April 27th, 2012
A proposed law calling for healthcare companies to build a U.S. system for tracking medications to minimize the threat of fake drugs is in jeopardy, thanks to arguments over cost and a looming deadline.
The U.S. Food and Drug Administration said earlier this year that counterfeit vials of cancer drug Avastin were sold to dozens of medical practices across the country, sparking new fears about the safety of the drug supply.
The agency has been working on a “track and trace” system for nearly a decade, and has until September to introduce it as part of its funding laws, or wait another five years for the opportunity under Congressional rules. Europe beginning in 2016 will require a unique identifier on all medicine packages.
“To learn that the cancer drug you were taking to save or prolong your life might be nothing but a counterfeit is unthinkable,” FDA Commissioner Margaret Hamburg wrote on the agency’s blog earlier this month. “We … need authority to require a robust system to track and trace all drugs throughout the supply chain.”