Originally Published PMPN October
2004
NEWS
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.
Copyright ©2004 Pharmaceutical & Medical Packaging News
