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.
Animal Drug and Animal Generic Drug User Fee Amendments of 2023 Animal Generic Drug User Fee Amendments of 2023 Animal Drug User Fee Amendments of 2023
To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.
Reforms the organizational structure for the Department of Transportation and Development including its duties, powers, and responsibilities of officers and employees (EN INCREASE SD EX See Note)