The Declining Standards of FDA Drug Approvals

Aug 16, 2022

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 $29m in 1993 to $884m in 2016.Industry fees were meant to speed up drug approvals – and they did.

In 1988, only 4% of new drugs introduced onto the global market were approved first by the FDA, but that rose to 66% by 1998 after its funding structure changed.

Now, there are four pathways within the FDA which are designed to speed up drug approvals.”

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