FDA Official Cites Problems With Prescription Drug Reimportation Programs
FDA Pharmacy Affairs Directory Tom McGinnis on Dec. 24 said that a safe, legal program to reimport lower-cost, U.S.-manufactured prescription drugs from Canada would likely cost hundreds of millions of dollars, the AP/Richmond Times-Dispatch reports. In addition, McGinnis said that the FDA would never rely on Canadian inspections of prescription drugs to determine their safety. McGinnis said that although the FDA inspects pharmaceutical companies worldwide, Health Canada relies on inspections conducted by the home nations of the companies. McGinnis said, "We've never accepted inspection results from another country." He added that a reimportation program is "just not going to work. There would have to be mechanisms set up, and we would have to get permission from the Canadian government to inspect." Health Canada spokesperson Emmanuel Chabot defended the safety of the Canadian inspection system. He said, "We conduct regulatory reviews of drugs to ensure there is sufficient evidence of safety, efficacy and quality before they receive authorization to be sold in Canada." According to the AP/Times-Dispatch, the FDA position on reimportation "sets the tone" for an HHS study on the safety of the practice required under the new Medicare law (Baldor, AP/Richmond Times-Dispatch, 12/25/03). In recent months, a number of state and local governments have asked the federal government to allow them to import prescription drugs from Canada, the Washington Times reports (Fagan, Washington Times, 1/2). More than 12 states -- such as Iowa, Illinois, Minnesota and New Hampshire -- have considered or plan to implement reimportation programs, USA Today reports. Kevin Concannon, director of the Iowa Department of Human Services, said that the statements FDA officials "make about consumer safety or drug safety are the most bogus words I've seen spoken from a government agency. ... There's more protection of pharmaceutical manufacturers than there is of patients" (Welch, USA Today, 12/31/03). However, HHS spokesperson Bill Pierce said that the agency has twice determined that "we could not guarantee the safety" of reimported prescription drugs, adding, "Nothing has changed since that time" (Washington Times, 1/2).
The Wall Street Journal reports that some Canadian pharmacies have begun to "worry about shortages" for local customers, and some are "refusing to fill large-scale orders" from the United States (Carlisle, Wall Street Journal, 12/26/03). The U.S. demand for prescription drugs from Canada has "explod[ed]" because of high domestic medication costs and a lack of adequate prescription drug coverage among residents, the Baltimore Sun reports (Zaneski, Baltimore Sun, 1/4). In addition, pharmaceutical companies such as AstraZeneca, Pfizer Canada, GlaxoSmithKline, Eli Lilly and Bayer have limited supplies to Canada or raised the prices of their products in Canada in an effort to limit sales from Canadian pharmacies to U.S. residents (California Healthline, 11/17/03). In response, groups such as the Coalition for Manitoba Pharmacy have moved to protect prescription drug supplies to and the businesses of "brick-and-mortar" pharmacies in Canada, the Sun reports (Baltimore Sun, 1/4). The Canadian International Pharmacy Association, which represents 27 online Canadian pharmacies, also has announced that members will not provide prescription drugs for state and local reimportation programs in the United States (Wall Street Journal, 12/26/03).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.