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Prescription Drug User Fee Amendments of 2007

Floor Speech

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Location: Washington, DC

PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 -- (Senate - May 02, 2007)

AMENDMENT NO. 982

Mr. COBURN. Mr. President, I rise to speak for a minute in support of Senator Allard's amendment. I also want to recognize Senator Dodd's work, and I believe he truly cares about us getting pharmaceuticals to children. But I think the bill as written today has some very great risks for our children.

I practice medicine. I can remember 25 years ago, for so many of the drugs, we did not know what we were doing as they related to children. We had sometimes great outcomes and sometimes poor outcomes as to the availability and knowledge of pharmaceuticals for children.

We have a system that started 10 years ago that has been highly successful. Mr. President, 144 drugs have now been studied in kids. We know what we are doing with 144 drugs. With 25 of those drugs, we now know not to use them for children.

How did we get there? We created an incentive that said: We will give you a 6-month patent extension if you will study pediatric indications and do a study on pediatric patients for this drug. It worked. As a matter of fact, it worked great.

Now, I am having trouble understanding, as a physician, the therapy Senator Dodd wants to put on this. He is back to practicing medicine the way we did pediatrics 25 years ago with his amendment. I certainly hope he is right if he wins because there are going to be a lot of children in trouble if he is not.

What his amendment actually says is, if you made $1 billion off a drug, you only get a 3-month extension. I can see how we could look and say they are making too much money. But only 1 out of every 10 drugs we studied in pediatrics was a blockbuster drug. So what is happening with these high-profile drugs they are making a lot of money off of is they are the things that are funding the other 130 studies of drugs that are not blockbusters, that are not profitable.

So what Senator Dodd has put in this bill--and I know it is well-meaning--is to limit that profitability, hoping drugs will become more reasonable, and gambling--a very risky gamble--that the research on pediatric drugs will continue with that 3-month extension.

He may be right. But as someone who cares for kids in my own practice, I am not willing to take that gamble. I am not willing to say: What if he is wrong? What if the studies go from 144 to 15?

Now that we are seeing all these new drugs coming out, we are not going to have a study for kids? We are going to take away opportunities for young children to have the benefits of a new drug because they are not studied? Or we are going to use the drugs anyhow, even though they are not indicated and we do not know what we are doing, in a hope--not in a knowledgeable, scientific way but in a hope we are doing some good?

We have a system that has worked very well. Senator Dodd was supportive of that system. I do not know that he is right. He could be right. But the question will be: What if he is wrong? What if the next 100 drugs that come out for maladies that could have an application for children--especially some very small used drugs, specialty drugs for chemotherapy, and have a very low incidence of usage in kids--what if they are not available?

What if they are not made available? How many children are not going to get that drug? Now the system is paying for 90 percent of the studies on drugs that aren't the blockbusters, and we are going to cut the incentive in half. It may work. I don't know where the knowledge is, the scientific inquiry, or the study that says that going from 6 months to 3 months is the right amount. What about 2 months? What about 1 month? What about 5 months? We don't know. So what are we going to do? We are now going to go back and practice on pediatric drug studies the way we used to practice on children. We are going to guess.

What the Allard amendment says is: We are not real happy there is this amount of tremendous profit, but we do understand that the profit off the blockbuster drugs is actually paying for 90 percent of the studies on nonblockbuster drugs for kids, that we are going to take away that incentive. It is really comforting as a physician to know now what I didn't know before in terms of giving a kid a medicine and knowing how it is going to be metabolized, knowing its half-life, knowing it is different in a child and being able to dose it correctly, and confidently saying to a parent: I have given you something that is going to fix your child, that is going to cure this illness, and I know you are not going to have a side effect from it.

What we have done has worked. Why would we mess with it unless we know? I have listened to this debate. I don't see anybody telling me how we know we are not going to disincentivize further drug studies. If somebody can show me that, then I will be happy to vote against the Allard amendment. But there is not anybody who can show me scientifically that we are going to have another 144 drugs studied if we cut this in half. Maybe we will, maybe we won't. I can't see into the future, but I am cautious enough to know I love the progress we have made.

If we change this, if we change it--and it sounds as if, from the debate here, the Allard amendment isn't going to be approved--we better darn sure know what we are doing, and we better darn sure say that taking money away from drug companies in terms of extending patents is not going to have a negative impact in terms of positive benefits.

I am not the greatest defender of the drug companies. I authored the first bill that was signed by President Clinton which allowed reimportation of drugs into this country. Why did I do it? I think we need to have a worldwide market on pharmaceuticals. We don't. We have a controlled market everywhere except in this country. The American taxpayers end up subsidizing the research and subsidizing the profits. But I also recognize that some of these drugs' profits are the very things that allow me to now give comfort to a mother and a father when they have a very sick child.

I hope Senator Dodd has the wisdom to know that he has done it just right and that there is not going to be one cancer chemotherapeutic agent that wasn't studied in children because it is not a blockbuster drug, and now that we are going to cut it to 3 months, that there will still be an incentive to make sure that the next child with a sarcoma or the next child with an aplastic anemia or the next child with a leukemia that is resistant to bone marrow transplant or anything else is going to be able to have the medicine.

We are going to go back to the way we practiced medicine 10 or 12 years ago. We are not going to know, and we are going to shoot from the hip and pray and hope. What we have today is we don't have to pray and hope anymore. We now have the studies.

I don't know the answer to it, and I am not saying Senator Dodd is wrong, but I think a legitimate question to ask is, What if he is wrong? What if he is wrong? How many children aren't going to have drugs? How many children are going to have a drug complication? How many children are going to have a drug interaction? How many children's lives aren't going to be saved because we decided the drug companies are making too much money and we are going to tell them how much they should make?

Mr. President, I yield the floor.

BREAK IN TRANSCRIPT

Mr. COBURN. Mr. President, I want to chime in for a minute on this amendment, and I want to set a little background. Why do we want to import prescription drugs? What is the reason behind it? The reason is that there is not a true international market in pharmaceuticals. Senator Stabenow quoted a figure of $29 billion worth of Government research. That is not quite accurate. There is $29 billion that goes to NIH, but that is not all related to drug development. Probably half of that is. So we do have a great investment in drugs. There is no question that the American consumer subsidizes the pharmaceuticals of almost every other nation in this world. So the purpose behind this amendment is a good one.

I would draw attention to the fact that Senator Brown and I passed a drug reimportation bill in the late 1990s that became law, and President Clinton signed it. Donna Shalala, however, under the same guidelines, refused to carry out that mandate--that bill is still on the books, by the way--claiming there was nothing they could do that would make them safe and that they could assure they were safe.

I am going to vote for this amendment, and I think it is right that we should develop a worldwide market on pharmaceuticals, but I am not sure we are going to accomplish this. Having authored the first bill on drug reimportation when I was a Member in the House, what I have seen is that the problem is much bigger than what we are attacking. I find it kind of peculiar and strange that we haven't gone a little further. What really needs to happen is we need to tell all our friends around the world that tell the pharmaceutical companies what price they will pay for drugs, we need to tell them what price we will pay for their products. As soon as we did that, guess what. There would be a worldwide market on pharmaceuticals. We may get there through reimportation, but I don't think so. I think it is going to get squeezed down. I think greed conquers technological difficulty almost every time.

So I think this is a good step, but if we really want to solve this problem, let us put an amendment on the floor which says that any country that essentially fixes the price on pharmaceuticals, their products coming into our country will have their prices fixed. Can you imagine if we were to tell BMW what they are going to get for a BMW 531, or Volkswagen what they are going to get for one of their vehicles, or Toyota what they are going to sell a car for? That is essentially what they are doing to the pharmaceutical industry in this country.

I believe this is a good amendment, and I am supportive of reimportation, but I don't believe it solves the problem. I don't want the American people to think that if we pass this, all of a sudden the price of drugs is going to come down. It will not. It is great that we are doing it, but we are not going far enough. We need to ask the administration to carry out the strength of their ability through Executive orders to create true competition throughout the country and throughout the world on pharmaceutical prices.

Regardless of all the precautions and the well-thought-out plans of Senator Dorgan--and I know Senator Brown has worked on this for years, as has Senator Stabenow and Senator Vitter and several others--I believe they will get around it. I believe they will sign contracts for fixed quantities of drugs, and then the countries that have the potential to take a drug that was produced here or produced by a manufacturer that is based out of this country, they will limit the amount of drugs that are available to them based on the contract they sign for the number of drugs. So we will have made everybody feel better, but we will not really have created a worldwide market for pharmaceuticals. That is what I think we have to do.

I would like to put out to the author of this amendment, as well as the sponsors, that we ought to think bigger on how to handle this because what we really have is one industry where there is not true free trading. We are not ever going to get the benefits, we are not ever going to relieve the burden of the American consumer, who is paying to subsidize drugs in Germany, in England, in France, and in Japan, we are not ever going to take that burden off until we really create a true worldwide market in pharmaceuticals. I am just hesitant to believe this is going to accomplish it.

Like I said, I am going to vote for it. I believe it is a step in the right direction, but I think we need to be more bold. If we really believe in the benefits of international free trade, then we should do whatever is in our power to insist it become an international market for pharmaceuticals. That way, the pharmaceutical companies won't have to use the only market there is in our country to subsidize the variable costs and the research that they contribute to a lot of the drugs that come today.

So I am supportive, I think it will pass, but I would reach out to the other Members who are interested and say: Let's do something bigger. Let's do something that will really fix it and do it fairly quickly. We will have a thriving pharmaceutical industry that way. It truly will be based on competition. Intellectual properties that are truly researched and supported by the country--we as Americans, if we have done that, we will get the better benefit from it if we have a true international market. I think the drug companies would like to see that as well.

I understand they are trying to get return on invested assets. I believe it is important that everyone has a fair price for a pharmaceutical and that people make money when they sell a pharmaceutical. But we have to have an international market, and we have to solve it that way.

I thank Senator Brown for allowing me the time, and I yield the floor.


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