It has been almost two years since I published “RFID is DEAD…at Unit-Level in Pharma” and we are approaching a pivotal decision by the Food and Drug Administration (FDA) that will determine whether or not RFID will be acceptable for identifying drugs in the U.S. supply chain. Last Thursday was the scheduled final closing of the recent request for comment issued by the FDA formally known as “Bar Code Technologies for Drugs and Biological Products; Retrospective Review Under Executive Order 13563; Request for Comments, 76 Fed. Reg. 66,235” (Oct. 26, 2011) [Docket No. FDA-2011-N-0719].
The closing of this request for comment (RFC) means that it is now time for the FDA to figure out what they might do with the original questions. That is, should they change the requirement for all packages of prescription drugs and many over-the-counter (OTC) drugs in the U.S. to contain the National Drug Code (NDC) encoded into a linear barcode? And if so, what should they replace it with? The RFC doesn’t give any hints about how far they might go and simply asks a series of questions of the industry and interested parties, letting the respondents propose whatever they think the agency should do.
I have spent my Sunday afternoon reading (OK, in some instances, skimming) through all of the responses. They are available for anyone to read (or skim) at http://www.regulations.gov (search for FDA-2011-N-0719). Considering that the input received from this RFC may influence the FDA’s decision about what to replace the linear barcode requirement with, I think the responses are particularly pertinent to RxTrace readers.
My reading has taken so long that I no longer have enough time left over to cover the responses in detail (consider yourself lucky), but there are a number of general themes that emerged from them in aggregate.
“Linear barcodes are so 2004″
Nearly all of the responses that answered the FDA’s specific questions indicated that it is time to move away from the use of linear barcodes. I think all of the responses were submitted prior to the publication of my essay “Why NOW Is The Time To Move Away From Linear Barcodes” so to them I was simply restating the obvious.
“Don’t mess with ISBT-128“
The members of the blood, tissue and organ supply chain were well represented in the responses with comments that were very similar, like this one from Pat Distler of the ICCBBA.
“…we strongly encourage FDA NOT to require NDC be bar coded on licensed products requiring biovigilance (e.g., cells, tissue, tissue derived products, organs for transplant, medical devices for which donor to recipient traceability is needed). Instead, FDA should expand the guidance given in Securing the Drug Supply Chain-Standardized Numerical Identification for Drug Packages to include all biologics such that the SNI for these products would be the unique identification number created for each package under ISBT 128 or other recognized standards.”
“Don’t restrict our choices”
Many of the respondents do not want the FDA to simply replace the word “linear” with some other specific symbology or technology. Here is a comment that is representative of this theme:
“…we do not believe FDA should restrict the type of machine readable technology within the regulation. The regulation should only state that machine readable information needed for traceability (unique identifier and product code) should be required.”
I was pretty surprised at how many respondents said that they wanted manufacturers to each decide which carrier technology to encode their NDC and other data in. This is exactly counter to my thoughts as expressed in the essay “Should Regulations Dictate Technology?” where I argued,
“It is the movement by the industry in unison that is the real benefit of carefully mandating a single technology for identifying drugs in the supply chain. It is the key to maintaining and even improving supply chain efficiencies.”
My concern is that, if every manufacturer can use whatever machine readable technology they think is best, then within a short time we will see every conceivable carrier technology in use within the supply chain at the same time. Every barcode symbology and every flavor of RFID—and there are some other pretty weird technologies out there. I think that’s a recipe for the degradation of interoperability.
Fortunately some of the responses in this category are simply concerned about the ease with which the FDA could change their regulations and so they didn’t think a full regulation should identify a specific technology. They think the FDA should issue less formal guidance documents to specify the acceptable technologies.
“The type of machine readable information (linear bar code, 2-D bar code, RFID, etc.) should be provided only in easily-changed guidance documents.”
For those responses that weren’t in the “Don’t restrict our choices” camp (and even including some of those) the most common recommendation was to replace “linear” with “DataMatrix”, one even providing additional technical detail, “DataMatrix ECC 200”. A representative example,
“GEHC recommends use of the GS1 Datamatrix as an alternative to the linear bar code.”
“Let GS1 decide”
Quite a few respondents recommended that the FDA turn over the choice of technology variously to GS1, GS1 US, GS1 Healthcare, or “the user community”, which is a euphemism for “companies who are members of GS1”. John Robert of GS1 US explains it this way.
“It is also recommended that the FDA should select one standards system; specifically, the GS1 System.”
“In order to accommodate a variety of environments and applications, the GS1 System supports six barcodes that industry partners can work with to support their supply chain needs. In addition, the GS1 System also supports two RFID data carriers…”
“Thus, it is recommended that the FDA not specify a proprietary data carrier, or any particular type of data carrier or technology. Instead, it is recommended that the FDA only specify automatic identification standards that can be used. Selection of data carriers must consider the constraints of the application. The best way to determine the right data carrier for the product/package is to embrace a user driven, global process where data carrier selections are based on the operational, regulatory, business and practical considerations of the trading partners and the drugs themselves. Therefore, the Bar Code Rule should not be based on a specific technology or a specific symbology. Rather, it is only necessary to embrace unique identification based on global standards, and leave the selection of symbology and technology to the user community.”
“Require Lot and Expiration Date”
Quite a few responses note that the new FDA carrier technology, whatever it turns out to be, will be able to accommodate additional data with ease and that leads them to support the requirement that the drug’s Lot and Expiration Date be included along with its NDC. Typical of these:
“PhRMA believes that both the product lot number and the product expiration date should be included in the barcode, along with the NDC number. This information is included in the 2D barcodes that manufacturers have begun to adopt and FDA’s rules should allow for the inclusion of these data elements in the product bar code. The inclusion of this information should be optional until 2016 and required after 2016.”
HEY, WHAT ABOUT RFID?
I know, I know, I promised you something about RFID, so here it is. Quite a few of the responses that didn’t want the industry to be restricted explicitly listed linear barcodes, 2D barcodes and RFID as examples of technologies that should be acceptable. Many of those would include any future technology so as not to stifle innovation (I shudder to think how many different kinds of readers we would all need to invest in!).
The only response that pushed hard for RFID over everything else was submitted by my old friend Randy Stigall of UPM RFID, an RFID tag manufacturer. Randy’s response was an essay called “Powerful drivers for RFID pharmaceutical serialization”, apparently a reprint of his article from a pharmaceutical magazine. In it he makes the case for the adoption of the latest High Frequency (HF) RFID standard from the International Organization for Standardization (ISO) and GS1, ISO 18000-3m3. It is interesting reading, but I don’t think it’s likely to sway the FDA to replace “linear” with “ISO 18000-3m3 HF RFID” (sorry Randy…hey, give me a call sometime).
On the other hand, if either the “Don’t restrict our choices” or “Let GS1 decide” arguments prevail and one of them is adopted by the FDA, maybe one or two drugs identified by ISO 18000-3m3 HF RFID will show up in your drug shipments sometime soon. What’s that? Your linear/2D/UHF RFID combo device can’t read ISO 18000-3m3 HF RFID? Quick. Time for an upgrade!
Didn’t submit a comment in response to the FDA RFC? That’s all right. Submit one to RxTrace below.