Start early, challenge conventional wisdom, have a plan
Horner: Start early.
Take a lifecycle approach to drug safety risk management and start early in the product development process. It's no longer acceptable to merely collect and analyze reports of adverse events during clinical trials. Safety planners must evaluate those reports more vigorously than ever, and also analyze related development issues that might impact the safety of those who use a developmental or marketed product--issues including drug and formulation design, as well as packaging design.
By "start early," I mean begin planning early in clinical development, during Phase I. Safety testing is the focus of Phase I, but usually not with an eye to REMS.
What I'm hearing at industry meetings is that researchers and risk strategists can do more to evaluate risk and develop mitigation strategies with the safety data available to them at and during Phase 1. Traditionally, safety managers have collected adverse events, but have not collated and used that information as proactively as they might for early REMS-type planning.
Fetterman: Challenge conventional wisdom.
First, challenge the idea that your internal risk characterization indicates product risks that are not significant enough for the FDA to require a REMS. Seeking outside verification of the risk characterization is critical.
Second, challenge the assumption that the FDA will not require a REMS for your product because products on the market with similar risks do not have REMS programs. Precedent, in the case of REMS, is not predictive.
Finally, challenge the idea that the FDA will not require REMS for potential risks or for off-label use concerns. It has required REMS for those reasons, and it will again.
Gallo: Have a development plan.
A systematic approach to developing a REMS strategy helps maintain efficient progress and expected results during the build, launch and maintenance of the REMS program. Often, companies with REMS waste time and money by developing strategies that aren't properly aligned with both the goals of the program and the commercialization plan of the product.
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