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ANDA PROTOCOLS FOR MANUFACTURING AND CONTROL CHANGES

Executive Summary

ANDA PROTOCOLS FOR MANUFACTURING AND CONTROL CHANGES could reduce supplemental filings, Lederle Labs Regulatory Affairs Manager Sanneka van Stratten maintained at the National Association of Pharmaceutical Manufacturers' (NAPM) Mid-Year Meeting in Washington, D.C. June 5. Van Stratten noted that the protocol approach was among recommendations made by NAPM in comments submitted to an FDA Center for Drug Evaluation and Research (CDER) working group currently studying the agency's ANDA chemistry review process ("The Pink Sheet," May 27, T&G-2). NAPM is recommending the protocol approach as a means of addressing industry confusion about the agency's application supplement filing requirements and reducing filing and review burdens in the supplement area. Van Stratten, who served on the NAPM technical committee framing the recommendations to the FDA working group, described how the protocols could work at the June 5 meeting. "Information needed to be sent [to FDA] on manufacturing and manufacturing site changes, packaging and packaging site changes" before and after approval "is unclear and inconsistent," Van Stratten said. In order to address this problem, she explained, NAPM is recommending "that protocols be set up for these types of changes, including commitments on what type of testing we will conduct, before you market the product." The protocols, she said, could be included with ANDAs at the time of submission and become "part of the upfront approval. FDA inspectors could then sign off on these" changes. Van Stratten noted that the CDER working group was "receptive" to the protocol idea at a May meeting with NAPM to discuss the generic drug association's recommendations and suggested that NAPM develop model protocols for FDA consideration. The protocol approach also was recommended as a means of addressing supplemental filing problems by the Generic Pharmaceutical Industry Association (GPIA) and the Pharmaceutical Manufacturers Association (PMA) in their respective comments to the CDER working group. According to PMA's minutes of its meeting with the FDA task group, the association explained that the protocols could provide for the demonstration of a product meeting or exceeding original specifications for changes involving the equipment or process, or for reworking. "Upon satisfactory completion of those testing protocols (e.g., stability and validation), the new changes can be put into place without pre-approval and the data submitted in the annual report," the PMA minutes state. FDA Office of Drug Evaluation I Deputy Director (Program Management) Richard Terselic, who heads up the CDER chemistry review working group, noted at the NAPM meeting that the lack of consistency among individual chemistry reviewers as well as their failure to follow the center's stated policies was a recurrent theme in the comments from the various associations. Terselic acknowledged the dilemma companies face in addressing these inconsistencies. Firm managers "typically tell their chemistry and regulatory affairs staff..... that they simply can't afford to risk the loss of time or risk antagonizing reviewers by debating whether what has been asked for is really appropriate." However, Terselic urged firms either individually or through their associations to bring the problems to FDA attention so that they can be corrected. While it might be most efficient to raise the issues as they come up, Terselic advised, "I would agree that it might be better for the sake of time to do what is asked at the moment, but then follow up after the matter is settled to address the issue" with FDA.
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