FDA Adopts Regulation for Women with HIV Allowing More Women to Participate in New Drug Trials

After more than three years of advocacy by the HIV Law Project and other activists, the Food and Drug Administration (FDA) has published the final rule that will allow more women to participate in new drug trials. The new rule amends the FDA's existing provisions governing drug trials. It allows the FDA to place a "clinical hold" (delay) on any trial involving new drugs to treat life-threatening diseases or conditions if the trial excludes women because of their childbearing potential. The complete rule can be found in volume 65 of the Federal Register, beginning on page 34, 963. It takes effect on July 31, 2000.

Numbers

As the number of women living with HIV/AIDS rises, medical research lags dangerously behind the reality of the epidemic. The Center for Disease Control estimates that 30% of new HIV infections are occurring in women, and of the newly infected women, 64% are African American, 18% Latina, and 18% Caucasian. Despite these numbers, drug companies have continued to avoid including women in new drug trials, often for fear of liability if a trial participant becomes pregnant and gives birth to a child who is harmed by the drug. As a result, drug companies have excluded women with HIV/AIDS from participating in trials to develop new, potentially viable HIV medications.

Be a Pioneer

For women with HIV, access to new HIV/AIDS drug trials is both a way to participate in pioneering research as well as an alternative course of medical treatment. Women's participation in drug trials can reveal important information about how medications affect women differently from men, differences in side effects, how hormonal changes may affect a drug's efficacy or safety, and whether women require different dosages.

Last Resort

The FDA says that it intends to use the new rule as a "last resort" and will focus its efforts on working with researchers at the time a new drug protocol is submitted to make sure that trials are not exclusionary. Although a more proactive approach would be preferred, the new rule is a significant first step in expanding the participation of women with HIV/AIDS in drug trials. In the meantime, the HIV Law Project will continue to advocate for more improvements in the area of women's access to clinical drug trials. The collection of more specific data by age, gender, class, and race to evaluate the safety and effectiveness of new drug therapies and to refine labeling and dosage. Advocates must continue to monitor future activities regarding new drug trials to ensure proper implementation of the new rule, and improved access to care and treatment for HIV-positive women.

For more information about the new amendment to the clinical hold provisions, please contact: Andrea Williams, Esq., Policy Unit, HIV Law Project, 841 Broadway, Suite 608, New York, NY 10003. 212.674.7590.

Thank You

Women Alive would like to thank our subscribers who have also helped to make this new rule for women a reality. Those letters and consensus statements you have signed and mailed all contribute to making positive changes for women with HIV/AIDS. Please keep in mind that this is a small victory and much work needs to be done before we all get quality care and treatment that will prolong our lives.