U.S. Sen. Roger Wicker (R-MS) on March 4 introduced a bipartisan bill that would strengthen the use of patient-experience data within the Food and Drug Administration’s (FDA) benefit-risk framework for the approval of new drugs.
Sen. Wicker sponsored the Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act of 2020, S. 3385, with cosponsor U.S. Sen. Amy Klobuchar (D-MN) to provide patients and advocates the ability to play a larger role in the FDA’s drug approval process.
“The government needs to put patients first during the drug approval process,” Sen. 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.”
If enacted, S. 3385 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 FDA’s risk-benefit assessment, including information developed by a product sponsor or a third party, such as a patient advocacy organization or academic institution, according to a bill summary provided by Sen. Wicker’s office.
“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 healthcare system, and it builds on the progress of the 21st Century Cures Act,” said Sen. Klobuchar.
The original BENEFIT Act received U.S. Senate approval during the 115th Congress, but was not considered by the U.S. House of Representatives, prompting Sen. Wicker to reintroduce the bill this week, according to his office.
The bill has been referred for consideration to the U.S. Senate Health, Education, Labor, and Pensions Committee.