RFID Law Blog

The FDA, which has been strongly supporting the use of RFID tags to reduce counterfeiting drugs, saw their Federal ePedigree regulation blocked by the courts. The court agreed with the small drug wholesalers, who argued that the statute required so-called “pedigree” information be transmitted with every wholesale distribution of pharmaceuticals. The court did acknowledge that the statute, exempts so-called “authorized distributors” from the pedigree requirement. Thus, the court said that “authorized distributors” are permitted to sell pharmaceuticals without having to convey any accompanying pedigree information. The requirement, which was scheduled to take effect on December 1, was successfully opposed by small, independent drug wholesalers who claimed it would have been too complicated and costly to implement.

This action by the courts demonstrates a point I have made repeatedly on this blogsite.  Some of those selling RFID products and services are hoping for a "quick fix" from the government to create a market for their products, with government mandates requiring their use in certain situations -- like on drugs.  But without cooperating and collaborating with your customers -- those who will actually have to comply with those requirements, you run the risk of turning potential advocates of RFID into hostile adversaries.  This was simply a lawsuit to delay implementation of the rule due to cost.  Others could raise arguments -- in the press, to policymakers -- that RFID is risky or dangerous or an invasion of privacy.  Or any other argument that has been already been spread by anti-RFID forces.

While it is true that cost is an issue, isn't it a bit odd that the three major distributors are exluded from any obligation to aid in the tracking of chain of custody? The fact is the regulation is weak and flawed. Pedigree tracking cannot assume where counterfeiting can occur. Like all security concerning U.S. supply chains, the pedigree should adhere to the standard for providing a seamless record of custody which must begin at the point of origin (manufacturer) all the way to the end-user, with no gaps. That must include the Big Three, who have clearly managed to "Lobby" their way out of the regulations. That's a loophole that defeats the integrity of chain of custody security, making this pedigree regulation more a victim of Washington politics, rather than RFID economics.

There are a number of holes in the ePedigree initiative that have not been filled. For example, if a counterfeit drug does make it through the system and a patient dies -- who is liable? Everyone in the manufacturing and distribution network? The RFID manufacturer? The software provider? The systems integrator? Like I said in my post, there are lots of stakeholders in this outcome, particularly within the RFID community, who have not approached this very important issue in a comprehensive and proactive manner -- leading to these kinds of outcomes.

PDMA is technology agnostics, not just about e-pedigree or RFID. See Q35 of FDA's November Q&A, which states:

"Both paper and electronic documents and signatures may be used to meet the pedigree requirement of the Act, provided that the requirements of 21 CFR 203.60 are met."

FYI, I have written on the business impact of this decision, most recently here:

http://drugchannels.blogspot.com/2006/12/impact-of-pdma-injunction.html

Adam

Why is the FDA not focused on drug manufacturers applying a serial number on each unit package (bottle or blisterpack) ?

If manufacturers simply applied a serial number in alphanumeric, 2D barcode or RFID to each package unit, pedigree adoption by wholesalers will be a relatively minimal expense.

I'd like to contribute that Pedigree is not about technology or the cost of record keeping.

As I presented at the recent FDA meeting on medical device marking, the automotive industry serializes 13 Billion parts a year. HP serializes every inkjet cartridge manufactured in Singapore.

The element of record keeping is the shortest milestone item in pedigree.

The most important component of pedigree is 'serialization' of package/shipping units.

In other words, all the drug manufacturers/wholesalers will need to do, is log all serial numbers transactions by either scanning the serial number or barcode, or reading the RFID label.

It's a significant leap forward in securing the drug supply chain if we simply logged serial numbers and should a negative event occur, we can pinpoint events in minutes by simple forensic tools of analyzing timestamp relationships to specific transactions using analytics tools that matured 10 years ago.

Jeff