[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

[[Page 56817]]

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]
BILLING CODE 4164-01-P