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FDA Official Rejected OTC Status for EC Plan B Against Advice of Own Staff, Says Decision Not Based on Politics
(Kaisernetwork www.kaisernetwork.org) Steven Galson, acting director of FDA's Center for Drug Evaluation and Research, on Friday during a teleconference said he made the decision to reject Barr Laboratories' application for over-the-counter status for its emergency contraceptive Plan B based on the data provided and against the recommendations of two advisory panels and his own staff, the Washington Post reports (Kaufman, Washington Post, 5/8).
A joint meeting of two FDA advisory panels in December 2003 voted 23-4 to recommend that Plan B -- which can significantly reduce the risk of pregnancy if taken within 72 hours of sexual intercourse -- be sold without a prescription. However, FDA on Thursday issued a "not approvable" letter to Barr, citing inadequate data on Plan B use among girls under age 16. The letter was unusual in that it was signed only by Galson and not by members of the FDA review team, as is routine (Kaiser Daily Reproductive Health Report, 5/7).
Galson said that after consulting with his staff and the FDA commissioner's office, he determined that the agency did not have enough scientific data to determine whether broader access to EC would increase the rates of sexual activity and sexually transmitted diseases among adolescent girls. Galson said, "From (ages) 11 to 14, where we know there are substantial amounts of sexual activity, there were no data in the application, and that really concerned me" (Kemper, Los Angeles Times, 5/8).
He added, "The worst-case scenario is that you've got a young couple and they would normally use a condom when they were having intercourse, but since they know they can run to the CVS to get Plan B, are they going to worry about that?" (Harris, New York Times, 5/8).
Political Connection?
Although Galson's concerns about making EC available without a doctor's prescription "echoed" concerns raised by some members of Congress in a letter to President Bush, Galson said that Bush administration officials did not influence his decision to reject Barr's application, the Los Angeles Times reports (Los Angeles Times, 5/8).
Forty-nine House Republicans in January sent a letter to Bush urging him to order FDA to reject Barr's application, saying that the FDA advisory panels only considered information on Plan B's safety and effectiveness in preventing pregnancy and did not consider the "significant impact" that wider EC availability will have on the "sexual health of adolescents and young people." The House members wrote that making Plan B available without a prescription could lead to more risky sexual behavior among adolescents and could result in an increased incidence of STDs. They concluded that easier access to EC "may ultimately result in significant increases in cancer, infertility and HIV/AIDS" (Kaiser Daily Reproductive Health Report, 1/14).
However, Galson said he made the decision himself and was not aware of any meetings the Bush administration held to discuss the issue, according to the Los Angeles Times (Los Angeles Times, 5/8). Galson said his decision "had to do with looking at all the data and reading all the transcripts" (Washington Post, 5/8).
A Bush administration spokesperson confirmed that FDA scientists alone made the decision to reject Barr's application, Reuters reports (Richwine, Reuters, 5/7).
Unusual Move
FDA observers said that it is "extremely uncommon if not unprecedented" for an agency to overrule its staff and advisory panels, the Post reports (Washington Post, 5/8).
Dr. Robert Fenichel, who worked for FDA for 12 years and left the agency in 2000, said that it is "simply unheard of" for the director of the agency's Center for Drug Evaluation and Research to issue a "not approvable" letter. Most such letters are issued at a "much lower level" than that of the director, according to the New York Times. Galson said he knew of just one instance in the past 10 years in which the director overruled the conclusions of the center's staff. He said, "This isn't common, but it's not unheard of" (New York Times, 5/8).
FDA follows the advice of its advisory panels about 90% of the time, according to the Boston Globe (Dembner, Boston Globe, 5/8).
Advisory Panel Members' Reaction
Some members of the advisory panels said they have considered resigning following the rejection of Barr's application, USA Today reports. Michael Greene, a Harvard OB/GYN who is a member of the Reproductive Health Drugs Advisory Committee, said, "E-mails suggesting mass resignations are already flying around among people who were on this committee." He added, "People are just hopping mad. The decision is blatantly contrary to the science and the facts and so blatantly politicized." Frank Davidoff, editor emeritus of the Annals of Internal Medicine who is a member of the Non-Prescription Drugs Advisory Committee, said he has considered resigning but likely will not do so. "There's always an issue: Can you do more good by hanging in there?" he asked (Rubin, USA Today, 5/10).
Other Reaction
A bipartisan group of 37 members of Congress who support abortion rights on Friday wrote a letter to FDA protesting its decision to reject OTC status for Plan B, the Post reports (Washington Post, 5/8).
In addition, women's rights advocates and reproductive health groups on Friday continued to denounce the agency decision. American College of Obstetricians and Gynecologists President Vivian Dickerson called the decision "morally repugnant" (Los Angeles Times, 5/8).
She added that it "is a tragedy for American women and a dark stain on the reputation of an evidence-based agency" (Reuters, 5/7).
Members of the Wish List, a fundraising group supporting Republican female candidates for Congress who support abortion rights, said that the decision represents a "lost opportunity to narrow the divide over the abortion issue," according to the Post. Wish List Chair Karen Judd Lewis said, "This is a bridge issue; one in which reasonable people on both sides, those who support abortion rights as well as those who oppose, can find common ground because Plan B can reduce the number of abortions in this country" (Washington Post, 5/8).
The U.S. Conference of Catholic Bishops, which opposes EC because of concerns that it can prevent a fertilized egg from implanting in a woman's uterus, supported the decision. Cathy Cleaver Ruse, planning director of the USCCB Secretariat for Pro-Life Activities, said, "A drug which can destroy human embryos and increases health risks to women and girls does not belong on the drugstore shelf" (Los Angeles Times, 5/8).
Next Steps
Galson said that FDA would "quickly" review any new proposals submitted by Barr, Reuters reports. "We're not shutting the door" on OTC EC, Galson said, adding, "Wide availability of safe and effective contraceptives is important to public health" (Reuters, 5/7).
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 over 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. Although Barr CEO Bruce Downey on Thursday said that the company was disappointed by FDA's decision, he added that Barr plans to do whatever is necessary to make Plan B available without a doctor's prescription. In addition, Barr spokesperson Carol Cox said that the company will pursue the age restriction option and provide FDA with additional information about the drug's safety for girls under age 16 (Kaiser Daily Reproductive Health Report, 5/7).
Source: Kaisernetwork
Publish Date: May 10, 2004
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