[Federal Register Volume 78, Number 18 (Monday, January 28, 2013)]
[Pages 5817-5818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-01640]



Food and Drug Administration

[Docket No. FDA-2008-D-0128; Formerly Docket No. 2007D-0396]

Detecting and Evaluating Drug-Induced Liver Injury; What's 
Normal, What's Not, and What Should We Do About It?; Public Conference; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
conference entitled ``Detecting and Evaluating Drug-Induced Liver 
Injury; What's Normal, What's Not, and What Should We Do About It?'' 
This conference will be cosponsored with the Critical Path Institute 
(C-Path) and the Pharmaceutical Research and Manufacturers of America. 
Its purpose is to discuss, debate, and build consensus among 
stakeholders in the pharmaceutical industry, academia, health care 
providers, patient groups, and regulatory bodies on how best to detect 
and assess the severity, extent, and likelihood of drug causation of 
liver injury and dysfunction in people using drugs for any medical 

DATES: The public conference will be held on March 20, 2013, from 8 
a.m. to 6 p.m. and March 21, 2013, from 8 a.m. until 4 p.m.

ADDRESSES: The conference will take place at the Marriott Inn & 
Conference Center, University of Maryland University College, 3501 
University Blvd., East Hyattsville, MD 20783.

Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 4307, Silver Spring MD 20993-0002, 301-
796-0518, [email protected].


I. Background

    In July 2009, FDA announced the availability of guidance for 
industry entitled ``Drug-Induced Liver Injury: Premarketing Clinical 
Evaluation'' (74 FR 38035; July 30, 2009). This guidance explained that 
drug-induced liver injury (DILI) was the most frequent cause of safety-
related drug marketing withdrawals for the past 50 years and that 
hepatotoxicity has limited use of many drugs that have been approved 
and prevented the approval of others. It

[[Page 5818]]

discusses methods of detecting DILI by periodic tests of serum enzyme 
activities and bilirubin concentration, and how changes in the results 
of those laboratory tests over time, along with symptoms and physical 
findings, may be used to estimate severity of the injury. It suggests 
some ``stopping rules'' for interrupting drug treatment, and the need 
to obtain sufficient clinical information to assess causation. FDA 
published a draft of this guidance in 2006, and comments on the draft 
were taken into consideration when issuing the final guidance in July 
2009 (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174090.pdf.). FDA 
is now interested in obtaining stakeholder input on the issues 
addressed in this guidance, including comments regarding potential 
revisions to the guidance.

II. The Public Conference

A. Why are we holding this conference?

    The purpose of the 2013 conference is to invite participants to 
present their data and views, and to hold open discussion.

B. Registration, Transcripts, and Additional Information on This 
Conference and Its Predecessors

    A registration fee ($600 for industry registrants and $300 for 
Federal Government and academic registrants) will be charged to help 
defray the costs of renting meeting spaces and the meals and snacks 
provided. The fee will also be used to cover travel costs incurred by 
invited academic (but not Government or Industry) speakers and other 
expenses. The registration process will be handled by C-Path, an 
independent, nonprofit organization established in 2005 with public and 
private philanthropic support from the southern Arizona community, 
Science Foundation Arizona, and FDA.
    The presentations and discussions will be transcribed and published 
on the Internet for public availability after minor editing by the 
organizers of the meeting.
    Additional information on the conference, program, and registration 
procedures may be obtained on the Internet at http://www.c-path.org, 
and also at http://www.fda.gov by typing into the search box ``liver 
toxicity''. (FDA has verified the C-Path Web site address, but is not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.) Material presented at past 
programs (from 1999 to 2012) may be accessed at www.aasld.org. Click on 
Education/Training and then scroll down to ``Drug Induced Liver Injury 
2012 Program.''

    Dated: January 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01640 Filed 1-25-13; 8:45 am]