Another FDA expert resigns over emergency contraception delay
New York

Janice Hopkins Tanne

Frank Davidoff, an internal medicine expert and former editor of the Annals of Internal Medicine, resigned last month as consultant to the US Food and Drug Administration. He said that the reason for his decision, which has only just become public, was the FDA�s postponement of a decision on over the counter sale of emergency contraception, despite overwhelming support for such a move by the FDA�s expert advisory committees and its professional staff.

Susan Wood, the FDA�s assistant commissioner for women�s health, resigned at the end of August for the same reason (BMJ 2005;331:596).

In his resignation letter, Dr Davidoff wrote, "I can no longer associate myself with an organisation that is capable of making such an important decision flagrantly on the basis of political influence, rather than the scientific and clinical evidence . . . I am truly sorry it has come to this, since the agency serves an extraordinarily important function, and I generally respect the staff and the work they do."

The FDA commissioner, Lester Crawford, resigned without giving a reason in September, only two months after being confirmed in the job. Two senators called for an inquiry into his departure amid rumours, denied by his wife, that he had not fully disclosed financial information (BMJ 2005;331:713 and BMJ 2005;331:796)

Dr Davidoff served on the FDA�s non-prescription drug advisory committee that, together with the committee on reproductive drugs, voted 23:4 that the emergency contraceptive pill, known as Plan B, be approved for over the counter sale to women of all ages in December 2003. FDA professional staff agreed. Antiabortion activists claimed the drug caused abortions, however.

In May 2004, Steven Galson, acting director of FDA�s centre for drug evaluation and research, over-ruled the recommendations, saying that teenagers might not understand the instructions. The manufacturer, Barr Pharmaceuticals, submitted a revised proposal: that Plan B be made available over the counter to women older than 16 but via prescription only for younger teens. Senators delayed Dr Crawford�s permanent appointment as FDA commissioner until they were assured of a ruling on Plan B by 1 September this year.

In August, Dr Crawford, now confirmed as commissioner, delayed the decision indefinitely because of concern over the same drug being available in two different ways, over the counter for one group of women and by prescription only for another.

After four years on the non-prescription drug committee, Dr Davidoff was asked to stay as a consultant to the FDA. He told the BMJ that he resigned because of Dr Crawford�s August delaying decision. "That decision surprised me. It was so contrary to the decision by the joint committee. I had thought of resigning earlier, but a line had been crossed. It was not appropriate behaviour on the part of the agency."

He told the BMJ that staff at the FDA believed that the drug was safe and effective and should be approved. Now, he said, the staff were "discouraged, depressed, and demoralised."

Dr Davidoff said he was concerned about the effect on public trust in the FDA�s integrity. "It�s potentially very damaging to the agency�s credibility," he said.

The FDA staff are "smart, competent, and conscientious, but they�re caught in the crossfire. It�s easy to see how good people will not want to stay in the agency," he said.