For Product Security, FDA Needed as a Partner, not a Regulator

Some in industry are asking FDA to take regulatory action against product counterfeiting and diversion. "Just as FDA has very strict regulations on everything from the raw materials to the manufacturing processes associated with pharmaceuticals, the agency should expand its role to focus on closing the loop between the manufactured product and the consumer, focusing on secured packaging as well," argues Adam Scheer, vice president of corporate development for American Bank Note Holographics (Elmsford, NY).

FDA should get involved—but not through regulation.

As you will read in this month's special feature on security packaging, "Securing Your Product through Packaging," which begins on page 44, several techniques can help firms mark product for tracking, tracing, and proving authenticity. Whether it's a hologram, an electronic article surveillance tag, or a covert or overt printing method, each of these techniques offers distinct benefits, and some may be better suited to certain products than others. Most importantly, they can be customized and updated as often as a manufacturer needs, and they can be layered to provide multiple protections.

But if FDA were to require drug makers to use any or all of these technologies, the agency would rob companies of the flexibility they currently have to adopt and drop techniques as needed. Such agility is often needed to fool nimble pirates. For instance, to trip up counterfeiters, manufacturers can print intentional errors in noncritical labeling areas or vary fonts and other elements, and these methods may be too subtle to meet any regulation. And even if a company were to adopt a sophisticated technique like holography, it should be able to evolve its use as its needs change without seeking regulatory approval.

Companies may even wish to rely on inspection rather than packaging. Analytical Spectral Devices (Boulder, CO) offers the QualitySpec TI near-infrared (NIR) inspection system, which is typically used to verify tablet placement on blister packaging lines before package sealing. A recent experiment showed that the system could distinguish the chemical composition of Tylenol from that of sugar tablets through a blister. "It would be very easy to see a counterfeit drug without opening the product," explains John Enterline, director of sales and marketing. "The other advantage of NIR technology is that it can show moisture gain in a product. This would show that a product has not been stored properly or that the wrong packaging material was used to keep moisture out," factors that are sometimes the result of unauthorized distribution or counterfeit manufacturing in a humid climate.

FDA seems to agree that drug makers need the freedom to choose security techniques that best suit their products. Benjamin England, FDA's regulatory counsel to the associate commissioner for regulatory affairs, has already taken steps toward forging an agency-industry working group. The group's goal will be to devise voluntary guidelines for incorporating anticounterfeiting, antidiversion, and antitampering elements into packaging. The agency plans to announce the working group in the Federal Register this winter. "We need to build security and tampering controls into the product itself," England says. To do so, "we need FDA and industry to work together to gather information."

FDA has already started some of the research. The agency has invited in different "groups that offer complex solutions for distribution and inventory control," such as bar coding systems, radio-frequency identification systems, and technologies such as x-ray and NIR to identify the drug without opening packaging. To combat security risks, "the layering of systems is necessary," England explains.

"The agency does a great job up until the packaging," says Scheer. "But after the packaging, they really leave it totally up to the pharmaceutical companies." Regulations would certainly force firms to put security elements like holograms to work. And if such elements were in wider use, counterfeiters and diverters would have a much harder job. However, requiring every drug manufacturer to follow a cookie-cutter approach to product security ignores unique product requirements, and it may even tip off criminals on what to copy or remove. Rather than regulate, FDA should communicate with industry. Fortunately, FDA's England is working to encourage that dialogue.

Daphne Allen, Editor

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