Premier Statement on FDA Annual Drug Shortages Report

By Soumi Saha, Senior Vice President of Government Affairs, Premier, Inc.

The Food and Drug Administration’s (FDA's) annual report to Congress on drug shortages highlights a pervasive problem as providers across the country continue to grapple with an inability to access the drugs they need to treat patients.

While it is broadly recognized that there is no single cause of drug shortages, and therefore no single solution, there is also recognition that the FDA could be doing more to mitigate drug shortages. Alongside lessons learned over decades about risks to the pharmaceutical supply chain and timeliness of action in the short and long-term, here are four key areas Premier believes the FDA can leverage under its current statutory authority to better address shortages:

1. Timeliness of action: Premier recently expressed concern over the FDA’s lag time of more than three years in releasing its draft guidance since CARES Act passage in March 2020. Drug shortages continue to plague the U.S. healthcare system, and it is troubling to see the FDA take a passive approach to implementing its new statutory authorities.
2. API reporting for greater visibility and earlier notification: Premier also voiced concerns that the FDA’s interpretation of a CARES Act provision runs counter to Congressional intent. In passing the CARES Act, Congress intended to create upstream visibility into potential pharmaceutical supply chain disruptions – and hold active pharmaceutical ingredient (API) manufacturers accountable for reporting discontinuances and interruptions to help mitigate potential downstream shortages as early as possible. Passing this burden to finished-dose manufacturers that may not have proper visibility into API production, supply or market share, rather than extending notification requirements to the API manufacturers themselves to determine early warning signals of a potential shortage is counter to the intent of the legislative language.
3. Quality management: Premier believes that the quality manufacturing standard for pharmaceuticals should focus on FDA approval and inspection, with all FDA-registered global manufacturers inspected equitably and consistently via unannounced inspections at the same time intervals. The  Fiscal Year (FY) 2023 Omnibus Appropriations Bill  contains a provision requiring the FDA to establish a pilot program for unannounced foreign inspections. Rather than a quality rating system that the FDA is currently considering, one quality standard equally applied to all domestic and overseas finished-dose and API producers can encourage domestic investment and shorten supply chains. And importantly, it preserves the FDA as the gold standard for all medical product and food inspections, of which U.S. consumers already rely.
4. Public-Private collaboration and data sharing: Premier and our members continue to advocate that the FDA make sourcing, quality, volume and capacity information publicly available for all healthcare products sold in the U.S. to improve transparency and support risk mitigation. A streamlined U.S. regulatory framework is needed that makes it easier to collect data, implement workarounds and guide conservation strategies for all products.

Premier remains committed to continued strong collaboration with the FDA and other industry stakeholders to develop meaningful solutions that will shift us from mitigation to the successful elimination of the drug shortages.

We urge the FDA to use these and other authorities at the agency’s disposal to support a more resilient supply chain, while both reducing regulatory burden as well as upholding the safety and quality of pharmaceuticals.