New so-called track-and-trace rules for drugmakers, wholesalers and logistics companies went into effect Jan. 1 requiring them to be able to provide full documentation of lots of prescription drug products all along the chain of custody. They did, but--and it is a significant but--the FDA at the very last minute said it would not enforce all of the new rules before May 1.
Track-and-trace is on its way. Eli Lilly, with its 10-year history of fighting counterfeits, is in a good position to make the switch, and now it's putting the wheels in motion to get the project underway.
Part of the new Drug Quality and Security Act, approved in the U.S. last fall, sets in motion a timeline to eventually have serialization on individual drug units and a system to track them from manufacturing to pharmacy.
At year end, owners, operators and insurers of the bankrupt New England Compounding Center came to a preliminary agreement to set up a victims' fund for those who were sickened in a fungal meningitis outbreak last year and their families.
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.