Monday, February 16, 2004

Science 23:4, Politics?: A Plan B Update

WASHINGTON — The government is postponing its decision on whether morning-after birth control should be sold without a doctor's prescription.

The delay comes with the Food and Drug Administration under intense political pressure to reject the move.

The FDA had been scheduled to decide next week on whether Barr Laboratories' version of emergency contraception, called Plan B, could be sold over the counter. Barr announced late Friday, however, that the FDA had extended its deadline for making that decision to May.

The FDA had requested more explicit information about 16- and 17-year-olds who have used the pills, and the agency now needs time to evaluate the data, said Barr spokeswoman Carol Cox.

The FDA's scientific advisors recommended in December that Plan B be sold without prescription, calling it a very safe and important way to decrease the number of abortions.
The delay sparked suspicion from contraception advocacy groups that the FDA was ignoring scientific advice because of political pressure.

"This delay is somewhat hypocritical," said Dr. Jeffrey Waldman of Planned Parenthood in California. "Every day someone doesn't have access [to the pills] is another day when someone's going to be pregnant when they don't need to be and don't wish to be."

The delay is "absolutely not" based on political pressure, FDA drug chief Dr. Steven Galson said. "It's totally based on scientific issues and questions."

Proponents have been further dismayed by news that FDA Commissioner Mark McClellan's office is weighing in on the review. But Galson said that consulting with the agency's chief was "not atypical for a contentious, difficult decision."

A coalition of conservative lawmakers, led by Rep. Dave Weldon (R-Fla.), is urging the Bush administration to reject the move, arguing that easier access to emergency contraception will increase unsafe sex, particularly among teenagers.

Proponents argue that there is no evidence that morning-after birth control lulls women into complacency about regular birth control or sexually transmitted diseases or encourages more sexual activity in general.
Not Political? And yet, we don't typically categorize scientific decisions as "contentious"; the vote of the scientific panel in December didn't seem contentious. But, as noted in my December post Plan B, We'll See, this , apolitical delay was not unanticipated.


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