US drug stores oppose new Rx pedigree rules

The US House of Representatives' Energy and Commerce Committee has been on the receiving end of intense lobbying by the National Association of Chain Drug Stores to oppose a pedigree requirement, which is designed to facilitate product recalls by the Food and Drug Administration. The track-and-trace element of a bill designed to reform the federal regulator's operations, was added in an amendment by Reps Steve Buyer (Republican, Indiana) and Jim Matheson (Democrat, Utah). According to a report by the CongressDaily, the amendment is likely to be dropped at the committee stage if a consensus of members is not reached.

The main problem for pharmacists and drugmakers over pedigree requirements has been its cost and standardization (Marketletters passim). The National Community Pharmacists Association produced a study in association with the NACDS which estimated the cost per pharmacy to introduce track-and-trace technology at $110,000. The drug stores group's vice president, Paul Kelly, told the CongressDaily that unlike the food industry, where a recent salmonella outbreak in tomatoes led to a nationwide recall, pharmaceutical product distribution is already heavily regulated and licensed, reducing the need for additional measures at the end of the drug supply chain.