The House Energy and Commerce Committee’s health subcommittee advanced three bipartisan bills aimed giving the FDA more oversight over generic drug labeling, orphan drugs and continuous manufacturing.
The subcommittee advanced H.R. 4712, which would require drugmakers who gain an orphan drug designation based on a cost-recovery analysis to demonstrate “the absence of any reasonable expectation” of cost recovery every year during the seven-year exclusivity period.
It also advanced H.R. 5668, which would allow the agency to require updates for outdated labeling for generic drugs when their reference products have been withdrawn.
A third bill, H.R. 4866, would authorize $80 million from fiscal years 2021 to 2025 for the FDA to designate National Centers of Excellence in Continuous Pharmaceutical Manufacturing.