FDA this week is expected to rule on a revised application from Barr Laboratories, which manufactures the emergency contraceptive Plan B, that would allow the pills to be sold without a doctor's prescription to women ages 17 and older but would require a doctor's prescription for women ages 16 and younger. In response to the original Plan B application from Barr, FDA in May 2004 issued a "not approvable" letter, which cited inadequate data on the use of the pills among girls ages 16 and younger. The FDA decision contradicted the recommendations of two agency advisory panels that in December 2003 voted 23-4 to recommend approval of the sale of Plan B without a prescription. Steven Galson, acting director of the FDA Center for Drug Evaluation and Research, said that he made the decision to not approve the application on his own and did not follow the recommendations of his staff (Kaiser Daily Reproductive Health Report, 1/10). FDA scientists disagreed with the agency's finding that there was not enough information on how Plan B would affect the sexual behavior of younger women, and a study published in the Jan. 5 issue of the Journal of the American Medical Association found that women who have ready access to EC are no more likely to engage in unprotected sex or abandon use of other contraception methods than women who do not have easy access to the pills (Kaiser Daily Reproductive Health Report, 1/5). Several newspapers have published editorials on the issue, some of which are summarized below.

• Des Moines Register: FDA's opposition to making Plan B available without a doctor's prescription "isn't about safety. It's about sex," a Register editorial says. Opponents' concerns that making the pills more readily available will "encourag[e] risky sexual activity" implies that "women can't make good decisions, read package directions or know the risks of unprotected sex aren't limited to pregnancy," the editorial says. FDA should approve Barr's revised application and "stick to its job of ensuring the safety and efficacy of drugs and avoid making decisions based on political considerations," the editorial concludes (Des Moines Register, 1/18).
  


• St. Louis Post-Dispatch: The "scientific consensus" on the safety of Plan B is "clear," leaving only questions of politics and morality, according to a Post-Dispatch editorial. Although such issues are "legitimate," they are "outside [FDA's] purview," which the agency should keep in mind as it prepares to rule on Barr's revised application for Plan B OTC status, the editorial concludes (St. Louis Post-Dispatch, 1/18).
  


• Washington Post: In place of a "reasonable" debate about FDA's concerns over Plan B's unknown affects on adolescents, the "argument has deteriorated into a mudslinging match about the politicization of science and the alleged influence of the White House and religious fundamentalists on the FDA," a Post editorial says. However, Barr's proposed age restrictions for the contraceptive eliminate FDA's original concerns, meaning "they should take this new application seriously and proceed to allow" OTC sales of the drug to women ages 16 and older, the editorial concludes (Washington Post, 1/18).