Us Congress House Bill HB3839

Us Congress 2023-2024 Regular Session

• Introduced: 6/6/23
• Refer: 6/6/23
• Refer: 6/9/23

Caption

To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.

Impact

If enacted, HB3839 would require the Secretary of Health and Human Services to disclose whether a generic drug is qualitatively and quantitatively the same as the existing listed drug. Additionally, should there be any deviations in the composition, the Secretary would need to identify the specific ingredients causing those deviations, including quantifying them. This level of transparency could potentially lead to more robust competition among generic drug manufacturers, as they would have clearer guidelines and information regarding the existing drugs they seek to emulate.

Summary

House Bill 3839 seeks to amend the Federal Food, Drug, and Cosmetic Act to enhance the transparency of generic drug applications. The bill aims to ensure that applicants who submit abbreviated applications for generic drugs receive clear information about the qualitative and quantitative similarities of their products in comparison to the listed drugs. This initiative is designed to streamline the approval process and improve the level of information available to manufacturers, thereby promoting a more informed development of generic medications.

Contention

Despite the potential benefits, there may be points of contention surrounding the bill. Critics might argue that increased disclosure requirements could complicate the approval process for generic drugs and discourage innovation among manufacturers who might fear more stringent scrutiny. Furthermore, there is concern regarding the capacity of the FDA to implement these changes effectively without further straining its resources. These discussions will likely revolve around balancing the need for transparency with the efficiency of drug approval processes.