Surrogate End Points Queried
Abstract
The Government Accountability Office (GAO) will review a drug approval process used by the Food and Drug Administration (FDA) that evaluates safety and efficacy based on surrogate end points in clinical trials. The review comes at the request of Sen Chuck Grassley (R, Iowa), who said March 4 that the FDA had approved several drugs that appeared to have little to no effect in protecting lives and improving health. Grassley singled out bevacizumab (Avastin, Genentech), rosiglitazone (Avandia,...