It's Official: Crawford Is White House Nominee For FDA

The White House announces intent to nominate acting Commissioner Crawford Feb. 14. Regulated industry applauds choice, but two consumer groups urge Senate to "vet the vet."

The Bush Administration's announcement that it intends to nominate Lester Crawford to be permanent FDA commissioner gives the agency forward-looking news to highlight as it heads into an advisory committee on the safety of COX-2 inhibitors.

The decision to nominate Crawford also creates the framework in which to unveil an enhanced FDA safety initiative, which is expected to be released this month (¹ (Also see "FDA Drug Safety Initiative To Be Unveiled In February" - Pink Sheet, 7 Feb, 2005.)).

The White House announced the decision Feb. 14, more than two weeks after Crawford met with President Bush to discuss the position (² (Also see "FDA Commissioner Choice Appears To Be Crawford" - Pink Sheet, 28 Jan, 2005.)).

The announcement comes on the eve of what is likely to be a pivotal step in FDA's response to the recent concerns about drug safety, a three-day review of the COX-2 inhibitor class.

[Editor's note: To ³ watch a webcast of the Feb. 16-18 advisory committee meeting on COX-2 inhibitors, visit FDAAdvisoryCommittee.com.]

Crawford has served two stints as acting head of the agency, and could become the first person to move from the acting role through full Senate confirmation.

Crawford was the first choice of former HHS Secretary Tommy Thompson to head the agency in 2001, but did not receive the White House nod at that time. Instead, he was named Deputy Commissioner and served as acting commissioner from February 2002 until November of that year, when Mark McClellan was confirmed by the Senate.

Crawford took the reins again in March 2004 when McClellan left to head Centers for Medicare & Medicaid Services.

Crawford's nomination appears to have the tacit support of most of the Senate Health Committee.

After the Bush Administration's intention to nominate Crawford came to light, a bipartisan group of committee members wrote a letter urging the President to nominate a commissioner "as soon as possible" (⁴ (Also see "FDA Needs Commissioner "As Soon As Possible," Senate Health Cmte. Tells President" - Pink Sheet, 1 Feb, 2005.)).

Health Committee Chairman Mike Enzi (R-Wyo.) issued a statement following the White House announcement. "I am pleased that the President has nominated Lester M. Crawford....and will convene hearings to review his nomination as quickly as possible."

However, some of the issues that were raised when Crawford was first proposed for the job in 2001 are likely to be raised again in 2005.

First, Crawford does not have a medical degree; he holds a degree in veterinary medicine from Auburn University and a PhD in pharmacology from the University of Georgia.

A group of consumer organizations led by Consumers Union and U.S. Public Interest Research Group is calling on the Senate to "vet the vet."

The groups said that they have not taken a position on the nomination, but "senators should ask Lester Crawford tough questions about his record at the FDA and his agenda before they vote up or down on his nomination....Under Dr. Crawford's watch, the FDA has failed to protect the public from dangerous prescription drugs, dietary supplements and contaminated animal feed that could carry mad cow disease."

Regulated industry is likely to welcome the nomination. The Biotechnology Industry Organization and the Generic Pharmaceutical Association both issued statements praising the choice.

HHS Secretary Mike Leavitt declared that "with Dr. Crawford's leadership, FDA will provide the world's safest drugs and empower citizens with the tools they need to make to make informed choices about their health."

Crawford "will lead the way as we enter a new era of individualized medicine and rapidly developing science," Leavitt said. During his own confirmation process, Leavitt made it clear that the FDA commissioner search was being led by the White House.

- M. Nielsen Hobbs