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BIOLOGIC PRODUCT AD REVIEW STAFF UNDER CONSIDERATION

Executive Summary

BIOLOGIC PRODUCT AD REVIEW STAFF UNDER CONSIDERATION by FDA's Center for Biologics Evaluation & Research, Associate Director for Policy Coordination Michael Beatrice said at a Sept. 14 Food & Drug Law Institute meeting in Washington, D.C. CBER is proposing to form "some sort of organizational component that will be dedicated to the review of advertising and promotional labeling," Beatrice stated. CBER is currently undertaking a feasibility study that includes looking at workload and backlogs to determine how many reviewers would be needed for an advertising staff. Ads and labeling for biological products are currently evaluated by product reviewers. CBER also is planning to update its tracking system for promotional materials. According to the current tracking system, Beatrice said, the number of promotional labeling and ad pieces jumped from 486 in fiscal year 1989 to 732 in FY 1990 and 1,126 in FY 1991. FDA sees this year's workload remaining steady at FY 1991 levels. Beatrice pointed out that violative promotional materials place a strain on the product review activities of CBER. "We spend a lot of time meeting with manufacturers and listening to complaints about other manufacturers, trying to get the documentation ourselves to support the scope of dissemination of disputed materials." He added: "And all of this is done by the same basic reviewers, especially when you have clinical claims that have to be checked out by our scientific staff that are reviewing applications." Beatrice advised companies not to send complaints about competitors' promotional practices through "faxes, telephone calls or other complaint vehicles without documentation; it's a waste of time." He explained that the Center has "a backlog of applications and amendments to review and it's just not worth us going out and finding or documenting complaints unless there's a serious public health need." CBER is anticipating an influx of product license applications, Beatrice noted. In response to the user fee initiative, the Center recently has developed projections for the number of PLAs to be filed over the next five years. CBER expects that 13 PLAs will be submitted in 1993, 14 PLAs in 1994, 20 in 1995, and 100 PLAs by 1997. The changes in ad review responsibilities would be part of a larger overhaul of CBER functions. Beatrice noted that the agency has a CBER reorganization "proposal, which has been submitted through the Commissioner to the Public Health Service and the Department of Health and Human Services." The plan was announced in May ("The Pink Sheet" June 1, p. 7). CBER has been working "long and hard to develop a streamlined, efficient and productive operating plan to accompany the proposed reorganization," Beatrice stated. The Center, for example, plans to have a more sophisticated tracking system for applications. CBER's reorganization plan, Beatrice said, "is based upon the premise that we can and should facilitate a better and more productive method of operating to accommodate what we know is going to be a tremendous avalanche of work over the next few years." He noted that "an examination of the interworkings of the current system has revealed a number of points at which bottlenecks, redundancies and inefficiencies have occurred and that happens in any system." Another initiative that CBER will implement is to disseminate policy information on promotional materials on a regular basis, Beatrice said. The Center is working on an article that will describe CBER's ad review procedures, he added. The article will appear in a journal that is targeted at the pharmaceutical industry. CBER has published articles in the past that discuss other issues such as PLA review procedures.
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