Recent drug counterfeiting cases have been a rough wakeup call, both for pharmaceutical companies and regulators, forcing them to look more closely at vulnerabilities throughout the drug distribution chain.
"Issues run through manufacturing, distribution, disposal and post-retail," says Lew Kontnik, drug facilitator for Product Surety, an FDA/industry initiative that is evaluating risk-assessment methods, new technologies and best practices for ensuring the integrity of pharmaceutical products. Excipients must be traceable and verifiable, and even waste packaging must be accounted for, to ensure that it's not being used to create the false impression of genuine new products, Kontnik says.
Concerns about public safety have been driving industry's efforts, but a healthy self-interest is also at work, as drug makers grapple with corporate liability. Consider the case of Serono: After counterfeits of the company's AIDS treatment, Serostim, first appeared in 2001, a patient sued Serono, along with wholesalers and distributors of the drug. The lawsuit charged that manufacturers and distributors of Serostim should have anticipated more counterfeits infiltrating the supply chain, and prevented them.
Although the case was settled out of court, it set an important precedent. The Counterfeiting Intelligence Bureau in Essex, U.K., expects to see more cases like Lynn v Serono surface in the U.S. and Europe. "There were multiple parties in [that] suit," says Serono spokesperson Carolyn Castel, "but, for individual companies, the risks are there."
Pharmaceutical manufacturers aren't waiting. Serono took action quickly and decisively, establishing a controlled distribution program to manage and monitor distribution of Serostim. Serono's program limits distribution to an approved network, and each package of the drug now contains a unique barcoding, hologram and tracking number, allowing it to be tracked from its shipping point.
The biopharmaceutical company Ortho Biotech also moved quickly when the anemia treatment, Procrit, was compromised by counterfeits in the spring of 2002. Ortho formed two teams, one to work with the FDA and customers, and another to identify and implement a solution to protect the remaining $1.2 billion in product that had not yet been shipped, according to John Dempsey, Ortho's executive director of trade and brand security.
Working with FDA, Ortho's redress team decided which anticounterfeiting technologies to use and incorporated them in packaging, achieving what many had considered impossible in just 20 days. "We found machinery, put it together, presented it to FDA, had it approved, then had to redress the first product lot so it could be shipped in July," Dempsey says.
Companies that are attacking counterfeits most successfully, Kontnik says, are taking a systems analysis approach, studying weaknesses and building in systems that address them into packaging, distribution and manufacturing. "You need to ask, not 'what technology do I put on my package?', but 'how do I solve this vulnerability problem throughout my operations?" he says.
Effective anticounterfeiting technologies are already available. Implementation is the current challenge, according to Kontnik. "The goal is a well-planned combination of technologies and practices, integrating best practices with protective devices," says Myles Culbertson, Director of the New Mexico University Physical Science Laboratory, a Product Surety partner.
In the meantime, the state of Florida is pushing the traceability envelope with a requirement that took effect on July 1. For prescription drugs on a specified drug list, wholesalers must provide a "pedigree" tracing that drug back to the manufacturer. The list of drugs may expand, and Florida "could be the icebreaker for other states and FDA," Kontnik says.
Traceability mandates will be critical if the U.S. Senate approves legislation approved by the House of Representatives last July, legalizing the import of cheaper prescription drugs. Currently, FDA estimates, about 2 million packages containing regulated products reach the U.S. illegally each year. And stemming that tide won't be easy. At a pilot test in Carson City, Calif., the Agency found that, although 650 suspect packages appeared each day, it could only inspect 381 suspect packages a week. Many of the drugs had been purchased over the Internet.