The Food and Drug Administration moved Tuesday to force drug companies to stop excluding young women from studies of promising new medicines merely for fear they’ll get pregnant during the research.
For years, doctors as well as the government considered it wise to keep women of childbearing age out of medical studies because some drugs can harm a developing fetus.
Women’s advocates attacked that policy as paternalistic, saying it kept women with life-threatening diseases away from studies of promising therapies even though women today can use highly effective contraceptives. Such studies are often how dying patients get the quickest access to new drugs.
AIDS activists especially urged a change, saying that HIV-infected women were being unfairly denied access to AIDS drug studies.
The FDA told drug companies in 1993 to include women in all phases of a drug’s testing. But when the agency examined 4,000 clinical studies performed in the last three years, it found about 25 percent still excluded women solely because they could have gotten pregnant, said Deputy Commissioner Mary Pendergast.
So Tuesday, the FDA proposed a regulation that would force companies to change by letting the FDA halt or prevent clinical trials of drugs for serious or life-threatening illnesses that exclude women for reproductive reasons.
Even if a drug is suspected of causing birth defects, “they have to give the woman the right to make the decision,” Pendergast said. The proposal “sends a strong message to the industry that we really do want them to open the doors of trials to women.”
The gender rules would not apply to clinical trials designed to study only healthy volunteers, not patients, or those studying male-only conditions like prostate cancer.
The public can comment on the proposal for 90 days; the FDA then will decide whether to make it final.