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Two ISPE Studies Cited in FDA Statement to Congress

January 6, 2014

Two recent ISPE studies were cited by Janet Woodcock, M.D., director of the US FDA’s Center for Drug Evaluation and Research (CDER), in her statement associated with her testimony to the U.S. Congressional Committee on Oversight and Government Reform’s Subcommittee on Energy Policy, Health Care and Entitlements.

In the December 12 hearing, “FDA Check Up: Drug Development and Manufacturing Challenges,” Dr. Woodcock stated that, with the proper strategies, novel manufacturing technologies could revitalize pharmaceutical manufacturing in the U.S., thereby reducing dependence on potentially vulnerable foreign-sourced materials. Dr. Woodcock reported that the FDA has been working in collaboration with industry experts to stimulate the development of new manufacturing technologies capable of responding rapidly to changes in demand.

Dr. Woodcock strongly advocated the use of Quality by Design (QbD) to enhance development capability and reduce manufacturing costs, while ensuring that patients receive high-quality drug products. As evidence, Dr. Woodcock cited the results of a survey conducted by the ISPE United Kingdom Affiliate’s Process Analytical Technology (PAT) Community of Practice, in which companies using QbD reported benefits such as improved product quality and process robustness, increased process capability, greater speed and reliability to market, as well as significant cost benefits.

QbD also can increase manufacturing capability and a firm’s ability to identify the root causes of manufacturing failures, said Dr. Woodcock, referencing ISPE’s Drug Shortages study and naming inadequate manufacturing capability as a frequent cause of critical drug supply shortfalls, particularly in the areas of lyophilization (freeze-drying) associated with the production of sterile products.

“We applaud the FDA’s collaborative approach to the development of new manufacturing technologies as a means of ensuring the availability of safe and effective medicines,” said Nancy S. Berg, president and CEO of ISPE. “The development and adoption of new and novel manufacturing technologies such as continuous manufacturing requires close collaboration and communication between the pharmaceutical industry and global regulators. As a neutral organization focused on product quality important to patient safety, we are pleased to provide the FDA with reliable, authoritative, scientific technical data and experience. We look forward to continued collaboration with the FDA to modernize manufacturing methods.”

Published in June 2013, ISPE’s Drug Shortages Survey report is available at www.ISPE.org/Drug-Shortages/2013JuneReport. The report also was cited in the FDA’s Strategic Plan for Preventing and Mitigating Drug Shortages published in October. ISPE plans to deliver additional updates during 2014.

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