Tom Harkin: “we are now on the motion to proceed, as you know, to the Food and Drug Administration Safety and Innovation Act of 2012…”

“we are now on the motion to proceed, as you know, to the Food and Drug Administration Safety and Innovation Act of 2012, which is basically the reauthorization of FDA for the prescription drug user fees and the medical device user fees. There are a couple of new provisions in this bill dealing with the generic drug user fees and the biosimilar drug user fees as well. So this bill is extremely important. We have been working in our committee for over a year on it, working with colleagues on both sides of the aisle. As both Senator Enzi, my ranking member, and I pointed out yesterday, this has been a true bipartisan effort. We did not divide up in terms of party--Democrat or Republican--we divided up in terms of interest areas, and we had working groups within our committee so that Senators who had a particular interest in one area or another were on that working group. We also had Senators who were not on the committee but who had interest areas in it involved in our working groups. So they and their staffs had full working knowledge of what was going on all the time and it was a true collegial effort. Those working groups completed their work earlier this year. We also called in all the stakeholders--the prescription drug manufacturers, the pharmacists, the drugstores, consumer groups, and practitioners. So we had all the stakeholders involved in this too. And now we have come up with a bill that has very broad support.…”