation authorizes the FDA to halt any research that excludes women with life-threatening illnesses from clinical trials based on their reproductive potential. The notice and comment period on the clinical hold rule ended on December 23, 1997. Still the FDA has not enacted the proposed rule as a regulation.

Women with life-threatening illnesses are entitled to seek the best medical care available, including that available to participants in clinical trials. Where discriminatory and substandard practices exist, research groups and pharmaceutical companies must be held accountable and it is the express task of the FDA to intervene in these cases.

Action Points:

1) The FDA must enable the clinical hold rule as published in the September 24, 1997 Federal Register.

2) The FDA must halt any current research which does not comply with the established guidelines for the inclusion of women.

3) All protocol criteria must be gender-neutral.

4) All reports mandated by the investigative new drug (IND) process must include a by-gender analysis.





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HIV Law Project
841 Broadway Suite #608
New York City, NY 10003
FAX: 212-674-7450

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This article was provided by Women Alive. It is a part of the publication Women Alive Newsletter.