Waking Up to REMS (Part 1): Don't Believe the Lack of Hype
This article was originally published in RPM Report
FDA's top management can't be accused of overstating the importance of the agency's new drug safety tools. But sponsors need to wake up to the reality: the REMS are a critical fact of drug development and marketing.
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FDA’s reconsideration of its new Risk Evaluation & Mitigation Strategy authority put the brakes on use of the new post-marketing safety tools as 2011 began, and a formal decision not to require REMS for all products with mandatory MedGuides means a significant step down in use of REMS in the future. But that doesn’t mean REMS won’t be routine in the future.
FDA’s new post-marketing risk management authorities are receiving much more public attention in the context of the Avandia decision…but use of the REMS is actually declining. As FDAAA turns 3, it is clear that REMS are going through some growing pains. The new tools will be refined—but they are definitely here to stay.
The second year of the FDAAA-era is over, and FDA is using its new drug safety tools (Risk Evaluation & Mitigation Strategies and mandatory post-marketing studies) more often. Not only are more drugs requiring REMS and mandatory trials, the burden of those programs is increasing.