AASLD first partnered with FDA and PhRMA in 2001 to initiate the hallmark conference on drug-induced hepatotoxicity.
2001
The FDA/CDER, in co-sponsorship with AASLD and PhRMA, planned a workshop regarding drug-induced hepatotoxicity. The FDA had several issues with drug-induced hepatotoxicity; thus an in-depth review of the state of knowledge on the issue of interactions between drugs and the liver was explored at a national level. The Hepatotoxicity Steering Committee was comprised of FDA, PhRMA, and AASLD senior level personnel formed to explore many issues with respect to drug-induced hepatotoxicity. Specifically, what could be done better to detect it in animals and people; the use of in vitro systems to predict it; the design of clinical studies to detect it; detecting it during NDA review; and detecting and characterizing it post-approval. This event brought together nationally known experts in the field of hepatotoxicity to share their knowledge. The event was a two-day conference, with approximately 600 people. The target audience for the workshop was scientists in government, industry, and academia interested in mechanisms of pharmaceutical hepatotoxicity from a clinical, pre-clinical, and post-marketing perspective.
From 2002 to 2006, a Steering Committee that met annually (approximately 30 people) to discuss new and evolving information was convened. Interest continued to grow, and the Special Interest Group decided that it was important to expand the area of influence to a broader population once again. AASLD provided access to experts in the field, and PhRMA companies had an interest in the outcome of any new discoveries.
After the steering committee met in 2006, it was determined that a larger workshop regarding drug-induced hepatotoxicity should be planned in 2007. The Hepatotoxicity Special Interest Group (formerly the Hepatotoxicity Steering Committee) was formed and was comprised of members from FDA, the National Institutes of Health (NIH), PhRMA and AASLD senior level personnel to explore many issues with respect to drug-induced hepatotoxicity. The event purpose was to bring together nationally known experts in the field of hepatotoxicity to share their knowledge.
The group convened again in 2008 and 2009
The FDA (CDER and CBER) developed a Guidance for Industry entitled “Premarketing Evaluation of Drug-induced Liver Injury” which was published for comment in the Federal Register in October 2007. Comments received were considered for incorporation into the final Guidance. The final Guidance is expected to be published in the Spring of 2009.