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Updated Drug Labeling for Patient Safety Act

12/15/2023, 3:59 PM

Summary of Bill HR 4134

Bill 118 hr 4134, also known as the Updated Drug Labeling for Patient Safety Act, is a piece of legislation currently being considered by the US Congress. The main goal of this bill is to improve the safety and effectiveness of prescription drugs by updating the labeling requirements for pharmaceutical companies.

Under this bill, pharmaceutical companies would be required to provide more detailed and accurate information on drug labels, including potential side effects, drug interactions, and proper usage instructions. This information would be designed to help patients and healthcare providers make more informed decisions about the medications they are taking.

Additionally, the Updated Drug Labeling for Patient Safety Act would also establish a process for updating drug labels in a timely manner when new safety information becomes available. This would help ensure that patients are always receiving the most up-to-date information about the drugs they are taking. Overall, this bill aims to enhance patient safety and improve the quality of care by providing clearer and more comprehensive information on prescription drug labels. It is currently being reviewed by Congress and has the potential to have a significant impact on the pharmaceutical industry and the healthcare system as a whole.

Congressional Summary of HR 4134

Updated Drug Labeling for Patient Safety Act

This bill allows generic drug manufacturers to revise labels with updated safety information that differs from the referenced brand-name drug.

Current Status of Bill HR 4134

Bill HR 4134 is currently in the status of Bill Introduced since June 14, 2023. Bill HR 4134 was introduced during Congress 118 and was introduced to the House on June 14, 2023.  Bill HR 4134's most recent activity was Referred to the Subcommittee on Health. as of June 16, 2023

Bipartisan Support of Bill HR 4134

Total Number of Sponsors
1
Democrat Sponsors
1
Republican Sponsors
0
Unaffiliated Sponsors
0
Total Number of Cosponsors
4
Democrat Cosponsors
4
Republican Cosponsors
0
Unaffiliated Cosponsors
0

Policy Area and Potential Impact of Bill HR 4134

Primary Policy Focus

Health

Potential Impact Areas

- Administrative law and regulatory procedures
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Prescription drugs

Alternate Title(s) of Bill HR 4134

Updated Drug Labeling for Patient Safety Act
Updated Drug Labeling for Patient Safety Act
To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish a process to allow the holders of abbreviated new drug applications to make labeling changes to include new or updated safety-related information, and for other purposes.

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