AAM Sees Mixed Progress On US Legislation
The latest health subcommittee amendments to generics- and biosimilars-related US draft legislation have provided a mixed bag for the AAM.
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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.
Proposals as part of the latest US budget to amend provisions around the 180-day exclusivity incentive for generics could risk weakening the critical driver of competition, the AAM has warned.
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.