FDA Reorganization Plan Would Eliminate One ODE, Split Neuropharm Division

FDA is planning to split the Division of Neuropharmacological Drug Products into two divisions - neurology and psychiatry - as part of the upcoming reorganization of the Office of New Drugs.

The current plan would have Neuropharm Division Director Russell Katz, MD, heading up the new neurology division, with a new director to be chosen for the psychiatry division. Both the neurology and psychiatry division would stay in the Office of Drug Evaluation I.

The proposed reorganization plan would be the first major update to the agency's new drug review management structure since the Center for Drug Evaluation & Research moved to the five ODE structure a decade ago in response to the new resources and deadlines created by the Prescription Drug User Fee Act.

FDA plans to finalize the reorganization in conjunction with CDER's move to the new White Oak, Md. campus, scheduled for April 2005.

The other immediate impetus behind the reorganization is the transfer of most biologic product reviews to CDER from the Center for Biologics Evaluation & Research (¹ (Also see "CDER “Comprehensive” Reorganization To Follow After CBER-CDER Merger" - Pink Sheet, 30 Jun, 2003.), p. 8).

Rather than consolidate biologic review functions directly into the existing five ODE structure, CDER created a sixth Office of Drug Evaluation to handle biologics reviews. The office is headed by Karen Weiss, MD, who had been director of CBER's Clinical Trial Design & Analysis Division (² (Also see "CBER/CDER Consolidation: Weiss Named Acting Director Of New ODE VI" - Pink Sheet, 23 Jun, 2003.), p. 24).

The ODE VI approach was announced as a temporary step to help to ease the transition and integration process for biologics reviews.

The ³ pending reorganization would re-establish a five office structure for new drug reviews, but with one of the offices designated as an Office of Oncology Drug Products rather than an ODE.

FDA formally announced the plan for the oncology office in July; it is the one review group that will continue to divide products between drugs and biologics rather than by indication (⁴ , p. 13).

The proposed structure calls for three divisions in the Office of Oncology: one for drugs, one for biologics, and one for medical imaging, which is expected to include non-oncology imaging agents.

The proposed structure would also elevate OTC reviews to the office level. The new office would be divided into OTC monograph and NDA review divisions.

The restructuring plan is in the final stages but needs approval from CDER leadership.

The main goal of the new divisional structure is to even out the workload among different review divisions while rationalizing the groupings of products by indication.

FDA is developing an implementation plan to ensure that product review remains smooth during the restructuring.

Among the issues the agency intends to tackle in the coming months is providing clear direction on the assignment of products that could plausibly fit in more than one review division.

The biggest changes in the restructuring will occur in ODE I (headed by Robert Temple) and ODE V (headed by Jonca Bull).

ODE I currently oversees the Oncology Drug Products Division, which will be the centerpiece of the new oncology office. By splitting the neuropharm division in half, ODE I will continue to have three divisions: Cardio-Renal, Neurology and Psychiatry.

The new divisional line-up in ODE I will align with FDA's existing advisory committee structure, which has separate panels for Peripheral & Central Nervous System Drugs and for Psychopharmacologic Drugs.

ODE II will continue to oversee the Pulmonary/Allergy and Metabolism/Endocrine divisions as part of the reorganization.

The third ODE II division, currently the Division of Anesthetic, Critical Care & Addiction Drug Products, would have a significantly expanded mission, picking up the arthritis and analgesic drug review responsibilities currently housed in ODE V.

The new division would be renamed Analgesics, Anesthetics & Rheumatology.

ODE III would retain responsibility for the Reproductive/Urology drugs division. The current Gastrointestinal/Coagulation division would focus exclusively on gastroenterology.

The third current ODE III division, Medical Imaging, will become part of the new Oncology Office. Under the reorganization proposal, ODE III would take over the Dermatology/Dental division from ODE V.

The Dermatology division is likely to retain responsibility for skin cancer therapies despite the creation of the separate Oncology office. FDA is also considering whether prostate cancer therapies should remain in the Urology division or move to the new office.

ODE IV would see the least change under the reorganization. The Anti-Infectives division would add responsibility for ophthalmology products (currently housed in ODE V). ODE IV would continue to oversee the Antivirals and Special Pathogen/Immunology divisions.

The end result is that ODE V would cease to exist under the new organizational plan. Its current divisions include OTCs (which will become an office-level group), dermatology/dental products (which will shift to ODE III) and anti-inflammatory/analgesics/ophthalmologic products (which will be divided between ODE II and ODE IV).

ODE V Director Bull is understood to be slated to become deputy director of the Office of Pharmacoepidemiology & Statistical Science.

The OPaSS deputy director position was created last year but has not been filled. Bull would report to OPaSS Director Paul Seligman, MD.

Seligman is also serving as acting director of OPaSS' Office of Drug Safety. Former ODS Director Victor Raczkowski, MD, left the post in October 2003 to join Cephalon as VP-regulatory affairs.

As head of ODE V, Bull has participated in two recent high-profile drug safety issues in the arthritis/analgesic categories that could have long-term implications for FDA's coordination of pre-market and post-market reviews.

Most prominently, Merck withdrew the COX-2 inhibitor Vioxx on Sept. 30, touching off inquiries from Congress about how FDA handled safety analyses conducted by ODS staff (⁵ (Also see "Antidepressant Hearings Offer Starting Point For Vioxx Investigation" - Pink Sheet, 11 Oct, 2004.), p. 3). An earlier internal dispute over the handling of safety assessments for Aventis' arthritis drug Arava received extensive media attention as well (⁶ , p. 29).

The agency is finalizing the reorganization while Office of New Drugs Director John Jenkins, MD, is on leave. Deputy Director Sandra Kweder, MD, is serving as acting director in his absence. Jenkins is expected to return.