FDA Raises the Stakes

Like the rest of the pharmaceutical industry, Pfizer must react to FDA guidance issued June 9 that speeds the adoption of track-and-trace technology—ultimately these will be radio-frequency identification (RFID) systems—in the nation's drug-supply chain. RFID tags on medicine packages emit a unique radio signal that, unlike a bar code, can be read in bulk by electronic readers, greatly reducing the time it takes to register the arrival or departure of individual packages within a large shipment of product. Whole lots can be read on pallets without being unpacked. By checking that every package carries a unique number, the system authenticates that each package in the shipment is the same as the one that left the manufacturer's facility on a certain date.

The June 9 report by the FDA Counterfeit Drug Task Force warns "that the US drug supply chain is increasingly vulnerable to a variety of increasingly sophisticated threats." In response, FDA will begin requiring distributors who have not been appointed "authorized distributors of record" (ADRs) by a manufacturer to maintain pedigree records that track the history of a drug's buyers and sellers on the way from the manufacturer to the consumer. But in the immediate future, at least, companies will not be safeguarding their supply chain using radio-frequency tags.

"RFID is not ready for prime time anywhere," said Pfizer CEO Hank McKinnell in an interview four days before the new FDA guidance was released. "Certainly not in the United States. In the United States, we sell, in many cases, bulk bottles to pharmacists, who compound and give you a new container. There is no way an RFID gives you end-to-end control of the product. It does give you control [up] to the first person you ship to. But if that person subdivides, or the pharmacist subdivides, you've lost control."

Outside the United States, McKinnell said, drugs are usually delivered to the consumer in a unit-of-use pack. "So when you buy one of our products in the pharmacy," he said, "you're given a sealed package. Which conceptually could have an RFID in it that traces it all the way from our factory to that pharmacy to you."

After staying the rules on pedigrees for nearly six years, FDA announced that it will begin to enforce them in December. The agency picked that date because "we were informed by stakeholders in the US drug supply chain that industry would adopt electronic track and trace technology by 2007...that could create a de facto e-pedigree," but that didn't happen, the report said.

In fact, the immediate solution is likely to be paper pedigrees or tracking by lot with bar codes. Recognizing the industry's technical shortcomings, the counterfeiting task force also recommended that FDA issue a draft compliance policy guide (CPG) for public comment by December to focus FDA's pedigree enforcement efforts on drugs most vulnerable to counterfeiting and diversions. FDA's acting commissioner Andrew von Eschenbach endorsed these measures at the time the report was issued.

"Our position as a company," says Peggy Staver, director, trade product integrity at Pfizer, "has been that we don't feel there's any one solution to address counterfeiting and supply chain integrity. It requires a multifaceted approach, if you will. So we have been enhancing business practices as well as addressing regulatory and legislative needs, and pushing for stronger enforcement and tougher penalties for those who manufacture, sell or distribute counterfeit products. So technology is just one aspect of this comprehensive strategy."

In fact, Pfizer is ahead of the game. Staver dates the company's strong interest in RFID technology to the 2003 case involving counterfeit Lipitor. That very public case involving a major brand spurred Pfizer to participate in early FDA pilot programs. At a cost of approximately $5 million, Pfizer put RFID tags on bottles, cases, and pallets of another important brand. Viagra is a strong candidate to be on FDA's list of easily counterfeited drugs, when the CPG is issued. Of course, not all distributors can track and trace products with RFID yet.

"Even where we have unit-of-use packaging," McKinnell pointed out, "we don't have the scanners and the standards in the pharmacy and in the distribution system. I think RFID is the ultimate answer, but it is a number of years away." Asked how many years, McKinnell ended the interview with a single word: "Five."