Tiny Antennas to Keep Tabs on U.S. Drugs

[R.A. Hettinga]

<http://www.nytimes.com/2004/11/15/health/15drug.html?ei=5006&en=574f3fc72a3ae235&ex=1101099600&partner=ALTAVISTA1&pagewanted=print&position=>

The New York Times

November 15, 2004

Tiny Antennas to Keep Tabs on U.S. Drugs
By GARDINER HARRIS

he 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 pain-control 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.

 Experts do not expect the technology to stop there. The adoption by the
drug industry, they 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 add a weapon in the battle against
cargo theft.

 "It's basically a bar code that barks," said one expert, 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 in
January. Radio tags on vehicles and passports could become a central tool
in government efforts to create a database to track visitors to the United
States. And companies are rushing to supply scanners, computer chips and
other elements of the technology.

The labels are called radio-frequency identification. As in automated
highway toll collection 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 the 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 very expensive and the need to ensure
their authenticity is great, officials said, the expense is justified.
Costs are still far too high for individual consumer goods, like the amber
bottles that pharmacies use to dispense pills to individuals. But prices
are expected to plunge once radio labels become popular, so drug makers
represent an important set of early adopters.

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 about ubiquitous use of the technology in the marketplace.
But under the current agreement, the technology would not be used at the
retail level.

 The food and drug agency's involvement is crucial because drug
manufacturers cannot change a 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.

Counterfeit drugs are still comparatively rare in the United States, but
federal officials say the problem is growing. Throughout the 1990's, the
F.D.A. 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, Calif., 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 profit potential is huge, he said.

 The weak point, Mr. Hubbard said, is the wholesaler system, which ships
more than half of the 14,000 approved prescription drugs in the United
States. 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 little more than a room with a refrigerator.

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 Florida.

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.

 Makers of prescription narcotics say radio labels could help cut down on
the booming trade in stolen pills.

 "We get calls once a week from state troopers saying they got a guy with
one of our bottles," said Aaron Graham, chief security officer for Purdue
Pharma, the maker of OxyContin.

 With radio labels, Purdue will be able to trace those bottles to
individual pharmacies. "If that pharmacy was robbed, we'll know for certain
that that guy is in possession of stolen property," Mr. Graham said.

 Radio labels could conceivably help ensure that imported drugs are safe,
Mr. Hubbard said. But drug manufacturers are unlikely to put radio labels
on drugs sold in other parts of the world for many years, he said. The
F.D.A. has been a fierce opponent of legalizing drug imports.

"This is about securing the domestic supply," said Tom McGinnis, the
F.D.A.'s chief pharmacist.

So far, the agency is relying on a nonprofit industry group, EPCglobal,
based in Lawrenceville, N.J., to set standards for radio labels. The labels
will remain voluntary until 2007. After that, the agency may require the
labels and specify which types must be used, Mr. Hubbard said.

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R. A. Hettinga <mailto: rah at ibuc.com>
The Internet Bearer Underwriting Corporation <http://www.ibuc.com/>
44 Farquhar Street, Boston, MA 02131 USA
"... however it may deserve respect for its usefulness and antiquity,
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