High-tech drug tracking slower than hoped, US says

Last Updated: 2006-06-09 14:14:10 -0400 (Reuters Health)

WASHINGTON (Reuters) - Widespread use of tiny radio transmitters on prescription drug bottles to track shipments and thwart counterfeiters will not occur by 2007 as previously hoped, U.S. regulators said on Friday.

The Food and Drug Administration has encouraged drug makers, wholesalers and distributors to implement electronic tracking systems with radio frequency identification, or RFID, technology, but stopped short of requiring it.

When health officials announced the efforts in 2004, they said companies had told them widespread adoption was feasible by 2007.

"Unfortunately this goal most likely will not be met," Steve Niedelman, FDA assistant commissioner for regulatory affairs, told reporters.

FDA officials said they could not say when the technology would be prevalent across the prescription drug supply chain.

They said they were taking steps to speed the adoption of RFID or other ways of tracing prescription drugs from the manufacturer to wholesalers and pharmacies.

Starting in December, the agency will require wholesalers to provide a "pedigree" showing a record of the drug's movements along the supply chain.

The pedigree requirements were postponed several times previously after small wholesalers in the so-called "secondary market" objected. Drugs may pass through several secondary sellers before reaching drug stores.

"This new paper trail will provide additional protection and certainty to the supply chain," said Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America.

McKesson Corp., Cardinal Health Inc., AmerisourceBergen Corp. and other major wholesalers that get medications directly from manufacturers will be exempt from the requirements.

Prescription drug counterfeits are rare but appear to be growing in frequency and sophistication, FDA officials said.

In recent years, authorities have uncovered fake versions of Pfizer Inc.'s Viagra and Lipitor, Johnson & Johnson's anemia drug Procrit and other widely used medicines.