FDA, EMA Decisions On Avandia Reflect The Power Of REMS
Contrasting decisions by FDA and the European Medicines Agency on the fate of GlaxoSmithKline’s Avandia reflect not so much a divergence of scientific opinion between the two regulators, but rather differences in how they chose to manage the drug’s cardiovascular risks and the tools available for doing so.
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As US FDA weighs fate of Takeda’s febuxostat, advisory committee members suggest REMS to ensure prescribers have informed benefit/risk conversation with patients, but agency staff highlight design and assessment challenges for such a program.
Decision to replace the rosiglitazone REMS’ distribution restrictions with prescriber training reflected a consensus opinion shared by leadership in three CDER offices, despite a poll of reviewers who participated in a June advisory committee meeting and favored eliminating the risk management program.
Comforted by the re-adjudicated RECORD results, agency directs rosiglitazone sponsors to provide training “based on the current state of knowledge” about the diabetes drug’s cardiovascular risk but eliminates the requirement that links drug access to provider, pharmacy and patient enrollment in the REMS.