The REMS Ramp Up: FDA Using New Safety Tools More Frequently In Year Two
This article was originally published in RPM Report
FDA has invoked formal Risk Evaluation & Mitigation Strategy Authority almost as often the last five months as it did in the first full year of the program. Use of more intense REMS-those with communication plans and elements to assure safe use-is increasing even faster, and indications are this is the leading edge of a wave of new restrictive programs. REMS unquestionably delay approvals, FDA officials acknowledge-and yet, more drugs are coming out of FDA.
You may also be interested in...
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.
Kaiser Pushes Back on REMS: Acorda Listens; Will FDA?
Kaiser recognizes that some sponsors are trying to use REMS to make an end-run around gatekeepers, and it is fighting back. The non-profit integrated care system wants FDA to help, filing a citizen petition that could profoundly affect commercialization of new products in the US. The recently approved MS drug Ampyra offers a case-in-point.
Single Product, Single Price: Medicare Will Include All Versions Of Active Ingredient For Negotiation
The US Medicare agency intends to treat all dosage forms of the same active ingredient as a single drug for purposes of its new price negotiation authority. The approach will have implications for product branding and line extension strategies.