A final comment....

Canada also instituted user fees for its new drug application reviews two years after the United States passed PDUFA. The Canadian law, unlike the US law, replaced government money with user-fee generated revenues; in the US, the user-fee program is intended to supplement the FDA's appropriations. Moreover, Canada has a relatively opaque drug approval processes; with increased industry participation through user-fees, this is unlikely to change. In the US, by contrast, considerably more information about the drug approval process (and about specific new drug applications) is and has always been publicly-available. Such transparency (which accounts for yet another cost in the approval process) is an important counter-balance to keep actual and perceived biases in the approval process in check.

Tremorgrrrl