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Pharmacy Board to Weigh Delays on Drug Tracking

The California State Board of Pharmacy will meet in San Diego for a second time this year to weigh arguments for delaying implementation of a statewide drug tracking system scheduled to take effect Jan. 1.

Drug companies big and small have lobbied for additional time on the requirement, which would put in place an electronic system, known as an “e-pedigree,” to track prescription drugs along the supply chain.

The pharmacy board has the authority to delay requirements for two years, as it did once before, though board members have made clear their desires to keep the deadline intact.

Virginia Herold, executive officer of the board, said members are weighing possible impacts on the industry.

“We’ve received a lot of inquiries, a lot of statements from the industry that the industry may not be ready by 2009 but may be ready by 2011,” she said.

Fake drugs, including those that have been diluted or altered, have become a growing concern in the industry. According to the state pharmacy board, 3.4 billion prescriptions were dispensed in the United States in 2006. If only 1 percent of those drugs were counterfeit, 34 million prescriptions would be affected.

From 2000 to 2004, the FDA reported a tenfold increase in the number of cases investigated involving counterfeit drugs.

Congress passed a law in 2007 that required the FDA to develop standards for a national tracking system by 2010. But federal standards have been put on hold, which means California could lead the way for electronic drug tracking as early as Jan. 1.


Supporters Admit

Even supporters admit that wholesalers and pharmacies might not be able to put electronic tracking in place by 2009. Two bills introduced in late February aim to modify current legislation. SB 1270, introduced by Sen. Gilbert Cedillo, D-Los Angeles, pushed to impose tracking requirements by an unspecified date. A proposal by Sen. Mark Ridley-Thomas, D-Los Angeles, SB 1307, would require a “unique identification number” on bottles of drugs.

Bill Hubbard, a former FDA associate commissioner said he thinks the pharmacy board should require pedigrees beginning Jan. 1 but allow more time for electronic track-and-trace systems.

“We think that, over time, this is going to be a widespread technology because it’s really the next generation of the grocery store scanner that we’re used to,” he said. “But that may be another 10 or 15 years away.”

Doug Farry, managing director in the San Diego office of McKenna Long & Aldridge LLP, pointed to challenges involved in the regulation of an e-pedigree system. If federal regulations were to take effect before California’s system went into effect, he said the FDA could face difficulties in enforcing the rules.

“The FDA was really built to regulate the safety and efficacy of drugs , that they’re not killing you and they’re working as advertised,” Farry said. “Enforcement mechanisms for retailers and others who manufacture these drugs are more unique challenges to their scope of authority.”

The board will meet at 9:15 a.m. March 25.

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