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FDA Declares Actions to Combat Counterfeit Drugs

Donna Young

Electronic track-and-trace and authentication technologies should be in place by 2007 so that Americans can know "with confidence" exactly where their prescription drugs were made and where those drugs have been, said FDA Commissioner Mark B. McClellan at a February 18 press conference 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 drugs—one involving a scheme in which counterfeiters relabeled Amgen's epoetin alfa product Epogen as a higher-strength Procrit, marketed by Ortho Biotech—FDA 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 October 2 and held a public meeting on October 15, at which Douglas Scheckelhoff, director of pharmacy practice sections for the American Society of Health-System Pharmacists (ASHP), 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, "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, radio frequency 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. 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.

The National Association of Boards of Pharmacy (NABP) on February 27 released its National Specified List of Susceptible Products—31 drug products that the association determined to be prone to adulteration, counterfeiting, or diversion.

NABP's list is patterned after one used in Florida, said Carmen A. Catizone, the association's executive director.

Florida passed legislation last year that requires wholesalers doing business in the state, including primary wholesalers, to provide a pedigree for drug products that have been identified as having a high risk for diversion and counterfeiting.

NABP's revised set of "Model Rules for Licensure of Wholesale Distributors," released by the association on February 20, requires that wholesalers considered by manufacturers as authorized distributors must keep complete pedigrees for drugs on the list.

Wholesalers not considered authorized distributors must keep a complete pedigree of all transactions of drug products, according to the revised rules.

The rules require that by January 1, 2007, all wholesalers, whether authorized or not, must keep an electronic pedigree of all drugs received and distributed.

NABP has recognized that technology must be available in order for a wholesale distributor to comply with the requirements, the rules state.

But the association asserts that, according to industry information, the January 2007 date is a "realistic goal" for enacting the requirement.

However, the association added, states should monitor the availability of technology in developing statutes and rules and allow for variances.

Catizone urged states to adopt NABP's list of susceptible drugs rather than developing lists of their own.

A national list, he said, will "make it easy for the states to work together on [combating counterfeit products], and not create a burden for wholesalers that have to do business in multiple states."

A national partnership. In early March, NABP invited pharmacy organizations, including ASHP, wholesaler and manufacturer associations, private companies, the United States Pharmacopeial Convention, and government agencies, including FDA, to participate in a coalition that will determine when drug products should be added or deleted from the list of at-risk products, Catizone said.

The spectrum of the coalition, he added, will be as broad as possible to ensure that the list is as "accurate and as fair as possible."

Tougher rules. The revised model rules targeted at wholesale distributors also include stricter licensing requirements, such as criminal-background checks, Catizone said.

In addition, the rules require that wholesalers seeking licensure pay a $100,000 surety bond.

NABP's original model rules, developed in the late 1980s in conjunction with the passage of PDMA, did not require wholesalers to undergo background checks or pay bonds, Catizone noted.

He appealed to states to adopt the model rules "in total," but added that NABP recognizes that some states may need to "trim" the rules to coincide with state laws.

A set of national standards, Catizone said, "makes everyone's job a little easier."

A national clearing-house. NABP is also establishing a clearing-house on wholesale distributors that will act as an accrediting body for wholesalers, Catizone said.

However, he added, states will continue to regulate wholesalers and make decisions about licensure.

The clearing-house program will be funded by fees paid by wholesalers seeking accreditation, Catizone said. The program is free for states.

NABP plans to have the program in place by the end of this year, he added.

As a service to states, the clearinghouse will conduct inspections of wholesale distributor operations, Catizone said.

"That's a service we're going to be offering to the states because we recognize that right now, with the budget cuts and shortages, states won't have the resources to do this," he said. "The benefit for the wholesalers is [that] they will undergo one inspection, and then all that information will be forwarded to all the state boards of pharmacy through our clearing-house."

The clearing-house will also hold the $100,000 bond required under the revised licensure rules, allowing wholesalers to pay only one bond instead of paying separately to each state, Catizone said.

But in order for the plan to work, states would have to agree to join the clearing-house and require that their wholesalers be accredited through NABP's program, Catizone noted.

A successful clearing-house program, he said, would help "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."