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GCN Home > 12/11/06 issue

FDA forces the issue on drug tracking

Agency orders use of electronic system to fight counterfeit prescriptions

By Mary Mosquera, GCN Staff

After nearly 20 years of gently prodding the pharmaceutical industry to adopt electronic track-and-trace technology, the Food and Drug Administration has decided to push.

As drug counterfeiting becomes more sophisticated and prevalent, FDA officials are requiring once and for all that distributors ensure the prescription drugs they sell are tracked throughout the supply chain, using documentation that could include radio frequency identification tags.

Electronic or paper documentation establishes a pedigree to protect consumers and industry against prescription drug counterfeiting.

“Industry needs to pick up the speed in implementing electronic pedigrees and the track-and-trace technologies to facilitate them,” said FDA acting commissioner Andrew von Eschenbach at a recent RFID in Health Care Industry Adoption Summit in Washington. “This would allow tracking drugs from the assembly line to the dispenser by being able to replace the paper pedigree with an electronic version that cannot be easily forged or tampered with.”

Distributors document the authenticity of their product and transaction history to each customer, who then appends his data for the next customer, and so on, all the way to the retail pharmacy or hospital.

Promising technology

Electronic pedigree built on radio frequency identification is the most promising technology and will provide a far more effective safety net than paper, von Eschenbach said.

FDA, an agency of the Health and Human Services Department, now requires a paper or electronic pedigree under the Prescription Drug Marketing Act enacted in 1988 because industry has dragged its feet on a voluntary pedigree. But under recent guidance, the rule took effect Dec. 1.

The agency delayed the pedigree provision for several years because it expected the technology to be in wide use by 2007. That didn’t happen. “FDA can no longer indefinitely delay having pedigrees,” von Eschenbach said.

Drug counterfeiting is growing and the perpetrators are becoming increasingly sophisticated, technically proficient and well-financed, he said.

Counterfeiters are targeting the U.S. market because that’s where the market value of the drugs is the highest, said Paul Chang, RFID lead executive for IBM’s Software Group in Baltimore.

FDA said in its compliance guidance that it would focus initial enforcement efforts on the drugs most susceptible to counterfeiting and diversion, those that are expensive and common.

To create a paper pedigree currently, drug wholesalers use batch or shipment information, much of it gathered manually or taken from other systems, Chang said. RFID would capture the product data automatically.

More news on related topics: Authentication / Identity Management, Health IT, IT Management



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