FDA Rethinks Women's Chief
Toigo Is Acting Head; Agency Denies Naming Veterinary Official

By Marc Kaufman
Washington Post Staff Writer
Tuesday, September 20, 2005

One week ago, the Office of Women's Health of the Food and Drug Administration sent an e-mail notice to women's groups and others announcing the appointment of Norris Alderson as its new acting director.

An FDA veteran trained in animal husbandry who spent much of his career in the agency's Center for Veterinary Medicine, Alderson quickly became the subject of active and largely negative comment on the Internet and elsewhere.

The Office of Women's Health serves as a liaison with women's health groups and as an advocate on women's issues; critics said that a man with a primarily veterinary background could not properly fill the role.

The last director, Susan Wood, resigned last month to protest the agency's unwillingness to make a decision on whether to make emergency contraception more easily available.

Three days after the Alderson announcement, the FDA main press office sent out a very different announcement. It said that 20-year FDA veteran Theresa A. Toigo would be the new acting director of the women's health office, and that she would be a champion for women's health inside and outside the agency. Alderson -- and the statement announcing his appointment -- was never mentioned.

Asked yesterday who exactly was running the office, FDA spokeswoman Suzanne Trevino said that Alderson had never been appointed acting director. She said that Toigo would take over from the departed Wood, and that her office knew nothing about the statement regarding Alderson, who is the agency's associate commissioner for science.

"There was no official decision made until we announced Theresa Toigo's appointment on Friday," Trevino said.

The seeming mystery thickened when several women's groups said that not only did they receive e-mails announcing Alderson's appointment, but also that he was also listed on a Health and Human Services directory last week as the acting director of the office. In addition, people who have spoken with women's health office staff said that Alderson was introduced to the staff last week as the new acting director, and that he even had some one-on-one discussions with staff members about future plans.

Sen. Barbara A. Mikulski (D-Md.), a longtime advocate for the FDA's women's health office, said she already had been concerned by Wood's resignation. "I was further concerned to learn last week that Dr. Norris E. Alderson, someone without women's health experience who has spent the majority of his career at the Center for Veterinary Medicine, was appointed acting director of this important office," she said in a statement yesterday.

Toigo has led the FDA's Office of Special Health Issues, which works with patient advocates on issues such as AIDS and cancer. The FDA announcement of her appointment also says that she has worked with the women's health office on agency initiatives related to the inclusion of women and minorities in clinical trials.

Former director Wood called Toigo a good choice. "She's a very capable and dedicated person who will do an excellent job," Wood said.

But many women's health groups remain unhappy with the FDA and what they consider to be the agency's questionable leadership.

"Once again, this episode shows the agency's complete tone-deafness," said Kirsten Moore, director of the Reproductive Health Technologies Project. "It underscores our concern about the degree of competence at the leadership level, and about political appointees who just don't know much" about the issues before the agency.

© 2005 The Washington Post Company