Nissen said: "I also think we need to distinguish between routine approval and approvals of drugs that are really breakthrough drugs. I would argue compelling reason to move drugs that have major new benefits through the process more quickly... But 'me-too' drugs -- that's another drug in the same class where there are already drugs available -- that may not fit the bill. What you really want to do is accelerate the novel drugs. PDUFA doesn't distinguish, but I think it's a problem."
The FDA said it was performing its own analysis.
Another study, this one published in the March 26 issue of the Journal of the American Medical Association, looked at differences in the approval process for two lipid-altering drugs.
The first, ezetimibe, was approved in October 2002 on the basis of its ability to reduce LDL ("bad") cholesterol levels but without evidence of its effects on atherosclerosis or clinical events. A large trial to evaluate the drug more closely for major cardiovascular events began in January 2006 but is not expected to end until January 2011. Nevertheless, the drug was approved and marketed aggressively (sales reached $5 billion in 2007).
On the other hand, torcetrapib, a drug developed to raise HDL ("good") cholesterol levels never made it to market because a large, well-designed trial found an increased incidence of major cardiovascular events and death. The trial was halted early and the drug was never approved.
"Of the two approaches, torcetrapib was clearly the more successful," wrote the study's author, Dr. Bruce Psaty of the University of Washington, in Seattl
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