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# Comments on FDA Benefit/Risk Assessment Framework
- URL: https://www.fdaweb.com/comments-on-fda-benefit-risk-assessment-framework/
- Published: 2019-06-19T12:00:00.000Z
- Updated: 2026-09-15T01:33:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144377

Pharmaceutical Research and Manufacturers of America (PhRMA) says there are important potential enhancements that can be made to FDA’s current benefit/risk framework, including incorporation of the patient’s voice throughout the drug development lifecycle and utilization of patient experience date to inform regulatory decision-making. [Commenting](https://www.regulations.gov/document?D=FDA-2019-N-1468-0010&ref=fdaweb.com) on an agency docket and public meeting, PhRMA says FDA should consider allowing the framework to include patient inputs such as limitations of current therapies; identifying a clinically meaningful benefit; consideration of tolerable risks that may be associated with a medical treatment; additional benefits of the product; and qualitative or quantitative information that indicates the benefit-risk trade-offs that patients currently make with existing therapies as well as those they are willing to make for new therapies in a given therapeutic area.

The Lupus Foundation [says](https://www.regulations.gov/document?D=FDA-2019-N-1468-0008&ref=fdaweb.com) it commends FDA for seeking input from external stakeholders as it seeks to improve the implementation of the benefit/risk assessment framework. It says it agrees it is important for the agency to consider feedback from patient advocacy organizations, biopharmaceutical companies, and other stakeholders on how to best implement the agency’s benefit/risk assessment framework for evaluating pre- and post-market medical products. “With only one therapy specifically approved to treat lupus,” the association says, “there is a pressing need to understand the benefit and risk balance that people with lupus are willing to accept in potential new therapies.”

The Consumer Healthcare Product Association (CPHA) [says](https://www.regulations.gov/document?D=FDA-2019-N-1468-0007&ref=fdaweb.com) its members agree that specific consideration should be given to nonprescription drugs as part of the agency’s ongoing focus on benefit/risk discussions. “CPHA members caution against drafting a guidance that covers drugs in general, assuming that principles used for prescription drugs can simply or easily be applied to nonprescription drug products,” the letter says. “FDA should establish separate draft guidance and even a separate benefit/risk assessment tool to be utilized with over-the-counter medicines.”