The Food and Drug Administration Amendments Act of 2007 (FDAAA) authorized the FDA to require sponsors to submit a risk evaluation and mitigation strategy (REMS) for drugs in cases in which the FDA determined that a REMS was necessary to ensure that the benefits of the drug would outweigh its risks.
We have applied our experience in developing and implementing risk management plans (RMPs) to helping our clients understand and meet requirements for REMS. Our REMS services include:
Consult on whether a REMS is required
The FDA may require a proposed REMS for a new drug as part of the regulatory submission package or as part of the submission package for an expanded label. Additionally, if new safety information becomes available for an existing approved drug, the FDA may require a REMS. Sponsors must submit a proposed REMS within 120 days of it being requested. Sponsors may voluntarily submit a proposed REMS without having been required to do so by the FDA. Whether a REMS is required or not, our experts can help you navigate the critical issues in developing your REMS strategy. Our consulting advice is supported with evidence from our understanding of FDA REMS guidance, reviewing current REMS programs, and observing trends with REMS submissions and implementation.
Develop the REMS proposal
We help our clients develop REMS proposals that are appropriate for the risks of concern and the target population. We are familiar with the state of the art of REMS programs and the tools currently in use to manage risk and ensure safe use. We can assist with all aspects of your REMS proposal including the medication guide, package insert, communication plan, and other elements to assure safe use (ETASU). Additionally, we can assist with developing the plan to assess and evaluate the REMS. The assessment plan must be submitted as part of the REMS proposal.
Implement the REMS
We can help you efficiently and effectively implement commitments made as part of your REMS proposals. Our expert services include:
- Development and cognitive testing of educational materials
- Creation and operation of registries for patients, physicians, and pharmacies
Assess and evaluate the REMS
Our systematic approach to REMS evaluations provides meaningful and actionable data. Our clients can use this information to update and refine their REMS programs so that patients receive the benefits of treatments and risks are minimized. As part of our assessment, we develop a study protocol that considers the unique characteristics of the product, patients, and prescribers and concerns of regulatory authorities. Key considerations include distribution, method of administration, frequency of use, population sampling methods, and methods to identify and minimize bias. We consider appropriate modes of collecting data including use of claims data, chart reviews, or prospective surveys.
We develop instruments that measure the key elements of the risk management plan, including receipt of educational materials, understanding of product safety and appropriate use, attitudes about safety messages, and actions taken to minimize risk. Instruments are evaluated using advanced cognitive testing processes.
We recommend appropriate survey methods based on the unique characteristics of the population being surveyed, with a focus on limiting the potential for bias. Our survey experience includes:
- Web surveys
- Paper-and-pencil questionnaires
- Electronic data capture (EDC) systems, including those loaded on tablet devices
- Medical chart abstraction
- In-person and telephone interviewing
Modify the REMS
Our assessment and evaluation of your REMS provides you with evidence that may allow you to propose and gain approval from regulatory authorities to modify your programs. Proposed changes may include addition, modification, or removal of the medication guide, patient package insert, communication plan, or elements to assure safe use (ETASU) and enhancement or reduction of other programs. Also, you may be able to gain approval for changes to the timetable for assessment, including eliminating assessment completely.
