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.

One objective of the Safeguarding America's Pharmaceuticals Act (HR5839), 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, 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.

FDA to publish CF drug list

Meanwhile, the US Food and Drug Administration (FDA) has also set a target date of end March 2010 for the publication of a list of drugs considered to be at high risk of counterfeiting. Drugmakers would then have 18 months to adopt standardised numerical identifiers on the relevant products, or a longer time frame for less high-risk agents.

An exemption procedure is included in HR 5839 for drugs where the pedigree requirements are either "not technologically feasible" or where the imposition of the regulation would reduce the medication's effectiveness or integrity in some way.

One aspect of the legislation that will be of interest to parallel trade firms is that procedures are included for repackagers to comply with the pedigree requirements. This suggests that HR 5839 would not, in itself, preclude parallel trading of prescription drugs.

A final element of the proposed law is to provide grants for pharmacies to help with the cost of installing an RFID system via the Department of Health and Human Services.