The Impact of REMS on Market Access

Jeff Fetterman, president and CEO of ParagonRX, on the upsides of Risk Evaluation and Mitigation Strategies (REMS).

Jeff Fetterman, president and CEO of ParagonRX, on the upsides of Risk Evaluation and Mitigation Strategies (REMS).

Risk Evaluation and Mitigation Strategies (REMS) have an unsavory reputation in the pharmaceutical industry. They add yet another regulatory hurdle to getting a product approved by the FDA, the logic goes, plus they restrict product access and reduce physicians willingness to prescribe.

All of which can be true, says Jeff Fetterman, president and CEO of ParagonRX, which specializes in the design and operation of REMS strategies.

ParagonRX conducted a study showing that REMS can reduce intention to prescribe by as much as 58 percent. On the other hand, the study found, if a REMS program is designed appropriately, it can increase physician likeliness to prescribe by as much as 42 percent.

The take-away, Fetterman says, is that if you know how to approach REMSand design a program that clinicians perceive as practical, useful and enhancing patient safetyit can be a major plus.

Fetterman will present on REMS at eyeforpharmas Market Access USA conference in Philadelphia on June 2nd  and 3rd. Discussion points will include how to capitalize on REMS design and how to prepare early to avoid regulatory slowdowns.

Fetterman spoke with eyeforpharma ahead of the summit for a sneak preview of his talk. Listen to it here.

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