Executive Summary
Counterfeit drugs, including fake, substandard, adulterated or falsely labeled (“misbranded”) medicines, have become a real and growing threat to global health. Increasingly sophisticated counterfeiting rings, often involving organized crime, are slipping their fakes into the legitimate drug supply of countries around the world. The problem is especially serious in developing countries, where hundreds of thousands die from ineffective medicines, and millions more from the drug-resistant strains of pathogens such as malaria, HIV/AIDS and tuberculosis that have been promoted by counterfeits’ suboptimal dosing of antibiotics and anti-viral agents.
Even the U.S. drug supply, among the most secure in the world, is increasingly threatened by counterfeit or substandard drugs. The last few years have seen a rising number of cases of counterfeits turning up in neighborhood pharmacies, including fake versions of some of the nation’s most popular drugs. The main point of entry for the counterfeits has been the “gray market,” a loose and complex network of drug diverters and secondary wholesalers that makes it possible for distributors to introduce diverted and sometimes counterfeit drugs into the legitimate drug supply chain. The risk of counterfeits is even greater with drugs that are unlawfully imported or bought from unregulated online sites.
Efforts to secure the system have focused on the pedigree provisions of the Prescription Drug Marketing Act (PDMA), which after two decades of delay, the FDA will soon begin to enforce. However, to be effective, the pedigree requirement must be combined in a multi-layered strategy with new emerging anti-counterfeit technology, such as RFID, and the reform of the wholesale industry. Moreover, because regulations are meaningless without effective enforcement, state and federal officials must be given the authority and resources they need to enforce the laws, and penalties must be increased for those who violate them.
How can consumers protect themselves? By paying attention to the drugs they take and their effects, and report anything suspicious or unusual to appropriate authorities. Online drug shoppers should only use those legitimate Internet pharmacies that have been approved by the National Association of Boards of Pharmacy (see the sidebar in the section “Internet Drug Stores” in Part III).
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