Senate Approves Permanent FDA Chief

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Andrew von EschenbachDec. 7, 2006 - The U.S. Senate voted 80-11 Thursday to back President' Bush's pick to lead the FDA.

The Senate's approval came after months of protests from Republicans and Democrats that blocked Andrew von Eschenbach, MD, from taking the politically sensitive office.

The agency has been without a permanent chief for nearly four and a half of the last six years. During that time the FDA has faced a range of perceived missteps that have increased lawmakers' appetite to reform the agency next year.

President Bush nominated von Eschenbach in March, six months after he became the FDA's acting director. At the time, von Eschenbach, 65, was already head of the National Cancer Institute.

A handful of lawmakers immediately blocked his nomination in protest of the FDA's delays in approving the emergency contraceptive drug Plan B. The agency eventually cleared the drug for over-the-counter sales to women aged 16 and older.

Sen. Hillary Rodham Clinton, D-N.Y., one of the lawmakers who initially held up the nomination, now says von Eschenbach is qualified to direct the agency as it prepares an overhaul on several issues, including the way it monitors the safety of drugs already circulating in the U.S. market.

"We need a leader, or nobody can resolve [the problems]. Right now we don't have a leader," Clinton tells WebMD.

"I'm willing to give him a chance," says Sen. Patty Murray, D-Wash., who also blocked the nomination over Plan B's approval earlier this year.

Republican Opposition

The nomination was also blocked for several months by Sen. Charles Grassley, R-Iowa, chairman of the Finance Committee. The committee has spent years investigating the FDA's operations, including its handling of the safety of antidepressants drugs and the painkiller Vioxx, and allegations that agency leaders prevented FDA scientists from bringing safety concerns to the public.

Grassley also clashed with the FDA over whether the agency properly monitored the safety of the antibiotic drug Ketek. His committee issued a pair of subpoenas earlier this year, though Grassley complained in an angry floor speech Thursday that the agency has only partially fulfilled them.

"If this is the type of cooperation I am getting from the FDA under Dr. von Eschenbach, I am very concerned about the cooperation, if any, we will have once he becomes the permanent commissioner," Grassley says.

"The way the FDA under this nominee has handled the investigation of Ketek shows the agency would like to keep its business secret," he says.

Grassley and other lawmakers are expected to introduce bills next year reshuffling the FDA and giving it more authority to order drug companies to perform safety trials.

Secretary of Health and Human Services Mike Leavitt expressed support for von Eschenbach's ability to handle the FDA's challenges. "Andy has the energy, vision and expertise that will help the agency to improve product safety, spurring innovation and helping lifesaving therapies reach patients faster," Leavitt says in a prepared statement.

source - WebMD