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CREATES Act: Republican Lawmakers Worry About Frivolous Lawsuits By Generic Firms

 
• By Derrick Gingery

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.

Some US House Republicans lobbed new concerns at legislation intended to end the use of FDA safety programs to prevent generic entry, potentially creating another hurdle that could threaten or delay enactment of the widely supported bill.

The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act would allow generic companies who are denied samples for testing to sue the brand manufacturer

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