FDA to use tiny antennas to deter drug fraud
WASHINGTON – The Food and Drug Administration and several major drug makers are expected to announce an agreement today to put tiny radio antennas on the labels of millions of medicine bottles to combat counterfeiting and fraud.
Among the medicines that will soon be tagged are Viagra, one of the most counterfeited drugs in the world, and OxyContin, a narcotic that has become one of the most abused medicines in the United States.
The tagged bottles – for now, only the large ones from which druggists get the pills to fill prescriptions – will start going to distributors this week, officials said.
But the technology is not expected to stop there. The adoption by the drug industry, officials said in interviews, could be the leading edge of a change that will rid grocery stores of checkout lines, find lost luggage in airports, streamline warehousing and fight against cargo theft.
"It's basically a bar code that barks," said Robin Koh, director of applications research at the Auto-ID Labs of the Massachusetts Institute of Technology. "This technology is opening a whole series of opportunities to make supply chains more efficient and more secure."
Wal-Mart and the Department of Defense have already mandated that their top 100 suppliers put the antennas on delivery pallets beginning next January. In June, Accenture, a technology consulting firm, won a contract worth as much as $10 billion from the Department of Homeland Security to use radio tags at United States border checkpoints. Other companies are rushing into the market for scanners, computer chips and other elements of the technology.
The labels are called radio-frequency identification. As with automated highway toll systems, they consist of computer chips embedded into stickers that emit numbers when prompted by a nearby radio signal. In a supermarket, they might enable a scanner to read every item in a shopping cart at once and spit out a bill in seconds, though the technology to do that is still some distance off.
For drug makers, radio labels hold the promise of cleaning up the wholesale distribution system, where most counterfeit drugs enter the supply chain – often through unscrupulous employees at small wholesale companies that have proliferated in some states.
Initially, the expense of the system will be considerable. Each label costs 20 to 50 cents. The readers and scanners cost thousands of dollars.
But because the medicines tend to be expensive and the need to ensure their authenticity is great, officials said, paying for the radio labels is justified.
Privacy-rights advocates have expressed reservations about radio labels, worrying that employers and others will be able to learn what medications people are carrying in their pockets. Civil liberties groups have voiced similar concerns. But under the agreement, the technology would not come into play at the retail level.
The FDA's involvement is crucial because drug manufacturers cannot change a drug's label without the agency's approval. In its announcement, the agency is expected to say that it is setting up a working group to resolve any problems that arise from the use of radio antennas on drug labels.
The actions "were designed with one goal in mind: to increase the safety of medications consumers receive by creating the capacity to track a drug from the manufacturer all the way to the pharmacy," said Lester M. Crawford, the acting food and drug commissioner.
Counterfeit drugs are still comparatively rare in the United States, but federal officials say the problem is growing. Throughout the 1990s, the FDA typically pursued about five cases of counterfeit drugs every year. In each of the last several years, the number of cases has averaged about 20, but law-enforcement officials say that figure does not reflect the extent of the problem.
Last year, more than 200,000 bottles of counterfeit Lipitor made their way onto the market. In 2001, a Sunnyvale pharmacist discovered that bottles of Neupogen, an expensive growth hormone prescribed for AIDS and cancer patients, were filled only with saltwater.
"We've seen organized crime start to get involved," said William Hubbard, an associate food and drug commissioner. With some drugs costing thousands of dollars per vial, the potential profits are huge, he said.
The weak point, Hubbard said, is the wholesaler system, which ships more than half of the 14,000 approved prescription drugs in the United States. And while three large companies – McKesson, Cardinal and AmerisourceBergen – account for more than 90 percent of drugs that are sent through wholesalers, there are thousands of smaller companies throughout the country, many of them little more than rooms with refrigerators.
State pharmacy boards are responsible for regulating drug wholesalers, but most boards do almost nothing to police them. In many states, only a small fee and a registration form are needed to set up shop. A 2003 report by a Florida grand jury found that the state had 1,399 approved wholesalers – one for every three pharmacies in the state.
Radio labels fight counterfeiting by providing a unique identifier that is almost impossible to copy. When pharmacists receive delivery, they should be able to pass a wand over the bottles and, through an online database, check the history of each.
Any bottles that have been reported missing or previously sold, have an unusual delivery history or are not recognized by the system will be flagged as suspicious.
By Gardiner Harris
November 15, 2004
November 15, 2004
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