The Food and Drug Administration released new policy guidelines designed to stimulate the use of passive radio frequency identification tags for prescription drugs.
Food and Drug Administration officials released new policy guidelines today designed to stimulate the use of passive radio frequency identification (RFID) tags for prescription drugs, and Purdu Pharma officials said they will start using the technology this week on shipments to two large customers of the company's OxyContin narcotic pain treatment drug.
FDA officials recommended in February that the pharmaceutical industry should adopt the technology by the start of 2007 to help combat the proliferation of counterfeit drugs. They added that they believe RFID will also eventually produce significant savings to the drug industry through supply-chain efficiency improvements.
Dr. Lester Crawford, acting FDA commissioner said at a press briefing that the new Compliance Policy Guide issued by agency officials today allows pharmaceutical companies to use the technology "without special requests for authorization.''
William Hubbard, the FDA's associate commissioner for policy and planning, said the new guidelines were issued to address concerns of drug manufacturers that they could be violating drug labeling regulations by using RFID tags that had not been cleared by the FDA. Hubbard said the FDA wants to keep its regulatory oversight of RFID to a minimum.
FDA officials said in a statement that the use of RFID tags on drugs would create an electronic pedigree that ensured the public receives real drugs by providing an electronic record of the chain of custody from manufacturer to retail or hospital pharmacy.
Purdu Pharma officials said they will apply RFID tags this week to wholesale, 100-pill bottles of OxyContin that they ship to Wal-Mart and H.D. Smith Wholesale Drug, the country's seventh largest drug wholesaler. Officials at Pfizer, based in New York, said they planned to start using RFID tags on all bottles of Viagra sold in the United States as soon as possible in 2005.
Officials at GlaxoSmithKlein, based in London, said in a statement that they plan to start using RFID tags on shipments of at least one of the company's products susceptible to counterfeiting within the next 18 months. Candidates for tagging include the company's Retrovir and Epivir drugs used to treat HIV and AIDS.
Liz Churchill, director of life sciences solutions at the RFID division of Symbol Technologies in Holtsville, N.Y., said in an interview the chain of custody would be ensured by RFID tag readers throughout the drugs manufacturing and distribution system. The technology also provides better inventory control, she said. Manufacturers, wholesale companies and retail pharmacies will all need to install the readers, but they would quickly reap benefits from better inventory management, Churchill said.
The ability to electronically track drug shipments with RFID would make recalls easier and cheaper by allowing manufacturers to quickly pinpoint the location of a particular bottle of a drug, Churchill said.
RFID tag readers cost $2,000, Churchill said, but Paul Rudolph, the FDA's senior advisor for medical and health care policy predicted that in a matter of years the cost of readers will drop below $1,000. Analysts estimate that the 34,000 chain-owned pharmacies in the country will need to install 170,000 readers to handle RFID tagged drugs.
Hubbard said early adoption of RFID technology will also help drug manufacturers and wholesale companies to develop a cost effective way to meet Florida's strict drug pedigree law which goes into effect in June 2006. Drug companies doing business in Florida after that date will face huge costs if they have to track the chain of custody with paper rather than electronic RFID based systems, Hubbard said.
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