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FDA rejects over-the-counter 'Plan B'

Contraceptive's safety for teens questioned

WASHINGTON -- The Food and Drug Administration yesterday rejected over-the-counter sale of the emergency contraceptive Plan B, saying that the distributor had not proven that young teens can take the drug safely without a doctor's guidance.

The decision was an unusual repudiation of the the lopsided recommendation of the agency's own expert advisory panel, which voted 23-4 late last year in favor of the switch and 27-0 that the drug could be safely sold over the counter.

The denial was a major goal of social conservatives, including members of Congress who lobbied President Bush on the issue. Reproductive rights advocates lobbied equally hard for its approval, and yesterday they criticized the decision as misguided and a blot on the reputation of the FDA as a science-based agency.

In a letter to Barr Laboratories, the agency said the application was denied because only 29 of the 585 women studied by the company were younger than 16 -- a sample that was too small to assess safety.

The agency held out the possibility of future approval if the company could prove the drug is safe for young girls or devise a plan to keep Plan B on prescription-only status for girls under 16. In its letter, the FDA said keeping the drug prescription-only for adolescents had been discussed with the company, but that not enough information was provided on how that might be accomplished.

"Clearly we're disappointed," said Barr CEO Bruce Downey, who had told investors last week that he expected an "approvable" letter from the FDA. "But the FDA has also provided us with pathways to a future approval, and we are committed to following the pathways until we get this product on the market over-the-counter."

He said he thought a new plan would take "months rather than years."

The FDA had no comment last night but will hold a news conference today to explain its decision. The "not approvable" letter was signed by acting director of the FDA's Center for Drug Evaluation, Steven Galson, not by members of the FDA review team, as is usual. Former FDA officials said that generally means the review team made a different recommendation.

Plan B consists of two high doses of a birth-control hormone called levonorgestrel, which has been shown to prevent pregnancy if taken within 72 hours after sex. Unlike Mifeprex, or RU-486, it is not considered by the medical profession to be an abortion pill, since it prevents a pregnancy from starting. Advocates of wider use say it would result in a decline in unwanted pregnancies and abortions.

Earlier this week, the main organizations that represent doctors who specialize in treating women -- including the American College of Obstetricians and Gynecologists -- said all the scientific questions about the safety and proper use of Plan B had been resolved.

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