Summary of Bill HR 3839
Bill 118 hr 3839, also known as the Generic Drug Application Transparency Act, aims to make changes to the Federal Food, Drug, and Cosmetic Act in order to enhance transparency in the generic drug application process. The bill seeks to address concerns regarding the lack of transparency in the approval process for generic drugs, 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 provide more information to generic drug manufacturers regarding the status of their applications. This includes notifying manufacturers of any deficiencies in their applications and providing them with an opportunity to address these issues in a timely manner.
Additionally, the bill requires the FDA to publish information on its website regarding the status of generic drug applications, including the number of applications pending, approved, and denied. This increased transparency is intended to help manufacturers better understand the approval process and make more informed decisions regarding their applications.
Overall, the Generic Drug Application Transparency Act aims to streamline the approval process for generic drugs and increase competition in the pharmaceutical market, ultimately leading to lower prices for consumers.
Congressional Summary of HR 3839
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.