A conversation with Jeff Fetterman, President and CEO of ParagonRx, about developing a Risk Evaluation and Mitigation Strategy (REMS) that clinicians will consider useful and that would raise their intent to prescribe.
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Risk management. REMS (Risk Evaluation and Mitigation Strategy). Danger management of your product's life cycle.
These topics are all crucial to brand managers and marketing executives. Did you know that a Risk Evaluation and Mitigation Strategy (REMS) can be a win-win-win situation for you, your product, and the patient? Or that the longer you wait in the product development process to start thinking about REMS, the more you will lose control of your product's future?
A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks of the product, and FDA notifies the sponsor. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system, and must include a timetable for assessment of the REMS.
Many Marketing people intuitively suspect any attempt to guide appropriate use of their fledgling product – such as a REMS or other risk management program – is going to negatively affect sales and reputation. But the facts don’t support the belief. Programs that define and guide appropriate use of medications minimize patient risk, address regulatory concerns, enhance proficient use by healthcare professionals, and preserve market access for patients who may benefit. All of these benefit a new product launch.
"Appropriate use" can have benefits beyond launching a new product. Our guest will summarize some of these benefits and present some physician survey data in support.
What exactly is REMS?
Why should pharmaceutical marketers care about REMS?
Tell us about your survey of Physicians regarding risk mitigation. What did you learn from the results?
Please summarize how a risk mitigation strategy that physicians consider useful can be beneficial to the brand.
Jeff Fetterman is President and CEO of ParagonRx, a company serving pharmaceutical, biotech, and medical device industries by designing, implementing, and continuously improving programs that guide appropriate use of medications and medical products. As co-author of two pharmaceutical risk management books and consultant for numerous risk management programs, he is helping to pioneer this emerging field in our industry. Having led the pre-startup safety assessment of the only nuclear reactor to be renovated following deactivation, Jeff is familiar with the cross-industry implications of risk management techniques.