FDA to Enforce Drug Pedigree Rule BETHESDA, MD, 09 June 2006 — Two decades after Congress passed legislation to help stop counterfeit, adulterated, misbranded, and expired drugs from entering the U.S. supply chain, drug regulators on December 1 will fully implement the Prescription Drug Marketing Act (PDMA) of 1987, officials announced today. FDA had five times delayed the date for when it would enforce a provision in PDMA that requires wholesale distributors to provide documentation of the chain of custody of drug products throughout the distribution system—a pedigree. Enforcement of the pedigree regulation was originally scheduled to take effect in December 2000. Regulators in February 2004—the last time FDA stayed the enforcement date of the pedigree requirement—said that the drug industry needed more time to adopt electronic technology for tracking drugs through the supply chain. FDA declared in a 2004 report that track-and-trace technologies, such as radiofrequency identification (RFID), would be in widespread use in the drug supply chain by 2007. Agency officials contended that if widely adopted, RFID could create a de facto electronic pedigree that would document the sale of a drug product from the place of manufacture through the U.S. drug supply chain to the final dispenser. However, this past February, FDA admitted that the 2007 prediction might have been too optimistic. In a report issued today, FDA's Counterfeit Drug Task Force said that the agency would not issue a new forecast or target date for the widespread adoption of electronic pedigrees "because we do not have enough information to do so at this time." The task force recommended that FDA continue to work with the drug industry to develop a timeframe for widespread use of an electronic pedigree, adding that members of the drug supply chain should be able to implement the necessary technology "in the very near future." "We're hoping that industry will continue to move forward with some speed to get the e-pedigree in place as quickly as possible," Steve Niedelman, assistant commissioner of regulatory affairs at FDA, said today during a media telebriefing. FDA continues to believe that RFID is the "most promising" technology for tracking and tracing drugs in the supply chain, said Randall Lutter, FDA's associate commissioner for policy and planning. The task force mentioned that other technologies, such as two-dimensional bar codes, should also be considered. Lutter admitted that FDA is unaware of any instance when a counterfeit drug was stopped from entering the supply chain through a company's use of RFID or other track-and-trace technology. Officials said that wholesalers would be required to keep paper pedigrees until electronic pedigrees are widely adopted. Regulators acknowledged that there has been much confusion as to who must pass on a pedigree. Authorized distributors of record (ADRs)—those companies that generally buy prescription drugs directly from the manufacturer—are not required to pass on pedigree information to the next buyer. Secondary wholesale distributors—companies that generally buy prescription drug products from other wholesalers rather than from the manufacturers—have argued that because ADRs are not required to provide pedigree information, companies that do business with ADRs are not able to meet PDMA's requirements. Many counterfeit drug products have entered the distribution chain through secondary wholesalers that obtained products without complete pedigrees listing all transactions, the task force maintained. Lifting the stay on the pedigree provision, Lutter said, will "clarify for stakeholders who is and who is not" required to pass on a pedigree. However, he did not address how secondary wholesalers would continue to operate without receiving pedigrees from ADRs. FDA today also issued a draft compliance policy guide to clarify for regulators and the drug industry how the agency intends to prioritize its enforcement of the pedigree requirements over the next year. The guide describes a "phased-in" approach for enforcing the pedigree provision. Regulators plan to focus enforcement efforts on expensive drugs, medications that are in short supply or high demand, and drugs that have a history or a reasonable probability of being counterfeited or diverted, Niedelman explained. "By providing guidance on the types of drugs that are currently of greatest concern to FDA, we believe that wholesale distributors will have a better idea of where and how to focus their initial energies as they implement systems to come into complete compliance" with PDMA, the guide states. "We are glad to see that FDA decided not to extend the stay of the regulation, and we believe that the compliance policy guide is a good step in the right direction in targeting counterfeit drugs," said Gary Stein, director of federal regulatory affairs at the American Society of Health-System Pharmacists. Lutter noted that counterfeit drugs have rarely made it into the U.S. drug supply. FDA's Office of Criminal Investigation initiated 32 new counterfeit drug cases in 2005, he said. But, Lutter said, that is a "significant" increase from the average 10 cases per year that FDA investigated in the 1990s. —Donna Young |
