Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
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United Press International; Tuesday, September 23, 1997 3:30 PM EDT
The FDA announced a request Tuesday for public comments on its proposal to prevent clinical trials for the most dangerous health problems from routinely excluding either women _ or men _ just because of potential risks to reproductive organs or offspring.
The FDA announcement says "limited surveys" have turned up examples of such clinical trials that automatically weeded out women with reproductive potential.
The rule grows out of an FDA attitude that volunteers for clinical trials be given enough information about the potential risks to make their own decisions.
The move comes after the Presidential Advisory Council on HIV/AIDS and the National Task Force on AIDS Drug Development highlighted the issue. The FDA announcement notes, "Many of the women who are affected by HIV and AIDS are young women with reproductive potential."
The agency has already issued guidelines, in 1993, to encourage women to join all phases for clinical trails. Today's announcement says, "By encouraging diversity at all stages of a drug's development, FDA hopes that drug sponsors will generate better data about how the drug will affect the populations that will receive it once it is marketed."
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