The QMN Weekly Bulletin

Stakeholders Want Flexibility in Standardization of REMS

Aug. 2, 2013

While agreeing on the need to standardize risk evaluation and mitigation strategies (REMS), PhRMA says drugmakers and healthcare providers should still have some flexibility on how to implement them.

At least one drugmaker has complained that uncertainty about the FDA’s requirements for shared REMS between brand and generic drugmakers leaves the innovator company vulnerable to anti-trust litigation.

During a two-day public meeting hosted by the FDA July 25-26 to discuss ways to standardize and evaluate the effectiveness of REMS, PhRMA spokeswoman Sarah Spurgeon said standardization can help make REMS more predictable and easier to measure for stakeholder compliance.

“However, PhRMA believes that some variation and flexibility in REMS is necessary and appropriate to address specific risks posed by particular drugs in a wide range of patient populations in health care settings,” she added. “And it is recognized that standardization alone cannot negate the need for strong sponsor stewardship over a product’s REMS.”

PhRMA says sponsors should be able to make “minor administrative and editorial adjustments” without prior approval. As examples, Spurgeon said sponsors need to have enough flexibility to move data from paper to Web-based systems to improve the enrollment process.

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