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BIO Comments on Benefit-Risk Assessments in Drug Regulatory Decision-Making

November 13, 2017

BIO submitted comments to the Food and Drug Administration (FDA) on Benefit-Risk Assessments in Drug Regulatory Decision-Making.

The benefit-risk framework is an important advancement in FDA product regulation because it reflects and reinforces the fact the FDA review process is grounded in the assessment of both benefits and risks. The FDA’s introduction and implementation of the structured benefit-risk framework has improved the transparency and communication of FDA’s decisions on approvals of new therapies. The framework has also allowed the FDA to share important information with the public about what to expect from approved therapies.

BIO supports FDA's continued efforts to evaluate and improve the clarity of the benefit-risk assessment process throughout the lifecycle of drug evaluation.

While the FDA benefit-risk framework has provided increased transparency and communication, additional work is needed in order to improve the framework. BIP provides recommendations for areas to continue to enhance the FDA’s benefit-risk framework, including transparency and flexibility of benefit-risk assessment in complete response letters, consistent use of the framework across review divisions, and including patient perspectives.

Download Full Comments Below
Benefit-Risk Assessments In Drug Regulatory Decision Making FDA-2017-N-4076
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