Speeches & Floor Statements

Floor Remarks of U.S. Senator Lamar Alexander (R-TN) Safety of Pediatric Medicine

Posted on May 1, 2007

Mr. President, first I would like to congratulate Senator Dodd and others who over the past 10 years have developed this piece of legislation. It has been remarkably effective. I think it is important as we talk about this that we remind ourselves what we are saying. What we are saying is, we live in this country with all of these wonderful pharmaceutical drugs for adults, but in many cases, before this legislation had been enacted, doctors were flying blind. They were guessing about the effect of these drugs on children. That sometimes had very unfortunate results. I know that in my home State of Tennessee a drug for whooping cough was given to a number of children. There had been a clinical trial for the effect it would have on adults but not on children. And the children were so seriously harmed by the drug that the Centers for Disease Control later found that the drug was the reason they needed stomach surgery. So it is remarkable that 10 years ago Senator Dodd and others -- Senator DeWine, Senator Hatch, and many others who have been mentioned -- came up with the idea that if we strike this balance that Senator Dodd has referred to several times and give the companies that make the drugs a little more time, 6 months with their patent, that they in return would then conduct trials on these drugs on how they affect children. No one knew at that time exactly what would happen. They were guessing. This is long before I came to the Senate. But they guessed well. As a result, as has been said, about one-third of the drugs that are given to children now have had testing and trials for use in children. Now doctors, when we bring our babies and grandbabies in, have a better idea of what they are doing. They are guessing less. It is better for the children. In my family we have two new grandchildren under the age of 2. Senator Dodd, being younger than I am, has two children who are young like that. Maybe he has heard what I have heard. My mother used to say to me when I would go to the babies and they were happy, she would say: "Son, don't try to make a happy baby happier." In effect, what she was saying is, leave it alone if it is happy. Well, this is a happy piece of legislation for which Senator Dodd and others should have a lot of credit. My suggestion would be let's not try to make a happy piece of legislation happier. It is happy because one-third of medicines are being studied, and doctors know more about what they are giving to their patients who are children. What the Allard amendment would do is keep the law the way it is. It is the bill that is on the Senate floor that would change things. I understand this is an estimate, but I listened to the testimony. The Senator from Connecticut suggested we are all racing here at the last minute and changing it. Wait a minute. We had a hearing on this some time ago. It was a terrific hearing. I was there. We heard various points of view, a lot of celebration about the effect of this act over the last 10 years. The only reason I was not a cosponsor of this legislation was because I wanted to hear the testimony about what the effect would be of changing this law that is a happy law that has worked so well for so long. As a result, it created the situation where a third of the children have drugs that doctors know more about. After listening to all the testimony, if I were going to change the law, I would make the incentive 7 months or 8 months or 9 months. Why would I do that? The reason is, at the hearing it was said that while a third of the drugs that are administered to children have had been tested for use in children, probably we need two-thirds of the drugs that are ready for adults to have that sort of testing. In other words, we are about halfway where we want to go if we want to have drugs that are tested to see what their effect will be on children. So my question was, if giving 6 months' incentive has gotten us halfway where we want to go, then maybe to get all the way where we want to go, we should go to 7 months' or 8 months' incentive. But my feeling at the end of the hearing was, well, the existing law has worked well by providing an incentive of 6 months. Let's leave it like it is. The end result of the legislation that is on the floor is not to leave it like it is but to change it, to reduce it from 6 months to 3 months, which is exactly backwards. What the effect of this reduction will be is to reduce the opportunities for tests of drugs for children, which would fail to move us along toward the goal of having two-thirds of drugs studied for use in children. I applaud Senator Dodd. I give him great credit for this. When he retires from the Senate in another 30 years, this will be one great feather in his cap, as well as for Senator Clinton and others who have worked on this. But I would go back to what my mother said: "Don't try to make a happy baby happy." Let's not try to make a happy piece of legislation happy. Let's leave it the way it is. It has worked for 10 years. Let's let it work for another 5 years the way it is. Adopting the Allard amendment would keep it the way it is. I have one suggestion for Senators Kennedy and Enzi, if I may. Maybe they would want to consider it as part of the managers' amendment. We heard testimony at our hearing that perhaps our goal should be someday to get two-thirds or three-fourths of the drugs that are for adults studied for use in children. Today it is one-third. I think it would be useful for us at a future time to know exactly what our goal ought to be. Maybe it ought to be 90 percent. Maybe it ought to be 50 percent. But I wanted to suggest to the Senator from Massachusetts and the Senator from Connecticut that we might want to include in this legislation asking the FDA or the appropriate agency to study what percent of drugs approved for adults should also be tested for children, what is that proper goal, so that the next time this issue comes up we have some informed judgment about it. A quick review of the medical literature shows there hasn't been any such study. I could be corrected if there has been. If there hasn't been, I suggest we make that a part of the legislation. I make that simply by suggestion, not amendment. I intend to vote for the Allard amendment, and I have stated the reasons why. If we have a happy piece of legislation, let's keep it happy. That will do it.