Bill > HR1843

This bill amends the Federal Food, Drug, and Cosmetic Act to improve transparency in the process of generic drug applications. Specifically, it requires the Secretary of Health and Human Services to provide more detailed information to applicants seeking to develop generic versions of existing drugs. When a company requests information about whether their proposed generic drug is qualitatively and quantitatively the same as the original listed drug, the Secretary must disclose specific details about any differences in ingredients or concentrations. If the Secretary determines the drugs are the same, they cannot rescind that determination without a valid reason, such as safety concerns or the identification of a significant error. The bill also mandates that the Secretary issue guidance within one year of enactment, outlining how they will assess whether generic drugs are equivalent to the original drugs, including a public comment period for the draft guidance. This legislation aims to create a more transparent and predictable process for generic drug development, which could potentially help reduce barriers to market entry and potentially lower drug costs by facilitating the introduction of more generic medications.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/1843/all-info