June 1998 AAOS Report

Urges clinical trials prior to biologics okay

James D. Heckman, MD, Academy president, urged the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research to balance the need for a rapid review method for new biological products with "the historical and rightful concern that uses of new products be safe and efficacious." In a letter to Jay Siegel, MD, director, Office of Therapeutic Research and Review, Dr. Heckman said, clinical trials of new products and procedures should be performed prior to general clearance, and FDA clearance should be based on the results of clinical trials. Clinical trials should be performed on a national basis and surgeons should be enrolled who can provide appropriate data. The design of clinical trials should consider the future evaluation of the uses of new products and procedures and the clinical trials should be standardized. Also, clearance for marketing new biologic products and procedures should be defined in a detailed manner because there are similar but varied pathologies to which products and procedures may be applied.

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