Public Citizen picks apart Cures 2.0 draft legislation, criticizing several RWE provisions
Consumer advocacy organization Public Citizen on Thursday sent a letter to congressional leaders, seeking changes to a key piece of legislation that will create new FDA reforms if it’s enacted.
The organization took particular issue with the bill, which is the second iteration of the mammoth 21st Century Cures Act or Cures 2.0, as it would increase the FDA’s reliance on real-world evidence in certain circumstances, such as verifying the clinical benefit of drugs following accelerated approvals. Public Citizen said that would:
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