The Hill Examines Hold on Crawford Nomination as FDA Commissioner Over Plan B
The Hill on Thursday examined two senators who are "making good on their promise" to place a hold on the nomination of acting FDA Commissioner Lester Crawford as permanent commissioner of the agency until FDA issues a decision on an application from Barr Laboratories to allow the sale of the emergency contraceptive Plan B without a prescription (Schor, The Hill, 6/16). The Senate Health, Education, Labor and Pensions Committee on Wednesday voted to approve the Crawford nomination, but Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) placed a hold on the nomination to block a full Senate vote. FDA in May 2004 issued a "not approvable" letter in response to the original Barr application, which would have allowed the sale of Plan B to any woman without a prescription, and the agency in January delayed a decision on the revised application, which would allow the sale of EC without a prescription to women ages 17 and older. In testimony at a confirmation hearing in March, Crawford told the committee that FDA would approve the revised application "within weeks" (Kaiser Daily Health Policy Report, 6/16). Barr chief lobbyist Jake Hansen said that FDA approval of the application for Plan B is less important than an agency decision on generic biologics. He said that Plan B is "not that large of a product," adding, "We'd be delighted if the sales were 50 million. ... If it were not approved, I doubt that it would really hurt the health of the company." Kirsten Moore, president of the Reproductive Health Technologies Project, said, "Barr (has) competing interests. They have a lot of products out there, and they can't afford to have the same kind of adversarial relationships" that reproductive rights advocacy groups can have with FDA.
Compromise Unlikely
According to The Hill, "No strategies for compromise or resolution of the hold are being publicly offered," and lobbyists have said that only a "swift FDA ruling on Plan B" will end the hold on the Crawford nomination. Committee Chair Michael Enzi (R-Wyo.) said, "I am not sure that the threat to hold up a nomination over one drug application currently under consideration at FDA is the right way to achieve a faster review and to ensure a review process free from the pressures of politics. In fact, I strongly believe that the opposite would occur" (The Hill, 6/16).
