Sometimes it seems like everybody and their brother is out there trying, but failing, to issue drug pedigree requirements. Okay, maybe that’s overstating it a bit. Maybe it’s not everybody. But Florida has started requiring drug pedigrees. And both the feds and the State of California are loudly proclaiming their intentions to attack drug counterfeiting with a pedigree requirement, though at this point we’ve seen more delays than implementation.
The feds didn’t delay intentionally, at least not in the most recent instance, which was caused by a court injunction against the U.S. Food and Drug Administration. And not all aspects of their regulation got halted by the injunction. But before that, it had taken them seven years to declare that their 1999 proposed rule would become effective. Remember that 1999 proposed rule? It was the one that implemented a 1992 law.
The court injunction I mentioned above hit just a few days after the December 2006 start date for FDA’s new pedigree requirement. For more on the requirements, see www.packworld.com/view-21241. The now ironic headline was “No more delays for drug pedigree requirement.”
Turning to California, that state’s pedigree requirement was to have begun at the start of this year. The federal rules only strongly suggested using e-pedigree technologies like radio-frequency identification (RFID), but the California law was poised to outright require e-pedigree. It would have required serial numbers on individual bottles, and it called for each player in the chain of commerce—manufacturer, distributors and even the pharmacist—to add information to the e-pedigree.
California delayed the start of its requirements from January 2008 until January 2009, though there’s talk of pushing it further, to 2011. The concern there is that the industry doesn’t yet have access to the necessary technology.
Whatever California does, of course, stands a good chance of becoming, in essence, national law. Packagers may be familiar with this phenomenon from their experience with California’s Proposition 65. That 1986 law calls for warnings before one exposes Californians to listed chemicals known to California to cause cancer or reproductive toxicity. It leads manufacturers to either put warnings on products or reformulate to remove the listed chemical. Faced with the choice of A) making a California-only version of their product or label in addition to their regular one and doubling SKU’s and complicating distribution, or B) simply changing their product or label for sale everywhere, most manufacturers choose B. Thus, a California requirement causes a change in products sold nationwide.
Similarly, some are predicting that since California is so big and its e-pedigree requirements so burdensome—they call for individual-package serialization—it would be too expensive to serialize for California only but not the non-California markets. So, California might drive the national e-pedigree bus.
Meanwhile, back at the ranch, as it were, FDA’s efforts to add pedigree requirements to thwart counterfeiters were themselves thwarted by a court injunction in December 2006, and the requirements remain in a holding pattern. FDA’s 2006 regulation had finally put into place two key parts of the pedigree regulation that FDA had long ago published but delayed. First, a provision detailing what information had to be included in a drug pedigree, and second, a definition of an “ongoing relationship” between a prescription drug manufacturer and a distributor.
That concept of who has an “ongoing relationship” is, in turn, key to the definition of “authorized distributor of record,” because the law calls for distributors other than “the manufacturer or authorized distributor of record...” to give pedigree information to the person that receives the drug from them. And the regulation declared that, for example, anyone with a written agreement with the manufacturer had an ongoing relationship. In a nutshell, written agreement equals ongoing relationship equals authorized distributor equals an exemption from having to provide pedigree information.
Thus, an important part of the law is that authorized distributors are exempt from the requirement to give a pedigree to their buyers. Congress set it up that way because it had found that most counterfeit, stolen, expired and fraudulently obtained drugs were handled by secondary wholesalers unauthorized by the manufacturer.
That exemption in the pedigree requirement exempted many, many players. Also, records all the way back can sometimes be impossible to obtain for smaller distributors or wholesalers who are not authorized by manufacturers: if, as often happens, an authorized distributor was part of the chain of commerce, they wouldn’t have to provide pedigree details to the unauthorized distributor.
Ironically, when the FDA finally decided to start requiring pedigrees of unauthorized wholesalers, FDA had said they hadn’t heard any complaints recently from small wholesalers who would have found the pedigree requirements burdensome. So FDA announced that the rules would kick in starting December 2006. Five days after the start date, the wholesalers filed a lawsuit to stop the new rules.
The U.S. District Court for the Eastern District of New York ruled that FDA’s requirement that the pedigrees reflect every transaction all the way back to the manufacturer exceeded what the law had required, which was simply a pedigree for each prior transaction.
“But,” said the court, FDA’s regulation “would essentially wipe out all the unauthorized distributors, leaving only authorized distributors who are exempt from the pedigree requirement. So none of the drugs ultimately going to the American consumer would contain pedigree information because the drugs would be provided solely through authorized distributors who are exempt from the pedigree requirement.”
So the court called the regulatory scheme “arbitrary” and placed an injunction against the new rules becoming effective, specifically, against the part of the rules that would require unauthorized distributors to give pedigree information all the way back to the manufacturer.
FDA says it thinks the law gives it the power to require the pedigree all the way back, but, because of the injunction, for now will not enforce it. They will only call for unauthorized distributors to have pedigrees back to manufacturer or the last authorized distributor.
Remember, this business of giving pedigrees all the way back to the manufacturer is, says the court, based on that controversial regulation. Even the court agrees that the law it’s based on is still in effect, and FDA points out that the law still requires authorized and unauthorized distributors to give some pedigree information, namely, pedigree back to the manufacturer, or the authorized distributor from whom the drugs were purchased.
Whether FDA tries to get the law changed and implement tougher requirements remains to be seen.
All we know right now is that California is slowly moving ahead with e-pedigree while FDA is in a holding pattern with the key parts of its provisions for pedigrees. A firmer pedigree regime is probably coming, but it’s still not clear whether it will be driven by federal requirements or that influential West Coast mega-state.
Eric can be reached at [email protected], and visit his firm’s Web site at www.ericfgreenbergpc.com.
