Executive Summary
Commissioner Califf says review staff reorganization based on disease will go ahead regardless of what other headway VP Biden’s initiative makes.
Oncology product regulation at FDA will be reorganized no matter what happens with VP Joe Biden’s Cancer Moonshot.
The White House initiative intended to boost efforts to find a cure for cancer is expected to include additional funding for NIH and FDA as well as encourage research collaboration between industry and government.
A reorganization of the FDA’s oncology divisions is thought to be a part of the effort, whose broader success will likely depend as much on Congress and other stakeholders than any remaining steps the Administration can take. But Commissioner Robert Califf said FDA intends to make that organizational change no matter what to encourage more collaboration among experts at the agency.
“The big deal for the FDA here is a lot of public pressure to create a center of excellence in oncology,” he told members of the Alliance for a Stronger FDA on April 19. “And we’re going to do that whether it’s part of legislation or not.”
The White House proposed allocating $1bn for cancer research as part of the Moonshot effort. It included funding for oncology research at the National Institutes of Health in addition to FDA (“Cancer Moonshot Initiative: FDA To Form Virtual Oncology Center of Excellence” — “The Pink Sheet” DAILY, Feb. 1, 2016).
FDA’s part of that request was relatively modest – the agency asked for an additional $75m for the Cancer Moonshot in its fiscal year 2017 budget request – but any changes the agency makes to product review could have an outsized impact (“FDA Budget Request Is Flat For Drugs, Pressuring Stakeholders” — “The Pink Sheet,” Feb. 15, 2016).
Several Cancer Moonshot provisions, including the center of excellence proposal and additional funding, could be attached to the Senate version of the 21st Century Cures legislation. However, a funding agreement has yet to be reached (“Senate’s Medical Innovation Bill Takes Cures’ Shape” — “The Pink Sheet” DAILY, Apr. 6, 2016).
Califf said the hope is that the change “will lead to more efficient, more responsive regulation related to particular diseases.”
“I’m not arguing that we ought to change the primary direction of control,” he said. “It still needs to be where it is. But we need to create mechanisms where people with a common interest can work together and think together so that we make better decisions as a whole.”
Eliminating siloes at FDA is among Califf’s priorities as commissioner. He also wants to create professional homes for statisticians, toxicologists and others who may work with different products, but share the same occupation (“Califf Lowering FDA Drawbridge To Work With External Expertise” — “The Pink Sheet,” Apr. 18, 2016).
Not Just Virtual
Califf did not reveal too many details about the design of the center for excellence other than that there would be concrete differences within FDA once it is established.
“The only thing I’ll say is that it’s not going to be purely virtual,” Califf said. “The rest of it we’re working on.”
The oncology center of excellence was the idea of the Friends of Cancer Research (FOCR), which argued that FDA needed a reorganization of staff to keep up with scientific and technological advances.
The group suggested dropping the existing structure that focuses on medical products like drugs and devices and instead reorganizing the agency by therapeutic area.
The idea is only expected to affect the clinical divisions at the agency (“FDA Reorganization Advocates Seek Senate Boost For Disease-Oriented Structure” — “The Pink Sheet,” Nov. 30, 2015).
It also appears aimed in part at improving the review of combination products, which are becoming increasing popular as more precision medicine treatments are developed.
Combination product reviews can be slow because they require clearance from the device and drug divisions. Reorganizing the agency by disease ideally would pair the relevant drug and device staff together so there would be fewer review delays. Califf also has said he is in favor of a combination product approval pathway (“Califf Supports Combo Products Pathway At Confirmation Hearing” — “The Pink Sheet” DAILY, Nov. 17, 2015).
More Centers Of Excellence Coming?
Califf appears interested in using the oncology division as a pilot for reorganization of staffing in other disease areas. FOCR officials and other stakeholders also felt that an oncology reorganization could help determine the best way to roll the idea out throughout the entire agency.
The Office of Hematology and Oncology Products within FDA’s Office of New Drugs in many ways already is organized by disease area.
Director Richard Pazdur created disease-focused teams several years ago in areas such as lung and breast cancer. His intent was to establish an academic environment that would be more enticing to potential hires (“FDA Talent Hunt: Is Recruiting From Academia Better Than Industry?” — “The Pink Sheet,” Nov. 30, 2015).
Whether or when the idea could be rolled out to other areas like cardiovascular or neurodegenerative diseases is unclear.
There continue to be compelling reasons for FDA to continue using its current structure. The agency also already is in the midst of a number of other reorganization efforts and may not want to uproot a large number of staffers again (“Don’t Rush To Reorganize FDA, McClellan Says” — “The Pink Sheet,” Feb. 29, 2016).
Among the largest ongoing reorganizations is the Program Alignment Group, which is moving inspection and other field staff to more specialized positions. The agency is expected to move from its geographically focused field office system to product-focused offices in strategic locations (“Updated: FDA Manufacturing Inspectors Could Be Further Divided Into Subspecialties” — “The Pink Sheet” DAILY, Sep. 29, 2015).
The Center for Drug Evaluation and Research also launched its Office of Pharmaceutical Quality in 2015, which moved chemistry, manufacturing and controls and related staff out of the Office of Generic Drugs and other offices into one group (“Woodcock’s Passion Project: CDER Chief Shifts Duties To Lead Quality Office” — “The Pink Sheet,” Jan. 19, 2015).
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