December 7, 2007

Women's health research lecture

A former official with the U.S. Food and Drug Administration (FDA) described how the agency has dealt with issues surrounding women's health and how those activities have sometimes been influenced by political considerations at the fourth annual "Improving the Health of Women through Research at Massachusetts General Hospital" lecture Nov. 7. Susan F. Wood, PhD, formerly assistant FDA commissioner for Women's Health and director of the agency's Office of Women's Health, outlined historic highlights before discussing the events that led her to resign from the agency in protest over its handling of approval for over-the-counter emergency contraception.

Wood described how the thalidomide disaster of the early 1960s led to the FDA's receiving increased authority over drug safety and how the problems with the Dalkon shield — a contraceptive device that injured some women in the 1970s — led to expanded FDA authority over medical devices. She also noted how practices shifted from a longtime exclusion of women of childbearing age from most drug trials to new 1993 guidelines calling for broader inclusion of women in trials to reflect any gender differences in the effects of new drugs.

While emergency contraception, achieved through a high dose of birth control pills, had been widely available for years and was approved by prescription in 1999, problems arose when the manufacturer of the "Plan B" product applied for over the-counter status in 2003. Wood explained how the normal six-month review process dragged on for several years, as decisions typically made at lower levels were repeatedly overruled or otherwise delayed by the presidentially-appointed FDA commissioner. Over-the-counter status was eventually granted in August 2006, but only for patients age 18 and older, a stipulation added despite the objection of the agency's internal reviewers.

"People at the FDA should make decisions based on the best science, on grounds related to evidence and interpretation of the evidence," Wood said. At a time when there is growing concern about how new drugs are reviewed and approved, about the safety of approved drugs and imported food products, she stressed, Americans need to be able to trust the information and decisions provided by the FDA.