The REMS Era Begins: FDA Applies Soft Touch With New Drug Safety Tools
This article was originally published in RPM Report
Executive Summary
Congress gave FDA some tough new tools to regulate drugs in September, but no one could know for sure how FDA would use them. Now there is some actual real world experience to judge by: a half-dozen drugs approved by FDA are subject to either a Risk Evaluation & Mitiagation Strategy or a mandatory post-marketing commitment. So far, the news is good for drug developers.
You may also be interested in...
A Transparency Case Study: Horizant Approval for RLS Offers Window Into Complexity of Complete Response Disclosures
The rejection of XenoPort’s restless leg syndrome therapy in February 2010 shocked investors, and so did the April 2011 approval of the application after a nifty piece of regulatory re-engineering by the sponsors. Would public release of the CR letter have helped investors handicap the prospects? That seems unlikely in this case.
FDAAA Impact Analysis (Year 3): REMS R.I.P.? Not Yet
FDA’s reconsideration of its new Risk Evaluation & Mitigation Strategy authority put the brakes on use of the new post-marketing safety tools as 2011 began, and a formal decision not to require REMS for all products with mandatory MedGuides means a significant step down in use of REMS in the future. But that doesn’t mean REMS won’t be routine in the future.
The Era of Drug Efficacy
FDA has been perceived by drug developers as a regulator obsessed with drug safety. But recent cases show serious safety concerns aren’t holding back new products: efficacy has been the deciding factor for approval.