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Pink Sheet – Multiple ‘Centers of Excellence’ At US FDA Could Create Review Inefficiencies – Jenkins

Pink Sheet – Multiple ‘Centers of Excellence’ At US FDA Could Create Review Inefficiencies – Jenkins

Executive Summary

FDA’s outgoing head of new drug review cautions against duplicating Oncology ‘Center of Excellence’ model across multiple therapeutic areas, advocating for a more ‘balanced portfolio’ in structuring review operations; other topics during podcast interview include Jenkins’ future plans in drug regulation and one major safety decision that turned out differently than expected.

The Food & Drug Administration’s Oncology “Center of Excellence” may be an efficient way to review new cancer treatments, but it is not a model that should be replicated for every therapeutic category across the agency, Office of New Drugs Director John Jenkins, MD, said during an exit interview podcast ahead of his planned departure from the agency on Jan. 6.


“There is a lot of history behind how FDA is organized, and there is some rationale about how FDA is organized around products,” Jenkins said. “The Oncology Center of Excellence is one model of trying to make sure that the clinical reviews of products in that area are consistent across product types. But I don’t know if that’s the best model for the agency for the long term.”


The Oncology Center of Excellence is part of President Obama’s Cancer “Moonshot” initiative, which was included in the “21st Century Cures” Act passed by Congress and signed by the president on Dec. 13. FDA moved ahead with the idea even before “Cures” gave FDA formal authorization and has been working to stand up the new oncology review structure for several months. (Also see “FDA Oncology Center Of Excellence Coming, Moonshot Or Not” – Pink Sheet, 20 Apr, 2016.)


The intention of the Oncology Center of Excellence model is to bring together clinical review teams for drugs, biologics, devices and diagnostics under one roof, resulting in better collaboration on drug/device issues. The idea – conceived by FDA oncology review chief Richard Pazdur and advocated for by Friends of Cancer Research – originally involved centers for several different therapeutic areas (oncology, cardiology and neurodegenerative disease), but quickly became cancer-focused.


The original intent of the Centers of Excellence was that it would be a model that could be expanded to other review categories at FDA. Indeed, the “Cures” Act stipulates that FDA create “one or more Intercenter Institutes for a major disease area or areas.” That language leaves open the possibility that only the Oncology Center of Excellence would be created – at least for the near-term. (Also see “Cures Bill Authorizes ‘Intercenter Institutes,’ But Will US FDA Create Them?” – Pink Sheet, 28 Nov, 2016.)


Jenkins thinks a single oncology-focused Center of Excellence may be best. “I fully understand the perspective of groups out there who think it’s more efficient and more effective to have all the products in a given therapeutic area reviewed in the same division or the same office.” But he also believes there is value in having experts focused on certain product attributes. Devices are regulated very differently than drugs, he noted, while in biologics, gene therapies and tissues are quite different than monoclonal antibodies.


“I don’t really like the idea of exceptionalism in a given therapeutic area because other therapeutic areas are important also. The patients who have diseases in those other areas deserve the same level of attention, and yet you can’t create 60 different Centers of Excellence within the FDA for these smaller therapeutic areas,” he said. “You’ve got to have a balanced portfolio of how you structure the agency.”


Jenkins had been planning his departure from FDA for several years, believing that after 25 years at the agency (including 15 years leading the Office of New Drugs), it was time for a new challenge. He plans to stay active in pharmaceutical regulation, but acknowledged that working outside the agency will be a bit of an adjustment. (Also see “Jenkins’ Exit Interview: He’ll Miss Insider Status Upon FDA Departure” – Pink Sheet, 13 Dec, 2016.)…