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Tuesday, August 08, 2006

Plan B for Plan B

Reuters reports today that Barr Pharmaceuticals will adjust their FDA request to sell the Plan B contraceptive without a prescription, delaying a decision for at least another two weeks.

Last week the FDA proposed allowing Plan B to be sold without a doctor's order for women 18 and older from behind the pharmacy counter, adding it would reopen discussions with Barr which had sought to sell the drug to women 16 and older.”

As reported in the Los Angeles Times:

A decision on Plan B has been pending since 2003. Two senators angry over delays said they would continue to block a floor vote on Von Eschenbach until the FDA made a firm ruling.

The FDA's announcement "is really a nondecision," said Sen. Patty Murray (D-Wash.), who with Sen. Hillary Rodham Clinton (D-N.Y.) is blocking the nomination.

Murray pointed out that as recently as last year, the Bush administration had promised a final decision, only to backpedal after a prior FDA commissioner won Senate confirmation. "Fool me once," she said. "We're not going to go there again. We will keep our hold on this nomination until we get a 'yes' or 'no' on Plan B."

This is a big deal because FDA officials have reported that access to Plan B was rejected well before FDA scientists finished their review, making the rejection a political maneuver rather than a health and safety precaution as depicted by the administration.

FDA officials say Plan B was rejected because of insufficient data on whether or not the drug could be safely used by younger girls. Critics of the FDA say the agency's early decision on Plan B indicates a trend within the agency of caving to political pressure instead of making sound scientific drug decisions to protect public health.”

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