Radio-Frequency ID (RFID) as an Answer to Pharmaceutical Drug Counterfeiting

Five myths about how Radio-Frequency ID (RFID) technology will stop counterfeit drugs.

PAGE 5

Yet no one-not the FDA, and not any of the pilot programs being done by the private sector-is actually proposing a way for consumers to validate the products. In fact, it seems likely that RFID tags will be disabled before the drugs reach consumers' hands. This is largely because of privacy concerns that, say, stores could use the information on RFID tags to know what bottle of pills a customer has in his backpack.

Even if the United States does eventually have a track-and-trace program that relies on RFID technology, ultimately the consumer will still be relying on something as old-fashioned as an ice-cream soda: trust in the local apothecary.

"Patients put trust in the states licensing the pharmacies, and that pharmacists are only buying legitimate products," says Carmen Catizone, executive director of the National Association of Boards of Pharmacies. "But right now, they can't do that, because they don't have a pedigree" of where the drug came from.

Myth 5: The pharmaceutical industry is this close to widespread RFID adoption.
Given all these challenges and limitations, it may come as no surprise that the move to implement RFID technology to secure the nation's drug supply has hit some speed bumps, years after it was first promoted as the Next Big Thing for pharma. The FDA, after delaying for years the deadline for when the industry should have electronic pedigrees in place-ones that it says, most likely, will rely on RFID technology-recently announced its biggest delay of all: It was giving up on setting a deadline.

Back in 2004, explains Ilisa Bernstein, the FDA's director of pharmacy affairs, "we thought there would be widespread use by 2007. We're not there. So rather than setting another deadline, we're leaving it to the stakeholders themselves to come up with a deadline." (An injunction of the Prescription Drug Marketing Act, the 1987 law that allows the FDA to set this regulation, has not helped. For more, see Legislative Tangle.)

Still, the FDA continues to say (as it has for years) that RFID technology is the "most promising" means of authenticating drugs.

"We keep saying this is a promising solution," Bernstein says. "We want to say that this is a solution, but we're not there yet because people haven't adopted it. There's a lot of work going on behind the scenes, but you have to cross over the line and just jump right in and start doing it."

In the end, it may turn out that both the RFID boosters and the naysayers are right: RFID technology may in fact be the most promising way to mitigate an unsolvable problem. But only time will tell.

RFID

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