Food and Drug Administration Safety and Innovation Act

Floor Speech

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Mr. COBURN. Mr. President, let me say how proud I am of all of the members of the HELP Committee on this difficult and complicated issue they are bringing before us. 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 done right, will have tremendous positive effects, and I think the Senators have put out a very good bill. I congratulate my colleagues and all the members on doing that.

I have two amendments, and I am going to speak for a very short period of time on both of them. I will work with the ranking member and the chairman to see if we can't get to where we don't have to vote on them.

I would like to give just a little history on PDUFA and MDUFA. The reason they were set up in the first place was to help fund the FDA, and the reason the manufacturers agreed to do that was to get more timeliness in terms of response to their applications. That was the whole basis for it. And what we have before us today is some improvement in terms of the FDA's response but really not everything 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 is 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 the FDA. What is missing is that same independent review in terms of drugs. It is one of those situations where we invest in something that would pay us additional big dividends. I know it will pay big dividends in the device area. It will also pay big dividends in the drug area. I don't know what the workings of the committee are and 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 are going to do for the device, which is in the bill already, we are also going to do for the drug side of the FDA. It is about gathering knowledge for both the FDA and for us as we help this agency perform very needed things.

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

All I am asking is that we treat all of the FDA the same in terms of taking a look at how well they are doing, what could they do better, and how they could do it better. That report comes to us and the FDA, and so we can see the weaknesses. We have not 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 people of this country in terms of the timeliness of drug presentation.

I won't speak any more to that. It is a commonsense, good-government amendment. Part of it is in the bill, and part of it is not in the bill. It is something that will pay us big dividends not only in terms of health care and improving the operation of the FDA but also in terms of improving our competitiveness worldwide.

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Mr. COBURN. Mr. President, this is an amendment that comes out of a study of GAO'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 GAO is telling us is that there is an irregular pattern of performance review at the FDA. Part of the evaluation of about 40 percent of the people who are involved in the drug and device approval process, in terms of their performance review, has to do with the timeliness of their work product. And it is only a small component, but it is still a component of it.

What this amendment does is it says: FDA, make this part of your component on the people who 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 GAO really said is that it is just a lack of management effectiveness that they have not installed it everywhere else. All this amendment says is that this should be one component as they evaluate their employees on their performance reviews and ask: How did you do on timeliness? Was your work product timely?

The idea behind this is not to push drugs out that should not be approved. It is not to push out devices that should not be approved. But remember that the purpose for PDUFA and MDUFA in the first place was to fund FDA with additional money so they would be more timely.

The opposition I hear to this amendment that we are afraid that if this is a component of review, they might review a product and let it go when they shouldn't does not make sense since already 40 percent of the employees doing this are being evaluated on this performance standard anyway. So I would raise the question: If we are 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, there is a concern? There is not a concern with it. It is a good management tool. It is used in all sorts of government agencies. And I commend to the attention of my colleagues the GAO report that backs up exactly what I am saying and their recommendation. These are not Tom Coburn's recommendations, these are the GAO recommendations for FDA. They address the concerns of inappropriate pressure for early approval or inappropriate approval for drugs or devices.

Again, it is good government and common sense. It is how one would manage a private organization. You would put every component that the employee is involved with as a component as part of the review process.

My hope is that we do not have to vote on this. When my colleagues actually thoroughly study the GAO report, they will embrace what they are saying. It is common sense with sound judgment that deals with the FDA.

I yield the floor.

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Mr. COBURN. My answer to the chairman through the Chair is that the FDA does nothing quickly now, and he knows that because he has been sitting in oversight over them for years. That is No. 1. The answer to No. 2 is, if the Senator reads the GAO report, they have no explanation on why they do it on some employees and not others. The fact is, if this is a bad thing, why are they doing it on 40 percent of the employees now? The No. 1 and No. 2 things the FDA is charged with are safety and efficacy. Safety comes first. They get graded on how well they do on that. So we have this counterbalance.

Well, what we have is a lack of responsiveness even though billions of dollars are going to the FDA from the device companies and the drug companies. Part of the deal was 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 is happening a lot of times is they are not.

I fully support the bureaucracy of the FDA in terms of them doing their job. I think they do an awfully good job. They are just awfully slow at it, and when you ask why, there is not a good answer.

The point is, if there are a large number of employees who are already reviewed as a small component, it doesn't have to be a major one, but it ought to be something you think about. Do I push this off my desk because I am bored with it? Does the timeframe mean anything?

We are not going after eliminating safety and efficacy, we are going after smart management, and those two things, safety and efficacy, reign supreme at the FDA. That is why we spend so much in this country. That is 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 safer and we are slow to approve, and rightly so, but we should not be like frozen ice slowly slipping down a hill. All this says is, let's make it one component of many in terms of review. Again, I tell the chairman, this is not my recommendation, this is the GAO's recommendation.

So I would appreciate consideration by the chairman and ranking member for these amendments. I think they are common sense. We could look at them again. If the Senator thinks there is a problem, we can put in a caveat. Let's look at it in a year and say: Have there been problems because we have done this? But it is good management, it does make sense, and they are already doing it on 40 percent of their employees who are involved in the approval of both drugs and devices.

I thank the chair for his question.

I yield the floor, and I will be back.

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