NACDS’ Nicholson testifies to House on drug supply chain safety

ALEXANDRIA, Va. The National Association of Chain Drug Stores today testified before the House Energy and Commerce Subcommittee on Health regarding the safety of the prescription drug supply chain. The hearing was titled, “Discussion Draft of the ‘Food and Drug Administration Globalization Act’ Legislation: Drug Safety Provisions.”

Kevin Nicholson, vice president of pharmacy regulatory affairs for NACDS, testified before the committee about chain’s pharmacy commitment to patient safety and ensuring the security of the prescription drug supply chain.

“Chain pharmacy supports requirements that will ensure the safety of the drugs dispensed to patients,” Nicholson stated. “We recognize the diligent efforts of the committee, and we appreciate the opportunity to work with the committee in this process. However, we want to urge the committee to resist any attempt to add a track-and-trace mandate. Such a mandate would be fraught with technical difficulties and formidable costs, and would not live up to safety expectations at this time.”

He also testified that though the NACDS strongly believes the domestic supply chain is safe, a set of principles called the Safe Drug Distribution Program will lead to a stronger and more secure system:

• Create federal requirements for strong, uniform state wholesale drug distributor licensure standards.
• Create a Food and Drug Administration-administered certification program for manufacturers, distributors and pharmacies assuring adherence to secure drug distribution supply chain practices.
• Require chain of custody pedigrees for distributions by uncertified supply chain entities.
• Ensure a uniform and strong national drug distribution safety regimen through federal preemption of state laws.

“These steps would build on effective systems currently in place,” Nicholson added. “This approach focuses on strengthening areas where safety problems may occur, and is more feasible than the disruptive and costly changes contemplated under track-and-trace proposals.”