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Senate Passes Wicker, Klobuchar Proposal to Increase Patients’ Role in FDA Drug Approval Benefit-Risk Framework

WASHINGTON – The Senate today unanimously approved a bill authored by U.S. Senators Roger Wicker, R-Miss., and Amy Klobuchar, D-Minn., to give patients and their advocates a larger role in the Food and Drug Administration’s (FDA) benefit-risk framework for drug approval.

The “Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act” builds on the foundation of the Wicker-Klobuchar “Patient-Focused Impact Assessment Act,” which became law in December 2016.

“The unique viewpoint of patients, including those with rare diseases like Duchenne muscular dystrophy, needs to be taken into account when the FDA assesses the benefits and risks of drug therapies,” Wicker said. “Our ultimate goal with this legislation is to ensure that all voices are heard in the search for breakthroughs or cures. I am hopeful that the House will follow suit and send this bill to the President for his signature."

The 21st Century CURES Act was an important milestone for incorporating the patient experience into the drug approval process, but we can’t stop there. This bipartisan legislation will strengthen the consideration of patient experience, especially those with rare diseases, when the Food and Drug Administration is assessing new treatments,” Klobuchar said.

Specifically, the legislation would address a significant requirement gap by amending the “Food, Drug and Cosmetic Act” to require that the patient experience, patient-focused drug development (PFDD), and related data be considered as part of the FDA’s benefit-risk assessment. The data would include information developed by a product sponsor or a third party, such as a patient advocacy organization or academic institution. This action would send an important signal to all stakeholders that patient experience and PFDD data are fully incorporated into the agency’s review process and would encourage such entities to develop scientifically rigorous and meaningful tools and data.

Congress has made considerable progress over the past five years to ensure that the perspective of patients is considered by FDA reviewers evaluating candidate drugs and other medical products. As a result of the last “Prescription Drug User Fee Act” updates from 2012 and, more recently, several provisions in the “21st Century Cures Act,” 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 patients’ perspectives.

8/3/17

Posted August 4, 2017 - 6:39 am

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