Radiofrequency identification appears to hold the most potential to increase the security of the pharmaceutical supply chain, stakeholders advise FDA, but important questions include how the radiofrequency emissions might interact with biologics and certain other kinds of drug products.

These ideas were contained in several comments submitted to FDA on technologies that might be useful to track and trace drugs throughout the distribution chain.

The FDA Amendments Act requires the agency to develop standards for a numerical identifier to be applied to a prescription drug at the point of manufacturing and repackaging to facilitate the product's identification, validation, authentication and tracking and tracing. FDA in March requested comments on the available or developing technologies (¹ Also see "FDA Begins Review Of E-Pedigree Options Just As California Delays Its Plan" - Pink Sheet, 31 March, 2008., p. 20).

"Biogen Idec believes that radiofrequency identification tagging represents the best and most promising technology for providing a high level of protection against counterfeiting," Senior VP of Regulatory Affairs Nadine Cohen says in a May 19 letter to the agency. "Because the encryption technology associated with RFID makes counterfeiting and diversion of product impossible from a practical perspective, RFID represents a substantial advantage to the next most promising technology currently being implemented, that of 2D barcoding."

Biogen Is Implementing 2D Barcoding

But despite this potential for RFID, the company told FDA it is moving forward instead with 2D barcoding.

"While both of these technologies carry adequate data to validate a product's transaction history, the impact of RFID readers on the molecular stability of therapeutic proteins and biologics has not been determined. Due to this uncertainty, Biogen Idec is proceeding with 2D barcoding technology to ensure compliance with upcoming pedigree legislation. "

The company called on FDA to take the lead in "developing both standards and implementation timelines for barcoding and RFID technology within the drug industry."

Pfizer currently uses RFID in the serialization of its erectile dysfunction treatment Viagra for the purposes of identification and to enable an authorization capability.

It describes the technology as providing "the most efficient means to read items once they are serialized and moving through the supply chain because it does not require scanning of individual items in order to read/authenticate the serial number." In its May 19 comments to FDA, Pfizer says "RFID may also afford greater protection against counterfeiting due to the complexity and cost to duplicate the tag itself, the tag manufacturer's encoded identification number and the pharmaceutical manufacturer's encoded serial number."

But Pfizer is also concerned about RFID's "unknown" effects on "certain product types, such as biologics. Consequently, if RFID is utilized for serialization purposes, a second data carrier will also need to be used for select products; this will increase the cost of implementation."

Various other comments to FDA questioned whether liquid products might block radiofrequencies or metal-containing products might interfere with them.

Although FDA is already soliciting data and perspectives on tracing methods, House Energy and Commerce Committee members Steve Buyer, R-Ind., and Jim Matheson, D-Utah, are pushing legislation that would require FDA to develop a numerical identifier system for drugs by March 2010 and to develop a list of drugs at high risk of counterfeiting or diversion. The system would be required to be implemented 18 months later (² Also see "House Bill Requires Standard Numerical Identifiers For Drug Tracking By 2010" - Pink Sheet, 21 April, 2008., p. 19). They hope to attach H.R. 6839 to any food and drug importation safety bill taken up in the committee.

No Data Suggests Product Problems in California

Despite manufacturers' concerns about whether RFID technology interacts with products, the California State Board of Pharmacy says that to date, "all of the available data of which the board is aware suggests there is no such effect, and the board has not been made aware of any studies where data demonstrate any such effect."

The California agency does advocate further exploration of the subject.

"The FDA might wish to establish guidelines or standards for such data collection or for application to biologics if the FDA determines that further testing is necessary to demonstrate this lack of effect," it states in comments forwarded to FDA May 12.

California is a leading state in pushing the adoption of electronic track-and-trace technology, with regulations on the books to mandate adoption for products distributed within the state. But the Board of Pharmacy has delayed implementation until Jan. 1, 2011, because many companies said they could not meet the planned Jan. 1, 2009 compliance deadline.

RFID Has Costs After Start-Up

Commenters also pointed out that use of RFID has ongoing costs.

Many noted that there are similar start-up costs for RFID and 2D barcodes, which many seem to favor as an alternative to RFID or at least a viable near-term solution. However, RFID comes with recurring costs.

"It is our experience that the one-time implementation costs associated with serializing products with 2D barcodes can be very similar to the one-time costs of implementing RFID," Pfizer notes, for example. "The advantage to barcodes is that once the serialization capability is implemented, the ongoing costs associated with serialization are minimal."

Pfizer said the cost of serialization for Viagra was approximately $5 million in 2005, while the cost to serialize Celebrex at the cast and pallet level with RFID in 2007 was about $4 million.

"Our solutions involved significant investments in our packaging operations, IT infrastructure, and our distribution facilities," Pfizer said. "The cost to implement a pedigree solution to exchange information about products as they move through the supply chain is in addition to the cost noted above. The ongoing cost of RFID tags is also not included in the cost information above."

Oracle, in undated comments to FDA, said that RFID labels cost between 10 cents and 25 cents, depending on volume and tag type, and that readers and printer hardware are "fairly expensive." The software company says an RFID read saves a user 10 to 30 seconds of data entry versus barcoding.

"If you eliminate the cost of hardware, at the current federal minimum wage ($5.85/hr or $0.0975 per minute), you'd need to re-read that RFID several times over the course of its path through your supply chain to justify the cost of the label alone," Oracle said. "Big manufacturers and distributors won't necessarily see efficiency or safety gains from this technology."

One of the major pharmaceutical distributors disagreed with the assessment that RFID will not be a cost-effective solution.

"McKesson believes that RFID technology has the greatest potential to secure the pharmaceutical supply chain while simultaneously enhancing its efficiency," the company states in May 19 comments.

However, the distributor also noted that success depends on participation by all elements of the supply chain participate.

"In order for this technology to be implemented, manufacturers must embrace RFID and assume the responsibility for placing electronic tags that uniquely identify their products," McKesson says. "Distributors and pharmacies must invest in the necessary infrastructure to accept and transmit the electronic data."

FCC Spectrum Issues Are Potential Hurdle

Another wrinkle that could significantly affect RFID cost is the role of the Federal Communications Commission, which regulates the frequency spectrum that RFID tags would use to transmit data.

The complicating factor is that there is no standard spectrum or frequency for RFID tags.

The National Association of Chain Drug Stores notes that there are two different frequencies (high frequency and ultra high frequency) as well as a number of International Organization for Standardization standards that have been adopted for RFID tags.

"Today, there are three drugs with standards-based RFID tags on their containers; however even with standards, each requires a different reader," NACDS wrote May 19. "Allowing for multiple data carriers - especially within RFID - where the cost of the readers is quite high, would add significant costs to pharmacies."

The trade association notes as well that "the recent release of 700 MHz spectrum by the FCC could lead to a shift to that frequency over the next few years, thus adding more complexity. As such, it is likely that continual changes will occur in the area of RFID technology and other technologies to track and trace prescription drugs. This state of flux will impact the drug distribution supply chain including operational efficiencies and costs if it is mandated before it is mature and the industry has the opportunity to study and evaluate pilots and test these technologies."

And while RFID may be seen as offering the most potential once the technology matures, some commenters caution FDA not to rely on it as the sole means of protecting the integrity of the supply chain.

"As has been noted by FDA and other stakeholders, there is no single 'magic bullet' that will secure the pharmaceutical supply chain and prevent counterfeiting," TAP Pharmaceuticals said. "All manufacturers already incorporate counterfeit-resistant technologies, and more efforts are under way."

Amgen concurred and advocated that regulations not mandate any specific track and trace technology. "The actual finished form of medicines varies widely (e.g. metered dose inhalers, liquids such as syrups or drops for topical application, ampoule, pre-filled syringe, auto-injector or most commonly a bottle containing solid oral dosage) as do the process of their manufacture, packaging and distribution, Because of this high degree of variability, Amgen believes that manufacturers are in the best position to determine what security features are most compatible with their own products."

- Gregory Twachtman (g.twachtman@elsevier.com)

RFID’s Possible Interaction With Biologics Queried By Biogen, Pfizer

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