Bloomberg Anywhere Bloomberg Professional About Bloomberg


 
Von Eschenbach Confirmed by Senate as U.S. FDA Chief (Update1)

By Justin Blum

Dec. 7 (Bloomberg) -- The U.S. Senate confirmed Andrew von Eschenbach, President George W. Bush's nominee to head the U.S. Food and Drug Administration, after lawmakers blocked a vote for months because of complaints about the agency.

The 80 to 11 vote today followed a procedural decision to cut off debate, which circumvented efforts by Republican Senators Charles Grassley of Iowa and David Vitter of Louisiana to stall confirmation.

Von Eschenbach, 65, who has held the commissioner's job on a temporary basis since September 2005, takes over an agency that members of Congress say hasn't done enough to ensure drug safety. They fault the FDA for its monitoring of medicines such as Merck & Co.'s Vioxx painkiller, which the company pulled from the market in 2004 after studies linked it to heart risks.

``We need a strong leader at the FDA now and one who has a mandate to act,'' Senator Michael Enzi, a Republican from Wyoming who serves as chairman of the health committee, said during today's debate. ``He needs full authority to bring back the morale of the department and get the job done.''

Bush nominated von Eschenbach, a urologist who previously headed the National Cancer Institute, in March. The FDA has been without a permanent leader since the resignation of Lester Crawford in September 2005, two months after he was confirmed.

Complex Issues

The agency faces ``increasingly complex scientific, medical and regulatory issues,'' von Eschenbach said in a statement issued after his confirmation. He said he is ``humbled by the responsibility with which I have been entrusted.''

Grassley used a legislative procedure to block a vote because he said the FDA hasn't fully cooperated with his investigation into a Sanofi-Aventis SA antibiotic called Ketek. The drug has been linked to liver damage and death.

``I've seen a complete and utter disrespect for congressional authority and hence the law,'' Grassley said on the Senate floor.

Grassley displayed enlarged versions of redacted documents provided to him by the FDA in response to subpoenas. He complained that the FDA's response to one of his document requests included a redacted version of a letter he had sent to the agency.

``It's not OK to impede congressional investigations,'' Grassley said. ``It's not OK to limit the Senate's access to documents, information and employees of the executive branch.''

FDA vs Grassley

The FDA has defended its response to Grassley and says it has provided extensive responses to his questions.

Vitter also tried to block the vote, saying the FDA should have set up a system to allow imports of some prescription drugs. The Bush administration opposes such a measure.

Senators voted to invoke cloture, the procedure to force an end to debate, getting around the ``holds'' by Grassley and Vitter.

Senator Jim DeMint of South Carolina had previously said he would block a vote because of concern that von Eschenbach hadn't discouraged use of the abortion drug RU-486. DeMint said in a statement today that he dropped his hold after meeting with von Eschenbach.

Democrats previously blocked consideration of von Eschenbach, a three-time cancer survivor. Senators Hillary Clinton of New York and Patty Murray of Washington blocked a vote on von Eschenbach until the FDA decided whether to allow sales without a prescription of the emergency contraceptive called Plan B.

Plan B Sales

The agency in August allowed limited over-the-counter sales of Plan B, following years of consideration, and Democrats dropped their objections. The Senate health committee voted in September to forward the nomination to the full Senate.

The FDA, which has more than 12,000 employees and a budget of $1.88 billion, regulates food, medicine, medical devices and cosmetics.

Bush's first FDA chief, Mark B. McClellan, left after 16 months to oversee Medicare, the federal health program for the elderly and disabled. Crawford, who replaced McClellan, abruptly resigned. Crawford pleaded guilty in October to failing to disclose owning shares in companies regulated by the FDA.

Lawmakers and pharmaceutical representatives said the agency has needed a permanent leader.

``A permanent FDA commissioner speaks with greater authority about the resource needs of the FDA during the budgetary process and is more likely to be focused on long-term programs and policies,'' said Billy Tauzin, the president of the Pharmaceutical Research and Manufacturers of America, an industry trade group in Washington, in a statement.

Von Eschenbach, who was chief academic officer at the M.D. Anderson Cancer Center in Houston before becoming director of the National Cancer Institute, said during a Senate hearing in August that the FDA needs to use modern information systems.

He also said the agency should ``streamline our regulatory processes to make them more efficient, rigorous and transparent.''

To contact the reporter on this story: Justin Blum in Washington at jblum4@bloomberg.net.

Last Updated: December 7, 2006 19:22 EST

Sponsored links