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Prompt Approval of Safe Generic Drugs Act
2/28/2025, 5:23 AM
Summary of Bill HR 843
The main goal of this legislation is to improve patient safety by ensuring that drugs with new safety information can be approved and made available to the public in a timely manner. By allowing for faster updates to labeling requirements, the bill aims to prevent delays in the approval process that could potentially put patients at risk.
In addition to addressing safety concerns, the bill also includes provisions for other purposes related to drug approval and labeling. These provisions are aimed at improving the efficiency and effectiveness of the drug approval process, while also ensuring that drugs are safe and effective for use by patients. Overall, Bill 119 HR 843 seeks to enhance the drug approval process by providing for the prompt approval of drugs when safety information needs to be added to labeling. By streamlining the approval process and ensuring that important safety information is communicated quickly, the bill aims to improve patient safety and ensure that drugs are safe and effective for use.
Congressional Summary of HR 843
Prompt Approval of Safe Generic Drugs Act
This bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a generic drug despite the omission of certain safety information from the generic drug's labeling.
Specifically, the FDA may not deem an abbreviated application for approval of a generic drug ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's patent or exclusivity protections. Similarly, a drug that is approved under this bill may not be considered mislabeled for lacking such safety information.
Generally, an abbreviated application, for the purposes of this bill, is one that (1) uses required information from studies not conducted by the applicant; or (2) seeks approval of a drug that is, for drug approval purposes, a duplicate of an already-approved drug (i.e., a generic drug). Currently, the labeling for such a generic drug must generally be identical to that of the already-approved drug. This bill provides an exception to that requirement under the specified circumstances.
For any drug approved under this bill, the FDA must require the drug's labeling to include any safety information that is necessary to assure safe use.
Read the Full Bill
Current Status of Bill HR 843
Bipartisan Support of Bill HR 843
Total Number of Sponsors
2Democrat Sponsors
2Republican Sponsors
0Unaffiliated Sponsors
0Total Number of Cosponsors
0Democrat Cosponsors
0Republican Cosponsors
0Unaffiliated Cosponsors
0Policy Area and Potential Impact of Bill HR 843
Primary Policy Focus
Alternate Title(s) of Bill HR 843
Comments
Neo Bowden
10 months ago
I don't like this bill, it's gonna mess things up for me and others. It's just not right, ya know? Who's gonna be affected by this mess? #confused
Lilly Parrish
10 months ago
I'm so glad this bill is passing, it's about time they start prioritizing safety when it comes to drugs. It's gonna make a big difference for all of us. #HRBill843 #safetyfirst
