• Institute of Medicine Warns About Counterfeit Diabetes Test Strips

    Editor’s Note:  The National Science Foundation’s Institute of Medicine has just issued a pre-publication edition of a report, Countering the Problem of Falsified and Substandard Drugs, which discusses the dangers of counterfeit and other falsified/illegitimate medical products.  IOM notes that:

    Poor quality medicines cause treatment failure, but doctors do not generally suspect medicines as a cause of disease progression. Lifesaving medicines can be of poor quality, which may be an uncounted root cause of high mortality in low- and middle-income countries. No class of drug is immune to being compromised.

    The new IOM report devotes a special highlight box to spotlighting the dangers of counterfeit glucose test strips.  The report explains, in part:

    Investigation traced the strips back to Halson Pharmaceuticals in Shanghai. The manufacturer sold approximately one million substandard test strips to importers, and from there the strips went through the supply chain to reach U.S. and Canadian pharmacies. Over the course of the next year, the test strips made their way to 8 countries and 35 U.S. states. The Chinese authorities eventually arrested and imprisoned Henry Fu, owner of Halson Pharmaceuticals (Bloomberg News, 2007).

    The LifeScan recall is a reminder that substandard medical products can find their way into countries with strong regulatory systems. The United States and Canada have systems in place for a prompt recall, allowing them to mitigate the threat the product poses to public health. Within 2 years the fake test strips were fully recalled in the United States, but between 2009 and 2011 customers and investigators still found them in other countries, including India, Egypt, and Pakistan (Loftus, 2011)

    CMS’ below-competitive prices are an open door invitation for counterfeit diabetes test strips to flood the US supply chain like cancer cells through a bloodstream.  Expanding the artificially depressed prices for test strips to in-pharmacy sales through exercise of “Inherent Reasonableness” will only add fuel to the fire.

    CRE has extensive experience in evaluating the nexus between public policy and counterfeit and diverted drugs, see our Dirty Deals white paper.

    CMS should consult with the Food and Drug Administation, the IOM and federal law enforcement/money laundering authorities before further expanding opportunities for criminals at the expense of public health.

    The IOM warning about counterfeit glucose test strips is attached here.

    The complete (300+ page) IOM report is attached here.

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