Protecting the Supply Chain
Be aware of your product and your supply chain. Be very aware. That was the advice from many of the speakers who gathered at The Supply Chain Integrity conference in Washington, DC, September 25–26. Almost in sync with the release of FDA’s interim report on anticounterfeiting measures, the event gave attendees a real idea of the threats facing manufacturers, and offered real solutions.
Benjamin England, former regulatory counsel to the associate commissioner for regulatory affairs of FDA’s Office of Regulatory Affairs, gave one keynote speech. He acknowledged that while FDA has always focused on product risk, it has usually been risk associated with the environment in which a product was made. But the agency is now focusing on external risks, he says, and it needs industry’s help in developing programs to combat counterfeiting.
England also suggested that manufacturers take a threefold approach to protecting their products. “Become aware of the risks . . . with your product throughout your product’s life cycle. Build security into your product or supply chains from the ground up, monitor your security measures, and challenge your own systems. And form partnerships to accomplish antiterrorism initiatives.” He added that “industry should be able to expect a reduction in regulatory burden for reducing risk that the government otherwise has to monitor, mitigate, and manage.”
Geoff Power and John Dempsey spoke about responding to instances of counterfeiting and preventing future ones. Power is director of packaging security for GlaxoSmithKline, and Dempsey is executive director, trade relations and brand security, for Ortho Biotech. Power pointed out the usefulness of covert and overt markers in packaging. “Security print design is a very effective way of producing imaginative pack designs incorporating a wide range of covert and semiovert measures, approaching the style of banknote designs,” he explained.
Eshetu Wondemagegnehu from the World Health Organization’s Quality Assurance and Safety of Medicines, Essential Drugs, and Medicines Policy gave another keynote address. He pointed out that holograms and blister packages are being counterfeited around the world. He compared pictures of the real and fake packages to demonstrate counterfeiters’ capability. He also showed pictures of real and fake Viagra, demonstrating that counterfeiters are even copying tablet impressions. To counter such threats, Wondemagegnehu urged governments to pay closer attention to supply chains, to regulate Internet drug trade, and to educate the public on the risks of purchasing drugs from unauthorized parties. Finally, “we must promote cooperation among manufacturers, distributors, health professionals, civil societies, and other stakeholders to combat counterfeiting,” he said.
In addition to sophisticated packaging and printing, RFID was put forth as another solution. Pat Rizzoto, vice president of global customer initiatives at Johnson & Johnson; Chris Hook, director of Zebra Technologies; and George Wright IV, vice president of Product Identification & Processing Systems Inc., showed how RFID and electronic product codes can facilitate inventory management and fulfillment as well as deter counterfeiting.
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