A serialization plan for the nation’s drug supply chain doesn’t seem likely to happen anytime soon; the House of Representatives and the Senate have failed to agree on an appropriate plan. Track and trace of drugs will likely not be a part of the FDA funding bill expected to be submitted to President Obama in the next two weeks.
Although the Congress and Senate each passed their own version of the bill recently, only the Senate version had a track and trace amendment. With this latest draft of the bill, neither the House nor the Senate can agree on specifics, including when the US would move toward a unit-level tracking system for individual drug containers.
Similar systems are already in place in countries like Belgium, Sweden, and Turkey, but the FDA and the pharmaceutical industry in the US have been having trouble deciding on the appropriate track and trace requirements. The FDA wants tracking on individual drug containers, but the pharma companies are resistant because of the cost and complexity of such a system.
Some groups in the industry are proposing a plan to track larger lots rather than individual containers for immediate implementation, with more stringent tracking systems later on.
The recent occurrences of fake versions of drugs like Avastin and Adderall point to the urgency of a national drug tracking system. California has passed its own track and trace law that is supposed to start in 2015. If other states follow California’s lead, the FDA and pharma industry will have even larger problems trying to adapt individual state plans into a cohesive system for the entire nation.