CDER Oncology Division Handling Most Cancer Prevention Drugs Ahead Of Reorg
This article was originally published in The Pink Sheet Daily
Executive Summary
Two approved products – Pfizer’s Celebrex and Axcan’s Photofrin – and 69 INDs were transferred to the Division of Oncology Drug Products, ahead of the creation of an Office of Oncology Drug Products. The transfer excludes biologics and those drugs aimed at reducing the risk of non-melanoma skin cancer.
|
CDER's Division of Oncology Drug Products now houses most cancer prevention drugs following FDA's recent transfer of the products. The agency transferred regulatory responsibility for most non-biologic cancer prevention applications to the Division of Oncology Drug Products in the Office of Drug Evaluation I during December and January. The move precedes a planned reorganization of the Office of New Drugs and creation of an Office of Oncology Drug Products. "Most applications to reduce cancer risk have been transferred from review divisions within CDER to the Division of Oncology Drug Products in ODE I, a division that will become part of the new Office [of Oncology Drug Products] when the planned Office of New Drugs reorganization is complete," FDA said in a March 8 1 notice. The reorganization is scheduled for April, when the Center for Drug Evaluation & Research begins the move to FDA's new White Oak facility. Following the reorganization, the Office of New Drugs will have five Offices of Drug Evaluation and the new Office of Oncology Drug Products (2 (Also see "FDA Reorganization Of New Drug Office Would Split Neuropharmaceutical Division" - Pink Sheet, 20 Oct, 2004.)). Cancer prevention agents that were not transferred to the Division of Oncology Drug Products include "products to reduce the risk of non-melanoma skin cancer, which will continue to be reviewed in the Division of Dermatologic & Dental Drug Products, and CDER-regulated biologic products to reduce cancer risk," FDA said. Cancer prevention biologics will continue to be reviewed in the Division of Therapeutic Biological Oncology Products in ODE VI. The therapeutic biological oncology products division, along with the Division of Oncology Drug Products and the Division of Medical Imaging Agents, will make up the new Office of Oncology Drug Products (3 (Also see "FDA Will Conduct "National Search" For Head Of Oncology Office" - Pink Sheet, 16 Jul, 2004.)). The cancer prevention applications were transferred to the Division of Oncology Drug Products in groups between Dec. 15 and Jan. 31. FDA had anticipated that cancer prevention therapies would move to the division by the fall of 2004 (4 (Also see "Chemo-Preventative Agents Will Move To New Cancer Office In Fall" - Pink Sheet, 16 Jul, 2004.)). As of Dec. 15, new applications for cancer prevention products should be submitted to their designated divisions, the notice says. "These reassignments refer only to products to reduce the risk of cancer, not products to treat cancer," FDA said. In total, two approved products - Pfizer's Celebrex (celecoxib) and Axcan's Photofrin (porfimer) - and 69 investigational new drugs were transferred to the Division of Oncology Drug Products. - Adam Eckstein |