The drug track-and-trace program the FDA had hoped would help it protect against counterfeiting got killed in final negotiations of the FDA user fee legislation, but a similar program for medical devices its getting its initial screening.
The FDA on Tuesday announced its proposed rule for the program which will require each medical device to have a unique identifying number. The industry now has 120 days to comment.
In its announcement, the FDA says: "A UDI is a unique numeric or alphanumeric code that acts as a key to certain basic identifying information about a device, such as the name of the manufacturer and the type of device, and may represent certain other information about the device, such as its expiration date and batch or lot number. This information will be contained in a publicly available UDI database, and no identifying patient information will be stored in this device information center."
It says the program will be phased in over several years "with the highest-risk medical devices first and exempting low-risk devices from some or all of the requirements. The FDA says the program will help in recalls and allow the agency to better review adverse event reports. But it also says it will provide the "foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies." It estimates the program could cost the industry $68.4 million a year.
A track-and-trace system for pharmaceuticals was in the Senate bill leading up to the FDA user legislation, but got cut in negotiations when the industry and the agency were unable to agree on what the FDA was seeking and what the industry was willing to sign off on. The industry wanted to phase in the rules, saying the cost of tracking drugs through the complex supply chain would be too expensive to quickly implement.
The need for drug tracking has been kicked around for at least a decade, but it took on renewed urgency this year when counterfeit version of such drugs as Roche's ($RHHBY) cancer treatment Avastin and Teva Pharmaceutical ($TEVA) ADHD treatment Adderall started popping up around the country. California has passed its own law that should start in 2015, which could lead other states to follow, a situation both the FDA and the industry has hoped to avoid.