Susan Wood, assistant FDA commissioner for women’s health and director of the Office of Women’s Health, has quit her post amid the furore over the emergency contraceptive pill, Plan B. The US Food and Drug Administration had originally promised a decision on whether to allow Plan B to be made available over the counter by September 1, but reneged on this at the end of last week saying it represented a “profound regulatory decision that cut to the heart of our work” and should be brought into an open forum [[31/08/05b]].
In statement, Wood commented: “I have spent the last 15 years working to ensure that science informs good health policy decisions. I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled.”
When FDA Commissioner Lester Crawford announced the delay to Plan B on Friday, he also revealed that the FDA’s drug center, the Center for Drug Evaluation and Research, had completed its review of the amended application, and had concluded that the “available scientific data are sufficient to support the safe use of Plan B as an over the counter product, but only for women who are 17 years of age and older.”
However, the agency said it was unable to reach a decision on the approvability of Plan B because of unresolved regulatory and policy issues – specifically whether the same compound can be made available as both a prescription and over the counter product for the same indication and in the same packaging.
Supporters of the Plan B application - including Senators Hillary Rodham Clinton and Patty Murray – have called into question the FDA’s ability to make decisions based on scientific evidence of safety and efficacy, and have urged the agency to be guided by science not politics.