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BIOTECHNOLOGY PRODUCT TOXICOLOGY TESTING: CASE-BY-CASE APPROACH

Executive Summary

BIOTECHNOLOGY PRODUCT TOXICOLOGY TESTING: CASE-BY-CASE APPROACH will more likely yield meaningful data than a "cookbook" protocol, Amgen Regulatory Affairs Director James Fenno stated at a Regulatory Affairs Professionals Society seminar on biotechnology Aug. 28 in Washington. Fenno said that when the cookbook method is used a clinical design is produced that ignores both the results of the toxicology study and the properties of the molecule in question. "With biologicals, expecially recombinant biologicals, you're not going to do a standard Phase I test," Fenno stated. The Amgen exec told the RAPS seminar participants that in designing toxicity studies they should look at route of administration, dose range, indication, the patient population, the properties of the molecule, purity of biochemical properties, pharmacological studies, species specificity, and in viro(END ITALICS) studies. "Take that information, take what you want to do in the clinic, and develop an initial toxicity study plan," Fenno advised. "If you're not used to dealing with biotechnology products, ignore the conventional wisdom of your company because it's probably wrong." He also said companies should get informal FDA input and have an early pre-IND meeting with the agency prior to designing the initial toxicity study. Fenno said both industry and FDA have set up barriers to a case-by-case method of conducting toxicology studies. He maintained that FDA creates barriers by requiring one company to do something simply because it has been required of another company, or because the agency had an unspecified problem with another drug that cannot be discussed. For its part, Fenno said, industry operates with the idea that if a company meets with FDA the agency will require extra testing. He added that industry also tries to second guess FDA by providing only what it thinks the agency wants. Further, Fenno said, companies may adopt the inflexible attitude -- "but we always do it this way. . ." In a document entitled "Points to Consider in the Production of New Drugs and Biologicals Produced by Recombinant DNA Technology," FDA said animal tests for recombinant DNA-derived products "are best addressed on a case-by-case basis with the appropriate" FDA regulatory office ("The Pink Sheet" Jan. 16, 1984). Fenno commented that the "points to consider" document is not very helpful as it does not provide much specific guidance. He also maintained that available toxicity test guidelines are out of date.
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