PSM2012: The UK (MHRA) approach to combating Falsified Medicines

Gerald W. Heddell, Director of Inspection, Enforcement & Standards Division at the Medicines & Healthcare products Regulatory Agency in the UK, was introduced by Brian Finlay, Senior Associate and Director of Managing Accross Boundaries at The Stimson Center. Heddell began his talk with a map of recent counterfeit incidents worldwide.  And then said, "Since I made this…

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PSM2012:Linda Marks, Senior Litigation Counsel, Consumer Protection Branch

After Nancy Kennedy, Linda Marks, Senior Litigation Counsel of the Consumer Protection Branch of the U.S. Department of Justice spoke. She also emphasized the international scale of the counterfeit drug problem.  Online reselling of unapproved, illegal and dangerous medications can have too much, too little, no, or the wrong active ingredient. General intellectual property crimes…

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PSM2012: Special Agent Nancy Kennedy Talks On International Counterfeit Drug Crime

Moderator Brian Finlay introduced speakers for the Drawing Outside Domestic Lines, International Cooperation panel. "Counterfeit medicine is an international human security and serious compelling public health issue." Speaker Special Agent Nancy Kennedy with FDA-OCI handles drug investigations, included counterfeit medicines. Kennedy began by discussing international cooperation between MHRA, two southern European countries and the U.S.…

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PSM2012 – PhRMA and GPhA Heads Discuss Counterfeit Medicine

Partnership for Safe Medicines’ Executive Director Scott LaGanga introduced John Castellani, President and CEO of the Pharmaceutical Research and Manufacturers of America.  PhRMA leads more than 600,000 of America’s leading biopharmaceutical professionals who develop new medicines to help people live longer, healthier lives. He also introduced Ralph Neas, the President and CEO of the Generic Pharmaceutical…

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PSM2012 – John Roth, Director of the FDA’s Office of Criminal Investigations

John Roth, Director of the U.S. Food and Drug Administration's Office of Criminal Investigations was the luncheon speaker at the Interchange, introduced by Partnership for Safe Medicine's Executive Director Scott LaGanga. Roth spoke on the FDA’s criminal priority areas, its recent experience (and challenges) with combatting counterfeiters, and more broadly about how criminal enforcement fits in with…

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PSM2012 – Payment Processing and Unlicensed Online Pharmacies

Moderator Linda Johnson, Pharmaceuticals and Health Business writer for The Associated Press, introduced Damon McCoy, researcher from George Mason University.   Said Johnson, "Through my work I’ve learned about the many implications that counterfeit drugs can have on the consumer.  So many people rely on and trust the drug supply chain for safe and effective…

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PSM2012: Opening Remarks and Introductions

Partnership for Safe Medicines Executive Director Scott LaGanga welcomed participants to the third annual Interchange, where key stakeholders discuss and begin to solve the global problem of pharmaceutical counterfeiting. Said LaGanga, "We believe that by working together, we can come one step closer to protecting the pharmaceutical supply chain from dangerous counterfeit drugs." Following LaGanga,…

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PSM2012 – Sally Greenberg, Executive Director of the National Consumers League

Sally Greenberg, the Executive Director of the National Consumers League, spoke on consumer concerns with counterfeit medications. She reviewed cases of counterfeit medicines that had damaged patients' health and spoke of their outrage and incredulity. She also discussed the fact that doctors can't identify fakes from real medication by looking at them, and that patients…

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PSM2012 – Technological Strategies: The Last Line of Defense

Anthony J. DeStefano, Ph.D. Sr. Vice President, Compendial Science at the United States Pharmacopeia spoke on technological strategies in protecting consumers from counterfeit medications. DeStefano delineated the many challenges to detection.  Said DeStefano, "About 80% of all active pharmaceutical ingredients are made outside the US, and detection of counterfeit or substandard products is often impossible to detect…

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