“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.