A Review of US REMS Regulation and Compliance


Company News Release

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.

iReminder’s Risk Mitigation Regulation and Compliance Review guides pharmaceutical and biotech companies tasked with implementing REMS programs on system design and implementation to both protect patients and provide an economic upside.

The recommendations are based on several case studies of systems built to meet a rigorous REMS requirement, called Elements to Assure Safe Use (ETASU). Included in the review are Roche’s iPLEDGE™ program for Accutane (isotretinoinoin), Amgen’s APPRISE erythropoiesis stimulating agents (ESA) class-wide program, and Gilead’s LEAP program for Letairis® (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:

• Automated IVR, email and SMS messages to patients to remind them of upcoming laboratory testing and refill dates

• Automated alerts to HCP and pharmacies when patients report that they will not comply with laboratory testing or refill pick ups

• Automated distribution and printing of Medication Guides at the pharmacy and HCP office

• Online access for: − Pharmacies to determine certification status of HCPs − Prescribers to determine certification status of pharmacies − Wholesalers to determine certification status of pharmacies − HCP and pharmacy training and certification

• Online storage of HCP and Patient Agreement documentation

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