Gottlieb Departure from FDA Surprises Industry

March 6, 2019 — FDA Commissioner Scott Gottlieb, M.D., recently stated that he was not leaving the FDA, so news of his departure at the end of the month sent shock waves through FDA-regulated industry yesterday.

Citing a need to spend more time with his family, Gottlieb tweeted that he is “immensely grateful for the opportunity to help lead this wonderful agency, for the support of my colleagues, for the public health goals we advanced together, and the strong support of [Health and Human Services Secretary Alex Azar] and [President Donald Trump]. This has been a wonderful journey and parting is very hard.”

“Dr. Gottlieb’s departure comes at a time when the FDA is ‘on a roll’ – making measurable progress on multiple initiatives, approving new medicines at a rapid pace, building public and industry confidence, and winning higher budgets to better enable the FDA to fulfill its responsibilities in regulating a fifth of the American economy,” stated Jon Bigelow, executive director of the Coalition for Healthcare Communication. “He also deserves applause for his forthright stance in taking action on e-cigarettes and flavored tobacco.”

Kate Rawson, senior editor, Prevision Policy, told the Coalition that “Scott Gottlieb will leave FDA on a high note, with a record-setting year on both branded and generic drug approvals. He was the rare Trump administration official who won broad support from both parties in Congress, and will leave FDA with a stronger reputation than when he joined the Trump White House. He may be best remembered as an incredibly effective communicator, using both Twitter and official press releases to promote even the smallest of agency actions as big-news items.”

Speaking at the CHC’s Post-election Conference in November 2018, Rawson noted that the biggest risk to the industry could be Gottlieb’s departure. She stated at the Coalition meeting that Gottlieb “has been the most activist commissioner we’ve seen, and is well-liked by industry.” She also reminded the audience that President Trump’s list of potential nominees before Gottlieb was nominated included “a lot of disrupters.”

“For healthcare marketers and communicators, as well as for the nation as a whole, it is important that the next Commissioner be a responsible policy leader who understands the evolution of drug development and marketing over recent decades and who will build upon Dr. Gottlieb’s initiatives,” stated Bigelow.

No announcements have been made yet about who would step in to helm the FDA in the short- or long-term. Azar said in a statement that “All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA. He has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation.”

Azar stated that “Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease, and more. The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.”