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FDAAA Pays Off: Drug Safety Controls Bring Immediate Returns to Sponsors

This article was originally published in RPM Report

Executive Summary

Companies as diverse as CV Therapeutics, UCB, GSK, Pozen and Biovail are all smiles about becoming unwitting guinea pigs in the new era of drug safety. None could have expected to be pioneers in facing new post-marketing burdens-but all are thrilled that their products were approved at all. And most have seen an immediate payback for their investors.

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Declaring Victory: How FDA Releases REMS

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.

FDAAA Impact Analysis (Year 3): REMS R.I.P.? Not Yet

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.

REMS 2.0: FDA Refining New Drug Safety Tools

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.

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