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Health and medicine

FDA adviser quits over Plan B delay

WASHINGTON - A consultant to a Food and Drug Administration advisory panel has resigned in protest of the agency's handling of the Plan B contraceptive.

Dr. Frank Davidoff, editor emeritus of the Annals of Internal Medicine, said the agency is ignoring science in favor of politics in delaying approval of the drug for over-the-counter sales.

He was a member of the FDA's Nonprescription Drugs Advisory Committee when it voted to approve Plan B for over-the-counter sales in 2003, and had served as a consultant to the committee since his term ended earlier this year.

Davidoff is the second person to publicly resign over Plan B. In late August, the top women's health official at FDA, Susan Wood, also resigned in protest. Former FDA Commissioner Lester Crawford has also since resigned.

Plan B, which can be used as emergency, morning-after contraception, is opposed by some religious conservatives.

The committee Davidoff was on is one of several scientific advisory committees that provide the FDA with an independent assessment of new drugs.

Davidoff resigned in September after the agency announced it was indefinitely postponing a decision to allow over-the-counter sales of the drug, despite recommendations from scientists that it is safe.

FDA rejected the recommendation, citing concern about young teens' use of the pills without a doctor's guidance. Manufacturer Barr reapplied but Crawford announced in August that any decision was on hold.

"There wasn't any observable scientific or procedural reason for them to first decline and then further delay the decision. I had to make the inference this was a decision that was made on the basis of political pressure, and it seemed to me that was unacceptable," Davidoff, of Wethersfield, Conn, said in a telephone interview.

[Last modified October 7, 2005, 01:51:07]