Requires the FDA to consider patient-focused data, such as patient-reported outcomes, in its risk-benefit assessment of new drugs.
Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2017 or the BENEFIT Act of 2017
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to consider patient-focused drug development data, such as patient preferences, patient-reported outcomes, and patient experiences, as part of the risk-benefit assessment of new drugs. Following approval of a drug, the FDA must include a description of how this information was considered in its statement of patient experience.
Original sponsor: Sen. Wicker, Roger F. [R-MS]
Cosponsors: Sen. Klobuchar, Amy [D-MN]
Passed Senate by unanimous consent.