- FDA Reorganization Takes on Cancer Moonshot and Other Initiatives
- August 15, 2016
- Law Firm: Mintz Levin Cohn Ferris Glovsky Popeo P.C. - Boston Office
On July 11, 1969, the United States accomplished the almost unthinkable - two men walking on the moon. Conjuring images of that moon landing, President Obama moved forward the “Cancer Moonshot” program at his January 2016 State of Union Address. Vice President Joe Biden—who recently lost his 46 year old son to brain cancer— was named as the program’s “Mission Control.” To combat such a complex and variable disease—for which the cure is unknown and where treatments vary significantly—in the aggressive way envisioned by the Cancer Moonshot program requires a restructuring of the FDA. The current FDA administrative structure does not organize around a particular disease, but rather product categories (i.e. drug, device, food).
Establishing a cross-sectional Oncology Center of Excellence (OCE) would theoretically increase the retention and recruitment of professional FDA personnel with disease- specific expertise, streamline drug and device review processes, and enhance outreach activities to patient groups. Rather than have individual FDA centers review oncology products and treatments in an uncoordinated way, the centralized OCE, would seek to coordinate and improve the process across the FDA.
Significant steps must be taken to realize the benefits of the OCE. The temporary director, Dr. Richard Pazdur, recently proposed the first steps to complete the task. He recommended cross-center monthly meetings to discuss central oncology issues and advances. Initially, Pazdur seeks to build a system for cross- disciplinary review staff, provide external outreach to diverse stakeholders, and ensure current administrative efficiency for review of significant cancer products.
Congress is also taking an interest in reorganizing the FDA. H.R. 5414, the FDA Cross-Center Collaboration Act of 2016, would establish Intercenter Institutes within the FDA to focus on specific diseases and coordinate activities between the agency’s drug, device, and biologic centers. Specifically, these Institutes would be tasked with coordinating activities, applicable to their specific disease areas, with the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health. In order to establish such Institutes, HHS would have to provide for a public comment period on the proposed Institute. A bipartisan Senate bill, S. 2700, also included language on Intercenter Institutes when it advanced out of committee in March.
Although Cancer Moonshot efforts within FDA are, pardon the pun, just taking off, we can already anticipate a number of challenges to creating the OCE and hurdles that may arise for product approvals within OCE. First, the FDA is in the midst of a massive administrative reorganization called Program Alignment, underway since 2014 that created the Office of Regulatory Affairs—a product based and vertically integrated inspection program—and the Offices of Manufacture and Pharmaceutical Quality. However, this reorganization is focused mainly on post- market compliance; thus it does not provide much framework for the lofty Cancer Moonshot goals focused on new treatments and cures. Second, an October 2015 independent report titled “Combination Product Review Intercenter Consult Process Study” identified key issues with the fully implemented office of Combination Products that could be very instructive to the FDA in developing the OCE or other Intercenter Institutes:
- Different Application Types and Timelines
- Separate Review and Tracking System in each Center
- Unclear communication channels between Centers
- Lacked Resources
While we don’t expect much to happen with the implementation of these initiatives in these final months of the Presidential election year, we are carefully monitoring all reorganization programs within the FDA so we can better identify opportunities and anticipate roadblocks for clients.