The Partnership for Safe Medicines
Weekly UpdateOctober 11, 2010
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FDA Commissioner Margaret Hamburg Joins with Public and Private Sector Leaders in Call to Address Global Counterfeit Drug Crisis

Partnership for Safe Medicines Hosts Inaugural Safe Medicines Forum; GPhA Joins Organization as Alliance Partner 

Washington, D.C. (October 8, 2010) - The U.S. Food and Drug Administration (FDA) is committed to keeping American drugs safe and needs new regulatory authority to do so, said Dr. Margaret Hamburg, Commissioner of the FDA, in prepared remarks at today's inaugural Counterfeit Drug Interchange Conference hosted by the Partnership for Safe Medicines (PSM). The conference brought together more than a hundred cross-industry stakeholders to discuss ways to stem the rising tide of counterfeit and unsafe medicines.

"The FDA is firmly committed to doing all that we can to further strengthen our nation's drug supply and ensure the quality and safety of all drugs and medical products on the U.S. market," said Hamburg. "It is clear that FDA needs new regulatory tools that provide the authority we need to meet the challenges we face in today's increasing globalized marketplace. And we look forward to working with Congress on legislation that will give FDA the ability to protect Americans from harmful drugs and medical products-and fulfill our fundamental public health mission."

Today's forum underscores the severity of the problem and the interest among all segments of the pharmaceutical sector - law enforcement, patient groups, government regulators, academics and manufacturers - to come together to discuss practical solutions.

"The U.S. has the safest drug system in the world, but that does not mean American consumers are immune. The instances of counterfeit drugs are increasing and the counterfeiters are becoming more sophisticated, which means that our drug safety is at risk," said Scott LaGanga, executive director of PSM. "PSM's goal with the Interchange is to raise awareness of the scope of this epidemic, as well as the need for global collaboration, information sharing and tools and resources that will help protect consumers across the globe."

In addition to Dr. Hamburg, speakers included an American victim of counterfeit drugs, representatives from the Drug Enforcement Agency and the Centers for Disease Control and Prevention, law enforcement officers, and patient advocacy groups.

At the event, PSM also announced that the Generic Pharmaceutical Association (GPhA) has joined the organization, adding their expertise and network to PSM's efforts to keep all medicines - generic and branded - safe for consumers.

"Given the role that generic drugs play in the global marketplace, PSM today is even more positioned to continue its battle to keep prescription medicines safe for consumers," said LaGanga. "We welcome GPhA to our membership and look forward to working together on this critical health issue."

Top News


NABP Acquires Public Education Website AWARxE


The National Association of Boards of Pharmacy (NABP) recently announced the purchase AWARxE, a website and campaign that seeks to educate the public about the dangers presented by illegal online pharmacies. AWARxE was started in 2007 by the Minnesota Pharmacists Foundation after it heard about the story of Justin Pearson, a 24 year old who accidentally overdosed and died from taking a variety of medication he purchased from illegal online pharmacies. "NABP has heard too many stories like Justin's," said William T. Winsley, NABP president, "and when the Foundation approached us about taking the AWARxE campaign national we knew we had been presented with an excellent opportunity to help save others from having a similar story. Using the AWARxE consumer protection program as a vehicle, NABP aims to educate and raise public awareness about rogue internet drug outlets, counterfeit medications, and prescription drug abuse, among other serious issues." More information on the AWARxE consumer protection program is available at (Partnership for Safe Medicines, October 7, 2010; Link here)

World News

Interpol Russia Launches Campaign to Fight Counterfeit Antibiotics and Others


Interpol Russia recently announced that it would start a major operation against fake drugs.


Rossiyskaya Gazeta announced the operation Monday September 27, 2010. The head of Russia's Interpol Bureau, General Timur Lakhonin, said that the operation would seek the sources of counterfeit drugs in the country, reports the ITAR-TASS News Agency. "At present, a special raid was launched to detect the channel of counterfeit medicines," he said. "This is a new direction in our work. We found 1,200 websites in the internet that sell fake medicines. These medicines are now being seized. The operation is underway in 25 countries and now it begins in Russia." Lakhonin said that certain segments of the pharmaceutical injury warrant more attention than others. "The most dangerous segment of the black market is [the] counterfeiting of different antibiotics, contraceptives, steroids and weight loss medicines," he said. (Partnership for Safe Medicines, October 7, 2010; Link here)



Pittsburgh Doctor Charged for Writing Prescriptions Illegally


A Bethel Park physician is accused of writing prescriptions for narcotics to patients he never met in person -- communicating, instead, through phone calls set up by online "doctor consultation" services. Dr. Charles McCool, 64, was indicted by a grand jury and charged with the unlawful prescription of a controlled substance, done outside the scope of a doctor-patient relationship.  McCool is accused of writing prescriptions to patients in five Pennsylvania counties from 2007-09. The prescriptions included Vicodin, Lortab and Valium. ("Bethel Park doctor charged in Internet prescription scheme," Pittsburgh Tribune, October 2, 2010; Story here)

About the Partnership for Safe Medicines
The Partnership for Safe Medicines is a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines. For more information, please visit