FDAnews Drug Daily Bulletin

Postmarket Surveillance for Surrogate Endpoint Drugs Needed, IOM Says

May 18, 2010
Congress should strengthen the FDA’s authority to request and enforce postmarket surveillance of drugs and biologics whose approvals are initially based on surrogate endpoints, according to a new report from the Institute of Medicine (IOM). Requested by the FDA, the report also suggests that HHS launch a departmentwide effort to encourage the collection and sharing of biomarker data. The FDA should use the same degree of scientific rigor to evaluate biomarkers used for drug clinical trial endpoints as it does for biologics or other regulatory areas, the report says.
Washington Drug Letter