The nation's first law that requires high-tech tracking devices to help thwart prescription-drug counterfeiters is facing one more hurdle as drug companies, wholesalers and pharmacies push for a two-year delay.
California's law, enacted in 2004, is the most ambitious effort in a push by regulators in several states after high-profile counterfeiting cases, including a 2003 recall of fake batches of the cholesterol drug Lipitor.
Today, the California Board of Pharmacy will consider whether to postpone the requirement, now due to take effect in January, until 2011. Industry groups say they need extra time to set up computerized systems that would individually track all shipments of prescription drugs from factory to pharmacy.
"California is the bellwether," says Carmen Catizone, executive director of the National Association of Boards of Pharmacy, who doesn't want the state to delay. "If it holds the deadline and industry complies, then we'll see other states follow quickly."
In some counterfeiting cases, the drugs changed hands many times through networks of wholesalers, allowing criminals to slip in fake or substandard drugs.
After a six-month review of counterfeiting efforts, the Food and Drug Administration in 2004 encouraged the drug industry to use tiny radio-frequency identification tags — which can store information and transmit their location — to track all shipments.
The agency did not make tracking mandatory, saying voluntary efforts could result in widespread use by 2007.
That hasn't happened. Some states, including Nevada and Florida, have tightened licensing of wholesalers. But no state has gone as far as California in requiring computerized records and individual package tracking.
The law doesn't say what technology to use, but radio tags are a possibility, as are bar codes similar to those used on some airline boarding passes.
Virginia Herold, executive director of the California Board of Pharmacy, which sought the law, says the board must now "balance public protection with whether or not the technology is ready."
In letters to the board, dozens of drugmakers, wholesalers, hospitals and pharmacies said they support the law's intent but asked for a delay.
One of the nation's largest distributors of prescription drugs, McKesson of San Francisco, wrote that many drug manufacturers aren't ready, which could hurt McKesson's ability to deliver the nearly 400,000 units of drugs it gets daily for California customers.
Without a delay, McKesson would be "in the very difficult and untenable position of having to refuse … shipment of a vast majority of the vital medicines needed by Californians," the company wrote.
A few companies, such as Catalent Pharma Solutions, a Somerset, N.J., packager of prescription drugs, wrote that the technology is ready.
Rick Roberts, a professor at the University of San Francisco who unknowingly used a counterfeit AIDS drug in 2000, wants protections quickly, but "at the same time, a system that doesn't really work won't deter counterfeiters."