HDA opposes permitting the importation into the U.S. of pharmaceuticals sold or designated for sale in foreign countries. HDA firmly believes that allowing importation increases the likelihood of counterfeit or adulterated drugs entering the United States and will not ensure meaningful reductions in the cost of prescription drugs.
The U.S. pharmaceutical supply chain is a sophisticated, efficient and highly secure system, and was further strengthened in 2013 by the passage of the Drug Supply Chain Security Act (DSCSA, or Title II of the Drug Quality and Security Act). The DSCSA provides for a federal traceability solution for prescription medicines, which by 2023, will lead to the establishment of FDA-regulated, electronic, unit-level traceability requirements across the entire supply chain for prescription drug products. Given the action Congress has taken to enhance supply chain safety and security, allowing for importation of prescription drug products runs counter to the efforts of the industry and regulators to further protect the supply chain and will expose the domestic supply and patients to unnecessary risk.
Recent congressional proposals include the voluntary passage of information for a transaction between an importer and foreign seller, per a similar provision in the DSCSA. However, in the DSCSA statute, this transactional information is mandatory and exchanged with each transaction made in the supply chain, providing supply chain partners with data to assist in the course of business, investigations or recalls. The DSCSA also contains numerous requirements for trading partners all working towards the goal of further securing the supply chain. The DSCSA is an extremely complex law and imported products designated for foreign markets will not meet the standards of safety and security necessary to ensure the integrity of the supply chain. Moreover, importation proposals run directly counter to the very objectives set out by Congress in the DSCSA.
Since the passage of DSCSA, HDA members have worked tirelessly to meet the spirit and intent of the law and have adapted their systems and business practices to meet its requirements. This work continues at an aggressive pace, as the industry strives to meet all of the goals in the law, which are phased in through 2023. Before considering importation of potentially dangerous products from other countries, whether through personal or commercial importation or Internet purchasing, Congress should consider the implications of introducing such risk to the pharmaceutical supply chain — a supply chain Congress sought to further strengthen through enactment of the DSCSA.
HDA Guidelines and Documents
U.S. Food and Drug Administration