Bill > S1897

This bill establishes a process for the Food and Drug Administration (FDA) to update the labeling of certain drugs with outdated labeling. The key provisions are: 1. The FDA can identify "covered drugs" - drugs with no unexpired patents or market exclusivity, where the approval has been withdrawn for reasons other than safety or effectiveness, and where new scientific evidence or relevant accepted clinical uses are not reflected in the labeling. 2. The FDA can initiate a process to update the labeling of these "covered drugs" if the available scientific evidence meets the standards for approval. The FDA will notify generic drug manufacturers and give them the opportunity to agree to the labeling changes or provide reasons why the changes are not warranted. 3. If generic drug manufacturers do not comply with the FDA's ordered labeling changes, their drugs will be considered misbranded. The bill limits the legal effects of these labeling changes for generic drugs to be the same as if a supplemental application had been approved. 4. The bill requires the FDA to report to Congress every 4 years on the actions taken under this new process.

Health and Social Services

https://www.congress.gov/bill/116th-congress/senate-bill/1897/all-info