FiercePharma Manufacturing's special report on planning for REMS was spot-on in our opinion. But we'd like to stretch the concept just a bit: What if the industry acted as if every product needed a REMS program?
Yes, we understand what a drag industry considers REMS to be on sales potential--there is no question about that. Also, having a REMS plan means the product's life cycle would be under more heavy scrutiny, which means there will be less room for error. (Actually, we think that's okay.) But if industry could get beyond that - get beyond that REMS is a regulatory tool - and consider what a boost REMS could be to sales potential, then we'd be getting some place.
What about considering the incorporation of a REMS program into early Phase 1? What if it was focused on patient monitoring and measuring adherence? Could this approach force departments within a company that did not normally work together, to begin closer collaboration from the start of the product's life cycle? We think so! Think of the potential, think of the problems that could be avoided. What about the public trust factor, is it possible to imagine the industry's image could be improved? Let us know your thoughts.