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FDA decision on morning-after pill  ‘unusual’

The Food and Drug Administration review of Barr Pharmaceuticals Inc.’s bid to sell the Plan B “morning-after” contraceptive without a prescription has been “unusual,” congressional investigators said in a report.
/ Source: The Associated Press

Federal health officials didn’t follow normal procedures in rejecting over-the-counter sales of the morning-after pill — and some documents suggest the decision was made even before scientists finished reviewing the evidence, congressional investigators reported Monday.

Politics trumped science, immediately charged long-suspicious members of Congress who had requested the independent audit.

“We are deeply opposed to this subversion of science,” Rep. Henry Waxman, D-Calif., and 17 other lawmakers wrote Health and Human Services Secretary Mike Leavitt.

They urged that Leavitt, who oversees FDA, intervene to assure that a pending reconsideration of the pill’s status “is based on the best available science instead of ideology.”

The morning-after pill is a high dose of regular birth control that, taken within 72 hours of unprotected sex, can lower the risk of pregnancy by up to 89 percent. The sooner it’s taken, the better it works, but it can be difficult for women to get a prescription in time.

In December 2003, FDA’s scientific advisers overwhelmingly backed over-the-counter sales for all ages, citing assessments that easier access could halve the nation’s 3 million annual unintended pregnancies. But the following May, FDA leaders rejected that recommendation, citing concern about young teens’ use of the pills without a doctor’s guidance.

The maker reapplied, seeking to sell Plan B without a prescription to women 16 or older while younger teens continue to get a doctor’s note, much like the age restrictions that govern cigarette sales. In August, FDA’s then-commissioner postponed that decision indefinitely, saying it wasn’t clear how the FDA could enforce an age limit.

The independent Government Accountability Office reviewed FDA’s first rejection, uncovering what they called “unusual” decision-making. Among the findings:

  • Conflicting accounts of whether the decision was made months before scientific reviews were completed.
  • Unusual involvement from high-ranking agency officials.
  • Three FDA directors who normally would have been responsible for signing off on the decision did not do so because they disagreed with it.