[Editorial by Jim Dickinson] For the first time in our 35-year history as the oldest FDA-centered news publisher, Dickinson’s FDA Webview is endorsing a candidate for FDA commissioner: Scott Gottlieb. His nomination, announced by President Trump 3/9, quickly drew predictable alarums about Gottlieb’s “deep ties” to the pharmaceutical industry — concerns we would normally share, based on sobering past incidents involving the unwholesome industry associations of some previous commissioners. Those rare episodes highlighted the importance of FDA commissioners aggressively holding public health and safety as their foremost charge, free of divided loyalties. Although we are limited like most others to Gottlieb’s public record in assessing his suitability to be commissioner, we are impressed by its extent and content, as well as by his performance while at the agency as deputy commissioner for medical and scientific affairs in the George W. Bush administration. This record indicates that when confirmed, he would become the most heavily industry-connected commissioner FDA has had. That is not necessarily a negative — indeed, we expect it to be quite the opposite. First, his appointment would require him to relinquish all of those connections. But his deep understanding of their interests should make him a realist in objectively balancing them against FDA’s mission. Second, his impressive public record indicates that he would have little or no need to “curry favor” while in office with the industry he might return to after he leaves the agency; we can expect his undivided loyalty to public health and safety and FDA’s mission. Third, some of his published ideas for FDA reform — such as easing approval requirements for complex generic drugs, restructuring FDA product reviews out of their current bureaucratic “silos” to adopt review principles in FDA’s successful Breakthrough Therapies program and factor-in broader medical practices that recognize that many drugs are components of medical treatment systems that depend on other products like diagnostic tests, and allowing companies to distribute objective off-label information, among others — are overdue for frontburner consideration. Fourth, his extensive research and analysis of FDA policies and practices, as well as his personal integrity as attested to by former FDA colleagues, strongly suggest he could be a transformative leader in the tradition of David A. Kessler who was the agency’s longest serving commissioner of the past 52 years. As former FDA associate commissioner for regulatory affairs John Taylor told the New York Times, while Gottlieb’s views were more conservative than his own, he grew to admire Gottlieb’s attention to detail and found him to be open-minded. “Scott and I have different ideological backgrounds, but I recognize that he does have a record of doing things that are for the benefit of the consumers,” the Times quoted him as saying. That’s good enough for us.
