Washington Editor

WASHINGTON - At last, Andrew von Eschenbach is officially the FDA's commissioner.

It's been a long time coming, more than a year since he took on the agency's top role on an interim basis before being nominated by President Bush earlier this year. But various roadblocks were thrown up along the way, and opposition remained until the very end Thursday despite the Senate's 80-11 vote to approve him before departing for the holiday recess.

It's good news for von Eschenbach's many drug industry supporters, most observers believe, given the expectation that he could effectively champion their interests in the coming year of expected congressional tweaking of the FDA. Jim Greenwood, the president and CEO of the Biotechnology Industry Organization (BIO), said in a statement that the confirmation would enable von Eschenbach "to provide effective leadership and vision for the FDA and is a critical step toward strengthening the FDA."

The agency is facing a significant year in terms of legislation, with the renewal of the Prescription Drug User Fee Act (PDUFA), one of several laws up for reauthorization in parallel with a number of proposed bills that could reshape the FDA's authority vis a vis drug safety oversight.

In a statement, von Eschenbach said he's "committed to leading this agency" in a way that "continues to earn" the public's trust and respect in the face of "increasingly complex scientific, medical and regulatory issues." In addition, he thanked outgoing Senate Majority Leader Bill Frist (R-Tenn.), who sought to settle the holds on von Eschenbach's nomination by calling for cloture - a procedure by which the upper chamber can vote to place a time limit on such a matter to overcome a filibuster by vote of three-fifths of the full Senate. In this case, the vote was 89-6.

Von Eschenbach also thanked the leaders of the Senate's Health, Education, Labor and Pensions (HELP) Committee, outgoing Chairman Mike Enzi (R-Wyo.) and future Chairman Edward Kennedy (D-Mass.). Both have vocally supported him in recent months; last week, Enzi called von Eschenbach a "supremely qualified nominee," and Kennedy said he looks forward "to working closely with the new commissioner" on the multiple FDA-related legislative matters coming up next year.

The nomination cleared the HELP Committee a little more than a month after it held a hearing on von Eschenbach. (See BioWorld Today, Aug. 2, 2006, and Sept. 21, 2006.)

Among those still fighting the nomination to the end and voting against von Eschenbach were Sens. Charles Grassley (R-Iowa), Jim DeMint (R-S.C.) and David Vitter (R-La.), each of whom had placed procedural holds in more recent months for three different reasons: subpoenas related to the antibacterial drug Ketek (telithromycin, from Sanofi-Aventis Group); safety issues on the abortion drug RU-486 (mifepristone, from Roussel Uclaf SA); and legalizing drug reimportation from Canada. Previous holds from Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) were lifted about two months ago after the agency approved over-the-counter use of the emergency contraceptive Plan B (from Barr Pharmaceuticals Inc.) in women 18 and older.

Earlier last week, Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs, predicted that the GOP senators' opposition would be overcome. Had this matter carried into the next legislative session, the nomination would have to be repeated. (See BioWorld Today, Dec. 6, 2006.)

Von Eschenbach first came to the FDA more than a year ago following previous Commissioner Lester Crawford's abrupt resignation, just months after receiving Senate confirmation himself. Previously, von Eschenbach led the National Cancer Institute. (See BioWorld Today, Sept. 27, 2005.)