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A Review of U.S. REMS Regulation and Compliance Assessing Program Implementation and Identifying Best Practices WESTFIELD, NJ [June 22, 2010] More than 10,000 children worldwide were born with deformities due to Thalidomide use, in the latter part of the 1950s and the early 1960s. Since then, the FDA has implemented several regulations to manage the risks and benefits of pharmaceuticals and biologics. A new whitepaper published by iReminder, LLC provides guidance on meeting FDA requirements set forth in the Food and Drug Administration Amendments Act of 2007 (FDAAA) for products with known or potential risks. This paper reviews mandated enforceable guidelines, called Risk Evaluation and Mitigation Strategies (REMS), and covers the strengths and challenges of existing implementations. In most cases, individual brands are required to shoulder the financial and administrative burden of implementing a REMS program, a potentially complex and costly system that can involve the participation of the patient, physician, pharmacy and distributor. iReminder's Risk Mitigation Regulation and Compliance Review guides pharmaceutical and biotech companies on system design and implementation of complex REMS programs to both protect patients and provide an economic upside. The recommendations are based on several case studies of systems built to meet the most rigorous REMS requirement, called Elements to Assure Safe Use (ETASU). Included in the review are Roche's iPLEDGE program for Accutane (isotretinoin), Amgen's APPRISE erythropoiesis stimulating agents (ESA) class-wide program, and Gilead's LEAP program for Letaris (ambrisentan). "Based on this extensive review, we were able to assemble a list of best practices and recommendations for designing REMS ETASU programs," said Jean Steckler, senior vice president of iReminder. "Optimal programs automate tracking to avoid burdening the health care providers and pharmacies," she added. Recommendations for designing efficient REMS ETASU programs include:
Pharmaceutical brand teams, managed care organizations and pharmacies can download the whitepaper at: http://ireminder.com/research/white-papers. About iReminder |
Implement REMS Requirements
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