FDA To Require Drug Makers To Adopt Supply-Chain Tracking System

In a move likely to accelerate the adoption of radio frequency identification technology by the pharmaceutical industry, the U.S. Food and Drug Administration will require that drug makers document the chain of custody of prescription drug products that go through their distribution systems.

But in a report released late last week, the FDA stopped short of mandating that pharmaceutical companies implement RFID. The report, developed by the agency's Counterfeit Drug Task Force, said the FDA had expected RFID to be in widespread use by 2007, but that it now appears those expectations were too optimistic.

While the Prescription Drug Marketing Act of 1987 required implementation of a drug track-and-trace or "pedigree" system, the FDA has repeatedly put that requirement on hold because of complaints from drug makers and wholesalers that a paper-based system would be unworkable. In a 2004 report the FDA said electronic technology—including RFID—for tracking drug shipments appeared to be the answer.

"Based on information from drug supply stakeholders, the FDA had expected this technology to be in widespread use in the drug supply chain by 2007, but it now appears that these expectations will not be met," the agency said in a statement.

The FDA says it can no longer justify maintaining the hold on the drug-pedigree regulations and will allow the hold to expire in December. During the next year the agency will focus it's pedigree enforcement efforts on drugs most susceptible to counterfeiting and diversion. A draft compliance policy spelling out just how the drug-pedigree tracking requirements will be enforced will be published in the "Federal Register" in the near future.

"The task force report also underlines the agency's belief that widespread use of e-pedigrees using electronic track-and-trace technology, including RFID, would provide an electronic safety net for our nation's drug supply," the FDA statement said.

There are several RFID pilot projects underway in the pharmaceutical industry, including Pfizer putting RFID tags on bottles of Viagra and Purdue using the technology to track bottles of its OxyContin painkiller. But beyond those high-visibility programs, adoption of RFID by drug makers has been slow. Questions over who will pay the costs of RFID systems and who would own the transaction data are seen as hurdles to broader adoption.