Pharma companies sweating over the pending electronic-pedigree law in California can breath a little easier. The California Board of Pharmacy announced last week that firms selling drugs in the state now have until January 2011 to set up a system to track each and every product as it travels through the supply chain. The pharmaceutical authorities may even grant a little wiggle room to push the deadline if a company is unable to implement all the technology necessary to attain full-blown ePedigree status.
"The board has concluded that in the absence of such delay, the California drug supply—and potentially the entire US drug supply may very well be negatively impacted—by an imperfect or non-uniform implementation of pedigree requirements," stated William Powers, president of the state board of pharmacy in a release.
The Price of "Progress"
For the last year and a half, the California board has been holding monthly meetings with pharma to monitor its progress—and the drugmakers have increasingly begun complaining about the cost of such a project.
"While some companies have successfully implemented the technology, to be honest, a larger population has not moved," Mark O'Connell, president and CEO of Supplyscape, one of the biggest ePedigree solutions providers, told Pharm Exec on Tuesday. "Last week, the senior vice president of McKessan sat in front of the board and said that of the 600 manufacturers that provide the company with product for the state, only 100 will be prepared by January 2009."
The board expressed concern that the companies were not moving fast enough to meet the deadline, but finally had to acknowledge how difficult it is to move that much technology into the supply chain.
"The board only wants one thing—complete compliance," O'Connell said. "This has been a major wake-up call for the industry. Now there is no place to hide."
A State or Federal Affair?
California's law calls for a rigorous electronic track-and-trace component that would require full-item label serialization—a pricey proposition. One large pharmacy chain told the board that just to bring the technology in state would cost $50 million. "If you are pharmacy chain that isn't making a lot of profit, $50 million is an enormous expense—and the complexity of getting that technology into the hands of a pharmacist is just beyond what they can do," O'Connell said.
But with California the only state to mandate ePedigree, many skeptics see it as a potential boondoggle in the making. An electronic track-and-trace system covering the whole country would offer much greater bang for the buck, they argue. Currently, 20 different states are working on similar legislation and a lot of folks are looking at the federal government to create a national uniform implementation.
"It's only a matter of time before FDA comes out with a mandate, but I think the government is giving the pharma industry some time to develop products and solutions that are workable for the industry," Bill Allen, group director for RFID at CMP Technology, told Pharm Exec in July 2007.
18 Months and Counting
The California board was clear that delaying the deadline by two years was the last compromise. Companies must now get serious about their ePedigree plans or face hefty fines of up to $5,000 for each saleable unit without a pedigree. And as it is, companies must have pedigreed drugs in the supply chain six months before the deadline to ensure that the entire supply is up to standard. That takes a big bite our of two years.
"The board is not going to go away," O'Connell said. "It is going to continue to make companies show progress. A lot of people look at the 2011 date as a blessing, but many realize they will still be paying fines because the project is that complex."