US Congress to pre-empt RFID standards

Members of the US House of Representatives have introduced legislation that would set a federal standard for drug pedigree requirements, which has been a long-standing issue for the drug industry and regulators (Marketletters passim). One objective of the Safeguarding America's Pharmaceuticals Act (HR 5839), sponsored by Reps Steve Buyer (Republican, Indiana) and Jim Matheson (Democrat, Utah), is to provide a pre-emption over attempts by the individual states to propose local legislation.

Already, California has introduced a proposal to compel radio frequency identification (RFID) by 2011, a move which would likely become standard for most of the USA. However, with the technology already considered too expensive to introduce for any but the most expensive drugs by their manufacturers, a series of state-by-state standards would present a regulatory and financial nightmare. The bill's sponsors expressed their intention to prevent the emergence of competing state control regimes, which would effectively break up the USA into 51 (including Washington DC) local markets.

According to attorneys from the Washington DC-based law firm, Hyman Phelps and McNamara, writing on the FDA Law Blog (www.fdalawblog.net), the introduction of HR 5839 would result in a six-month deadline for all prescription drugs in the USA to have a paper or electronic pedigree. Drugmakers amd distributors would then have a grace period to implement electronic tracking and tracing of individual items across the entire supply chain.