[Federal Register: April 8, 2009 (Volume 74, Number 66)]
[Notices]
[Page 15993-15994]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap09-77]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration.
[Docket No. FDA-2009-N-0167]
Propylthiouracyl (PTU)-Related Liver Toxicity; Public Workshop
AGENCY: Food and Drug Administration, HHS.
[[Page 15994]]
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a 1-day
public workshop, cosponsored with the American Thyroid Association
(ATA), entitled ``Propylthiouracyl (PTU)-Related Liver Toxicity.'' This
public workshop is intended to provide a public forum for discussion of
the clinical, scientific, and regulatory issues pertaining to PTU-
induced hepatitis to seek constructive input from academia, regulatory
scientists, and other interested parties on the topic of PTU-induced
hepatitis. The input from this public workshop will help the ATA to
develop guidelines for the management of hyperthyroidism and help
inform FDA about necessary changes to prescription drug labeling for
PTU.
DATES: This public workshop will be held on Saturday, April 18, 2009,
from 8 a.m. to 3:30 p.m. However, depending on the level of public
participation, the meeting may be extended or may end early. Written or
electronic comments will be accepted after the workshop until June 19,
2009.
ADDRESSES: The public workshop will be held at the Madison Hotel at
1177 15th St., NW., Washington, DC 20005, 202-862-1600. We are opening
a docket to receive your written or electronic comments. Written or
electronic comments must be submitted to the docket by June 19, 2009.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to: http://
www.regulations.gov.
Comments should be identified with the docket number found in
brackets in the heading of this document.
Transcripts of the workshop will be available for review at the
Division of Dockets Management and on the Internet at http://
www.regulations.gov approximately 45 days after the workshop.
FOR FURTHER INFORMATION CONTACT: Jeff O'Neill, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6167, Silver Spring, MD 20903, 301-796-
0777, FAX: 301-847-8753, e-mail: jeff.o'neill@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
PTU-related liver toxicity has been reported in the published
literature, and while direct comparative studies to another approved
anti-thyroid medication, methimazole, are lacking, case series and
postmarketing adverse event reports suggest a greater risk associated
with PTU than methimazole. From prescription usage data, it appears
that PTU is used less frequently than methimazole with perhaps a
preferential use during pregnancy because of concerns about a rare
congenital defect described in case reports of methimazole use.
However, some data question whether an advantage of PTU use over
methimazole exists, even during pregnancy.
FDA and ATA are sponsoring this open public discussion involving
academia, regulatory scientists, and other interested parties on the
topic of PTU-induced hepatitis, because it is important to the health
of patients with thyroid disease that the applicable scientific,
clinical, and regulatory issues are raised and fully elucidated, and,
to the greatest extent possible, consensus is reached.
The ATA serves clinicians, scientists, and patients to facilitate
open interchange and dissemination of scientific knowledge. The
workshop is intended to provide a forum for discussion of the clinical,
scientific, and regulatory issues pertaining to PTU-induced hepatitis.
II. Registration
There is no fee to attend the workshop, and attendees do not need
to register. Seating will be on a first-come, first-served basis. If
you need special accommodations because of disability, please contact
Jeff O'Neill (see FOR FURTHER INFORMATION CONTACT) at least 7 days
before the workshop.
Dated: April 2, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7993 Filed 4-7-09; 8:45 am]
BILLING CODE 4160-01-S