As expected, the report recommends a number of different approaches to the problem, based on technology, changes in business practice and tighter legislation. For the pharmaceutical industry, the main implication is that the agency expects 'track and trace' technologies to be in place in 2007 in order to provide an audit trail for drugs from production to dispensing.
"The adoption and common use of reliable track and trace technology is feasible in 2007, and would help secure the integrity of the drug supply chain by providing an accurate drug 'pedigree', which is a secure record documenting the drug was manufactured and distributed under safe and secure conditions," says the report.
RFID tagging of products by manufacturers, wholesalers, and retailers is the most promising approach to reliable product tracking and tracing, according to the FDA, which maintains that it will also bring cost-benefits to the industry in areas such as inventory control.
"Most importantly, reliable RFID technology will make the copying of medications either extremely difficult or unprofitable," it said.
Throughout the remainder of 2004, the FDA is recommending that RFID feasibility studies be conducted on pallets, cases and packages of pharmaceuticals, with some manufacturers, drug wholesalers, hospitals and chain drug stores starting to adopt the technology in 2005. In 2007, the system should be in widespread use across the industry.
Looking at other ways of discouraging the counterfeiters, the agency has concluded that unit dose packaging (such as blister packs) is not enough of a cost deterrent to counterfeiters, even when combined with tamper-evident technologies.
This means that some other form of authentication technology will likely be required, particularly for products at high risk of being copied. How companies go about notifying the agency of these will be the subject of a separate consultation.
In the meantime, the FDA plans to make it easier for companies that use technologies such as taggants in medicines or inks and holograms on their packaging to get the changes through the regulatory process.
The scale of the problem
Although counterfeiting is still not considered a major public health concern in the US, the FDA has been spurred into action by counterfeit drug investigations that have increased to over 20 per year since 2000, after averaging only five per year through the late 1990s.
Increasingly, these investigations have uncovered well-organised criminal operations involving products that may closely resemble legitimate drugs yet may contain only inactive ingredients, incorrect ingredients and doses, or be contaminated, posing a real public health and safety concern.
According to World Health Organisation estimates, counterfeit medicines comprise 6 per cent of the world market, higher in some areas, and including developed countries. A complicated distribution chain involving several wholesalers and brokers increases the risk of counterfeit products entering this chain.
Moreover, according to a study in The Lancet, in Vietnam, 64 per cent of an anti-malaria pill collected in an investigation did not contain the active drug and led to deaths of patients, while in Africa around half of all malaria drugs are thought to be fake.
The FDA report makes no attempt to gauge the cost of implementing RFID tagging across the pharmaceutical supply chain, nor does it provide any specific guidance for companies importing finished products into the US that have been made overseas.