The nomination of Lester M. Crawford, the administration's embattled choice to head the Food and Drug Administration, got a boost yesterday when three senators agreed to lift their holds and allow a vote on the Senate floor.
But the nomination still faces hurdles, as lawmakers have formally questioned travel expenses and employee bonuses at the agency under Crawford's leadership as acting commissioner for the past year. In a letter to Crawford yesterday, Sen. Charles E. Grassley (R-Iowa) asked why bonuses to top officials tripled during Crawford's tenure.
In addition, the travel of one of Crawford's top advisers is the subject of an inquiry by the inspector general of the Department of Health and Human Services, according to two sources. The official, Susan Bond, director of science policy development, accompanied Crawford on five trips -- including ones to London, Geneva and Iceland -- to provide "staff support," FDA documents show.
Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) announced their decision to lift their holds on the nomination after receiving written assurances that the agency will decide by Sept. 1 whether to allow sale of the emergency contraceptive Plan B without a doctor's prescription.
The senators have accused the FDA of giving in to pressure from social conservatives who oppose the Plan B application, which was filed more than two years ago. An FDA advisory panel voted overwhelmingly in favor of making the product more easily available, and the agency's scientific staff made a similar recommendation.
"It is long past time that the American people had a decision on Plan B, and the FDA has finally agreed to give women across the country what we have fought for from the beginning -- a yes or no decision," Clinton and Murray said in a statement.
"While we continue to have concerns about the lack of leadership and independent decision-making that Dr. Crawford and the FDA have shown in this case, we have been clear all along that our hold on this nomination is about one thing only: the FDA's failure to provide an answer on Plan B," they said.
The assurance of a decision by Sept. 1 came in a letter from Health and Human Services Secretary Mike Leavitt to Sen. Mike Enzi (R-Wyo.), chairman of the committee that voted to endorse Crawford's appointment. "I have spoken to the FDA," Leavitt wrote, "and, based on the feedback I have received, the FDA will act on this application by September 1, 2005."
Sen. Tom Coburn (R-Okla.) had also placed a hold on the nomination, but his issue has also been resolved, spokesman John Hart said. Coburn objected to the fact that the FDA had not changed the labeling on condom packages to reflect potential risks of when they may fail, as required by a 2000 law.
Hart said Coburn had been assured that the agency would "implement the law."
A spokesman for Enzi said a date for a final vote on Crawford's confirmation may be set Monday.
Yesterday's letter from Grassley to Crawford questioned why yearly bonuses to top FDA officials increased from about $160,000 when Mark McClellan was commissioner to more than $500,000 in the past year under Crawford. Most of the bonuses went to employees in the Senior Executive Service (SES), a select group of officials with lifetime jobs and higher pay than civil service workers.
Grassley, who has been highly critical of the FDA's record on drug safety issues under Crawford, asked for an individual breakdown of which top officials received bonuses over the past five years.
Rep. Rosa L. DeLauro (Conn.), ranking Democrat on the House committee that oversees the FDA budget, earlier asked the FDA for information about bonuses and travel by high-ranking officials.
In a written response, FDA said its employees received a total of $19.6 million in bonuses from Jan. 1, 2003, to April 16, 2005, including more than $840,000 to the SES employees. There are 44 SES employees with lifetime positions in the 10,000-employee agency.
"This agency has claimed repeatedly to not have the budget resources necessary to do its job -- providing drug safety reviews and oversight of advertising for these drugs," DeLauro said. "You shouldn't put someone with questionable management practices into an agency that has existing management problems."
In answer to questions from DeLauro about travel, the agency also detailed trips taken since Jan. 1, 2003, by 25 top agency officials. Included in those records are details about five trips that Bond took with Crawford. The purpose for the trips was listed as "staff support to Dr. Crawford."
The agency's inspector general also investigated allegations that Crawford improperly promoted Bond and concluded that officials had conflicting recollections of how and why she was promoted to the Senior Executive Service.
The FDA and inspector general's office declined to comment about any inquiry regarding FDA employees and their travel.
Leavitt's statement that the Plan B application will be acted on by Sept. 1 was welcomed by women's health advocates, who said a decision is overdue.
"President Bush's FDA has 46 days until they must decide whether to side with the doctors and scientists who overwhelmingly support giving women over-the-counter access to the pill or, once again, cave in to the anti-birth-control radical right," said Nancy Keenan, president of NARAL Pro-Choice America. "The 'morning-after' pill is a safe, effective way to help women prevent unintended pregnancies."
But opponents of Plan B said the drug -- a concentrated form of the normal birth control pill -- should be treated carefully.
"The FDA has been right to be resistant," said Wendy Wright, senior policy director for Concerned Women for America. "It's a bizarre precedent that's been proposed -- making the high dose of a drug easily available when a low dose requires a prescription." She said efforts to restrict the use of emergency contraception will continue whether the FDA approves it for nonprescription sale or not.