FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

Phase Two of CBER/CDER Product Consolidation Concludes

Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D., today informed employees of the Food and Drug Administration (FDA) that the agency's Consolidation Working Group has completed phase 2 of the consolidation of certain biologic product reviews in FDA's Center for Drug Evaluation and Research (CDER). The consolidation of certain product review functions in CDER, announced last September, is expected to produce a more efficient, effective, and consistent review program for human drugs and biologics.

In an email message to all employees in CDER and in FDA's Center for Biologics Evaluation and Research (CBER), Dr. McClellan announced the planned transfer of nearly $32.9 million from the biologics program to the human drugs program's budget. This amount reflects the full year costs associated with the transfer of therapeutic product reviews from CBER to CDER.

The categories of products are being transferred include, generally:

• Monoclonal antibodies intended for therapeutic use
• Cytokines, growth factors, enzymes, and interferons (including recombinant versions) intended for therapeutic use and
• Proteins intended for therapeutic use that are extracted from animals or microorganisms, other than human blood and blood components and derivatives.

The funds to be transferred represent approximately 208 full-time equivalents (FTE's) from CBER and 5 FTE's from FDA's field operations from FY 2002 staffing levels - and the possibility of an additional 8 FTE's if the President's FY 2003 budget is adopted.

The Commissioner also announced that, because of important complementarities with other vaccine and cellular research in CBER, review of therapeutic vaccines (such as vaccines for cancer) would remain in CBER. Under the new structure, clinical review of therapeutic vaccine- associated Investigational New Drug applications (IND's) and Biologics License Applications (BLA's) will be fully coordinated with the appropriate area of clinical expertise in CDER. CDER and CBER will establish a process for conducting prompt, reimbursable consultations on product reviews when such consultation is necessary.

The Consolidation Working Group, co-chaired by Principal Associate Commissioner Murray M. Lumpkin, M.D., and Assistant Commissioner for Planning Theresa Mullin, Ph.D., will now move on to its third and final phase of work. This phase will focus on the logistics of the transfer and on developing procedures and timelines for actual transfer of review responsibilities for specific licensed/approved products and INDs from CBER to CDER. This phase is expected to be completed by early February.

####

Media Contacts   |   FDA News Page   |   FDA Home Page

Office of Public Affairs
Web page created by tg 2003-JAN-08.