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RFID Myths & Counterfeit Pharmaceuticals

The subject continues to be the threat posed by counterfeit medicines to our Nation's patients and to the World, especially people in the third world where the prevalence of fake drugs attacks the unassuming and innocent.

It has been said that "Counterfeiters are the lowlife of bio-terrorism."

Still, there is continued confusion about the role of RFIDs in the supply chain of legitimate pharmaceutical products and separate importance of very different authentication technology solutions. Part of the problem in my opinion is the way in which the Food and Drug Administration defined the track and trace requirements in their Final Report of their Counterfeit Drug Task Force.

"...it is feasible for use by 2007. Radiofrequency Identification (RFID) tagging of products by manufacturers, wholesalers, and retailers appears to be the most promising approach to reliable product tracking and tracing. Significant feasibility studies and technology improvements are underway to confirm that RFID will provide cost-reducing benefits in areas such as inventory control, while also providing the ability to track and trace the movement of every package of drugs from production to dispensing. Most importantly, reliable RFID technology will make the copying of medications either extremely difficult or unprofitable. FDA is working with RFID product developers, sponsors, and participants of RFID feasibility studies to ensure that FDA's regulations facilitate the development and safe and secure use of this technology. FDA is also working with other governmental agencies to coordinate activities in this area.

As innocent as that statement may seem, it was read by the media and many people as defining RFIDs as an anticounterfeiting solution. This, despite the fact that the very next conclusion discussed "authentication" technologies. To this day, and despite the reality that RFID tags have been cloned (in other more secure applications like the e-passport), the FDA maintains that there never was a mandate for the pharmaceutical industry to use the RFID for the track and trace requirement.

From Chief Security Officer (CSO online), an article titled "The 5 Myths of RFIDs" provides adequate challenge to the misconceptions that have persisted.

The problem is that decades after RFID technology was invented, and years after the U.S. Food and Drug Administration started touting it as the most promising way to authenticate drugs, RFID technology as an anticounterfeiting technology remains just that: "promising"-yet far from proven.

The myths:
1. RFID tags are anticounterfeiting devices.
...an RFID tag is first and foremost a tracking device, not a security one. Further, "it's not an anticounterĀ­feiting device in the way that, say, a hologram label is supposed to be."

2. RFID technology is necessary to track the movement of legitimate drugs. AmerisourceBergen (a major pharmaceutical distributor) is engaged in a track-and-trace pilot project "to check the source of any drugs that pass through one of its distribution facilities...RFID technology is just one tiny piece of the project-the one that (hopefully) makes it operate quickly, rather than securely.

3. RFID technology can be used to mark pills, tablets and elixirs themselves. According to Novartis's James Christian, "No one is marking drugs, only the packaging."

- "The packaging isn't what's important."
- pharmaceutical products are routinely and legally repackaged in both the United States and the European Union.

4. RFID technology will let consumers verify that they have purchased legitimate products. The ultimate goal of using RFID technology as part of an electronic pedigree or track-and-trace program is to allow customers to know that the drugs they have in their medicine cabinet are authentic ones.,,Yet no one-not the FDA, and not any of the pilot programs being done by the private sector-is actually proposing a way for consumers to validate the products.

5. The pharmaceutical industry is this close to widespread RFID adoption. The FDA, after delaying for years the deadline for when the industry should have electronic pedigrees in place-ones that it says, most likely, will rely on RFID technology-recently announced its biggest delay of all: It was giving up on setting a deadline.

Somehow, this doesn't jibe with my having been told that there was no FDA mandate to use RFIDs for track and trace in the supply chain. Admittedly my opinion is influenced by personal issues, counterfeit pharmaceuticals is a supply chain issue and it is in many ways a law enforcement or private security issue where counterfeits can be identified. There are solutions "out there," they just aren't being used yet.

Please refer to New FDA Legislation Could Impact RFIDs and the Safety of Medications and the World Health Organization Fact Sheet on Counterfeit Medicines.