WASHINGTON - There is a high likelihood that the Senate will confirm Andrew von Eschenbach's nomination as FDA commissioner this week, said a senior agency official.
Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs, said he's "hopeful" for resolving this extended vacancy in official leadership before Congress goes on Christmas recess. "If we don't get it done this week, it's not going to happen for a while," he said, noting that this legislative session ends in a few days. "I don't think the FDA should go into the holiday season without a confirmed commissioner."
The "one remaining" hurdle, Gottlieb said, is a block from Sen. Charles Grassley (R-Iowa) on subpoenas related to the antibacterial drug Ketek (telithromycin, from Sanofi-Aventis Group). The Finance Committee chairman is the latest lawmaker to officially obstruct the confirmation process, charging that von Eschenbach has been central in preventing a more thorough investigation into the drug's safety, but Gottlieb said an "everyday" dialogue between the two camps has advanced the issue.
"We've been having ongoing discussions for weeks now on trying to work through some of the issues that have been an obstacle to getting this done," he told BioWorld Today. "The more we talk to people, the more people seem to recognize that it's important to get a confirmed head of FDA. It's important to public health and important for the agency."
Indicating that no specific actions or concessions have been made to satisfy Grassley, he said appropriate discussions can get the ball rolling to secure a vote on the Senate floor.
Throughout the impasse, Gottlieb said the FDA has made "thousands and thousands" of pages of documents available for Grassley's query, in addition to "unprecedented access" to interview a number of staffers involved in Ketek. "The agency has tried to be responsive," he added, noting that the remaining stalemate has focused on "a handful of information requests" that historically have not been made available.
"The authority and integrity of Senate and committee processes are being challenged," Grassley wrote in a letter to Senate Majority Leader Bill Frist (R-Tenn.), "and due concern should be shown to this nomination." (See BioWorld Today, Nov. 21, 2006.)
While Gottlieb declined to explicitly say whether there has been resolution on another hold on von Eschenbach's nomination from Sen. Jim DeMint (R-S.C.) on safety issues around the abortion drug RU-486 (mifepristone, from Roussel Uclaf SA), Gottlieb indicated that that domino would fall when the Ketek flap wraps up. "Oftentimes, just having a reasonable discussion and explaining things to people helps resolve impasses here in Washington, hard as it is to believe," he said. "People on the Hill recognize the importance of getting a permanent head of FDA."
The agency is holding a two-day advisory committee meeting next week on Ketek's overall benefit to risk considerations in acute bacterial exacerbations of chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia, its current indications.
Another recent hold on von Eschenbach's nomination had been placed by Sen. David Vitter (R-La.) over his push to legalize drug reimportation from Canada. Previous higher-profile holds from Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) on making the emergency contraceptive Plan B (from Barr Pharmaceuticals Inc.) available without a prescription were lifted about two months ago, after the agency approved its over-the-counter use in women 18 and older.
That allowed the nomination to clear the Senate's Health, Education, Labor and Pensions (HELP) Committee a little more than a month after a hearing on von Eschenbach. That day, Chairman Mike Enzi (R-Wyo.) wryly noted that getting through the confirmation process "has to be the toughest thing outside a Supreme Court justice to get passed around here." (See BioWorld Today, Aug. 2, 2006, and Sept. 21, 2006.)
Acknowledging the immediacy of the coming recess, Gottlieb predicted that the incoming Democratic majority in Congress would move quickly to confirm von Eschenbach in the next term. But should that matter extend into the next legislative session, the nomination would have to be repeated.
The drug industry has steadfastly supported von Eschenbach, who first came to the FDA more than a year ago following previous Commissioner Lester Crawford's abrupt resignation just months after receiving Senate confirmation himself. Previously, von Eschenbach led the National Cancer Institute. (See BioWorld Today, Sept. 27, 2005.)