FDA issues policy guidelines to boost use of tags on prescription drugs
Food and Drug Administration officials released new policy guidelines last week designed to stimulate the use of passive radio frequency identification (RFID) tags for prescription drugs.
Purdu Pharma officials said they will start using the technology this week on shipments to two large customers of the company's OxyContin, a narcotic for treating pain.
FDA officials report that counterfeit prescription drugs are not widespread within legal manufacturing and distribution channels, but counterfeiters are using increasingly sophisticated methods to try to move their products through legitimate channels.
In February, FDA officials recommended that the pharmaceutical industry adopt RFID technology by the start of 2007 to help combat the recent proliferation of counterfeit drugs. They added that they believe RFID will eventually produce significant savings for the drug industry through more efficient distribution processes.
Dr. Lester Crawford, the FDA's acting commissioner, said at a press briefing that the new Compliance Policy Guide issued by agency officials Nov. 15 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 ensures that the public receives real drugs by providing an electronic record of the chain of custody from manufacturer to retail or hospital pharmacy.
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 the chain of custody would be ensured by RFID tag readers through the drug manufacturing and distribution system.
The technology also provides better inventory control, she said. Manufacturers, wholesale companies and retail pharmacies will all need to install RFID readers, but they would quickly reap benefits from better inventory management, she added.
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, she said.
RFID tag readers cost $2,000, Churchill said, but Paul Rudolph, the FDA's senior adviser 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 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 penalties if they have to track the chain of custody with paper rather than electronic RFID-based systems, Hubbard said.
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