Commentary
The U.S. Food and Drug Administration (FDA) has a legal obligation to protect the public and ensure that the benefits of medicines outweigh the harms before being marketed to people.
But the agency’s increasing reliance on pharmaceutical industry money has seen the FDA’s evidentiary standards for drug approvals significantly decline.
The Need for Speed
Since the enactment of the 1992 Prescription Drug User Fee Act (PDUFA), the FDA’s operations are kept afloat largely by industry fees which have increased over 30-fold from around $29 million in 1993 to $884 million in 2016.
Industry fees were meant to speed up drug approvals—and they did. In 1988, only 4 percent of new drugs introduced onto the global market were approved first by the FDA, but that rose to 66 percent by 1998 after its funding structure changed….