The National Association of Chain Drug Stores stressed to lawmakers that chain pharmacies are commited to patient safety as part of the next Prescription Drug User Fee Act (PDUFA) reauthorization.

National Association of Chain Drug Stores, NACDS, Prescription Drug User Fee Act, PDUFA, PDUFA reauthorization, drug safety, Pharmaceutical Distribution Security Alliance, PDSA, pharmaceutical supply chain security, chain pharmacies, House of Representatives Energy and Commerce Subcommittee on Health, FDA User Fees, Risk Evaluation and Mitigation Strategies, REMS, drug store operations, prescription drug distribution, chain pharmacy industry

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NACDS gives take on PDUFA reforms

March 8th, 2012

ALEXANDRIA, Va. – The National Association of Chain Drug Stores stressed to lawmakers that chain pharmacies are commited to patient safety as part of the next Prescription Drug User Fee Act (PDUFA) reauthorization.

NACDS on Thursday submitted written testimony to the House of Representatives Energy and Commerce Subcommittee on Health ahead of a hearing titled "FDA User Fees 2012: Hearing on Issues Related to Accelerated Approval, Medical Gas, Antibiotic Development and Downstream Pharmaceutical Supply Chain."

The association also said Thursday that it and several of its members have joined the Pharmaceutical Distribution Security Alliance (PDSA), which aims to promote pharmaceutical supply chain security.

In its testimony to the House subcommittee, NACDS emphasized that community pharmacist-provided services help improve health outcomes without the introduction of unproven technologies. The association said it supports some drug safety reforms included in the proposed PDUFA reauthorization, including the use of drug industry fees to review drug applications for sound-alike proprietary names and factors that could lead to medication errors, such as unclear label language or package designs.

NACDS also backs the proposal to standardize Risk Evaluation and Mitigation Strategies (REMS) and further incorporate these risk mitigation plans into the healthcare system. As Congress considers the REMS program, the Food and Drug Administration should include the development of methodologies to gauge the effectiveness of REMS and get pharmacy input, since these strategies could impact drug store operations, the association noted.

"NACDS and the chain pharmacy industry are committed to partnering with policymakers and the supply chain stakeholders on viable effective strategies to enhance the safety and security of the U.S. prescription drug distribution supply chain," NACDS stated in the testimony. "Our members have invested significant resources and efforts towards this goal, including changes in purchasing practices and actively supporting state legislation that strengthened the supply chain integrity. Nothing is more important to our industry than the health and safety of our patients."

Chain pharmacy has supported the development of state-level chain of custody "pedigrees" for medicines distributed outside normal distribution channels, which have demonstrated improvements in supply chain security, according to NACDS. Still, the association pointed out that premature drug "track and trace" models could unnecessarily boost health care costs and impose burdensome technologies to little or no effect in enhancing supply chain security.

"As lawmakers, we urge you to consider approaches that are feasible and workable for the supply chain and to recognize the importance of not requiring untested costly mandates such as a prescription drug 'track and trace' system for supply chain stakeholders,” NACDS' testimony said. "Such requirements would add billions in additional costs to the health care system and take time and resources away from pharmacies' ability to provide pharmacy services to their patients."

Reflecting its commitment to drug safety, NACDS noted that it supports many of the Pharmaceutical Distribution Security Alliance's policy recommendations, including the adoption of uniform federal wholesale drug distributor licensing requirements to spur consistency in regulations nationwide and prevent "bad actors" from avoiding stringent laws by crossing state lines. The association said it also supports the PDSA proposal to implement lot-level tracing and is providing recommended edits to the alliance's policy discussion draft to address various concerns.

Also, NACDS said it supports the development of a registry of safe online pharmacies to help consumers identify legitimate pharmacy websites and the FDA's development of a "one document solution" to replace the multiple drug information inserts.