As the December 1 deadline for adopting FDA's drug-tracking system looms, drug companies are kicking their compliance efforts into high gear--while wholesalers seek an injunction to delay the law.
The so-called pedigree system, mandated in June, has been a work in progress for nearly 20 years, beginning with the Prescription Drug Marketing Act of 1987. Largely due to protests by wholesalers, which argue that the expensive technology required for drug tracking is too costly and cumbersome, FDA's efforts to require adoption have fallen short.
Without formal guidance, pharmaceutical companies have over the years made disparate efforts to thwart counterfeiters, making it difficult to formulate an industry standard. In light of FDA's pedigree system finally coming to fruition, however, drug companies appear inspired to take on more substantial drug-tracking efforts.
"The industry has actually been taking this very seriously," said Brenda Kelly, vice president of marketing and regulatory affairs at SupplyScape, which sells e-pedigree products. "Quite a few companies are making investments now."
AstraZeneca, for one, recently launched a global security initiative to protect two of its most vulnerable products--including its top brand Nexium (esomeprazole)--using 2D bar-coding technology. The drug-tracking program is being rolled out in 22 countries.
"AstraZeneca is the first in the industry to take a broad brush and say, 'We're going to take a leadership position,'" said David DeJean, director of global sales at Systech, which is working with AstraZeneca. "A lot of companies took a wait-and-see approach to serialization."
Pfizer and Purdue Pharma have been two of the most vocal proponents of FDA's pedigree system for their heavily targeted Viagra (sildenafil) and OxyContin (oxycodone). The agency mandated the use of tracking technology in June, touting radio-frequency identification (RFID) as a potential industry standard. But at $0.40 per prescription, smaller drug companies were cool to the law. And when wholesalers and pharmacies realized that they would have to pony up for pricey RFID scanners to read product codes, they became disenchanted.
"Pharmaceutical companies realize there's no benefit to having adulterated product on the market," said Jeff Steinberg, a partner in Ernst & Young's Business Risk Services group.
Asked who is likely to take the lead on implementing a universal tracking standard, Steinberg replied, "I think it will be the pharmaceutical companies."
And where does FDA stand? A spokeswoman declined comment on pharma or wholesaler efforts, nothing that the agency would issue additional information "shortly."