National Association of Chain Drug Stores Pushing For Separate Food, Drug Regulations
The National Association of Chain Drug Stores has begun lobbying House Energy and Commerce Committee leaders' staff in opposition to stricter track-and-trace rules in the wake of the recent salmonella outbreak, CongressDaily reports. Committee Chair John Dingell (D-Mich.) recently released a revised version of the drug portion of an FDA overhaul bill on which he is working that would give the agency more authority to oversee food and drug products. According to CongressDaily, when Dingell's bill was first released in April, Reps. Steve Buyer (R-Ind.) and Jim Matheson (D-Utah) proposed adding a track-and-trace element -- a so-called "pedigree requirement" -- to the bill. Committee staff members have indicated that they will not add a pedigree requirement unless everyone involved can reach a consensus.
Although pharmaceutical distributors are "generally pleased" with the Buyer/Matheson proposal, and the brand-name and generic drug industries are "looking for changes," representatives of the pharmacy industry "have dug in their heels against it," according to CongressDaily. Lobbyists for the pharmacy industry say the Buyer/Matheson proposal does not account for the cost and complexity of track-and-trace technology. According to a June study by NACDS and the National Community Pharmacists Association, it could cost each pharmacy as much as $110,000 in the first year to implement new track-and-trace technology. Paul Kelly, vice president of government affairs for NACDS, added that the drug industry -- unlike the food industry -- already has strong regulations and licensing that ensure the products are safer. NACDS is lobbying for stronger wholesale distributor licensing standards and a requirement that FDA administer a certification program for manufacturers, distributors and pharmacies.
Kelly said, "All this talk about tracking and tracing food, we thought it was time to remind our friends that 'Hey, they're not the same'" (Edney, CongressDaily, 8/7).
