Box 21 Fda Plans To Shift Review And Approval Of Wellcharacterized And Recombinant Biotechnology Products From Its Biologics Division To Its Drug Division

On September 6, 2002, the Food and Drug Administration (FDA) announced its intention to consolidate review of most new biotechnology products under its drug division, the Center for Drug Evaluation and Research (CDER), rather than its bio-logics division, the Center for Biologics Research and Evaluation (CBER). While the plan's details are being developed by a working group, chaired by Senior Associate Commissioner Murray M. Lumpkin, it is likely that review and approval of well-characterized and recombinant biotechnology products, including therapeutic proteins and antibodies, will be the under the purview of CDER instead of CBER, possibly as early as 2003. This move has been anticipated as some recombinant proteins and therapeutic antibodies and related derivatives are now being reviewed by CDER. Recent examples of biopharmaceu-ticals reviewed and approved by CDER include Intron A (interferon- a2b); human insulins such as Humalog, Humulin, and Iletin I; and antibodies such as Mylotarg.

Under the revised system, CBER will continue to review blood products and vaccines. These product areas are CBER's strengths and the basis for creation of the biologics division. CBER will also be responsible for evaluating gene therapy and tissue transplantation products as the development of these novel entities comes to fruition.

While consolidation plans have been in the works for several years, many believe that the process was accelerated by Congress, particularly those members and staffers involved in the investigation of the FDA's handling of the approval application for Erbitux. Erbitux is a controversial cancer drug sponsored by ImClone Systems, a firm riddled with scandal. In a written communication to the FDA, the House Committee on Energy and Commerce stated, "There appears to be a different and better approach to the expedited review of (other) cancer drugs in CDER" than in CBER, the division that reviewed Erbitux. (For additional details regarding Imclone Systems and Erbitux, see Chapter 4, Section 4.3.2.)

It is anticipated that CDER will shorten the review time for biotechnology products, and make the review process for biologics and traditional chemical drugs more parallel. Media reports say that the biotechnology industry welcomes this move with the hope that it will expedite new drug approvals.

Currently, most recombinant proteins such as erythropoietin, colony-stimulating factors, and interferons are reviewed by CBER. Under the proposed consolidation plan, these well-characterized and recombinant products are likely to be reviewed by CDER.

Even with these regulatory changes, manufacturing and assay costs for biologic macromolecules remain much higher than for traditional drugs. Biologics not considered to be well-characterized, such as blood and tissue and their components and inactivated vaccine antigen preparations, continue to be developed, manufactured, and reviewed for approval under pre-1996 regulations.

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