With each breathless announcement and triumphant press release, it seems clear that the Food and Drug Administration is approving new drugs at a record pace under Dr. Scott Gottlieb.
But we wanted to put that appearance to the test. So we gathered more than five years of approval data from Evaluate Pharma, covering more than 200 first-time drug approvals. And it turns out, the FDA has actually been reliably speedy under multiple administrations, consistently OK’ing drugs ahead of schedule.
To do the analysis, we zoomed in on the difference between each drug’s actual date of approval and what’s called its PDUFA date, the point by which the FDA promises — nonbindingly, of course — to give a company a yes or no decision.
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Numbers are high but more than 50% are re-lables. That is not new approvals. Who is kidding who.