FDA claims victory after medicines importer shutdown
pharmafile | November 25, 2003 | News story | |
The FDA has claimed a significant victory in its battle against imports of prescription medicines from Canada after a court order closed a US-based business.
The US regulator has taken a hard line against the growing cross-border trade in cheap medicines from Canada to the US, which it says is illegal and puts patient safety at risk, and has hailed a federal judge ruling as a victory.
Judge Egan ruled that Rx Depot, a company acting as a go-between for US patients and Canadian pharmacies was illegal and that the safety, purity and efficacy of drugs it sold could not be guaranteed.
The FDA said the ruling has sent "a clear signal that those who would put profit before safety will not be allowed to threaten public health," and is now looking for rulings on a number of other businesses providing similar services.
The pharmaceutical industry is also extremely concerned by the increase in parallel trade into the US over the course of this year, and in March GlaxoSmithKline became the first company to restrict supplies of medicines to Canada wholesalers to stem the flow.
Many other major pharma companies have now followed its lead but have come up against fierce opposition from some seniors and politicians who see the imports a solution to the US' high prices.
In the latest twist, in Minnesota – a border state where support for the trade is strong – the state Attorney General has declared plans to investigate the legality of GSK's attempts to block imports.
The development underlines the lack of clarity about the practice, with many states in direct opposition to the FDA stance, which also reflects views in the White House.
In a statement, GSK said it was 'standing firm' against the trade, and questioned the legal basis of the Attorney General's investigation.
"Attorney General Hatch apparently disagrees with the FDA, federal law and the federal court, and does not believe the safety concerns raised by the medical experts at the FDA and elsewhere.
The statement added that the Attorney General was "entitled to his opinions" but was not entitled to investigate GSK's efforts to counter the trade, which federal law says is illegal.
The controversy is closely linked with the ongoing battle to reform the country's health insurance scheme Medicare, which currently offers little payment for prescription drug costs.
The pharmaceutical industry and the FDA are pushing strongly for agreement to be reached on a new Medicare guaranteeing greater insurance on prescription costs, which they hope will eliminate the demand for the cross-boarder trade.
