The US Food and Drug Administration has announced new steps to strengthen existing protections against the growing problem of counterfeit drugs, centering on expanded use if drug ‘pedigrees’ and technologies such as tagging to make it harder for fake goods to enter the supply chain.
The measures were recommended in a report released by the agency's Counterfeit Drug Task Force.
Regarding the pedigree, the FDA said it will move ahead with a full implementation of regulations related to the Prescription Drug Marketing Act of 1987, which requires drug distributors to provide documentation of the chain of custody of drug products throughout the distribution system.
The FDA had initially decided not to implement some of the measures because of concerns raised about the impact on small wholesalers, but now says it has no concrete evidence that there players will be damaged by the new framework.
In addition, the agency delayed them to allow the industry time to adopt electronic technology for tracking drugs through the supply chain, but while the FDA had expected this technology to be in widespread use in the drug supply chain by 2007, this is now unlikely to occur, so the agency has decided to press ahead rather than delay the process further.
“Continuing the hold would perpetuate the current confusion and further allow opportunities for counterfeit and diversionary practices. The FDA has, therefore, determined that it can no longer justify not implementing these regulations,” said the agency in a statement.
The US Healthcare Distribution Management Association said it supported the agency's decision to lift the stay on the PDMA Final Rule. HDMA chief executive, John Gray, said: "this is an important step in an ongoing, multi-layered battle plan to further secure the supply chain and protect patient safety," adding that the association will continue to work with the FDA and other authorities to secure safe medicines.
On the technology side, the FDA said it had also expected that tagging technologies such as radiofrequency identification (RFID) would be much more widespread in the supply chain by 2007, and this was another reason for delaying the final rule. But once again these expectations proved false, so the final rule should go forward with the anti-counterfeiting technology already available, it said.
RFID and similar technologies still represent the best prospect for safeguarding the drug supply from counterfeiters, and the agency called for renewed efforts to develop them for products most susceptible to faking.
Over the next year, the FDA’s enforcement of the pedigree regulations will focus on products most susceptible to counterfeiting and diversion. The agency intends to announce, in the Federal Register, the availability of a draft compliance policy guide for public comment describing this enforcement approach.
This should give wholesale distributors a better idea on where and how to focus their initial energies to come into complete compliance with the regulations for all the prescription drugs they distribute, it said.