Women's Health

Although men and women can, due to physiological differences, respond very differently to the same prescription drug, evidence suggests that drug companies may not be studying drug test data for possible gender-related differences. Concerns have been raised that women could be at risk if the Food and Drug Administration (FDA) approves drugs on the basis of clinical trials that underrepresent women. FDA guidance to drug manufacturers urges that they test new drugs on representative patient populations, yet FDA does not define "representative" and manufacturers are inconsistent in applying FDA's guidance. One-quarter of the drug manufacturers in one survey reported that they make no effort to recruit representative numbers of women for drug trials, and more than 40 percent said that FDA had not asked them to include women. Women were included in clinical trials for all the drugs in GAO's survey but were generally underrepresented. Even when enough women are included in drug testing, trial data are often not analyzed to determine if women's responses differed from those of men. Also, many drug manufacturers do not study whether their drugs interact with hormones present in women, including hormones commonly found in oral contraceptives. FDA should ensure that the drug industry consistently includes sufficient numbers of women in drug testing to identify gender-related differences in drug response and that such differences are explored and studied.

GAO found that: (1) a quarter of the drug manufacturers in an industry survey reported that they did not deliberately recruit representative numbers of women as participants in drug trials; (2) half of the companies surveyed said that FDA asked them to include women in drug trials, but the remainder said they had not been asked; (3) women were included in clinical trials for all the drugs in the survey, but were generally underrepresented; (4) for more than 60 of the drugs, the representation of women in the test population was less than the representation of women in the population with the corresponding disease; (5) there were enough women represented to detect gender-related differences in response for most drugs in the survey; (6) FDA often does not analyze trial data to determine whether women's responses to a drug differ from men's; and (7) many drug manufacturers do not study whether their drugs specifically interact with the hormones present in women.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

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