How the FDA Impedes Innovation

Three facts are clear. First, the FDA’s regulatory reach and intensity has increased over the past 10 years. FDA employment grew by 33 percent between 2000 and 2011, even as employment in the regulated industries—pharmaceuticals, medical devices, and biotech--only rose by 3 percent.Second, in the wake of high-profile episodes such as the Vioxx case, the FDA has gotten stricter about requiring evidence of safety and effectiveness before approving new drugs. Third, the number of new drugs approved fell sharply over the past decade compared to the decade before.