A portion of FDA's drug pedigree requirements have been stalled by court order. Drug wholesalers filed a complaint claiming that the FDA drug pedigree rule unconstitutionally imposed different requirements on authorized and unauthorized distributors. The Prescription Drug Marketing Act (PDMA) defines authorized distributors as those "with whom a manufacturer has established an ongoing relationship to distribute such manufacturer's products." Under the PDMA, all authorized distributors are exempt from the pedigree requirements.
FDA's implementation of a drug pedigree system, originally mandated by Congress in 1988, has been delayed most often due to the unavailability of the technology necessary to seamlessly integrate a drug pedigree system. This track-and-trace capability originally tested on several drug products most susceptible to counterfeiting and diversion will be required for all drug products once implemented. Another issue stalling the start of the drug pedigree system is that while FDA requires pharmaceutical tracking, responsibility for implementation falls to the states. Those states facing the most problems with drug counterfeiting and diversion have developed pedigree plans, but with different tracking requirements placed on pharmaceutical manufacturers, wholesalers, and retail establishments.
This patchwork approach prompted Rep. Steve Buyer (R-Indiana) and Rep. Jim Matheson (D-Utah) to introduce legislation in April 2008 requiring the FDA, with oversight by the Government Accountability Office, to develop a drug identification and tracking system that will "authenticate the wholesale distribution history of any prescription drug." This legislation, "The Safeguarding America's Pharmaceuticals Act of 2008" (H.R. 5839) requires development of a standardized numerical system that is unique to each unit of a prescription drug.
Costs associated with implementation of track-and-trace technology is estimated at $84,000 to $110,000 per pharmacy site. These costs have prompted groups such as the National Community Pharmacists Association and the National Association of Chain Drug Stores to push back, citing that other more cost-effective measures to ensure the security of the U.S. drug supply be explored.