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Pink Sheet – “Nobody Was Armed At NCI”: US FDA Head Sharpless Adjusts To Life As Regulator

Pink Sheet – “Nobody Was Armed At NCI”: US FDA Head Sharpless Adjusts To Life As Regulator

Executive Summary

Acting commissioner is entering the usual learning curve for new leaders of the agency. It’s a reminder of how unusual it was to skip that step under his predecessor.


After one month on the job, acting US FDA Commissioner Ned Sharpless is starting to take on a higher public profile.


On 2 May, Sharpless made public addresses at two of the organizations that exist as forms of external support for FDA: the Food & Drug Law Institute (whose members help FDA interpret its statute, albeit often via adversarial proceedings) and the Reagan-Udall Foundation (chartered by legislation to facilitate external partnerships to advance regulatory science).


Not surprisingly, Sharpless didn’t break a lot of new ground in his first appearances after less than a month on the job. He did offer some self-deprecating observations about the breadth of FDA’s regulatory role (famously encompassing 25% of the US economy). (Also see “Sharpless Calls For A Nimble, Flexible, More Efficient US FDA” – Pink Sheet, 2 May, 2019.)


The careful roll-out of a new commissioner is standard in the history of the agency. But it is a stark reminder of how different things were under Sharpless’ predecessor. Scott Gottlieb joined FDA with unprecedented experience from his prior stints at the agency (including time as deputy commissioner) – and, just as importantly, immediately after an informal period as the Republican “shadow commissioner” of sorts during the Obama Administration.


FDA’s center directors noted that difference in Gottlieb’s tenure during a public event last fall. As Center for Biologics Evaluation & Research Director Peter Marks put it, “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.” (Also see “Keeping Up With “The Energizer Bunny”: US FDA Commissioner Gottlieb As A Boss” – Pink Sheet, 25 Nov, 2018.)


For Sharpless, the transition is both helped and complicated by his most recent post as head of the National Cancer Institute. During his appearance at the Reagan-Udall Foundation, in fact, Sharpless focused primarily on the similarities and differences between NCI and FDA during a “fireside chat” with Friends of Cancer Research founder Ellen Sigal. (Also see “External Collaboration At US FDA Is More Difficult Than At NIH, Sharpless Says” – Pink Sheet, 2 May, 2019.)


Sigal began by reminding Sharpless that she warned him that it would be different running FDA because “50% of the people hate you, no matter what you do.” Sharpless laughed and replied: “I think that’s an underestimate.”


In addition to the breadth of FDA’s work – reaching far beyond oncology into all aspects of medical products, food safety, cosmetics, and tobacco – Sharpless emphasized the cultural difference between a regulatory/enforcement agency like FDA and a more purely scientific body like NCI. He remarked on learning that FDA has more than 100 employees who are issued firearms as part of their duties. “Nobody was armed at NCI,” he joked.


Sharpless has also observed a toughness at FDA in a different context: in pickup basketball games he has participated in. He told Sigal that he “couldn’t put on my wedding ring for a year” after one game, observing with admiration that “those FDA guys are intense.”


The experience has also given him a level of familiarity with some FDA staff that is definitely unusual in a new commissioner. He joked that he learned valuable lessons in those pick-up games, like “you gotta make Paul Kluetz go to his left.” (Kluetz is an associate director in FDA’s Oncology Center of Excellence.)…