Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains the burden to the health system when FDA waives a single shared REMS requirement.
When the FDA waives the requirement of a single shared REMS system, what additional burden does that waiver place on the FDA?
A waiver of a REMS doesn’t really add a burden to the FDA. There may be a small burden because they’ve got to review and approve 2 different REMS, but the work it takes to help companies agree to a single shared REMS I think is at least as burdensome for FDA as reviewing and approving 2 REMS. I think where the real burden lies, and this is where FDA’s main concern is, is on the healthcare system. For instance, pharmacies and hospitals, they may get used to brands REMS and then all of a sudden, a generic is approved and if it has its own REMS, now you’ve got 2 different REMS that you’ve got to try and juggle. I think pharmacies don’t like it, physicians don’t like it, hospitals don’t like it, and I think that’s where FDA’s real concern is and why they’ve been so hesitant in a lot of cases to waive the single shared REMS requirement.