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.

Written by the Congressional Research Service, Library of Congress.