Senate Confirms Crawford as FDA Commissioner; Bush Administration Says Concerns Over Plan B Will Be Addressed

The Senate on Monday voted 78-16 to confirm the nomination of acting FDA Commissioner Lester Crawford as permanent commissioner of the agency after months of delay, the New York Times reports (Harris, New York Times, 7/19). Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) had blocked a full Senate vote on the Crawford nomination and said that they would maintain the holds until FDA made a decision on a revised application from Barr Laboratories to allow the sale of the emergency contraceptive Plan B without a prescription. 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." HHS Secretary Mike Leavitt on Friday in a letter to Senate Health, Education, Labor and Pensions Committee Chair Mike Enzi (R-Wyo.) said that FDA will make a decision on the revised application by Sept. 1. In response to the letter, Rodham Clinton and Murray agreed to lift their holds on the Crawford nomination. Sen. Tom Coburn (R-Okla.), who had placed a hold on the Crawford nomination because FDA has not required condom packages to include warnings that they do not provide complete protection against sexually transmitted diseases, also agreed to lift his hold. According to a Coburn aide, FDA officials assured the senator that the agency will require more accurate information on condom packages (Kaiser Daily Health Policy Report, 7/18). Both Rodham Clinton and Murray voted against the Crawford nomination; Coburn abstained from the vote (Mondics, Philadelphia Inquirer, 7/19).

Comments
Enzi in a statement said, "While I respected the right of my colleagues to disagree with a president's choice, in the end, I believe we have made the right decision to promote Dr. Crawford. He has a long and distinguished history of leadership and public service, and I look forward to his continued work in promoting and protecting the public health" (Kaufman, Washington Post, 7/19). Enzi added, "FDA is at a critical point. The country deserves to have a fully functioning FDA" (Heil, CongressDaily, 7/19). Before the vote, Sen. Edward Kennedy (D-Mass.) said, "Crawford is well-qualified to be commissioner. He deserves to have full authority as commissioner" (AP/USA Today, 7/19). He added, "Under Dr. Crawford's leadership, we have seen stepped-up efforts to monitor drug safety and to inform patients and doctors about the risks of drugs" (New York Times, 7/19). "Clearly more must be done, and with a commissioner in place, we can work more effectively on the key issues facing the agency" (Washington Post, 7/19). After the vote, Leavitt said, "Crawford is a dedicated public servant who has ably led the agency. I look forward to working with Dr. Crawford and FDA as we seek to continue advancing the nation's health" (AP/USA Today, 7/19).

Some Opposition
Sen. Chuck Grassley (R-Iowa), who has criticized FDA in recent months and voted against the Crawford nomination, said before the vote, "Crawford has not stepped up to the plate. I have seen no recognition of the depth and breadth of the problems at the FDA. I have only seen a few short-term Band-Aids" (Washington Post, 7/19). He added, "The systemic problems at the FDA demand visionary leadership. Dr. Crawford has not shown me he is the leader to fix the FDA" (Schuler, CQ Today, 7/18). Murray said in a statement, "I have been continually concerned during Dr. Crawford's tenure that FDA hasn't shown the independence and adherence to science necessary to inspire public confidence. As FDA tackles considerable challenges that lay ahead, there can be no question of the integrity or independence of the commissioner" (Henderson, Boston Globe, 7/19).

Reimportation Hold
Before the vote, Sen. David Vitter (R-La.) placed a hold on the Crawford nomination in an effort to force Senate Majority Leader Bill Frist (R-Tenn.) to address a bill (S 109) he has introduced that would allow the reimportation of lower-cost prescription drugs from other nations. However, Vitter agreed to lift his hold, in part because of "overwhelming Senate support for filling the top job at the FDA," The Hill reports. A Frist spokesperson declined to comment on whether Vitter would receive concessions for his agreement to lift the hold. An Enzi spokesperson said that the senator has no plans to hold additional hearings or address legislation related to prescription drug reimportation (Young, The Hill, 7/19).