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Strengthening of drug supply chain's effects on independent pharmacies raises concerns

House Subcommittee on Health sponsors hearing on discussion draft of supply chain bill

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WASHINGTON — The House Committee on Energy and Commerce Subcommittee on Health heard testimony on Thursday morning from representatives of the Food and Drug Administration and several industry trade groups following the introduction of draft legislation that sponsors said would strengthen the country's pharmaceutical supply chain.

The hearing, Securing Our Nation's Prescription Drug Supply Chain, focused on what subcommittee chairman Joe Pitts, R-Pa., called in his opening remarks the "downstream" supply chain, which includes pharmacies, repackagers, third-party logistics providers, wholesale distributors and manufacturers. On Monday, Reps. Bob Latta, R-Ohio, and Jim Matheson, D-Utah, introduced a discussion draft of legislation that would amend the Federal Food, Drug and Cosmetic Act to strengthen the supply chain.

Pitts noted that while some supply chain provisions were included in the Food and Drug Administration Safety and Innovation Act, a comprehensive "track and trace" policy has yet to be finished.

"In order to ensure that counterfeit or stolen drugs do not enter the supply chain and harm patients, states have passed laws that require or will require those involved in the downstream supply chain to keep pedigrees or transaction histories of drugs," Pitts said. "Some believe that these differing state requirements should be replaced with a reasonable, practical and feasible federal policy.

Witnesses testifying included representatives from the FDA, the Generic Pharmaceutical Association, the National Community Pharmacists Association (NCPA), the National Association of Boards of Pharmacy, the Healthcare Distribution Management Association and others.

Speaking on behalf of the NCPA, Beaver, Pa., pharmacy owner Tim Davis expressed concerns about what the group calls the potentially burdensome legislative requirements on independent pharmacies and talked about how pharmacies are already addressing problems.

"It is my belief that the United States pharmaceutical supply chain is largely safe and secure," Davis said in his testimony. "Most practicing pharmacists today have a heightened awareness of the possibility of counterfeit or diverted drugs and therefore recognize the critical importance of purchasing medications only from trusted trading partners or wholesalers."

Davis said the "patchwork nature" of state-level drug-pedigree laws creates uncertainty and possible vulnerabilitie. discussions about track-and-trace at the individual unit level are worrisome because the technologies required are not fully developed.

Rep. Morgan Griffith, R-W.Va., echoed Davis' concerns, noting that his state is largely rural and home to many independent pharmacies.

"People are used to going to those pharmacies; they like those pharmacies," Griffith said while questioning FDA Center for Drug Evaluation and Research director Janet Woodcock, who responded by saying that implementing policies like track-and-trace in a "stepwise way" would be the best approach.

Meanwhile, the Generic Pharmaceutical Association expressed support for making medicines traceable.

"We believe that every American deserves a uniform, nationwide system for monitoring and protecting the medicines they rely on," GPhA SVP policy and strategic alliances Christine Simmon said, expressing support for a "building blocks" approach to securing the supply chain. "To fully realize the benefits of an improved system, it is critical that we construct a path that both improves safety and provides a practical roadmap for implementation."

The GPhA and NCPA both expressed opposition to implementing a system like the one that will soon be implemented in California, saying that its requirement to track and trace throughout the supply chain at the individual level would be overly burdensome.

 

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