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Akron Univ. School of Law

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Monday, October 24, 2005

Susan Wood: Why I Resigned From the FDA

Do you remember Susan F. Wood, Ph.D?  She was the assistant commissioner for women's health and director of the Office of Women's Health at the Food and Drug Administration from November 2000 to August 2005, when she resigned in protest over the FDA's decision to indefinitely defer a decision whether to approve nonprescription sales of the emergency contraceptive Plan B to women 17 years of age and older.  She has an opinion piece (free access) in the current New England Journal of Medicine in which she explains the reasons for her resignation.  Here' a quote:

If the FDA is to continue to fulfill its important role in public health, both in the United States and internationally, its professional scientific and clinical staff must maintain its independence and thus its scientific credibility. In compromising these values and ignoring the expertise within the agency, the FDA's leadership has compromised the health of women and families.

The article doesn't come out and say, in so many words, that the agency bowed to political pressure, but it is damning in the way it details the mysterious and unprecedented departures from agency practice represented by the Plan B decision. 

The GAO is apparently prepared to be more explicit about the way science was trumped by politics at the FDA.  According to the Kaiser Family Foundation's "Daily Women's Health Policy Report," the GAO is circulating a draft report that says the decision on Plan B was" made with uncharacteristic involvement from leading agency officials and might have been decided several months prior to its formal announcement."  The Washington Post reports that a final version of the GAO report is due out at the end of this month.  [tm]

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