Patient Advocate Says 'Cures' Registry Provisions Worry FDA Scientists

The 21st Century Cures draft legislation heading for Energy and Commerce Committee markup starting Tuesday (May 19) contains little-noticed language that would let pharmaceutical companies use “clinical experience” from observational studies and registries to support the approval of a new indication of a marketed drug. The language, which builds on a Brookings Institution proposal to utilize and expand FDA's Sentinel System to capture data on effectiveness, was blasted by a patient and research advocate, who described it as one of...