After an 18-Year Delay, Government Tracks Prescription Drugs

June 9, 2006 — -- The Food and Drug Administration will now enforce an 18-year-old law that requires drug wholesalers to track pharmaceuticals every time they change hands from the factory to the pharmacy.

The counterfeit drugs are the same color and have the same labels as the legitimate medication, but they have either been knowingly exposed to contaminants or do not have the benefit of an active ingredient that is known to be safe and effective at treating the patient's medical condition, according to the FDA's associate commissioner for policy and planning, Randy Lutter.

This is a growing concern at the FDA, which investigated 58 cases of counterfeit drugs in 2004, and 32 cases of counterfeit drugs in its 2005 fiscal year. There were, however, only six cases in 2000.

Stephanie Aleong, a former Florida prosecutor and one of the first people to pursue counterfeit drug cases, said the FDA's decision to track pharmaceuticals is important and long overdue.

"It's sort of like having a magnum gun," said Aleong. "It's just incredible because you can have the proof you need to convince the jury that these are counterfeit drugs. The alternative is to be able to, every time, catch the counterfeiter in the back alley making counterfeit labels and counterfeit drugs, which you're never going to be able to do."

The FDA has hesitated to enforce the law since 1988 at the request of secondary wholesalers, who believed the tracking requirement could put them out of business.

The agency was also waiting for the drug supply industry to adopt radio-frequency identification (RFID) technology, which Lutter said is believed to be the most effective way to track drugs as they move through the supply chain.

"There's an arms race," Lutter said. "The criminals are always anxious to discover one new way of fooling investigators, fooling public health authorities and the FDA, and fooling manufacturers. And our job is to be one step ahead of them."

The FDA said they are not requiring the pharmaceutical companies and retailers to adopt the tracking technology at this time because it will only further delay implementation of these regulations. Instead, the new requirement is focused on secondary wholesalers who, beginning Dec. 1, 2006, will have to maintain a "pedigree" of the drug, said the Maggie Glavin, the FDA's associate commissioner for regulatory affairs.