For years, many of us in the health policy community have been warning of the threat of counterfeit prescription drugs entering the U.S. drug supply chain. The naysayers—especially those who, like Senator John McCain (R. Ariz.), have repeatedly pushed legislation allowing the importation of prescription drugs from foreign countries—dismissed the warnings. “Show me the bodies,” the critics used to say.
Well, counterfeits are here and will only grow unless Congress and the U.S. Food and Drug Administration (FDA) devise a better way to monitor prescription drugs from inception to ingestion. Fortunately, the latest version of the Prescription Drug User Fee Act, referred to as PDUFA V, has passed Congress and includes a “placeholder,” which allows Congress to figure out the best way to track prescription drugs as they move through the supply chain to the patient. It’s an important step.
Those who questioned the threat of counterfeits regularly argued that the drugs being shipped to U.S. consumers from foreign sources were the same as what Americans could buy at their local drugstore. However, the experts know that many of those drugs are mislabeled, compromised (e.g., not stored or transported properly, expired, etc.), or fake. But most of those drugs were just pills, some of which might be a little more tolerant of limited mishandling.
Today, most innovator drug companies are increasingly turning to biologics, injectable drugs that are much more complex—and much easier to compromise through mishandling, lack of appropriate refrigeration, etc., when they aren’t outright fakes. Oh, and those drugs are also more expensive, making them more profitable—and hence a more lucrative target—for counterfeiters. That’s what recently happened with the cancer-fighting drug Avastin. The fake Avastin was made of salt, starch and other chemicals—more cancer causing than cancer fighting ingredients.
Medical practices that bought the fakes thought they were getting real Avastin; had a proper “track and trace” system been in place, they could have known for sure. PDUFA V has created the opportunity for Congress, the FDA and health care stakeholders to devise a single, nationwide standard to track and trace drugs as they move through the supply chain. It won’t be easy, but it must be done. Otherwise we will begin to see those “dead bodies,” the inevitable result of a compromised drug supply chain.