Reorganizing FDA's structure so disease experts work together may be necessary as Congress and the Obama administration consider agency reforms, but former Commissioner Mark McClellan suggests the status quo is most efficient in some cases.

A proposal from the Friends of Cancer Research would group experts by diseases such as cancer or cardiovascular disorders together and remove FDA's traditional divisions based on drugs, devices and biologics.

The idea is intended to ensure that those throughout the agency who are the most knowledgeable about a disease area like oncology would work together on product reviews.

But McClellan, director of the Duke University-Robert Margolis Center for Health Policy, said those pushing for change should remember that FDA resources are limited. He said FDA has tremendous cancer expertise, but that group is small compared to the rest of the agency.

"Not to defend the status quo, but there are some good efficiency reasons for having the same expert regulatory staff dealing with products across a number of areas," McClellan said during a Feb. 24 congressional briefing on the FOCR proposal.

"That's why I think this point about really looking at where the biggest bang for the buck is going to be in terms of a more integrated structure is very important."

FOCR's proposal for virtual centers of excellence at FDA emerged last fall and is included in VP Joe Biden's Cancer Moonshot initiative ([A#14160201004]). FDA asked for $75m in its fiscal 2017 budget to fund moonshot activities ([A#00160215006]).

FOCR, an advocacy group and think tank that also helped create the popular breakthrough therapies program in 2012, wants to encourage more collaboration between the agency's clinical centers.

The group believes the existing FDA organization is outdated and does not reflect the overlap between the drug, device and biologic product categories. The model has changed, as many therapies now have all three types of products and should not be reviewed in isolation, FOCR has said Also see "FDA Reorganization Advocates Seek Senate Boost For Disease-Oriented Structure" - Pink Sheet, 30 November, 2015..

Combination Product Solution

The idea seems particularly aimed at FDA's combination product review, which has been problematic because the drug and device review schedules often do not mesh.

McClellan suggested the proposal needs more fine-tuning to identify the largest product development and scientific challenges. His prime example is the combination product approval process, an area where FDA already is considering changes.

"Given the rapid growth in the development of targeted treatments and how well it fits with issues like the whole focus in the cancer moonshot and the president's precision medicine initiative on furthering the use of targeted therapies … that may be a really good place to start," McClellan said.

"Start asking the questions of what's the best way forward in the short term and maybe the longer term."

Problems with combination product applications are well documented.

In some cases the Center for Drug Evaluation and Research has assumed responsibility for both parts of a combination rather than dividing it between the drug and device centers.

To smooth the process, FDA is formulating concepts for a new approval pathway and potentially a new user fee for combination products.

Changes like that would require legislation, but they are on the congressional radar and were disused at the Senate confirmation hearing for new FDA Commissioner Robert Califf ([A#05160229010]).

Oncology The Best Place To Start

During the briefing, FOCR chair and founder Ellen Sigal insisted there is nothing wrong with FDA's current structure and productivity. But she thinks the agency can do better.

Only FDA's clinical divisions would be affected by the reorganization, with manufacturing, legal and other similar offices remaining as they are, she said.

Sigal also noted that any change would require more resources, and would have to integrate outside as well as FDA input.

"We really have to look at this integration in a way that will be meaningful," she said. "It should not be disruptive. It should be thoughtful."

Moving the pieces around the agency likely would have to be done slowly. FOCR suggested that oncology, followed by cardiovascular, neurodegenerative and infectious diseases could serve as the pilot programs before a broader change is implemented.

George Demetri, director of the Harvard Medical School Ludwig Center, said oncology works for a proof-of-concept phase because there already are a growing number of oncology drugs with diagnostic and biologic components.

Richard Pazdur, director of the Office of Hematology and Oncology Products within FDA's Office of New Drugs, reorganized his staff several years ago into disease-focused teams. The reorganization was in part an attempt to create an academic environment that would attract more qualified staff Also see "FDA Talent Hunt: Is Recruiting From Academia Better Than Industry?" - Pink Sheet, 30 November, 2015..

McClellan said there also could be less disruptive methods to improve collaboration. In the past FDA has created commissions with representatives across centers to deal with specific issues, a process that could be used while a larger reorganization is researched.

Does FDA Want Another Reorg?

Otis Brawley, chief medical officer and vice president of the American Cancer Society Cancer Action Network, said the proposal has a chance to improve drug and diagnostic review efficiency and is not simply a change for the sake of change.

But FDA officials already are concerned about radical adjustments to the agency's structure, especially coming from external stakeholders.

There also may not be much of an appetite for a reorganization, given that one still is ongoing and others were recently completed. FDA continues to work on its Program Alignment Group reorganization, which will make field staff more specialized.

The agency is expected to abandon its regionally focused district offices and instead create several offices in which drug-focused investigators would be based ([A#14150929002]).

Within CDER, the launch of the Office of Pharmaceutical Quality in January 2015 moved chemistry, manufacturing and controls and related staff out of the Office of Generic Drugs and other offices into one group ([A#00150119004]).

OGD also underwent a transformation due to new responsibilities and an infusion of resources from the generic drug user fee program Also see "FDA Generics Office Drinks Super Serum, Then Shrinks" - Pink Sheet, 16 December, 2013..

And former Commissioner Margaret Hamburg reorganized FDA into directorates and also created the deputy commissioner for medical products and tobacco position in 2011 Also see "FDA Reorganization Adds "Directorate" Layer, But Sharpens Agency's Focus" - Pink Sheet, 18 July, 2011..

[Editor's note: "The Pink Sheet" also published this article. "The Tan Sheet" brings selected complementary coverage from our sister publications to our subscribers.]

Look Before Leaping To Reorganize FDA – Former Commissioner McClellan

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