ROCKVILLE, MD. The Food and Drug Administration has reassured pharmaceutical companies that they can use radio frequency identification technology in product packaging without running afoul of agency rules, at least through 2007.
"Today's actions were designed with one goal in mind: to increase the safety of medications consumers receive by creating the capacity to track a drug from the manufacturer all the way to the pharmacy," acting FDA Commissioner Lester M. Crawford, D.V.M., Ph.D., said in a press briefing sponsored by the FDA.
At the same time, Purdue Pharma LP, Pfizer, and GlaxoSmithKline all said they soon would begin using radio frequency identification (RFID) technology in packaging for some of their products.
RFID is slowly being adopted by retailers to track inventory. Tags that contain information about the product can be embedded into pallets or labels and then read by wireless scanners.
The new FDA policy should convince drug makers that they can safely use RFID tags, said Paul Rudolf, M.D., FDA senior adviser for medical and health policy. Between now and 2007, companies can experiment with RFID without fear of sanctions, he said.
FDA officials said that until now pharmaceutical manufacturers have hesitated to incorporate the tags into their products out of concern that the agencywhich by law must approve everything about a drug's labelmight then consider a drug mislabeled.
The agency believes RFID technology could also deter counterfeiting. A tag could be embedded into a large pill bottle or block of packages at the factory, with information on the drug's potency, its destination, and other important data. Using special scanners and software, the distributor and the pharmacy will then be able to read the tag. RFID will help create an "electronic pedigree," allowing manufacturers, distributors, and pharmacists to verify the drug's legitimacy, according to the FDA.
"The entire chain of custody can be followed," Dr. Rudolf said.
"The threat [of counterfeiting] is real and needs to be addressed in a real and strong way," said William Hubbard, FDA's associate commissioner for policy and planning, who added that the "drug supply in this country is very safe now."
There have been some instances, however, when impurities have been discovered in counterfeit pharmaceuticals, and in one case, where an injectable drug was filled with "nothing more than tap water," explained Thomas McGinnis, Pharm.D., FDA's director of pharmacy affairs.
At press time, Purdue Pharma, which has weathered difficulties with theft and diversion of its pain killer OxyContin (oxycodone), said it would begin sending RFID-tagged 100-tablet bottles to Wal-Mart and H.D. Smith Wholesale Drug Co. The company is also donating 100 handheld scanners to law enforcement groups around the country and using special color-shifting ink on the label that will let pharmacists know that the bottle came from Purdue.
GlaxoSmithKline said it would start using RFID tags on at least one of its products deemed to be susceptible to counterfeiting in the next year-and-a-half. Those products include Retrovir (zidovudine), Combivir (lamivudine/zidovudine), Epivir (lamivudine), Trizivir (abacavir, lamivudine, and zidovudine), Ziagen (abacavir), and Zofran (ondansetron), according to the company.
Pfizer said that it expected to have RFID tags for Viagra (sildenafil) by the end of next year.
Dr. Rudolf added that he did not expect the cost of anticounterfeiting technology to be passed on to consumers, as it would save money by curbing counterfeiting.
A report by the Healthcare Distribution Management Association's Healthcare Foundation seems to back up that assertion: The report estimated that $200 million to $400 million could be saved each year by decreasing drug counterfeiting.