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# Drug Benefit-Risk Assessment Framework Explained
- URL: https://www.fdaweb.com/drug-benefit-risk-assessment-framework-explained/
- Published: 2019-05-28T12:00:00.000Z
- Updated: 2026-09-15T01:29:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144192

Two FDAers involved in the agency’s development and implementation of a benefit-risk framework throughout a drug’s lifecycle told a 5/16 [public meeting](https://healthpolicy.duke.edu/events/benefit-risk-framework-public-workshop?ref=fdaweb.com) held in conjunction with the Duke-Margolis Center for Health Policy that stakeholders should be thinking about benefit-risk at each stage of drug development. CDER associate director for strategic initiatives **Theresa Mullin** told the gathering that the agency piloted a benefit-risk framework in 2009 and moved the process forward through commitments in PDUFA 5 and 6.

She said FDA will issue a drug benefit-risk guidance in 2020 and will conduct another program evaluation in 2021.

In PDUFA 5, she said, FDA took a more systematic approach to the framework and in PDUFA 6 is enhancing use of the framework in decision-making. Outcomes sought from the framework, she said, are **(1)** a clear and concise snapshot, **(2)** an approach that is consistent and accessible, and **(3)** an approach that aligns with the agency’s review process.

Mullin said FDA has received feedback from agency staff and external stakeholders indicating that they are on the right track, and also has received suggestions for improving and expanding the framework. The benefit-risk assessment, she said, must always fit in the FDA regulatory context and also within FDA processes.

CDER Office of New Drugs medical officer **Kerry Jo Lee** noted that FDA has always conducted a benefit-risk assessment as the foundation of its decision-making. However, she said, the push to centralize and present the benefit-risk assessment is new.

She said part of the process is developing a new integrated review for marketing applications that communicates, is inter-disciplinary, and is issue-based.

The meeting covered FDA’s planned benefit-risk assessment guidance, activities that occur in pre-market development that best inform the agency’s benefit-risk assessment, effectively communicating benefit-risk assessment information, and using benefit-risk assessment to inform FDA and sponsor decision-making in the post-marketing setting.