The Power Of The Public: Isotretinoin iPLEDGE Advisory Cmte. Is Case Study In An Effective OPH

Open public hearings can include both emotional patient testimony and angry, anti-industry proclamations. During the isotretinoin REMS panel, the OPH was particularly effective in making a case for easing patient access despite the risks. Will it get FDA on board?

smiling acne
Even professionals presenting patient perspectives can be persuasive. • Source: Shutterstock

It has been 12 years since the US Food & Drug Administration convened an advisory committee review of the Risk Evaluation & Mitigation Strategy for the acne drug isotretinoin, and in many ways, it was business as usual: dermatologists advocated for loosening of restrictions, with FDA and generic drug sponsors pushing back against too much change.

That was certainly the scene during the last advisory committee review of iPLEDGE in 2011, when committee members encouraged FDA to pull back what is arguably the most restrictive distribution program for any teratogen, including thalidomide

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