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FDA decision-making on emergency contraception 'unusual,' report says



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WASHINGTON (CP) - 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," California Democrat Henry Waxman and 17 other legislators 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 per cent. 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 three million annual unintended pregnancies in the United States. 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.

Health Canada approved the sale of levonorgestrel, known as the Plan B morning-after birth control pill, without a prescription in April. The drug is distributed in Canada by Paladin.

Health Canada's decision was supported by leading Canadian medical authorities, including the Society of Obstetricians and Gynecologists of Canada, the Canadian Medical Association and Planned Parenthood Federation of Canada.

© The Canadian Press, 2005

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