Paucity of Biopharma Approvals Raises Alarm: Lower Numbers, Novelty, and Economic Impact Indicate Problems

摘要

FDA pharmaceutical approvals in recent years, particularly in 2007, have noticeably decreased. Typically, coverage of declining FDA approvals has concentrated on pharmaceuticals in general or those regulated as drugs. This article reviews 2006 and 2007 approvals of new biopharma-ceutical treatments and notes some disturbing trends. These include fewer drugs given the green light in recent years and particularly in 2007, a lower level of novelty as well as healthcare and economic impact.