FDA Combats Counterfeit Drugs

Moving to strengthen protections against the growing problem of counterfeit drugs, the Food & Drug Administration on June 9 said it will require pharmaceutical wholesalers to document the chain of custody as drug products pass through the distribution system.

The tracking requirement, which takes effect on Dec. 2, "will further reduce the risk that counterfeit products will enter the U.S. drug-distribution system and reach patients," says Andrew C. von Eschenbach, 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,??? von Eschenbach adds.

Globally, drug counterfeiting is a $32-billion-per-year business, and an estimated 8???10% of the global medicine supply chain is counterfeit, according to the World Health Organization. FDA says its criminal office of investigations opened 32 counterfeit drug cases in fiscal 2005 and 58 the year before, compared with just six in 2000.

On April 27, Sen. David B. Vitter (R-La.) introduced legislation that, if passed, would require all manufacturers to use counterfeit-resistant technologies when packaging and shipping prescription drugs throughout the U.S.

In 1999, FDA issued a regulation under the Prescription Drug Marketing Act that requires drug distributors to produce a ???pedigree,??? or record, detailing each drug???s movement through the supply chain. But the agency has repeatedly put the rule on hold because of concerns raised about the impact on small wholesalers.

Most recently, in early 2004, FDA delayed the effective date of the pedigree requirement to allow the industry time to adopt electronic technology for tracking drugs throughout the distribution system.

???Based on information from drug supply stakeholders, 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,??? the agency says in a statement. ???Continuing the hold would ??? further allow opportunities for counterfeit and diversionary practices to flourish.???

As a result, when the latest hold expires in December, FDA says wholesalers will be required to begin providing paper or electronic pedigrees tracing a drug's movement from the manufacturer to drugstore shelves.

Over the next year, the agency says, its enforcement of the pedigree regulation will focus on products most susceptible to counterfeiting and diversion. FDA plans to publish guidance in the Federal Register on the types of drugs that are currently of greatest concern.