This bill authorizes the Food and Drug Administration (FDA) to require updates to outdated labels for certain generic drugs if the updates will provide a public health benefit. Generally, the FDA may use this authority to update the label of a generic version of a brand-name drug that has been withdrawn from the market for reasons other than safety or effectiveness.
Congressional oversightDrug safety, medical device, and laboratory regulationPrescription drugs
A bill to establish a process for updating the labeling of certain drugs with outdated labeling.
USA116th CongressS-1897| Senate
| Updated: 6/19/2019
This bill authorizes the Food and Drug Administration (FDA) to require updates to outdated labels for certain generic drugs if the updates will provide a public health benefit. Generally, the FDA may use this authority to update the label of a generic version of a brand-name drug that has been withdrawn from the market for reasons other than safety or effectiveness.