Women's Health:

FDA Needs To Ensure More Study of Gender Differences in Prescription Drugs Testing

HRD-93-17: Published: Oct 29, 1992. Publicly Released: Oct 29, 1992.

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Pursuant to a congressional request, GAO examined the Food and Drug Administration's (FDA) policies and the pharmaceutical industry's practices regarding research on women in prescription drug testing, focusing on: (1) the representation of women in drug testing; (2) the sufficiency of female participation in drug trials to asses significant gender-related differences; (3) the extent to which FDA analyzes trial data for differences in response related to gender; and (4) whether studies were conducted to examine drug interaction with the varying hormonal status of women and oral contraceptive use.

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.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    Recommendation: To ensure that women are adequately studied in drug trials and that data derived from testing are used to determine whether gender influences drug response, the Commissioner of Food and Drugs should issue more explicit policy guidance on the inclusion of women in clinical drug trials. This guidance should tell drug manufacturers how to determine when enough women are included in drug trials to assess potential differences in safety and effectiveness by gender.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Implemented

    Comments: In July 1993, FDA published a guideline entitled "Guideline for Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs." This guideline provides new guidance on FDA expectations regarding inclusion of women in drug development, analyses of clinical data by gender, and conduct of specific additional studies on women, where indicated.

    Recommendation: The Commissioner of Food and Drugs should require that drug manufacturers analyze trial data by gender.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Implemented

    Comments: FDA has advised its reviewers that when a new drug application is received, they need to determine whether the data analyses (by gender, age, and race) called for in FDA guidelines are included. If they are not included, the reviewers will request that drug sponsors provide the appropriate analyses. FDA expects to issue a letter to drug sponsors in 1993 to advise them of this policy. In March 1993, FDA issued a letter to pharmaceutical manufacturers advising them of this policy. In July 1993, FDA published a guideline entitled "Guidance for Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs." This guideline provides new guidance on FDA expectations regarding inclusion of women in drug development, analyses of clinical data by gender, and conduct of specific additional studies on women, where indicated.

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