The FDA's proposal for a system to track and trace drugs from manufacturers to consumers got left on the floor of a political backroom last fall. It was excised from the FDA reauthorization bill when backers and industry couldn't reach an understanding over particulars of how to quickly to create a nationwide system that could identify and follow an individual drug through the serpentine supply chain. But with California set to implement its own law in 2015 that would require the industry to track individual units, industry this week signaled its readiness to return to the negotiating table in hopes of getting a national standard instead.
That indication came when the top dogs at the key pharmaceutical and drug distribution industry groups published an op-ed piece on Politico saying, "Now is the time to pick up where the previous effort left off." The letter comes from John Castellani, CEO of Pharmaceutical Research and Manufacturers of America (PhRMA); Ralph Neas, CEO of the Generic Pharmaceutical Association (GPhA) and John Gray, CEO of the Healthcare Distribution Management Association (HDMA).
Mark Grayson, deputy vice president of public affairs at PhRMA, today said, "everybody believes time is running down and many in Congress believe that there is a need to do something." Grayson would not comment on whether the impending California law was the motivator but did say, "This is the time they need to sit down and come through with a national standard."
The letter calls for a system that would use technology to "determine the product's source and distribution history; provide "immediate protection" as well as use a "building block approach" for enhancements; give the FDA authority for the system and apply the "efficient, cost-effective system" to all 50 states.
The letter provides no indication of how the stumbling blocks that killed the program last year can be overcome. The HDMA gained some insights last year from a pilot study conducted with participation from the Veterans Health Administration and its Consolidated Mail Outpatient Pharmacy. The program tracked 23 serialized cases and 138 items of a cold-chain drug from an Abbott Laboratories ($ABT) plant to different VA hospitals for 9 months. The process even allowed the VA to link data to individual prescriptions and to conduct a mock recall to keep the drug from being delivered.
- here's the op-ed piece