Senate Committee Delays Vote on Nomination of Lester Crawford as FDA Commissioner

The Senate Committee on Health, Education, Labor and Pensions on Wednesday postponed a vote on FDA Acting Commissioner Lester Crawford's nomination to head the agency amid concerns over FDA's delay in issuing a decision about whether to approve Barr Laboratories' application to allow the emergency contraceptive Plan B to be sold without a doctor's prescription, Reuters reports (Reuters, 4/13). Committee Chair Michael Enzi (R-Wyo.) on Wednesday announced the postponement, saying that the committee needs additional time to "address issues that have been raised" about Crawford's nomination, the New York Times reports.

In a joint statement, Enzi and Sen. Edward Kennedy (D-Mass.), the ranking Democrat on the committee, said that both Democrats and Republicans had raised "concerns" about Crawford that the committee plans to investigate before holding a vote on his nomination, according to the Times (Kornblut, New York Times, 4/14).

One of the issues the committee hopes to resolve are concerns about FDA's delayed decision on Plan B, the Wall Street Journal reports (Wilde Mathews/Lueck, Wall Street Journal, 4/14).

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 Kennedy 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, 4/7).

Health committee spokesperson Craig Orfield said Enzi had requested that FDA's Office of Internal Affairs "open an investigation into allegations concerning Dr. Crawford 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, the AP/San Francisco Chronicle reports (Sniffen, AP/San Francisco Chronicle, 4/13).

No details about the allegations have been released, according to CQ Today (Schuler, CQ Today, 4/13). FDA had no immediate comment. White House Press Secretary Scott McClellan said President Bush believes Crawford is "highly qualified" to be FDA commissioner, and the White House hopes the matter will be resolved "quickly," according to the AP/Chronicle (AP/San Francisco Chronicle, 4/13).

In the statement, Enzi and Kennedy said they hope the postponed vote will allow the committee to "focus on maintaining the FDA as an agency free from politics" (Rovner, Reuters Health, 4/13).

"In my view, FDA's mission to protect the public health has never been more important," Enzi said, adding, "It is critical that the Senate confirm a qualified nominee in an atmosphere free from political agendas." Kennedy said, "I hope that the administration will take seriously the concerns raised in our committee" (Enzi/Kennedy statement, 4/13).

However, Enzi said he would not postpone a committee vote until FDA makes a ruling on Plan B (CQ HealthBeat, 4/13).