[Federal Register Volume 76, Number 215 (Monday, November 7, 2011)]
[Notices]
[Pages 68766-68767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-28669]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0771]


Draft Blueprint for Prescriber Education for Long-Acting/
Extended-Release Opioid Class-Wide Risk Evaluation and Mitigation 
Strategy; Availability; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Blueprint for Prescriber 
Education for the Long-Acting/Extended-Release Opioid Class-Wide REMS'' 
(Blueprint). The draft Blueprint contains core messages intended for 
use by continuing education (CE) providers to develop educational 
materials to train prescribers of long-acting and extended-release 
opioids under the required risk evaluation and mitigation strategy 
(REMS) for these products (Opioid REMS). FDA seeks stakeholder input on 
the document. After comments are received, FDA will revise the 
Blueprint as appropriate, incorporate it into the Opioid REMS when it 
is approved, and post it on FDA's Web site for use by CE providers.

DATES: Submit either electronic or written comments on the draft 
Blueprint by December 7, 2011.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft Blueprint. Submit electronic comments on the draft 
Blueprint to http://www.regulations.gov. Submit written comments to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Michie I. Hunt, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6153, Silver Spring, MD 20993-0002, (301) 
796-3504.

SUPPLEMENTARY INFORMATION:

I. Background

    The Food and Drug Administration Amendments Act of 2007 (FDAAA) 
gave FDA the authority to require manufacturers to develop and 
implement a REMS when necessary to ensure the benefits of a drug or 
biological product outweigh its risks.

A. REMS for Long-Acting and Extended-Release Opioids

    On February 6, 2009, FDA sent letters to manufacturers of certain 
opioid drug products indicating that these drugs will be required to 
have a REMS to ensure that the benefits of the drugs continue to 
outweigh the risks.\1\ The affected opioid drugs include long-acting 
and extended-release brand name and generic products and are formulated 
with the active ingredients buprenorphine, fentanyl, hydromorphone, 
methadone, morphine, oxycodone, oxymorphone, and tapentadol. After 
sending the letters, FDA held a series of meetings with stakeholders 
and convened an advisory committee to obtain input on the appropriate 
elements of the Opioid REMS.
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    \1\ See the Opioid REMS Meeting Invitation Template at http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM163652.pdf and the Opioids Products Chart at http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163654.htm.
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    On April 19, 2011, in conjunction with the Office of National Drug 
Control Policy (ONDCP) release of the Obama Administration's Epidemic: 
Responding to America's Prescription Drug Abuse Crisis--a comprehensive 
action plan to address the national prescription drug abuse epidemic, 
FDA issued letters to application holders directing them to submit a 
REMS within 120 days and describing the elements that needed to be 
included in the REMS (REMS notification letters). The central component 
of the Opioid REMS program is an education program for prescribers 
(e.g., physicians, nurse practitioners, physician assistants) and 
patients.

B. REMS Prescriber Education

    In the REMS notification letters, FDA provided an outline of the 
required prescriber education. The outline specified that the education 
must include information on weighing the risks and benefits of opioid 
therapy, choosing patients appropriately, managing and monitoring 
patients, and counseling patients on the safe use of these drugs. In 
addition, the education must include information on how to recognize 
evidence of, and the potential for, opioid misuse, abuse, and 
addiction. The REMS notification letters stated that although there is 
no mandatory requirement that prescribers take the course as a 
precondition to dispensing the medication to patients, application 
holders will be required to establish goals for the number of 
prescribers trained, collect the information about the number of 
prescribers who took the courses, and report the information to FDA as 
part of periodic required assessments.

C. CE Providers Will Conduct Prescriber Education

    The REMS notification letter expressed FDA's expectation that the 
training would be conducted by accredited, independent continuing 
education providers. FDA later elaborated on its vision for prescriber 
education stating that we expect the CE training to be provided without 
cost to the healthcare professionals and that sponsors would offer 
unrestricted grants to accredited CE providers to develop CE for the 
appropriate prescriber

[[Page 68767]]

groups.\2\ We believe having the training provided by CE organizations 
will be an incentive and will not create new burdens on prescribers 
because most healthcare professionals are routinely engaged in CE 
activity.
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    \2\ See FDA Opioid REMS Meeting with Industry (May 16, 2011), at 
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258184.htm and Preliminary Responses to Industry Questions About 
Opioid REMS at http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258113.htm.
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D. The Blueprint Will Provide the Basic Outline and Core Messages for 
CE

    In response to the April REMS notification letter, application 
holders, through an industry working group, submitted an expanded 
outline of the potential topics to be covered in the CE, noting that 
education incorporating all of the topics in the outline could require 
30 or more hours of education. FDA's expectation is that the initial or 
basic REMS related CE that should be offered to all prescribers of 
long-acting and extended-release opioids should consist of a ``core'' 
content of about 2 to 3 hours. FDA has reviewed the industry submission 
and developed a basic outline and the core messages that FDA believes 
should be conveyed to prescribers in this basic educational module. 
After it is completed and approved as part of the REMS, the Blueprint 
will be posted on FDA's Web site for use by CE providers in developing 
CE courses. Although FDA recognizes that additional training modules 
could be helpful, FDA's goal is to require basic education for all 
prescribers of long-acting and extended-release opioids, and at this 
time, FDA does not intend to develop or approve messages as part of the 
REMS beyond those approved in the basic core module. Using the 
Blueprint on FDA's Web site, CE providers can develop accredited CE in 
the manner they choose.\3\
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    \3\ Since early May 2011, FDA has held teleconferences and met 
with representatives from the CE accreditor and provider 
communities. We have expressed our interest in understanding the 
challenges of the CE providers, including the need to be in 
compliance with the Accreditation Council for Continuing Medical 
Education (ACCME) Standards for Commercial Support and the need to 
ensure that the content of CE remains beyond the control of 
industry. We are confident that the ACCME standards will be met and 
ACCME will be satisfied that FDA will control the content of REMS 
CE.
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    With this document, FDA is announcing the availability of the 
Agency's draft Blueprint for prescriber education and soliciting public 
comment. The draft Blueprint is available on the Internet at 
www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM277916.pdf. FDA will consider any comments submitted and make 
appropriate revisions before approving the Blueprint as a part of the 
Opioid REMS.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments on the draft 
Blueprint. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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.

    Dated: November 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28669 Filed 11-4-11; 8:45 am]
BILLING CODE 4160-01-P