Bethesda, MD– Quality, procurement and operations experts representing global pharmaceutical manufacturers, working side-by-side with the U.S. Food and Drug Administration (FDA), articulated tangible solutions for securing components and finished products during high-level breakout discussions at the 2010 PDA/FDA Pharmaceutical Supply Chain Workshop.
Concerned over the growing problem of cargo theft and a myriad of other security and quality vulnerabilities in the pharmaceutical supply and distribution chain, and the threat to public health that these pose, FDA championed the workshop in an effort to get drug manufacturers to share and implement best practices. Janet Woodcock, MD, Director, CDER, U.S. FDA, gave the keynote address at the workshop.
Over 200 experts representing quality, procurement, operations divisions within pharmaceutical firms, suppliers of active ingredients and excipients, the FDA, and other stakeholders answered the call to action. Attendees broke into five different brainstorming sessions to share ideas and identify best practices that can be implemented immediately at their respective firms. These were summarized and presented during the meetings final day.
Priority solutions identified include proactive mapping of the ingredient supply chain for each product, the use of risk models to identify which ingredients pose the highest threat to patients, the implementation of standardized global auditing practices, and the development of an industry-wide alerting process to help identify unethical and criminal suppliers.
The Parenteral Drug Association (PDA) will continue to support the industry and FDA’s efforts to protect the public health from insecure pharmaceutical supplies. The Association will send out preliminary reports from the workshop to all attendees in the near term. In the coming weeks, PDA will work with conference planners and discussion facilitators to develop and publish detailed reports on the best practices identified.
Deborah Autor, JD, Director, Office of Compliance, CDER, U.S. FDA, said that industry needs better systems in place for safeguarding its products and must start thinking about where the gaps are and what is missing in its supply chain controls “The biggest risk is the risk we haven’t thought of,” she said.
“The public and the industry should appreciate FDA’s role in helping to find and pushing for common solutions to the serious challenges and risks inherent to the global pharmaceutical supply chain and marketplace,” PDA President Richard Johnson said following the workshop.
The FDA took advantage of the forum to announce that it was sending a letter to companies and a wide range of key stakeholders regarding the serious and growing problem of cargo and warehouse thefts of FDA-regulated products. The letter requests that companies report thefts immediately to FDA, and notify the public through news releases and possible product recalls.
The FDA held a stakeholder teleconference just hours after the PDA/FDA workshop concluded to explain the letter in more detail. Ilisa Bernstein, PharmD, JD, Director of Pharmacy Affairs, Office of Commissioner, Office of Policy, U.S. FDA, who also presented at the workshop, spoke at the teleconference about the importance of industry reporting cargo thefts to ensure patient safety.
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