House Members Ask FDA To Reconsider Rejection of Over-the-Counter Plan B
Forty-one House members on Friday sent a letter to acting FDA Commissioner Lester Crawford urging the agency to "quickly rethink" its decision to reject Barr Laboratories' application for over-the-counter status for its emergency contraceptive Plan B, Reuters reports (Richwine, Reuters, 5/12). FDA last week issued a "not approvable" letter to Barr, citing inadequate data on the use of Plan B -- which can significantly reduce the risk of pregnancy if taken within 72 hours of sexual intercourse -- among girls under age 16. The agency's decision was unusual because it contradicted the recommendations of two FDA advisory panels, which in December 2003 voted 23-4 to recommend that Plan B be sold without a prescription. In addition, Steven Galson, acting director of FDA's Center for Drug Evaluation and Research, has acknowledged that he made the decision to reject the application on his own and did not follow the recommendation of his staff (California Healthline, 5/7). Peter Pitts, FDA associate commissioner for external relations, said that the agency would consider a new application from Barr but currently stands by its decision to deny OTC status for Plan B, according to Reuters. "We presented to Barr a bright path forward to approval," Pitts said (Reuters, 5/12). In its letter to Barr, FDA said that the drug maker could submit an alternative proposal to market Plan B over the counter to women older than 16 and require a doctor's prescription for younger girls to access the drug. In that case, Barr would be required to show how the age restriction would work (California Healthline, 5/7).
Twelve House members on Wednesday called on Galson and Crawford to resign for allowing "politics to trump science" in the agency's decision, the Washington Post reports (Kaufman, Washington Post, 5/13). Rep. Louise Slaughter (D-N.Y.) at a news conference on Wednesday said, "The FDA's decision to ignore its own scientific advisory and its own staff clearly demonstrates that the leadership would rather pander to conservative interests than protect women's health and well-being." Slaughter on Wednesday joined several other House members and representatives of Planned Parenthood Federation of America, the National Organization for Women, the National Women's Law Center and several other groups to call on the General Accounting Office to investigate FDA's decision on Plan B (Kerr, Long Island Newsday, 5/13). Rep. Carolyn Maloney (D-N.Y.) said she plans to introduce legislation that would require Crawford to formally review FDA's decision on Plan B and affirm to Congress that the decision was made based on "sound science and FDA precedent," according to the AP/Las Vegas Sun (AP/Las Vegas Sun, 5/12). Maloney said, "When a scientific panel votes 23-4 in favor of over-the-counter status but the FDA goes the other way, there has to be something at work other than science," adding, "No one should object to this bill. If politics indeed didn't influence the decision, they should affirm that without fear." Galson has said that Bush administration officials did not influence his decision to reject Barr's application (Washington Post, 5/13). Pitts said that FDA officials are willing to meet with Slaughter and other lawmakers to discuss the decision, Reuters reports (Reuters, 5/12).
Despite FDA's rejection of OTC status for Plan B, six states -- California, Washington, Alaska, Hawaii, New Mexico and Maine -- currently have laws allowing EC to be sold without a doctor's prescription, and several hotlines and Web sites provide information about how to access EC without a regular doctor's prescription, the Wall Street Journal reports. PPFA operates hotlines and Web sites in several states that help women obtain EC, and Princeton University's Office of Population Research provides EC information on its hotline -- 1-888-NOT-2-LATE -- and its Web site, not-2-late.com. On the Web site getthepill.com, women can fill out a questionnaire and pay a $25 fee to have a doctor call in a prescription for EC to a local pharmacy, according to the Journal. The pills then cost an additional $30 at the pharmacy, according to the Journal. Women also may "make their own" EC by taking two, four or five of their regular birth control pills, depending on the brand, according to the Journal. However, "do-it-yourself" EC works with only 18 brands of birth control pills and is not as effective as Plan B, according to the Journal. The American College of Obstetricians and Gynecologists recommends that physicians give patients advance prescriptions for EC or undated prescriptions so that women will be able to access the pills when they need them, according to the Journal (Parker-Pope, Wall Street Journal, 5/13).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.