Hapless and lame

September 06, 2005

POOR Lester M. Crawford. The guy can't win for losing.

Since last year's Vioxx flap, the head of the Food and Drug Administration has taken lots of heat because his agency appeared to be less concerned about safety than about pleasing the drugmakers whose products the FDA regulates.

Now, Dr. Crawford is being careful -- really careful -- about granting approval for morning-after pill contraceptives to be sold over the counter to women 17 and older. And he's getting clobbered.

Maybe the reaction resulted from the FDA commissioner's lame excuse for delaying the decision a few more months: He couldn't figure out how to solve the "novel" problem of making a product accessible to adults but not to children. Alcohol, cigarettes and nicotine gum, hello?

The hapless Dr. Crawford really stirred up a hornet's nest, though, by crossing two senators, Hillary Rodham Clinton of New York and Patty Murray of Washington, who were promised FDA action on the Plan B pill by Sept. 1. A decision had been pending for more than a year, and a scientific advisory committee had urged approval back in 2003. The senators were so frustrated they held up a vote on Dr. Crawford's confirmation until Health and Human Services Secretary Michael O. Leavitt assured them a decision would come soon.

Now Senators Clinton and Murray feel snookered, and are promising tough days ahead for the beleaguered bureaucrat. It isn't easy being an administration stooge.

It's clearly no coincidence that Dr. Crawford's abundance of caution is being applied to the most controversial medicine his agency has reviewed in a decade. Religious conservatives consider the pill a form of abortion because it can prevent pregnancy if taken within 72 hours of intercourse.

The FDA approved the pill for sale with a prescription in 1999 during the Clinton administration, but has refused to allow over-the-counter sales since President Bush took office in 2001. Top agency officials said they feared the morning-after pill would encourage young teens to have sex and questioned their ability to follow dosage instructions.

Requiring girls 16 and younger to obtain a prescription is reasonable, and could be easily enforced by keeping the pills behind the pharmacy counter.

Would there be violations, as there are with cigarettes and alcohol? Of course. But in this instance, a violation that allows a young teen access to a pill that can prevent premature parenthood -- or more likely an abortion -- poses less risk, not more.

Dr. Crawford has been forced to adopt many improbable positions in order to keep his job. But now he's at risk of turning the world's most respected drug-reviewing agency into a laughingstock. Nobody wins if that happens.

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