John Shimkus actually said...

Well, we have got Obamacare, million dollars of tax increases now and fee increases, so we are not sure it is all about money.

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.