The bill, H.R. 1919, would impose new regulatory requirements on the network of companies that produce, handle, distribute and dispense drug products. Entities in the distribution chain would be required to provide notification to state and federal regulators about products that may be unsuitable to distribute and would be required to comply with record-keeping standards.
Congress is focusing on protecting the U.S. drug supply after a fungal meningitis outbreak last year killed more than 50 people. The outbreak was traced to contaminated compound drugs.
The measure “is an important step to ensure greater patient safety for all Americans,” Ohio Republican Bob Latta, who introduced the bill, said during debate on the House floor. He said it will replace “the current patchwork” of state and federal rules to “protect against the threat posed by counterfeit drugs.”
The FDA would establish a licensing program for third-party providers of logistics services, and would be permitted to collect fees and spend the money to cover the program’s costs. Pharmaceutical tracing requirements for drug lots would be established for makers, wholesale distributors, pharmacies and repackagers.
Drug suppliers, including third-party logistics providers, would be required to do business only with registered or licensed entities. Makers would have to serialize prescription drugs at the unit level.
California Democrat Henry Waxman said the bill “falls far short” of adequately protecting the drug supply chain, adding that “it preempts important existing state safeguards.”
It may be a challenge to reconcile the legislation with a Senate version, S. 959, which would tighten manufacturing rules to crack down on counterfeit drugs and clarify the FDA’s authority over commercial compounding manufacturers, said Brian Rye, an analyst with Bloomberg Government.
“House Republicans view last fall’s deadly meningitis outbreak as a failure to enforce existing, adequate laws, and aren’t in favor of giving federal authorities greater oversight,” he said.
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