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 California Decision Delayed, as Companies Are “Trying,
Working, Moving” toward Electronic Pedigrees
Drug manufacturers, professional organizations, and public
welfare advocates met a frustrated California Board of Pharmacy at its
Enforcement Committee meeting January 23 in San Diego. The meeting included the
workgroup on e-pedigree subcommittee, which took up the perennial issue
of whether to extend the fast-approaching 2009 implementation deadline.
Arguments for and against a stay to 2011 created a stalemate, and the
board reached no conclusion on granting another extension. Board
members called for an additional meeting on March 25, which they said
“must be a decision-making meeting.”
A large group, 400 attendees by some estimates, gathered to hear the
proceedings. The majority of the speakers asked for a stay of
implementation, basing their arguments largely on the fact that no
single technology has been officially designated.
Some manufacturers have hesitated to create a serialization strategy
because neither high-frequency RFID, ultra-high-frequency RFID, nor 2-D
bar codes has emerged as a glitch-free option. They took the meeting as
an opportunity to express their concerns and request a delay.
 Companies
such as Amgen Inc. said they were unable to meet the upcoming deadline,
despite attempts at serialization programs. Calling themselves
“good corporate citizens,” representatives from the company
argued that since 2004 they’ve earnestly invested in compliance
initiatives. They claimed that after implementing a lot-level pedigree
program, the law was changed to item-level serialization, and the
company had to start over to create a new system.
The board was not swayed. “I haven’t heard anything today
to change my mind,” said Tim Dazé, public member of the board. He
said he’d heard this argument from Amgen, as well as confirmation
that they’d meet a later date, at previous meetings.
“Can’t you understand our concerns?” Stanley
Goldenberg, chairperson of the board work group, added. He implored
Amgen to prove that if they were granted a stay they could be compliant
by 2011.
“I can’t commit the company,” said Lewis Kontnik,
director of brand protection at Amgen. This statement went against the
core of what the board sought, which was evidence of future
compliance.
“Present us with ideas, evidence, so we can go forward, and not
let history repeat itself,” Goldenberg urged. “The ball is
in your court.”
Others received stern words from the board as well. The National
Association of Chain Drug Stores (NACDS) posited that if 2-D bar codes
were adopted as the e-pedigree standard, untold hours of manpower would
go to waste in scanning products.
“Legislation will cut pharmacy revenue,” said
Steve Perlowski, who works with industry affairs at NACDS. Appealing to
the board to accept inference as an option, he added: “One-tote
traceability would make our lives easier.”
To this, to board replied: “You’re acting like a victim.”
Some speakers took the stance that the deadline should remain 2009.
“Failure to engage in a timeline is a choice,” said
Stephanie Feldman Aleong, former Florida Statewide Prosecutor whose
counsel in the fight against counterfeit drugs was featured in the book
Dangerous
Doses. The book chronicled cases of counterfeit
pharmaceuticals, Epogen in particular. Aleong said no deadline will
satisfy manufacturers, believing that they will argue indefinitely over
which technology to adopt.
“The board will drive a data carrier decision, not
industry,” she said. “Delay, not a standardized carrier, is
the common thread of the group.”
Countering this position on the data carrier debate, the Pharmaceutical
Research and Manufacturers of America (PhRMA) wrote a letter asking for
more time. The group says that companies involved in pilot programs
have identified many “technical problems” with the
available electronic serialization options.
“A 2009 deadline would force pharma to cut off its technology
investigation,”
said Marjorie Powell, senior assistant general counsel for PhRMA, at
the January meeting. “Some things are out of our control.”
The best she could offer is that “companies are trying, working,
moving,” toward compliance.
At the previous meeting held December 5, the board asked for feedback
from those arguing for a stay and provided a template and instructions
for the requested information. The 38 letters that came in response
appeared paltry to board members, who voiced their dismay.
“It’s almost embarrassing that so few companies
responded to the template,” said Goldenberg. He added that of
those who replied, few provided the requested information. Copies of
the letters are available on the board of pharmacy’s Web
site.
In closing, board members elected to hold a special session March 25 in
San Diego.
They insisted that this be a decision-making meeting.
Anastasia
Thrift
Managing Editor
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