The State and Consumer Services Agency has come out
against a bill sponsored by one of its own boards,
the Board of Pharmacy.
At issue is a technology, known as ePedigree, designed
to track prescription drugs from factory to pharmacy
using a system of electronic or bar-coded tags. The California Board of Pharmacy has sponsored
legislation—SB 1307 from Senator Mark Ridley-Thomas, D-Los Angeles—that would set a schedule for fully phasing in ePedigree
Now the board’s parent agency, Consumer Services, is actively opposing
AB 1307. On June 13, the agency proposed a set of amendments to the bill.
After Ridley-Thomas rejected the amendments, the agency sent representatives
to testify against the bill when it was heard by the
Assembly Business and Professions committee on June
Greg Hurner, deputy secretary for legislation with
Consumer Services, said that they objected the parts
of the bill that would delay the implementation of
ePedigree until 2015, from the current target date of 2011. He said the administration has been actively pushing
measures that would increase consumer safety, such
as electronic prescriptions designed to prevent mistakes
coming from “doctor’s chicken scratch.” Ridley-Thomas bill as currently written, he said, would increase
drug costs while doing little to address issues such
as drug counterfeiting.
“We wanted to see if there was a way we could improve
consumer protection without increasing costs,” Hurner said.
On June 20, Hurner sent an “oppose unless amended” letter to Ridley-Thomas. It cited the cost of the tag-reading hardware that pharmacies and hospitals would
need to buy and warning the bill “would likely require tens of millions of dollars annually” from the General Fund at a time “of increased budget pressures.”
Ridley-Thomas countered that the amendments would essentially
mean that the bill no longer addressed ePedigree. The
proposed amendments sent by Consumer Services included
the substitution of the phrase “the point it leaves the accredited distribution chain” in place of “its initial manufacture.” According to Ridley-Thomas, this would effectively exempt drug manufacturers
from the requirement while still maintaining it for
secondary wholesalers who do much of the distribution
of prescription drugs.
“What seems to be going is a reversal of the ePedigree
work and policy that has been done over the past two
or three years in the state of cal,” Ridley-Thomas said. “That’s very problematic. The administration has entered
this discussion very late.”
Wholesalers could also exempted, via an accreditation
process overseen by the Board of Pharmacy. Under the
proposed amendments, Consumer Services suggested using
the National Association of Board’s of Pharmacy’s (NAPD) Verified-Accredited Wholesale Distributors (VAWD) program as a model. However, Hurner indication that
Consumer Services was withdrawing that suggesting and
looking at other models.
On July 9, the NAPD sent a letter to Ridley-Thomas advising him that VAWD was not the proper model.
The letter, signed by executive director Carmen Catizone,
went on to state “we cannot support a proposal that would take California
a step backward with their pedigree system.”
Several large pharmaceutical companies have been pushing
for similar amendments to the legislation. But Rachel
Cameron, a spokeswoman for the governor, dismissed
the idea that the administration was working on behalf
of drug companies. She also confirmed that a state
agency would not take an oppose position on a bill
that the governor supported.
“The governor has always been a strong advocate of using
technology to improve government functioning,” Cameron said. “While the governor has not taken a position on this
particular legislation, he looks forward to working
with legislature to ensure consumer protect as well
as carefully balancing the affordability of prescription
She pointed to administration support for AB 2911, a 2006 bill from Assemblyman Fabian Núñez, D-Los Angeles, to establish a discount prescription drug
program within the Department of Health Services. Schwarzenegger
signed the bill, but its $6.5 million in funding was cut by the legislature in the
current budget, Cameron said.
In May and June, several large pharmaceutical makers
weighed in against the bill. This included Pfizer,
Bristol-Myers Squib and Teva Pharmaceuticals USA, along with
the drug store chain Rite-Aid. The warned of major costs passed on to consumers
and urged that any legislation focus on drugs that
are of “high risk” of being counterfeited.
Pfizer, Teva and Rite-Aid are also on the support list for another ePedigree
bill, SB 1270 by Senator Gil Cedillo, D-Los Angeles. This bill would establish a task force
to study phasing in ePedigree. An earlier version of
Cedillo’s bill would have repealed most of the ePedigree requirements,
limiting it to “dangerous drugs” that were outside of the normal chain of distribution.” Cedillo’s office did not return a call seeking comment.
Some advocates of ePedigree were not impressed with
“You spend enough time in Sacramento, as well as Washington,
[you realize] when you establish a task force it means you have
an excuse to do nothing,” said Dr. Brian Liang, executive director of the Institute
for Health Law Studies at the University of California
at San Diego. “We’re not really for prime time yet, but I don’t think we can waste any time.”
The original ePedigree requirement came from a bill
passed by former Senator Liz Figueroa in 2004, also numbered SB 1307. In 2006, Figueroa carried legislation the put the ePedigree
deadline off from 2007 to 2009. The Board of Pharmacy decided earlier this year to
put this off another two years.
Liang and others have characterized these changes as
“delaying tactics” by drug companies who don’t want to spend the money needed to make ePedigree
work. Pharmaceutical makers have said they needed more
time for implementation and to allow the technology
to mature and to deal with the complexity of implementing
the systems needed.
Drug makers have also said they want to avoid a situation
where different states impose different ePedigree standards.
There are numerous pieces of legislation currently
alive at the federal level. Probably the most important
of these is HR 5839, the Safeguarding America’s Pharmaceuticals Act of 2008, which would establish “national standards” for the drug supply chain.
Pharmaceutical makers have repeatedly said they support
national standards and hope to avoid a patchwork of
state laws. Hurner said that the administration has
been urging federal action.
“It’s a federal responsibility and the federal government
needs to act,” Hurner said. “If you design a state by state system, it will create
difficulties in enforcement.”
However, Ridley-Thomas noted that his legislation contains language
it would cede to a federal standard as soon as one
exists. While he supports a federal solution, Ridley-Thomas said the changes could “take California out of a position of providing leadership.”