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BLOG: FDA shares 5-year blueprint for designing more structured risk-benefit analysis

From international law firm Arnold & Porter LLP comes timely views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.

On March 8, the FDA published in the Federal Register a notice of the availability of its draft five-year plan describing the Agency’s approach to developing and implementing a structured framework for benefit-risk assessment.

 

Publication of this plan fulfills one of FDA’s obligations under the Food and Drug Administration Safety and Innovation Act (FDASIA). The plan sets out FDA’s initial benefit-risk framework, which incorporates key decision factors of Analysis of Condition, Current Treatment Options, Benefit, Risk and Risk Management. In addition, the plan outlines further work FDA will undertake in the next five years to build the benefit-risk framework into CDER and CBER review templates and evaluate and adapt it to ensure it will apply both to pre-market and post-market considerations.

Ultimately, FDA plans to implement the benefit-risk framework in a staged rollout from FY2014 through 2017. The Agency will accept comments on the plan through May 7, 2013.

Diane Bieri, Partner, can be reached at Arnold & Porter LLP, 555 12th St. NW, Washington, DC 20004-1206; 202-942-6310; email: Diane.bieri@aporter.com