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 map last week, add Canada,…

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 statute has been enhanced specifically…

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.  She said that international cooperation…

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 Association.  GPhA represents the manufacturers…

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 the broader FDA regulatory strategy. …

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 treatment, but the dangers of…

The opening speaker for the 2012 Interchange was Scott T. Williams, Vice President of Men’s Health Network.  Men’s Health Network (MHN) is a national DC based non-profit organization, founded in 1992, whose mission is to reach men and their families where they live, work, play, and pray with health prevention messages and tools, screening programs, educational materials. Williams spoke about the…

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, Dr. Marv Shepherd, Director of the…

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 are dependent upon pharmacists to…

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 visually." DeStefano went on to…