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FDA to Battle Counterfeiting in Multipronged Attack

Donna Young

There is no single "magic bullet" to stop the growing number of drug counterfeiters, an FDA task force concluded in an interim report released today by the agency.

John M. Taylor III, associate commissioner for regulatory affairs at FDA and cochair of the task force, said the agency has rejected a "one-size-fits-all" strategy as a way to protect the nation's drug supply and is developing a multipronged approach that, he said, would make it more difficult for counterfeiters to introduce misbranded or adulterated drug products into the medicine distribution system.

The interim report is a follow-up to the agency's initiative announced in July to combat counterfeit drugs, Taylor said.

FDA has seen an increase in recent years of the number of criminal investigations involving counterfeit drugs—from an annual average of five in the 1990s to more than 20 last year.

In its report, the task force has outlined "potential options" that should be used to "stimulate further discussion and critiques, and to support the development of clear proposals that are likely to succeed."

FDA plans to continue its discussion at an Oct. 15 public meeting in Bethesda, Md., and has invited drug manufacturers, wholesalers, repackaging companies, trade associations, and the public to offer comment and suggestions for the agency to consider for its final report, due to be released in January 2004, Taylor said.

FDA has also invited vendors, such as makers of radio frequency identification (RFID) technology, to display products that could be used to make it easier to spot counterfeit drugs.

Taylor said that FDA has examined several new technologies and methods that could be used in the future to protect the integrity of drug products and packaging, but he considered many of those as "promising ideas" that are not fully developed.

The agency, he said, is relying on the public and industry to provide broad comment at the October meeting to help guide FDA in developing its strategy to curb counterfeiting of pharmaceuticals.

The timing of FDA's initiative and release of its interim report is unrelated to the reimportation legislation that Congressional negotiators are considering as part of the Medicare reform bill, Taylor said.

They are "two separate and distinct issues," he said. "What we are focused on here is protecting the domestic marketplace [and] ensuring American consumers still have a high level of confidence in the products that they purchase from their neighborhood pharmacies," he said.

Vulnerabilities. The report noted that the greatest opportunities for counterfeiters to introduce fake drugs into the supply chain comes in the "intermediate steps" of the distribution cycle when wholesalers and repackagers obtain products from sources other than the original manufacturer.

"There are obviously instances where weaknesses in that system have allowed for the introduction of counterfeit drugs into the marketplace and in some cases have contributed to their wider distribution," Taylor said.

Repackaging, the report stated, may destroy anticounterfeiting measures used in a drug product's original packaging and labeling.

"It may also provide a point of entry for expired, adulterated, or counterfeit drugs into the distribution system because they may be repackaged in a way that makes them appear to be legitimate products," the task force said, adding that "counterfeit and diverted product may be commingled with authentic product during the repackaging process and find its way to an end user."

But Taylor doubted that FDA would impose newer or tougher regulations for repackagers.

"There currently are regulations in place that provide repackers with guidance that we hope will ensure that products are repacked properly," he said. "Specifically the good manufacturing practices requirements are meant to ensure that repackers are handling product in a way that allows the repackers to trace the product, but also in a way that ensures that the American public is getting the product that they think they are purchasing when they go to the pharmacy or when they purchase a product over the counter."

Taylor said it is not FDA's "intent or desire" to "get rid of the industry" or to seek a "reduction in the number of repacking" companies.

"Our desire" he said, is to "take a number of steps that will ensure that the consumer is getting what the consumer thinks is a safe and effective product."

FDA suggested that manufacturers could package many of their products in unit-of-use dosage forms to deter counterfeiters.

Weak link. An incomplete pedigree—a document that traces the sales history of the product back to the legitimate manufacturer—is one of the weaknesses in the system that makes it possible for counterfeiters to introduce their products into the medicine supply chain, the task force said.

But FDA has postponed enforcement of the pedigree requirement, originally scheduled to take effect in December 2000, until April 2004.

If all entities in the drug distribution chain use electronic technology, such as RFID, an "electronic pedigree" would be created "de facto" to track and trace drug products, FDA said.

But Taylor declined to provide details about how the agency would implement and enforce an electronic pedigree.

"At this point in time one of the things that has been interesting about our discussions [is] that it's industry itself who is excited about this technology," he said. "It is industry itself that is driving the move towards this technology, not only for security reasons, but for good business practice reasons." 

FDA, Taylor said, would communicate later whether it intended to again postpone the pedigree requirement.

The agency, he said, wants to "encourage the further development and the further adoption of [an electronic pedigree] and make sure that FDA isn't taking any steps that would actually serve as an impediment to the adoption of technology that we think over time will create a more secure and stronger framework."

Pharmacists' role in protecting drug supply. To ensure the integrity of drug products used in health systems, said Douglas Scheckelhoff, M.S., director of practice leadership and management for the American Society of Health-System Pharmacists (ASHP), pharmacists should regularly check Web sites from FDA, group purchasing organizations, and ASHP for new reports about counterfeit products.

Pharmacists should also ask their wholesalers about their anticounterfeiting measures and sources of products, and insist that suppliers are taking steps to limit sources of products to authorized manufacturers and authorized distributors, he suggested.

Pharmacy directors should make sure that they have educated their staff about the problem of counterfeit pharmaceuticals and how to recognize and report a suspicious product, said Scheckelhoff, who will attend FDA's public meeting in October to present comments from ASHP.

A health-system pharmacy, he counseled, should periodically contact its state board of pharmacy to inquire if there are any problematic wholesalers doing business in the area.

A pharmacy should limit or eliminate the use of secondary distributors if possible, he recommended. But, he added, if a pharmacy must rely on a secondary wholesaler for products, it should verify that the company is an authorized distributor licensed by the state, and that it purchases it products from an authorized manufacturer.

Pharmacy directors should also reevaluate the pharmacy's security measures to minimize the risk of diversion and entry of counterfeit products, Scheckelhoff said.