Setting the Precedent in Patient Safety

UBC has experience with more than 100 REMS programs

Setting the Precedent in Patient Safety

Without a strict set of safety guidelines in place, some much-needed therapies would not be available for patients who need them most.

Currently, 66 drugs on the market require a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug or biologic outweigh its risks. Approximately half of those drugs with a REMS include Elements to Assure Safe Use (ETASU), which ensure additional safety measures are in place before patients receive their medication.

With the growing complexity of new medications, the Food and Drug Administration has increasingly required manufacturers to institute REMS programs. REMS may be put in place for a new medication, or a new safety issue might be identified in an already marketed drug, causing the FDA to impose a REMS requirement on an older product.  As pharmaceutical companies focus on narrower patient populations for specific drugs and biologics, the need for REMS programs to monitor the real-world effect of these new medications is greater than ever before.

Prior to REMS, a small number of pharmaceutical products were required to have Risk Minimization Action Plans (RiskMAPs) to enhance appropriate and effective use of drugs, biologics, and medical devices and to minimize the occurrence of adverse events. UBC has worked with many manufacturers during the transition from RiskMAPs to REMS.

Before RiskMAPs were required, the industry utilized Perfomance-Linked Access Systems (PLAS) to ensure necessary restrictions were in place for the safety of patients. UBC scientists developed one of the first PLAS instituted in 1999. That program, for a drug that treats patients with schizophrenia, is still in effect today.

Through many industry changes, UBC continues to work with all stakeholders – patients, pharmacies, and prescribers – to ensure patients receive safe and timely access to the therapies they need.

Proactive vs. Reactive Approach

In the early days of REMS, the process was largely reactive and only considered after FDA’s feedback and request.  Today, however, REMS have become an established part of the marketplace landscape, and manufacturers are developing proactive strategies, knowing that bringing a product to market may require a REMS. 

At times, some manufacturers have been concerned that REMS restrict access to the very products they’ve spent much time and resources developing.  In addition, they are concerned patients and prescribers might presume that a product is “dangerous,” reducing a product’s marketability.  These are valid concerns, and that’s why a proactive plan, early in the drug development process, will help minimize obstacles to drug approval and integration into the healthcare system.

FDA is working to establish rules or direct guidance to provide insight into the circumstances under which the FDA might impose a REMS.  FDA has provided some factors that influence their decision making process.  These include:

  • Estimated size of the patient population
  • Seriousness of disease or condition
  • Expected benefit of the drug
  • Expected duration of treatment
  • Seriousness of known or potential adverse events
  • Whether the drug is a new chemical entity

The Best Indicator of Future REMS is Past REMS

Insights into the kind of REMS program, if any, that may be required can most likely be found by looking at approved REMS in the marketplace. Whether a drug is in the approval process or already on the market, the FDA often relies on precedents when evaluating REMS requirements.

That’s why UBC’s experience has played a significant role in the REMS industry.  UBC teams, made up of epidemiologists, safety scientists, data analysts, software developers, and patient educators, to name a few,  have designed, implemented, and/or evaluated more than 100 RiskMAPs and REMS programs for drugs to treat everything from diabetes to organ transplant rejection.

Lessons Learned

Working with many stakeholders and patient populations across a wide variety of therapeutic areas has taught us many valuable lessons about REMS programs and drug safety, including:

  • Drug Safety Starts Early
  • Communication and Collaboration Are Key
  • Patients Matter Most

The ultimate goal of a successful REMS program is to get the right therapy to the right patients at the right time. 


To receive our new whitepaper, 100 REMS Programs and Counting – Top Lessons Learned, by Annette Stemhagen, register for our upcoming webinar, Multi-Faceted Approaches to Meet Payer and Regulatory Evidence Requirements.  The free webinar will be led by Janine Collins, MD, Senior Director, European Risk Management, and Krista Payne, Med, Executive Director, Senior Research Scientist, Value Demonstration and will be held Wednesday, March 19, 11:00 a.m. EST.  Register to attend the live webcast or to receive a reminder when the event is archived and available for on-demand viewing.