Current Class Of Risk Evaluation & Mitigation Strategies
This article was originally published in Pharmaceutical Approvals Monthly
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FDA’s new post-marketing risk management authorities are receiving much more public attention in the context of the Avandia decision – but use of Risk Evaluation and Mitigation Strategies is actually declining. As FDAAA turns three, it is clear that REMS are going through some growing pains. The new tools will be refined, but they are definitely here to stay.
Pharma’s opponents believe passage of the Inflation Reduction Act represents a momentum shift that will make it easier for politicians (even some Republicans) to take on the industry. They’ll need to count on that as they still have a long list of targets ahead on their lower-drug pricing agenda.