Saturday, October 9, 2010

FDA Commissioner Margaret Hamburg Joins with Public and Private Sector Leaders in Call to Address Global Counterfeit Drug Crisis

"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, “ stated Dr. Margaret Hamburg, Commissioner of the FDA.

Dr. Hamburg made this statement at the inaugural Counterfeit Drug Interchange Conference hosted by the Partnership for Safe Medicines (PSM).

This conference brought together more than a hundred cross-industry stakeholders to discuss ways to stem the rising tide of counterfeit and unsafe medicines.

Highlights from the press release by PSM included:

• "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 Pharmaceuticals 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."

Secure Pharma Chain endorses the need form more FDA regulatory authority especially as it pertains to dealing with adulterated, fraudulent and counterfeit medications and raw materials in the proliferating global pharmaceutical supply chain.

Secure Pharma Chain also believes that it is incumbent on all members of the pharmaceutical supply chain to proactively protect their industry, inventories and most importantly the consumer by deploying best practices, solutions and technologies to combat this deadly criminal act.

To view the entire PSM press release, visit:

To learn more about anti-counterfeiting technologies for pharmaceuticals, visit:

No comments: