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Food and Drug Administration Safety and Innovation Act of 2012--Continued

Floor Speech

By:
Date:
Location: Washington, DC

BREAK IN TRANSCRIPT

Mr. ENZI. Mr. President, I thank the chairman of the committee. I thank him for his kind words, but I also thank him for his leadership on this issue. We have had a great teamwork effort both between the Senators and between the staff. This isn't something that just came together a couple of weeks ago. This is something that has been worked on for about 1 1/2 years, with pretty constant meetings on Fridays of all of the interested groups and then stakeholders. It takes a tremendous amount of work to put something like this together and have it be in a bipartisan way like this. It is largely because it came to committee.

In committee we took a look at all of the amendments that were suggested, we got the people together who had very similar amendments, and they usually were able to work out something to satisfy everybody in that instance, and we came up with a bill. As Senator Harkin mentioned, it passed 96 to 1. Anytime we get something to pass, it is kind of a landmark success. But when we get something that bipartisan, it is even more landmark.

We have been trying to get this bill wrapped up before the Supreme Court decision came out on health care. The reason we have been trying to do that is, who knows what it is going to say or what kind of ideas people will come up with when that happens. This is a group of 100 idea generators, so we wanted this cleared up by that time. We are on a path to get that done right now and a path that will keep the people employed who are taking a look at new drugs and devices and generics and biosimilars and continue to get those on the market so people will have the latest innovations.

One of the things we included in the bill was some use of foreign clinical trials if they were approved by the FDA, and that should even speed up the process. Of course, when

we went to conference there were a lot of things people wanted to have that they brought up as amendments. It is very critical in the bill, and we get some of them and we don't get others.

I know Senator Alexander played a huge role; he had seven items in the bill and we got six of them. Senator Burr had 12 items in the bill, and we got 11 of them. I have to mention, of course, that the one we did not get is a particularly important but particularly difficult issue that is going to take more time to get worked out. It is one that deals with drug distribution security, and that is something we cannot avoid. We have to do it. But it is going to take longer to work that out. It deserves some extra time and some more understanding on both sides of the aisle on that one and in a number of different States. It doesn't just involve the Senate; it doesn't just involve the drug companies; it also involves the whole chain that these things have to go through, including the local pharmacist whom we don't want to overload with work, and the people who have to transport these drugs whom we don't want to overload with work or make it extremely complicated when they cross different State lines and have to do different kinds of reporting.

Senator Isakson had four amendments, and we were able to get three of them. Senator Paul had two, and we got one. Senator Hatch had six, and he got all of them. Senator McCain had two, and we got one. Senator Roberts had two, and we got both of those. Senator Murkowski had two, and we got both of those. Senator Kirk had two, and we got one of those. Senator Grassley had two, and we got one of those. Senator Portman had two, and we got both of those. And Senator Coburn had two, and we got one of those. Senator Corker had two, and we got both of those.

So there are a lot of things we did on the Senate side that became possible on the House side. There are a number of things they did on the House side that we couldn't agree with on this side either. But we did reach agreement--and we reached it in pretty much record time. We now have a bill that can go ahead and be passed and go to the President for signature to assure that the level of safety we have in our drugs not only continues but improves, and drugs can get on the market faster than they had before by streamlining the process and also making sure there are better foreign inspections so the ingredients that go into the drugs don't cause problems.

So this legislation reauthorizes the Food and Drug Administration's user fee program, and it ensures that Americans get better access to safe innovative medicines and medical devices. It will make significant changes. It will improve the FDA's review and approval of new drugs and devices.

Unfortunately, FDA's current process for reviewing and approving medical devices too often creates delay and unpredictability. This in turn threatens patient access to the best possible treatments for their conditions. In some cases, this has forced American patients to travel overseas to obtain access to lifesaving new devices that FDA has not approved in the United States.

The bill goes a long way toward solving these problems and makes the most significant changes to the law of governing FDA's review of devices in decades.

This bill will speed the approval of devices by reducing the redtape associated with the ``least burdensome'' standard that FDA uses to approve such devices. The bill will also make it easier for FDA to approve devices for patients with rare diseases who might not otherwise be able to have their conditions treated most effectively. It will also enable FDA to expedite safety determinations, to resolve appeals, and to improve their postapproval surveillance activities to detect problems as they occur. It is not good enough to get them approved, we also want them watched after they are approved, and this will do it.

The bill also contains important reforms to foster drug innovation and patient access to new therapies. It modernizes the accelerated approval pathway for drugs to reflect advances in science over the past 20 years. It formalizes a new process to expedite the development and approval of breakthrough therapies. These changes are particularly important for patients with rare diseases where there are no therapies available, and it is not feasible or ethical to require large conventional clinical trials.

Nobody wants to be the one who is a test case when there might be something that would work for them, and there aren't the sizes of the populations to do the conventional clinical trial anyway. The patient community strongly supports these improvements because these will save lives.

The bill also contains important reforms that will help mitigate the problems associated with drug shortages. It will require better coordination within FDA as well as the other Federal agencies such as the DEA. It will also allow FDA to move faster, to take actions, and to address shortages through expedited reviews and approvals.

The bill also makes important changes to how FDA uses Risk Evaluation and Mitigation Strategies, REMS. REMS play a critical role in protecting patients and public health and this bill includes a provision that clarifies the process for modifying REMS--especially with regard to minor modifications.

The provision in the bill being passed today does not change Congress' expectation that a non-minor modification will generally be based on the best available science including an assessment demonstrating that the modification is necessary or appropriate. Nor does the clarification indicate that a modification should be approved if it would reduce the REMS' effectiveness in addressing the drug's

known risks.

The bill follows what I call the 80 percent rule. When we focus on 80 percent of the issues on which we can reach agreement rather than focusing exclusively on the parts and the issues we can never resolve, we can achieve amazing results. Over 1 year ago staff began to work on identifying the 80 percent. A group of staff from Republican and Democratic offices on the Health, Education, Labor, and Pensions Committee began a series of standing meetings and proceeded to meet every week for several months. They met with stakeholders and discussed policy solutions that each member thought would solve the problem.

After much discussion of the benefits, costs, and possible unintended consequences, members agreed on a list of policy concepts. If there was not a consensus on a particular policy, it wasn't included. This is the 80 percent rural in action.

As this process has progressed, my staff also met with the Republican staff on the Health Committee for at least 2 hours every week to keep them informed and to seek their input. I also personally met with the members of the committee before markup to ensure I understood their priorities.

This bill reflects the work of every member of the Health, Education, Labor, and Pensions Committee. All of them have at least one provision included in this legislation. Many members of the committee worked with us to find consensus measures that addressed their priorities as well.

As I mentioned, not everyone got everything they wanted. We did, however, find the 80 percent of each solution that we could all agree would help solve the problem, and the bill passed the committee by a voice vote. This legislation could be a model for how the process can and should work regardless of the political environment. We followed this model as we transitioned from the committee process to the Senate floor. We worked with members who filed amendments in committee to address some of the concerns in the manager's amendment.

We also worked with Members who filed amendments on the Senate floor.

We did the same thing in our discussions with the House. You can see that the results are very positive. We preserved and we improved policies to foster drug innovation and patient access, and to promote accountability and transparency at the FDA. We also made significant improvements to the Senate's medical device reforms for startup and emerging growth companies, and with respect to the 510(k) process.

We thank Senator Harkin for his tireless effort on this bill. I know he spent countless hours and attended dozens of meetings, working with Senators and stakeholders and advocates to address their concerns. This bill would not have had such broad bipartisan support without all of his work.

Senator Harkin's staff has also worked tirelessly on this bipartisan bill. Their knowledge, professionalism, their graciousness were instrumental in addressing all of the issues in this bill. They worked many late evenings, they worked through weekends, they worked through countless working group discussions to be able to get the bill where it is today.

Specifically, I want to recognize Elizabeth Jungman, Bill McConagha, Kathleen Laird, and Kate Wise for all their work. I thank Pam Smith, Senator Harkin's staff director, for her leadership getting this bill to the finish line. I especially want to recognize Jenelle Krishnamoorthy, whose organization and diplomatic skills helped us resolve the most difficult challenges and made sure that the priorities of all the members of the committee are reflected in the bill.

I also wish to thank the staffs of the Legislative Counsel, the Congressional Budget Office, and the Federal Drug Administration for all of their technical assistance. Again, there are people in those groups who had to work through the weekends when we were finishing up.

Finally I would thank my staff--Keith Flanagan, Melissa Pfaff, Grace Stuntz, Katy Spangler, Rob Walton, and my health policy director, Chuck Clapton.

I would be really remiss if I didn't thank my staff director Frank Macchiarola for his work on this bill, especially as the bill progressed through the HELP Committee, the Senate floor, and discussions with the House. My staff has been working around the clock for many days, for weeks, and for months. I sincerely appreciate their dedication to getting this bill passed and for helping to work with the 80-percent rule.

I urge my colleagues to support this bipartisan bill that makes important changes to the FDA and I ask them to support this process that expedites getting the conference done. We will have a real and meaningful impact on millions of American patients.

I yield the floor.

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