Those of us who have worked with Scott Gottlieb were not surprised at the extraordinary energy and focus he brought to the job as FDA Commissioner. Similarly, it was unsurprising that Scott announced his resignation effective next month. As dedicated as he was to the role at the FDA, he is even more devoted to his family.
His tenure was short but his impact on the agency and the public health will be enduring. Scott spent most of time and energy implementing the 21st Century Cures act and building the infrastructure to move product development away from randomized controlled trials and encouraging the use of predictive biomarkers and real-world evidence. His public pronouncements about drug prices, PBMs and vaping were not mere rhetoric. Though all the initiatives in these areas are not fully implemented, it is to be noted that Scott never said or tweeted anything he was not prepared to back up with action.
Most important, Scott raised the bar for the next FDA commissioner. The agency – and the country – has been blessed with a series of solid FDA commissioners over the past decade or more. Mark McClellan, Andy von Eschenbach, Peggy Hamburg, Rob Califf all made important contributions to the FDA’s modernization and its movement away from what Scott called the hunger for statistical certainty. It can be truly said that the FDA is now leading the way in personalized medicine, regenerative medicine and applying regulatory policy to promote competition.
There are some who still wish to turn the clock back on a decade of FDA reform. Organizations funded by John Arnold, in particular, want to use FDA regulation to slow down drug development, limit investment in orphan drugs and eliminate patient-centered drug development. But Scott has, by showing how smart regulation is done, demonstrated that much would be lost if we turn back now. He built, enlarged and secured a broad consensus about FDA’s mission. In doing so, Scott did something nearly impossible in public policy today: he turned a government agency into a source of health, hope, and possibility.