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.
The Pharmaceutical Distribution Security Alliance (PDSA), backed by manufacturers and wholesalers, instead supports the RxTEC
model that calls for manufacturers to establish data systems that hold individual drug unit serial numbers. While PDSA claims
this system could help regulatory authorities validate products, detect counterfeits, and manage drug recalls and returns,
Coukell objected that because the thousands of bottles in a lot may travel through multiple distributors, the tracking system
needs to link unit serial numbers to shipping cases in order to know where a black-market vendor obtained illegal goods.
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.
1. C. Weaver and J. Whalen, Wall Street Jour. (July 20, 2012).