By David Mittleman

FDA’s Faster Drug Approval Process Linked to Safety Issues

In 1992, the FDA sped up its drug approval process with the passage of the Prescription Drug User Free Act (PDUFA). Overall, the PDUFA allowed the FDA to collect large fees from prescription drug companies to fund the drug approval process. In return for these “user fees”, the FDA must meet a certain set of benchmarks during the approval process; particularly, the speed at which a drug is approved. The primary argument was that prior to the imposition of “user fees”, the FDA could not approve …read more