CREATES Act: Republican Lawmakers Worry About Frivolous Lawsuits By Generic Firms
Association for Accessible Medicines' Davis tries to counter concerns that the long-stalled measure would incentivize lawsuits against brand companies; witnesses at a House subcommittee hearing on drug pricing legislation also testified that the BLOCKING Act would create an overly broad and complicated framework for triggering 180-day exclusivity.
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Agency seeks legislative authority to update outdated generic drug labels when the reference product has been withdrawn.
AAM's Chip Davis said a user fee cut is not in order, but industry consolidation and product launch problems may mean it cannot accept another large increase.
Republican House Energy and Commerce Committee members say potentially taking a company's revenue for blocking a generic company from obtaining samples, rather than profit, is excessive.