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New FDA Legislation Could Impact RFIDs and the Safety of Medications

One of the very real issues facing people, especially older Americans, is the cost of prescription medications. To deal with these costs, many have turned to importing their pharmaceuticals from Canada or Mexico or to buying them over the Internet.

The question, then, is whether or not these products are real or counterfeit or perhaps outdated. It has been said that "Counterfeiters are the lowlife of bio-terrorism." The issue of counterfeit medicines is very much an issue of security and safety. The World Health Organization estimates that more than 10% of the pharmaceuticals in worldwide distribution are counterfeit, with value of counterfeits expected to reach $75 billion in 2010.

It was only a few years ago that it was hard to get anyone to admit that there was a problem with counterfeit pharamaceuticals. Then, the Food and Drug Administration convened a panel, the Counterfeit Drug Task Force (with the public meeting in October 2003) and as a result of its deliberations and public testimony, a Final Report was published. Since I had/have a vested interest in the Report, I'm not going to go into "chapter and verse" of its findings or implications (if anyone has a specific question, I'll try to respond).

Just the first "finding" is relevent right now:

Implementation of new technologies to better protect our drug supply. Because the capabilities of counterfeiters continue to evolve rapidly, there is no single "magic bullet" technology that provides any long-term assurance of drug security. However, a combination of rapidly improving "track and trace" technologies and product authentication technologies should provide a much greater level of security for drug products in the years ahead. Similar anti-counterfeiting technologies are being used in other industries, and FDA intends to facilitate their rapid development and use to keep drugs secure against counterfeits.

Last week, a new piece of legislation was passed by the U.S. Senate that could impact the RFID industry's application for pharmaceuticals (New Law Serves as Warning to RFID Industry). Specifically it relates to the sale of prescription drugs over the Internet, and mandates (if also passed by the House and signed by the President) that such products carry a visual, anti-counterfeiting key (something that you can see without aide of a machine) to allow the consumer to recognize the product as real and not counterfeit. The important point here is that the legislation "explicitly excludes technology like RFID or barcodes that require a supporting infrastructure of readers, antennas, etc."

Interesting in the article is the position of the editors that "engaging with Washington in the formation of public policy can further adoption of RFID; conversely, neglecting Washington can be harmful." As noted by Doug Farry, managing director of the government affairs practice at McKenna Long & Aldridge LLP, a Washington-based law firm:

While advocates of a particular technology generally recognize the benefit of having that technology required by law for a given application, they are less aware of the possibility that their technology could be legislated against. "The RFID industry might have made the case that the mandated technology be RFID," said Farry, "but at minimum they could have fought to keep the door open to RFID." If the law passes as is, that door will close.

Now, as an "interested party" I have wondered for some time now how there was continued justification for RFIDs as the "preferred" track and trace modality (given the possible vulnerabilities), along with the misperception that RFIDs provided anti-counterfeit benefits. But now, even more, with the mandate that Internet purchased pharmaceutical products carry "a visual technology similar to what is used in paper currency...and that the technology be visible to the naked eye and not require separate readers or scanners for verification" questions should be raised. One question, especially should be whether the imported pharmaceutical products are really being protected, and in turn, are consumers being protected against not only counterfeit medications, but also out of date products.

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