Track and trace on hold

FDA believes that the best way to keep counterfeit, diverted, and adulterated drugs out of the US supply chain is to establish a comprehensive drug track-and-trace system that can account for legitimate products at every step in the distribution process. In testimony last March before the House Energy & Commerce Health subcommittee, Janet Woodcock, director of the FDA Center for Drug Evaluation and Research (CDER), emphasized the need for a system that can provide complete records on all parties involved in distribution after a product leaves the manufacturer. FDA can set standards for drug identification and authentication, as seen in recent guidance for manufacturers to implement standardized numerical identification for prescription drug packages, Woodcock explained. But the agency lacks explicit authority to require implementation of a national tracking system throughout the supply chain. Without such a system, added Allan Coukell of the Pew Charitable Trusts' Pew Health Group, there is no way to check whether an individual vial or bottle is authentic or fake.

Industry opposes such an approach as unworkable and too costly and blocked it from inclusion in the FDA Safety & Innovation Act (FDASIA) approved by Congress in June. Manufacturers claim that the technology to support a fully electronic tracking system is unreliable, and that establishing such capabilities would raise the cost of medicines by billions of dollars. Pharmacists, moreover, protested having to check the authenticity of every drug unit coming in from wholesalers and distributors.

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The Senate proposed to include the RxTEC proposal in its initial version of FDASIA, but the House did not agree, and pressure to approve a final bill by the end of June prompted the legislators to drop the issue. Instead, FDASIA contains important provisions that can help block the import of violative products and imposes stiffer penalties on counterfeiters. FDASIA allows FDA to destroy certain counterfeit or adulterated imports instead of having to return them to sender and strengthens requirements for manufacturers to notify FDA of stolen products or evidence of counterfeiting. Trafficking in counterfeit drugs was made a criminal offense, and persons who knowingly and intentionally produce counterfeits or sell them would face fines up to $4 million and 20 years in jail.

These added authorities can help FDA uncover and prosecute drug counterfeiters, now a task for the Office of Drug Security, Integrity and Recalls (ODSIR) in CDER's Office of Compliance. FDA also continues to encourage manufacturers to incorporate physical-chemical identifiers into drug products, as seen in a guidance issued in October 2011 that describes considerations for adopting such formulations for solid oral dosage forms.

Agency officials continue to press for a more comprehensive drug-tracking system, while also seeking additional opportunities to collaborate with other government agencies and international organizations to combat counterfeiters. FDA works with the Commerce Department anti-counterfeiting task force and federal law enforcement and customs agencies, as well as with the World Health Organization, to build global capacity for monitoring supply-chain threats. The agency participated in an INTERPOL-led exercise to target websites supplying illegal and dangerous drugs.

A report from the Institute of Medicine due in 2013 will outline further anticounterfeiting proposals for collective action among regulatory authorities, along with actions that the experts feel that industry should address. FDA Commissioner Margaret Hamburg will discuss these and other efforts to combat drug counterfeiting at the annual Partnership for Safe Medicines Interchange at the end of this month. All parties will be looking for effective and affordable strategies for improving drug tracking through the supply chain and for distinguishing genuine from adulterated medical products.

Reference

1. C. Weaver and J. Whalen, Wall Street Jour. (July 20, 2012).