Executive Summary

Three center directors agree that Gottlieb’s facility for public communications is a boon for FDA – and that the commissioner is appropriately hands-off when it comes to day-to-day decisions on scientific or policy issues.

US FDA Commissioner Scott Gottlieb has been getting generally high marks from the agency’s external stakeholders, and it seems he is just as popular with some of the key managers who report to him.

Three FDA center directors – Janet Woodcock (Center for Drug Evaluation & Research), Peter Marks (Center for Biologics Evaluation & Research) and Richard Pazdur (Oncology Center of Excellence) – were asked to talk about the experience of working for Gottlieb during the Prevision Policy/Friends of Cancer Research Biopharma Congress Nov. 14.

Collectively, their comments are an important vote for continuity at FDA following the midterm elections – or, perhaps, an early indication of the testimonials Gottlieb will receive if he chooses to depart after about two years on the job. (Also see “US FDA May Largely Avoid House Democrats’ Investigation Agenda” – Pink Sheet, 7 Nov, 2018.)

They all agreed that Gottlieb’s extraordinary communication skills are an immense help to their jobs, both in terms of securing necessary support for key priorities and for shaping the narrative about FDA’s activities. They also all agreed that Gottlieb leaves them to run their centers, based on the science and policy, without political interference.

Pazdur put it most succinctly. After noting that Gottlieb was able to secure the initial funding to launch OCE “when no one else did,” Pazdur offered to describe his leadership in three sentences: “(a) He got us our money. (b) He sings our praises in oncology. (c) He leaves us alone. What more do you want from a boss?”

Woodcock was more expansive in describing the value of Gottlieb’s communication skills – reflecting, no doubt, her experience as FDA’s most prominent spokesperson during the legislative work on 21st Century Cures, compounding and other issues during much of Commissioner Margaret Hamburg’s tenure.

“Scott is very conscious of participating in the external narrative,” Woodcock said. “That is very important and very helpful, because if we don’t participate in it, it can get away from us. It can be a narrative that isn’t related to what we are actually doing. But that takes a lot of work.

“His focus on that is very helpful for me personally, because I have to do a lot of other things,” Woodcock continued. “I have to supervise 5,500 people. … and then we have the science and we have the policy and so forth.” Having Gottlieb manage “our interactions and our relationships with the Administration, with Congress, with the media – who really is another estate – those things are very important and very helpful.”

However, Woodcock noted, Gottlieb’s high profile can sometimes lead to a false impression. “I always have to laugh when we approve a drug [and people say] ‘Dr. Gottlieb must have done that.’”

Woodcock took credit for – in effect – training Gottlieb not to get directly involved in drug approval decisions. “He knows from having worked with me the last time he was at the agency: commissioners should not get involved – unless they have to – in individual product decisions.” And, in fact, “he does not get involved in that, because he knows that the professional staff understand the standards and he does trust us.”

Gottlieb’s past experience at the agency clearly feels like an asset to the center directors. “His previous history at the agency was important,” Pazdur said. “He had been training for the position for many years, unlike other commissioners that come into the agency that didn’t have an antecedent history with drug regulation.”

Woodcock interjected to quip, “Yeah, I gave him a hard time the entire time he was here last time.”

Pazdur continued by noting that “even after he left he kept up on what was going on. It wasn’t a void.”

CBER’s Marks took up that theme. “Part of the problem with a commissioner who is new, who has no experience with the agency, it probably takes them one to two years to get up to speed with the tools they have, the levers they have to actually create change, and then they’re gone. Whereas Scott came in running with that.”

Marks also acknowledged that Gottlieb’s pace can pose challenges. “It is sometimes hard to keep up with the Energizer Bunny, because he is constantly doing stuff, his speed of communication keeps our communication shops very busy.”

“Spinning,” Woodcock interjected.

That said, Marks continued, “it has been wonderful for us because he’s been very willing to help us get funding or help us get support behind initiatives, and then he gets out of the way and lets good things happen.”

“That’s exactly what you want from your boss,” Marks concluded.

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