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2/19/2004

FDA Urges Adoption of Anticounterfeit Technologies by 2007

Donna Young

By 2007, Americans should expect to know "with confidence" exactly where their prescription drugs were made and where those drugs have been, said FDA Commissioner Mark B. McClellan at a press conference yesterday in Washington, D.C.

McClellan joined the agency's anticounterfeit drugs task force and Department of Health and Human Services Secretary Tommy G. Thompson in releasing a final report that outlines steps that drug makers, wholesale distributors, and health care professionals can take to avert the entry of fake drugs into the U.S. market.

FDA's investigations of counterfeit drugs have increased to over 20 per year since 2000, after averaging only 5 per year through the late 1990s.

"We have started to see a tremendous increase in the volume and, more importantly, the sophistication of counterfeit and other unsafe drugs entering our supply," Thompson said.

After several recent high-profile investigations of counterfeit drugsone involving a scheme in which counterfeiters relabeled Amgen's epoetin alfa product Epogen as the higher-strength Procrit, marketed by Ortho BiotechFDA announced this past July that it was forming a task force to examine ways to stop phony drugs from entering the supply chain.

The task force released an interim report on Oct. 2 and held a public meeting on Oct. 15, at which ASHP's Douglas Scheckelhoff, director of pharmacy practice sections, and representatives from other pharmacy organizations, pharmaceutical makers, distributors, and government officials presented ideas to help secure the drug supply.

"In our public health mission," McClellan said yesterday, "we face many issues that are controversial, in which different consumer, professional, and industry groups hold different opinions. This is not one of them."

FDA aims to create a "sophisticated comprehensive framework that uses 21st century solutions to combat criminal efforts to inject counterfeit drugs into our drug supply," McClellan declared.

Alert network. Part of FDA's plan includes partnering with national health care organizations, including ASHP, consumer groups, and the pharmaceutical industry to deliver time-sensitive messages about specific counterfeit-drug incidents, educational messages, and information about how and when to report suspect counterfeit drug products.

The Counterfeit Alert Network will link existing counterfeit notification systems, according to FDA.

"We are pleased to be able to use ASHP's electronic resources to communicate counterfeit drug alerts to members in a timely manner," Scheckelhoff said. "Communicating this information to pharmacists will allow them to inspect stock and help prevent counterfeit drugs from reaching patients."

FDA's report clearly recognizes the role of pharmacists in ensuring the integrity of drugs used in patient care, he added.

ASHP has developed a list of strategies that pharmacists can use to protect against drug counterfeiting.

Track and trace. Electronic track-and-trace technologies will soon be able to provide a high level of confidence that a drug was manufactured safely and distributed under proper conditions, McClellan said.

Right now, he said, radiofrequency identification (RFID) technology appears to be "the most promising approach to providing this assurance."

The use of covert authentication technologies, such as taggants or chemical markers, is another way drug makers can protect their products from counterfeiters, the task force reported.

Unit-of-use packaging and tamper-evident packaging "may be beneficial in fighting counterfeiting," FDA said.

To facilitate the use of authentication technologies on existing products, FDA plans to publish draft guidance for manufacturers on notification procedures for making changes to products, their packaging, or their labeling for the purpose of deterring and detecting counterfeit drugs, according to the report.

No mandate. But the agency is not forcing drug companies, through new regulations, to adopt the new technologies. Instead, the government is relying on the industry to adopt the safeguards voluntarily.

Plus, FDA is once again—for the fifth time—delaying implementation of a regulation that requires wholesalers, other than primary wholesalers, to maintain and forward to buyers a pedigree—a complete history that identifies each prior sale, purchase, and trade of a prescription drug product.

By December 2006, the new implementation date for the pedigree requirement, the Prescription Drug Marketing Act (PDMA) of 1987—legislation designed to help stop counterfeit, adulterated, misbranded, and expired drugs from entering the supply chain—will be nearly two decades old.

The pedigree regulation was originally scheduled to take effect in December 2000.

Some counterfeit drug products have entered the distribution chain through wholesalers that obtained products without complete pedigrees listing all transactions.

FDA's task force noted in its interim report that products with incomplete pedigrees make it more difficult to track and trace the authenticity of those drug products.

But, McClellan argued, PDMA "is a law written in the 1980s based on 1980s paper technology" and the pedigree requirement "would be costly to implement."

PDMA, he asserted, "does not include a comprehensive system for getting reliable records of where a drug's been and where it's intended to go."

At the time PDMA was enacted, the only way to pass on a pedigree for drugs was to use paper, the task force stated in its final report.

"RFID technology, which would provide a de facto electronic pedigree, could surpass the intent of PDMA and do so at a lower cost," the task force maintained. "Adoption of electronic track and trace technology would help stakeholders meet and surpass the goals of PDMA. Therefore, FDA intends to focus its efforts on facilitating industry adoption of this technology within the next few years."

McClellan defended the agency's decision to delay the pedigree requirement and said that by giving the drug industry more time to implement track-and-trace technologies, it would "get us to that complete system in a faster time period at a lower cost in a way that will provide a higher level of security for Americans."

Drug list. Until an electronic pedigree for all drugs is established, ASHP's Scheckelhoff told FDA's task force last October, a limited, uniform list of drug products considered to be at high risk for counterfeiting should be maintained through a paper system based on Florida's model.

Florida this past fall started requiring wholesalers doing business in the state, including primary wholesalers, to provide a pedigree for 30 drug products identified as having a high risk for counterfeiting and diversion.

FDA's task force concluded that there would be "great value" in the creation of a national list of drug products most likely to be counterfeited.

"We would like to see a national list developed, and this is something we want to work with other state organizations and industry to make sure we get right," McClellan said.

Carmen A. Catizone, executive director of the National Association of Boards of Pharmacy (NABP), said his organization, "with the assistance of FDA, will be releasing a list of susceptible drugs next week that we developed using the Florida model and recent information from the FDA on counterfeit products. We are asking for a national coalition to continue to maintain that list to avoid any states developing their own list."

Model rules for states. NABP tomorrow will release its revised set of Model Rules for Licensure of Wholesale Distributors that "address gaps in the system that were identified by recent isolated incidents," Catizone announced at the press conference.

"It is our hope that the states will adopt the model rules and implement the NABP clearinghouse on wholesale distributors to reinstate uniform regulations across the states and continue to ensure that the medication distribution system in the U.S. is safe, secure, and the best in the world," he added.