Bush named Andrew von Eschenbach, MD, to head the agency nearly six months after commissioner Lester Crawford abruptly resigned amid questions over stock transactions.
Von Eschenbach currently serves as both the FDA's acting commissioner and the director of the National Cancer Institute.
His nomination comes at a time of tumult in the agency. Widely publicized safety problems with pain drugs like Vioxx, antidepressant medications, and heart pacemakers have focused public and congressional attention on how the FDA operates.
The agency has also faced withering criticism for delaying a decision on a 1.5-year-old application to make the emergency contraceptive drug Plan B available without a prescription to women over age 16.
The issue appears to be a likely hurdle to von Eschenbach's quick approval by the Senate. At least two Democrats vowed to block his nomination until the FDA issues a long-awaited decision on Plan B.
A federal advisory panel voted 23-4 in 2004 to approve over-the-counter sales of the drug, though the agency did not approve the application at that time. The delay led the FDA's director of women's health to resign in protest, saying the agency had ignored the science surrounding the drug because of politics.
FDA officials have said that they still have some safety concerns and have cited questions on how to regulate the drug.
Crawford's bid to take over the permanent post was temporarily blocked last year by Democrats upset over the delay. He was approved after Bush administration officials promised that a decision on the drug was imminent. The agency still has not issued a ruling six months later.
The Hold Up Continues
On Wednesday, Sen. Hillary Rodham Clinton (D-N.Y.) said in a statement that she would repeat her previous block on the nomination.
"It is past time for the FDA to stop dragging its heels and make a decision on Plan B. We will place a hold on the nomination of Dr. von Eschenbach until the FDA issues a decision on Plan B, yes or no," Clinton said.
Sen. Patty Murray (D-Wash.) echoed Clinton's sentiments. "I've made it clear. Until the agency makes a ruling on the science one way or the other, I'll put a hold on it," she tells WebMD.
Even if the FDA clears up the Plan B decision, von Eschenbach's nomination is likely to focus even more attention on the FDA's safety monitoring and other operations.
Sen. Charles E. Grassley, who leads the Finance Committee, continues to lead several investigations into the FDA's decision making. Grassley suggested Wednesday that he would closely scrutinize the nomination.
"The FDA has an enormous mission. It needs a permanent commissioner who's willing and able to take on its entrenched cultural problems and turn them around," he said in a statement. "The next commissioner can't accept business as usual at an agency that protects the well-being of all Americans."
SOURCES: Sen. Hillary Rodham Clinton (D-N.Y.). Sen. Patty Murray (D-Wash.). Sen. Charles E. Grassley (R-Iowa).
By Todd Zwillich
Reviewed by Brunilda Nazario, MD
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