FDA Commissioner Mark McClellan Discusses Opposition to Prescription Drug Reimportation at Senate Hearing
FDA Commissioner Mark McClellan, whom President Bush has nominated to serve as the new CMS administrator, on Monday at a confirmation hearing before the Senate Finance Committee "defended his opposition" to the reimportation of lower-cost, U.S.-made prescription drugs from other nations, the AP/Houston Chronicle reports. McClellan said, "We've seen a lot of examples of unsafe imports into this country." McClellan said that prescription drugs purchased directly from Canadian pharmacies likely are safe, but he raised concerns about medications purchased from online pharmacies (Black, AP/Houston Chronicle, 3/8). "Our laws are not set up to deal with these categories of importers," McClellan said (Heil, CongressDaily, 3/9). McClellan also said that legislation to allow reimportation could lead to an increase in expired, ineffective, counterfeit or mislabeled medications in the U.S. prescription drug supply (Mollison, Cox/Contra Costa Times, 3/9). However, under "intense questioning," McClellan did "soften his tone a bit" on his opposition to reimportation, the New York Times reports. McClellan said that could support reimportation legislation that would place limits on "the scope and type of drugs that can be imported" and would provide FDA "more money, more personnel and more power to police imports," the Times reports (Pear, New York Times, 3/9). McClellan also said a committee that HHS Secretary Tommy Thompson last month appointed him to lead will study proposals to make reimportation safe. Senate Finance Committee Chair Chuck Grassley (R-Iowa) told McClellan that he and Sen. Edward Kennedy (D-Mass.) plan to introduce a bill that would provide FDA with the authority and funds to establish a regulatory process to track reimported prescription drugs, CQ Today reports (Schuler, CQ Today, 3/8). McClellan said that such a bill "is the right direction" to take on the issue (CongressDaily, 3/9).
At the confirmation hearing, McClellan said that he would appear before the Senate Commerce, Science and Transportation Committee to testify about his position on reimportation but only after his confirmation as CMS administrator, the AP/Las Vegas Sun reports (Sherman, AP/Las Vegas Sun, 3/8). Senate Commerce Committee Chair John McCain (R-Ariz.) and Sens. Byron Dorgan (D-N.D.) and Debbie Stabenow (D-Mich.) have announced plans to delay a final confirmation vote on McClellan because of his position on reimportation (Calfiornia Healthline, 3/4). McCain has "blasted" McClellan for his past refusal to testify before the committee on the issue, and his conditional agreement to testify "only stoked the fracas," according to CongressDaily (CongressDaily, 3/9). "It's an absurd response to the request that has been made to him," Barry Piatt, a spokesperson for Dorgan, said, adding, "It's absurd and borders on arrogant" (CQ Today, 3/8). Piatt said that Dorgan has "made it clear that this nomination is going nowhere ... until he gets some serious public policy questions answered" (AP/Houston Chronicle, 3/8). Marshall Wittman, a spokesperson for McCain, said that the senator has not received a formal response from McClellan on whether he will testify before the committee (AP/Las Vegas Sun, 3/8).
At the confirmation hearing, McClellan defended the new Medicare law but had "no immediate answer" when Sen. Bob Graham (D-Fla.) asked him "why the administration had assumed that increased enrollment in private plans would drive up Medicare costs rather than save money," the Times reports. "There are a lot of steps we can take to bring down costs and increase competition," McClellan said. McClellan also said that as CMS administrator, he would not move to revise the False Claims Act, which rewards individuals who report fraud in government-administered programs such as Medicare and Medicaid. In addition, McClellan said that he would not approve state Medicaid program waivers that would place limits on federal spending or would eliminate the guarantee of specific benefits for low-income beneficiaries. "Caps on spending are not envisioned as part of the structure" of Medicaid, McClellan said, adding that "the individual entitlement cannot be waived" (New York Times, 3/9). The Senate Finance Committee on Tuesday likely will vote to confirm McClellan, Grassley said, adding that he hopes the nomination will reach the Senate floor this week, CQ Today reports (CQ Today, 3/8). According to the AP/Sun, senators have "no dispute" about the qualifications of McClellan, and as a result, his nomination likely will "clear the Senate easily" (AP/Las Vegas Sun, 3/8). Sen. Max Baucus (D-Mont.) told McClellan, "If anyone is up to the job (of) administering the ground-breaking Medicare bill Congress passed last year, you may be the man" (Cox/Contra Costa Times, 3/9). However, McCain, Dorgan and Stabenow could "use Senate procedures to drag out the confirmation," according to the AP/Sun (AP/Las Vegas Sun, 3/8). Jill Gerber, a spokesperson for Grassley, said, "It's certainly any senator's prerogative to hold up a nomination when it goes to the floor. Sen. Grassley would hope that members wouldn't hold up this nomination" (CQ Today, 3/8).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.