FDA Rejects Over-the-Counter Status for Emergency Contraceptive

FDA on Thursday rejected Barr Laboratories' application to sell the emergency contraceptive Plan B over the counter, citing concerns that the company had not proved that teenagers could take the drug safely without doctor supervision, the Washington Post reports. In its "not approvable" letter to Barr, FDA said it denied the application because the number of women under age 16 involved in Plan B studies represented a sample that was "too small to assess safety," according to the Post (Kaufman, Washington Post, 5/7). FDA also pointed out that no women under age 14 were included in the studies (Kemper, Los Angeles Times, 5/7). FDA in the letter wrote that to gain approval to sell Plan B over the counter in the future, the company must show how to prevent young teenagers from buying it or show in a new study that the drug is safe for young girls to use without a doctor's guidance, according to the New York Times (Harris, New York Times, 5/7). FDA also said that Barr 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 (Los Angeles Times, 5/7). In that case, FDA said that Barr would be required to show how the age restriction would work, according to the Wall Street Journal (Abboud, Wall Street Journal, 5/7). FDA is scheduled to hold a news conference on Friday to further explain its decision, according to the Post.

The FDA decision was an "unusual repudiation" of the recommendations of the agency's advisory panels, the Post reports (Washington Post, 5/7). 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 (California Healthline, 12/17). The panels also voted 27-0 that the drug could be sold safely without a doctor's prescription, according to the Post (Washington Post, 5/7). In addition, although FDA originally was supposed to make a decision on Plan B by Feb. 20, the agency in early February announced that it was postponing its decision for 90 days, citing a need for more information on the drug and its use among teenagers. However, advocates of increased access to EC said the reasons for the delay were more political than scientific, noting that since the advisory panels' recommendation FDA had sent several questions about Plan B to Barr -- many of which involve issues raised in a letter from 49 House Republicans that urged FDA not to allow EC to be sold without a doctor's prescription (American Health Line, 2/17). Also unusual is the fact that the not approvable letter to Barr was signed by Steven Galson, acting director of FDA's Center for Drug Evaluation and Research, rather than members of the FDA review team, as is routine, according to the Post. That break from custom likely indicates that the review team made a different recommendation than Galson, according to former FDA officials, the Post reports (Washington Post, 5/7).

Barr CEO Bruce Downey said that the company is "disappointed" by the FDA's decision but the agency left "pathways to a future approval, and we are committed to following the pathways until we get this product on the market over the counter" (Washington Post, 5/7). Downey said, "It's a matter of weeks and months to deal with this objection," adding, "Clearly ... the door's open, and we plan to go through it" (Neergaard, AP/Las Vegas Sun, 5/7). Barr spokesperson Carol Cox said that the company will pursue the age restriction option and provide FDA with more information about the drug's safety for girls under age 16, according to Long Island Newsday (Kerr, Long Island Newsday, 5/7).

Although FDA's decision on OTC status for Plan B had to be based on the "very narrow issue" of whether the drug is safe for use without a doctor's supervision, "social and cultural issues also crept into the debate," according to the Wall Street Journal (Wall Street Journal, 5/7). "This is nothing but politics trumping science," Dr. Paul Blumenthal, an OB/GYN at Johns Hopkins Hospital, said, adding, "What the FDA has just done is deny access to an important pregnancy preventive agent to millions of women" according to the Chicago Tribune (Graham, Chicago Tribune, 5/7). Reproductive Health Technologies Project President Kirsten Moore said that FDA is "being unfair" by denying Barr's application, according to the Post. Moore said, "Yes, the data on women 16 and under is limited, but that's because use is very limited," adding, "The FDA is supposed to make risk-benefit decisions about the public health, and it was absolutely clear that women would be best served by easier access to emergency contraception" (Washington Post, 5/7). Presumptive Democratic presidential nominee Sen. John Kerry (Mass.) also criticized FDA's decision, according to the AP/Washington Times. Kerry campaign spokesperson Phil Singer said, "The White House is putting its own political interests ahead of sound medical policies that have broad support" (Neergaard, AP/Washington Times, 5/7). The FDA decision was "a major goal of social conservatives," including the members of Congress who lobbied President Bush on the issue, according to the Post (Washington Post, 5/7). Wendy Wright, senior policy director with Concerned Women for America, said, "The FDA is right to be cautious about having a potent drug that can be harmful to women sitting next to toothpaste and deodorant in drugstores," adding, "We are grateful that [FDA] is putting public health above political pressure" (Chicago Tribune, 5/7).

• NPR's "All Things Considered" on Thursday reported on the FDA decision (Rovner, "All Things Considered," NPR, 5/6). The complete segment is available online in RealPlayer.
  


• NPR's "Morning Edition" also reported on the decision. The segment includes comments from Barr President Carole Ben-Maimon, Rep. Dave Weldon (R-Fla.) and Dr. Alastair Wood, assistant vice chancellor for research at Vanderbilt University and a member of one of the FDA advisory panels that in December recommended OTC status for Plan B (Rovner, "Morning Edition," NPR, 5/7). The complete segment is available online in RealPlayer.