[Federal Register Volume 78, Number 18 (Monday, January 28, 2013)]
[Notices]
[Pages 5817-5818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-01640]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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
purpose.
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.
FOR FURTHER INFORMATION CONTACT: Lana L. Pauls, Center for Drug
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].
SUPPLEMENTARY INFORMATION:
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]
BILLING CODE 4160-01-P