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Thank you for passing the BENEFIT Act S. 1052
Dear [Decision Maker],
Thank you for passing the Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act, S. 1052. led by Sen. Roger Wicker (R-MS) and Sen. Amy Klobuchar (D-MN). This legislation will amend the Food, Drug and Cosmetic Act (FDCA) to ensure that patient experience, PFDD and related data including information developed by a product sponsor or a third party such as a patient advocacy organization or academic institution be considered as part of the risk-benefit assessment. This action will send an important signal to all stakeholders that patient experience and PFDD data will be fully incorporated into the agency's review process and will encourage such entities to develop scientifically rigorous and meaningful tools and data.The BENEFIT Act will also enhance an important transparency and accountability provision included in the 21st Century Cures Act by requiring the FDA to say how such patient experience and PFDD data was considered within the risk-benefit assessment for any approved therapies. This will provide additional learnings to all stakeholders, particularly patients, and help further refine and develop such tools going forward.
Sincerely,[Your Name] [Your Address] [City, State ZIP][Your Email]