Executive Summary

Commissioner Gottlieb says new centers would follow template of Oncology Center of Excellence.

US FDA Commissioner Scott Gottlieb has two additional centers of excellence already in mind – immunology and neuroscience – should the model implemented for oncology work as planned.

Both, like the Oncology Center of Excellence that launched at the beginning of 2017, would allow experts in the fields from across the various product centers and offices at FDA to increase collaboration and potentially speed product reviews.

Gottlieb told the House Energy and Commerce Subcommittee on Health Nov. 30 that the agency was “contemplating” both potential centers. “It’s very important that we get it right in setting up oncology since this is our test case and our first model for this,” he said during the hearing, which was called to discuss ongoing implementation of the 2016 21st Century Cures Act.

Gottlieb also discussed a potential expansion of accelerated approval during the subcommittee hearing. (See sidebar for related story.)

The Cures law allowed for creation of the Oncology Center of Excellence, which launched in January. (Also see “FDA’s Pazdur Jumps Over To New ‘Moonshot’ Role” – Pink Sheet, 29 Jun, 2016.) Cures also requires FDA to create multiple iterations of what were called “intercenter institutes.” (Also see “Cures Bill Authorizes ‘Intercenter Institutes,’ But Will US FDA Create Them?” – Pink Sheet, 28 Nov, 2016.)

FDA would not comment on when a decision could be made on creation of the immunology and neuroscience centers. Gottlieb said during the hearing that the agency believes “that this kind of center approach represents the future.”

The two sectors seem to fit in terms of cross-center collaboration, in part because combination products could emerge in both settings. For neurology, the agency has divisions in the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health that oversee the products. CDRH and the Center for Biologics Evaluation and Research also have divisions devoted to immunology.

Reviews of drug-device combinations have been problematic in part because the review timelines often are not congruent. (Also see “Combo Product Review Pilot At US FDA Will Offer All Applications Intercenter Consults” – Pink Sheet, 20 Dec, 2016.) FDA officials also have said the next center of excellence likely will grow from areas with a lot of combination product activity. (Also see “FDA Tussles With Combination Products, Fires Up Oncology Center Of Excellence” – Pink Sheet, 26 Jun, 2017.)

There has been a lot of speculation as to where the next center of excellence could be placed. Neurology, infectious diseases, and cardiology were offered as potential next steps by the Friends of Cancer Research, which proposed the original Oncology Center of Excellence idea. (Also see “FDA ‘Intercenter Institutes’ Legislation Headed For Senate Mark-Up” – Pink Sheet, 28 Mar, 2016.)

And Office of New Drugs Deputy Director Peter Stein has said FDA also was thinking about whether a rare disease center of excellence was needed. (Also see “US FDA Drug Office Reform: ‘Everything’ Is On The Table” – Pink Sheet, 15 Nov, 2017.)

Former Commissioners Like Idea

Former FDA Commissioner Robert Califf agreed that immunology and neurology were good choices for additional centers of excellence. He also told the Pink Sheet that he hopes cardiovascular disease will “evolve in this direction.”

While the biomedical world is grouped by disease type, stage of life and body part, “the FDA was configured by ‘product type’ and that made sense in the ‘good old days,'” said Califf, who now is vice chancellor for health data science at Duke University and an advisor for Verily Life Sciences.

Califf added that a reservoir of knowledge by product type still is needed, but as medicine evolves into a patient- or person-centered world for benefit, risk and safety assessment, FDA should align with the “real world.”

“People generally have concerns about the same clinical outcomes regardless of product type, and there is real value in providing consistent advice and decision making,” Califf said.

Mark McClellan, also a former FDA commissioner as well as a former CMS administrator, told the Pink Sheet that immunology and neurology make sense as centers of excellence because there are examples of combination products and targeted immunotherapies in those areas where a cross-disciplinary approach would help.

But McClellan, currently director of the Duke University-Robert Margolis Center for Health Policy, also has warned that reorganizing FDA to focus on diseases rather than products may not be the most efficient use of resources in all cases. (Also see “Don’t Rush To Reorganize FDA, McClellan Says” – Pink Sheet, 29 Feb, 2016.) Former Office of New Drugs Director John Jenkins also has advised against making too many organizational changes. (Also see “Multiple ‘Centers of Excellence’ At US FDA Could Create Review Inefficiencies – Jenkins” – Pink Sheet, 19 Dec, 2016.)

OND is in the midst of a restructuring, where many review practices could change. (Also see “US FDA Drug Office Reform: ‘Everything’ Is On The Table” – Pink Sheet, 15 Nov, 2017.)

Funding Remains Impediment, McClellan Says

While McClellan was optimistic that the OCE model could work in other diseases, he also said that it will require the necessary funding to realize its full potential.

Cures included a mandate that NIH transfer money to the agency for cancer-related activities, but no statutory authority was included to allow the inter-agency moving of funds. That has left the OCE without any Cures-related money.

McClellan said the OCE has not “fulfilled its full potential yet because the funding hasn’t been able to be worked out.” Without the money, it will be difficult for the agency to use the model in other areas, he added.

The House fiscal year 2018 appropriations bill would fix the funding problem (Also see “FDA’s Budget Flat In House Bill, But Path For ‘Cures’ Funding Cleared” – Pink Sheet, 28 Jun, 2017.), but it has not been passed.

FDA also ran into problems receiving other Cures-related funds, although that has since been resolved. (Also see “US FDA Still Waiting For Cures Money, Woodcock Says” – Pink Sheet, 25 Apr, 2017.)

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