We need your help! Please encourage your Senators to cosponsor the BENEFIT Act. 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.
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Cosponsor the Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT Act)
Dear [Decision Maker],
Congress and the Food and Drug Administration (FDA) have made considerable progress in driving forward policies and procedures to ensure the patient perspective is considered by FDA reviewers evaluating candidate drugs and other medical products. As a result of the Prescription Drug User Fee Act (PDUFA) updates from 2012 (FDASIA) and several provisions in the 21st Century Cures Act passed into law in 2016, the FDA has a number of programs and policies in place to evaluate the benefits and risks of potential therapies and to gather and assess the patient perspectives.While much progress has been made, some significant gaps remain. One such gap is the lack of any requirement in law today that the FDA include as part of its risk-benefit framework any patient experience or patient-focused drug development (PFDD) data. This means that the agency's signature tool for evaluating risk-benefit does not have data from the patient experiences that could be critical to informing the agency's evaluation and, ultimately, the decision on whether or not to approve a product.To address this gap, Sen. Roger Wicker (R-MS) and Sen. Amy Klobuchar (D-MN) and Representatives Doris Matsui (D-CA) and Brad Wenstrup (R-OH) have introduced the Better Empowerment Now to Enhance Framework and Improve Treatments or the BENEFIT Act. (S.373/H.R. 4472)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 continue this evolution by filling a sizable gap by ensuring such data is fully considered as part of the FDA's risk-benefit assessment for any new products. Advance patient engagement by cosponsoring the BENEFIT Act today.
Sincerely,[Your Name] [Your Address] [City, State ZIP][Your Email]
