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Drug Shortages Shelf Life Extension Act
12/29/2022, 11:48 PM
Summary of Bill HR 7669
The bill proposes that the Food and Drug Administration (FDA) be given the authority to extend the expiration dates of drugs that are in short supply. This would help to ensure that patients have access to the medications they need, even if they have been on the market for longer than originally intended.
The Drug Shortages Shelf Life Extension Act aims to prevent situations where patients are unable to access life-saving medications due to shortages. By allowing for the extension of expiration dates, the bill seeks to alleviate the strain on the healthcare system and ensure that patients receive the care they need. Overall, the Drug Shortages Shelf Life Extension Act is a bipartisan effort to address the issue of drug shortages and ensure that patients have access to the medications they need. It is currently being debated in Congress and may be voted on in the near future.
Congressional Summary of HR 7669
Drug Shortages Shelf Life Extension Act
This bill requires the Food and Drug Administration (FDA) to issue or revise guidance to address issues relating to extending drug expiration dates.
Specifically, the guidance must address recommendations to drug companies relating to (1) submitting stability testing data in applications for market approval for drugs or biological products; (2) establishing on drug labels the longest feasible expiration date scientifically supported by such data, taking into consideration how extended expiration dates may help prevent or mitigate drug shortages and affect product quality; and (3) using innovative approaches to stability modeling to support initial product expiration dates and expiration date extensions.
The FDA must also periodically report to Congress certain information about requests to change the expiration date on a drug label, including the number of such requests from the FDA to the manufacturer and the rationale for each request.
