FDAnews Drug Daily Bulletin


March 31, 2006

The chances of Senate Democrats lifting their hold on president Bush's nomination of Andrew von Eschenbach as permanent FDA commissioner diminished after several key senators recently met with the nominee, a congressional staffer says.

Von Eschenbach, the agency's acting commissioner, sat down with Sens. Patty Murray (D-Wash.), Hillary Rodham Clinton (D-N.Y.) and Mike Enzi (R-Wyo.) to discuss the FDA's pending review of the controversial contraceptive Plan B. Democrats, including Murray and Clinton, have vowed to hold the nomination until the agency sets a timeline for deciding whether to grant Barr Laboratories' application to sell the drug over the counter (OTC).

But the senators are less likely to lift the hold after meeting with von Eschenbach, Murray's spokeswoman Alex Glass told FDAnews. Von Eschenbach refused to provide a timeline for an agency decision, which heightens the lawmakers' concerns that he will not be sufficiently independent of outside influence, Glass said. The FDA has been accused of letting political pressure from the Bush administration influence its decision on Plan B, a claim the agency has repeatedly denied.

The lawmakers had hoped the nominee would provide some detail as to the FDA's future schedule on Plan B approval, Glass noted. Instead, the senators "got nothing" from von Eschenbach.

"It's the same old, same old with them," Glass said. Von Eschenbach needs to show he is willing to take a different approach to sensitive policy issues by being independent of outside influence, she added, noting this does not seem to be the case based on the meeting and that is "certainly a concern." The lawmakers have scheduled no further meetings with the agency and are not likely to meet with the FDA again on the issue, Glass said.

The same obstacle faced former FDA Commissioner Lester Crawford, as opponents held his nomination pending a decision on Plan B. Lawmakers, including Murray, lifted that hold when HHS Secretary Mike Leavitt pledged last September that the FDA would make a decision on the application, Glass said. But no decision occurred, and lawmakers do not intend to lift their hold on von Eschenbach based on a mere pledge. "We won't make that mistake again," Glass said.

Enzi, chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee -- which has jurisdiction over the agency -- has been a key supporter of the von Eschenbach nomination. The HELP committee staff has told the White House that the FDA must make a decision on Plan B in order to get Von Eschenbach confirmed by the Senate, an Enzi spokesman told FDAnews.

The FDA declined to provide details of the meeting. "We are not commenting, other than to confirm the meeting took place," an agency spokeswoman said. The agency has previously said it has not made a decision yet because it is still reviewing public comments received on the Barr application.

Barr first sought OTC status for Plan B (levonorgestrel) in 2003, but the FDA rejected the request, saying the application lacked scientific data on the product's OTC use among adolescents younger than 16. The agency also rejected the advice of an FDA advisory panel that recommended OTC use.