Industry concerns and challenges
Despite the growing number of counterfeits, there is confusion in industry over how, when, and even whether to implement anticounterfeiting and supply-chain security measures. This hesitation likely stems from several factors such as a low awareness of risks, the costs of deployment, and the lack of industry standards for implementing these measures. An incomplete understanding of counterfeiting risk or a reluctance to admit a problem could be a barrier in some instances, says Carla Reed, principle of the consulting group New Creed. "Part of the solution in any case is acknowledging the problem," she says. "Companies need to be proactive rather than reactive."In many cases, early adopters of anticounterfeiting solutions did so because there was a counterfeiting problem. For example, Pfizer's (New York) problems with counterfeiters copying Viagra (sildenafil citrate) and Purdue Pharma's (Stamford, CT) similar issues with its painkiller OxyContin (oxycodone hydrochloride) led the companies to implement radio-frequency identification (RFID) to track those drugs through the supply chain.
Another roadblock for industry could be the lack of standards when it comes to measures such as serialization and electronic pedigree (ePedigree) requirements. From state to state in the US and in countries throughout the world, different requirements exist. The ability to closely trace products can prevent diversion and the introduction of counterfeit products into the supply chain, but technological details and best practices of how to achieve this are a work in progress for state and federal regulators.
Among the public comments on the draft guidance is input from pharmaceutical companies such as Endo Pharmaceuticals (Chadds Ford, PA), Hoffman–La Roche (Basel), Talecris Biotherapeutics Research Triangle Park, NC), Novo Nordisk (Bagsvaerd, Denmark), as well as the California State Board of Pharmacy, the Parenteral Drug Association, the Generic Pharmaceutical Association, the Biotechnology Industry Organization, and the supply-chain standards organization GS1 (2). A key concern is that FDA's recommended 8-digit SNI is too small, and that GS1's standard identifier Global Trade Item Number (GTIN), which is already in use by industry, should be adopted. In its comments, GS1 states that the GTIN is currently used to identify pharmaceutical products in 65 countries worldwide.
Some comments applauded the draft guidance for being technology neutral in terms of the data carrier used to comply, but California's board of pharmacy urged FDA to designate a data carrier, specifically, the use of RFID. Bikash Chatterjee, president and chief technology officer of the consultancy Pharmatech Associates, supports FDA's stance of not endorsing a specific technology.