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PharmaSecure attends PSM Counterfeit Drug Congressional Briefing

J. B. Reed/Bloomberg News

Moving Beyond the Avastin Incident

On Thursday, March 15, the Partnership for Safe Medicines, along with Congressman Brian Bilbray and Senator Michael Bennet, organized a panel discussion to explore the growing impact counterfeit drugs are having in the United States. With the recent discovery of counterfeit version of Avastin in the States, finding a solution to this growing issue was the briefing’s main focus.Speakers included Senator Michael Bennet, Connie T. Jung, U.S Food and Drug Administration’s Center for Evaluation and Research, Shay Reid, Pharmaceutical Distribution Security Alliance, and Joel White, Partnership of Safe Medicines.In his opening remarks, Senator Bennet addressed the current state of the counterfeit drug issue in the U.S. and called for a uniformed drug distribution system that won’t increase costs for any part of the supply chain but will protect public health.

“We need to do more to improve the security and safety of our drug supply and distribution system,” Bennet said. “We need to know who handles our medicines from the manufacturers to the pharmacies, hospitals, wholesalers and ultimately the patient.”As was the case in the recent fake Avastin scare, most counterfeit drugs that reach Americans are bought through online pharmacies. According to a screening done by the National Association of Boards of Pharmacy, 96% of online pharmacies acquired medicines from questionable sources, opening the window for counterfeiters that authorities hope to close.

At the moment, the FDA is looking into different technologies to help track pharmaceuticals to ensure drug safety and has developed its own vision and goals for introducing a robust track-and-trace system to the United States.

“We believe that they are out there, they are being used in other industries to track other products,” Jung said. “We also know that there are several members of the supply chain that are participating or plan to participate in pilots to see if this would work.”

The system would ideally prevent counterfeit drugs from harming Americans, facilitate the identification of prescription drugs, increase transparency within the supply chain and improve the efficiency of recalls. The FDA’s model system would use a serialization mechanism that would give each pharmaceutical package a unique number that cannot be duplicated. This would facilitate the authentication process, and document the product’s history as it moves through the supply chain.

It is clear from this briefing and other recent activities focused on counterfeit drugs in the US that there will be greater attention to the problem and its solutions in the coming year.