To permit manufacturers of generic drugs to provide additional warnings with respect to such drugs in the same manner that the Food and Drug Administration allows brand names to do so.
About This Bill
Committee
Latest Action · September 21, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
This bill would allow manufacturers of generic drugs to update warning labels and safety information on their products without waiting for approval from the Food and Drug Administration, matching the flexibility currently available to brand-name drug manufacturers. Currently, generic drug makers face stricter labeling rules and cannot independently change their warnings, even when new safety information emerges. The legislation would apply to all generic drug manufacturers and would give the FDA authority to require corresponding label updates for brand-name drugs and competing generics to maintain consistency across the market. The bill does not include specific funding or implementation timelines. This change is intended to improve patient safety by allowing generic drugs to keep pace with updated safety warnings in the same way brand-name drugs can.
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