BENEFIT Act of 2021
- Last Action
- 2/23/2021
Actions
- 2021-02-23Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 2021-02-23Introduced in Senate
CRS Summary
As of 2021-02-23 (00)
Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2021 or the BENEFIT Act of 2021
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.
Cosponsors (3)
- Amy Klobuchar (D-MN)
- Deb Fischer (R-NE)
- Susan Collins (R-ME)
Subjects
- Drug safety, medical device, and laboratory regulation
- Health information and medical records
- Product development and innovation
Sourced from Congress.gov (public domain).
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.