Praise, Suggestions for Draft REMS Guidance
The Association for Affordable Medicines says the recommendations in an FDA draft guidance on Risk Evaluation and Mitigation Strategy (REMS) assessment, reporting, and survey methodologies are easier to implement in a brand REMS context and will be much more difficult to employ for a single, shared system REMS or separate shared REMS that have multiple ANDA participants. The group’s comment letter also raises concerns about confidentiality of patient adverse event data being shared among multiple sponsors in a single, shared system or separate shared REMS that will be very hard to overcome to meet FDA recommendations. And it says that in a shared REMS context, some of the recommended assessments would lead to significant overlap and duplication of data.
The American Pharmacists Association (APhA) says it applauds FDA “for seeking to standardize assessments and for suggesting those assessments contemplate whether the REMS is meeting its goals and objectives.” APhA says it supports clarifying that REMS with elements to assure safe use should assess whether the burden on the healthcare delivery system is having the least impact to the greatest extent possible.
In its letter, the Benefit-Risk Assessment, Communication, and Evaluation Special Interest Group of the International Society for Pharmacoepidemiology says it is pleased to see the draft guidance and overall feels it provides much needed content and structure to assist sponsors in planning and designing REMS assessments. The group encourages FDA to use the guidance to enhance transparency and further the regulatory science in this area by making the results of REMS assessment reports, redacted of proprietary information, or at least the key conclusions from FDA’s assessments, available to the public through the agency REMS Web site.
Celgene commends FDA for providing guidance on REMS assessment development and how REMS sponsors can best assess if their REMS are meeting their specified goals. “We believe that for each REMS program, a holistic evaluation of available REMS data, stakeholder feedback, safety profile information, and drug utilization data can be an invaluable strategy to create and provide a successful REMS program,” the company says. “We fully support FDA’s approach to introduce a comprehensive and appropriately standardized method to REMS program assessment.”
The Biotechnology Innovation Organization says the draft “offers clear, practical information to sponsors and other stakeholders who are involved in the design and effective evaluation of REMS programs…. Of note, it is not clear from the draft guidance how existing/well-established REMS for existing drugs will be addressed. BIO encourages FDA to clarify that existing REMS would be grandfathered, particularly regarding evaluation of burden on the healthcare system and patient access.
Novartis proposes that throughout the guidance, where there is reference to “knowledge survey,” it should be changed to “knowledge, attitudes, and behavior survey” as the design of the surveys is to test not only stakeholder knowledge of the key risk messages but also the attitude and behavior of stakeholders towards prescribing practices.
All commenters included specific recommended changes for FDA to consider