Track And Trace
The tracking of individual drug units looks to be coming to the U.S, just not for 15 years or more. A bill being pushed by U.S. House Republicans would start the process for tracking lots of drug units through the supply chain but would not allow the FDA to even consider tracking on the unit level until 2017, Reuters reports.
India may be closer to implementing a track and trace system for drug distribution than the U.S. is.
The FDA's proposal for a system to track and trace drugs from manufacturers to consumers was excised from the FDA reauthorization bill last fall. 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.
China's API and drug manufacturing industries and regulatory oversight are often painted as backward compared with the western drug manufacturing industry. But China's State Food and Drug Administration (SFDA) has set out new rules and a three-year plan that could move it ahead of the U.S. when it comes to monitoring drugs through the supply chain.
The calls for a national track and trace system, which had died down when legislation was nixed last year, have been revived after more counterfeit cancer drugs have been discovered in the U.S.
The holiday's are upon us and we realize many of our readers will be taking a break. We intend to join you. The next issue of FiercePharmaManufacturing will be Jan. 3, after the holidays.
It looks like a national track and trace system is going to be implemented in the U.S. sooner rather than later. Differences between what industry believes it is capable of handling and what regulators believe it must kept it out of the FDA reauthorization bill, but no one should think that put it into the deep freeze.
The idea of creating a national track and trace system for the pharmaceutical supply chain is apparently alive and kicking around Congress.
Despite increasing reports of drug counterfeiting, track and trace programs designed to help attack the problem continue to have problems getting off the ground in the face of industry opposition.
Track and trace has apparently been trashed, at least for now. Unable to agree on details between what the FDA was seeking and what the industry was willing to sign off on, the plan to finally create a nationwide system that could identify and follow individual drugs through a serpentine supply chain got left on the negotiating floor, Reuters reports, citing anonymous sources.