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Home arrow Leading The News arrow FDA nominee feels political heat
Leading The News PDF Print E-mail
FDA nominee feels political heat
Posted: 08/02/06 12:00 AM [ET]

Democratic senators sought yesterday to paint the Food and Drug Administration (FDA) as an agency in crisis at a Senate hearing to consider President Bush’s nominee to oversee the embattled agency.

During a confirmation hearing on Andrew von Eschenbach held by the Health, Education, Labor and Pensions (HELP) Committee yesterday, Democrats complained about the FDA’s numerous delays on ruling whether the emergency-contraceptive drug Plan B should be available without a prescription.

The panel’s Democrats joined their Republican colleagues in praising the qualifications of von Eschenbach, a urological surgeon whose résumé includes stints as head of the federal National Cancer Institute and the M.D. Anderson Cancer Center in Houston. Sen. Hillary Rodham Clinton (D-N.Y.) described von Eschenbach’s credentials as “impeccable.”

But von Eschenbach may never get a chance for Senate confirmation, as at least three senators have placed holds on his nomination.

Clinton and fellow Democratic Sen. Patty Murray (Wash.) have vowed to block his nomination until the FDA either accepts or rejects nonprescription sales of Plan B. In addition, Republican Sen. David Vitter (La.) has placed a hold on the nomination in the hopes of securing a floor vote on his bill to permit the importation of less expensive prescription drugs from abroad, repeating a tactic he employed on the previous nominee to be FDA commissioner last year.

The FDA has lacked a permanent commissioner for all but 18 months of Bush’s presidency, which largely reflects the political sensitivity of the post.

Several Democrats speculated yesterday that the president might use a recess appointment to cement von Eschenbach’s spot in the commissioner’s office, but the nominee said at the hearing that he wants to see the Senate vote to confirm him. HELP Committee Chairman Mike Enzi (R-Wyo.) said that the panel’s vote on the nomination would not take place until September at the earliest. Von Eschenbach has helmed the FDA in an acting capacity for 11 months.

Democrats used the hearing as an opportunity to repeat their charges that the Bush administration has allowed political considerations to trump scientific evidence and suggested that the lack of a decision on Plan B was the result of interference with the FDA’s scientific mandate.

Sen. Tom Harkin (D-Iowa) sharply criticized the administration for what he deemed to be a pattern of valuing political considerations more highly than scientific evidence.

“We all know what’s going on here. This is disregarding science for ideological concerns,” Harkin said.

“How much have we seen that in this administration? Need I mention any more than the stem-cell debate?” he said, referring to President Bush’s decision to use his first veto last month to reject legislation to expand federal support for research on embryonic stem cells.

Von Eschenbach vowed that under his leadership the FDA would never allow political considerations to influence its decisionmaking, but Democrats gave no indication they were taking him at his word.

Clinton made clear that von Eschenbach’s nomination to run the FDA is part of a broader struggle between congressional Democrats and the administration, one that has become particularly contentious during this election year.

“Like so much else in this government in the last five and a half years, it has been turned into a political football, and you’re on the field,” Clinton told von Eschenbach. “You are caught, unfortunately, in a situation that gives great pause to many of us because of what it means to the direction of the FDA.”

Von Eschenbach responded: “I would hope that you would judge me on my record.”

Several senators said the agency’s final decision on the drug would be seen as a harbinger of whether von Eschenbach is fit to be commissioner of the FDA.

“The pending decision on the Plan B is a test case of the FDA’s integrity,” said Sen. Edward Kennedy (Mass.), the committee’s ranking Democrat. Murray described the Plan B controversy as “symbolic of people’s crisis of confidence in the FDA.”

Lawmakers in both parties have assailed the FDA in recent years for reasons other than Plan B, such as the agency’s handling of safety issues connected to prescription drugs such as Vioxx.

Von Eschenbach surprised most observers Monday when he notified Plan B manufacturer Barr Laboratories that its stalled application to remove the prescription requirement for its drug for women older than 18 could be finalized within weeks.

Plan B has been available as a prescription drug since 1999, and the drug’s original patent holder filed for over-the-counter sales status in 2003. The FDA repeatedly has postponed a final ruling on over-the-counter sales of the drug.

 
 
 
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