Post by Tulameen on Nov 16, 2004 15:16:01 GMT -5
Prescription Drugs to Get Electronic IDs
By Amanda Gardner
HealthDay Reporter
MONDAY, Nov. 15 (HealthDayNews) -- The U.S. Food and Drug Administration on Monday announced an anti-counterfeiting initiative that would provide prescription drugs with an electronic fingerprint by outfitting them with tiny chips and antennas.
The announcement was closely timed with moves by several pharmaceutical giants to place radio frequency identification (RFID) tags on certain products susceptible to counterfeiting, including Viagra and OxyContin.
These moves, in turn, set the stage for RFID technology to supplant bar coding as the "inventory control technology for the future," William K. Hubbard, the FDA's associate commissioner for policy and planning, said at a news teleconference.
The technology would enable the packages to be scanned and tracked, making it easier to authenticate them throughout the distribution process. In a statement, Pfizer Inc., among the first to jump on the bandwagon, said that because the RFID system is hard to copy, it "will help protect the pharmaceutical supply chain, and ultimately consumers, from fake medicines." Its blockbuster erection pill Viagra is among the most counterfeited.
For the moment, the FDA's plan stops short of requiring any action, and consists of the publication of a guide intended to spur companies to conduct feasibility studies and pilot programs using RFID.
"Studies on chips and antenna can be used without special requirements or FDA's authorization, and will not result in an enforcement action under existing rules governing labeling," said acting FDA commissioner Dr. Lester M. Crawford. "The FDA has stepped up its efforts to protect safety and security of the U.S. drug supply with the use of RFID technology."
"We are providing guidance to assure companies that if they do use this tagging, that they won't be violating our labeling regulations," Hubbard added. "This compliance gives them assurances they need to move ahead."
In the past, the lack of firm leadership on the matter was holding the industry back, officials said. "Certain pilot studies were inhibited, and may have been delayed while waiting for a response from us for those questions," said Dr. Paul Rudolf, the FDA's senior advisor for medical and health policy.
The action is a follow-up to an FDA report, issued in February, on fighting counterfeit drugs. It recommended that RFID technology be in widespread use throughout the pharmaceutical industry by 2007.
www.forbes.com/lifestyle/health/feeds/hscout/2004/11/15/hscout522366.html
By Amanda Gardner
HealthDay Reporter
MONDAY, Nov. 15 (HealthDayNews) -- The U.S. Food and Drug Administration on Monday announced an anti-counterfeiting initiative that would provide prescription drugs with an electronic fingerprint by outfitting them with tiny chips and antennas.
The announcement was closely timed with moves by several pharmaceutical giants to place radio frequency identification (RFID) tags on certain products susceptible to counterfeiting, including Viagra and OxyContin.
These moves, in turn, set the stage for RFID technology to supplant bar coding as the "inventory control technology for the future," William K. Hubbard, the FDA's associate commissioner for policy and planning, said at a news teleconference.
The technology would enable the packages to be scanned and tracked, making it easier to authenticate them throughout the distribution process. In a statement, Pfizer Inc., among the first to jump on the bandwagon, said that because the RFID system is hard to copy, it "will help protect the pharmaceutical supply chain, and ultimately consumers, from fake medicines." Its blockbuster erection pill Viagra is among the most counterfeited.
For the moment, the FDA's plan stops short of requiring any action, and consists of the publication of a guide intended to spur companies to conduct feasibility studies and pilot programs using RFID.
"Studies on chips and antenna can be used without special requirements or FDA's authorization, and will not result in an enforcement action under existing rules governing labeling," said acting FDA commissioner Dr. Lester M. Crawford. "The FDA has stepped up its efforts to protect safety and security of the U.S. drug supply with the use of RFID technology."
"We are providing guidance to assure companies that if they do use this tagging, that they won't be violating our labeling regulations," Hubbard added. "This compliance gives them assurances they need to move ahead."
In the past, the lack of firm leadership on the matter was holding the industry back, officials said. "Certain pilot studies were inhibited, and may have been delayed while waiting for a response from us for those questions," said Dr. Paul Rudolf, the FDA's senior advisor for medical and health policy.
The action is a follow-up to an FDA report, issued in February, on fighting counterfeit drugs. It recommended that RFID technology be in widespread use throughout the pharmaceutical industry by 2007.
www.forbes.com/lifestyle/health/feeds/hscout/2004/11/15/hscout522366.html