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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Highlights
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.
Recommendations
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Food and Drug Administration | 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. |
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.
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| Food and Drug Administration | The Commissioner of Food and Drugs should require that drug manufacturers analyze trial data by gender. |
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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Topics
Drug testingDrugsHealth surveysMedical researchPharmaceutical industryPharmacological researchStatistical methodsTestingWomen's rightsPrescription drugs