Premier Weighs in with FDA on Drug Shortage Notification Draft Guidance

Premier submitted comments in response to FDA’s draft guidance on drug shortage notifications. In its comments, Premier expressed concern over the lag time of more than three years in releasing the draft guidance since the passage of the CARES Act in March 2020.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 authority.

Premier also voiced serious concerns that FDA’s interpretation of the CARES Act provisions is counter to Congressional intent. In passing the CARES Act, Congress intended to create upstream visibility into potential disruptions in the pharmaceutical supply chain 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 who may not have proper visibility into API production, supply, or market share to determine early warning signals of a potential shortage is counter to the intent of the legislative language which is to hold manufacturers of API accountable for supply chain sustainability. Therefore, Premier urged FDA to reevaluate its interpretation of the CARES Act provisions and extend notification requirements regarding discontinuances and interruptions in the manufacturing of API to the manufacturer of the API itself.