Fixing a broken drug development process

Abstract

It costs about $1.2 billion to bring a single new drug to market in the U.S. today.[1] With a combination of high late-stage failure rates and the high cost of drug trials, the number of new drugs being approved by the FDA has flat-lined at historically low levels, falling from 53 in 1996 to just 19 in 2009.[2] If the cost of drug trials doesn’t come down, we will see far fewer new drugs on pharmacy shelves. [1] Pharmaceutical Research and Manufacturers of America Profile 2009. Washington, DC: PhRMA. [2] Hughes B. 2009 Drug Approvals. Nature Reviews Drug Discovery 9, 89-92 (February 2010)