Senate Approves FDA Chief

Frist Ends 'Holds' That Long Stalled Vote on Von Eschenbach

The Senate broke with tradition yesterday in clearing a path for Andrew C. von Eschenbach to become commissioner of the Food and Drug Administration despite attempts by two lawmakers to block the final vote.

In one of his last official acts, retiring Majority Leader Bill Frist (R-Tenn.) forced a procedural vote that ended debate and set up the 80 to 11 approval of von Eschenbach. In doing so, Frist swept aside "holds" by fellow Republicans Charles E. Grassley (Iowa) and David Vitter (La.). They had for weeks taken advantage of their informal prerogative to keep a measure or nomination from coming to the floor, a power enshrined in longstanding Senate practice.

Von Eschenbach, 65, a urologist and former director of the National Cancer Institute, had been acting commissioner since September 2005. But his nomination to take over the job permanently had been bogged down in Congress for nine months, with at least five senators holding up a vote at various times.

Von Eschenbach "has demonstrated the capacity to lead and to administer in an exceptional way," Frist, who is also a doctor, said just before the final vote. "The FDA deals with sensitive issues on a daily basis. It's important that we have a permanent person in that position, and he is the ideal candidate to do just that."

With more than 10,000 employees and a $1.9 billion budget, the FDA ensures that food and cosmetics are safe, and evaluates the safety and efficacy of prescription drugs and medical devices -- products that account for about a quarter of the U.S. economy. The agency has lacked a confirmed commissioner for all but 18 months of President Bush's term, a leadership void that government scholars say can undermine an agency's mission.

Next year could be challenging for the FDA. Democrats will have control of Congress, and many have complained that the agency has fallen short in monitoring the safety of medicines, citing the 2004 withdrawal of the arthritis drug Vioxx because it raised the risk of heart attacks. Moreover, the law that allows the FDA to collect fees from companies to speed the new drug-approval process expires next year. Democrats are expected to use the reauthorization of the legislation as a vehicle to push for changes at the agency.

"For too long, the FDA has needed a Senate-confirmed leader with the mandate that Senate confirmation provides," said Sen. Mike Enzi (R-Wyo.), chairman of the Health, Education, Labor and Pensions Committee, which vetted von Eschenbach's nomination.

Sen. Edward M. Kennedy (D-Mass.), who will head the committee next year, said confirming von Eschenbach would help "restore leadership to this essential agency, and begin the process of addressing the many major concerns that have gone unmet for so long."

Health and Human Services Secretary Mike Leavitt called him "a superb choice."

The new FDA chief faced a lot of opposition along the way, however. Democratic Sens. Hillary Rodham Clinton (N.Y.) and Patty Murray (Wash.) held up his nomination earlier this year to force the agency to end a three-year delay in approving over-the-counter sales of the emergency contraceptive, or "morning after" pill. Sen. Jim DeMint (R-S.C.), who voted against von Eschenbach, temporarily put a hold on the nomination because he wants the agency to suspend the sale of RU-486, a drug that induces abortion.

Vitter blocked confirmation as part of an ongoing fight over whether to legalize importation of cheaper prescription drugs from Canada and other countries. Grassley announced his "hold" to protest what he said was the FDA's failure to give Congress enough information about an investigation into possible fraud in clinical trials of an antibiotic.

"A vote for this nominee would be an endorsement of the stonewalling but more importantly the disrespect for Congress that he has shown by not cooperating with congressional oversight," Grassley said.

All those voting against von Eschenbach were Republicans except Sen. Max Baucus (D-Mont.). The outcome illustrates that senatorial "holds" -- an arcane, secretive and oft-criticized practice that can delay or doom controversial initiatives -- are not unbreakable. While not specifically sanctioned by Senate rules, holds have routinely been honored by Senate leaders as an advance warning of other delaying tactics, such as a filibuster. The practice began as a courtesy, but over the years it became an instrument of obstruction sometimes exercised in the form of "revolving holds," imposed by one senator after another to defeat a bill through endless delays.

Norman J. Ornstein, a congressional scholar at the American Enterprise Institute, said he was not surprised that Frist forced the vote because the agency is important and has been leaderless for a long time. Still, he said, holds remain a powerful -- and sometimes misused -- tool to gain leverage over legislative opponents or the administration.

"In some of these, you can kind of understand the frustration of senators, where they will have what they believe is a legitimate issue," he said. "They'll go to an agency and the White House, and they'll basically get stonewalled."