FDA Nomination Stalls Amid Inquiry

The appointment of Lester M. Crawford to be commissioner of the Food and Drug Administration has stalled in committee as an inspector general investigates allegations of misconduct, and three senators say they will put a hold on his nomination should it reach the Senate floor.

The inspector general of the Department of Health and Human Services began investigating Crawford at the request of the Senate a month ago, and a spokeswoman for the IG said there is no indication when the inquiry might be finished.

"My understanding is that we're waiting for some records," said Judy Holtz, spokeswoman for the IG. "There have been some issues of timing in terms of getting copies of things." But beyond that, Sen. Tom Coburn (R-Okla.) confirmed that he intends to place a hold on Crawford's nomination if it ever does get out of the Senate Health, Education, Labor, and Pensions Committee. His spokesman, John Hart, said Coburn is concerned that the FDA under Crawford's leadership as acting commissioner has not implemented a law requiring new labels for condoms that describe their limitations.

Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) have also said they intend to block the nomination until the FDA decides the long-delayed question of whether the emergency contraceptive Plan B will be approved for sale without a prescription.

Both committee Chairman Mike Enzi (R-Wyo.) and an HHS spokesman said yesterday that the Bush administration believes the nomination should and will go forward.

"Chairman Enzi continues to fully support the president's nomination of Dr. Crawford as head of the FDA, and is working to move forward with a vote on his nomination as quickly as possible," an Enzi spokesman said in a statement.

"We would hope the Senate would move quickly to confirm him," said HHS spokesman William Hall. "The FDA needs a permanent commissioner, and the country is not well served by not having one."

FDA spokeswoman Suzanne Trevino said the agency could not comment on an open investigation but said "we stand ready to provide any documents or records requested."

The Senate committee was about to vote on Crawford's confirmation on April 13 until a letter arrived concerning the acting commissioner that Enzi said was "badly spelled, badly written, in terrible condition." He said at the time the allegations involved questions of "personal propriety," but he declined to offer more information.

According to two Senate staffers familiar with its contents, the letter raised questions about Crawford and a woman in the FDA commissioner's office who recently received significant promotions.

Coburn's problem with Crawford involves a law, passed in 2000, that requires manufacturers to provide information that condoms do not prevent all sexually transmitted diseases. While the FDA did develop regulations that were sent to the Office of Management and Budget earlier this year, Coburn is concerned that Crawford has not implemented the law during his almost two years of service as acting commissioner.

The Plan B controversy, which also could jeopardize Crawford's nomination, took on additional momentum yesterday with reports that a conservative doctor on an FDA advisory panel played a central role in the agency's decision to reject the application last summer.

W. David Hager, who was appointed to the reproductive drugs advisory panel by the Bush administration in 2002, said in a recently discovered videotaped sermon that he was asked to submit a memo to the FDA commissioner on why the agency should ignore the 23 to 4 committee vote in favor of approval and reject the application. The rejection that followed was for the reasons that Hager had suggested.

Yesterday Clinton and Murray asked HHS Secretary Mike Leavitt for an investigation into Hager's involvement with the Plan B decision. "We are concerned that the FDA's decision-making process is placing personal beliefs over science," they said.