Bill > HR5668

This bill, the Making Objective Drug Evidence Revisions for New Labeling Act of 2020 (or the MODERN Labeling Act of 2020), amends the Federal Food, Drug, and Cosmetic Act to establish a process for the FDA to update the labeling of certain generic drugs. The key provisions include: (1) defining "covered drugs" as those with no unexpired patents or exclusivity, withdrawn approvals for reasons other than safety/effectiveness, and new scientific evidence or accepted clinical uses not reflected in the labeling; (2) allowing the FDA to identify covered drugs and initiate a process to update their labeling; (3) requiring generic drug manufacturers to either agree to the label changes or provide reasons why the changes are not warranted; (4) providing the FDA authority to order label changes it deems appropriate; and (5) requiring regular reporting to Congress on the implementation of this program.

Business and Industry, Health and Social Services

https://www.congress.gov/bill/116th-congress/house-bill/5668/all-info