A bill to strengthen the use of patient-experience data within the benefit-risk framework for approval of new drugs.
(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)
Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2017 or the BENEFIT Act of 2017
(Sec. 2) 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.Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.(consideration: CR S4787-4788)
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. (consideration: CR S4787-4788)
Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(text: CR S4788)
Passed Senate without amendment by Unanimous Consent. (text: CR S4788)
Message on Senate action sent to the House.
Received in the House.
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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