March 20, 2017 – Although medical marketers are very familiar with Scott Gottlieb, President Donald Trump’s choice for the top job at the FDA and a former FDA deputy commissioner for medical and scientific affairs, they can only make educated guesses about how he will run the agency of 14,000 people and what his positions will be regarding FDA regulation and policy. Gottlieb, a physician, beat out venture capitalist Jim O’Neill, who was backed by Trump crony Peter Thiel, for the nomination, which must be approved by the Senate.

Gottlieb currently is a resident fellow at the American Enterprise Institute, has opposed many FDA regulations during his career, and has close ties to industry, which likely will come up as concerns at his Senate confirmation hearings but could ultimately benefit drug makers.

APCO Worldwide’s Wayne Pines told the Coalition for Healthcare Communication that “Scott is an excellent choice for FDA. He is familiar with the agency and its culture and mission. He understands not only the issues but also the challenges that FDA faces. I think his immediate challenges are to assure that FDA has adequate funding, and that FDA recruits and hires the staff it needs to understand and review new medical technologies and to facilitate the enactment of the user fee legislation.”

“The two most important issues for medical marketers are drug approvals and marketing policy,” noted Coalition Executive Director John Kamp. “Gottlieb is good news on both counts. Gottlieb and CDER Director Janet Woodcock are longtime colleagues and good friends, having occupied adjoining office suites as deputies for former FDA Commissioner Andrew von Eschenbach,” Kamp continued. “The two will work hand-in-hand in any reforms of the drug approval process. At the same time, Gottlieb has been a critic of current FDA regulation of off-label communication and is likely to address the issues around it sooner rather than later during his tenure.”

According to Scientific American, “Gottlieb praised the 21st Century Cures Act (which was signed into law in December 2016), and said that it would help smooth the way for quicker approvals by zeroing in on results from small trials and interim study results instead of waiting for more traditional clinical trial findings.” Gottlieb also has supported streamlining efforts to bring generic drugs to the market faster.

A March 10 article in Forbes, to which Gottlieb has been a frequent contributor, states that his writings in the publication “reveal the sharp mind of a man who doesn’t believe the system is fundamentally broken, but who is distrustful of bureaucracy as a solution and attuned to the way that small policy changes can have outside effects.”

Further, Pines commented that Gottlieb “understands the importance of gaining the confidence of the professional staff at FDA and I’m sure he’ll be able to do that successfully.”

For the very best of educated guesses on what to expect from the Gottlieb-led FDA, don’t miss the FDA expert panel at the Coalition for Healthcare Communication Rising Leaders meeting, held on May 15 and 16 in Washington, D.C. The panel, moderated by Kamp, includes three preeminent experts on FDA matters:

• Kay Holcombe, BIO lobbyist and Hill and FDA veteran, who has helped negotiate virtually all the PDUFA bills passed to fund the FDA;
• APCO Worldwide’s Pines, FDA expert on crisis communication and medical marketing, also an FDA veteran; and
• Mit Spears, former General Counsel of both PhRMA and the Federal Trade Commission, who is on several lists for a senior policy position in the Trump administration.

If usual Congressional confirmation timing holds, Gottlieb’s Senate confirmation hearing will be scheduled near the time of the Rising Leaders meeting.

Register now for the Coalition’s Rising Leaders conference. The event begins with dinner on May 15, featuring former Commissioner Robert Califf as the dinner speaker, and continues the next day with a wide array of inside-the-beltway experts on medical policy issues. Contact John Kamp for registration and further information at: jkamp@cohealthcom.org.