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To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
3/21/2025, 5:32 PM
Summary of Bill HR 1843
Bill 119 HR 1843, also known as the "Increasing Transparency in Generic Drug Applications Act," aims to amend the Federal Food, Drug, and Cosmetic Act in order to enhance transparency in the process of approving generic drugs. The bill seeks to address concerns about the lack of transparency in the generic drug application process, which can lead to delays in bringing affordable medications to market.
Specifically, the bill includes provisions that require the Food and Drug Administration (FDA) to publish information about the status of generic drug applications on its website. This information would include the date of submission, the current status of the application, and any reasons for delays in approval. By making this information publicly available, the bill aims to increase accountability and transparency in the generic drug approval process.
Additionally, the bill includes provisions that require the FDA to provide more detailed explanations for any delays in approving generic drug applications. This would help to ensure that the FDA is held accountable for any delays and provide greater transparency for both drug manufacturers and consumers. Overall, Bill 119 HR 1843 seeks to improve the transparency of the generic drug approval process in order to facilitate the timely approval of affordable medications. By increasing transparency and accountability, the bill aims to ensure that generic drugs are brought to market in a timely manner, ultimately benefiting consumers by increasing access to affordable medications.
Specifically, the bill includes provisions that require the Food and Drug Administration (FDA) to publish information about the status of generic drug applications on its website. This information would include the date of submission, the current status of the application, and any reasons for delays in approval. By making this information publicly available, the bill aims to increase accountability and transparency in the generic drug approval process.
Additionally, the bill includes provisions that require the FDA to provide more detailed explanations for any delays in approving generic drug applications. This would help to ensure that the FDA is held accountable for any delays and provide greater transparency for both drug manufacturers and consumers. Overall, Bill 119 HR 1843 seeks to improve the transparency of the generic drug approval process in order to facilitate the timely approval of affordable medications. By increasing transparency and accountability, the bill aims to ensure that generic drugs are brought to market in a timely manner, ultimately benefiting consumers by increasing access to affordable medications.
Congressional Summary of HR 1843
This bill requires the Food and Drug Administration (FDA) to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). The FDA must also update or publish guidance on how it makes such determinations.
Read the Full Bill
Current Status of Bill HR 1843
Bill HR 1843 is currently in the status of Bill Introduced since March 5, 2025. Bill HR 1843 was introduced during Congress 119 and was introduced to the House on March 5, 2025. Bill HR 1843's most recent activity was Referred to the House Committee on Energy and Commerce. as of March 5, 2025
Bipartisan Support of Bill HR 1843
Total Number of Sponsors
3Democrat Sponsors
0Republican Sponsors
3Unaffiliated Sponsors
0Total Number of Cosponsors
1Democrat Cosponsors
1Republican Cosponsors
0Unaffiliated Cosponsors
0Policy Area and Potential Impact of Bill HR 1843
Primary Policy Focus
HealthAlternate Title(s) of Bill HR 1843
To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
Comments
Sponsors and Cosponsors of HR 1843
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