John Shimkus actually said...

Yes, historically, I think we have all believed that FDA has been really the gold standard.

I think focusing on the risk-based approach in the recent reports is right on.

Why is that not working here? Why isn't there a signal being sent to manufacturers, hey, there is a demand that is not being filled.

I also deal with democracy movements in former captive nations, eastern Europe, whatever you want to call them.