Peri-Approval
Clearly, risk mitigation could be an issue for your NME since one-third of approved NMEs since the FDAAA took effect in March 2008 have required REMS submissions. Sixteen drugs with existing risk management programs were "deemed REMS" in 2008, and over eighty eight new REMS have been approved through January, 2010.
By addressing risk mitigation early, you'll avoid regulatory delays and facilitate review by payers. Yet most therapy carries risk, so how do you efficiently decide on the top priorities in a way that is meaningful to constituents?
Should regulators require a REMS, this entails needs assessment, planning, implementation and evaluation. Most REMS consist of a Medication Guide for patients and supporting communication, but other elements may be necessary, including controls on physician prescribing, pharmacy dispensing and patient registries.
Near product and REMS approval, you may need support with Advisory Committee preparations, regulatory agency negotiations and making final modifications to your REMS. If a REMS is part of an NDA, the FDA reviews the methodology used to design the REMS, as well as actual REMS elements. This can include anything from Medication Guide content to Web site screen shots.
Outside the US, the EMEA and other regulatory agencies are increasingly moving toward international harmonization, yet you still must reconcile each country's policies.
Obviously, designing tools for a product's lifetime is a major commitment; to make changes later, Agency re-approval will generally be required. Getting it right the first time is key. And someone will have to coordinate the internal activities and details involved in order to launch a risk mitigation program the same day as your product.