|
 Silence Is Not
Golden: California Seeking Data as It Considers
Pedigree Delay
A delay in
California’s Electronic Pedigree rule appears to be
on many wish lists this year. Judging from the
number of pharmaceutical companies and retail
pharmacies asking for such a delay at the State
Board of Pharmacy’s Enforcement Committee meeting in
December, most stakeholders do not appear poised to
comply in 2009. While such reports disappointed the
committee, it has not yet issued its final
decision.
Instead, the enforcement committee
has provided a template
for delay-seekers to follow as they provide
written requests. All delay requests must follow
this template. “A lot of companies have spoken to us
that are ready to pass compliant product by 2009,”
said Joshua Room, California’s deputy attorney
general and the committee’s lawyer, during the
December meeting. “The board needs to decide whether
extending the date is in support of its goal to
protect patients.”
All requests must
be submitted to the committee for discussion at the
January 23 meeting in San Diego. The board "will not
consider any request not submitted in writing, and
not received at least two weeks before a full Board
meeting, e.g., by no later than January 9, 2008, to
be timely for the January 23, 2008, meeting," writes
the board in its template notice.
“My fear is
that if we more forward with a delay, how will we
know that we won’t be sitting here in two years
hearing the same comments?” asked committee member
Stanley Goldenberg. “How will we know that
[electronic pedigrees] won’t fall off everyone’s
radar screen for another two years?”
Goldenberg expressed such concern after hearing from
pharmaceutical companies and others that more time
is needed. He had pressed four drug manufacturers
(Amgen, Johnson & Johnson, Pfizer, and Roche)
for impromptu progress reports, asking them to come
forward from the audience to speak directly the
committee. He had asked them to respond to a
presentation from Alien Technologies, whose Victor
Vega reported that ultrahigh-frequency RFID is ready
for item-level tagging.
“We are aware of the
challenges,” said Goldenberg. “Help me understand
whether the information presented is what you have
found in your labs.”
Johnson & Johnson
and Amgen both expressed concerns about the use of
RFID with biologicals. “We need guidance from FDA,”
said J&J’s Mike Rose. Added Amgen’s Lew Kontnik:
“There is no clarity about safety or regulatory
guidance.” Both companies discussed 2-D bar codes
for biologicals. Rose indicated that J&J’s
consumer products are RFID tagged at the case
level.
Room wondered aloud whether industry
had investigated RFID for serialization but then put
it aside while it pursued 2-D bar codes, doing
nothing more with RFID for the smallest saleable
units.
Peggy Staver explained that Pfizer
was tagging Viagra bottles with high-frequency RFID
as well as printing 2-D bar codes, and it is working
with case and pallet UHF RFID tagging for Celebrex.
But “it is misleading to say that all UHF issues
have been resolved. [We] have not made any decision
to move away from HF, and [there is] no decision yet
on 2-D bar coding versus RFID.”
It could
take “five to seven years to serialize all our
products,” she added. She also said that Pfizer
could make a decision, but if the rest of the supply
chain doesn’t make the same decision, then it would
have made a costly decision that doesn’t accomplish
the goal of serializing products to protect
patients.
The board also heard from the
Generic Pharmaceutical Association, which detailed
the costs of electronic pedigree implementation, and
some of its members. GPhA member company Teva spoke,
whose associate general counsel, Brian Shanahan,
said it could cost $35 million to install 2-D bar
coding on packaging lines. After committee member
Robert Swart responded that, “on a grand scale, that
figure is not a lot,” Shanahan said the challenge
was to “commit to one approach that the rest of the
industry” would use.
Challenges and costs
didn’t seem to worry the enforcement committee,
however. “There is nothing in this presentation that
you couldn’t have said two years ago,” said Room,
responding to one presentation. “Perhaps if you had
attended this task two years ago, maybe you would
have had answers by now.”
Said Swart: “I
don’t want to hear [that companies need] a
five-to-seven year timeline. If people start dying,
this board will not have done its job.”
Data
are needed to help the board make its decision,
emphasized Room. “Data demonstrating compliance
efforts so far, such as money spent and pilot
findings, as well as a timeline for when companies
can be fully compliant, such as products in its
portfolio and the steps to comply, are needed,” he
explained. All in writing and on company letterhead,
added Virginia Herold, executive officer for the
board. “Explain how such a delay would benefit
public health,” she said.
“We need a timeline
that will allow California consumers to be
protected,” stated Goldenberg.
Amgen’s
Kontnik asked whether there would be a template for
such data. The board agreed to prepare one. It has
now been posted to the enforcement committee’s
meetings agenda site.
Room
pointed out that the board had provided another
template for submitting input on the issues of
inference and grandfathering, but that they had
received nothing before the day of the meeting.
“If the board doesn’t see a long timeline
and a good-faith effort, it is difficult for the
board to make progress. It seems like [some are]
only getting started,” worried Room.
If your
company is seeking a delay, click here
for the template. You've only got until January
9, 2008!
Silence is no
longer golden!
Daphne
Allen
Editor |
Two-Layer
Duplex Films
Multifunction Leak
Tester