Carving REMS Out of Oncology? FDA, ASCO Plan Follow-Up Workshop
This article was originally published in RPM Report
FDA and the oncology community will continue discussions about the role of REMS in cancer care. The agency is clearly taking pushback from providers seriously.
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FDA continues to use the formal Risk Evaluation & Mitigation Strategy authority very infrequently in the context of new drug approvals. There is one countervailing trend: the agency is imposing mandatory communication plans for some of the new oncology therapies – including two “Breakthroughs.”
FDA’s use of REMS continues to fall to almost undetectable levels, with the agency using the safety tools just a handful of times in the sixth full year of the program. REMS are now very much the exception and not the rule for new products – but still a very important exception.
Nplate and Promacta aren’t the most important products sold by Amgen and GSK. But they are among the fastest growing in 2012—thanks to a decision by FDA to relax post-market controls at the end of 2011. The change underscores the case for a different approach to REMS in oncology, and may point the way forward for broader use of the new tools in a less intrusive way.