Pfizer Voices Support for FDA's Anti-Counterfeiting Report

NEW YORK--()--Pfizer said today it supports the FDA's Anti-Counterfeiting Report, a series of proposals to combat the growing problem of pharmaceutical counterfeiting. The report-which focuses on eight areas including the pharmaceutical distribution system, governmental oversight of wholesalers through the licensing process, and track-and-trace technology-is the result of several months of deliberation by the agency's Anti-Counterfeit Drug Initiative.

"We share the FDA's deep concern that patient health is put at risk by counterfeit medicines and we strongly believe that the time to act is now," said John Theriault, vice president of global security for Pfizer. "While there is no single solution to the counterfeiting problem, the proposals highlighted in this report will help achieve the overall goal of guaranteeing that prescription medications are both safe and effective."

Pfizer said track-and-trace technology, which received significant attention in the report, has the potential to become the cornerstone of future anti-counterfeiting efforts. "But this technology alone won't be the solution, particularly in the short term," Theriault pointed out. He said the industry needs the multi-faceted approach recommended by the FDA to guarantee the integrity of the pharmaceutical distribution system.

To that end, Pfizer supports a more coordinated effort on the part of manufacturers, wholesalers and dispensers to better track medicines through distribution channels to customers. State governments also play an important role in establishing tighter licensing controls for wholesalers and distributors, Pfizer said. Criminal penalties are needed to appropriately punish those who are convicted of counterfeiting, or who fail to follow regulatory procedures that aim to inhibit the flow of counterfeits.

Pfizer is taking a number of steps to discourage the counterfeiting of its products, including the recent modification of its terms-of-sale agreement to require Pfizer-authorized wholesale customers to purchase the company's products directly from Pfizer or other Pfizer-authorized wholesalers.

Pfizer also is a member of an industry group that will assess the value of radio frequency identification (RIFD) technology and the track-and-trace concept. The company incorporates a number of anti-counterfeiting technologies into its products and packages and works closely with the FDA and other government and law enforcement agencies globally to investigate and address counterfeiting activities.

Pfizer monitors a number of Internet web sites that offer Pfizer medicines-or potentially counterfeit versions of those medicines-as part of its anti-counterfeiting efforts. The company also has established a companywide product integrity team to evaluate and recommend solutions to counterfeiting and other potential threats to its products.

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