Food and Drug Administration officials announced Monday that they are relaxing some regulations in an effort to make it easier for companies to use anti-counterfeit microchips (search) on prescription drug packages.
Agency officials say they believe that the microchips — basically tiny radio antennas similar to those used in automatic toll booth payment cards — can help reduce what they see as a growing problem of fake and adulterated drugs in the U.S. supply.
Officials maintain that counterfeiting is rare in the U.S. and that the prescription drug supply here is safe. But they also point to what they say are a growing number of incidents involving fakes or misdirected drugs.
The microchips, known as radio frequency identification tags (search), can store information about a package’s point of origin and its trip through the network of wholesalers and distributors that make up the U.S. drug supply chain. Repeated reading by electronic scanners can create a detailed record of where the drug has been on its trip from the pharmaceutical factory to the pharmacy.
A February 2004, FDA report recommended widespread but voluntary use of the chips by drug makers by the end of 2007. But companies were apparently slow to react for fear that implanting microchips on their bottles or packages could violate strict FDA rules governing drug labels.
The agency issued guidance to companies Monday informing them that regulators would not enforce label rules on companies that run experiments or full-scale use of the microchips before December 2007.
“In some technical fashion they may have been concerned,” says William K. Hubbard, the FDA’s associate commissioner for policy and planning. “We’re essentially saying don’t worry about that.”
Floridais set to begin implementing a new law in January requiring detailed paper records for all pharmaceutical shipments. Many safety experts like the idea of computerized microchips because they can potentially accomplish the same record keeping more cheaply and efficiently.
Officials say they have no plans to require the use of radiofrequency microchips or readers. The decision Monday also applies only to drugs intended for the domestic market and not those that come into the country via overseas Internet sales or by other means.
Increasingly popular overseas shipments of drugs are thought to be the main source of fake or adulterated drugs, says Michael Cohen, a pharmacist who is president of the Institute for Safe Medication Practices.
“This would be something for the pharmacists to assure that they got a U.S. product,” Cohen says. “I don’t see where it’s a direct help to consumers.”
Cohen notes that the proposal is a step in the right direction for keeping counterfeit drugs off the American market. “I am all for this as long as it doesn’t add tremendous cost to already costly medications,” he says.
Purdue Pharma, announced Monday that it would begin placing tracking chips on 100-tablet bottles of the narcotic pain killer OxyContin destined for Wal-Mart stores and drug distributor H.D. Smith. OxyContin, widely sought after for illicit street sales, is among the fastest rising drugs of abuse in the U.S., according to federal drug surveys.
“Our objective in implementing these security features is to deter counterfeiting, reduce diversion, and help ensure the authenticity, safety, and integrity of our products,” Aaron Graham, the company’s vice president and chief security officer, said in a statement.
Pfizer, Inc. announced that it would begin using microchips on U.S. shipments of its popular drug Viagra, the industry’s most frequently counterfeited drug. British drug maker GlaxoSmithKline also announced it would experiment with electronic tags on one of its range of anti-HIV drugs within the next year and a half.
SOURCES: William K. Hubbard, associate commissioner for policy and planning, FDA. Michael Cohen, president, Institute for Safe Medication Practices. Aaron Graham, vice president and chief security officer, Purdue Pharma.