New measures announced by US FDA to protect citizens against counterfeit drugs

On June 9, the US Food and Drug Administration announced new steps to strengthen existing protections against the growing problem of counterfeit drugs (Marketletters passim). The measures, which were recommended in a report released by the agency's Counterfeit Drug Task Force, emphasize certain regulatory actions and the use of new technologies for safeguarding the integrity of USA's drug supply.

"The adoption of the FDA Counterfeit Drug Task Force's recommendations will further reduce the risk that counterfeit products will enter the US drug distribution system and reach patients," said Andrew von Eschenbach, the FDA's Acting Commissioner. "We must remain vigilant in our efforts to ensure our nation's drug supply is protected against an increasingly sophisticated criminal element engaging in a dangerous type of commerce," he commented.

Among other new measures, the FDA will fully implement regulations related to the Prescription Drug Marketing Act of 1987, which requires drug distributors to provide documentation of the chain of custody of drug products - the so-called "pedigree" - throughout the distribution system. The FDA had placed on hold certain regulatory provisions because of concerns raised at the time about the impact on small wholesalers. Most recently, in early 2004, it delayed the effective date of certain regulatory provisions regarding pedigrees to allow the industry time to adopt electronic technology for tracking drugs through the supply chain. Based on information from drug supply stakeholders, the FDA had expected this technology to be in widespread use in the drug supply chain by 2007, but it now appears that these expectations will not be met.