Risk Assessment Mitigation Strategy

Risk Assessment Mitigation Strategy (REMS)- 14 Years Later

REMS and Manufacturers

REMS has been in existence for 14 years now as shown in the timeline above.

In September 2020, the Office of the Inspector General (OIG) criticized the REMS program for missing the mark with regard to addressing the opioid crisis.1 Looking at the REMS for transmucosal immediate-release fentanyl (TIRF) and extended-release/long-acting opioids (ER/LA) from 2011 through 2017, including all drug manufacturer-submitted assessments, FDA decision memoranda, assessment reviews, and inspection reports, OIG concluded that FDA struggled to measure the effectiveness of REMS in mitigating misuse and manufacturers failed to meet their goals and data submitted for some of the REMS goals was inadequate. While FDA did request that manufacturers submit more and better data, they were unable to do so. This represents just the latest example of issues with the REMS program, ranging from limited effectiveness to challenges  faced by stakeholders. High indirect costs to the healthcare system, increased stringent requirements placed on the drugs, and the burden on patient access to care are frequently identified issues.2,3

On November 5, 2020. FDA announce its plan to increase REMS assessment transparency and provide its “report card” on how manufacturers are doing.4 Manufacturers are required to provide regular assessments to FDA but this data has never been revealed. Such data can affect a company stock prices and investor attractiveness.

REMS in the Specialty Pharmacy Space

FDA acknowledges that pharmacists bear the most requirements for assuring that REMS requirements are met.5 More specialty drugs are approved pursuant to a REMS program and there are many challenges in integrating REMS elements into pharmacy systems especially workflow obstacles. The pharmacy must, at a minimum, provide patient or caretaker consultation for every fill; obtain and maintain confirmation and authorization numbers; track each dispensing to adhere to quantity restrictions; and ensure appropriate documentation is received. Studies have shown that trying to implement new REMS systems can take anywhere from three weeks to three months per program as each is unique, including an additional 160 hours of pharmacy workload.6

Frier Levitt offers complete third party REMS administration to optimize both patient safety and access, including:

  • FDA submissions and support of approvals of REMS programs
  • Structured prototype REMS with timeline assessment
  • Standardization across products in a class with document integration into healthcare systems
  • Preparation and review of required safety communications such as a Boxed Warning, a Medication Guide, a Patient Package Insert, a “Dear Healthcare Professional” letter, and modernized risk advisory information for the media
  • Development of a communication plan for healthcare providers
  • Development of Elements to Assure Safe Use (ETASU) Implementation Systems, including training and certification programs
  • Development of strategic program designs for REMS clearance prior to the prescription being presented at the pharmacy
  • Risk monitoring and adverse event capturing, clinical data collection and analysis
  • Rigorous program compliance monitoring and auditing services
  • Reporting Guidance including surveys and assessments of program effectiveness through patient, healthcare provider, healthcare setting, and pharmacy surveys
  • False Claim Act Litigation over REMS

Frier Levitt specializes in REMS program design, implementation, maintenance, and FDA reporting to address your REMS needs, creating a one-stop-shop for our clients. Our attorneys assist clients in increasing program efficacy and provide an opportunity to ease the burden on key stakeholders.  Contact us to speak to a Frier Levitt attorney.


1 Office of the Inspector General. FDA’s Risk Evaluation and Mitigation Strategies: Uncertain Effectiveness in addressing the Opioid Crisis.OEI-01-17-00510. September 2020.
2 Barlas S., FDA Intensifies Drive to Reduce REMS Burdens. Pharmacy & Therapeutics, 2016, 41(2):103-119.
3 Projects, A. S. Implications of Risk Evaluation and Mitigation Strategy (REMS) Programs for Managed Care Pharmacy.  J Managed Care Pharm. 2012, 18(3):268-275.
4 A listing of all drugs pursuant to REMS is available at the FDA’s Website.
5 2014 FDA Draft Report on Standardizing and Evaluating REMS.
6 Barlas.