米FDAの女性健康問題最高責任者、プランB店頭販売解禁延期に抗議し辞任

FDA Official Quits Over Delay on Plan B
Women's Health Chief Says Commissioner's Decision on Contraceptive Was Political
By Marc Kaufman
Washington Post Staff Writer
Thursday, September 1, 2005; A08

The top Food and Drug Administration official in charge of women's health issues resigned yesterday in protest against the agency's decision to further delay a final ruling on whether the "morning-after pill" should be made more easily accessible.

Susan F. Wood, assistant FDA commissioner for women's health and director of the Office of Women's Health, said she was leaving her position after five years because Commissioner Lester M. Crawford's announcement Friday amounted to unwarranted interference in agency decision-making.

"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," she wrote in an e-mail to her staff and FDA colleagues.

Crawford said last week that unresolved regulatory issues made it impossible to approve expanded use of the emergency contraceptive. Wood said the decision was widely seen in the FDA as political.

"Many colleagues have made it known that they are deeply concerned about the direction of the agency," she said in an interview.

Wood also said other FDA officials who are typically involved in important matters were kept in the dark about the contraceptive, called Plan B, until Crawford announced his decision, which she believed was made at higher levels in the administration. Wood said that when she asked a colleague in the commissioner's office when the decision would be made, the answer was, "We're still awaiting a decision from above; it hasn't come down yet."

In a statement, the FDA said Wood's resignation "is unfortunate as we work toward solving the complex policy and regulatory issues related to Plan B. . . . The FDA is committed to protecting and advancing women's health, and under Susan Wood's leadership, the agency has made significant strides."

Before coming to the FDA in 2000 in a civil service position, Wood was the director for policy and program development at the Department of Health and Human Services' Office on Women's Health, where she led the development of policy for the office, and recommended initiatives for the secretary and assistant secretary for health. She has also worked as a research scientist specializing in the biochemistry of smell at Johns Hopkins University.

Her FDA job description was to "be a champion for women's health."

The Plan B issue has become an emotional one both for advocates who believe that the contraceptive will reduce the number of unwanted pregnancies and abortions, and for opponents who believe that it will encourage teenage promiscuity and that, in some cases, its mode of action constitutes abortion.

The FDA and mainstream medical associations say Plan B, which is generally effective in preventing pregnancy if taken within 72 hours of a contraceptive failure or unprotected sex, prevents a pregnancy rather than ends one.

Religious conservatives and some members of Congress say that pregnancy begins with the fertilizing of the egg. They argue that anything that harms the resulting embryo amounts to abortion. Although Plan B generally works by preventing fertilization, researchers believe that in some cases it might keep a fertilized egg from implanting in the uterus.

Wendy Wright, policy director for Concerned Women for America and a critic of easier access to Plan B, welcomed Wood's resignation.

"Thank goodness there is now one less political activist at the FDA who puts radical feminist ideology above women's health," she wrote in a statement. "Now that Susan Wood has some free time on her hands, she can look at the studies from countries that have made the morning-after pill available without a prescription. She'll find it creates a public health hazard, with no decrease in pregnancies, no decrease in abortion, but a substantial increase in sexually transmitted diseases."

Plan B has been available as a prescription-only drug since 1999, and distributor Barr Laboratories Inc. applied in 2003 for permission to sell it over the counter. An FDA expert advisory panel voted 23 to 4 in favor of the switch, which agency staff members believe would significantly cut the number of abortions and unintended pregnancies.

The FDA rejected the application last year, however, saying it did not have enough information about the possible consequences on teenagers younger than 16. At the suggestion of FDA officials, Barr Labs filed a new application that would allow over-the-counter sales for women 17 and older and prescription-only sales for those younger than 17. Crawford said Friday that the proposed division by age poses "unique" regulatory problems that cannot be resolved without a formal rule-making, which could take years.

Crawford also said FDA scientists and executives had concluded that the drug could be safely sold over the counter.

Many supporters of the Plan B application -- including Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) -- accused Crawford of making a political decision that ignored science and public health. The two senators were especially angry at Crawford's ruling because they had lifted a hold on his pending nomination based on promises, relayed by HHS Secretary Mike Leavitt, that the Plan B issue would be resolved by Sept. 1.

Clinton and Murray have accused the administration of breaking its promise, but Leavitt has disagreed. "The commitment was they would act," he told Reuters on Monday. "Sometimes action isn't always yes and no. Sometimes it requires additional thought."

US FDA official quits over contraceptive delay
Wed Aug 31, 4:51 PM ET - Reuters

A senior women's health official at the Food and Drug Administration resigned on Wednesday to protest the agency's failure to approve over-the-counter sales of a "morning-after" contraceptive despite favorable recommendations from staff scientists.

The FDA said Friday it was indefinitely postponing a decision on Barr Pharamceuticals Inc.'s bid to sell the Plan B contraceptive without a prescription.

A decision that "continues 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," said Susan Wood, the FDA's assistant commissioner for women's health and director of its office of women's health.

"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 overuled. I therefore have submitted my resignation effective today," Wood said in an e-mail to colleagues.

Wood was a career scientist who worked at the FDA for nearly five years. She holds a doctorate in biology and has worked on women's health issues for about 15 years.

The FDA praised Wood's work at the agency, saying in a statement that her leadership led to "significant strides" in women's health that "undoubtedly helped thousands of consumers."

"Her decision to leave is unfortunate as we work toward solving the complex policy and regulatory issues related to Plan B," the statement said.

Plan B is a set of pills that may prevent pregnancy if taken within 72 hours of sexual intercourse. The product is available now with a doctor's prescription.

Supporters say easier access is needed to make sure women get the pills in time. Opponents, including some conservative lawmakers and groups, say wider availability could increase promiscuity and sexually transmitted diseases.

Some Democrats and women's groups have charged the FDA with letting politics interfere with science in the Plan B review.

Wood, in an interview, said she did not know if politics played a role because "it was a very closed decision" made by FDA Commissioner Lester Crawford rather than the head of the FDA's drug center.

"I know a lot of professional staff at FDA are deeply concerned about a loss of credibility for the agency" on Plan B and other issues, Wood said.

Crawford announced on Friday that officials were unable to decide whether to approve Barr's bid to sell Plan B over the counter to females age 16 and older.

Agency scientists agreed Plan B could be used safely without a prescription by girls and women 17 and older, but other questions including how to enforce an age limit were unresolved, Crawford said. The agency is taking public comment for 60 days.

The application to sell Plan B over the counter was first submitted in April 2003. A panel of outside advisers voted 23-4 in December 2003 to urge the FDA to reclassify Plan B from a prescription to over-the-counter drug.