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Drug Shortage Prevention Act of 2023
3/13/2024, 3:34 AM
Summary of Bill S 2362
The bill aims to prevent drug shortages by requiring drug manufacturers to notify the Food and Drug Administration (FDA) of any circumstances that could lead to a shortage of a drug. This notification must be made at least six months in advance, giving the FDA time to take action to prevent the shortage from occurring.
Additionally, the bill requires the FDA to maintain a publicly accessible list of drugs that are currently in shortage or at risk of shortage. This list will help healthcare providers and patients stay informed about potential shortages and take steps to mitigate their impact. Furthermore, the bill includes provisions to incentivize drug manufacturers to increase production of drugs that are in shortage. This could include providing financial incentives or expediting the approval process for new manufacturing facilities. Overall, the Drug Shortage Prevention Act of 2023 aims to improve the availability of essential medications in the United States and prevent disruptions in patient care due to drug shortages.
Congressional Summary of S 2362
Drug Shortage Prevention Act of 2023
This bill requires drug manufacturers to notify the Food and Drug Administration (FDA) if there is an increased demand, export restriction, or other circumstance that may result in a shortage of certain critical drugs.
Currently, drug manufacturers are required to notify the FDA in the event of a discontinuation or interruption in the supply of prescription drugs that are life-supporting, life-sustaining, or used for a debilitating disease or condition, including those used in medical emergencies, surgeries, or public health emergencies.
The bill requires drug manufacturers to also notify the FDA if there is an increased demand, export restriction, or other circumstance that may result in a meaningful shortfall or delay in meeting the demand for such drugs. Manufacturers must notify the FDA as soon as possible but no later than 10 days after the onset of the relevant circumstance. The notice must include the reasons for the increased demand, the expected duration, and any other information the FDA requires. The bill's requirements apply to both prescription and nonprescription drugs.
Drug manufacturers must also report twice a year (rather than annually) information on the quantities of drugs produced; manufacturers must also provide the names of the suppliers of corresponding active ingredients.
