A Medical Device Daily

In what may be emerging as the mother of all conundrums, it appears that the nomination of Andrew von Eschenbach, MD, to become commissioner of the FDA has hit yet another roadblock as two Republican senators reportedly are promising to block his nomination.

Sen. Jim DeMint (R-South Carolina) said he will block the nomination unless the FDA takes steps to remove the abortion drug RU-486 from the market, Wesley Denton, Sen. DeMint's press secretary, told the New York Times.

Von Eschenbach's selection to head the agency, has previously been blocked by those on the other side of the aisle who objected to the delay in approving the commercialization of what is known as Plan B.

“Senator DeMint believes that a qualified FDA nominee would publicly discourage RU-486's use and take immediate steps to remove it from the market,” DeMint told the Times, adding that “the senator's not going to budge until they wake up over at FDA.”

Sen. David Vitter (R-Louisiana) also raised another objection to Von Eschenbach's selection, saying that the Bush administration must legalize imports of some prescription drugs before he would allow the nomination to proceed. “It could be from Canada only, or for personal use only, or a pilot or limited program. But it has to be meaningful.”

Vitter predicted that the nomination would not be acted upon this year. “We're running out of time,” he said.

This latest in a string of political ploys tied to the FDA nomination comes just weeks after von Eschenbach approved Barr Pharmaceuticals (Woodcliff, New Jersey) supplemental new drug application, allowing for the Plan B (levonorgestrel) emergency contraceptive to be sold without a prescription to women 18 years of age or older (Medical Device Daily, Aug. 25, 2006). By approving the application, it appeared that von Eschenbach was moving toward a vote in the Senate and likely confirmation.

The Plan B approval had spurred two Democratic senators — Sens. Hillary Clinton (D-New York) and Patty Murray (D-Washington) — to drop long-standing objections to President George Bush's nomination of von Eschenbach.

Clinton and Murray had said for months they would block a full Senate vote on the nomination until the agency decided whether to allow wider access to the controversial contraceptive, after what they saw as a betrayal by the agency on an earlier promise to vote on the product as a condition of lifting a prior hold on von Eschenbach's short-lived predecessor, Lester Crawford, MD.

Susan Bro, a senior communications adviser at the FDA, said, “We're certain both the Senate and FDA are in mutual agreement that what's critical to ensuring the best interest of all Americans is permanent leadership at the FDA.”

With the lifting of the Democratic Senators' hold on the nomination, Sen. Michael Enzi (R-Wyoming), the chairman of the Senate Health, Education, Labor and Pensions Committee, had scheduled a vote on the nomination for next Wednesday. The committee was widely expected to vote to send the nomination to the full Senate. But after the committee votes, any senator can issue a “hold” that blocks consideration of a nomination approved by committee.

With little time left before Congress adjourns, any holds, even brief ones, could scuttle von Eschenbach's nomination until next year. President Bush would then have to renominate von Eschenbach next year, or he could decide to give him a recess appointment.

If the president were to make a recess appointment this year, he would have to reappoint von Eschenbach next year. Either way, von Eschenbach could continue to lead the agency in the interim.

The Bush administration has had a confirmed FDA commissioner for less than two of nearly six years in office.

“The job is important enough that it should be subject to Senate confirmation, but unfortunately it's become so politicized that it's become a hard job to fill,” Dan Troy, a former FDA general counsel, told the Times. “You can and are attacked by both sides of the political spectrum.”