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ISPE Named as a Source in FDA Strategic Plan for Preventing and Mitigating Drug Shortages



11/1/2013 11:44:39 AM

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(TAMPA, FLORIDA, USA, 31 October 2013) – ISPE’s report on its 2013 Drug Shortages Survey was cited twice in the Strategic Plan for Preventing and Mitigating Drug Shortages released today by the US Food and Drug Administration (FDA). The plan also formalized the FDA’s commitment to engaging with ISPE “to analyze data from a recent global survey ISPE conducted on the technical, scientific, manufacturing, quality, and compliance issues that have resulted in drug shortages.” Dr. Douglas Throckmorton, deputy director of the FDA’s Center for Drug Evaluation and Research (CDER), said later on a teleconference with stakeholders, “We are looking forward to continuing to work with ISPE.”

Published in June 2013, the report on ISPE’s Drug Shortages Survey is available at www.ISPE.org/Drug-Shortages/2013JuneReport. The comprehensive global survey revealed no single technical or manufacturing cause for drug shortages. Instead, initial data analysis showed:

• Issues within the quality systems of manufacturing can lead to drug shortages.

• Companies that have successfully avoided drug shortages focus on strong quality systems, and the involvement of company leadership is notable in those companies that avoid shortages.

• Improved regulatory interaction can mitigate the likelihood of a shortage

“We are pleased that ISPE’s work has been helpful to the FDA in its consideration of the challenges of addressing drug shortages,” says Nancy S. Berg, President and CEO of ISPE. “The survey revealed many new opportunities for ISPE to facilitate dialogue throughout the industry, advancing our collective understanding of the causes of drug shortages and leading to process improvements that may mitigate or avoid them. As a neutral organization focused on product quality and patient safety, ISPE is uniquely positioned to play this role.”

Since the report’s initial release the ISPE Drug Shortages Task Force has continued to examine the data and further investigate key issues. These findings will be reported Monday, 4 November at ISPE’s Annual Meeting in Washington, DC. The Society will also release its 2014 schedule of events related to Drug Shortages in conjunction with the meeting.

About ISPE

ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA. Visit www.ISPE.org for more information. To learn more about ISPE’s Annual Meeting, visit www.ISPE.org/2013AnnualMeeting.

For more information contact:

Danielle Hould

ISPE Membership Marketing Communications Manager

Tel: +1-813-960-2105, ext. 277

Email: dhould@ispe.org

www.ISPE.org

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