When it's a medguide ... maybe.
FDA is searching for a way out of imposing a REMS when only a medication guide is required.
According to John Jenikns, director of the Office of New Drugs (and the best dressed man at the FDA), having to develop and then assess the impact of medication guides as part of the REMS program is a burdensome administrative task for the agency, as well as for sponsors and pharmacies and society at large.
"We are looking to try and be creative in how we interpret that part of the statute, so stay tuned to see if we're able to find some creative ways around this," he said.
In the meantime, medguides remain a component of a REMS and "until we work through this further, there are a lot of medication guide-only REMS - a lot of burden on us, a lot of burden on you - that we'd like to try to get out of."
As of June 3, FDA had listed 123 REMS on its website. Eighty-four consist only of a MedGuide, while another 25 involve a medguide and communication plan. The other 14 REMS require sponsors to adopt elements to ensure safe use. Five of those also involve a MedGuide; three also have a communication plan; and the other six also require both a MedGuide and a communication plan.
If FDA does not find a solution it can implement itself, the next reauthorization of the Prescription Drug User Fee Act in 2012 offers an opportunity for legislative change. Industry and other stakeholders already have cited REMS as an area for focus during PDUFA V.
(And, hopefully, that's "V" like in "victory.")
When is a REMS not a REMS?
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