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What does the recently passed FDA Revitalization Act (S.1082) mean for the battle against pharmaceutical counterfeiting, for the heretofore preferred RFID technology, for consumers who buy from questionable sources?
The US Senate recently passed FDA Revitalization Act (S.1082). While this is an omnibus bill created to allow the US authorities to continue collecting fees from authorized pharmaceutical producers and distributors, its Section 514 (Counterfeit-Resistant Technologies) has implications for the pharmaceutical industry’s anti-counterfeiting efforts in general and RFID (Radio Frequency Identification Technology) companies in particular.
The bill’s product authentication provisions require pharmaceuticals sold to the US public by internet pharmacies to use “overt optically variable counterfeit-resistant technologies”.
SEC. 514. 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 non-visible 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.
Specifically, the bill mandates that the prescription drugs’ packaging incorporate a unique numerical identifier and overt optically variable counterfeit-resistant technologies that provide for visual authentication and are similar to those used to secure US currency.
With this legislation, the government wants to ensure that pharmaceutical products’ authenticity can be verified without the use of any type of scanner, microscope or any other specialized reader. Although the Act does not prohibit the additional use of automatic identification technologies (it in fact includes provisions for covert security features as well), it is clear that neither RFID, once seen as the FDA’s preferred technology to fight counterfeit medicines, nor bar codes alone would be enough to comply with the provisions of the Act.
The provisions reflect the increasing popularity of non-US Internet-based pharmacies in that it includes a provision for "a standardized numerical identifier…unique to each package of such drug, applied at the point of manufacturing and repackaging ..." The purpose of this provision is to prove that the drug shipment comes from a licensed pharmaceutical supplier and provides a standardized source code for the drugs whether it comes in the original packaging or has been repackaged.
However, automatic identification technologies like RFID are still in the picture with many RFID implementation projects for pharmaceuticals in the US and Europe. And currently, the US FDA requires a bar code identifier of manufacturers and products on "the lowest level of packaging" -- but not necessarily the "unit of use" -- for prescription drugs.
While some RFID providers and supporters are claiming that their anti-counterfeit technology competitors are using the legislative process to dominate the pharma market and RFID-based law practices are calling for the industry to “keep the door open” to this technology, many in the authentication field agree with Section 514, arguing that RFID technology on its own is not an effective way to combat fake medicines.
However, while from a consumer perspective, the use of overt, optically verifiable anti-counterfeiting technologies makes sense and helps cut down on the number of possible sources for counterfeits, the technology will not protect consumers from fraud if they buy their medicines from questionable sources in the first place. That ultimate protection may come from one’s ability to know what to look for when trying to spot fakes.
The provisions are to be implemented within 18 months of the passage of the Act for the top 50 prescription medicines in the US, and within 24 months for all other medicines.
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