Three US senators last week tried to push the administration into making emergency contraception available over the counter by blocking the appointment of a government nominee to a senior administrative post.
Immediately after a divided Senate committee approved the nomination of the acting commissioner of the Food and Drug Administration, Lester Crawford, to become the permanent commissioner, the three senators said they would block necessary approval by the full Senate.
The senators said they would put a “hold” on his nomination—a Senate tradition that prevents a nomination moving forward. It is used to draw attention to an issue, to force negotiation, or to end an issue. It can be overridden by a vote of 60 of the 100 senators. No date has been set for when Dr Crawford's nomination will be introduced in the Senate.
Controversy over the Crawford nomination focuses on the FDA's long delayed decision on the sale over the counter of the emergency contraception known as Plan B and on whether President Bush's administration has put conservative beliefs ahead of science (BMJ 2004;328:1219).
Two Democratic senators, Hillary Rodham Clinton of New York and Patty Murray of Washington, said they would block the Senate vote on Dr Crawford's nomination until the FDA made a decision on the over the counter sale of the emergency contraceptive. The FDA was supposed to rule in January but still has not, despite Dr Crawford's statement at a confirmation hearing in March that the FDA would approve the application within weeks.
A third senator, the conservative Republican Tom Coburn of Oklahoma who opposes government funding of family planning programmes, said he would place a hold on the nomination until the FDA issues new labelling for condoms that spells out their effectiveness in preventing pregnancy and says that they do not provide complete protection against sexually transmitted diseases.
Karen Pearl, interim president of Planned Parenthood, said Dr Crawford had a serious credibility problem. “We need an FDA commissioner who is committed to advancing public health, not imposing barriers to women's access to contraception,” she said.
Dr Crawford, who has doctorates in pharmacology and veterinary medicine, is the first non-doctor in 25 years to be nominated to head the FDA.
An FDA committee recommended approval for over the counter sale of Plan B in December 2003. Plan B comprises two tablets of 0.75mg levonorgestrel and, when taken within 72 hours after unprotected intercourse, is 85% effective in preventing pregnancy. Many medical and health organisations supported the application.
However, in May 2004 the FDA denied the application by the manufacturer, Barr Laboratories, because of concerns about its use among women aged under 16. In July 2004 Barr submitted a new application that Plan B would be available over the counter to women 16 or older, while younger women would need a doctor's prescription. The FDA was supposed to rule on the new application in late January but still has not. In hearings held in March about his nomination, Dr Crawford said the agency would act on Plan B soon.
Conservative groups in the US oppose Plan B because they believe a new human life begins at the moment of fertilisation. Conservatives also think that Plan B would lead to promiscuity and an increase in sexually transmitted infections.
Dr Crawford's nomination was also delayed while the Health and Human Services Department investigated a charge that he had had an affair with an FDA employee and that she had received favourable treatment. The charge was investigated and no evidence was found.