Thursday, February 22, 2007

FDA asserts need for more user fees

There should be no confusion about who FDA serves … It’s important to get drugs rapidly to market, but rapid does not mean reckless …We’re not focused on where our resources come from — only on what they allow us to do!” These assertions, taken from FDA commissioner Andrew von Eschenbach’s opening remarks at a public meeting to discuss reauthorization of the Prescription Drug User Fee Act (PDUFA 4), betray a clear sensitivity to charges that the integrity of the regulatory process has been compromised by FDA’s increasing reliance on user fees provided by the regulated industry.