An appeals court has upheld a decision preventing the FDA from implementing a law that would force distributors to keep a record of everyone who has handled a drug. A three-judge panel of the US Court of Appeals for the Second Circuit released an order last week in a case filed by the FDA againstRxUSA Wholesale, which argued the FDA unfairly attempted to enforce the law governing distribution.
At issue is the Prescription Drug Marketing Act, which requires each person engaged in distributing prescription drugs must provide a statement "identifying each prior sale, purchase, or trade of such drug.” However, as the court noted, a 2006 amendment does not specifically state whether identification must extend back to the drugmaker, or must only extend to the last authorized distributor. Here is the order.
Under the PDMA, all authorized distributors are exempted from the statute’s pedigree requirements. So if the FDA’s regulation were put into effect as written, all lower-level distributors would be required to provide pedigree information that is currently held only by authorized distributors. The lower court determined this would effectively make it impossible for lower-level distributors to comply with the law.
Moreover, the appeals court wrote, the FDA’s regulation is inconsistent with the position taken by the agency in its original 1988 guidance letter, and it runs directly counter to the 20-year history of industry reliance on the FDA’s initial position. The lower court decided RxUSA had a better than even chance of showing the regulation was arbitrary and capricious.
In a backgrounder posted on its web site, the FDA maintains the order prevens the agency from implementing the language in the law that requires a pedigree to identify each prior sale, purchase, or trade of a drug back to the drug's original manufacturer. And the FDA is also prevented from implementing a section of the law that specifies the different types of information, including lot numbers and container sizes that must be included in a pedigree.