Key appointment is made at FDA

Uhl to advocate on women's health issues

November 22, 2005|By JONATHAN D. ROCKOFF | JONATHAN D. ROCKOFF,SUN REPORTER

WASHINGTON -- The Food and Drug Administration appointed an agency veteran yesterday to take on the politically sensitive role of advocating for women's health issues as it faces criticism that abortion politics are affecting decision making.

Dr. Kathleen Uhl will replace Dr. Susan F. Wood, who resigned as director of the Office of Women's Health in September to protest the FDA's decision to delay approval of over-the-counter sales of the "morning-after" pill. Wood accused the agency of caving in to conservative pressure and ignoring sound science.

"Kathleen brings a breadth of professional experience, as well as a strong science background and passion for women's health, to her new position," acting FDA Commissioner Andrew von Eschenbach said in a statement.

A family physician and clinical pharmacologist by training, Uhl joined the FDA in 1988 and has held a variety of jobs reviewing the safety of drugs, devices and other products. Most recently, she has been leading an office that is trying to improve warning labels for women who are pregnant or lactating.

With a staff of 15 and a $4 million budget, the women's health office serves as the FDA's liaison with outside groups. The office has urged the agency's staff to see whether drugs, devices and other products might have different effects on women than on men and to make sure women are adequately represented in clinical trials.

Uhl will become director in the middle of next month.

She said in an interview that she wanted to emphasize the office's role funding scientific research related to women's health. She stressed that the office merely provides input and doesn't make decisions to approve drugs, devices and other products.

"The Office of Women's Health is not entirely about reproductive issues," she added. "We are interested in areas that span the whole gamut of a woman's life."

Interest-group advocates listed a range of pending issues that Uhl's office will face, such as the agency's authorization of silicone gel breast implants and health concerns about the contraceptive patch for women. They agreed that a big part of the new director's job will be weighing in on abortion-related issues, including approval of Plan B, the "morning-after" pill, which the FDA is considering.

"Anything that gets into contraception or abortion is definitely going to be an issue for that office," said Pia de Solenni, director of life and women's issues at the Family Research Council. The conservative group isn't familiar with Uhl, added de Solenni.

"Our only hope is that she will focus on the science and not be a political activist like Susan Wood," she said.

In an interview, Wood called Uhl "very capable" but said her successor will face "less than supportive circumstances" at the FDA. "I hope she'll be able to work with the new acting commissioner, and I hope she'll be able to make the right decision on emergency contraception and women's health issues," Wood said.

Amy Allina, program director of the liberal National Women's Health Network, said Uhl appears well-qualified, but cautioned that her success will depend on the support she receives from FDA management and the Bush administration.

"Coming in with a clean slate, Dr. von Eschenbach and Dr. Uhl have a chance to restore scientific integrity to the FDA and to reinvigorate public confidence in its ability to protect and advance people's health," Allina said in a statement.

In August, the FDA delayed approving sales of the morning-after pill to women age 17 and older without a prescription, saying more study was needed.

Since then, some Democratic senators and liberal groups have attacked the decision as political, especially after congressional investigators found that high-level officials may have reached a conclusion before staff finished their scientific reviews.

The agency castigated the congressional investigation as flawed. Some conservatives have defended the delay, saying it has helped prevent the spread of sexually transmitted diseases and protect the health of teenage girls.

jonathan.rockoff@baltsun.com

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