March 22, 2017

Former FDA commissioners warn against Rx drug importation

Daily Briefing

    Four former FDA commissioners in a letter sent last week to members of Congress cautioned lawmakers against allowing U.S. patients to import drugs from other countries.

    Lawmakers in the House and Senate earlier this month introduced legislation (HR 1245, SB 469) that would allow the United States to import certain prescription drugs from Canada.

    Letter details

    The letter was signed by former FDA Commissioners:

    • Robert Califf, who served as commissioner from February 2016 to January 2017;
    • Margaret Hamburg, the foreign secretary of the National Academy of Medicine and president-elect of AAAS, who served as commissioner from 2009 to 2015;
    • Mark McClellan, director of the Duke-Robert J. Margolis Center for Health Policy at Duke University, who served as commissioner from 2002 through 2004; and
    • Andrew Von Eschenbach, senior fellow at the Milken Institute and president of Samaritan Health Initiatives, who served as commissioner from 2006 to 2009.

    They wrote that U.S. residents and some members of Congress "have expressed serious concerns about access to and cost of prescription drugs," and while they "share [those] concerns and believe [the United States] need[s] better systems that enable affordable access to life-saving medicines," they do not think that importing drugs from other countries is "the right approach."

    The former FDA commissioners cited various concerns with allowing U.S. patients to import drugs from other countries. For instance, the former commissioners wrote that FDA does not have the necessary resources to properly oversee a large drug importation program. They added that imported drugs could be adultered, fake, substandard, or unsafe, and that allowing importation could pose serious risks to consumers and patients.

    In addition, the former commissioners wrote that allowing drug importation likely would achieve only minimal cost savings. Further, they wrote that allowing importation ultimately could decrease patients' access to drugs because treatments that are in limited supply would be open to a new influx of patient demand.

    The former FDA commissioners suggested policymakers look into alternatives such as tying drugs' prices to their clinical values and streamlining the approval processes for generic and biosimilar drugs. They concluded, "We urge Congress and the many others concerned about the cost of drugs to deal directly with the issues driving the cost of medicines and not to place false hope in measures that will place patients who need treatment at risk and jeopardize public health" (Bean, Becker's Hospital Review, 3/17; McGinley, "To Your Health," Washington Post, 3/17).

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