Noting a dramatic increase in counterfeiting within the U.S., and more-sophisticated packaging and distribution channels, FDA has rolled out a new initiative designed to protect the public from counterfeit products. The Agency, which says it typically investigated five such cases a year in the 1990s, launched 20 investigations of counterfeit pharmaceuticals in 2001, and 22 such cases last year (graph). Pharmaceutical manufacturers also face increasing losses (graph) and liability from counterfeiting.
Recent cases have involved such valuable products as the cholesterol-reducing drug, Lipitor, Serostim, a growth-hormone-based product used to prevent weight loss in AIDs patients, and the anemia treatment, Procrit. The counterfeit threat, FDA says, has shifted from raw bulk materials and active ingredients, once a key concern, to finished pharmaceutical products. In some Serostim cases, counterfeit packages were found to contain no active ingredient. In the recent Procrit case, containers held untreated tap water. FDA has prosecuted counterfeiters vigorously, imposing stiff fines and jail sentences.
FDA plans to develop strategies for decreasing the risk of counterfeit drugs entering the U.S., identify "best practices" for manufacturers and distributors, improve patient, pharmacist and physician education, and strengthen ties with the Customs Bureau and the Departments of Justice and Homeland Security.
An important part of the Agency's program will be assessing new technologies, such as taggants, smart packaging, and radiofrequency ID (RFID). Later this month, Product Surety, a working group project involving pharmaceutical companies, FDA, New Mexico State University's Physical Sciences Lab, and the corporate partners Reconnaisannace International, Axxess Technologies, and Sigma 4, will release the results of a study of risk assessment, technologies, and best practices for preventing counterfeiting.
"Track and trace will play a bigger role, not just in protecting products from tampering and theft, but in allowing people to know where that product has come from, where it has been and where it is going," says Myles Culbertson, director of New Mexico State U's Physical Sciences Lab, which is testing the technologies.
Companies affected by counterfeiting, including Serono, Pfizer, Amgen and Ortho Biosciences, have also developed strategies of their own, including new packaging designs and controlled distribution. To increase cooperation between industry and the Agency, a new voluntary program has been set up where drug manufacturers notify FDA within five days if they have reason to believe a product has been counterfeited.
In July, the State of Florida passed regulations that require distributors of any pharmaceutical to provide a detailed "pedigree" tracing the drug back to its manufacturer. A number of states are currently studying Florida's rule.