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Prescription Drugs to Get Electronic IDs

FDA, pharmaceutical measure aims to curtail counterfeiting

MONDAY, Nov. 15, 2004 (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.

Although officials stated that counterfeit drugs are not yet a serious problem in the United States, they did acknowledge the problem is on the rise. "We know that counterfeit drugs around the world are endemic. In some countries, you are more likely to get counterfeit drugs than real ones," Hubbard said. "In the U.S., we have a strong system, but we are seeing increasing numbers of counterfeit cases and we are concerned that there could be additional threats."

"We think that the drug supply in this country is very safe now, and the chances of getting counterfeit drugs is very small. But we have seen increase in cases, and counterfeiters would love to break into our market," Hubbard added. "We believe the threat is real, and needs to be addressed in a real and strong way."

RFID involves putting electronic tags on products to keep better track of them as they move through the supply chain. The technology is similar to that used for tollbooth and fuel purchasing passes. These electronic tags contain information on the entire chain of custody of a bottle, potentially allowing investigators to find out who might have stolen it or where it went from a specific store. The information on the tag lets pharmacists authenticate the product, verifying that it is legitimate.

Although the initial financial investment would be "significant," Rudolf said, he also expects prices to fall dramatically as demand increased. "Readers that may cost $1,000 may come down to $200, and tags that cost 20 to 50 cents may come down to 10 cents," he said.

This electronic system will also be less expensive than a paper pedigree system, which will benefit Florida, which has a new law requiring that a pedigree system be in place by June of 2006.

"There will be some initial up-front costs, but over time it will save the drug distribution system hundreds of millions -- if not billions -- of dollars," Hubbard said.

Right now, the system is envisioned only for the domestic drug market and would not affect imports. "We would think that any electronic tagging in the world market would be many years away," Hubbard said.

Officials also admitted that privacy issues need to be worked out. "I believe the pharmaceutical industry is very well aware of those potential issues, and right now there are technologies being developed that will enable ID tags to be inactivated or killed in some way, shape, or form once a purchase has been made that has a tag in it," Rudolf said.

More information

See the report on fighting counterfeit drugs at the U.S. Food and Drug Admistration.

SOURCES: Nov. 15, 2004, news teleconference with Lester M. Crawford, D.V.M., Ph.D., acting commissioner, U.S. Food and Drug Administration (FDA); William K. Hubbard, associate commissioner for policy and planning, FDA; Paul Rudolf, M.D., senior advisor for medical and health policy, FDA; Pfizer Inc. statement
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