FDA is proceeding with the restructuring of the Office of New Drugs ahead of a formal switch to the new organization in September.

While the Center for Drug Evaluation & Research's Office of New Drugs is not slated to commence operations under a revamped structure until this fall, FDA has already begun implementing some of the planned changes.

The formal switch to the new structure, which includes dismantling two Offices of Drug Evaluation, will coincide with the drug center's move from its office in Rockville, Md. to White Oak, Md.

That process, however, has been twice delayed due to construction problems at the White Oak site. The move - and subsequent reorganization - was expected to take place in April, but has now been postponed to September.

Should the most recent timeline for the move remain firm, the reorganization of the Office of New Drugs would be fully implemented nearly one year after FDA proposed the new structure.

In October 2004, FDA announced plans to phase out ODE V and reshuffle a number of divisions among the different offices (¹ Also see "FDA Reorganization Plan Would Eliminate One ODE, Split Neuropharm Division" - Pink Sheet, 25 October, 2004., p. 3). The structure also includes a previously planned office outside the traditional "ODE" structure for oncology reviews (² [A#00660300007], p. 13).

For reasons unrelated to the delayed relocation to White Oak, FDA has taken steps to implement the planned changes ahead of the original timeline.

While FDA originally intended to implement the restructuring at the time of the move, the agency later decided that phasing in the reorganization could prove less disruptive and present an opportunity to apply "lessons learned" to the full implementation process.

Given the need to have the oncology office up and running as soon as possible, FDA tapped Oncology Division Director Richard Pazdur to head the Office of Oncology Drug Products, effective May 1 (³ Also see "CDER Drug Safety Website Model Includes Elidel; Novartis Objects" - Pink Sheet, 25 April, 2005., In Brief).

The oncology office will become fully operational in July and will combine the Division of Oncology Drug Products (ODE I), the Division of Therapeutic Biological Oncology Products (ODE VI) and other biologics review functions.

The remaining half of ODE VI - the Division of Therapeutic Biological Oncology Products and part of the Division of Review Management & Policy - will continue to report to ODE VI Director Karen Weiss. Upon the move to White Oak, Weiss will become Pazdur's deputy in the oncology office.

Also in July, FDA will split the Division of Neuropharmacological Drug Products into neurology (under Russell Katz) and psychiatry (under Tom Laughren).

As a first phase of the restructuring, FDA has dissolved ODE V and distributed its divisions to other offices within CDER.

The phase-out of ODE V began with Director Jonca Bull's appointment as deputy director of the Office of Pharmacoepidemiology & Statistical Science (⁴ Also see "IoM’s Drug Safety Cmte. Will Meet In June; Panel Includes Ex-FDAer Ellenberg" - Pink Sheet, 9 May, 2005., In Brief).

Bull's deputy director in ODE V, Brian Harvey, has been tapped to head gastrointestinal drug review efforts under ODE III Director Florence Houn. After the restructuring this fall, the GI division will be renamed the Division of Gastroenterology Products.

The change gives Harvey, who joined FDA in 1995 as a reviewer in the Center for Devices & Radiological Health Gastroenterology & Renal Devices Branch, FDA's first stand-alone GI division. (Coagulation reviews will be transferred to the Medical Imaging & Hematology Division in the new oncology office.)

As a result of the changes at the top of ODE V, the three divisions - Anti-Inflammatory, Analgesic & Ophthalmologic Drug Products; Dermatologic & Dental Drug Products; and Over-the-Counter Drug Products - have been moved elsewhere in CDER.

Harvey also served as director of the Division of Anti-Inflammatory, Analgesic & Ophthalmologic Drug Products; anti-inflammatory and analgesics have moved to ODE II under Robert Rappaport, while ophthalmology is now in ODE IV under Janice Soreth.

The Division of Dermatology & Dental Drug Products has moved to ODE III under Jonathan Wilkins, and the OTC drug division has been elevated to the Office of Non-Prescription Products.

FDA Phasing In Restructuring Of Drug Office; Move To White Oak Postponed

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