How a Rapid and Well-Messaged US FDA Offense Is Driving Spectators to Their Feet and Twitter Accounts

Consultant examines why FDA seems to be accomplishing so much under FDA Commissioner Gottlieb’s leadership and how this could inform future leadership selections.

What is the "secret sauce" to Commissioner Gottlieb's success?

“How is FDA doing under Commissioner Scott Gottlieb?” is a question that, as a regulatory policy and strategy consultant, I am asked regularly. With amazing frequency, the questioner follows up with a twinkle in the eye and a statement that is similar to a rock star groupie suggesting: “Isn’t he dreamy?”

So, let me tell you, most FDA watchers who long to hear from the agency early and often, and who benchmark it by the rapid-fire announcements and new initiatives, think FDA is moving forward full throttle in the right direction under his leadership.

Reflecting on a panel I moderated at the Drug Information Association (DIA) Annual Meeting a few weeks ago, “Analyzing Innovation’s Progress in the Gottlieb Era,” I started trying to put my finger on why FDA seems to be accomplishing so much under this commissioner. Understanding this commissioner’s special sauce recipe could help inform future commissioner selections and assist in replicating the current FDA leadership success.

The main special sauce ingredient to date is an urgent, well-planned, multi-flanked offensive. FDA has been making announcements and publishing draft guidances at a record-breaking pace, keeping agency watchers scrambling to keep up. For example, FDA recently dropped six new draft guidances on gene therapy product development on the same day. (Also see "Gene Therapies Need Long-Term Follow-Up Plan From Outset Or Risk Clinical Hold " - Pink Sheet, 11 Jul, 2018.) This type of approach has allowed FDA to quickly set the agenda, the pace and tone, without letting up. The urgency is a new addition. Gottlieb understands that he serves at the pleasure of the president; as such, he might hold the job for five years, five months or only five days more, so he is meeting directly with this leadership team to accomplish and implement objectives quickly, even if they are not fully complete.

Communication is the second but most outwardly facing and obvious ingredient in the sauce.  Gottlieb is a master. He started honing his communication skills during his first tour of duty at the FDA in the commissioner’s office under Mark McClellan, where he served as the behind-the-scenes voice, the commissioner’s consiglieri with trade press, often planting stories or pre-briefing the press under embargo. He saw firsthand the value of a well-placed article by a well-briefed press to telegraph success.

The current FDA team has developed a highly organized and disciplined offensive strategy to communicate agency goals and accomplishments, not only to the press and sophisticated FDA-watchers, but now directly with the public through Gottlieb’s Twitter account. The commissioner has concentrated FDA announcements to one voice: his. By being essentially the only agency spokesperson, he is training people to pay attention to his every speech and every word. Clearly there is a reason that people are tracking his word count and that senior industry thought leaders, who may have shied away from social media in the past, are signing up for Twitter just to get his Tweets. He is also constantly telegraphing and offering new tidbits of information on where the agency is headed, even though a particular project is not yet complete, draft guidance not yet finalized, or the pilot not yet launched, to keep audiences focused on him.  It is like adding a little sugar to any complex sauce: it adds a depth and a sweetness, which, when served up, is a crowd-pleaser. He is using his bully pulpit to his optimal advantage. 

He has also prioritized cultivating personal relationships with the press, Capitol Hill, and industry leaders, as well as policy leaders inside and outside the government. And when you look at the congressional turn around on FDA’s budget over the last year, it is a “how to” for future FDA commissioners. When President Trump took office, he included in his first budget the concept of zeroing out FDA appropriations and moving toward the agency being funded solely by user fees. Today, FDA’s appropriations stand at $2.8bn for the current fiscal year (annualized continuing resolution level), and the president’s budget request for FY 2019 includes an increase of $473m over the existing level to $3.2bn.

Having a commissioner who knows the details of FDA policies and can explain them clearly, and who is politically astute and can avoid getting burned, helps the agency stay ahead of the curve. Unlike many other Trump administration leaders, the FDA commissioner choice was a person who could walk into FDA’s Building 1 with a pretty complete knowledge of the personalities and skill sets of the leadership, the challenging issues the agency was facing, and history of the agency. Gottlieb entered the role with experience writing articles and testifying before Congress on FDA matters; it allowed him to jump in with both feet.  He also came in fully understanding many of the key agency supporters and detractors.

Politics needs to be played: despite the fact that FDA is a regulatory agency guided by science, the agency does not thrive unless its leadership team has a keen sense of politics. Just look at how well the National Institutes of Health have done over the years as Francis Collins has built relationships in Congress. FDA under Gottlieb seems to have focused more commissioner time on Capitol Hill outreach than in previous administrations.  But knowing and having a comfort level with politics is critical to allow an agency to take both safe and precarious positions. It is interesting that just recently, Gottlieb announced a new FDA effort to consider importation, not in only manufacturing shortage situations, but when prices are high and impeding access. (Also see "Drug Importation Can Be Triggered By 'Excessive' Price Increases; Now US FDA Has To Decide What That Means " - Pink Sheet, 19 Jul, 2018.) Gottlieb must sense that FDA support is at a high, and he is cashing in some pharma industry good will earned in this first year. He is stepping out and cementing his position in the administration ranks by supporting the Trump/HHS Secretary Alex Azar effort to deal with drug pricing -- even if it shakes a bit of his support base. 

This commissioner trusts the strength of the current center directors and is encouraging them to advance forward leaning ideas. For example, the Center for Devices and Radiological Health’s effort to establish a Software Precertification (Pre-Cert) pilot program is really novel for an agency like FDA, focusing on a firm-based, rather than product-based, approach to review; if successful, this approach is something that might be applied to other technologies. (Also see "FDA Readies Digital Health Pre-Cert Program For Lift Off" - Medtech Insight, 26 Apr, 2018.) Though somewhat behind the curve, CDRH is pivoting to address the needs of the coming wave of new digital health technologies by establishing a Digital Health Unit. On the drug side, Gottlieb seems to be allowing Janet Woodcock, CDER director, to also launch some new initiatives like finding ways to use real-world evidence (RWE) in clinical trials and testing seamless clinical trials. (Also see "US FDA Wants More Examples Of Real-World Data Use" - Pink Sheet, 5 Aug, 2018.)

So, what is Gottlieb doing that is so different from other commissioners, whom people thought were terrific too?

To sum up what is in the special sauce at FDA under this commissioner:

• Start on the offensive.

• Add in agency knowledge, substantive expertise and a significant, relevant network.

• Stir in the ideas of the agency’s most experienced and innovative leadership and support their movement forward.

• Then marinate it in a sophisticated communications effort:

                          - Sprinkle both grassroots and tops in equal measure.

                           - Do not wait for all projects to be fully baked; it is not necessary.

                           - Package both warm and hot initiatives together, airing them often, to show progressive thinking; continuously announce new initiatives in multiple areas to keep everyone  reacting to FDA’s news.

                          - Spice up and re-craft agency messages to support the Administration’s agenda, to ensure Administration support.

• Incorporate all the low-hanging fruit and already initiated efforts for easy wins, then build on it with the inertia.

• Serve up your messages at carefully selected speaking opportunities with a diversity of interest groups that meet messaging goals.

• Funnel announcements from the top to ensure maximum visibility

This recipe has served Gottlieb and his leadership team, and potentially the next wave of commissioners, well. And in just over one year on the job, Gottlieb has already put the agency in a strong, forward leaning position with effective resource requests, and set up the building blocks for an FDA that enjoys public support and efficiently accomplishes its mission.

Nancy Bradish Myers, JD, president of Catalyst Healthcare Consulting, is a Washington, DC-based attorney with deep expertise in health care law and regulation, policy development, and government relations. She served as senior policy counsel in the Office of the FDA Commissioner, as well as special assistant/senior strategic advisor to the FDA acting deputy commissioner for operations. She has been closely involved in drug, biotechnology, and medtech regulatory issues for more than 25 years.