Crawford's hasty exit from FDA raises concerns about vetting

The abrupt and mysterious resignation of Lester Crawford as commissioner of the Food and Drug Administration (FDA) has prompted questions from a Senate committee about the Bush administration’s vetting process.

Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Mike Enzi (R-Wyo.) and ranking member Edward Kennedy (D-Mass.) are concerned that reports about information missing from Crawford’s financial disclosure forms might be a sign the administration is not being careful enough when it OKs nominees for high-profile positions such as FDA chief, an Enzi aide said.

The committee leaders are seeking information to explain what prompted Crawford to walk away from a job he waited several years to lock up, but they are also eyeing answers to broader questions, according to Enzi’s aide.

Enzi and Kennedy want to “understand whether there was some sort of deficiency in the data supplied in the original, pre-confirmation review” provided by the administration that might be symptomatic of shortcomings in the vetting process itself, the Enzi aide said.

Enzi is weighing a committee investigation, but the staff has not begun making inquiries.

The HELP Committee’s decision about an investigation is not contingent on actions that might be taken by the inspector general of the Department of Health and Human Services (HHS), the Enzi aide said. Enzi and Kennedy have asked Inspector General Daniel Levinson to look into the Crawford matter.

Although the chairman and ranking member would like feedback from Levinson, the panel can obtain all the information it needs under its oversight powers, the staffer said.

Enzi is confident that the FDA would not attempt to stonewall the panel or the HHS inspector general, his aide said. “We inherently assume, because of our jurisdiction, that FDA is going to be cooperative,” he said.

On Thursday, Enzi and Kennedy requested that Levinson review Crawford’s financial disclosures for conflicts of interest related to his holdings. Speculation about Crawford has centered, in large part, on the possibility that previously undisclosed financial holdings might present the appearance of a conflict.

In media reports, Crawford has denied that financial issues contributed to his departure. However, he has not given any clear indication of why he quit so suddenly.

In their letter to Levinson, Enzi and Kennedy strongly hint at one underlying reason for their request. “Numerous presidential nominees must be approved by this committee. It is essential that this committee be able to rely on the information presented involving each nominee,” they wrote.

The committee is not looking to reopen a previous investigation by the HHS inspector general into the nature of Crawford’s relationship with a female subordinate. The inspector general found no evidence of an improper relationship, but questions linger about travel expenses incurred when the woman accompanied Crawford on business trips.

Enzi and Kennedy fought hard to move Crawford’s nomination through the Senate over objections from committee members in both parties and others, such as Sens. Chuck Grassley (R-Iowa) and David Vitter (R-La.). The HELP Committee leaders eventually brokered an agreement that led the Senate to back his assignment to the FDA by a 78-16 vote only two months ago.

Enzi and Kennedy were not the only ones who reached out to secure Crawford’s confirmation. HHS Secretary Mike Leavitt made promises, based on Crawford’s assurances, that the FDA would rule on over-the-counter sales of an emergency contraceptive “morning-after pill” known as Plan B by Sept. 1 to satisfy the demands of Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.). Instead, Crawford announced another delay.

The House Energy and Commerce Committee, which also has oversight responsibility for the FDA, is not considering any action related to Crawford, a spokesman said. Chairman Joe Barton (R-Texas) has not expressed concerns about Crawford’s departure or the continuing shakeup in leadership at the agency.

One aspect of the FDA snafu might have been disarmed Friday. After a receiving a barrage of criticism, acting FDA Commissioner Andrew von Eschenbach reversed himself and relinquished his position as National Cancer Institute (NCI) director while he acts as caretaker at the FDA. At Leavitt’s request, an NCI deputy director, John Niederhuber, will take over management of the agency, which is part of the National Institutes of Health. “I am now devoting my energies to the work of FDA,” von Eschenbach wrote in a memo to FDA employees Friday.