Given the stringent regulatory requirements in the health care industry, it is important for bio-pharmal companies to develop innovative Risk Evaluation and Mitigation Strategies (REMS) plans during the commercialization of certain products to ensure an acceptable risk-to-benefit ratio.
This benchmark study published by Best Practices, LLC examines how companies develop and execute successful Risk Evaluation and Mitigation Strategies (REMS) plans for newly-approved drugs in the U.S. market. This study can help bio-pharma companies in creating successful REMS programs.
Best Practices, LLC Strategic Benchmarking Research
Models & Trends in Supporting REMS Program Success
Table of Contents
Executive Summary pg. 3
Research Overview pg. 4
Participating Companies pg. 5
Abbreviations Used pg. 6
Key Recommendations pg. 7
Key Findings & Insights pgs. 8-10
Benchmark Class Profile pgs. 11-12
REMS Program: Structure & Responsibilities pgs. 13-17
Industry Experience in Developing & Deploying pgs. 18-22
Successful REMS Plans
REMS Approaches for New Products pgs. 23-26
Leveraging Resources for REMS Efficiency & Excellence pgs. 27-31
REMS Communication Plans: Current Challenges pgs. 32-36
About Best Practices, LLC pgs. 37-38
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REMS Benchmark Research: Objectives, Methodology & Topics
New regulatory requirements, such as those outlined in the Food and Drug Administration’s Amendments Act of 2007, create
compliance hurdles for pharmaceutical organizations. As a result, pharmaceutical companies must develop effective REMS
program strategies to help achieve both compliance and commercial objectives.
Structure of Risk Evaluation & Mitigation
Strategy (REMS) teams
Key activities across functions
Regulatory imperatives and commercial
objectives associated with REMS
How Market Research teams are used to
support and benefit REMS programs
Best Practices, LLC engaged 20
leaders from 17 biopharmaceutical
& medical device companies for
This benchmark study examines
how companies develop and
execute successful Risk
Evaluation and Mitigation
Strategies (REMS) plans for
newly-approved drugs in the U.S.
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Benchmark Class and Representative Job Titles of Participants:
This study engaged 19 healthcare executives and leaders supporting REMS programs at 17 leading life sciences and medical
device companies. More than 50% of research participants work at the level of director or senior director. Roughly one-fifth of
participants serve either as president or CEO.
Universe Of Learning: 17 Companies Participated in Study
Associate Director Phase IV Clinical Trials
Chief Medical Officer
Deputy General Manager
of Epidemiology Field Studies
Founder and CEO
Global Medical Director
Local Safety Manager
Risk Management Consultant
Senior Medical Director
Senior Director Benefit-risk
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The following acronyms are used frequently in this research. Definitions are provided below.
Acronyms Used in this Study
REMS: "Risk Evaluation and Mitigation Strategy" - A set of plans and activities required by the FDA
(per the Food and Drug Administration Amendments Act of 2007) and undertaken by a drug
manufacturer to educate patients and physicians on the risks associated with certain newly-
approved products in the United States.
ETASU: "Elements to Assure Safe Use" - A component of certain REMS plans, often for drugs with
potentially serious risks. For example, ETASUs can require prescriber training or certification,
certification of dispensers, the restriction of drug administration certain healthcare settings, and
other steps on the part of the manufacturer.
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Key Findings & Insights
Few of the key findings and insights that emerged from this study:
Pharmacovigilance & Medical Affairs Functions Lead REMS: According to this research study,
REMS programs are mainly led by Pharmacovigilance (at 42% of benchmark companies) and
Medical Affairs (26%). Additional support functions such as Regulatory Affairs, Clinical, and
Commercial also support overall REMS activities at some organizations. Market Research also
serves a limited role in REMS at many participating companies.
Internal Databases and Past Internal REMS Plans Serve as Most-Used Internal Resource:
Most companies closely study previous internal REMS programs undertaken within the company,
both for drugs in a different therapeutic area (65%) or same therapeutic area (53%). Almost half of
companies also refer to internal research repositories / databases to gain further insights.
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Q. What functional group leads the REMS program at your
Ultimate responsibility for REMS programs tends to reside within either the Pharmacovigilance (42% of benchmark companies)
or Medical Affairs (26%) function. Regulatory/Compliance, Medical Affairs, Commercial/Clinical, and PV/Safety are functions that
provide a secondary support role with REMS programs at 44% of participating companies.
Pharmacovigilance, Medical Affairs Typically Lead REMS
*Other: Multidisciplinary but Safety (PV) has largest
role, Finance/BCP/Compliance, CRO
*Other: Risk Management, Epidemiology,
Other Lead Functions:
Q. List any function or group who have a secondary leading
role for the REMS program at your organization.
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Q. Which of the following REMS Plans does your organization have experience in supporting?
Where REMS plans are required, the benchmark class has the most experience in developing Medication Guides and
Communication Plans to support physicians and patients. Slightly less prevalent are “Elements to Assure Safe Use”
components (e.g., diagnostic tests, physician training) and Implementation Plans, such as physician or distributor certifications.
89% Have Experience with REMS Medication Guides
REMS Plan Experience Areas:
ETASU (e.g., diagnostic tests, physician
Implementation Plans (e.g., certifying
physicians, distributors; patient registries)
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Q. What resources does your REMS function use to leverage internal research completed by brand teams and franchise
Instead of trying to “re-invent the wheel” for each new REMS product, 65% of companies capitalize both on past internal REMS
data for drugs within different therapeutic areas, while another 53% of companies use past REMS program for drugs within same
therapeutic areas is such experience is available within the organization.
Companies Draw on Past REMS Product Experience if Available
Internal REMS Plans Data Used:
A centralized knowledge-sharing or Center of
Internal research repositories / databases
Past internal REMS programs for other drugs
within the same therapeutic area
Past internal REMS programs for other drugs
across different therapeutic areas
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Best Practices®, LLC is an internationally recognized thought leader in the field of best practice
benchmarking®. We are a research, consulting, benchmark database, publishing and advisory firm that
conducts work based on the simple yet profound principle that organizations can chart a course to superior
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