Earlier this year, the United States Food and Drug Administration (FDA) published a Federal Register notice requesting comments on changes to third-party vendors for Risk Evaluation and Mitigation Strategies (REMS) systems, in compliance with the Consolidated Appropriations Act of 2023. While the comment period ended in July 2023, many of the comments that came in asked the FDA to take a flexible approach when reviewing changes, arguing that a restrictive approach could limit patient access to important and life-saving drugs.
While some comments did include support for more oversight by the agency, many included the belief that no two REMS systems (or REMS administrators) are alike. Therefore, many comments highlighted the need for flexibility when assessing changes to REMS vendors and to look at each REMS system on an individual basis.
Commenters shared concerns about the impact of changes to REMS systems on patient access, especially in light of changes to the iPLEDGE REMS system for isotretinoin and the REMS program for clozapine, both of which caused disruptions to patient access. Ultimately, in each of those instances, the FDA did exercise enforcement discretion to ease the REMS requirements to improve access, but market factors continue to cause disruptions, including REMS administrators leaving the field.
For example, the REMS Industry Consortium said that drugmakers participating in REMS are already facing challenges in patient access to drugs, including some essential drugs that are subject to shortages. In its comment, the Consortium noted “It cannot be overemphasized that flexibility remains paramount in REMS program development and management, and the need for flexibility and ‘right-sizing’ an approach applies across the entire REMS system – from stakeholder feedback to pre-launch testing to timelines and metrics to measure success.”
The Association for Accessible Medicine echoed those comments, saying, “Changing a REMS vendor is complicated and costly and has important implications for the long-term marketability of drug products covered by the REMS. REMS vendors are selected with care from a limited pool of potential vendors, and that pool is shrinking as vendors have consolidated or left the market.” The comment went on to note that, “The shrinking pool of vendors able to provide the necessary services can increase the costs for REMS participants, and for small generic companies these costs can be prohibitive, causing some to exit the market or withdraw pending abbreviated new drug applications (ANDA), ultimately compromising patient access to medicines.”
Pharmaceutical company GSK also submitted comments, where the company said, “”Early in the REMS development process, the REMS sponsor(s) should consult with impacted distribution channel entities (e.g. distributors, specialty pharmacies, retail pharmacies), healthcare systems, patient advocacy groups, prescribers, and health professional organizations to proactively identify possible challenges and barriers as well as ideal implementation timelines.”
Comments also included responses to how much time stakeholders need to transition from one REMS system to another, varying from just a few months to a year.
The American Academy of Dermatology Association believes that REMS administrators and drug sponsors should have at least 12 months so they can run a pilot test of a new REMS system before fully rolling it out. The Healthcare Distribution Alliance, on the other hand, noted that a minimum of 90 days should be provided so that significant changes can be effectively implemented into an existing REMS program.
All comments can be viewed here.