Canadian Call For Cross-Border Drug Approvals With USA

A leading Canadian AIDS researcher has called for new drugs to be approved simultaneously in the USA and Canada, after a new AIDS treatment was cleared in Canada six months later than its approval in the USA.

The drug, Merck & Co's protease inhibitor Crixivan (indinavir), was approved by the US Food and Drug Administration on March 13 (Marketletter March 25) in a new record time of 42 days after filing, but took 172 days in Canada, reaching approval on September 13. This means, says Dr Christos Tsoukas, director of the Immune Deficiency Treatment Center at the Montreal General Hospital, that for six months Canadian AIDS patients were denied access to the drug "for no logical reason."

The USA and Canada have exactly the same licensing processes, said Dr Tsoukas, adding that "it would be very simple logic to come to the conclusion that we ought to have combined licensing of drugs across the border."