FDA Official Talks RFID at HCPC Showcase

Steve Niedelman, FDA’s assistant commisioner for regulatory affairs, speaks about RFID’s role in fighting counterfeit drugs at this year’s HCPC Showcase.

Radio-frequency identification (RFID) is the cornerstone of FDA’s plan to fight counterfeit drugs, the agency’s assistant commissioner for regulatory affairs told attendees at the Healthcare Compliance Packaging Council Showcase, September 14–15, 2004. Speaking at the conference, which took place at the Honeywell Learning Center (Morristown, NJ), FDA’s Steve Niedelman also said the agency intends to closely monitor and facilitate RFID adoption.

“Counterfeiting represents nothing short of an assault on the drug industry and the general public,” said Niedelman. He also noted that FDA’s counterfeit investigations now number more than 20 per year.

Niedelman also pointed out that better counterfeit technology, more-organized criminals, the on-line sale of prescription drugs, and weak spots in the distribution chain have all played a role in the increase in incidents.

Speaking about FDA’s Counterfeit Drug Task Force report, Niedelman reiterated the agency’s stance that there is no magic bullet in the fight against counterfeiting. “We believe RFID will play an important role, however,” he said. He also maintained that the agency believes widespread adoption of RFID is feasible by 2007.

Niedelman also outlined FDA’s plan for the next three years, which he said will include adoption of model rules for state licensure of wholesale distributors and more-widespread international collaboration on anticounterfeiting. Within the next year, Niedelman reported, the agency expects to increase its inspection frequency for repackagers. It will also issue a guidance on physical facility security.

In addition, he said that FDA will:

• Work with sponsors and participants of pilot studies on issues like labeling.
• Request that the U.S. Sentencing Commission increase criminal penalties for counterfeiters. Niedelman noted that counterfeiting a label is subject to a 10-year maximum jail sentence, while counterfeiting the drug itself is subject to only a three-year sentence.
• Strengthen its collaboration with industry to more rapidly identify and respond to counterfeits.
• Create a Counterfeit Alert Network. The agency is currently in the middle of a nationwide Public Service Announcement series of print ads.
• Work with WHO, Interpol, and others to create international standards for RFID use.

Near the end of his keynote address, Niedelman suggested that unit-of-use packaging does not create a high enough hurdle to deter counterfeiters. And there are added costs associated with this form of packaging, he said.

Also presenting at the conference were representatives from Alcan Packaging, Alcoa Flexible Packaging, Anderson Packaging, Caraustar, Car-dinal Health, Honeywell, Howell Packaging, Hueck Foils, Klöckner Pentaplast, MeadWestvaco, Reed-Lane, Sharp Corp., SolVin, and Uhlmann Packaging Systems. All of the companies spoke about new developments in compliance packaging, with a special emphasis on RFID and other anticounterfeiting solutions.

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