Delay of Crawford Nomination as FDA Commissioner Not Based on Allegations

The Senate Committee on Health, Education, Labor and Pensions' decision to postpone a vote on FDA Acting Commissioner Lester Crawford's nomination to head the agency was in large part because of concerns about the agency's delay in issuing a decision about whether to approve Barr Laboratories' application for the emergency contraceptive Plan B, Committee Chair Michael Enzi (R-Wyo.) said on Thursday, CQ Today reports. Although Enzi confirmed that he had received a letter from an anonymous FDA employee that included allegations about Crawford, Enzi said the allegations were not the reason for the delayed vote, according to CQ Today.

Enzi said the delay is an attempt to allow the committee to discuss various "concerns" about FDA's decision-making process, CQ Today reports. "The only thing that's holding up the vote is the pure safety issue," Enzi said (Schuler, CQ Today, 4/14). Enzi said he hopes the delay will allow the panel to unanimously approve Crawford in the next two weeks, CongressDaily reports (Heil, CongressDaily, 4/15).

Allegations Background

Committee spokesperson Craig Orfield on Wednesday said that Enzi had requested that FDA's Office of Internal Affairs begin an investigation into allegations made by an anonymous FDA employee. According to Orfield, the FDA employee delivered the allegations to the committee and Enzi forwarded them to the White House (California Healthline, 4/14).

Enzi on Thursday did not give any additional details about the allegations but said that the letter is "badly spelled and badly written" and that he is convinced that the allegations are false, CQ HealthBeat reports (CQ HealthBeat, 4/14). According to congressional staffers, the letter involves allegations about Crawford's "personal relationship" with a senior female FDA staff member and raises questions about the woman's "significant promotions," the Washington Post reports (Kaufman, Washington Post, 4/15).

Plan B Background

Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) earlier this month said they planned to block a full Senate vote on Crawford's nomination after a meeting with Crawford and Sen. Edward Kennedy (D-Mass.) that ended without a commitment by Crawford about when FDA would make a decision on Barr's application.

FDA in January expected to rule on a revised version of Barr's 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. However, the agency in January announced that the decision would be delayed. On March 17, Crawford in a confirmation hearing told the Senate health committee that FDA would approve the application "within weeks." The agency in May 2004 issued a "not approvable" letter in response to Barr's original application, which would have allowed Plan B to be sold to any woman without a doctor's prescription.

The agency decision contradicted the recommendations of two agency advisory panels and cited inadequate data on the use of the pills among girls ages 16 and younger (California Healthline, 4/14).

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