Federal Drug-Tracking Program Flawed, Expert Says The FDA’s plan to fight counterfeiting by tracking drugs through a pedigree system is not likely to accomplish the agency’s goals because of flaws in the federal statute, an expert says. The FDA is planning to require manufacturers to have pedigrees for their products beginning Dec. 1 in an effort to curb drug counterfeiting. A pedigree is a record of all transactions a drug goes through, from the manufacturing plant to the dispensing pharmacy. But the agency is hamstrung by limitations in the Prescription Drug Marketing Act (PDMA), including a broad exemption from pedigree requirements and the lack of a federal preemption clause, Eric Greenberg, an attorney who specializes in regulatory and labeling requirements, said during a Sept. 7 audioconference sponsored by FDAnews. The result is a program that “doesn’t seem to be set up to do what it’s supposed to do” — ensure a chain of custody for a product in order to prevent counterfeiting. Loopholes Found The act, which is an amendment to the Federal Food, Drug and Cosmetic Act, exempts the manufacturer and the “authorized distributor of record” from providing a pedigree. The PDMA states that an authorized distributor of record is a wholesaler with an “ongoing relationship” with a manufacturer to distribute that manufacturer’s drug. To become an authorized distributor, a company merely needs to receive written permission from the manufacturer. The problem is that up to 80 percent of distributors are authorized by the manufacturer, Greenberg said. This exempts the majority of parties from having to track their drugs. These authorized distributors also do not need to provide tracking information to unauthorized companies who later handle these products, meaning that a break in the pedigree chain is likely to occur and instances of counterfeiting may go unnoticed. This approach also puts smaller companies at a disadvantage because, while they must document their products, authorized distributors are not required to provide them with information about the product earlier in the chain of custody, he said. State Laws Win Furthermore, the act does not allow the federal standard to preempt state pedigree requirements. Consequently, the federal requirements are “irrelevant” and companies must make sure to comply with every state standard where they do business, Greenberg said. This makes compliance very difficult for companies as some states, like Florida, are more stringent than the federal standard. For instance, Florida, which implemented its standard July 1, does not have an exemption for authorized distributors. One solution would be to have Congress revisit the statute, Greenberg said. But he did not know whether lawmakers had any interest in doing so. The FDA issued final regulations governing pedigrees in 1999 that were to go into effect in December 2000. However, after receiving negative comments on the regulations, the agency delayed the effective date several times. In February 2004, the FDA again delayed the effective date, believing the industry would voluntarily adopt electronic track-andtrace technology. In fact, the agency urged industry to adopt such technology — giving special emphasis to radio-frequency identification (RFID) tags — in its final Counterfeit Drug Task Force report issued that same month. A recent report found that only about 10 prescription drug products are expected to contain RFID tags on a large scale this year. FDA officials did not respond to a request for comment. — Stephen Langel. |
