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AASLD-FDA-NIH-PhRMA*- Hepatotoxicity Special Interest Group Meeting
2008 Presentations
Program: Detecting and Investigating Drug-Induced Liver Injury During Clinical Trials
Industry Perspectives [PDF] 
Jay Barth, M.D.
Merck Research Laboratories
Abstract:
The FDA draft guidance, "Drug-induced Liver Injury: Premarketing Clinical Evaluation," issued October 2007, has received favorable reaction from the pharmaceutical industry, based on the comments submitted by pharmaceutical companies. The guidance is recognized as a thoughtful approach to a complex issue, and will help standardize practices in an area in which pharmaceutical companies have pursued individual strategies. The overall goal of the pharmaceutical industry is to develop and market safe and effective drugs. Drug-induced hepatotoxicity is a common cause of delays and discontinuations of development programs, and is the most common reason for drug withdrawals post-approval. The guidance specifies methods of monitoring, analyzing data, and recognizing signals of hepatotoxicity during clinical development. These will help protect the safety of patients in clinical trials and of the public. The draft guidance, while comprehensive, leaves some issues that merit further clarification. Examples of these are the inclusion of patients with underlying liver disease in clinical trials, the impact of Hy's Law cases on clinical programs, appropriate practices in discontinuation of treatment, detection of signals of hepatotoxicity during clinical development, and issues surrounding the preclinical and post-approval periods. The pharmaceutical industry appreciates the opportunity to work with the FDA on these issues, and to remain involved in ongoing research in this area, particularly in the identification of patients at risk for the development of drug-induced hepatotoxicity.
Jay Barth
Biography
Jay Barth, MD is Executive Director of Clinical Research at Merck Research Laboratories, and is responsible for clinical research programs in the areas of gastroenterology and respiratory medicine. Prior to joining Merck in 2007, he worked the Clinical Research departments at Eisai Inc. and Altana Pharma Inc. Dr. Barth received his B.A. from Columbia University and his M.D. degree from the University of Pennsylvania. He completed his residency in pediatrics at Columbia Presbyterian Medical Center in New York, and his fellowship in pediatric gastroenterology at New England Medical Center in Boston. Before joining the pharmaceutical industry, Dr. Barth was on staff in the division of pediatric gastroenterology, hepatology and nutrition at Mount Sinai Medical Center in New York.
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Date created: April 29, 2008 |
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