Prescription Drug User Fee Amendments of 2007

Floor Speech

PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 -- (Senate - May 01, 2007)

BREAK IN TRANSCRIPT

Mr. ENZI. Madam President, this morning there have been a couple of topics brought up. The bill before us, of course, is the reauthorization of the Food and Drug Administration, several important parts of the Food and Drug Administration, and a new section on drug safety to give the Food and Drug Administration a few more tools for their tool box. So I will stick to that topic instead of addressing the one more recently brought up. I have some very strong feelings on that and some very strong opinions on how America ought to be involved in the war and what the consequences are of us pulling out. However, I want to stick to the topic of the day, which is our pharmaceutical supply.

Most Americans who turn to imported drugs do so because of the cost. We need to answer a lot of questions before we open our borders to imported drugs to be sure we don't endanger consumers or jeopardize research or jeopardize the development of new lifesaving products. Senator Dorgan, of course, introduced a bill last year. He made the statement that miracle drugs provide no miracles for those who can't afford them. I don't think there is anybody in this Chamber who couldn't agree more with that statement, but I am sure they would agree that a counterfeit or tainted drug is unsafe at any price.

As we consider the issue of drug importation, the safety of our citizens must be our primary concern. As ranking member of the committee charged with public health, it is certainly mine. You will find the focus of the bill that is before us to be on safety. I think everything in the bill leads to safety. I don't want to come up with a countersituation now that might put people at risk.

I am reminded we are going to have a little bit of debate on the safety of our food supply--we talked about that a little bit last night--because there is a crisis with pet food, in particular, but even some potential for human consumption, partly because of the pet food, partly because of some other possibilities. There are some kids dying in China because they have melamine in their food. This is a product that is added to food to increase the appearance of protein. If you add that to grains or other things, you can get a higher protein count, and usually the protein count relates to the price you get. The more protein, the higher the price.

I was talking to the Senator from Colorado, Mr. Allard, who is a veterinarian, and he was pointing out this morning that if you take a fingernail, that is 100 percent protein. If you take the liver, that is 100 percent protein. One of the differences is if you grind liver up and you put it in food, it is digestible. If you grind a fingernail up and put it in food, it isn't digestible at all. So you are not getting any protein out of it. So kids have died in China who thought they were getting sufficient food, and they weren't. The cause of death was starvation. One of the countries that could be getting drugs to the United States would be China. If they are fooling with our food supply, do you think they would hesitate a minute to fool with our prescription drug supply? It worries me a lot. There is a lot of risk that is involved in this.

The Senator from North Dakota held up two bottles. The bottles were identical. One was cheaper in Canada than the same bottle in the United States. In a minute, I will go into how that price difference happens. I could hold up two bottles that would look exactly the same. One would appear to come from Canada, but it might very well come through Canada from Saudi Arabia, have exactly the same packaging, labeling, colors, seals, even the same look of a pill. But one of the things we found out from some of these drugs that have come from other countries through Canada is that they don't work. If you grind them up, they have exactly the same chemicals in them, but it isn't just the chemicals that do it, it is the way they are put together that makes it possible for them to solve a medical problem. If they are put together wrong, they may not even digest. If they don't digest, similar to a fingernail, you don't get the benefit from the drug. If you don't get the benefit from the drug, you shouldn't pay anything for it. In fact, there ought to be some pretty severe action taken against the person or country or company that produced that kind of a drug. We are not able to do that.

The Food and Drug Administration is charged with watching our borders and the things that come in to see if the drugs that come into this country are legitimate. There are warehouses full of drugs they have found that are not legitimate. So it is a matter of safety, and we are concentrating on the safety portion of this bill. So I am hoping we will save the drug importation question for a separate debate of its own.

We know each one of us takes a risk every time we take a drug, but Americans who buy prescription drugs in Canada and other countries or purchase drugs from Internet pharmacies that operate outside the United States are taking an even greater risk by obtaining their prescription medicine from pharmacies and Internet sites that don't always meet the high standards we require here at home. Here is where my concern lies. We already have a problem with counterfeit and substandard drugs in the United States. Concern about the quickly growing counterfeit market is not limited to the United States. In Europe, dangerous counterfeit drugs are already a problem, and the problem is growing as the European Union expands. In addition, we have little knowledge of the extent of counterfeiting in Asian markets such as India, Pakistan, and China, other than that it may be the best.

Now, prior to legalizing an untested, drug importation project on a large scale across our Nation, we must consider any new vulnerabilities in our drug distribution system, especially since those vulnerabilities could be massive in size. I know we all share the same goals. We want to ensure that drugs are safe, effective, and will not compromise the integrity of our Nation's prescription drug supply or our world-leading pharmaceutical research, and we want it to be at the lowest possible cost. Similar to many Americans, I am concerned about the high and rising cost of prescription drugs. However, I doubt the importation of drugs from other countries will solve that problem all by itself. We better be certain about exactly what we are doing and how we are going to do it. We have had some hearings on that. We have also gotten some phone calls from the Canadian Minister in charge of the program who has said: Do you realize that if America suddenly started buying its drugs from Canada, we would have to prohibit Americans from doing it. We are a small country. We could not take the amount of orders we might possibly get because we do have price fixing.

We talk about negotiated prices and we talk about that in the context of Medicare drugs. Congress passed and the President implemented Medicare Part D that actually came in considerably lower in cost for drugs for American seniors than what we or the Government Accountability Office had ever anticipated--dramatically lower. Why? Because of competition. How does a country negotiate drug prices? Well, the way Canada did it was they said: If there are five drugs that treat heart problems, we make a bid for one drug against another drug. If there are five heart drugs, they all don't do the same thing. Some doctors would prescribe one and others would prescribe another. But if you are going to negotiate prices, you make the five bid against each other and you pick one or two, and you tell the rest of them they can't sell their drugs there, that the Government would not have any part of it. This eliminates choices.

Then there is another little caveat that some of the countries add to that which says: If you don't come in with a low enough price, we are going to give your patent away and you would not get anything for it. We have some real patent issues if we are going to have people investing in the research to get new drugs passed and approved, and we should take a little look at the process that you have to go through to get a drug approved. It is about a $1 billion project to get a drug approved. They don't do that because they are wanting to donate $1 billion; they are doing it because they expect there will be some profit on the other end of selling the drug. Otherwise they wouldn't go through all that research, all the trouble, all the clinical trials, and then turn it over to people for free. They give away quite a few drugs, but that is to people who can't afford them. There is a lot to the fact that we have more pharmaceutical companies developing more drugs than anywhere else. I am pleased that through our committee we found out there are over 650 clinical trials happening right now on various cancer drugs. That is just in the area of cancer: 650 drugs in the pipeline. That is a lot of billions of dollars being spent for us.

Every once in awhile somebody mentions the high cost of insurance. That is something else our committee is working on. I think we have some potential for making some good changes there. But one thing I always remind people of is I could get them 1980 insurance prices if they would settle for 1980 treatments. Then they start to realize how many things that have been invented since 1980 that make a difference in our life and in our longevity. I don't know of anybody who wants to settle for pre-1980 treatments, but they are cheaper.

In any importation discussion, it is critical we limit imported drugs only to those that have been approved by the FDA. It is important to understand how small differences between drugs can mean big differences in patient health. We are talking about a drug safety bill on the Senate floor this week. We all acknowledge that there are drug safety problems that must be addressed. It makes no sense to open up our borders when we don't have things quite right here at home. Imagine trying to handle the world's drug safety when we are having some problems handling drug safety in the United States. Furthermore, we should not tell companies with whom we must do business how much they have to sell and at what price they have to sell it. Those are mandates I strongly believe will ultimately limit consumer access to drugs.

So I look forward to a spirited discussion. I think it will answer some of my questions about the legislation and will hopefully inform us all on the best direction we can take from here. There are possibilities for solutions on drug importation. I hope it will be a separate discussion from how the Food and Drug Administration administers the safety of pharmaceuticals and medical devices and particularly when they concern children. We actually forced the pharmaceutical companies and the medical device companies to pay to have their products tested and reviewed. That is what a big portion of this bill is about: how they will pay for having the products tested and reviewed.

That needs to be reauthorized before September, or it expires. That would mean a lot of additional costs on the taxpayer if we don't do those two parts.

There is also a portion on that which deals with pharmaceuticals for children. It is important that tests be done with the pharmaceuticals to be sure they are safe for children and in what dosage they are safe for children. There is a portion of the bill which gives incentives to companies that will go to that extra length to see which of the drugs can be used for children as well. That is another potential for a fascinating discussion over the next couple of days.

I compliment the Members who have been working on that. Many are on the HELP Committee and have been looking into this with as much depth and detail as I have seen on any bill we have ever done. I have also seen as much cooperation between both sides of the aisle as I have seen on any bill we have done--working together to find a way to take care of the concerns and make sure we are improving the safety but also making it possible for people to get the pharmaceuticals and get them as quickly as possible. It doesn't do any good to have a miracle drug and not be able to get it on the market. It doesn't help to have a miracle drug with some problems and, because FDA doesn't have the tools to change some of those problems, they have to pull it off the market and take it away from some people who really rely on that drug. That is what this bill does essentially.

I think in the substitute, or managers' amendment, that will be coming out, many of the difficulties people have will have been worked out. People are working on them as we speak. That is why the managers' amendment has not been laid down. It has been vetted with all Members who are interested and working on this, and there has been incredible cooperation. I hope people will continue to work with us.

I do not want anybody to think this bill is a complete answer to safety. It doesn't cover some topics. That is because we are still working on some topics that are not developed to a point yet where they can be done. One is this drug importation. It is being looked at, hearings are being held, and we are trying to find out some way prices can be lowered in the United States.

Another problem is biosimilars. There is a whole new area of drugs that has come out because the genome has been unlocked and proteins can be developed which can be used as medication which will solve some of those genetic problems. Those are called biologics. There are people who would like them to become generics right away because that would bring the cost down. Again, we want to make sure we have a bill that takes care of the safety of the biosimilars, to be sure they truly are similar and will have the same effect. The Europeans have been working on that for a while. We have looked at their model and a number of Senators--again from both sides of the aisle--have been working on that problem. Senator Clinton and Senator Hatch have been very involved in that, providing guidance from both sides of the aisle. We appreciate their efforts on it. I do not expect that to be a part of this bill.

There are a number of tobacco issues, and our committee has a lot of concern on that. There are some bills which would provide a different way of doing that--maybe put the regulation of tobacco under the jurisdiction of the FDA. I hope that will not be a part of this bill. That is not ready yet, either. We have a lot of parts that are ready, and particularly the user fees need to be done before a deadline that is coming up.

I really appreciate the cooperation we are having in making sure we can meet the deadline and have an FDA that is even more responsive and has more tools in their toolbox to make sure the drugs out there are safe and that there is a system for making sure safety is maintained and if there is a problem, that it can be corrected with some of the new tools in the toolbox.

I thank everybody for their cooperation and patience.

I yield the floor.

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