In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights throughout the years. Parts I, II, and III focused on Hatch-Waxman, medical privacy laws, and FDA’s user fees, respectively. Today’s blog looks at the evolution of prescription drug traceability and tomorrow’s blog will discuss drug GMP requirements.
The ability to track the commercial life of a finished prescription drug, from the point at which it leaves the manufacturer to the point at which it is dispensed or administered to a patient, has proven elusive. Congress intended for The Prescription Drug Marketing Act (PDMA) to reduce the risk of counterfeit, adulterated, misbranded, subpotent, or expired drugs being sold to patients. President Reagan signed the PDMA into law on April 22, 1988; yet, twenty-five years later, the PDMA was never fully implemented and it is only with last year’s passage of Title II of the Drug Quality and Security Act, the Drug Supply Chain Security Act (DSCSA), that the goals of the PDMA will, eventually, be realized.
The PDMA sought to achieve its lofty, public health goals through a variety of means. It provided for FDA’s establishment of minimum standards for the licensing by State authorities of wholesale distributors of prescription drugs. The State wholesale distributor licensing provisions of the PDMA were implemented in a final rule, 21 C.F.R. Part 205.
The PDMA also banned the sale, purchase, or trading of drug samples and established requirements for drug sample distribution, storage and handling. It further restricted the re-importation of prescription drugs and prohibited, with certain exceptions, the sale, purchase, and trade of prescription drugs purchased by hospitals or other health care entities, or donated or supplied at a reduced price to charities. FDA promulgated final regulations to implement these provisions of the PDMA. 21 C.F.R. Part 203, Subparts B, C, and D.
The PDMA also sought to require unauthorized wholesale distributors – frequently referred to as “secondary wholesalers” – to provide purchasers with a statement (a “pedigree”) that identified each prior sale of the drug.
It was here that the PDMA floundered.
FDA promulgated a final rule, codified at 21 C.F.R. § 203.50(a), that implemented these requirements. 64 Fed. Reg. 67,720 (Dec. 3, 1999). Amid public outcry, FDA stayed the rule until October 1, 2001, and then, until April 1, 2002 . . . and several more times thereafter. Finally, in June 2006, FDA announced it would not further delay implementation and § 203.50(a) would go into effect on December 1, 2006. 71 Fed. Reg. 34,249 (June 14, 2006).
On September 20, 2006, a group of unauthorized wholesaler distributors sued FDA seeking, among other things, a declaratory judgment that § 203.50(a) erroneously interpreted the PDMA’s pedigree requirement. RxUSA Wholesale, Inc. v. HHS, 467 F. Supp.2d 285 (E.D.N.Y. 2006). The plaintiffs eventually prevailed and halted FDA’s implementation of 203.50(a). In 2011, FDA withdrew the regulation. 76 Fed. Reg. 41,434 (July 14, 2011).
In the Federal Register notice announcing the withdrawal, FDA reiterated that it wasn't giving up:
[We] will continue to move forward, working with the private and public sectors to improve the security of the drug supply chain and implement measures to further protect Americans from counterfeit and diverted drugs.
…[S]uch measures include implementation of tracking and tracing, which would help secure the integrity of the supply chain by providing an accurate electronic record of transactions in the drug supply chain. Such electronic records documenting the movement of a drug product from the manufacturer to the dispenser would be an important step in preventing counterfeit and diverted drugs from entering the drug supply chain.
76 Fed. Reg. at 41437.
In November 2013, a coalition of drug supply chain stakeholders, working closely with FDA and Congressional staff, achieved the passage of the next stage of the PDMA, the DSCSA. Over the next ten years (now nine), FDA along with manufacturers, distributors, dispensers, repackagers, and third-party logistics providers, will work to develop an electronic system for the exchange of information about individual packages of prescription drugs. The system that will allow for the identification and tracking of where a drug has been in the supply chain. Important provisions of the law include:
The first significant DSCSA milestone arrives January 1, 2015, when manufacturers must provide data about each product transaction and wholesale distributors must receive and be able to transmit that data.
For those of us who have been with this from the beginning, the path to product traceability has been rife with false starts and delays. Now, the DSCSA gives the supply chain and FDA a roadmap to achieving that goal. It will be a 35-year journey, but the end is in sight.