REMS Excellence: Models & Trends in Supporting REMS Program Success

STUDY OVERVIEW

Given the complexity of balancing regulatory imperatives and commercial objectives, Best Practices, LLC conducted a benchmarking study to explore how pharmaceutical companies develop and execute effective Risk Evaluation and Mitigation Strategy (REMS) plans for newly-approved drugs in the U.S. market.

The report provides leading insights and benchmarks around the structure and responsibilities of REMS teams, use of market research teams to support and benefit REMS programs, physician/ distributor compliance on ETASU, current challenges in REMS communication plans and innovative REMS approaches for new products.

KEY TOPICS

• REMS Program: Structure & Responsibilities
• Industry Experience In Developing & Deploying Successful REMS Plans
• REMS Approaches For New Products
• Leveraging Resources For REMS Efficiency & Excellence
• REMS Communication Plans: Current Challenges

• Function/Group leading REMS program at benchmarked companies
• Effectiveness of communication plan and ETASU activities managed by REMS organization
• Percentage of research associated with REMS plans conducted internally versus outsourced to external vendors
• Resources used by REMS function to leverage external approved REMS plans (data) from other companies
• Resources used by REMS function to leverage internal research completed by brand teams and franchise units

• Pharmacovigilance & Medical Affairs Functions Lead REMS: According to the study, REMS programs are mainly led by Pharmacovigilance (at 42% of benchmark companies) and Medical Affairs (26%). Additional support functions such as regulatory affairs, and sub-functions such as clinical and commercial also support overall REMS activities at some organizations. Market Research serves very limited role in REMS at any participating companies.
  
  
• The FDA Website Is the Most Often Used External Resource: Some 74% of REMS teams refer to the FDA website for REMS plan direction. But a majority of companies also leverage internal research repositories and third-party vendor propriety databases to build out their REMS plans and execution steps.

METHODOLOGY

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.

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