
[Federal Register: November 18, 2009 (Volume 74, Number 221)]
[Notices]               
[Page 59568-59569]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18no09-75]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0143]

 
Risk Evaluation and Mitigation Strategies for Certain Opioid 
Drugs; Notice of Public Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public meeting.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a meeting 
with sponsors of certain opioid drug products regarding the development 
of Risk Evaluation and Mitigation Strategies (REMS) for these products. 
Other members of the public are invited to attend and observe. The REMS 
is intended to ensure that the benefits of these drugs continue to 
outweigh certain risks. FDA has encouraged affected sponsors to work 
collectively to develop a proposed REMS. The purpose of this meeting is 
to hear from sponsors about the status of the development of a proposed 
REMS and their views regarding the specific features of the REMS for 
these products. To promote transparency of the REMS development 
process, other members of the public are invited to attend the meeting 
as observers. Additional opportunities for public input will be 
provided before FDA finalizes the elements of the REMS.

DATES:  The meeting will be held on December 4, 2009, from 9 a.m. to 1 
p.m. To ensure consideration at the meeting, submit comments by 
November 27, 2009. Register to attend the meeting by November 27, 2009. 
See section III of this document for information on how to register for 
the meeting.

ADDRESSES:  The public meeting will be held at the Holiday Inn 
Washington-College Park, 10000 Baltimore Ave., College Park, MD 20740.
    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. All comments should be identified with the docket 
number found in brackets in the heading of this document.
    A live webcast of this meeting will be viewable at http://
ConnectLive.com/events/fda120409 on the day of the meeting. A video 
record of the meeting will be available at the same Web address for 1 
year.

FOR FURTHER INFORMATION CONTACT:  Theresa (Terry) Martin, Center for 
Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6196, Silver Spring, MD 20993, 301-796-
3448, FAX: 301-847-8753, or
    Patrick Frey, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6350, 
Silver Spring, MD 20993, 301-796-3844, FAX: 301-847-8443, e-mail: 
OpioidREMS@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On February 6, 2009, the Food and Drug Administration (FDA) sent 
letters to manufacturers of certain opioid drug products, indicating 
that these drugs will be required to have a Risk Evaluation and 
Mitigation Strategy (REMS) to ensure that the benefits of the drugs 
continue to outweigh the risks. A table of opioid products that will be 
required to have REMS is available on the agency's Web site at http://
www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163654.htm. 
Copies of this document may be requested from Theresa (Terry) Martin 
(see FOR FURTHER INFORMATION CONTACT). The affected opioid drugs 
include brand name and generic products and are formulated with the 
active ingredients fentanyl, hydromorphone, methadone, morphine, 
oxycodone, and oxymorphone. The REMS would be intended to ensure that 
the benefits of these drugs continue to outweigh the risks associated 
with: (1) Use of high doses of long-acting opioids and extended-release 
opioid products in non-opioid-tolerant and inappropriately selected 
individuals; (2) abuse; (3) misuse; and (4) overdose, both accidental 
and intentional. REMS for these opioids would likely include elements 
to assure safe use to ensure that prescribers, dispensers, and patients 
are aware of, and understand, the risks and how these products should 
be used.
    On March 3, 2009, FDA held a meeting with affected sponsors to 
discuss how the REMS could be designed to manage the risks while also 
minimizing burdens to the health care system. FDA presented a high-
level overview, regulatory background, and the proposed elements of the 
REMS followed by questions and comments from the sponsors. At this 
meeting, FDA encouraged sponsors to work collectively to develop a 
proposed REMS. The FDA presentations and minutes from this meeting are 
available on the agency's Web site at http://www.fda.gov/Drugs/
DrugSafety/InformationbyDrugClass/ucm163660.htm. In May, FDA held 
meetings with other affected stakeholders including health care 
professionals, patient advocates, and pharmacy groups. FDA then held a 
public meeting on May 27 and 28, 2009, where FDA heard from members of 
the public on what the REMS should look like for these products, how to 
minimize the burden on the health care community and patients, and how 
FDA should evaluate the REMS to determine whether it achieves its 
objectives. Nearly 100 members of the public spoke at the meeting, and 
many others have submitted written comments to the docket (Docket No. 
FDA-2009-N-0143). For additional background information about this 
issue see 74 FR 17967, April 20, 2009.

II. Purpose of Meeting

    The purpose of this meeting is for FDA to hear from sponsors of 
long-acting opioids and extended-release opioid products on the 
development of the REMS for these products and their views about the 
specific features of the REMS. Other members of the public are invited 
to attend the meeting as observers. Because this is a meeting between 
FDA staff and the sponsors, only FDA staff will be permitted to 
question the sponsors at the meeting. However, interested persons who 
attend the public meeting will be given an opportunity to provide 
suggestions for questions for FDA staff to ask the sponsors, at FDA's 
sole discretion. Index cards will be provided for this purpose. There 
will be additional opportunities for public input before FDA finalizes 
the elements of the REMS.

III. Attendance and Registration

    Registration: Register by e-mail to OpioidREMS@fda.hhs.gov. Provide 
complete contact information for each attendee, including name, title, 
affiliation, address, e-mail, and phone

[[Page 59569]]

number. Registration requests should be received by November 27, 2009. 
Registration is free and will be on a first-come, first-served basis. 
Early registration is recommended because seating is limited. FDA may 
limit the number of participants from each organization based on space 
limitations. Registrants will receive confirmation once they have been 
accepted. Onsite registration on the day of the meeting will be based 
on space availability on the day of the event starting at 8 a.m.
    If you need special accommodations because of disability, please 
contact Theresa (Terry) Martin (see FOR FURTHER INFORMATION CONTACT) at 
least 7 days before the meeting.
    In addition, a live webcast of this meeting will be viewable at 
http://ConnectLive.com/events/fda120409 on the day of the meeting. A 
video record of the meeting will be available at the same Web address 
for 1 year.

IV. Comments

    In addition, any person may submit written or electronic comments 
to the Division of Dockets Management (see DATES and ADDRESSES). Submit 
a single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Transcripts

    Transcripts of the meeting will be available for review at the 
Division of Dockets Management and on the Internet at http://
www.regulations.gov approximately 30 days after the meeting. A 
transcript will also be made available in either hard copy or on CD-
ROM, upon submission of a Freedom of Information request. Written 
requests are to be sent to Division of Freedom of Information (HFI-35), 
Office of Management Programs, Food and Drug Administration, 5600 
Fishers Lane, rm. 6-30, Rockville, MD 20857.

    Dated: November 12, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27718 Filed 11-17-09; 8:45 am]

BILLING CODE 4160-01-S
