FDA Completes Final Phase of Planning for Consolidation of Certain Products from CBER to CDER

FDA announced today that it has completed the third phase of its work leading to implementation of the transfer of certain products reviews from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER). This third phase dealt primarily with larger logistical issues involved in the product consolidation.

"We are well on our way to implementing an organizational and management structure that will promote both greater consistency and broader expertise in the way FDA regulates the increasingly diverse products used to treat specific diseases," said FDA Commissioner, Mark B. McClellan, M.D., Ph.D. "In addition, this consolidation will allow us to use our resources in the most efficient way possible so that both CBER and CDER can better fulfill their mission of protecting and promoting the health of the American people."

The major decisions announced today include:

• The target implementation date of the consolidation is June 30, 2003 pending final consultation with Congress and satisfying obligations under FDA's contract with the National Treasury Employees Union.
• Of the resources to support the previously announced transfer of 208 employees to CDER, those resources will be used to support approximately 194 employees who will be reassigned to CDER, 6 vacant positions to be recruited by CDER, and 8 positions that will remain in CBER but which CDER will support for shared services primarily on the NIH campus.
• Within the new few weeks, CBER will post on its website the numbers for all applications being transferred to CDER. Sponsors will be encouraged to check the number listing to ascertain if any of their applications are being transferred.
• Once the transfer takes place place, CBER's present Division of Clinical Trial Design and Analysis and Division of Application Review and Policy, with the leadership they have in place at that time, will initially function as a new office within CDER's Office of New Drugs. Likewise, CBER's Division of Monoclonal Antibodies and Division of Therapeutic Proteins, with the leadership they have in place at that time, will initially function as a new office within CDER's Office of Pharmaceutical Sciences. Over time, CDER's senior leadership will reassess its organizational structure to determine if a more efficient structure is needed for the review of all of the products for which it will then have responsibility.
• It was again reiterated that under the new structure the biologic products transferred to CDER will continue to be regulated as licensed biologics.

The first phase of the planning involved identifying which the products to transfer; the second phase determined the financial and human resources to transfer to support the work required for the identified products; and now the third phase has determined the critical logistical pathways for the consolidation. Today's announcement brings to a close the main planning for the transfer of certain product review function from CBER to CDER.

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Office of Public Affairs
2003-MAR-17.