Is REMS the new market access moderator?

Andrew Tolve and Jeff Fetterman

eyeforpharma and ParagonRx

The path to regulatory approval in the United States has always been riddled with setbacks, surprises, and last-second modifications. The newest challenge is Risk Evaluation and Management Strategies, or REMs. Added in 2007, REMS is required of a steadily increasing number of products, specifically specialty products whose benefit risk profiles don’t land clearly on the side of benefits. By the end of 2009, the FDA was requiring REMS of roughly 75 percent of all specialty products.

“Certainly the initial reaction by many in the industry is that REMS is a new challenge, a new problem, and hence a negative issue,” says Jeff Fetterman, president and CEO of ParagonRx, which specializes in the design and operation of REMS strategies. “The assumption is that REMS will restrict access to the product, that physicians and patients will perceive it as designating a product as potentially risky and potentially dangerous and therefore may reduce a physician’s willingness to prescribe.”

“By the end of 2009, the FDA was requiring REMS of roughly 75 percent of all specialty products.”

ParagonRx conducted a conjoint analysis among 475 physicians whose results suggest that physician intention to prescribe can indeed be negatively impacted by the presence of REMS. In some cases, the study found, physician intention to prescribe can plummet by as much as 58 percent. On the other hand, if a REMS program is designed appropriately, the study found that physician likeliness to prescribe can increase by as much as 42 percent. The take-away, Fetterman says, is that if you know how to approach REMS and design a program in a way that clinicians perceive as practical and useful and enhancing patient safety, it can be a major plus.

One of the keys to designing a successful REMS program is to form an internal, cross-functional team to operate the process, says Fetterman. That means including folks from regulatory, drug safety, pharmacovigilance, clinical development, and marketing. “What we see as a real critical success factor,” says Fetterman, “is to form a cross-functional team that brings in the experiences of these various individuals within the organization to make sure that the best decisions are being made about the REMS and also to bring in different perspectives on where possible risks are in the use of the medication, so that all of this can be anticipated and addressed in the development of the REMS.”

Another key according to Fetterman is to use a replicable, science-based process in designing the REMS. All too frequently companies develop REMS based on precedence, that is, looking in the rear-view mirror at programs that have worked for other products and hoping that in this case, just this once, one size will fit all. Rarely does it. “Our recommendation is to use a science-based approach that identifies all the various risks of the medication in the care delivery process,” says Fetterman, adding that there are a variety of science-based processes out there, “Failure modes and effects analysis” being the one that ParagonRx uses most often. “It’s a way that elevates the outcome of your planning process from being one which is opinion-based or precedent-based to now being one which is science-based and invites a science-based response.”

“…if a REMS program is designed appropriately, the study found that physician likeliness to prescribe can increase by as much as 42 percent.”

Fetterman’s third piece of advice is to start the REMS planning process well before the eleventh hour, so the FDA doesn’t throw any last-second surprises your way. Starting in advance will also allow you to create contingency planning, so even if the FDA does surprise you, you’ll have alternatives or solutions prepared. Fetterman says that ParagonRx encourages its clients to consider the various issues that could occur late in the approval process and to plan what to do in the event they occur. “Because this is one of the very final things that gets negotiated along with labeling just prior to approval of the product,” Fetterman says, “and to the extent that companies can be ready to negotiate those and have very fast turnaround on requests from the FDA is the extent to which they minimize any potential delay of the approval of the product.”

Fetterman, who in addition to his work at ParagonRx has co-authored two pharmaceutical risk management books, will present about REMS at eyeforpharma’s upcoming Market Access USA conference, held in Philadelphia June 2nd and 3rd. To hear a sneak preview of his talk, please click here.

About the author:

Andrew Tolve is a medical writer who has published on a range of issues impacting on the pharmaceutical market. For any queries regarding this article, please address these to Andrew c/o Maria Relaki, Vice President at eyeforpharma on

Jeff Fetterman is CEO of ParagonRx, please visit for more information.

For more details of the upcoming Market Access USA conference, at which Jeff Fetterman will be speaking please visit the event website.

Should REMS be in place for all pharma products?