Paul Dietze, Elizabeth Crompton in Law360: FDA's Risk Evaluation Guidance Brings Clarity, Not Solutions

April 29, 2019

This April, the U.S. Food and Drug Administration issued final guidance clarifying how the FDA applies the factors in section 505-1 of the Federal Food, Drug and Cosmetic Act to determine whether a risk evaluation and mitigation strategy is necessary to ensure that the benefits of a drug outweigh its risks.

Section 505-1 of the FD&C Act was created as part of the Food and Drug Administration Amendments Act of 2007. A REMS is a required risk management plan to ensure that the benefits of a drug outweigh its risks.

To approve a drug, the FDA must determine that the drug is safe and effective for its labeled indications under its labeled conditions of use. The REMS guidance notes that “FDA’s determination that a drug is safe, however, does not suggest an absence of risk” and that “a drug is considered safe if it has an appropriate benefit-risk balance.”

A major factor in assessing benefits vs. risks is management of those risks, including both risk assessment and risk minimization. This is an iterative process that involves: “(1) assessing a drug’s benefit-risk balance, (2) developing and implementing tools to minimize the drug’s risks while preserving its benefits, (3) evaluating tool effectiveness and reassessing the benefit-risk balance, and (4) making adjustments, as appropriate, to risk minimization tools to further improve the benefit-risk balance.”

The process continues throughout a drug’s life cycle, as the results of risk assessment inform the sponsor’s decisions regarding risk minimization. …

To read the full article, click on the PDF linked below.


First appeared in Law360 on April 26. (Subscription required)

Media Contacts