FDA opens door to RFID packaging

FDA opens door to RFID packaging

George Koroneos

The Food and Drug Administration announced in November an initiative that would implement radio frequency identification (RFID) technology to curb counterfeit-drug trafficking in the nation’s pharmaceutical supply chain.

RFID relies on microchips embedded in labels and tags that can store a substantial amount of information and provide the ability to track and trace a package through a supply chain (depending on the type of RFID tag used). Although the technology has been used for years now in the retail supply chain and as a payment device in gas stations and tollbooths, RFID has not caught on as fast in the pharmaceutical industry.

According to Acting FDA Commissioner Lester M. Crawford, “In recent years, bogus medication has become a growing public health threat, because of the counterfeiters’ ability to infiltrate our drug distribution system with worthless copies that look exactly like the authentic FDA-approved products.”

Crawford explained in a media conference call that FDA officials have had a tough time identifying counterfeit products and tracing them back to the points of entry into the supply chain. “We are issuing a compliance policy guide that makes clear to industry that studies involving the use of RFID tags, chips, and antennas on drug containers can be conducted without special request for FDA authorization,” Crawford said. “It will not result in an enforcement action on existing rules governing labeling, in so far as they are triggered by RFID technology.”

This policy will remain in effect until 31 December 2007, allowing companies time to become familiar with the technology and run pilot programs incorporating RFID tags. FDA officials said that they expect drug manufacturers and distributors to use the technology’s track-and-trace feature to establish an electronic pedigree “for products that are most likely to be counterfeited from the point of manufacturing to the point of dispensing,” Crawford said. FDA made it clear that this initiative is not a mandate. Rather, the agency is relaxing its labeling rules, as they pertain to RFID, to allow companies to explore and pilot the technology

Companies such as Pfizer (New York, NY), Purdue Pharma (Stamford, CT), and GlaxoSmithKline (Philadelphia, PA) already have announced that they will ship some of their high-risk drugs with RFID tags. According to a press release issued by Pfizer, the company will add passive RFID tags to cases and retail packages of Viagra at an estimated initial cost of several million dollars. Pfizer doesn’t expect to achieve any cost savings at this point.

“Drug counterfeiting is a serious problem, and RFID offers the potential to be an important anti-counterfeiting technology of the future,” stated Tom Phillips, vice-president of the US Trade group for Pfizer. “It’s certainly not the only solution. Changes to state regulations, more stringent licensing of pharmaceutical wholesalers, modifications of business practices, and increased enforcement also are very important. But RFID does offer a great promise as an effective tool in the battle against counterfeiting.”

For Purdue Pharma, this pilot will not just be a “slap and ship” project, says Charles Nardi, executive director of corporate and supply chain systems. RFID technology will be fully integrated into the company’s manufacturing cycle. The data on the RFID tags will include the item’s global trade identification number, serial number, and business information such as individual production orders and sales orders. This creates a virtual license plate for the product, allowing the company to track a bevy of information about each shipment.

Purdue Pharma will ship 100-tablet bottles of OxyContin and Palladone with Class 0 (read only) RFID tags to two of its largest customers, Wal-Mart and H.D. Smith.

Wal-Mart is no stranger to RFID. The retail giant has mandated that its top 100 vendors switch from standard barcode labeling to RFID by early 2005. Although the Wal-Mart directive calls for pallet-level tagging, pharmaceutical companies hope to eventually tag individual items for increased security.

“What we will be seeing is RFID at a package level,” says Dan Mullen, president of AIM Global (Warrendale, PA). “We are going to see tags on more finite, granular packaging. Where there is security or safety reasons, or where the value of the item is such that the need for the data justifies the cost of the tag, particularly in pharmaceuticals, electronics and higher-end apparel.”

By placing track-and-trace RFID tags on individual items, the pharmaceutical industry will eventually be able to electronically track the pedigree of a drug from creation to purchase more easily than with the paperwork used today. “There is a statutory requirement (and in Florida a state requirement) for paper pedigree, which [may be] very expensive for the industry,” says William Hubbard, FDA associate commissioner of policy and planning. “A technology like RFID could provide the kind of protection that paper pedigree would institute, but with much greater security.” The high cost of RFID tags (20 to 50 cents as opposed to a 2-cent barcode), however, might prohibit companies from fully implementing e-pedigree program on a full-scale level at this time.

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