Prolific author and CNN commentator Fareed Zakaria recently lent his weight to a rising tide of informed opinion seeking an end to FDA's gatekeeping role as well as a greater FDA focus on helping product innovators.
On his CNN program Global Public Square, Zakaria invoked Indian technocrat Kiran Mazumdar-Shaw's opinion “that the entire American-style set of regulations, clinical trials and lengthy waiting periods are now a serious deterrent to innovation.”
It was once considered bizarre to foist a commitment to innovation on a regulatory agency. No longer! FDA's newest statute bears the title Food and Drug Administration Safety and Innovation Act. And as it was being enacted, the Biotechology Industry Organization called on FDA to name a Chief Innovation Officer.
A harsher cure was proposed by libertarian New York University law professor Richard Epstein, who wrote in his blog that FDA “represents a major systematic threat to drug innovation and public health. It should be stripped of its power to block the entry of new drugs and medical devices into general use.”
These are just a few examples of the widespread discontent with this agency. In over 30 years of reporting on FDA, I have never seen so many serious proposals that it be relieved of its gatekeeping role.
While this election season amplifies any ideas about the role of government, regulation and innovation, this syndrome gains substance when observers like Zakaria suggest that seismic change is needed if the US is to reverse its global decline.
Expect FDA's role to be right in the thick of such change—both before and after the elections.
James G. Dickinson is editor of Dickinson's FDA Webview (fdaweb.com).