5:35 PM
Mar 08, 2019
 |  BioCentury  |  Regulation

Gottlieb’s exit interview

FDA Commissioner Scott Gottlieb’s exit interview

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”).

Sidebar: FDA considering vector-based Orphans

He addressed criticism of digital health policies FDA has rolled out over the last year, presented his view on how digital products should be regulated, and outlined his response to controversies over steps FDA has taken on opioids.

One of his most important accomplishments, Gottlieb said, has been to change FDA’s thinking about opioids. This includes moving FDA beyond evaluating the benefits and risks of the intended uses of opioids to an approach that explicitly considers abuse potential (see “Turning the Tide”).

Gottlieb thinks the public conversation over approval of Dsuvia sufentanil, a sublingual tablet made by AcelRx Pharmaceuticals Inc., drifted off course and missed an opportunity to debate the merits of approving opioids based on characteristics that differentiate them from marketed drugs (see “Gottlieb Justifies Approval of Dsuvia, a New Opioid”).

Gottlieb said he’s going to call for Congress to pass legislation creating an explicit comparative effectiveness standard for opioids. He also vowed to use the coming month to push for enactment of a new framework for regulating diagnostics (see “Debating Diagnostics”).

He declined to say what he’ll do after leaving FDA.

A transcript of BioCentury’s discussion with Gottlieb, edited for...

Read the full 3697 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury

Article Purchase

$150 USD
More Info >