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# CDER Benefit/Risk ‘Structured Framework’ Explained
- URL: https://www.fdaweb.com/cder-benefit-risk-structured-framework-explained/
- Published: 2017-02-16T12:00:00.000Z
- Updated: 2026-09-14T22:07:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137995

Three staffers in the CDER Division of Bone, Reproductive, and Urologic Products say that the Center’s new structured framework for drug benefit/risk assessment “will facilitate a better understanding of the data and uncertainties underlying drug approvals and will make the information more transparent to the public.” Writing in the *New England Journal of Medicine*, the three provide a detailed [look](http://www.nejm.org/doi/full/10.1056/NEJMra1602972?query=TOC&ref=fdaweb.com) at the agency’s process and procedures in regulating prescription drugs.

They say that the structured framework covers the target condition and available treatments, the benefits and risks of the drug under review, and strategies for managing risks. An analysis of the target condition and available treatments provides the context for weighing a drug’s benefits and risks, the authors say. Thus, a drug intended to treat patients with a life-threatening disease for which no therapy is currently available may have benefits that outweigh its risks, even if those risks would be considered unacceptable for a condition that is not life-threatening.

The benefit/risk assessment, according to the article, is based on information submitted in the marketing application, with uncertainties arising from imperfect data such as conflicting findings, missing data, and other limitations taken into account.

The primary tool for managing risk is the FDA-approved drug label, the authors write. If risk mitigation strategies are needed to ensure that the drug’s benefits outweigh its risks, they say, FDA will require a Risk Evaluation and Mitigation Strategy.

The article notes that many of the agency’s benefit/risk assessments and decisions are straightforward, but sometimes it is confronted with a difficult set of benefits, risks, and uncertainties. In such situations, according to the authors, FDA and the drug company may reach different conclusions based on the same facts, or there may be differences of opinion among members of the CDER drug review team.

“FDA encourages transparent, robust scientific discussions among its staff and has processes for handling differences of opinion,” the article concludes. “There is also a process for drug companies to appeal an FDA decision. Such situations can be highly charged and can elicit strong public reactions, with some people criticizing FDA for being too conservative and delaying access to new drugs, and others criticizing FDA for being too lenient and approving drugs on the basis of limited data.” The authors express the hope that the framework will help ease those tensions.