FDA Issues Guidelines for Use of Radio Tracking Chips on Prescription Drugs
As expected, FDA on Monday announced that some pharmaceutical companies will begin placing radio frequency identification devices on the labels of medication bottles "to help thwart counterfeiters," and the agency issued guidelines for use of such devices, USA Today reports (Appleby, USA Today, 11/16). The initiative is expected to lead to "better monitoring of the supply chain" by "creating an electronic pedigree that details a drug's trail" from manufacturer to supplier, according to the Wall Street Journal (Won Tesoriero, Wall Street Journal, 11/16).
RFID tags, which have the appearance of "ordinary labels," are computer chips with labels rapped around them. The devices work like passports, receiving a "stam[p]" at each stage of distribution when the chip is activated by sensors with radio waves at distribution centers and is electronically read. A counterfeit drug would have no record.
FDA "worked through the kinks" in the initiative during a $3 million pilot project that included Johnson & Johnson, Merck and Wyeth, as well as CVS and Rite Aid (Sherman, AP/Seattle Post-Intelligencer, 11/15). New Jersey-based EPCglobal will "set standards" for the RFID tags, which will remain voluntary until 2007, after which FDA might require the labels and specify which types could be used (California Healthline, 11/15).
Purdue Pharma officials said that the company this week will begin shipping bottles of its painkiller OxyContin with RFID labels to Wal-Mart and wholesaler H.D. Smith. Purdue also will donate 100 devices to scan the chips and read the information on bottles (USA Today, 11/16).
Purdue officials said the technology initially will cost $2 million, plus 50 cents per RFID tag (Wall Street Journal, 11/16). Pfizer by the end of the year will embed RFIDs in packaging of impotence treatment Viagra, company officials said (USA Today, 11/16). GlaxoSmithKline officials said in the next year to year and a half the company will tag one or more of its often counterfeited HIV/AIDS medications, such as Retrovir, Combvivir and Epivir.
Issues that have yet to be worked out include how to protect proprietary information that will be included on the RFID tags, such as sales volume and shipment frequency; how to allow data to be shared; and how to establish industrywide standards, according to the Journal. FDA will provide guidelines for RFID pilot projects and has created a work group to monitor implementation (Wall Street Journal, 11/16).
"In order for it to work, everyone up and down the supply chain has to be able to participate," Myles Culbertson, director for the Product Surety Center at New Mexico State University, said (USA Today, 11/16).
William Hubbard, associate commissioner for policy and planning at FDA, said RFID tags could be used to verify the legitimacy of prescription drugs purchased from Canada, although such a use is not a goal of the initiative. He added, "This is not about setting up a process to allow reimportation of drugs from other countries. It's about protecting the security of the drug supply" (Godinez, Dallas Morning News, 11/15).
Several broadcast programs reported on the announcement on the use of RFIDs by FDA and drug companies:
- ABCNews' "World News Tonight": The segment includes comments from Aaron Graham, vice president of Purdue Pharma, and Jack Grasso, senior director of public relations for EPCglobal (Potter, "World News Tonight," ABCNews, 11/15). A video excerpt of the segment is available online in RealPlayer.
- NBC's "Nightly News": The segment includes comments from Katherine Albrecht, founder of Consumers Against Supermarket Privacy Invasion and Numbering; Hubbard; Robin Koh, director of applications research at the Auto-ID Labs of the Massachusetts Institute of Technology; and pharmacist Lanier Mull (Teague, "Nightly News," NBC, 11/15). The complete segment is available online in Windows Media.
- NPR's "All Things Considered": The segment includes comments from Graham and Hubbard (Prakash, "All Things Considered," NPR, 11/15). The complete segment is available online in RealPlayer.