Heather Bresch
Analyst · RBC Capital Markets
So Randall, I hope that, as I stated, October starts the beginning of the third year of GDUFA, which should really be the transformational year as far as metrics and starting to get to the -- and starting to get to where the overall vision of GDUFA was in the first place, which is to accelerate approvals to be able to raise that bar on quality and enhance the transparency. And I, unfortunately and disappointingly, tell you it's gone every -- the wrong direction up until now. I think FDA is aware of this. I hope that going into the very early part of next year, we will be able to see a market -- a markedly different metrics in place for applications that were filed after October 1. I think that where we have been vigilant on with FDA is the backlog issue. So anything before October 1 of 2014, that would have been filed, how they prioritize those. We've been very vocal about, first, generics, how important that is to the market. I think there are certainly broad implications around the lack of approvals that we've had this year. I mean, I think it's been quantified into the billions because of the inability to get products approved at market formation. And I think that as Congress continues to take a hard look at that, I think as a lot of the consumers, that that's really a driving factor and that's what we keep reminding people that we've got to get those approvals in. That's what -- that's the mission statement around OGD. That's what -- that driving force should be there to deliver that to the United States, both as a taxpayer and as to the consumers to get affordable medicine out there. So I can assure you we've not lost sight of the broader mission picture and we'll continue to do our part to make sure everybody else is understanding that, that needs fixed before anything else. Because if we can't get approvals, really fixing anything else isn't going to be very meaningful. And as far as the pricing implications, look, I think -- I continue to say that I think that's a supply-and-demand issue. So yes, do I think there's been opportunities around certain products? But I will say, overall -- I have continued to say generics, overall, per dose or pennies. So it's really, I think, looking -- really looking at the wrong end of the spectrum of where we should be looking at, and it's not the pricing of generic drugs that's driving anything around this health care system, it's really we need to get products approved and get them into the hands of the patient. So with that, thank you.