COUNTERFEITING RISKS ASSOCIATED WITH IMPORTATION ARE PREVENTABLE, EXPERT SAYS
With some lawmakers expected to push hard for prescription drug importation this fall, the debate will likely focus on the possibility of unsafe drugs entering the U.S. supply chain. One expert says protecting Americans from counterfeit products under an Rx importation scheme is possible and could be done at a reasonable cost.
Legalizing importation wouldn't necessarily open the floodgates to bogus products, said Ron Buzzeo, chief regulatory officer at Dendrite International, which provides marketing, sales and compliance services to the pharmaceutical industry.
Systems can be put in place that would protect the supply chain, Buzzeo told FDAnews. "There are ways to decrease the potential for counterfeit products, and there are ways to decrease it tremendously. It could be done at a reasonable cost."
What is required is a multipoint program, said Buzzeo, who doesn't espouse a position on the drug importation debate. Elements of such a program would include inspections of the total distribution chain; track-and-trace technology; an educational program for patients, physicians, healthcare professionals, wholesalers and pharmacies; and international cooperation and sharing of information. In addition, Buzzeo recommended increased law enforcement efforts and increased criminal penalties for offenders, including lengthy prison sentences.
Still, he acknowledged, any move to legalize importation would be seen as a tempting opportunity for counterfeiters. Some studies estimate that roughly 2 percent to 8 percent of drugs currently in the U.S. supply chain could be counterfeit, said Buzzeo, the former deputy director of the Drug Enforcement Administration's Office of Diversion. Outside of the U.S., counterfeits may account for 15 percent to 80 percent of Rx supplies in some countries, he added.