“Adaptive Licensing” Proposals View REMS As Answer To Limited Evidence

Some ideas for new drug approval pathways seem to envision the use of Risk Evaluation and Mitigation Strategies as a means for preventing and monitoring off-label use following initial approval, apparently without regard to the seriousness or extent of a product’s risks. Given the burdens currently created by REMS, any effort to expand and retrofit the programs to a new approval pathway is likely to draw pushback from the health care community.

FDA’s Risk Evaluation and Mitigation Strategy program is being viewed as a potential tool to be used in “adaptive licensing” proposals, which suggest the risk management programs could expand from their current role of reducing serious drug risks to address products with limited evidence available at the time of initial approval.

Various ideas for new drug approval pathways, sometimes referred to as adaptive licensing or “progressive approval,” seem to look upon...

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