The industry has been talking about, and slowly working toward, track-and-trace for many years. Now Pharma faces real deadlines that require action.
The Drug Quality and Security Act, approved by the Senate Monday and now awaiting the president's signature, lays out limited FDA powers to oversee the compounding pharmacy industry and kicks off the process of establishing a so-called national track-and-trace system
A longtime goal of the FDA is for the industry to put in place a national system that would allow it to follow a drug product from manufacturer to pharmacy. After years of back-and-forth with the industry about how that would be done, it is about to get started.
Track-and-trace, the ability to follow a drug product from manufacturer to pharmacy, has been a longtime goal of the FDA. The agency believes it would help foil drug counterfeiting and expedite recalls for any reason. Drugmakers have said they thought it was a good idea but were reluctant to commit to a date certain since the system requires investments and coordination from every link in the supply chain. Now, a bill poised for passage has put a timeline to it: 10 years to have all the pieces in place and the system operational.
GlaxoSmithKline is joining Sanofi in adding 2-D barcodes to the packaging for most of its vaccines sold in the U.S., allowing doctors' offices to scan crucial information into electronic medical records and potentially saving them significant time.
The industry is headed toward some form of track-and-trace in the U.S. but what shape it will take and whether it will get to the unit level is the question on everyone's mind. A bill advancing in the U.S. Senate would make that happen sooner than later, but the U.S. House has pushed through a proposal that would put off that level of drug monitoring for more than a decade.
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.