CREATES Act Will Not Lead To Frivolous Lawsuits, Says AAM's Davis
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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Industry has welcomed the passage of the CREATES Act in the US, which is aimed at curbing originator attempts to deny access to samples by abusing FDA safety programs.
The latest health subcommittee amendments to generics- and biosimilars-related US draft legislation have provided a mixed bag for the AAM.
US FDA would get an overall increase in funding under the president's fiscal year 2020 budget proposal, although the generic drug industry opposes reforms targeting the 180-day exclusivity clock for first filers.