Women’s Health Chief Quits FDA Over Delays on ‘Morning After’ Pill
The head of the Food and Drug Administration’s women’s health office resigned Wednesday in a widening protest over delays in deciding whether the “morning after” contraceptive could be sold without a prescription.
Susan F. Wood, a biologist who has served in two administrations and in a number of jobs on Capitol Hill over 15 years, took the unusual step of announcing her resignation in an e-mail to friends and colleagues that was distributed to the media by a policy group that supports reproductive choice.
“I can no longer serve ... when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled,” wrote Wood, 46, who had been at the agency for about five years and had held the title of assistant commissioner.
FDA Commissioner Lester M. Crawford had announced Friday that even though the drug was safe, proposed restrictions on teenage girls’ access to it had raised legal issues that needed to be examined in a process that could take months, or longer. The FDA had earlier promised a decision by today.
Wood’s resignation brought calls from prominent Democratic lawmakers for hearings into the agency’s handling of the issue. Already under criticism for drug safety lapses, the FDA is being drawn into a polarizing debate about reproductive choice and sexual mores.
Proponents of the contraceptive, marketed as Plan B, say making it more easily available will prevent unwanted pregnancies and reduce the number of abortions. Opponents, including social conservatives seen as the Bush administration’s political base, say it will encourage promiscuity, and they compare it to an abortion drug -- a position that is counter to the FDA’s.
Some outside medical advisors to the FDA said the agency had compromised its scientific reputation.
Sen. Michael B. Enzi (R-Wyo.), chairman of the Health, Education, Labor and Pensions Committee, is considering whether to hold hearings on the FDA’s handling of Plan B, said spokesman Craig Orfield. Enzi had expected “a firm decision” from the FDA, not further delays, Orfield said.
The agency issued a one-paragraph statement calling Wood’s decision “unfortunate.” It said regulators had made “significant strides” under her leadership in protecting and advancing women’s health.
In an interview, Wood described herself as a “behind-the-scenes kind of person” who was not politically active.
“The reason I left is that if I’m going to be standing there as the face of women’s health at the commissioner’s level, to stand there quietly is to support [the FDA position] ... and I really just couldn’t do it,” she said.
Wood said colleagues had called or stopped by to express support. “There are people within FDA who are concerned the agency will lose credibility by the way [the Plan B] decision is being handled.”
A conservative group issued a news release applauding Wood’s resignation.
“Thank goodness there is now one less political activist at the FDA who puts radical feminist ideology above women’s health,” said Wendy Wright, policy director for Concerned Women for America.
In a statement, Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) said that “the FDA and the American people have lost a strong voice for scientific integrity in Dr. Wood.”
Separately, in a letter to Enzi, they asked for formal hearings.
“A delay is not a decision, and no amount of semantics can change that,” Clinton and Murray wrote. “It is time for the FDA to stop playing games with the health and well-being of millions of American women.”
Two members of the FDA’s advisory committee on reproductive drugs said in interviews that the controversy had damaged the agency’s standing in the scientific community.
“There is a feeling that the [FDA’s] decision was political,” said Dr. Charles J. Lockwood, chairman of the obstetrics and gynecology department at the Yale University School of Medicine. “What is at stake is the objectivity and scientific integrity of not just the FDA, but all federal panels. This is not any longer a concern by left-wing-oriented people -- we are talking about the whole scientific community.”
Lorraine J. Tulman, a professor at the University of Pennsylvania’s nursing school, said Wood showed “courage and a commitment to women’s health” by resigning. “I wish there were more people in government who felt they could take such a stand.”
But Dr. Susan Crockett, a San Antonio-area obstetrician and gynecologist, said the agency was doing the right thing by taking time to examine the legal implications of allowing Plan B to be sold without a prescription to women age 16 and older.
“We are being faced with ... a new way of distributing a prescription medication,” said Crockett, a past member of the FDA’s reproductive drugs panel. “It is worth going through the process of setting it up right.”
Crockett said she thought Plan B should remain available only by prescription. That way, she said, women who use it could receive counseling from their doctors and be tested for sexually transmitted diseases.
“I have more of a concern about the public health aspects,” she said. “As a gynecologist, I see good reasons for it to stay as a prescription drug so I get to see my patients, and they get to see me, and they are well taken care of.”
Plan B, made by Barr Laboratories, won FDA approval as a prescription drug in 1999. Its path to over-the-counter designation has been convoluted.
Last year, the FDA overruled an advisory panel recommendation and decided to keep Plan B as a prescription drug. But the agency invited Barr to reapply after submitting additional data, and the company asked that the drug be made available to women 16 and older. Younger girls would need a prescription.
The FDA’s Center for Drug Evaluation and Research has determined that the product can be safely sold without a prescription to women 17 and older. An FDA fact sheet said Plan B worked “like other birth-control pills to prevent pregnancy.”
The medication consists of two high-dose contraceptive pills. The first must be taken within 72 hours of unprotected sex, and the second 12 hours after the first. No deaths have been reported among women using Plan B.