The FDA has suffered no small amount of criticism recently, and, according to the Wall Street Journal,Â the agency's efforts to protect itself from naysayers have contributed significantly to he low number of new drugs approved in 2007. So far this year, the FDA has approved only 15 new molecular entities (NMEs) and is on track to approve about 18 by December. That's down from 22 NMEs in 2006, 20 in 2005 and 36 in 2004. (This does not include vaccines or sNDAs).
The much-talked-about Vioxx debacle and continuing safety concerns with diabetes drugs and anemia drugs caused the FDA to get cold feet when it came to approving drugs such as Novartis' Galvus and Sanofi-Aventis' Acomplia. "It just indicates to you that when bureaucrats come under pressure, they tend to choose the path of asking for more data, as opposed to approving the drug," notedÂ Schering-Plough's CEO Fred Hassan in a recent interview.
Additionally, for companies looking to launch drugsÂ for diseases that already have treatment options, the FDA has raised the bar significantly. The agency seems to be looking for drugs that go above and beyond current treatment options--not drugs that simply offer patients and doctors another option. However, the FDA claims that criteria for approving new drugs hasn't changed drastically this year, and that each drug is approved or denied based on the merit of its application.
- read the WSJ article for more
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