FDA Commissioner Mark McClellan Named To Lead Study on Prescription Drug Reimportation

HHS Secretary Tommy Thompson on Wednesday named FDA Commissioner Mark McClellan to lead a committee that will conduct a study on the reimportation of lower-cost, U.S.-manufactured prescription drugs from Canada, the Wall Street Journal reports (Wall Street Journal, 2/26). The one-year study, required under the new Medicare law (HR 1), will examine whether the United States could safely reimport prescription drugs if the federal government hired additional inspectors, shipments of reimported medications entered through specific ports and the treatments had small electronic tags to trace them as they moved through the U.S. supply chain. The nomination of McClellan to lead the committee "infuriated" reimportation supporters because McClellan has "adamantly opposed any relaxation of the rules barring" the practice, the New York Times reports (Pear, New York Times, 2/26). Sen. Byron Dorgan (D-N.D.) said, "Dr. McClellan has clearly made up his mind not to allow importation and has done everything in his power to stop it," adding, "It gives new meaning to putting the fox in charge of the chicken house" (Congressional Quarterly Today, 2/25). A spokesperson for Sen. John McCain (R-Ariz.) said that the senator "is concerned because Dr. McClellan has already displayed a personal bias" against reimportation. According to Thompson, the committee that will conduct the reimportation study will hear testimony from governors and federal lawmakers on both sides of the issue, the Times reports (New York Times, 2/26). In addition to McClellan, the committee will include officials from CMS, the Drug Enforcement Administration and the Bureau of Customs (Congressional Quarterly Today, 2/25).

An Illinois couple on Wednesday plans to file a class-action lawsuit against HHS, FDA and Thompson in U.S. District Court in Washington, D.C., to challenge a federal law that bars reimportation, USA Today reports. The couple, Ray and Gaylee Andrews, both 74, said that they spend $800 to $1,000 per month on prescription drugs (Appleby, USA Today, 2/26). The lawsuit alleges that the law restricts "access to medical choices ... in ways that violate the Constitution," Robert Clifford, a Chicago trial attorney who represents the Andrews, said. Clifford added that FDA violates the equal protection clause because the agency does not take legal action against U.S. residents who "drive across the bridge from Detroit to Windsor, Canada" for prescription drugs but threatens to prosecute residents who reimport medications (Connolly, Washington Post, 2/26). Illinois Gov. Rod Blagojevich (D), after he learned that the Andrews planned to file the lawsuit, "steered them toward Clifford," a supporter and campaign contributor, the Chicago Sun-Times reports (McKinney, Chicago Sun-Times, 2/26). Abby Ottenhoff, a spokesperson for Blagojevich, said that although Illinois is not a party to the lawsuit, the state may file a legal brief in support of the plaintiffs (New York Times, 2/26). A senior aide for Blagojevich said that if the Andrews win the lawsuit, "FDA must (draft) rules for importation, and Illinois and all the other states that are working for a way to do this will be able to do it. All of the obstacles that have been put in our way will be wiped away" (Chicago Sun-Times, 2/26). HHS spokesperson Bill Pierce said that the department cannot comment on the lawsuit (USA Today, 2/26).