California's e-pedigree law could ultimately create a de facto standard for unit-level serialization and track and trace of individual prescription drugs. On the other hand, if a U.S. federal rule is issued, that rule could largely preempt California and other state efforts.
No matter how the law, or laws, shake-out, leading national and global pharma firms will find it difficult not to implement national and/or global compliance processes and technology. One major reason is that a few wholesale and distribution companies control the vast majority of shipments, and segregating shipments by state would limit geographical market coverage and entail special handling charges. But it's possible that if a federal law doesn't come, and states proceed with compliance deadlines, smaller companies may be able to make such arrangements with their wholesalers.
But what if a pharmaceutical company can't meet California’s e-pedigree deadline? One theory circulating is that California will work-out a system that would have manufacturers who aren't ready "work out a deal" such as a system of fines, new deadlines and bigger fines of those new deadlines are missed, said Dublin Ohio-based consultant Dirk Rodgers in an educational session at Pack Expo 2012 in Chicago.
For months, leaders in the pharmaceutical and related packaging industry have expected that California’s compliance much-delayed deadlines would hold, requiring initial phases to be implemented in January 2015. The California drug e-pedigree law was first enacted in 2004, and was initially set to go into effect in 2007, but legislative changes delayed implementation to 2009, 2011, and to the current 2015. But additional delays are possible, and questions remain.
The "legacy of delays," Rodgers says, in combination with the many delays that the pedigree provisions of the Federal Prescription Drug Marketing Act (PDMA) of 1987 experienced before it, have led people to be skeptical that any pedigree regulation will actually go into effect on the dates that are specified at any given time. Justifiably so it seems."
He continues to be asked: "Do you think the California ePedigree dates will slip again?" At and since Pack Expo 2012, he has continued tracking the issue and sharing his thoughts on the subject. His short answer, at present, is: "I predict that it will NOT get delayed again." To find out how he arrived at that prediction…