Yankus warns that counterfeit medicines pose a growing threat to consumer health, and that U.S. regulators and companies need to improve their efforts to protect the U.S. drug supply.

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 when individuals import drugs or purchase 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.