Strengthening the global supply chain for medical products is a lofty goal and FDA is striving to make that a reality. Yesterday, the agency trumpeted its leading role in partnering with Asia Pacific Economic Cooperation (APEC) economies to create a supply chain security toolkit for medical products designed “to maximize available global resources and to deliver quality trainings and best practices and for securing the global supply chain for medical products.”
According to FDA, the toolkit “covers the entire supply chain and lifecycle of medical products from raw materials to use by patients. It focuses on developing — and implementing through training programs — processes, procedures, and tools directed at enhancing global medical product quality and supply chain security.” FDA envisions this toolkit “will be used by industry stakeholders and regulators from around the globe to adopt best practices, for training purposes, and to strengthen laws and regulations to protect consumers from unsafe and substandard drug products.”
While this is a truly worthy affair, I question whether FDA has demonstrated a similar resolve to address longstanding state and federal regulatory inadequacies which continue to plague our own supply chain. FDA must have dedicated a lot of valuable resources to this international project, including many foreign meetings over the last several years, but an environment of mounting supply chain abuses by secondary wholesale distributors and independent pharmacies requires FDA to take a similar tack with its state counterparts. Problems will surely arise if FDA’s domestic and global supply chain strategies are not properly aligned.
The counterfeit Avastin and Altuzan incidents, mammoth prescription drug diversion cases, and numerous instances of supply chain abuses involving independent pharmacies must not be ignored. FDA’s presence on the global stage is noble, but must not distract from its crucial mission to ensure the integrity of our nation’s drug distribution process and to protect vulnerable patients from the ever-increasing diverted and counterfeit drug threat.