H.R. 843: Prompt Approval of Safe Generic Drugs Act

The "Prompt Approval of Safe Generic Drugs Act" is a proposed piece of legislation aimed at amending the Federal Food, Drug, and Cosmetic Act. Here’s a breakdown of what the bill would do:

1. Purpose of the Bill

The bill seeks to change the way certain drugs can be approved for public use. Specifically, it focuses on processes related to the approval of generic drugs, which are copies of brand-name medications. The main goal is to speed up the approval process when safety-related information is added to a drug’s label.

2. Key Changes Proposed

• Eligibility for Approval: Drugs that have been submitted for approval or have already been approved under specific conditions will not be disqualified because their labeling does not include certain safety information, as long as that missing information is protected by exclusivity, patent rights, or other legal protections.
• Labeling Requirements: Even if a drug's approval omits certain safety information, it will still need to include any appropriate safety information that is deemed necessary by the Secretary to ensure safe usage of the drug.
• Maintenance of Exclusivity: The bill clarifies that the availability or scope of exclusivity or extensions of such exclusivity will not be affected by these changes, meaning patent protections and exclusivity terms for existing drugs will still be valid.
• Other Considerations: The proposed changes will not impact the approval eligibility of any applications that are missing any other labeling aspects protected by exclusivity laws.

The focus of these changes is to encourage the quicker availability of generic drugs to the market while still maintaining some level of safety oversight in their labeling.

Relevant Companies

• AMGN - Amgen Inc. - As a major biopharmaceutical company, Amgen could see an impact on its portfolio of generic drugs, especially if the speed of approval for their generics increases.
• PFE - Pfizer Inc. - Pfizer, which owns several brand-name drugs, may face increased competition from generic versions if the approval process is expedited.
• GILD - Gilead Sciences, Inc. - Gilead may experience quicker entry of generics that are similar to its drugs, affecting its market share and pricing strategies.