FDAnews Drug Daily Bulletin


Nov. 30, 2005

The FDA has selected agency veteran Kathleen Uhl to head its Office of Women's Health (OWH) — the position abruptly vacated earlier this year by Susan Wood in the wake of the controversial handling of the emergency contraceptive Plan B.

Uhl, who most recently served as a supervisory medical officer in the FDA's Center for Drug Evaluation and Research (CDER), will take over the OWH post in December, the FDA said recently. Uhl joined the FDA in 1998 as a reviewer in CDER's Office of Clinical Pharmacology and Biopharmaceutics, and later served as deputy division director and acting division director of the Office of Postmarketing Drug Risk Assessment.

She has previously collaborated with OWH on a variety of FDA initiatives related to the inclusion of women and minorities in clinical trials and, more recently, served as reviewer and supervisory medical officer in CDER's Pregnancy and Lactation Labeling Team in the Office of New Drugs, the agency said.

Uhl replaces former OWH director Wood, who stepped down from the office in the wake of the controversy over Plan B (levonorgestrel), for which Barr Pharmaceuticals is seeking FDA approval to sell without a prescription to women 16 years of age and older. The FDA was supposed to make a decision on Barr's application by Sept. 1, but announced Aug. 26 that it needed more time to decide whether the contraceptive should be sold OTC.

At the time of her resignation, Wood said the FDA's decision to limit women's access to a product that would reduce unintended pregnancies and reduce abortions is "contrary to my core commitment to improving and advancing women's health."

Theresa Toigo, director of the FDA's Office of Special Health Issues, has been running OWH on an acting basis since Wood's departure.