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 overwhelming support from the US Senate, and approval by President Barack Obama, the 21st Century Cures Act became law—one that will boost funding for medical research, reduce hurdles in the path of developing experimental treatments, and also support 2 huge projects that were set in motion by the current government: the Precision Medicine Initiative and Cancer Moonshot.
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 was established as part of the Cancer Moonshot to expedite the oncology drug development process. Headed by Richard Pazdur, MD, a veteran at the FDA who also leads its Office of Hematology and Oncology Products, the center will promote collaboration by sharing information and best practices among regulatory scientists and reviewers with oncology clinical trial expertise at the FDA.
In a blog post, Pazdur wrote that a significant emphasis of the center will be on revisiting clinical trial design and shifting away from the long-standing traditional method of drug evaluation. Changes include eliminating the “phased” approach to trials and replacing it with a more seamless process. Another major change is the use of common control trials, which involve sharing a common control arm for multiple drugs—across multiple companies—for the same indication, with the objective of decreasing the number of patients that need to participate, optimizing resource utilization, and reducing the overall time needed to conduct the study.
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 panel at a meeting organized by the Friends of Cancer Research earlier this year, McClellan said, “Given the limited resources at FDA, making them go as far as possible means it may not be the most efficient thing to reorganize all the way around diseases of treatment areas. There are a range of options that can be used that have a more progressive effect on structure and organization at the agency.”
Such a cohesive approach, however, would be important for patients. The bill’s provisions have laid guidelines for establishing an intercenter institute, including:
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 FDA commissioner takes charge in the new year, an agency reorganization may not be high on the list of priorities.
Gingery D. Cures bill authorizes 'intercenter institutes,' but will US FDA create them? Pink Sheet;78(49):6-7.