FDA Initiates Programs To Improve REMS, Ease Pharma Manufacturers' Burdens

In a move to improve its Risk Evaluation and Mitigation Strategies (REMS), the U.S. Food and Drug Administration (FDA) plans to implement four pilot programs, as part of its commitments under the Food and Drug Administration Safety and Innovation Act (FDASIA). With a plan in place, the FDA is ready to "measure the effectiveness of REMS and standardize and better integrate REMS into the healthcare system."

REMS is a series of restrictions that were put in place to ensure that dangerous drug products remain out of patients’ hands. Pharmaceutical manufacturers have long complained about how inefficient and cumbersome REMS are.  One particular issue is that REMS are based on a specific drug, and not a wider drug class, making a REMS plan a time consuming and expensive endeavor for companies to develop and implement, according to the Regulatory Affairs Professional Society (RAPS).

REMS normally include a communication plan, medication guide, and an implementation plan. It also aims to ensure safe use (ETASU) of the drug and highlights prescriber requirements, enrollment forms, training materials, process controls, consent forms, safety controls and monitoring programs.

The FDA seeks to execute the following projects in order to target REMS improvement:

• Provide benefit-risk information to patients, in which the FDA will strive to improve the tools used when prescribers counsel patients about REMS drugs. It will do so by conducting research into existing tools, counseling initiatives, and counseling literature to hone in on problems and enable the creation of better tools.
• Focus on prescriber education and will seek to assess "whether it is feasible to provide continuing education (CE) … associated with a specific REMS," according to the report.
• Integrate REMS documentation into the SPL format, allowing it to integrate more easily into pharmacy systems and health IT systems.
• Build a web page repository containing "centralized, standardized, reliable and user-friendly repository of information about REMS, including stakeholders' specific activities and requirements under each REMS program."