ARTICLE | Politics & Policy

Stakeholders ask FDA to standardize REMS

July 29, 2010 12:30 AM UTC

Participants in a two-day public meeting hosted by FDA to discuss the agency's draft REMS guidance agreed that the process needs to be standardized to reduce its burden on the healthcare system. Industry, physician, patient and pharmacist groups felt that because the components of a REMS are specific to each drug, they are burdensome to the healthcare system, taking time away from the prescriber and/or physician that could be spent with the patient. Suggestions for reducing the burden included templates for different classes of drugs and linking prescriber certification and/or verification of patient counseling to electronic health records. ...