Administration, Ridley-Thomas duel over drug safety

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 by 2015.

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 24.

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 drugs.”

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 Cedillo’s legislation.

“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.”