FDA Aims to Standardize REMS Programs

  • October 24, 2014

By Emily Krulewitz

On September 23, FDA released a report regarding “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)”. This fulfills FDA’s PDUFA commitment to issue a report of findings regarding REMS standardization after collecting stakeholder input through public meetings and workshops. REMS programs are put in place to control patient ensure risk and can consist of many different components. Some REMS programs may require a medication guide to be dispensed with the prescription, some may require doctors to have certain training before prescribing, while others may require that patients enroll in a registry and have monthly doctor visits. For more information on REMS systems, please see our webinar from June 2014 titled “Single and Shared REMS Systems: The Past, Present, and Future.

Though REMS programs provide an additional safeguard for potentially dangerous drugs to be used by those in need, REMS programs have always been a controversial topic because of the burden placed on the healthcare system. Physicians are already very busy, and given the choice between obtaining specialized education in order to be able to prescribe a certain drug or not prescribing that drug at all, some physicians have chosen the latter, thus restricting patient access. Additionally, the important safety information about each drug is often communicated in an inconsistent manner, which leads to confusion among pharmacists and physicians who are attempting to understand the drug’s risks and comply with the REMS requirements. The FDA report is designed to address and acknowledge the feedback received by stakeholders and outline priority projects to improve REMS systems.

The priority projects are outlined below:

Project 1 Patient Benefit/Risk Information under REMS This project seeks to improve the way physicians communicate the benefits and risks of a drug to their patients. FDA proposes to research existing REMS counseling tools and seek feedback from stakeholders to improve REMS counseling.
Project 2 Prescriber Education under REMS This project seeks to provide continuing education (CE) credit to physicians who undergo certain REMS training programs. FDA proposes to evaluate the types of CE models that would work best and analyze the resources required to implement this idea.
Project 3 Pharmacy Systems under REMS This project seeks to include REMS information in the structured product labeling (SPL) format for drugs with REMS. FDA proposes to standardize the way REMS information is presented for ease of FDA review and make structured information available to physicians, patients, and FDA.
Project 4 Practice Settings under REMS This project seeks to provide a central source of REMS information for practice settings. FDA proposes to investigate a central source of information about what stakeholders are required to do in each REMS program, help stakeholders learn, understand, and comply with REMS requirements, and allow for comparison of REMS requirements across REMS programs.


The report addresses challenges for those seeking to understand and apply REMS information, specifically physicians, pharmacists, and patients. However, the report does little to address the inherent problems for drug sponsors. One such issue is the amount of time and money sponsors spend developing their REMS program, as REMS systems are specific to each individual drug (with a few exceptions, such as the ER/LA Opioids Analgesics REMS). Sponsors are also faced with the controversial requirement to negotiate shared REMS systems with potential competitors, sometimes during concurrent patent litigation.
Comments on this docket (FDA-2013-N-0502) are due on November 24, 2014 by 11:59 PM. It may behoove sponsors to respond to the docket with concerns and suggestions that would improve REMS systems from their perspective. However, until standardization and clearer guidance is issued, sponsors will have to accommodate to and work with the existing system. Sponsors are encouraged to consult The Weinberg Group to develop and implement their REMS system.

Emily Krulewitz is a Researcher at The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please contact us.