Reactions were mixed to the FDA’s proposed rule that drug companies may no longer exclude women from clinical trials for reproductive reasons. For years, AIDS activists have shouted about the lack of drug research in women with HIV. “It’s been a long-time coming, and it sends a strong message to drug companies,” Terry McGovern, of the HIV Law Project, said. “This is the first time the FDA can stop a trial.”
But will the agency? wonders Linda Meredith, an advocate for women with HIV, who is pushing for forced inclusion of women in studies. “This is insulting,” she said. “They’re making a big deal that they’ve lifted the mandatory exclusion. Is this the 1940s? I don’t think it’s going to change a thing.”
An FDA examination of 4,000 trials over the last three years found that 25 percent excluded women because they could have gotten pregnant.