FDA Commissioner Mark McClellan To Testify Before Senate Commerce Committee on Prescription Drug Reimportation

FDA Commissioner Mark McClellan, the nominee to serve as the new CMS administrator, on Wednesday "bowed to demands" and agreed to testify on Thursday before the Senate Commerce, Science and Transportation Committee about his opposition to the reimportation of lower-cost, U.S.-manufactured prescription drugs from other nations, USA Today reports (USA Today, 3/11). In a confirmation hearing before the Senate Finance Committee on Monday, McClellan, who refused invitations to testify about the safety of reimportation before the Senate Commerce Committee, agreed to testify, but only after his confirmation as CMS administrator. In response, Sen. Byron Dorgan (D-N.D.), a member of the Senate Commerce Committee, moved to block a floor vote on the McClellan nomination after the Senate Finance Committee on Tuesday voted 18-2 to approve the nomination. In recent weeks, Dorgan, Senate Commerce Committee Chair John McCain (R-Ariz.) and Sen. Debbie Stabenow (D-Mich.) have announced plans to delay a floor vote on the McClellan nomination because of his position on reimportation (California Healthline, 3/10). According to CongressDaily, the decision by McClellan to testify before the Senate Commerce Committee is part of an agreement negotiated by Senate Majority Leader Bill Frist (R-Tenn.), who hopes that the Senate will confirm McClellan this week (Rovner/Heil, CongressDaily, 3/11).

FDA Associate Commissioner Peter Pitts said that McClellan decided to testify before the Senate Commerce Committee because he "believes he needs to step forward and reverse the trend that puts politics in front of public health." However, Barry Piatt, a spokesperson for Dorgan, said, "This isn't about politics. It's about a very serious issue. It's about prescription drug prices" (Los Angeles Times, 3/11). Piatt added that Dorgan will not decide whether to remove the hold on the McClellan nomination until after he testifies. McClellan "needs to answer questions and have a forthcoming conversation," Piatt said (CQ Today, 3/10). McCain, who supported the decision by Dorgan to place a hold on the McClellan nomination, said, "I'm going to reserve judgment until I hear" from McClellan (CongressDaily, 3/11). White House spokesperson Scott McClellan, brother of Mark McClellan, said that the hold "is complicating the administration's quest to implement the president's recent overhaul of Medicare," the Washington Times reports. "All members should keep in mind that this is about America's seniors and providing them the health care that they need. Get this nominee in place so that we can work to implement these improvements," Scott McClellan said (Sammon, Washington Times, 3/11).

In related news, HHS spokesperson Bill Pierce announced Mark McClellan will no longer serve as the chair of a task force that will conduct a study on the safety of reimportation, the Los Angeles Times reports (Los Angeles Times, 3/11). Last month, HHS Secretary Tommy Thompson appointed McClellan to lead the one-year study, which is required under the new Medicare law (California Healthline, 2/26). Thompson said that he withdrew the appointment in response to "concerns that McClellan's past opposition" to reimportation "might bias the findings," CQ Today reports (Shuler/Carey, CQ Today, 3/10). Thompson said that he would name a new chair and the other members of the task force "in the next day or two," adding that the task force will hold the first of a series of public hearings on March 19. Thompson said that he hopes the task force will complete the reimportation study this summer (CongressDaily, 3/11).