FDA Announces Conference Regarding Drug-Induced Liver Injury

  • January 28, 2013

By Bob Roth

Drug-induced liver injury was the most frequent cause of safety-related drug marketing withdrawals in the past 50 years and hepatotoxicity has prevented the approval of many other drugs.

In today’s Federal Register, the FDA announced the scheduling of a two-day public conference entitled “Detecting and Evaluating Drug-Induced Liver Injury; What’s Normal, What’s Not, and What Should We Do About It?” The conference is to be held on March 20 and 21, 2013 in East Hyattsville, MD.

The FDA is holding this conference in order solicit comments regarding potential revision of an existing guidance entitled “Drug-Induced Liver Injury: Premarketing Clinical Evaluation.” Topics to be discussed will focus on the definition of normal vs. abnormal liver test, clinical trial stopping rules based on liver function measurements, distinguishing between true positive study drug effects vs. underlying processes in the study population, and lessons learned from related disorders such as the hepatorenal syndrome. It was also announced that the conference will discuss the use of new biomarkers. This should be a particularly interesting portion of the meeting, likely focusing on the important concepts of sensitivity, specificity and predictive value.

Bob Roth is Vice President and Worldwide Medical Director and Nick Fleischer, R.Ph., Ph.D. is Vice President, at The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please contact us.