TAILIEUCHUNG - FDA Needs to Ensure More Study of Gender Differences~ in Prescription Drug Testing

Midwives and maternity services face considerable challenges but also unparalleled opportunities in providing and maintaining high quality midwifery services. The importance of high quality maternity services to the health and wellbeing of the population is increasingly recognised by women and their families, by policy makers and by clinical staff. Understanding and meeting rising expectations is a key component of quality. Maternity service providers and midwives will therefore want to consider how to adapt the way they work and organise themselves to deliver, flexibly, the highest quality of care | GAO United States General Accounting Office_ Report to Congressional Requesters October 1992 WOMEN S HEALTH FDA Needs to Ensure More Study of Gender Differences in Prescription Drug Testing GAO MRD-93-17 GAO United States General Accounting Office Washington . 20548 Human Resources Division B-243898 October 29 1992 The Honorable Henry A. Waxman Chairman Subcommittee on Health and the Environment Committee on Energy and Commerce House of Representatives The Honorable Patricia Schroeder Co-Chair Congressional Caucus for Women s Issues House of Representatives The Honorable Olympia J. Snowe Co-Chair Congressional Caucus for Women s Issues House of Representatives Drug therapy is the most common and one of the most important forms of medical treatment used for men and women. Because of physiological differences however men and women can respond differently to the same prescription drug. For example women tend to metabolize some antihypertensive and cardiovascular drugs at a slower rate than men. Also drug interactions with women s hormones and women s use of oral contraceptives during their childbearing years can cause different responses. Despite evidence of important differences in the way gender can affect drug response drug manufacturers may not be studying drug test data for possible gender-related differences. Given the potential for different responses to drugs based on gender you expressed concern that women could be at risk if the Food and Drug Administration FDA approves drugs on the basis of clinical trials1 in which women were underrepresented. At your request we examined FDA s policies and the pharmaceutical industry s practices regarding research on women in prescription drug testing. We reviewed FDA s policy guidance for drug manufacturers and interviewed FDA National Institutes of Health nih and Institute of Medicine officials pharmaceutical representatives and experts in pharmacology. We also performed an extensive literature search on topics .

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