FDA Task Force Releases RFID Recommendations

FDA Task Force Releases RFID Recommendations
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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.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.

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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."

Click here to read more about pharmaceutical RFID adoption.

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.

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