
Will the FDA Replicate the Oncology Center of Excellence?
The 21st Century Cures Act mandates the creation of "one or more" intercenter institutes at the FDA. But is such a massive reorganization feasible within the FDA?
With
In addition to the above, and a number of other provisions, the law also mandates the FDA to create centers for better coordination among its staff when handling major diseases. These include experts who are a part of the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health. One such center, which was launched in summer 2016, could serve as a model—or an experiment.
The Oncology Center of Excellence
In a
While the Cures bill mandates that the FDA “shall establish one or more” intercenter institutes, questions related to existing bandwidth and the impact of such a major reorganization remain. The bill has dedicated $500m to the FDA, which the agency will receive over an 8-year period between 2018 and 2026, which could provide the impetus to do more.
Mark McClellan, MD, PhD, a former FDA commissioner, believes that such a reorganization may not be the most efficient change for the FDA. Speaking during a
Such a cohesive approach, however, would be important for patients. The bill’s provisions have laid guidelines for establishing an intercenter institute, including:
- Coordination of staff expertise in a major disease area
- Promote scientific programs within centers related to a major disease area
- Recruit, train, and provide continuing education programs for expert personnel
- Enhance patient interactions
- Facilitate collaboration with other agencies within HHS
Meanwhile, therapeutic area recommendations have been made for intercenter institutes, including for rare disease, infectious diseases, and cardiovascular diseases.
While the concept is great in theory, such a massive overhaul within one of the most bureaucratic organizations in the country may not be an easy task. And when the new
Reference
Gingery D. Cures bill authorizes 'intercenter institutes,' but will US FDA create them? Pink Sheet;78(49):6-7.
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