FDA's Office of Oncology Drug Products is undergoing a reorganization aimed at making its structure more similar to the rest of the review offices in the Center for Drug Evaluation and Research.

Currently, the oncology office has three review divisions, organized primarily around the type of molecule being reviewed: the Division of Drug Oncology Products, led by Robert Justice; the Division of Biologic Oncology Products, led by Patricia Keegan, and the Division of Hematology Products, led by Ann Farrell.

"That's the only remaining place in CDER where we make that distinction based on the type of product, and we're working toward moving to more of a disease-specific model," Office of New Drugs Director John Jenkins said in an interview.

The new model that the oncology office is progressing towards would be similar to how most oncology centers in academic institutions are organized, Jenkins said, in which "you have experts who specialize in breast cancer or colon cancer rather than people who might just review small molecules versus large molecules."

A Legacy Of The Review Transfer From CBER

The oncology offices molecular structure is a vestige of the last great reorganization of drug reviews, following the integration of therapeutic biologics into CDER. BLAs initially were reviewed in their own OND office after they came over from CBER in 2003, and eventually were spread out by therapeutic area into the various other drug evaluation offices as part of a reorganization that became effective in 2005 (¹ Also see "FDA Reorganization Plan Would Eliminate One ODE, Split Neuropharm Division" - Pink Sheet, 25 October, 2004.).

The Office of Oncology Drug Products was created as part of that reorganization, but it retained the large molecule/small molecule divisions.

Now, that structure also is being broken up. "When the names will actually change I can't really say," Jenkins said, "but the process of starting the move towards more of a disease-specific model is already under way. ... It involves giving staff an opportunity to declare what diseases they are most interested in focusing their attention on."

Additional restructuring of the Office of New Drugs that went into effect March 15 will help with the effort. Under that reorganization, medical imaging reviews were separated from the hematology division and moved to another office.

The new hematology division will now begin to absorb products from the other two oncology divisions, Jenkins said, because when it was a joint division with imaging, the products it reviewed were "primarily benign hematology ... things like drugs for anemia, or noncancer hematology indications."

Hematologic malignancies - including leukemia and lymphoma - will be moved to the new hematology division, which Jenkins notes is "consistent with how academic medical centers are organized. You tend to find in those medical centers that the hematologists are where you go if you have leukemia. If you have breast cancer, you go to a solid tumor oncologist who specializes in breast cancer."

The move away from a biologic-focused organization comes as FDA is weathering controversy related to Dendreon's Provenge (sipuleucel-T). The prostate cancer vaccine was initially rejected by FDA after a favorable advisory committee, prompting protests - and even a lawsuit - from patient advocates. Now, a reworked application appears on track for approval by its May 1 user fee date (² Also see "No Drama Dendreon: Anticipated Provenge Launch Appears On Track" - Pink Sheet, 23 February, 2010.).

Workload Issues Trump Therapeutic Focus

The most recent round of OND restructuring that separated hematology and medical imaging also involved moving rheumatology reviews - all part of an effort to better balance workload between divisions and offices (³ Also see "Office Of New Drugs Reorganization Should Better Balance Workload, FDA Says" - Pink Sheet, 9 March, 2010.).

Spinning imaging out should help its staff become better consultants for trials on a variety of products (see ⁴ Also see "Drug Review Reorganization Boosts Advisory Role Of Medical Imaging Division" - Pink Sheet, 12 April, 2010.), but moving the division to what had been the Office of Nonprescription Products (now ODE IV) has raised concerns from some in industry that FDA is not focusing sufficiently on OTC issues (⁵ Also see "FDA's ONP Reorganization Challenges Industry To Prioritize OTCs" - Pink Sheet, 15 March, 2010.).

"We're not downgrading them in any way," Jenkins emphasized. "This is just logistics. The nonprescription office was relatively small. Other offices were getting very large."

Reorganization is part of a continuous cycle as work in various therapeutic areas ebbs and flows, Jenkins said. "It's an ongoing process. ... We will have to realign over time."

- M. Nielsen Hobbs ( ⁶ n.hobbs@elsevier.com )

Oncology Drug Reviews To Be Restructured As Office Shifts Away From Divisions Organized Around Molecule Size

More from Archive

More from Pink Sheet