Thursday, May 17, 2007

The Anti-RFID Amendment

My good friend Senator Byron Dorgan tacked S.242 Pharmaceutical Market Access and Drug Safety Act of 2007 onto the Senate’s reauthorization of the drug safety bill. Fortunately, an amendment inserted by Senator Cochran neutralized the importation aspect.

In an interesting twist, the RFID Law Blog reports that the Senate’s reauthorization of the PDUFA also includes another amendment that specifically excludes anti-counterfeiting technologies such as RFID or barcodes. According to US Senate Passes Amendment That Bypasses RFID on Pharmaceuticals:

“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.”

Personally, I don’t see how this would anything because it sounds like nothing more than package design security, which has not been a big barrier to counterfeiters. It also becomes irrelevant when products are repackaged or packaging is altered, a persistent concern of Pfizer about parallel trade.

Such a solution also “solves” the authentication challenge facing all anti-counterfeiting system by simply eliminating the need for authentication and serialization.

Whatever -- sounds like I should spend more time in Washington. In the meantime, check out the many comments on RFID Un-Hype. Very lively debate!


  1. AnonymousMay 17, 2007

    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 " 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.


    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.

  2. Thank you for the clarification. As I am not familiar with the specific amendments, I was relying on the RFID Law Blog's interpretation. (FYI, the RLB is written by attorneys from the law firm McKenna Long & Aldridge.)

    Regardless, it does seem like we will be faced with a proliferating set of requirements, some of which may conflict with each other.

    Good to know that I have knowledgeable readers!


  3. The RFID Law Blog posted a good clarification of this amendment:

    More on RFID and Pharma Legislation...