July 17, 2019

The U.S. Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) program is relatively recent, dating back to passage of the Food and Drug Administration Amendments Act (FDAAA) in 2007.1 But it has been very active, and REMS programs have evolved substantially in both scope and complexity since then. Approximately 80 REMS (including shared REMS) programs were in place as of April 2019.2

Implementing and managing a REMS program takes a distinct set of skills and expertise. Manufacturers often struggle, however, to find an organizational “home” for those responsible for administering these programs, whose roles are often spread across pharmacovigilance, drug safety and regulatory affairs functions. Furthermore, those charged with overseeing and administering REMS programs within sponsor companies often have limited direct REMS experience or REMS-specific training. When looking externally for talent, sponsors run into the same problem, encountering difficulty finding and hiring experienced REMS professionals, especially those with experience in overseeing the implementation of shared REMS programs.

 

The need for REMS-specific training and professional development was one of the subjects of a Syneos Health-sponsored Leadership Forum for REMS executives, convened October 3-4, 2018, in Austin, Texas. Participants discussed how to better prepare associates for their REMS managerial and supporting roles, and ways to bring greater awareness to REMS program design, implementation and assessment as a specialized discipline.

The status quo: learning by doing

REMS programs can be relatively straightforward, requiring only a medication guide, an informational website and a call center for stakeholders who have questions. Complexity increases with the number and type of Elements to Assure Safe Use (ETASU), such as restricted distribution or registry requirements, as well as the need to manage multiple service providers. A shared REMS program can magnify these complexities considerably, requiring companies that are likely also competitors to do what does not come naturally— closely coordinate and share information to ensure successful program oversight and administration.

REMS programs, therefore, are distinguished by their cross-functional, multidisciplinary nature and the need for extraordinary levels of coordination and communication among multiple internal and external stakeholders. It is a challenging environment in which to “learn by doing.” But that is exactly what many who find themselves in the midst of designing, implementing and operationalizing a REMS program must do.

While certification and training programs in disciplines such as regulatory affairs, drug safety and pharmacovigilance may include high-level content on REMS, they typically focus on the basics and do not provide in-depth exposure to the development, implementation and operational intricacies associated with launching and managing REMS programs. REMS-specific professional development opportunities are further limited because there is not typically a dedicated REMS “home” or department within most organizations and no clear career path for professionals working in this space.

As a result, many pharmaceutical companies struggle to find and hire knowledgeable REMS associates with the right mix of skills and expertise. It is more common for organizations to develop people for these roles internally by assigning them to work on a live REMS program— the “learn by doing” approach. Becoming well-versed in all aspects of a REMS program, however, can take months to years, placing an excessive burden on an organization’s assigned resources and potentially increasing internal operational costs. Even then it is unlikely that an associate will be fully knowledgeable about all aspects of the program, from initial notification through operations. Lack of training opportunities and experience can lead to inadequate execution of REMS elements, and potentially puts organizations at risk during audits or regulatory inspections.

The need: REMS-specific training and professional development

Changes in the regulatory climate and changing perspectives and expectations among key stakeholders mean that REMS programs are continuing to evolve at a fast pace. A REMSspecific training program, perhaps spearheaded by a professional society and developed in collaboration with sponsor companies, may help to meet these challenges. REMS associates require not only specific skills and capabilities to develop, implement and manage REMS programs as they are today, but also must remain up-to-date with changes in regulatory actions, perspectives and REMS best practices and to engage in proactive dialogue with regulatory authorities.

While designed primarily for REMS associates, a REMS-specific training program could also be beneficial for other individuals and functions within the organization. Regulatory teams are often deeply engaged in the early stages of a REMS program and could benefit from more thorough understanding of ongoing implementation processes and best practices to inform REMS design. The same is true for individuals with REMS exposure in legal and finance functions, enabling them to be more effective in their REMS-related roles. A modular training and professional development program, scalable to each target audience’s role and level of experience, would be ideal given the wide range of people and functions that REMS programs touch throughout an organization.

Executive leadership could also benefit from REMS-specific educational efforts, with emphasis on cultivating a proactive, comprehensive approach to integrating strategies for REMS design, implementation and oversight into every phase of development, across the clinical-commercial spectrum. Such an effort would also elevate awareness industry-wide about the importance of taking a holistic approach to managing and communicating risk/benefit (and, by extension, product value), consistent with the evolving needs and expectations of patients, providers and payers.

In summary

Biopharmaceutical companies have a difficult time finding associates who can quickly become active managers of and contributors to REMS programs. Developing a REMS-specific training program would likely decrease the amount of time it takes to onboard new REMS associates, maximize the effectiveness of these associates, heighten REMS awareness and coordination throughout an organization, and promote REMS as a professional field.

References
  1. U.S. Food and Drug Administration. Food and Drug Administration Amendments Act (FDAAA) of 2007. Available at: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/food-and-drug-administrationamendments- act-fdaaa-2007.
  2. U.S. Food and Drug Administration. Approved risk evaluation and mitigation strategies (REMS). Available at: https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm.
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