Patient Experience Should be Considered During Drug Approval Process

U.S. Senators Roger Wicker, R-Miss., and Amy Klobuchar, D-Minn., today reintroduced the Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act. The legislation would provide patients and advocates the ability to play a larger role in the Food and Drug Administration’s (FDA) benefit-risk framework for drug approval.

“The government needs to put patients first during the drug approval process,” Wicker said. “As co-chairs of the Senate Rare Disease Caucus, we are committed to elevating the role of patients as new treatments and cures are considered.”

“Incorporating patient experience data as part of the Food and Drug Administration’s drug approval process is a crucial part of strengthening the patient voice in our health care system, and it builds on the progress of the 21st Century Cures Act,” Klobuchar said. “The BENEFIT Act would ensure that the FDA considers patient experience data when evaluating a new drug application for approval.”

The BENEFIT Act would amend the Food, Drug and Cosmetic Act to ensure that the patient experience, patient-focused drug development (PFDD), and related data be considered as part of the risk-benefit assessment. This 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 will be fully incorporated into the agency’s review process and will encourage such entities to develop scientifically rigorous and meaningful tools and data.

Congress has made considerable progress to ensure that the perspective of patients is considered by FDA reviewers evaluating candidate drugs and other medical products. As a result of updates to the Prescription Drug User Fee Act and 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 patient perspectives.

During the 115th Congress, the BENEFIT Act was passed by the Senate but was not considered by the House of Representatives.

Senator Roger Wicker Press Release

3/4/2020