Monday, November 14, 2005

More double standards & moves toward theocracy at FDA

Probe Finds FDA Deviated in Morning-After Pill Decision
By Ricardo Alonso-Zaldivar
Times Staff Writer

2:04 PM PST, November 14, 2005

WASHINGTON — The Food and Drug Administration deviated from its normal scientific and regulatory procedures when it withheld approving the morning-after birth control pill for use without a prescription, congressional investigators said today.

The conclusion by the nonpartisan Government Accountability Office bolstered charges by critics that the agency had yielded to pressure from social conservatives, who fear that easier access to the drug will encourage promiscuity.

The contraceptive, marketed as Plan B, is now available only by prescription, and a decision on whether it can be sold over-the-counter is in regulatory limbo.

In an examination of a 2004 FDA ruling that kept Plan B available only by prescription, the GAO found that "four aspects of [the] review process were unusual," and that the entire decision was "not typical," compared to how other drugs were handled.

This year, another round of delays by the agency added to the controversy.

"GAO's final report describes an appalling level of manipulation and suppression of the science," said Rep. Henry A. Waxman (D-Los Angeles), who requested the inquiry.

Based on scientific reviews, three separate FDA offices and two panels of outside advisers had recommended that Plan B be approved for sale without a prescription. But the GAO found that the agency's top management blocked the decision from going forward.

In a written response to congressional investigators, the FDA defended its decision, saying there was nothing unusual about the involvement of top officials in high-profile decisions.

"GAO finds what parents would want: that the FDA handled a controversial drug with great caution," said Wendy Wright, policy director for Concerned Women for America, a conservative group that opposes making Plan B available without a prescription.

Susan F. Wood, who once headed the women's health office at the FDA, said the GAO report showed that the agency has lost its independence.

"The decision was contrary to the evidence and contrary to the consensus that had been reached by all the review levels below," said Wood, who resigned this summer in protest over the FDA's delays on Plan B.

Time to get a clue America! Who do you want making your medical decisions: you and your doctor or the Feds, the preachers, the busybodies?


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