Proposal:BENEFIT Act of 2020

This proposal is archived and closed to further debate. It was introduced in the 116th Congress, which has concluded, and the bill was not enacted into law.

Bill	S 3385
Type of Legislation	Senate Bill
Congress	116
Source	View original on Congress.gov

Geographic Scope

National

Description

Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2020 or the BENEFIT Act of 2020

This bill requires the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies and patient-reported outcome data, in the risk-benefit assessment framework used in the process for approving new drugs.

After a new drug application has been approved, the FDA's public statement about how it used patient experience data shall include a description of how such data was considered in the risk-benefit assessment framework.

Bill Title

BENEFIT Act of 2020

Linked Goals

• Goal:Promote General Welfare

Steps

• 2020-03-04: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
• 2020-03-04: Introduced in Senate

Projected Outcome

A more informed proposal or public response aligned with the Promote General Welfare goal.