Will the road get bumpy for counterfeiters? And for you?

By Eric Greenberg, Attorney-at-Law on December 31, 2005

Watch out: The U.S. Food & Drug Administration thinks that the voluntary approach to implementing radio frequency identification (RFID) for drug packaging is moving too slowly. If voluntary steps don't work, mandatory ones might be next.

This is just one of several recent developments in the realm of threats to drug product integrity.

The problem of drug counterfeiting is perhaps the greatest current threat to the drug marketplace. Aspects of the issue have been discussed here in the past (see, for example, PD, April '04, p. 22).

More and more consumers are shopping for prescription drugs and dietary supplements online, driven by the search for lower prices or by the perceived lack of available therapies in the U.S. The drug distribution system in the U.S. is already complex—many hands touch most of the drugs between the manufacturer and consumer, and FDA says that multiplies the opportunities for counterfeits to get into the distribution stream. These online orders add another potential source of introduction of counterfeits.

As FDA has correctly noted, a range of packaging technologies, like latent codes and inks, holograms, bar codes and RFID, can work well to thwart counterfeiters and limit the effects of their nefarious actions. Technologies that allow manufacturers and distributors to confirm the authenticity of a particular product or package, and to track their movements, will be increasingly important to combat counterfeiting.

In November, FDA associate commissioner Randall Lutter, Ph.D., told a conference audience that when the agency had decided to allow industry to continue its steps to implement RFID as a method of "electronic track and trace," it had expected that market trends already in place would be sufficiently established by 2007 to make mandatory requirements unnecessary.

The 2007 date was relevant because FDA had decided to stay, or hold off on, its regulations fleshing out the requirement for drug "pedigree" recordkeeping under the 1988 Prescription Drug Marketing Act until the end of 2006. FDA figures that the electronic pedigree will more than meet the requirements of the law.

And the drug counterfeiting problem, while still evidently a bigger concern in other nations, is not going away by itself—not hardly. In keeping with the tendency of counterfeiters to pick on the big-name, big-sale drugs, sure enough, some counterfeit bird-flu drug was discovered and seized by customs agents in San Francisco in November. Labeled as generic Tamiflu, the counterfeit product was grabbed up as someone was trying to send it into the U.S. The seized product reportedly had none of the active ingredient of Tamiflu.

The fake Tamiflu, however, is a completely different problem than products making phony claims of effectiveness against bird flu, something that at least nine companies allegedly have been doing recently. FDA hit all of them with Warning Letters. Eight of the products were ostensibly dietary supplements (though their claims of effect on disease rendered them drugs). The fact that consumers are relying on these unproven products "increases the risk of catching and spreading the flu rather than lessening it because people assume they are protected and safe, and they aren't," notes acting FDA commissioner Andrew von Eschenbach, MD.

A further, different problem is the apparently false "Canadian" drugs being ordered online by consumers. An FDA investigation found that many of the drugs that consumers recently bought online, thinking they were from Canada—which many people consider an indicator of reliability when making such purchases—were actually from other countries.

FDA urges caution to any consumer ordering drugs or other medical products online. Many online pharmacies are legitimate and offer convenience, related services and, often, good prices. FDA warns that imported drugs ordered online present additional questions, since they may not be approved by FDA or may not have been made, labeled or distributed in accordance with FDA requirements.

For example, an FDA release says, "Of the drugs being promoted as 'Canadian,' based on accompanying documentation, 85 percent actually came from 27 countries around the globe." FDA examined incoming parcels at three U.S. airports. The parcels came from India, Israel, Costa Rica and Vanuatu (a South Pacific island nation). Out of about 4,000 parcels, nearly 1,700 had been ordered from so-called Canadian Internet pharmacies. These drugs were said to be from Canada, but only 15 percent of them turned out to be from that country. Many of the products lacked proper English-language labeling. What's more, some of these products were counterfeit.

Because FDA's Counterfeit Drug Task Force identified RFID as a technology with unique promise to attack the problem, the agency is planning some steps to help speed the progress of the technology into the marketplace. It will hold workshops for the public in early 2006 aimed at helping industry efforts to set standards for RFID technologies and discuss pedigree issues generally.

The push and facilitation these meetings provide might aid in the further development of RFID for drug packaging in the next year. This could help the industry avoid the unpleasant prospect of an FDA-ordered implementation. The counterfeiting problem does not appear to be going away, so the pressure for these measures cannot be expected to lessen, either.

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