The importation of prescription drugs from foreign markets has emerged as a quick-fix proposal to enhance affordability and patient access. Supporters believe the fundamental goal is laudable, however, the risks far outweigh the benefits. Importation would threaten and destabilize the significant industry-government collaboration already underway to ensure the safety and security of the domestic pharmaceutical supply chain.
This week, the Senate Health, Education, Labor and Pensions (HELP) Committee convenes to consider legislation surrounding the reauthorization of the Prescription Drug User Fee Act. Ahead of the mark-up, the Healthcare Distribution Alliance (HDA) and the National Association of Chain Drug Stores (NACDS) — representing the nation’s primary pharmaceutical distributors and pharmacies — are voicing our strong opposition to any amendment that would allow for drug importation.
Such a proposal will dismantle the hard work supply chain stakeholders and regulators have undertaken since the passage of the groundbreaking Drug Supply Chain Security Act (DSCSA) nearly four years ago.
The U.S. pharmaceutical supply chain is a sophisticated, efficient and highly secure system, and in 2013, Congress made a firm commitment to further strengthening it by passing DSCSA. This federal law — which was enacted to establish a uniform national framework for tracing prescription medicines — was supported by the entire supply chain.
Pharmaceutical supply chain stakeholders are currently engaged in implementation efforts to meet DSCSA milestones, with the goal of achieving electronic, unit-level traceability of prescription drug products by 2023. Pharmaceutical distributors and pharmacies are working daily on implementation, together with their supply chain partners, running pilot programs, and establishing comprehensive systems for traceability, data exchange and retention to make our pharmaceutical supply chain more secure.
The DSCSA is an extremely complex law that includes important mandatory requirements for all supply chain sectors. These include the standardized application of unique product identifiers by manufacturers, a streamlined regulatory framework with stringent wholesaler licensure requirements, and a provision that all business be conducted between “Authorized Trading Partners.” In addition, the law requires the exchange of transaction data that will enable tracing of prescription drug products through the supply chain, including enhanced capabilities to identify and investigate instances of suspect and illegitimate product.
Importation proposals currently on the table would not fully incorporate the critical provisions established by the DSCSA, which are necessary to ensure the integrity of the U.S. drug supply and ultimately, patient safety. As former FDA Commissioners Robert Califf, Margaret Hamburg, Mark McClellan and Andrew Von Eschenbach noted in a letter to members of Congress, the approach is “complex and risky.” They further affirmed that “the ‘closed’ distribution system undertaken by the FDA under the direction of broadly supported drug safety legislation, provides assurance that good manufacturing practices are used and that the increasingly complex supply chain, including shipment and storage, is carefully monitored to ensure the quality and security of approved medications.”
HDA and NACDS urge the Senate HELP Committee, and other members of Congress, to honor their commitment to protect patients and the safety of the supply chain by rejecting any importation proposal. Not only do these proposals contradict past congressional activity, the concerns and risks posed by importation far outweigh any potential benefit to the supply chain, public health or patients. We, and ultimately the patients we serve, simply cannot afford to risk the entrance of substandard, unsafe medicines into one of the safest and strongest supply chains in the world.
John M. Gray is the president and CEO of Healthcare Distribution Alliance (HDA) and Steven C. Anderson is the president and CEO of National Association of Chain Drug Stores (NACDS).
(Source: The Hill)