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Executive Summary

FDA approval criteria for changes in production of recombinant biologic products should focus on in vitro tests for characterization instead of the clinical validation tests now required for biologic products, Interferon Sciences VP-Regulatory Affairs Albert Ghignone suggested at a recent Food and Drug Law Institute conference. Under current FDA procedures, Ghignone explained, "if there is a minor change such as adding [a] filter in the process . . . [or] just doubling your [production] capacity, basically what's happening today is the agency is asking for clinical validation because of these changes." The criteria "makes sense if you're talking about an old biologic," but should not apply to the newer biologics, Ghignone maintained. Unlike older biologics, newer biologics do not require the same kind of controls over production process because "whether they be natural materials . . . or made by recombinant technology, [they] are very highly characterized and of very high purity," Ghignone asserted. "I think what the emphasis should be on [with] the new products . . . is characterization, thereby, from an in vitro standpoint, validating the [production] change and, therefore, eliminating the time, the expense, and the effort that goes into putting a product into the clinic." Ghignone cited FDA's requirements for production changes as one example of industry's concern that FDA's current regulatory framework is not set up to handle the newer biologic products efficiently. Ghignone told the Sept. 13 FDLI conference on biologics regulation that the industry's major concerns relate to whether a new product will be reviewed by FDA's drug divisions or biologic divisions and whether the centers are capable of conducting independent reviews. "Of utmost major concern to the industry is who reviews my submission," Ghignone said. "FDA has not given us proper guidance in this area. For example, epidermal growth factor [is] regulated by the Center for Drug [Evaluation and Research, while] fibroblast growth factor [is] regulated by the Center for for Biologics [Evaluation and Research.]" So, he continued, "it is a bit confusing on the industry's part, to say the least." Ghignone pointed our that inconsistency in assignment of products could be problematic if, for example, a supplemental application for a new indication were to be assigned to a different center than the one responsible for the initial review. "What, in effect, has happened now is we've taken a submission from a review division [which] after many months has become thoroughly familiar with the submission, and given it to a new group, [which] has to go through the same learning process again, Ghignone said. "I don't believe this is an efficient way to approach a review process." Cross reviews -- where one center assists the other in the review of a product -- might also be an inefficient approach to product review, Ghignone asserted. "There are two major problems that I can foresee with a cross review: first of all, the individual is located at a different facility and secondly, they have an already established workload," he said. "Now what you have to do in order to have this individual assist is . . . adjust their time schedules, their work schedule, plus now travel time to help assist on a particular review." In addition, Ghignone said, "the individual most likely will not be familiar with the type of product [i.e., drug v. biologic] he is going to review." Addressing the conference at an earlier session, FDA Office of Biological Product Review Director Donald Burlington, MD, noted that the biologics divisions "fairly frequently" ask the drug divisions to assist in reviews when there is a question about preclinical toxicology or chemistry "because Biologics doesn't have a formal pharmacology program." However, he said, it "seems quite unlikely" that cross reviews are "going to happen with every product."

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