Giuliani report claims imports hike counterfeit risk
political battle surrounding the issue of drug reimportation in the
US, saying that the trade 'poses a serious threat to safety due to
the increased prevalence of counterfeit medicines entering the
country', reports Phil Taylor.
The pharmaceutical industry has long argued that parallel trade - in which a trader sources lower-priced products from one country and imports them for sale in another where prices are higher - introduces a risk of mislabelling that puts patients at risk, an entry point for counterfeit goods and even an opening for bioterrorists.
Giuliani Partners, a think tank set up by the former mayor, said its new research found that around 90 per cent of all suspected drug packages randomly examined at JFK Airport mail facilities contained prescription medicines not approved by the US Food and Drug Administration (FDA). Only one to two per cent of the packages received on a daily basis were inspected, it added.
The report, entitled Examination and Assessment of Prescription Drug Importation from Foreign Sources to the United States, does not provide new data on the proportion of imported drugs that are fakes. However, it extrapolates from the finding on unapproved drugs to suggest that the importation of foreign medicines exposes US consumers to a heightened risk of exposure to counterfeits.
Its findings will add to the evidence available to those who argue against allowing drug reimports in the US, and those - including the US Food and Drug Administration (FDA) - who are proposing greater use of technology such as radiofrequency identification (RFID) tagging of medicines to improve the security of the supply chain.
Faced with an escalating national bill for prescription drugs, the US is currently seeing a bipartisan effort by Senators to introduce a bill that would legalise access to cheaper reimported medicines, which at the moment is technically illegal under US law. Some states, notably Illinois, Vermont, Wisconsin and Minnesota, have already set up cross-border measures to get access to lower-priced medicines from Canada.
This is a mistake, according to Giuliani. "We should not contemplate opening our borders to threats to our medicine supply when in all other aspects we are searching for ways to tighten the security of our borders," he said.
This sentiment was echoed by Mike Patton, executive director of the Illinois Pharmacists Association. "Safety is the paramount issue with drug importation," he said. "While an Internet drug outlet may claim it is importing drugs from Canada, you simply cannot trust that the Web site is in Canada and that these medicines are not coming from third-world countries infested with counterfeit drugs."
Meanwhile, last week, AstraZeneca chief executive Sir Tom McKillop said that his company would consider pulling facilities out of the US if the country did not draw back from encouraging drug reimportation, claiming that the US would find its lead in R&D swiftly eroded by the undermining in profitability and research investment that would ensue. This has already been seen in Europe, where this type of parallel trade has been welcomed by governments, he said.
But the view is not shared by the whole drug industry. One executive from US drug giant Pfizer - Peter Rost - stood in front of the Senate's Health, Education, Labour and Pensions Committee earlier this year and argued that there was no security issue with imported drugs, citing the near-absence of any cases of counterfeit drugs being encountered in Europe as a result of this trade.
