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FDA Growing Impatient With Big Pharma's RFID Efforts

The pharmaceutical industry isn't moving very fast to adopt radio frequency identification technology to combat drug counterfeiting. And the U.S. Food and Drug Administration is about to apply some pressure to speed things up. The FDA's Counterfeit Drug Task Force is due to issue a report by the end of the month on whether drug manufacturers should be required to have a system in place that ensures a drug's pedigree by tracking it from its manufacturer, through wholesalers and distributors, to its sale by retail pharmacies. There are indications the report will be critical of the industry's cautious approach to RFID--if it doesn't set an outright deadline.

While the Prescription Drug Marketing Act of 1987 required implementation of a drug track-and-trace program, the FDA has postponed that requirement in the face of complaints from drug makers and wholesalers that a paper-based system would be unworkable. But in a 2004 report, the FDA said RFID appeared to be the answer and suggested such a system could be in place by 2007. In November 2004, the FDA even issued a policy guide to assist drug makers with RFID implementations.

Since then there have been some high-visibility RFID pilot projects, including Pfizer's placement of RFID tags on bottles of Viagra and Purdue's use of the technology to track bottles of its OxyContin painkiller. But there have been hints the FDA doesn't consider that enough, including comments by FDA officials at a public anti-drug counterfeiting workshop earlier this year that progress has been disappointing. Questions over who will pay the costs of the RFID systems and who would own the transaction data are among the hurdles to broader adoption.

Among those hearing that the upcoming report could call for faster RFID implementation is Paul Chang, who manages RFID initiatives for life sciences within IBM Business Consulting Services. Count him among those who think RFID has matured and that a stronger mandate from the FDA will provide the needed impetus for companies up and down the pharmaceutical supply chain to pick up the pace.

Big Pharma may be running out of excuses.

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