Calling up Coburn Amendment 2131:

Mr. Coburn: Let me say how proud I am of the ranking member and all the members of the HELP Committee on this very difficult and complicated issue that they are bringing before us. FDA having been in business and under the control of the FDA as a medical device manufacturer, this is a very complicated area of law that if it's done right will have tremendous positive effects on this company. I think you have put out a very good bill, and I congratulate you and all the members on doing that.

I have two amendments i'm going to speak a very brief period of time on both of them, and then I will work with the ranking member and chairman to see if we can get them [included] so we don't have to vote on them.

Regarding the PDUFA and MDUFA, the reason they were set up in the first place was to help fund the FDA and the reap the manufacturers did that was to get more timeliness in response to their applications. that was the whole basis for it. what we have before us today is some improvement in terms of the FDA's response but really not everything that we should have gotten.

I, along with Senator Burr, asked for a GAO study to the FDA in terms of meeting stated performance goals, and we found out a whole lot about that, and that's my next amendment, but I say that to preface why i have this amendment. in this bill is a wonderful requirement that causes the FDA to contract with an independent management company to assess the management of the missions and resources of the device regulation component of FDA what is missing is that same independent review in terms of drugs. it's one of those things where we would invest in something that is going to pay us additional big dividends.

I know it's going to pay us big dividends in the device area. it's also going to pay us big dividends in the drug area. i don't know the workings of the committee, why they decided not to put this in as far as the drug review process, but having a second look at a very complicated regulatory and approval structure could be very beneficial in terms of improving both the quality of the outcome as well as the timeliness. so this amendment simply says that what we're going to do for the device in the bill already, we're also going to do for the drug side of the FDA it's about gathering knowledge, both for the FDA and for us, as we help this agency perform very needed things.

I read a lot about new science on new drugs as a physician. I want to tell you, the things that are coming into this country are going to be phenomenal in terms of new treatments and new drugs and new capabilities. we need in terms of our competitiveness worldwide but also in terms of how we address these diseases to have the most efficient regulatory agency we can.

All I’m asking is that we treat all of FDA the same in terms of taking a look, how well are they doing, what could they do better, how could they do it better? that report comes to us and the FDA we haven't been through every area of the FDA as members of the senate, and to have an independent assessment of the drug side as well as the device side will pay huge benefits to the FDA, but mostly it will pay huge benefits to the people of this country in terms of timeliness of drug presentation. so with that, i won't speak any more to that. it's a commonsense good government amendment. part of it is already in the bill.

Part of it is not in the bill. it's something that will pay us big dividends both in terms of health care, both in terms of improving the operation of the FDA, but also in terms of improving our competitiveness worldwide. I would ask that that amendment be set aside and call up 2131.

This is an amendment that comes out of a study of g.a.o.'s findings, and GAO did a wonderful job looking at the FDA what we found out, part of it will be covered if, in fact, we do this other study on the management, but what g.a.o. is telling us is there is an irregular pattern of performance review at the f.d.a. about 40% of the people who are involved in the drug and device approval process, part of their evaluation in terms of their performance review has to do with the timeliness of their work product. and it's only a small component but it's yet still a component of it, and what this amendment does is just said f.d.a., make this a part of your component on the people that are actually reviewed in the review process. not to try to push them to do it better but to have a management tool with which to evaluate individual employees doing this.

The fact that they are already doing this on some and what g.a.o. really said is just a lack of management effectiveness that they haven't installed it everywhere else, all this amendment says is this should be a component, as they evaluate their employees that are associated, as one component of their performance review, how did you do on timeliness? was your work product timely?

The idea behind this is not to push drugs out that shouldn't be approved. it's not to push out devices that shouldn't be approved, but remember the purpose for pdufa in the first place and mdufa.

The purpose was to fine FDA with more money so they would be more timely. the opposition that i hear to this amendment is that we're afraid if this is a component of review that they might review a product and let it go when they shouldn't doesn't make sense since already 40% of the employees that are doing this are being evaluated on this performance standard anyway.

So I would raise the question if we're in opposition to this amendment, why in the world haven't we eliminated this as a part of all the review process already if, in fact, it's a concern. and there isn't a concern with it.

It's a good management tool. it's used in all other sorts of government agencies. i would commend and ask unanimous consent to put the g.a.o. report in the record that backs up exactly what i'm saying, and their recommendation. these aren't tom coburn's recommendation.

These are the GAO recommendations for f.d.a., and they address the concerns of inappropriate pressure for early approval or inappropriate approval for drugs or devices. so, again, it's good government, it's common sense, it's how you would manage a private organization. you would put every component that the employee is involved with as a component of part of their review process. and my hope is that we don't have to vote on this, when you actually thoroughly study the g.a.o. report, you will embrace what they are saying as common sense with sound judgment that will actually improve the f.d.a. with that, I would yield the floor.

My answer to the chairman through the chair is the f.d.a. does nothing quickly now, and he knows that because he has been sitting in oversight over him for years. that's number one. number two, the answer to that is they have no explanation if you will read the GAO report on why they do it on some employees and not others. so the fact is if this is a bad thing, why are they doing it on 40% of the employees now? it's not. the number one and number two things that the FDA is charged with is safety and efficacy, safety and efficacy. safety comes first. they get graded on how well they do on that. so you have this counterbalance, but what we have is a lack of responsiveness even though billions of dollars are going to the f.d.a. from the device companies and the drug companies. part of the deal was is to make them more timely. that means in no way do you ignore safety and in no way do you ignore efficacy. the fact is they do deserve answers, and what has happened is a lot of times they are not. i fully support the bureaucracy of the f.d.a. in terms of doing their job. i think they do an awfully good job. they are just awfully slow at it. when you ask why, there is not a good answer. and so the point is if there is a large number of employees that are already reviewed, a small component, it doesn't have to be a major one, but it ought to have to be something you think about. you know, do i push this one off my desk because i'm bored with it? does the time frame mean anything? we're not going after eliminating safety and efficacy.

We're going after smart management. and those two things, safety and efficacy reign supreme at the f.d.a. that's why we spend so much in this country. that's why most of the drugs are approved outside of this country way ahead of when they get approved here, because our drugs and devices are safe and we're slow to approve and rightly so but we shouldn't be like frozen ice slowly slipping down a hill, and all this says is let's make one component of many in terms of the review, do it. again, i would tell the chairman, this is not my recommendation. this is the GAO's recommendation. so i would appreciate the consideration by the chairman and regular member for these amendments. i think they are common sense. we can look at them again. if you think there is a problem, we can put a caveat. let's look at them in a year and say have there been problems because we have done this. but it is good management, it does make sense. they are already doing it on 40% of their employees who are involved in the approval of both drugs and devices.