Waking Up to REMS (Part 3): Redefining Marketing
This article was originally published in RPM Report
FDA's new post-marketing safety authorities place unprecedented burdens on pharmaceutical marketers. But they do something else: redefine a favorite target of industry critics as a regulatory requirement rather than a suspicious activity.
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There is a new category of FDA action letter: a REMS release. Dozens of sponsors of “MedGuide-only” REMS received them after an FDA policy change. But now, FDA is issuing them regularly to sponsors whose communication plans have met their goals – or at least run their course.
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.