FDA Assistant Commissioner for Women's Health Susan Wood on Wednesday resigned from the agency in protest of its action to indefinitely defer a decision on Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B, the AP/ABC News reports (Neergaard, AP/ABC News, 8/31). FDA Commissioner Lester Crawford on Friday said the agency is opening a 60-day public comment period and did not give a timetable for a final decision on Barr's application. The agency in May 2004 issued a "not approvable" letter in response to Barr's original application to allow Plan B to be sold without a doctor's prescription and in January delayed a ruling on Barr's revised application, which would allow EC to be sold without a doctor's prescription only to women ages 17 and older. Crawford at a press conference on Friday said that science supported giving nonprescription access to Plan B to women ages 17 and older but added that the application presented FDA "with many difficult and novel policy and regulatory issues," including how to keep girls ages 16 and younger from obtaining the drug (Kaiser Daily Reproductive Health Report, 8/30). Wood, a biologist, had served as assistant FDA commissioner since 2000 (Rockoff, Baltimore Sun, 9/1).

Wood Comments
"I can no longer serve ... when scientific and clinical evidence, fully evaluated and recommended for approval by professional staff here, has been overruled," Wood wrote (Alonso-Zaldivar, Los Angeles Times, 9/1). FDA's decision not to approve Barr's original application for Plan B contradicted the previous recommendations of two advisory panels and cited inadequate data on the use of the pills among girls ages 16 and younger (Kaiser Daily Reproductive Health Report, 5/13). Wood said Crawford's decision to delay Barr's current application "was not made in consultation with the normal people who are involved with the decision-making at the agency," adding, "Even in the commissioner's office, it seems there was very little awareness about what the decision would be. It seemed to be very closely held and not at all transparent to the professional staff" (Rubin, USA Today, 9/1). She said the decision on Plan B "shouldn't be about abortion politics," adding, "This is a way to prevent unwanted pregnancy and thereby prevent abortion." Wood said she "doesn't find persuasive" Crawford's arguments for delaying the Plan B application, adding that it is unlikely FDA will make a decision on it "in the foreseeable future" (Harris, New York Times, 9/1). "I admire and respect FDA as an institution, and I worry about its credibility," Wood said, adding, "I couldn't stand there and be the face of women's health at the agency during such a decision" (Wilde Mathews, Wall Street Journal, 9/1). Wood said she does not know where she will work next (McCullough, Philadelphia Inquirer, 9/1).

FDA, Political Reaction
FDA in a statement said Wood's resignation "is unfortunate as we work toward solving the complex policy and regulatory issues related to Plan B," adding, "The FDA is committed to protecting and advancing women's health, and under Susan Wood's leadership, the agency has made significant strides" (Kaufman, Washington Post, 9/1). Meanwhile, Wood's resignation "ramped up the political tension" surrounding the Plan B application, the Wall Street Journal reports (Wall Street Journal, 9/1). As a result of the delay, Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) in June blocked a full Senate vote on Crawford's nomination for commissioner. However, the senators in July agreed to lift their holds after HHS Secretary Mike Leavitt in a letter to Sen. Mike Enzi (R-Wyo.), who chairs the Senate Committee on Health, Education, Labor and Pensions, said that FDA would act on Barr's application by Sept. 1. Leavitt on Monday defended FDA's action of indefinitely deferring a decision on Barr's application for nonprescription sales of Plan B, saying that he promised senators that the agency would act by Sept. 1 but never guaranteed a "yes or no" decision (Kaiser Daily Reproductive Health Report, 8/30). Rodham Clinton and Murray on Wednesday renewed their request for Enzi to hold a hearing on the delay of a decision on Barr's application, saying that Enzi promised them such a hearing if FDA did not make a final decision by Sept. 1, CQ HealthBeat reports. Enzi spokesperson Craig Orfield said that Enzi is reviewing the request and will consider holding a hearing (CQ HealthBeat, 8/31). Orfield said Enzi had expected "a firm decision" by FDA on Plan B, not further delays (Los Angeles Times, 9/1). A group of House Democrats, including House Minority Leader Nancy Pelosi (D-Calif.), has sent a letter to President Bush concerning the issue of "political influence" on scientific decisions, the Journal reports (Wall Street Journal, 9/1).

Reaction
"Losing somebody like [Wood] is a big deal," Diana Zuckerman, president of the National Research Center for Women & Families, said, adding, "It shows such a lack of confidence in the agency" (Henderson, Boston Globe, 9/1). Wendy Wright, policy director of Concerned Women for America, said, "Thank goodness there is now one less political activist at the FDA who puts radical feminist ideology above women's health." However, Lorraine Tulman, a professor at the University of Pennsylvania School of Nursing, said that Wood showed "courage and a commitment to women's health" by resigning. Susan Crockett, a San Antonio-based OB/GYN and former member of FDA's reproductive drugs panel, said FDA was correct in taking more time in examining the legal implications of approving Barr's application. "We are being faced with ... a new way of distributing prescription medication," Crockett said, adding, "It is worth going through the process of setting it up right" (Los Angeles Times, 9/1). The Society for Women's Health Research in a statement said Wood's resignation is a "severe loss to the advancement of women's health" (SWHR release, 8/31).

NPR's "Morning Edition" on Thursday reported on Wood's resignation. The segment includes comments from Karen Pearl, interim president of the Planned Parenthood Federation of America; Jim Sedlak, vice president of the American Life League; and Wood (Rovner, "Morning Edition," NPR, 9/1). The complete segment is available online in RealPlayer.