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    Drug importation: Shortsighted and ineffective

    Drug prices are a problem, but importation isn’t the solution


    Based on a partnership with Urology Times, articles from the American Association of Clinical Urologists (AACU) provide updates on legislative processes and issues affecting urologists. We welcome your comments and suggestions. Contact the AACU government affairs office at 847-517-1050 or [email protected] for more information.


    After storming onto the scene following a few highly publicized controversies, the cost of prescription drugs continues to be at the forefront of the health care debate in America, and for good reason. List prices for drugs in the U.S. are on the rise, and, as the health care system gets more complex and convoluted, even those with insurance are being forced to pay more out of pocket for their prescriptions. It is therefore hardly surprising that according to a recent poll, 77% of Americans believe the cost of prescription drugs is unreasonable, and 74% think Americans pay higher prices for their drugs than people in Canada, Mexico, and Western Europe.

    In the face of mounting pressure to take definitive action to keep the costs of prescriptions down, an increasing number of legislators are addressing drug costs in a variety of ways.

    One method that is gaining traction in Washington is drug importation. Sen. Bernie Sanders (I-VT) recently introduced a bill to permit drugs to be imported first from Canada and then from other developed countries after 2 years. The proposed legislation has become somewhat popular among Democrats in Congress. On its surface, it appears to be an appealing idea: drugs are cheaper abroad due to price controls and other mechanisms, and bringing in those cheaper drugs gives Americans lower cost alternatives to U.S.-manufactured medications. But as alluring as it may seem at first glance, drug importation in reality is as dangerous as it is ineffective.

    More from AACU: JAC 2017: IPAB repeal, liability reform see renewed focus

    The closed distribution system for prescription drugs in America allows the FDA to monitor virtually every aspect of the supply chain, all the way from manufacturing to distribution, in order to ensure that patients receive safe, effective, and quality medications. This closed system is critical to protecting patients from unsafe, substandard, adulterated, and counterfeit medications and has made the U.S. drug market the most trusted and secure in the world. The importation plan established under the proposed legislation would undermine the fundamental integrity of this closed system, compromising the many safety protections it affords.

    To its credit, the bill does attempt to address these safety concerns by requiring all foreign exporters to be certified and by prohibiting importation of drugs not manufactured at FDA-inspected facilities. But despite claims that importation under this plan would be adequately monitored to assure drug quality and safety, these provisions are simply insufficient to prevent adulterated, contaminated, or counterfeit drugs from infiltrating the U.S. supply chain and could put patients at risk for potentially serious harm.

    Next: "Unfortunately, this risk is far from imaginary"


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