A Conversation with the FDA About the Nature of REMS

  In 2007, the Food and Drug Administration Amendments Act (FDAAA) was signed into law by President Bush.  The legislation contained a great deal of reform of FDA regulation over the pharmaceutical and biotech industries, one element of which was to allow the FDA to require a Risk Evaluation and Mitigation Strategy (REMS) where a Risk Minimization Action Plan(RiskMAP)had once been deferrable, in effect giving the FDA the authority to demand a risk strategy. 

Any large-scale policy transition normally carries with it confusion.  How is a REMS program different from a RiskMAP?  The FDAAA references MedGuides as an example of a REMS element, a tool that was common with RiskMAPs.  How is REMS different from RiskMAPs?

The lack of widespread understanding about the nature of REMS seems apparent among companies given the number of Complete Response Letters that have been issued based on the lack of a REMS program. 

It therefore seemed like a good idea to get some clarification in the form of a podcast to a few key questions.  I sat down yesterday with two key FDA officials – Jane Axelrad, J.D., Associate Director for Policy for the Center for Drug Evaluation and Research (CDER) and Dr. John Jenkins, Director of the Office of New Drugs. 

We first explored what is different with REMS from RiskMAPs and we discussed the evaluative aspects of REMS, which is essentially two-fold.  On the one hand, the FDA has to evaluate the candidate compound to determine whether or not risk mitigation actions are a key part to approval and on the other, the sponsoring company must have a component of its program to evaluate the effectiveness of the interventions.  We also discussed the matter of timing – when should companies begin planning REMS and working with the FDA to address risk issues.  We closed with a discussion about creative approaches to REMS programs, including digital resources.

I want to again thank Dr. Jenkins and Ms. Axelrad for the time they took with me and for the opportunity to share their outlooks.