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White Coat Notes

Morning-after pill age limits struck down by judge

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A federal judge in New York has reversed a decision by the US Food and Drug Administration that restricted the sale of the morning-after pill to girls age 16 and under without a doctor’s prescription.

The agency in 2006 approved over-the-counter sales of Plan B for adult women and by prescription for adolescents, but three years later was ordered by the court to make it available without a prescription for even the younger group.

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After a delay of several years, Health and Human Services Secretary Kathleen Sebelius in 2011 rejected the FDA’s plan to make the drug available over the counter. At the time, President Obama said it was the right decision, ensuring that young girls can’t buy the emergency contraceptive “alongside bubble gum or batteries.”

Pam Belluck of the New York Times, in a story breaking the news about the court decision this morning, explained the internal dispute this way:

“Scientists, including those at the F.D.A., have been recommending unrestricted access for years, as have major medical groups, including the American Medical Association, the American Congress of Obstetricians and Gynecologists, and the American Academy of Pediatrics. In 2011, the F.D.A. commissioner, Dr. Margaret A. Hamburg, issued a statement saying that after rigorous study the agency concluded it was safe to sell Plan B One-Step over the counter. But she was overruled by Ms. Sebelius, the Health and Human Services secretary, the first time such a public countermanding had ever occurred.”

Judge Edward R. Korman’s decision includedsome strong words for the government’s process in reviewing the matter and denied a request by the agency to take the issue through a rule-making process:

“The FDA has engaged in intolerable delays in processing the petition. Indeed, it could accurately be described as an administrative agency filibuster. Moreover, one of the devices the FDA has employed to stall proceedings was to seek public comment on whether or not it needed to engage in rulemaking in order to adopt an age-restricted marketing regime. After eating up eleven months, 47,000 public comments, and hundreds of thousands, if not millions, of dollars, it decided that it did not need rulemaking after all. The plaintiffs should not be forced to endure, nor should the agency’s misconduct be rewarded by, an exercise that permits the FDA to engage in further delay and obstruction.”

Chelsea Conaboy can be reached at cconaboy@boston.com. Follow her on Twitter @cconaboy.
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