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Recall Unsafe Drugs Act of 2022
12/19/2023, 9:00 PM
Summary of Bill HR 6834
If passed, this bill would require drug manufacturers to notify the Food and Drug Administration (FDA) of any potential safety issues with their products. The FDA would then have the authority to investigate these claims and, if necessary, order a recall of the drug in question.
Additionally, the bill would require drug manufacturers to provide refunds or replacements for any recalled drugs, as well as to notify healthcare providers and patients of the recall. This is intended to ensure that consumers are made aware of any potential risks associated with the drugs they are taking. Overall, the Recall Unsafe Drugs Act of 2022 aims to improve drug safety in the United States by establishing a clear process for the recall of unsafe drugs and ensuring that consumers are informed of any potential risks. It is currently being debated in Congress and may be subject to amendments before it is voted on.
Congressional Summary of HR 6834
Recall Unsafe Drugs Act of 2022
This bill authorizes the Food and Drug Administration (FDA) to order the recall of certain adulterated or misbranded drugs and contains other related provisions.
A producer of a medication must notify the FDA of the identity and location of a drug if the producer has reason to believe that (1) the drug is adulterated or misbranded, and (2) there is a reasonable probability that the drug will cause a threat of serious adverse health consequences or death to humans or animals.
If use of a drug may cause serious adverse health consequences or death, the FDA may order the producer to immediately cease distribution and notify affected individuals. After issuing such an order, the FDA may also order a recall after affording the producer an opportunity for an informal hearing.
If a drug presents an imminent threat of serious adverse health consequences or death, the FDA may order the producer to immediately recall the drug and notify affected individuals. The distributor may appeal such an order.
An individual or entity required to register as a producer of drugs or medical devices must have a recall plan in effect.
