FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
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. 

T98-1                         Print Media:         301-827-6242
Jan. 14, 1998                 
                              Consumer Inquiries:  800-532-4440

FDA BIOLOGICS APPROVALS IN 1997

FDA's Center for Biologics Evaluation and Research in 1997 continued to improve the speed of its processes while completing 35 major approvals covering a broad spectrum of new products, technologies, manufacturing methods, indications and premarket applications.

The greatest acceleration affected 22 approvals -- involving 11 product and biological license applications (PLAs and BLAs) and 11 PLA and BLA supplements -- that were part of the agency's user fee program. The PLA/BLA user fee approvals were completed in the median time of 14.45 months, or 20 percent faster than the corresponding median time of 18.06 months in 1996. The median time for the approval of PLA/BLA supplements for user fee products last year was 10.77 months, compared with 12.32 months the year before.

Ten -- two more than in 1996 -- of the major approvals were first approvals of products containing a substance or a combination of substances never before approved for the U.S. market. The median time for first-time approvals in 1997 was 12 months, 20 percent shorter than the median time of 15.08 months required for such approvals in 1996.

The most significant first approvals last year were BeneFIX, a new recombinant DNA-derived clotting factor for people with hemophilia B, a rare congenital blood disorder; Zenapax, a product that helps prevent kidney transplant rejection; and Rituxan, a monoclonal antibody for treatment of patients with one type of lymphoma, a cancer of the immune system. BeneFIX was approved in 5.39 months, Zenapax in 6 months, and Rituxan in 8.9 months.

Other first approvals last year included Regranex, the first biotechnology product for the treatment of deep diabetic foot and leg ulcers; Carticel, a product that uses a patient's own cartilage cells to treat certain knee injuries; Neumega, which helps reduce the need for frequent platelet transfusions following chemotherapy; and Infanrix, a new vaccine for infants and children.

The remaining major biological approvals included software to enhance the safety of blood products, expanded indications for approved products, and new manufacturing methods and technologies to improve the safety of biologics.

The consistently high performance of FDA's biologics program in 1997 reflected the importance of the agency's managerial reforms and of the additional resources provided by the industry under the Prescription Drug User Fee Act (PDUFA) of 1992, which sunset last September.

Recognizing PDUFA's contribution to the agency's success in speeding up the processing of pharmaceutical submissions, Congress with FDA's and the industry's support last fall further enhanced the user fee program and extended it for another five years. The FDA Modernization Act of 1997, which includes PDUFA II, calls for still shorter review times and defines new administrative goals which are designed to further accelerate the drug development process.

####

[FDA HOME PAGE]