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Tuesday, September 16, 2014
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Published: Friday, 9/2/2005

Politics at the FDA

THE long arm of politics reaches deep inside agencies in the federal government, sometimes pulling the strings for officials whose decisions have far-reaching consequences.

Lester M. Crawford's decision on one issue at the U.S. Food and Drug Administration suggests that the reach extends into science-based agencies that should be better insulated from partisan politics.

Mr. Crawford, the FDA chief, is indefinitely postponing a ruling on whether to allow over-the-counter sales of Plan B, the morning-after pill. Intended for use when Plan A (contraception) fails or is skipped, this medicine can prevent unwanted pregnancy if taken within three days of unprotected sexual intercourse.

Plan B has been available by prescription only, and there is an urgent need for easier and wider access to the drug. Some estimates suggest that nonprescription sales would reduce the number of abortions by 800,000 annually.

Abortion opponents and religious conservatives, however, have flooded the White House with objections. They regard Plan B as an abortion medicine, rather than emergency contraception, and fear it may increase promiscuity among teens.

FDA's scientific advisers concluded in 2003 that Plan B is safe enough to be sold without a prescription. The FDA staff agreed. FDA managers, however, rejected the advice - supposedly because younger teenagers might not understand instructions for taking the pill.

The drug's manufacturer then asked for an OK to sell Plan B over the counter only to older teens. FDA's scientific staff backed the idea of limiting sales to women age 17 and older.

While acknowledging that science supports the approach, Mr. Crawford now claims that FDA needs months more to consider the issue. One big concern, he said, is figuring out how to keep younger teenagers from buying the drug.

Go figure: How about having store clerks check the buyer's ID, as they do for tobacco and alcohol?

Mr. Crawford's other excuses for stringing out this process sound just as lame and reek of political meddling in science.

To underscore the problem, Susan Wood, the FDA's assistant commissioner for women's health, resigned her post Wednesday, saying she had been cut out of the process that led to Mr. Crawford's decision.

Public confidence in the FDA already is shaky, amid criticism that it ignored scientific warnings about the heart-attack side effects of the painkiller Vioxx and the use of antidepressants in children.

FDA's Plan A should be to confront concerns that politics trumps science in its executive suite and stop stalling on Plan B.



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