[Med-privacy] RFID

[Peter Marshall]

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Privacy groups question RFID use in medicine tracking
The FDA says it won't trace which drugs consumer use


  News Story by Todd R. Weiss

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<bold><bigger><bigger><x-tad-bigger>Privacy groups question RFID use
in medicine
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<bigger>The FDA says it won't trace which drugs consumer use



</bigger><x-tad-smaller> News Story by
</x-tad-smaller><color><param>0000,3333,9999</param><x-tad-smaller>Todd
R. Weiss</x-tad-smaller></color><x-tad-smaller>=20

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oA0K

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  OCTOBER 14, 2005  (COMPUTERWORLD)  -  As the U.S. Food and Drug 
Administration considers the use of radio frequency identification tags 
to help fight counterfeit prescription drugs, privacy advocates are 
cautiously watching to be sure consumer privacy isn't lost in the 
process.

Last year, the FDA called for the widespread use of RFID tags to help 
ensure that drugs sold to consumers are legitimate (see "FDA Backs RFID 
Tags for Tracking Prescription Drugs". Under the FDA proposal, RFID 
tags would be used on cartons and pallets of drugs throughout the 
pharmaceutical supply chain by 2007.

The problem, according to privacy advocates, is that the FDA is 
considering more than just tracking large shipping containers or crates 
of medicines with RFID tags; it could also use the tags to track 
individual medicine bottles or even individual tablets. That, privacy 
advocates said, would be invasive.

Dr. Scott Gottlieb, deputy commissioner of medical and scientific 
affairs at the FDA, said the agency has talked with pharmaceutical 
companies, retailers, scientists and others for the past several years 
to ensure that consumers get legitimate drugs when their prescriptions 
are filled. Today's "track and trace" methods use paper records to 
follow drug shipments from manufacturers to wholesalers and retail 
stores.

But paper records are not foolproof, Gottlieb said. By moving to 
electronic methods, including the use of RFID, the drug distribution 
system could be made safer against counterfeiting, he said.

"We think RFID is the most promising and achievable means to get to 
electronic track and trace or electronic pedigree by 2007," Gottlieb 
said. An "electronic pedigree" is a record of custody for a drug, which 
would include all transactions from its place of manufacture to where 
it is shipped, stored and sold. The FDA has been looking at RFID and 
other electronic technologies for the past three years, with a goal of 
having procedures in place by 2007.

In addition to using RFID, the FDA has eyed the use of special inks on 
individual pills or holographic images on medicine bottles, he said. 
"We've always said that we don't think there's a single magic bullet" 
to solve the problems and that several techniques will be needed to 
fight counterfeiting, Gottlieb said.

RFID technologies could even be used inside a consumer's medicine 
bottle or potentially on individual pills themselves, Gottlieb said.

Gottlieb said the FDA doesn't intend to use RFID tags to trace 
prescription drug use by individual consumers. "We are continuing to 
look at doing this without affecting consumer health or privacy," he 
said.

But consumer advocates remain wary.

"When I hear the FDA say, 'We're not interested in tracking individual 
consumers,' but then they want to put RFID tags on individual bottles, 
that's worrisome to me," said Katherine Albrecht, founder and director 
of Consumers Against Supermarket Privacy Invasion and Numbering, a 
Boston-based consumer rights group. Use of RFID chips is fine for 
supply chain bulk movement and tracking of merchandise, she said, as 
long as there are provisions to destroy the tags once the products 
reach consumers.

"I agree with the industry that there is a potential problem with 
counterfeiting" of prescription drugs, Albrecht said. But when RFID 
tagging reaches into consumers' homes, that's a problem, she said.

Cedric Laurant, a policy counsel at the Washington-based Electronic 
Privacy Information Center, said the concerns about RFID tags at the 
individual bottle or pill level relate to concerns about patients' 
privacy. How the information contained in the tag is used could be 
worrisome for consumers, Laurant said. Tags could include records of 
the transaction and other financial and personal data.

The FDA would have to show that there would be a "huge advantage" to 
fighting counterfeiting by tagging prescriptions at the bottle or pill 
level, Laurant said. "I don't exactly know if they could make the 
case," he said. "They would have the burden to prove it."

Instead, he said, as long as the tags are on large containers that 
don't identify consumers, "most privacy groups don't oppose the 
technology."

"They should be using a very strict rule that there be no RFID link on 
a specific product and the patient" who takes the medicine, he said.

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<fontfamily><param>Helvetica</param><x-tad-smaller> OCTOBER 14, 2005 
</x-tad-smaller><color><param>0000,3333,9999</param><x-tad-smaller>(COMPUTERWORLD)</x-tad-smaller></color><x-tad-smaller> 
-  As the U.S. Food and Drug Administration considers the use of radio
frequency identification tags to help fight counterfeit prescription
drugs, privacy advocates are cautiously watching to be sure consumer
privacy isn't lost in the process.


Last year, the FDA called for the widespread use of RFID tags to help
ensure that drugs sold to consumers are legitimate (see
</x-tad-smaller><color><param>0000,3333,9999</param><x-tad-smaller>"FDA
Backs RFID Tags for Tracking Prescription
Drugs"</x-tad-smaller></color><x-tad-smaller>. Under the FDA proposal,
RFID tags would be used on cartons and pallets of drugs throughout the
pharmaceutical supply chain by 2007.


The problem, according to privacy advocates, is that the FDA is
considering more than just tracking large shipping containers or
crates of medicines with RFID tags; it could also use the tags to
track individual medicine bottles or even individual tablets. That,
privacy advocates said, would be invasive.


Dr. Scott Gottlieb, deputy commissioner of medical and scientific
affairs at the FDA, said the agency has talked with pharmaceutical
companies, retailers, scientists and others for the past several years
to ensure that consumers get legitimate drugs when their prescriptions
are filled. Today's "track and trace" methods use paper records to
follow drug shipments from manufacturers to wholesalers and retail
stores.


But paper records are not foolproof, Gottlieb said. By moving to
electronic methods, including the use of RFID, the drug distribution
system could be made safer against counterfeiting, he said.


"We think RFID is the most promising and achievable means to get to
electronic track and trace or electronic pedigree by 2007," Gottlieb
said. An "electronic pedigree" is a record of custody for a drug,
which would include all transactions from its place of manufacture to
where it is shipped, stored and sold. The FDA has been looking at RFID
and other electronic technologies for the past three years, with a
goal of having procedures in place by 2007.


In addition to using RFID, the FDA has eyed the use of special inks on
individual pills or holographic images on medicine bottles, he said.
"We've always said that we don't think there's a single magic bullet"
to solve the problems and that several techniques will be needed to
fight counterfeiting, Gottlieb said.


RFID technologies could even be used inside a consumer's medicine
bottle or potentially on individual pills themselves, Gottlieb said.


Gottlieb said the FDA doesn't intend to use RFID tags to trace
prescription drug use by individual consumers. "We are continuing to
look at doing this without affecting consumer health or privacy," he
said.


But consumer advocates remain wary.


"When I hear the FDA say, 'We're not interested in tracking individual
consumers,' but then they want to put RFID tags on individual bottles,
that's worrisome to me," said Katherine Albrecht, founder and director
of
</x-tad-smaller><color><param>0000,3333,9999</param><x-tad-smaller>Consumers
Against Supermarket Privacy Invasion and
Numbering</x-tad-smaller></color><x-tad-smaller>, a Boston-based
consumer rights group. Use of RFID chips is fine for supply chain bulk
movement and tracking of merchandise, she said, as long as there are
provisions to destroy the tags once the products reach consumers.


"I agree with the industry that there is a potential problem with
counterfeiting" of prescription drugs, Albrecht said. But when RFID
tagging reaches into consumers' homes, that's a problem, she said.


Cedric Laurant, a policy counsel at the Washington-based
</x-tad-smaller><color><param>0000,3333,9999</param><x-tad-smaller>Electronic
Privacy Information Center</x-tad-smaller></color><x-tad-smaller>,
said the concerns about RFID tags at the individual bottle or pill
level relate to concerns about patients' privacy. How the information
contained in the tag is used could be worrisome for consumers, Laurant
said. Tags could include records of the transaction and other
financial and personal data.


The FDA would have to show that there would be a "huge advantage" to
fighting counterfeiting by tagging prescriptions at the bottle or pill
level, Laurant said. "I don't exactly know if they could make the
case," he said. "They would have the burden to prove it."


Instead, he said, as long as the tags are on large containers that
don't identify consumers, "most privacy groups don't oppose the
technology."


"They should be using a very strict rule that there be no RFID link on
a specific product and the patient" who takes the medicine, he said.  

</x-tad-smaller></fontfamily>
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