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Recall Unsafe Drugs Act of 2023
2/5/2024, 2:30 PM
Summary of Bill HR 3688
The bill outlines specific criteria for determining when a drug is considered unsafe, including instances where the drug poses a significant risk to public health or has been found to be ineffective in treating the condition for which it was intended. It also requires drug manufacturers to promptly notify the Food and Drug Administration (FDA) of any safety concerns or adverse effects associated with their products.
Additionally, the Recall Unsafe Drugs Act of 2023 aims to streamline the recall process by giving the FDA more authority to order the removal of unsafe drugs from the market. This includes the ability to issue mandatory recalls if a drug is found to pose an immediate threat to public health. Furthermore, the bill includes provisions for increased transparency and accountability in the drug recall process. It requires the FDA to publicly disclose information about recalled drugs, including the reasons for the recall and any potential risks to consumers. It also mandates regular reporting to Congress on the status of drug recalls and any actions taken by the FDA to address safety concerns. Overall, the Recall Unsafe Drugs Act of 2023 seeks to enhance consumer protection and ensure that unsafe drugs are promptly removed from the market to prevent harm to the public. It represents a bipartisan effort to improve the safety and effectiveness of the pharmaceutical industry in the United States.
Congressional Summary of HR 3688
Recall Unsafe Drugs Act of 2023
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.
