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Mixing politics with science

A Times Editorial
Published November 17, 2005

So poisonous is the atmosphere surrounding pregnancy and abortion that even emergency contraception now must pass a political test in a federal agency created to examine science. For those who suffered any illusions about the strange behavior inside the U.S. Food and Drug Administration, a new congressional report removes any doubt.

Plan B, a high-dose birth-control pill that can prevent pregnancy if taken within 72 hours of unprotected sex, was clearly ordered for a political hit.

Here is just a sample of what the nonpartisan Government Accountability Office found:

Three FDA offices and two panels of science advisers had recommended that Plan B be approved for sale without a prescription. Yet the department's drug chief, Steven Galson, overruled them and told employees as early as January 2004 that rejection was "recommended" by agency superiors.

Three division directors who normally sign such recommendations refused, and the women's health chief resigned in protest.

The rationale to reject over-the-counter sale of Plan B, that it might encourage teenagers to buy it, "was novel and did not follow FDA's traditional practices." Not once in the previous 10 years of approving medications for sale without prescription has FDA raised the issue.

Consistent with the games FDA is playing on Plan B, the agency now has failed to accept even the compromise it proposed. Barr Laboratories agreed to sell the drug only to females 16 and older, and the FDA responded by asking for further study. The deadline it set for public comment, Nov. 1, has passed and now the agency won't even say what it plans to do.

This is tampering and warrants a full congressional investigation. If the FDA is to act merely as a tool for political interests, then the government might as well shut it down and save the money.

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