Senate by Voice Vote Confirms FDA Commissioner Mark McClellan as New CMS Administrator

The Senate early Friday morning by voice vote confirmed FDA Commissioner Mark McClellan as the new CMS administrator with no debate, the AP/Houston Chronicle reports. Sen. Byron Dorgan (D-N.D.), who had placed a hold on the McClellan nomination, said that he agreed to lift the hold because Senate Majority Leader Bill Frist (R-Tenn.) had secured the votes required for confirmation, the AP/Chronicle reports. Dorgan added that Frist had agreed to begin a process that could lead to legislation that would allow the reimportation of lower-cost, U.S.-manufactured prescription drugs from other nations. "We're trying to move the ball forward here, to make progress" toward reimportation, Dorgan said. Frist said that he, Dorgan and others would begin to develop legislation to allow the safe reimportation of prescription drugs, although "no timetable was specified," the AP/Chronicle reports. In a statement, Frist said that McClellan is "an extremely bright and capable public servant" who will provide "strong leadership at this critical time" at CMS (AP/Houston Chronicle, 3/12). Dorgan, a member of the Senate Commerce, Science and Transportation Committee, had placed the hold on the nomination because McClellan had said that he would testify before the committee about the safety of reimportation only after his confirmation as CMS administrator. However, McClellan on Wednesday agreed to testify before his confirmation (California Healthline, 3/11).

In testimony during a hearing that the committee held on Thursday, McClellan discussed his opposition to reimportation (AP/Houston Chronicle, 3/12). According to the Washington Post, the testimony "did little to calm the growing political storm over soaring drug prices and FDA's long-standing opposition to drug importation" (Connolly, Washington Post, 3/12). McClellan said that FDA cannot guarantee the safety of reimported prescription drugs, adding that "we neither have the authority nor the resources to assure safety" of such medications (Rovner, CongressDaily, 3/11). However, McClellan said that he would work with Congress on legislation to provide FDA with the resources required to make the reimportation safe, CQ Today reports. "I'm absolutely willing to work with Congress to come up with the right answer," McClellan said (Schuler, CQ Today, 3/11). McClellan "avoided specifics" on legislation that would allow the safe reimportation of prescription drugs, the Wall Street Journal reports (Mathews, Wall Street Journal, 3/12). He said that FDA would require "several hundred million dollars a year" to regulate reimported medications, adding that the federal program that inspects the safety of food imports "might be a good model" (Pear, New York Times, 3/12). McClellan also said that the cost of a program to regulate reimported prescription drugs could prove "higher or lower" than his estimate (CQ Today, 3/11). "We want to be flexible in working with Congress to address these safety concerns," McClellan said. The "lack of specifics provoked" committee Chair John McCain (R-Ariz.) "to pepper him with questions and complaints," the Journal reports. "We rely on the administration and people like you to give us proposals so we can examine them. ... I think it's time the administration came up with a proposal," McCain said (Wall Street Journal, 3/12). McCain added, "Despite the power of the pharmaceutical companies, we will pass ... requirements for the ability to reimport drugs from Canada. My suggestion is that you prepare for it and be part of the solution" (CQ Today, 3/11).

During the committee hearing, supporters of reimportation "gained a significant convert" when Sen. Trent Lott (R-Miss.) said that he supports the practice, the Times reports. "I cannot explain to my mother any longer why she should pay twice or two-thirds more than what is paid in Canada and Mexico," Lott said (New York Times, 3/12). Lott added, "I've warned the (pharmaceutical) industry for years -- fix this problem" of high prescription drug prices, "because if you don't, we will" (CQ Today, 3/11). In addition, Sen. John Cornyn (R-Texas), who had opposed reimportation, said that he has decided to switch his position because "he has become convinced that drug imports can be regulated much as imported food is," the Post reports. AARP CEO Bill Novelli also "expressed growing frustration" with pharmaceutical companies and said that the group has taken "tougher stance" against them because they have moved to end supplies to Canadian pharmacies that sell prescription drugs to U.S. residents, the Post reports. AARP recently purchased full-page advertisements in newspapers and sent a letter to pharmaceutical companies about prescription drug prices. "We think the industry has got to see the writing on the wall and begin to help" develop a safe system for reimportation from Canada, Novelli said (Washington Post, 3/12).

MPR's "Marketplace" on Thursday reported on the problems with the confirmation of McClellan because of his opposition to reimportation. The segment includes comments from Stuart Altman, health economist and professor of national health policy at Heller School for Social Policy and Management at Brandeis University; Dorgan; and HHS spokesperson Bill Pierce (Palmer, "Marketplace," MPR, 3/11). The complete segment is available online in RealPlayer. In addition, CBS' "60 Minutes" on Sunday will include a segment on the high cost of prescription drugs for U.S. residents (Safer, "60 Minutes," CBS, 3/14).