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Drug Shortages Prevention and Quality Improvement Act
3/13/2024, 5:03 PM
Summary of Bill S 2586
The bill also aims to increase transparency in the pharmaceutical industry by requiring manufacturers to provide the FDA with information on the production and distribution of drugs, as well as any potential risks to the supply chain. Additionally, the bill includes provisions to incentivize the production of generic drugs and encourage the development of new medications to prevent shortages in the future.
Overall, the Drug Shortages Prevention and Quality Improvement Act is designed to ensure that patients have access to the medications they need and to prevent disruptions in the supply chain that can lead to shortages. The bill has received bipartisan support in Congress and is currently being considered for passage.
Congressional Summary of S 2586
Drug Shortages Prevention and Quality Improvement Act
This bill establishes several programs and requirements to address potential shortages of critical drugs.
For example, the bill requires manufacturers of life-saving drugs to submit data to the Food and Drug Administration (FDA) to help determine the longest possible expiration dates for these drugs. Manufacturers must also notify the FDA of any increased demand for life-saving drugs that could lead to shortages. Manufacturers are subject to civil penalties for violations.
The bill also (1) establishes a grant program to support advanced manufacturing of essential sterile injectable drugs that are vulnerable to shortages, and (2) requires the Government Accountability Office to study the extent of recent shortages of drugs for which payment is made to hospitals under Medicare and whether payment changes could minimize shortages.
