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The Food and Drug Administrations Counterfeit Drug Task Force announced June 9 its recommendations for the pharmaceutical industry regarding the use of radio-frequency identification technology to fight the proliferation of some 35 million counterfeit drugs in America.
The report recommends that the FDA remove its “hold” on its so-called pedigree act, reinstating the 2007 deadline for those in the pharmaceutical supply chain to implement some form of electronic tracking technology, be that RFID, bar codes or a combination of both.
While the Task Force didnt actually mandate the use of RFID to track and trace drugs through the pharmaceutical distribution chain—from manufacturer to wholesaler to retailer to consumer—it did point to RFID as “the most promising technology for implementing electronic track and trace in the drug supply chain,” and suggested that “stakeholders move quickly to implement this technology.”
The concept of utilizing RFID to track drugs stems from the FDAs 1987 Prescription Drug Marketing Act that requires drug distributors to provide a “pedigree” for pharmaceuticals—documentation of the chain of custody of drug products.
In 1999 the FDA published its final PDMA regulations, which were to take effect the following year.
After a lot of negative feedback—from trade associations and from Congress—the FDA delayed the effective date until 2001.
With little impact on changing practices along the supply chain, in 2004 the FDA again delayed the provision—this time until December 2006.
The latest deadline was set “because we were informed by stakeholders in the U.S. drug supply chain that industry would adopt electronic track and trace technology by 2007,” according to Fridays report.
The thought was that when widely adopted, the new technology—RFID—would create a sort of de facto e-pedigree standard that would amount to documenting the movement of drugs.
While an industry-wide adoption of RFID by 2007 hasnt actually panned out, during a fact-finding mission in 2006 the Task Force found that what had once been considered an onerous undertaking—developing an electronic drug pedigree—might not be that difficult, according to the June 9 report.
However, the Task Force is not pushing the 2007 deadline.
“We continue to believe that RFID is the most promising technology for electronic track and trace across the drug supply chain. However, we recognize that the goals can also be achieved by using other technologies, such as 2D barcodes,” the report states.
“Based on what we have recently heard, we are optimistic that the hybrid environment of electronic/paper and the use of RFID/bar code is achievable in the very near future.”
The report, however, cautions that RIFD is not a panacea for the problem of tracking counterfeit drugs.
It lists a number of big issues to overcome including: a lack of standards (e-pedigree fields and format, data systems, international transmission and hardware specifications); privacy concerns; concerns about the ownership of confidential business transaction data; challenges in serializing products; concerns over the speed and accuracy of electronic devices and systems; and a lack of definitive data to determine how RFID will affect sensitive products like liquids and biologics.
Next Page: Growing controversy.
Growing Controversy
While there has been growing controversy in consumer advocate groups over a number of areas the Task Force highlighted (privacy and security chief among them), vendors have also had battles regarding standards.
One brouhaha is over whether HF (high frequency) or the newer UHG (ultra high frequency) is the better tag and reader frequency on which industries should standardize—particularly in the case of tagging sensitive drugs.
The fear with UHF, which is based on the Gen 2 standard for tags and readers, is that the electricity generated from the reader to the tag during a read would be similar to popping a cup of coffee in the microwave for too long.
Proponents of UHF, primarily vendors looking to implement Gen 2 in their products, say the claims are bunk. On June 8 a consortium of companies—ADT/Tyco Fire & Security, Alien, Impinj, Intel, Symbol and Xterprise—sponsored a white paper meant to dispel myths about UHF vs. HF.
In summary, the FDA Task Force made a number of recommendations to those along the pharmaceutical supply chain: that they continue moving forward in implementing RFID; that they consider a phased-in approach to RFID, targeting high-value and high-theft drugs first; and that stakeholders explore the use of RFID for tracking medical countermeasures.
At the same time, the report recommends that the FDA work with industry, standards organizations and others to facilitate RFID implementation, and that it move to quickly to complete its own RFID Impact Study—and publicly share the results.
The report also has some significant recommendations privacy and data encryption.
In addition to forming its own task force to test RFID, the report recommends the FDA create an industry-wide label pointing out RFID-tagged drugs, and that it commit resources to a public education program on RFID.
“Privacy issues are a real concern for consumers and FDA. These concerns will continue unless there is appropriate disclosures of the presence of an RIFD tag on containers given to patients and sufficient education about the application, true risks, benefits and vulnerabilities associated with RFID on drug products,” reads the report. “This is no easy task.”