Senate Committee Approves Crawford’s FDA Commissioner Nomination; Senators Block Floor Vote Over Agency Delay on Plan B

The Senate Committee on Health, Education, Labor & Pensions on Wednesday approved the nomination of acting FDA Commissioner Lester Crawford to head the agency, but several committee members placed a hold on his nomination, blocking immediate consideration of it on the Senate floor, the AP/Yahoo! News reports (AP/Yahoo! News, 6/15). Following the vote, Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) moved to block a full Senate vote on Crawford's nomination, saying that the hold would remain in effect until FDA makes a decision on Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B (Reuters, 6/15). The agency in May 2004 issued a "not approvable" letter in response to Barr's original application to allow Plan B to be sold without a doctor's prescription, and FDA in January delayed its decision on Barr's revised application, which would allow EC to be sold without a doctor's prescription to women ages 17 and older but be dispensed only with a doctor's prescription for girls ages 16 and younger. During a confirmation hearing in March, Crawford told the Senate health committee that FDA would approve the application "within weeks" (Kaiser Daily Health Policy Report, 6/10).

Senator Comments, Vote Details
Murray said she is "not asking for a specific outcome" in Barr's application but is instead asking "for a leader to make a decision" (Schuler, CQ Today, 6/15). However, Sen. Orrin Hatch (R-Utah) said that Crawford could not make a decision on Plan B until he is confirmed as the agency's permanent commissioner because it is a "political issue" (Harris, New York Times, 6/16). Rodham Clinton and Murray were two of at least three committee members voting against Crawford's nomination during the voice vote. Sen. Barbara Mikulski (D-Md.) also dissented. Sen. Edward Kennedy (D-Mass.) voted in favor of Crawford's nomination despite his own concerns about FDA's handling of Barr's Plan B application. He said that Crawford -- who is a veterinarian and pharmacologist by training -- is qualified for the position, the Washington Post reports (Kaufman, Washington Post, 6/16).

Coburn Hold
Following the vote, Sen. Tom Coburn (R-Okla.) also placed a hold on Crawford's nomination, according to his staff members, the AP/Yahoo! News reports (AP/Yahoo! News, 6/15). Coburn said his hold would remain in place until FDA issues congressionally mandated labeling for condoms that clarifies the limits of their effectiveness (Washington Post, 6/16). Coburn has said current condom labels are not accurate and that the packages must specify condoms' effectiveness in preventing pregnancy and sexually transmitted diseases (Reuters, 6/15). An unnamed aide to Coburn said the senator has consulted with Crawford but added that Coburn "won't want to comment at this time about what the criteria would be for lifting the hold" (Povich, CongressDaily, 6/15).

Next Steps
Committee Chair Mike Enzi (R-Wyo.) and Kennedy, who is the ranking Democrat on the committee, said it is too soon to tell if the Senate will be able to overcome the holds and vote on Crawford's nomination, the Post reports. At least 60 votes are needed to override a hold on a nomination (Washington Post, 6/16). Senate Majority Leader Bill Frist (R-Tenn.) said the timing of a possible floor vote on Crawford's nomination was not certain, adding that he is discussing the concerns of the senators who have placed the holds (CQ Today, 6/15).