REMS Need Metrics For Assessing Success, Burden On Health Care System

30 Jan 2012

• By Cathy Dombrowski

“We don’t really have clear methods for assessing burden and access,” CDER’s Mary Willy acknowledges. A lack of baseline information hinders the measurement of whether REMS and their components are working.

Metrics remain an issue as FDA and drug companies attempt to measure the effectiveness of Risk Evaluation and Mitigation Strategies (REMS) and their impact on the health care system.

A big challenge confronting the agency is how to determine whether a REMS impedes efficient delivery of, and patient access...