RFID Law Blog

Last week, the US Senate passed legislation that reauthorized the federal user fees on pharmaceuticals that help fund the FDA. Buried in the legislation was a provision -- posted earlier on this blog site -- authored by Senator Judd Gregg of New Hampshire, that would require Internet pharmacies selling to US citizens to use tracking technology to minimize the risk of counterfeiting.
An amendment to that language, offered by Senator Michael Enzi of Wyoming, legislates a specific technology solution - and it's not RFID. Indeed, it specifically excludes anti-counterfeiting technologies like RFID or barcodes that require readers, scanners or other devices to verify authenticity -- replacing the FDA's preferred tools with anti-counterfeiting technologies akin to those used on US currency.
This is yet another example of where those interested in RFID are missing the boat -- RFID providers are finding that other technology competitors are using the government process to exclude them from the pharma market. And those in the pharma space -- drug manufacturers, distributors, wholesalers, etc -- who have been spending time and money on RFID solutions may find that they need to accommodate two systems. RFID and this optical technology.

Get in the game, folks.

S.1082, sec. 514:

SEC. __. COUNTERFEIT-RESISTANT TECHNOLOGIES.

Notwithstanding any other provision of this Act, the requirement that the Secretary of Health and Human Services certify that the implementation of the title of this Act relating to the Importation of Prescription Drugs will pose no additional risk to the public's health and safety and will result in a significant reduction in the cost of covered products to the American consumer shall not apply to the requirement that the Secretary require that the packaging of any prescription drug incorporates--

(1) not later than 18 months after the date of enactment of this Act, a standardized numerical identifier (which, to the extent practicable, shall be harmonized with international consensus standards for such an identifier) unique to each package of such drug, applied at the point of manufacturing and repackaging (in which case the numerical identifier shall be linked to the numerical identifier applied at the point of manufacturing); and

(2) not later than 24 months after the date of enactment of this Act for the 50 prescription drugs with the highest dollar volume of sales in the United States, based on the calendar year that ends of December 31, 2007, and, not later than 30 months after the date of enactment of this Act for all other prescription drugs--

(A) overt optically variable counterfeit-resistant technologies that--

(i) are visible to the naked eye, providing for visual identification of product authenticity without the need for readers, microscopes, lighting devices, or scanners;

(ii) are similar to that used by the Bureau of Engraving and Printing to secure United States currency;

(iii) are manufactured and distributed in a highly secure, tightly controlled environment; and

(iv) incorporate additional layers of nonvisible convert security features up to and including forensic capability; or

(B) technologies that have a function of security comparable to that described in subparagraph (A), as determined by the Secretary.

Thanks for posting this information. I had no idea that this occurred. I've included a link to your story on my blog:

http://www.drugchannels.net/2007/05/anti-rfid-amendment.html

Adam

A commenter on Adam Fein's Drug Channels stated as follows:

Anonymous said...
I don't interpret the legislation as prohibiting RFID. I interpret the legislation as having two requirements that must be incorporated into prescription drug packaging:

The paragraph (2) describes overt optical technologies that doesn't need scanners, etc which would prohibit RFID. This needs to be implemented not later than 24 months after the enactment of th legislation.

However, paragraph (1) seems to indicate a completely separate requirement. It indicates that not later than 18 months after the legislation is enacted, a unique serial number must be on the packaging. The paragraph indicates "...to the extent practicable, shall be harmonized with international consensus standards for such an identifier..". I don't see any text prohibiting any particular technology of how this serial number is on the package. It could be RFID, 2D, whatever.

Could you please clarify your post in response to this comment?

I don't interpret the legislation as prohibiting RFID. I interpret the legislation as having two requirements that must be incorporated into prescription drug packaging:

The paragraph (2) describes overt optical technologies that doesn't need scanners, etc. For this requirement, RFID would be prohibited. This needs to be implemented not later than 24 months after the enactment of the legislation for top 50, and 30 months for all.

However, paragraph (1) seems to indicate a completely separate requirement. It indicates that not later than 18 months after the legislation is enacted, a unique serial number must be on the packaging. The paragraph indicates "...to the extent practicable, shall be harmonized with international consensus standards for such an identifier..". I don't see any text prohibiting any particular technology of how this serial number is on the package. It could be RFID, 2D, humand readable, whatever.

The Amendment language doesn't "prohibit" the use of RFID by the pharmaceutical industry.

But the language specifies that manufacturers must use an anti-counterfeiting technology that is visible with the naked eye and does not require a scanner or reader to function. That is not RFID, obviously.

Now I can see the argument that a company could use both -- RFID to satisfy the requirement to provide a unique identifier and another technology to visually authenticate the drug without needing a reader or scanner. But that could be redundant and expensive.

There are lots of conceivable ways to put a unique ID number on a package of drugs besides RFID -- printed serial numbers on a lable, laser etching on the bottle, etc. There are IT pros and cons to each, obviously.

To the degree that some complain that the Pharma industry has been too slow to adopt RFID as a solution, the uncertainty about what the Secretary might adopt as the anti-counterfeiting technology standard will not speed RFID adoption along -- that's for certain.

The bigger issue though is that the US Congress, via legislation that has already passed the Senate, is making decisions that may dramatically shape the future of the RFID industry in this market -- facilitate it, direct it, or kill it.

And until I posted it on this blog site, no one in the industry seemed to notice. And they certainly are not organized to make their case to Congress about a preferred outcome that will benefit RFID adoption. Somebody is bending the Senate's ear about anti-counterfeiting technology for drugs -- and it's not the RFID crowd.

Remember this when Congress turns to food safety issues, or tracking hazardous chemicals, or facilitating product recalls, or debating personal authentication technologies for immigrants seeking jobs in the United States. Are those in the RFID space making their voices heard?

An article from the RFID Journal on it.

http://www.rfidjournal.com/article/articleview/3322/1/1/

There are three mark requirements of the bill: overt, covert, and serialization.

These authentication technologies would add up - particularly if RFID was incorporated.

And cost result MUST be the final consideration for the Secretary of HHS. Why? Because none of this goes into effect unless the Secretary certifies these technologies result (Section 811) "in a significant reduction in the cost of covered products to the American consumer."