Drug safety has always been a concern of FDA and drug manufacturers. Recently, however, FDA is paying even more attention to drug safety issues. The Food and Drug Administration Amendments Act of 2007 (FDAAA) granted the FDA the authority to require pharmaceutical companies to submit and implement a REMS -- Risk Evaluation and Mitigation Strategy -- if the FDA determines a REMS is necessary to ensure that a drug's benefits outweigh its risks. About 33% of new molecular entities approved since FDAAA became effective on March 25, 2008 have required a REMS, and 75% of these required a Medication Guide, which contains information for patients on how to safely use a drug product, with a REMS assessment. So, REMS are becoming more common than in the past, although they are not yet "the rule."
"Risk management, REMS, danger management of your product's life cycle, whatever you call it, all are crucial to brand managers and marketing executives," said Jeff Fetterman, President and CEO of ParagonRx (www.paragonrx.com), a Delaware-based company which specializes in programs for the appropriate use of medications.
This article summarizes Fetterman's ideas about how to develop a REMS that can be a win-win-win situation for you, your product, and the patient.
Topic headings include:
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- REMS 101
- Balancing Interests
- REMS Program Impact on Intention to Prescribe
- Alignment of Interests
- ParagonRx's Science-Based Methodology
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