81 FR 2222 - How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials?

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 10 (January 15, 2016)

The Food and Drug Administration (FDA) is announcing a public conference entitled ``How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials?'' This conference will be cosponsored with the Critical Path Institute (C- Path). The purpose of the conference is to discuss, debate, and share views among stakeholders in academia, patient groups, regulatory bodies, and the health care and pharmaceutical industries on how best to measure, evaluate, and act upon liver injury and dysfunction caused by drugs used during clinical trials.

[Federal Register Volume 81, Number 10 (Friday, January 15, 2016)]
[Notices]
[Pages 2222-2223]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-00690]


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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)]


How Should Liver Injury and Dysfunction Caused by Drugs Be 
Measured, Evaluated, and Acted Upon in Clinical Trials?

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
conference entitled ``How Should Liver Injury and Dysfunction Caused by 
Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials?'' This 
conference will be cosponsored with the Critical Path Institute (C-
Path). The purpose of the conference is to discuss, debate, and share 
views among stakeholders in academia, patient groups, regulatory 
bodies, and the health care and pharmaceutical industries on how best 
to measure, evaluate, and act upon liver injury and dysfunction caused 
by drugs used during clinical trials.

DATES: This public conference will be held on March 23, 2016, from 8 
a.m. to 6 p.m., and on March 24, 2016, from 8 a.m. to 4 p.m.

ADDRESSES: This public conference will be held at the College Park 
Marriott Hotel & Conference Center, 3501 University Blvd., East 
Hyattsville, MD 20783. The hotel's phone number is 301-985-7300.

FOR FURTHER INFORMATION CONTACT: Lana L. Pauls, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4478, Silver Spring, MD 20993-0002, 301-
796-0518, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In July 2009, FDA announced the availability of a guidance for 
industry entitled ``Drug-Induced Liver Injury: Premarketing Clinical 
Evaluation'' (74 FR 38035, July 30, 2009, https://www.thefederalregister.org/fdsys/pkg/FR-2009-07-30/pdf/E9-18135.pdf). First, this guidance explains that 
drug-induced liver injury (DILI) has been the most frequent cause

[[Page 2223]]

of safety-related drug marketing withdrawals over the past 50 years and 
that hepatotoxicity has both limited the use of many drugs that have 
been approved and prevented the approval of others. Second, this 
guidance discusses methods of detecting DILI by periodic tests of serum 
enzyme activities and of bilirubin concentration and how changes in the 
results of these laboratory tests over time, along with symptoms and 
physical findings, may be used to estimate the severity of the injury. 
Third, this guidance suggests some ``stopping rules'' for interrupting 
drug treatment and mentions the need to obtain sufficient clinical 
information to assess causation. FDA published a draft of this guidance 
in 2006, and comments on that draft were taken into consideration when 
issuing the final guidance in July 2009.

II. Conference Information

    The purpose of the 2016 conference is to invite participants to 
present their data and views and to hold an open discussion. The 
meetings in recent years have been attended by members of industry, 
regulatory bodies, and academic consultants, and the topics discussed 
have included several unresolved issues on which consensus was sought.
    Registration: A registration fee ($650 for industry registrants and 
$325 for Federal government and academic registrants) will be charged 
to help defray the cost of renting the meeting space, providing meals 
and snacks, and covering the travel fees incurred by invited academic 
(but not government or industry) speakers, as well as any 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.
    Additional information on the conference, program, and registration 
procedures may be obtained on the Internet at http://www.c-path.org, 
and at http://www.fda.gov by typing ``liver toxicity'' into the search 
box. (FDA has verified the Web site addresses but is not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management, Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. The Freedom of 
Information office address is available on the Agency's Web site at 
http://www.fda.gov.
    Materials presented at past programs (from 2007 to 2015) (including 
copies of slides shown, comments made about the slides, and discussions 
following the slides) may be accessed at http://www.aasld.org/events-professional-development/drug-induced-liver-injury-2015-program. (FDA 
has verified this Web site address but is not responsible for any 
subsequent changes to it after this document publishes in the Federal 
Register.)

    Dated: January 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00690 Filed 1-14-16; 8:45 am]
BILLING CODE 4164-01-P