FDA Notes

November 9, 2005
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

CDER 2005 Product Approval Totals Proposed CDER Reorganization

Proposed CDER Reorganization

Washington, DC, Nov. 4 - CDER Director Steve Galson circulated a memo outlining a proposed reorganization that would bring the Center into alignment with FDA's Critical Path Initiative and "improve regulatory and drug development science."

Observing that, "To date, the Center has not been staffed to support needed work on the critical path and has not been configured to provide organizational 'ownership' of these activities." Galson made a series of proposals to support the Critical Path initiative, increase safety oversight, and encourage cross-office activities (see draft organizational chart):

  • Create a new office to catalyze Critical Path activities. This new group would absorb the current Office of Clinical Pharmacology and Biopharmaceutics and the Office of Biostatistics.
  • Create a new group to report to the Office of Medical Policy to address Critical Path projects in the area of clinical trial design and analysis.
  • Appoint a new associate center director to focus on broad drug safety policy and safety communication.
  • Consolidate certain drug safety-related activities to report to this new associate center director, including two MedWatch and the Drug Safety Oversight Board staff.
  • Realign the pediatric drug development review staff currently in OCTAP so that they report directly to the Office of New Drugs.
  • Establish the Office of Counterterrorism and Emergency Operations, which will report directly to the Office of the Center director.
  • Realign the Division of Scientific Investigations (DSI) from the Office of Medical Policy into the Office of Compliance.

"As I emphasized in my State of CDER address," Galson wrote, "making organizational changes--moving boxes on a chart--only sets the stage upon which the Center priorities can best be addressed. A reorganization is not designed to achieve instant solutions to the challenges CDER faces, although I believe it will address many of the criticisms and suggestions which have been offered on how to approach our work, including drug safety. I truly hope that the proposed realignment will merely create a more efficient and effective environment to further the Center's activities. Other important changes in policy and/or processes (including decision-making) will continue to be discussed and implemented as needed to achieve our shared goals for CDER."