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Politics over science

Though an advisory panel recommended nearly two years ago the morning-after pill be available without prescription, the FDA continues to stall.

As the Bush administration plays abortion politics, the U.S. Food and Drug Administration has announced what amounts to a Plan C for the morning-after pill marketed as Plan B: Stall.

The grounds for regulatory delay are particularly untenable. A scientific advisory panel voted 23-4 nearly two years ago to allow Plan B to be sold without prescription. But that didn't stop FDA Commissioner Lester Crawford from announcing last week that the issue needs more study. Forget about safety or science. This time, he characterized as "profound" the implications of a cutoff age for girls who could receive the pill over the counter. Further, he said, "If we do use age as the only criterion on which we decide whether a drug is sold as a prescription product, or an over-the-counter product, how, as a practical matter, would such a limitation be enforced?"

A pharmacy can't check a person's ID? Isn't that what happens with cigarettes, which pose a much greater health risk?

The delay could be dismissed as more of the same abortion politics, except that Plan B is not abortion. RU-486 is a chemical method of terminating a pregnancy. Plan B is emergency contraception. Plan B, made by Barr Laboratories, is simply a higher dose of the hormones available in birth control pills and has no effect on a woman who is already pregnant. Plan B must be taken within 72 hours of unprotected sexual intercourse, which is why prescription availability often makes its use untimely.

Emergency contraception is already available without prescription in seven states and 34 countries, and no one seems to question its safety or efficacy or that it reduces abortions. Rather, in May 2004, the FDA rejected Barr's application on the grounds that girls under the age of 16 might not understand the drug's packaging instructions and might be more apt to have more sex. Barr then took what it figured to be the easy route: It revised its application to eliminate girls younger than 16. But the FDA still managed to find fault.

Maybe President Bush wants to punt this ball down the field for the next president, but he will be hard-pressed to answer for a commitment that Health and Human Services Secretary Michael Leavitt made in writing to the Senate in July. Leavitt, working to get Crawford's nomination through the Senate, wrote: "I have spoken to the FDA, and, based on the feedback I have received, the FDA will act on this application by Sept. 1, 2005." Guess it depends on what he means by the word "act."

Plan C is beginning to feel like a filibuster.

[Last modified August 31, 2005, 01:21:25]