Myth 3

RFID technology can be used to mark pills, tablets and elixirs themselves.

When RFID boosters praise the technology as the solution to counterfeit drugs, here's one objection that Novartis's James Christian is quick to raise: No one is marking drugs, only the packaging.

"We have had experience with counterfeit product in genuine packaging, and genuine product in counterfeit packaging," says Christian, who is CSO of the $US37 billion company based in Switzerland, which manufactures a variety of prescription and over-the-counter drugs. "The packaging isn't what's important."

What's more, he says, pharmaceutical products are routinely and legally repackaged in both the United States and the European Union. "If a pharmaceutical company invests a great deal of money into putting security devices in packaging, the product could easily be transferred legally to a package with no security device," he says. "And now someone has a collection of genuine packaging with security devices that they might throw away or use in another manner."

In Christian's opinion, at least, changing the rules that govern how legitimate drugs are distributed could be more effective than using RFID technology in defeating counterfeit drugs. This could mean changing repackaging laws or increasing penalties for counterfeiters. Whether any of this would be easier to accomplish, though, is anyone's guess.

Myth 4

RFID technology will let consumers verify that they have purchased legitimate products.

The ultimate goal of using RFID technology as part of an electronic pedigree or track-and-trace program is to allow customers to know that the drugs they have in their medicine cabinet are authentic ones. "The benefit is at the consumer end — knowing that the product you're getting came from where it should have come from," says Julie Kuhn, vice president of operations, health-care supply chain services at Cardinal Health, the $US81 billion wholesaler based in the US.

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 US 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 breakout) 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.

"We need more customer validation of the solutions that are being used today," says Michael Liard, a research director at US-based ABI Research, who studies RFID. "If companies are finding ROI or business benefits, they're hard-pressed to share those because those are now sources of competitive differentiation. So getting them to communicate the benefits that they're realizing is a challenge that we're going to have to address as an industry."

Legislative Tangle

While the US Federal Government's push to trace the movement of drugs has been slowed, several states have stepped in with rules of their own. Late last November, the US Food and Drug Administration's attempts to require the pharmaceutical industry to establish electronic pedigrees — documents that trace the movement of drugs throughout the supply chain — hit yet another roadblock. A district court in New York enjoined the government from enforcing a portion of the Prescription Drug Marketing Act (PDMA), the law that allows the FDA to implement pedigree requirements.

The lawsuit, filed by several secondary wholesalers, has to do with whether a drug's pedigree must extend back to the manufacturer or only to the most recent "authorized distributor of record". The plaintiffs claim that having to trace drugs back to the manufacturer would effectively put them out of business. The FDA has appealed the decision.

"We view the effort to implement widespread use of electronic pedigrees as somewhat separate from the PDMA," says Ilisa Bernstein, the FDA's director of pharmacy affairs. "What [the lawsuit] does affect is the information that's on the pedigrees that are required to be passed today."

At the same time, however, the FDA pushed back its December 2006 target date for when electronic pedigrees must be implemented. "Back in 2003 and 2004, wholesalers, pharmacies and manufacturers told us 'RFID is promising; we're going to have widespread use of track and trace by 2007'," Bernstein says. Now, the FDA is leaving it up to private industry to say when e-pedigrees will be fully implemented.

Meanwhile, several US states have taken matters into their own hands. Carmen Catizone, executive director of the US National Association of Boards of Pharmacies, is watching three states in particular:

California has passed a law requiring electronic pedigrees, using RFID technology, beginning in 2008. Catizone says that the law has run into serious resistance, due to industry complaints that the technology is not ready and also is too expensive.

Florida has passed a law that requires paper or electronic pedigrees for all prescription drugs. However, Catizone says, it applies only to secondary wholesalers rather than the main supply chains.

Oklahoma has passed legislation involving drug pedigrees but is just starting a task force that will decide how to implement the law.