While praising the benefits of radio-frequency identification (RFID), the US Food and Drug Administration (FDA) has refrained from demanding its implementation in new measures it unveiled to combat counterfeit drugs, asking instead for a "pedigree" throughout the distribution system.
Of course, legislation requiring drug distributors to provide documentation of the chain of custody of drug products has already been in the US statute books for 18 years, but fears of its impact on small wholesalers meant the law was never enforced - until now.
The agency intends to let the current hold on the application of the track and trace rules of the Prescription Drug Marketing Act of 1987 expire on December 1 2006, the date when wholesalers will have to start supplying pedigree information.
While the problem of counterfeit drugs is still small in the US, it is becoming a burning issue for the FDA, which investigated 58 cases of fakes in 2004 and 32 cases of counterfeit drugs in 2005 as opposed to only six cases in 2000.
Yet although the FDA never fails to assert its faith in RFID as "the most promising technology for implementing electronic track and trace in the drug supply chain," it does not claim the pedigree has to be in the form of RFID, indeed it can be anything from paper documentation to barcodes.
Moreover, authorised distributors which get their medicines directly from the manufacturers will be excluded from the pedigree requirements, leaving out companies such as McKesson, AmerisourceBergen and Cardinal.
This is not to say that wholesalers have not adopted several initiatives to ensure the integrity of the supply chain; Cardinal for example announced last month it is embarking on an RFID pilot to label an undisclosed generic solid-dose drug product with RFID tags.
Still the fact remains that in 2004 the FDA had hoped that by 2007, RFID technology would be widely adopted, a target which now seems remote.
Because of the high cost of implementation as well as concerns about security, reliability and privacy, only few drugmakers, such as GlaxoSmithKline, Pfizer and PurduePharma have adopted the technology, and even then only for particularly commercially successful and vulnerable products, such as Viagra, and only in just some markets.
Nevertheless, the FDA believes the pharma industry cannot be regulated into accepting RFID, at least not yet.
"We believe that RFID is the most promising technology for electronic track and trace, but it is not the only technology that will work," FDA spokeswoman Karen Mahoney told In-PharmaTechnologist.com.
"We are leaving it to the supply chain to determine what works best."
Despite its enthusiastic endorsement of RFID, the FDA still is weary of the lack of definitive data to determine how the radio signals may affect sensitive products such as liquids and biologics.
In addition, the agency acknowledges there are still no universal standards in the industry but it claims those standards are close to completion, and, once that happens, it expects to see a rapid growth in the implementation of RFID in the drug supply chain, albeit in a timeframe it now refuses to specify.
The FDA's measures, which were recommended in a report released by the agency's Counterfeit Drug Task Force, will focus on products it deems most susceptible to counterfeiting and diversion, as it encourages the drugmakers to following a phased-in approach to placing RFID tags.