§353d Process to Update Labeling for Certain Generic Drugs

Summary

The Secretary (the FDA) can pick certain approved drugs whose label information should be updated to protect public health. A covered drug is one that has no active patents or exclusivity, or whose approval was withdrawn for reasons other than safety or effectiveness, and where new science, a current clinical use, or required label format changes are not reflected on the label. If the FDA finds the evidence meets the usual approval standards, it will tell makers of any generic versions what new, changed, or extra label text is needed. The drug maker has 30 days to agree or to explain in writing why they think the change is not needed. The FDA will review objections, may talk with the maker, and can order the label change. Paper labels must be updated at the next printing, electronic labels within 30 days, and the maker must file the change using the form called “Supplement—Changes Being Effected.” If a maker does not follow an ordered change, the generic drug will be treated as misbranded under section 352. The FDA may use public meetings, comment periods, or contracts with experts to decide which drugs to review. The agency cannot pick a drug only because of new safety information, and any required labeling changes do not create new exclusivity for the maker. The usual rules and approval standards still apply, and the FDA keeps its other labeling powers. The Secretary must report to two Congressional committees not later than 4 years after December 27, 2020, and every 4 years after that, describing which drugs were selected, why, how many disagreements happened, how they were resolved, and any suggested changes to the program.