Archive for September 2012

Leading Health Care, Law Enforcement and Government Officials Join with Industry and Patient Advocates to Assess State of Counterfeit Medicines

U.S. FDA Commissioner Hamburg Urges Physicians,
Patients to Only 
Purchase Medicines from Reliable Sources to
Better Protect Against Fake Drugs

Washington, D.C. (September 28, 2012)The Partnership for Safe Medicines (PSM)
today convened
leading domestic and international stakeholders in the fight
against counterfeit and substandard medicines, making a renewed commitment to
work together and implement new solutions to protect
patients worldwide. U.S. Food and Drug Administration Commissioner Dr. Margaret
Hamburg, in a keynote to the conference, highlighted new efforts her agency is
undertaking to reduce the threat and pledged the FDA’s ongoing support to
ensure a safe U.S. drug supply.

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PSM2012: FDA Commissioner Margaret Hamburg’s Keynote Speech

Dr. Margaret Hamburg, FDA Commissioner, addressed the Interchange in her keynote speech. Hamburg said that "We need to work together to stay ahead of the many avenues that criminals are finding that are putting the health and safety of American citizen's at risk." Calling them 21st Century snake oil peddlers, Hamburg said that FDA has…

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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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