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Cure Sanfilippo joins in calling Congress to support The BENEFIT Act

April 29, 2021

Cure Sanfilippo Foundation has signed-on to a stakeholder letter that calls for the U.S. Congress to support the Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act (S. 373), sponsored by U.S. Senators Roger Wicker (R-MS) and Amy Klobuchar (D-MN).

The letter demonstrates a united front of patient advocacy groups in support of the BENEFIT Act all, agreeing on the need to fully understand the impact of patient input on U.S. Food & Drug Administration (FDA) decision making.

The 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.

The BENEFIT Act would require that the FDA disclose whether and how patient experience and/or preference data was used in the benefit risk assessment of a new drug. It will ensure that patient voices are being heard and allow for patient stakeholders to continue to work with FDA to refine the data that they need to make decisions.

The legislation is important to advancement of patient-focused drug development (PFDD) work at the FDA. Past PDUFAs and the 21st Century Cures Act have spurred much progress, and the FDA now works closely with patient advocacy groups on developing and listening to PFDD.

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