Second expert resigns over FDA delay
Says contraceptive's over-the-counter status mired by politics
WASHINGTON (Reuters) -- A second medical expert has resigned to protest the Food and Drug Administration's failure to allow over-the-counter sales of a "morning-after" contraceptive made by Barr Pharmaceuticals Inc.
Dr. Frank Davidoff, an internal medicine specialist, said Thursday he stepped down from his position as a consultant to the FDA's Nonprescription Drugs Advisory Committee about a month ago. Members of that panel and another committee of outside experts voted 23-4 in December 2003 to recommend non-prescription sales of the contraceptive, called Plan B.
The FDA so far has rejected that advice, as well as support from the agency's scientific staff. Then-FDA Commissioner Lester Crawford announced August 26 he was postponing a decision indefinitely and taking public comment for 60 days.
That delay "crossed the line for me," Davidoff said in an interview.
In his resignation letter, Davidoff said he wrote: "I can no longer associate myself with an organization that is capable of making such an important decision so flagrantly on the basis of political influence, rather than the scientific and clinical evidence."
Some conservative groups have lobbied fiercely to keep Plan B as a prescription-only product. Plan B is a set of pills that can prevent pregnancy if taken within 72 hours of sexual intercourse.
An FDA spokeswoman said Davidoff had been "a valued member of FDA's advisory committee" since 2001, and the agency "had hoped to continue using his services as an FDA consultant" after his term expired this year.
"His decision to resign as a consultant is an unfortunate loss of expertise as we work toward solving the complex policy and regulatory issues related to Plan B," she said.
Crawford said in August that officials still were grappling with how to keep a prescription requirement for girls younger than 17 while easing access for older women.
Davidoff's resignation, reported earlier this week by the Hartford Courant newspaper, follows the departure of Dr. Susan Wood, the FDA's top women's health official. Wood, who has a doctorate in biology, quit in August to protest the Plan B decision.
Davidoff, editor emeritus of the journal Annals of Internal Medicine, said he felt Plan B met all the criteria for an over-the-counter drug, including the requirements that users could understand instructions and use it properly without a doctor's guidance.
"As far as I was concerned, all the evidence presented to the committee, and we got a lot of it, ... was fully consistent with those requirements," he said.
