One of the interesting issues we've had with drug shortages is this question of....
I think one of the challenges we all have is that the drug regulatory process and the exchange of information that goes on between the drug regulator and the manufacturer, whether it's FDA or Health Canada, is pretty much a black box. We really don't know what goes on in there.
One of the important issues around regulation of manufacture.... We've had two instances in the last two years in Canada involving manufacturing plants. One was in 2010, with the plant in Etobicoke, a generic manufacturer. To all intents and purposes Health Canada was comfortable with the manufacturing facility, as far as we know, but then we had the situation in which action was taken by FDA that resulted in shortages from both those plants.
The basis of our recommendation is that one of the things we'd like to see is much greater collaboration between Health Canada and FDA with respect to regulation and manufacturing.