The bill is designed to secure drug distribution through the supply chain, from manufacturers to patients.
Two federal lawmakers introduced a bill this week that seeks to prevent the distribution of counterfeit and fraudulent prescription drugs by mandating the use of RFID or similar supply chain tools.
Rep. Gil Gutknecht (R-Minn.) and Rep. Dan Burton (R-Ind.) introduced the legislation Wednesday. Dubbed Reducing Fraudulent and Imitation Drugs Act of 2006, it calls for the Food and Drug Administration (FDA) to mandate -- rather than make optional -- radio frequency identification (RFID) or similar track-and-trace supply chain tools by the year 2008.
The bill is designed to secure drug distribution through the supply chain from manufacturers to patients.
"Counterfeit drugs in the U.S. are rare," Randall Lutter, associate commissioner for policy and planning at the FDA, told attendees at RFID World 2006 in Dallas Wednesday. The bill's implications were widely discussed at the trade show. "The FDA has been concerned that the drug supply is under increasing threat of attack from sophisticated counterfeiters."
While criminal FDA enforcement cases rose sharply in the past few years, preliminary data suggests a decline in 2005, Lutter said.
Nearly 4 billion prescriptions were filled in 2005. The FDA's criminal office of investigations in 2005 opened 38 counterfeit drug cases, down from 58 in 2004, and up from 30 in 2003.
Lutter, however, said it takes more than electronic track-and-trace technology, such as RFID, to stop counterfeiting. Holograms, color shifting inks, increased awareness, penalties and state enforcement are also suggested. The FDA plans to release a report in May on recent findings. The government agency also will make an announcement on the state of the electronic pedigree rule later this year.
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