DRUG WHOLESALERS SEEKING INJUNCTION TO STOP DRUG TRACKING PROGRAM
A coalition of drug wholesalers will soon seek an injunction in federal court to delay the implementation of the FDA's long-awaited drug tracking program, contending the new requirement will devastate their businesses.
The National Coalition of Pharmaceutical Distributors and companies like RxUSA Wholesale are challenging the FDA's plan to require certain manufacturers to have pedigrees for their products beginning Dec. 1. A pedigree is a record of all transactions a drug goes through, from the manufacturing plant to the dispensing pharmacy.
Smaller wholesalers say the program will ruin their businesses by establishing a requirement they are unable to meet. The problem is that these wholesalers purchase their products from larger authorized distributors that are not required to keep these records or provide them to the unauthorized companies.
The agency based its rule on the Prescription Drug Marketing Act (PDMA). The act, which amended the Federal Food, Drug and Cosmetic Act, exempts a drug's manufacturer and the "authorized distributor of record" from the pedigree requirement.
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 net effect of the rule is that "the entire secondary wholesale industry will be completely and immediately destroyed," the groups argued in their Sept. 20 complaint before the U.S. District Court for the Eastern District of New York. The parties allege that the rule is unconstitutional, denying them equal protection under the law.
Other observers have pointed out flaws in the federal statute that will undermine the rule. The agency is hamstrung by limitations in the PDMA, including the 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 FDA is still reviewing public comments on the rule and will soon respond to them and publish guidance to address questions about the rule, an agency spokeswoman said.