[Federal Register Volume 79, Number 184 (Tuesday, September 23, 2014)]
[Notices]
[Pages 56816-56818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22513]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0502]
Report on the Standardization of Risk Evaluation and Mitigation
Strategies; Availability
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 report entitled ``Standardizing and Evaluating
Risk Evaluation and Mitigation Strategies (REMS)''. This report
describes the Agency's findings concerning strategies to standardize
risk evaluation and mitigation strategies (REMS), where appropriate,
with the goal of reducing the burden of implementing REMS on
practitioners, patients, and others in various health care settings. As
part of the reauthorization of the Prescription Drug User Fee Act
(PDUFA), FDA has committed to standardizing REMS to better integrate
them into the existing and evolving health care system. FDA is
publishing this report to allow the public to provide comment on the
report as it relates to PDUFA.
DATES: Submit either electronic or written comments by November 24,
2014.
ADDRESSES: Submit written requests for single copies of the draft
report to the Division of Drug Information, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft report.
Submit electronic comments 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. Identify comments with the docket number found in brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: Richard Currey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6125, Silver Spring, MD 20993-0002, 301-
796-3918, FAX: 301-595-7910, email:
[email protected]; or Adam Kroetsch, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-0002; 301-
796-3842, FAX: 301-847-8443, email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft report entitled
``Standardizing and Evaluating Risk Evaluation and Mitigation
Strategies (REMS).'' This report describes the Agency's findings
concerning strategies to standardize REMS, where appropriate, with the
goal of reducing the burden on practitioners, patients, and others in
various health care settings. The Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110-85), enacted on September 27, 2007,
established FDA's authority to require REMS for prescription drug and
biological products when it determines that such a strategy is
necessary to ensure that the benefits of a drug outweigh the risks.
Since that time, REMS have become a key tool in augmenting FDA's drug
safety capacities. The Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144), enacted on July 9, 2012,
amended FDA's REMS authorities and strengthened the Agency's ability to
safeguard and advance public health. Among other things, FDASIA
reauthorized the Prescription Drug User Fee Act (known as ``PDUFA V,''
reflecting the fifth reauthorization of PDUFA). As part of its PDUFA V
commitments, FDA agreed, among other things, to ``measure the
effectiveness of REMS and standardize and better integrate REMS into
the health care system.'' To this end, ``FDA will . . . continue to
develop techniques to standardize REMS and with stakeholder input seek
to integrate them into the existing and evolving (e.g., increasingly
electronic) health care system.'' FDA also agreed to hold one or more
public meetings to explore strategies to standardize REMS, where
appropriate, with the goal of reducing the burden of implementing REMS
on practitioners, patients, and others in various health care settings,
and to issue a report of the Agency's findings identifying at least one
priority project with a work plan for project completion in the areas
of pharmacy systems, prescriber education, providing benefit-risk
information to patients, and practice settings.
FDA held a 2-day public meeting on REMS Standardization and
Assessment on July 25-26, 2013, on approaches to standardizing REMS and
better
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integrating them into the health care delivery system. A transcript of
the public meeting and a background document, as well as FDA
presentations made at the meeting, are available on FDA's Web site at
http://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm351029.htm.
This report summarizes stakeholder engagement achieved in fiscal
year (FY) 2013, including suggestions and recommendations received from
meetings, an expert panel workshop, and comments received
electronically (posted to a Federal docket) and via teleconferences.
Stakeholder feedback guided the Agency in selecting four priority
projects within the areas specified by PDUFA V: (1) Providing benefit/
risk information to patients, (2) prescriber education, (3) pharmacy
systems, and (4) practice settings. This report briefly reviews the
background and context for REMS as well as FDA initiatives for REMS
administration and program improvement, summarizes key feedback from
stakeholders and experts, and presents the design and the proposed
workplans of projects in the four designated priority areas.
II. Draft Report Describing Findings Concerning REMS Standardization
and Plans for Projects To Standardize REMS
A. Stakeholder Recommendations
Stakeholder input and recommendations received by FDA in 2013
emphasize the need for better communication by FDA about REMS, improved
leveraging of information technology, and flexibility to tailor REMS
programs to specific health care settings. The four priority projects
that are discussed in detail at the end of the report flow, in part,
from these recommendations, and represent the Agency's next steps
toward an improved and integrated REMS strategy.
FDA found that stakeholders in various settings have successfully
implemented REMS requirements, in some cases developing systems to
manage REMS requirements specific to their institutions and integrate
the REMS into their practices. However, FDA also heard that REMS
programs affect specific stakeholder responsibilities and
organizational structures differently, presenting a central challenge
to standardizing REMS while meeting the needs of multiple stakeholders
across an array of health care environments. Stakeholders indicated
that they want flexibility to implement a REMS program based upon the
nature of the health care setting.
Stakeholders emphasized that communication by FDA about REMS should
be improved. They stated that FDA communications about REMS are often
inadequate, inconsistent, unclear, or too difficult to access,
navigate, and digest.
Stakeholders recommended that FDA create more comprehensive,
evidence-based, and organized communications that can function within
existing health care systems; deliver clear, actionable information to
clinicians; and help to ensure that patients receive the drugs they
require with excellent safety monitoring and oversight. They frequently
suggested that FDA invest in and improve leveraging of existing
information technology systems to better integrate REMS into standard
medical practice and ongoing health care delivery.
Several stakeholders noted that current REMS documentation is not
standardized and generally cannot be easily searched, queried, or
managed. They recommended Structured Product Labeling (SPL) as a
possible designated standard that may allow for a centralized,
standardized REMS information repository.
Several stakeholders expressed interest in human factors evaluation
methods like Failure Modes and Effect Analysis (FMEA) or a ``Health
Care FMEA'' that might be deployed to help to develop criteria for
levels of risk (e.g., illness, injury, death) that could prompt
regulatory action.
Stakeholders suggested that REMS assessments might benefit from
leveraging of data sources (e.g., electronic health records, claims
data) to conduct assessments. A related recommendation was that FDA
assess programs earlier and more frequently throughout a product's life
cycle, and apply information gleaned from assessments to modify REMS if
needed.
B. Priority Projects
Guided by stakeholder feedback and recommendations, FDA has
identified four priority projects, one for each topic area described
previously. Each project responds to input the Agency has received
regarding significant areas of opportunity for REMS standardization and
evaluation efforts.
Project 1: Providing Benefit-Risk Information to Patients
This project aims to improve the tools used for prescriber-to-
patient counseling about REMS drugs. To that end, FDA proposes to
conduct research into existing REMS patient counseling tools, other
patient counseling initiatives, and counseling literature to identify
current tactics and strategies for patient counseling about medication
benefits and risk. The Agency intends to seek feedback from a range of
stakeholders to identify opportunities to improve the content, format,
processes, techniques, and delivery of effective counseling within REMS
programs. In addition, FDA intends to develop a public report of
findings and counseling processes and tools that could serve as the
basis for designing new tools and validating them in demonstration
projects.
Project 2: Prescriber Education
Numerous stakeholders asked FDA to facilitate the provision of
health care provider continuing education (CE) for the education and
training that is provided in a REMS program. This project will assess
whether it is feasible to provide CE certified by the Accreditation
Council of Continuing Medical Education, Accreditation Commission for
Education in Nursing, and Accreditation Council for Pharmacy Education
associated with a specific REMS. FDA will seek to determine at what
stage in the drug approval process CE development would best fit (e.g.,
before or after product approval) and which CE model(s) would be best
suited for this type of activity; and provide an analysis of the time
and resource burden associated with developing such CE programs.
Project 3: Pharmacy Systems
FDA proposes to identify an approach for incorporating REMS
information into SPL. The project's purpose is to develop a method to
share clear and consistent information about the content of REMS,
including REMS documents, requirements, and materials. Doing so will,
among other things, facilitate integrating REMS into pharmacy systems
and health information technology, including systems for electronic
prescribing. SPL will also enable FDA to make structured REMS
information available to health care providers and patients, and
provide a single conduit of comprehensive information about REMS
programs.
Project 4: Practice Settings
The purpose of this project is to provide a centralized,
standardized, reliable, and user-friendly repository of information
about REMS, including stakeholders' specific activities and
requirements under each REMS program. FDA intends to develop its REMS
Web page as a central source of REMS information, which will provide
stakeholders in a range of practice settings with a reliable and
accessible resource to help them quickly learn
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about REMS programs, understand and comply with REMS requirements, and
compare requirements across REMS to minimize confusion associated with
complying with multiple REMS programs.
C. Scope of the Report
This report describes the Agency's findings concerning strategies
to standardize REMS where appropriate, with the goal of reducing the
burden of implementing REMS on practitioners, patients, and others in
various health care settings. This report contains project plans to:
(1) Increase access to REMS-related information through the use of SPL,
(2) enhance the Agency's REMS Web page to better meet the needs of
stakeholders, (3) assess the feasibility of using accredited CE courses
for prescriber training, and (4) enhance existing tools for prescribers
to communicate with patients regarding risks of drugs with REMS, and
how those risks should be weighed against the potential benefits of the
drug.
III. Electronic Access
Persons with access to the Internet may obtain the document on
FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm350852.htm or http://www.regulations.gov.
IV. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of 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, and will be posted to the docket at http://www.regulations.gov. After consideration of comments, FDA will
finalize the report and project plans. The Agency intends to post
updates to the project plans on FDA's Web site.
Dated: September 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22513 Filed 9-22-14; 8:45 am]
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