FDA Commissioner Scott Gottlieb sat down with BioCentury after announcing his resignation to discuss his approach to promoting medical product innovation, the importance of strategic communications, and how a reorganization will bring FDA drug reviews from PDFs to the cloud.
Gottlieb’s comments illuminate how he has shaped public debate over controversial topics, and the ways he has tried to bake new thinking into FDA so it remains after he’s moved on. He also touched on policy challenges he hopes Congress will take up soon.
Gottlieb’s approach to communications goes far beyond Tweets and speeches to include personally reviewing, and often rewriting, almost every document FDA releases to the public.
Gottlieb revealed that he spends week nights and every Sunday working on communications - which may explain why, after two years on the job, he’s eager to spend more time with his family.
Strategic use of communications, Gottlieb said, is essential to developing support for policy. The idea is to show both the problems FDA is tackling and how it plans to prevent them from recurring.
FDA is moving forward with a proposed initiative, first described to BioCentury in December 2018, to take an active role in facilitating access to unapproved drugs (see “FDA to Facilitate Access to Unapproved Drugs”).
He called the debate over right-to-try legislation “galvanizing,” but rejected the idea that FDA creates barriers to accessing investigational products.
Gottlieb also previewed the upcoming announcement of a new policy that will make it possible for gene therapies to obtain Orphan exclusivity based on delivery vectors (see Sidebar: “FDA Considering Vector-based Orphans”).