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• Jeff Fetterman

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  Risk Evaluation and Mitigation Strategies, or 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 that proved that physician intention to prescribe can be negatively impacted by the presence of REMS, reducing 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 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

  Fetterman, who has co-authored two pharmaceutical risk management books and who has extensive experience in the pharmaceutical industry (among other accomplishments he led marketing, strategic planning, and business development at DuPont Pharmaceuticals before co-founding Empower Health), will present about REMS at eyeforpharma's Market Access USA conference, held in Philadelphia June 2nd and 3rd. Discussion points will include how to capitalize on REMS design and how to prepare early to avoid regulatory slowdowns. Jeff spoke with eyeforpharma ahead of the summit for a sneak preview of his talk.

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