Floor Statements

Mr. President, I appreciate the question. I appreciate the effort that has gone into adding ways the drug supply can be more safe in the United States. Of course, we are interested in that. The primary focus of the bill was to make sure the U.S. drug supply was as safe as possible.

There were a number of amendments, one of which was withdrawn last night, that dealt with Internet sales. That could have been Internet sales in the United States as well as Internet sales outside of the United States. The reason it was withdrawn is the sponsor of it did not want it to get polarized into a debate as to whether that would undo what you have been working on. It was not. It was to add some more safety and security.

Senator Kennedy and I have been working on this FDA bill for over 2\1/2\ years now. We also have been working on some things that deal with pedigree and licensure in the United States as well as outside of the United States. We did not put that in. We didn't want it to be something, again, that would polarize people and maybe distract from being able to do it at a very logical time.

So most of our effort right now is to make sure we do not enter into some budget points of order, that we are able to accomplish the bill and get it to conference where additional changes will be made.

Our committee works maybe differently from others; I am not sure. I know it works differently from the Banking Committee that I also serve on. It has been one of the most contentious committees in the Senate. But over the last 2\1/2\ years we have changed that perspective a bit and really accomplished a lot.

One of the biggest changes we have had is the way that we do a bill. Before we tried to stuff it at every possible opportunity; that meant in committee as well. You will notice this bill had only 1 day of markup. That is phenomenal for that committee. Three days a week is not unusual for the committee. We got it out of there in 1 week, which helped us to understand the concerns of the people on the committee.

We promised to work on that when it went to the Senate floor. We have worked on it after it came to the floor. More amendments have been put in. We have worked with people. Senator Durbin had one on food safety. We worked with him and got that in; anything that does not appear to polarize, does not appear to add budget points of order, and things that have been considered before, we are trying to work into this bill. New concepts, we would like to talk about them a little bit more, explore them a little bit more, but we want everything to be as safe as possible. That is what we are working for.

There are some huge costs that may potentially be involved in what you are talking about there. If the costs add to the costs of drugs, then someone has to pay it. Then, perhaps, we will be making less access to drugs. We do not want that, and I know you don't want that. Your focus has been on getting lower cost drugs to everyone.

It is the same with the amendment that Senator Stabenow has. We have worked on that for days. It is a concept that we have been working on before and held some hearings on. I think we have arrived at some compromises to put that in. We are trying to wind up with some bipartisan things that we can do to get it to conference where more can be done. And some of these issues we have revisited.

We are one of the busy committees on the Hill. We are holding a hearing as we speak. I had to leave that to come over to the floor to do just exactly this.

I appreciate the Senator's efforts and ideas and creativity. I hope he will work with us.

Mr. President, I would like to respond.

I like his example of the twenty-dollar bill or any other denomination. This has nothing to do with the pharmaceutical companies. This is a discussion Senator Kennedy and I have had ongoing for a long time, and we brought in some technical people to figure out how we can provide that security in a number of different ways. The way that differs from the twenty-dollar bill is that for everybody who handles-- not everybody, most people--twenty-dollar bills on a regular basis, the same design stays in play for a long time. But with the pill bottle, maybe the first pill bottle one gets will be the only pill bottle. Having the knowledge of what exactly to look for on there is not something we teach in school or in pharmacies or anywhere else. It has to be something that people can tell whether it truly is. That is what adds to the cost when it comes to pharmaceuticals. We are looking at inventors who are coming up with different ways all the time to make things secure, not just medicines. We haven't found the answer yet.

Mr. President, that is correct. We have been working on a pedigree and licensure amendment--it is actually structured as a separate bill--in anticipation of trying to add to this when we can find a solution that we feel comfortable with, and we haven't gotten there yet. I think we are close, but we haven't gotten there yet. It has been a joint effort with Senator Kennedy and I and both our staffs.

Mr. President, another technicality that we work on on this and a principle we have established that works well for the committee is we try not to be ultraspecific on what we are doing so that we are picking winners and losers. That is a difficulty we had with the amendment the Senator proposed as well. Not that it can't be worked with and come up with something that fits the criteria of the principle. One of the difficulties of debating things on the floor as a new amendment and unamendable is that usually there are other ideas, some principles, other ways of working with it that are very difficult to do from the floor standpoint.

That is why we start with the markup and some of the other things and keep working with them. I think you have to admit this has been pretty progressive in trying to get something done. There hasn't been the effort to stall things out. There has been a lot of opportunities to do that, but we have been trying to keep things going and hope to get something finished up on this bill so it can get to conference.

Mr. President, I thank the Senator from Ohio for his comments. But I wish to give a little bit more of an answer to the Senator from North Dakota, who has invested a lot of time and effort over the years in a variety of these issues that deal with the safety of our drug supply. I have to tell him, we got his second-degree amendment. Anything we have had has been a very cursory look. We are willing to sit down. We hope his staff will sit down with my staff and take a look at it and see what can be done.

Mr. President, I am hoping that since we did not have a chance on drug importation--and I wish to make the point that that is importation, not reimportation--we didn't have a chance to sit down and work on that and work through it and see what changes could be made, it would only be logical that for a portion of that, we probably ought to sit down and look at it. We are never sure on a second-degree amendment whether it is exactly the same, but we didn't have the opportunity to work on it with the Senator. I think all the staffs that have been working on this have been working in a bipartisan way to come up with a solution. We will take a look at that specifically and see what can be done with it.

I yield the floor.

Reserving the right to object, there are several other people in that same position of wanting to call up amendments. We are trying to come up with a logical order, so I do object.

Mr. President, I congratulate everybody on reaching the point we just reached with the unanimous consent agreement that was done. I thank the Senator from Ohio for his tremendous work on the committee and then on the floor, and on working through some of these amendments.

I particularly thank Senator Kennedy for his efforts. He is having a spectacular day. I am sure actually he is probably on a plane again now. He represented the United States at the unification treaty signing in Ireland today. He left as soon as we finished voting last night, traveled through the night, attended that ceremony, and will travel virtually through the night tonight to get back again so he will be here for tomorrow morning's votes.

That is just the kind of tireless dedication that he puts in on international issues, as well as the issues that come before our committee. I am very impressed with the stamina he has and the capability he has to do all these things.

This has been a long road and it has had a few lumps in it, but there has been cooperation on both sides. The staff people who have worked on this have gone into excruciating detail on every amendment to make sure it would do what people said it would do and that it would work, both in a United States context and in an international context.

I think we have progressed to a point where we can do three votes and then final passage tomorrow and have this on the way to having the Food and Drug Administration reformed so they have more tools in the toolbox and can get the job done that we have always been expecting, and have more confidence that our food and drug supply in the United States will be safe.

Everybody has been tremendously cooperative. We look forward to finishing in the morning.

I yield the floor.

I would also like to take the opportunity to express my support for the need to address the issue of unsafe Internet pharmacies. We have worked very hard in other portions of this bill to ensure the safety of prescription drugs on the market, and as this bill advances, I look forward to working with you both to enhance the provisions in this bill relating to the safety of Internet pharmacies.

Madam President, on our side of the aisle I do appreciate the tremendous amount of effort Senator Kennedy and his staff and many others on the other side of the aisle who have worked with those of us on this side of the aisle to get particularly the major concerns that were brought up during the markup in committee taken care of. There are tremendous amounts of things in here both sides have worked on and in some cases come up with a third way of doing it. I think we are on the right track here. The product will make a huge difference in the bill, and I hope we can move forward.

Cloture Motion

Would the Senator yield for a moment? I want to commend Senator Hatch for raising this issue of antimicrobial resistance and the need for innovation. The problem that the Senator is addressing here is a real threat to public health. The Director of the CDC reports that more than 63,000 patients in the United States die every year from hospital-acquired, antibiotic resistant infections. Although I strongly support this amendment as it is an excellent first step, a comprehensive response is needed. I hope we can continue to address the broader issue within the Committee this Congress. I also agree that we need to continue to work with FDA on this issue of accountability and look forward to working with the Chairman and other members of the Senate on this issue.

As the Senator from West Virginia knows, we included language in the underlying bill on authorized generics in part due to his urging. Our bill would require the Food and Drug Administration to keep track of authorized generics marketed since January 1, 1999, and to make such data publicly available in electronic form. The language in our bill will help the Federal Trade Commission complete its study in a timely fashion, and it will also help to shed some light on this elusive marketing practice. Let me be clear: I do not agree with the other policy statements being made regarding authorized generics because I don't believe we have enough information yet to make those assessments. However, I do agree that we need more information to shed light onto this subject. That is why I supported the language in the underlying bill to allow us to have that data and to provide a strong platform for future discussions.

Certainly.

Mr. President, I yield 10 minutes to the Senator from Mississippi.

Mr. President, I yield 5 minutes to the Senator from New Jersey.

I yield 4 minutes to the Senator from North Carolina.

Mr. President, what is the time situation?

Mr. President, I rise to oppose cloture on the amendment. I find it ironic that in the midst of the work on the biggest drug safety reform in the last decade, perhaps longer than that, we are even considering the issue of drug importation.

Our drug safety bill is an acknowledgment that we don't have things quite right in our domestic drug safety system. I am baffled that we want to take on all the hard work and effort to fix our drug safety problems and throw it away by opening our borders to foreign drugs.

When I was Chairman of the HELP Committee, we held three hearings on drug importation. The witnesses at the hearings raised a number of problems and questions about importation in general, and this bill in particular. In fact, one of those hearings was entirely about this bill. At that time, I asked my colleague from North Dakota if he would work with me to develop a State-based pilot program for drug importation. He turned me down. He was convinced then, as he is now, that this bill is the way to go. I would like to take these kinds of proposals in small chunks, if we are going to have to take them, to ensure we don't create a large-scale disaster. I hope we are not going to create a disaster here by accepting this amendment without further consideration.

I respectfully suggest that this bill is not the way to go, and even if it were, this isn't the time for it to go there. We have heard a lot of comments about the Washington Post editorial, and I refer people to that editorial. They

cover a number of factors, but they do emphasize that the main bill, the safety bill--the FDA safety reform bill that we are working on--is a very important bill. They do recognize this amendment would add some very strong complications to it. The Senator from North Dakota suggests we read the bill. You know, that is a good suggestion for anything we cover around here. I make an effort to read all of the bills we do, and I have read this one. I hope everybody takes a look at this one.

I think you will vote against cloture if you read the bill. It is a roadmap to loopholes. Yes, every time somebody brings up a potential safety issue, they stick another clause in there that might cover that gap. But it shows where the gaps are most likely. They keep adding paragraphs to try to patch up these loopholes. We have an amendment that would have been a second degree, but it was too late for it to be submitted as a second degree, so it is a first-degree amendment that would deal with anti-counterfeiting.

That is another area that has to be looked at carefully. The Senator from Vermont talks about taking people into Canada to buy drugs. Well, you know they are going to the exact pharmacy at that point. They are not going through the Internet or through the telephone. These drugs can be intercepted--there are false sites that are set up out there, and people may think they are getting drugs from Canada, but are actually getting them from Saudi Arabia and other places around the world. It is so easy to get information and believe it is coming from a particular location--they may even imply it is a particular location to get the consumer's confidence. There are so many ways they can mislead consumers and it may not be that location. To try to solve some of that, Senator Gregg has an amendment that would perhaps tighten up the Internet problems. But look at that, too, and you will see there are problems if you are not getting it directly from the pharmacy.

I am a strong supporter of people getting drugs from their local pharmacist, the one who will help you interpret all of the sheets of paper that come with the prescription. They are going to know what other drugs you are taking and if there are possible interactions. Local pharmacists are the most valuable asset we have in the entire pharmaceutical chain. But bills like this work against them and may have consequently put them out of business. That is going to be a tragedy for America.

I have read the amendment. I encourage people to read it and look at the complexity of the amendment and look at the loopholes they are suggesting they have fixed. See if you think this patchwork fixed them. But I also ask that you look at what the Washington Post said, and I am not one of those who normally advocates that you listen to what they say. But it is definitely food for thought on this bill. It will take away a major reform that we could have by throwing something else in that we need to discuss more.

I ask my colleagues to oppose cloture for the sake of the safety of our drug supply. Let's get it fixed at home before we try to open it up to the world.

Mr. President, how much of my time remains?

Mr. President, in order to allow the Senator from North Dakota to have the final word, since it is his amendment, I ask people to vote against cloture.

I yield back the remainder of my time.

I object.

There is still a lot of work being done on this amendment. Senator Kyl and others are involved in it and would not want the debate until we had more chance to work on it.

I object.

Madam President, what we are actually on, of course, is the 30 hours of debate postcloture on the drug importation amendment, and I do want to make some comments on that. I perhaps should have done more extensive debate before, rather than agreeing for a time specific for a vote on it, but that option has passed at the moment. I congratulate Senator Dorgan for his tremendous victory.

I am hoping there will be some changes yet. Perhaps there will not be. We took a 300-page bill that dealt with drug safety in the United States and we then added a 140-page bill that deals with bringing in drugs from other countries. It is a limited number of countries, to start with, but it is bringing in drugs from other countries. I suggest if they are as safe as what we have been told, parts of this bill would not exist.

For instance, page 48, on bioequivalence. It was my understanding what would be brought into the United States would be drugs from companies from the United States that went to Canada, or went to some other place, and could be brought back into this country. These would be FDA-approved drugs. These would be the ones we rely on the FDA for. If they are exactly the same drugs, by exactly the same company, why would there be a section on bioequivalence?

It says:

. . . if the Secretary determines that the qualifying drug

is not bioequivalent . . . the Secretary shall . . . include

in the labeling provided under paragraph (3) prominent

advisory that the qualifying drug is safe and effective.

Well, let me see. We didn't ask them to review it, we didn't ask that it go through the same procedure, but we want the Secretary to provide labeling that says it is safe and effective. I don't know why we would expect the FDA to say anything that is bioequivalent should have their endorsement of being safe and effective. If we do, it expands their job dramatically and there ought to be resources that go with it to be sure that what we are promising will be done gets done.

There are a lot of pages here, a lot of different things. I am definitely not going to hit on all of them, but I am going to mention a few that people probably ought to be a little concerned about.

Here again, on page 56, I thought it was going to be U.S. drugs, or at least drugs from U.S. companies that are already FDA approved that we were going to make sure there was an absolute chain of making sure they got back into the United States so that you could trust what came from U.S. companies. Yet on page 56 we see:

Notice; drug difference not requiring approval.

What?

. . . supplemental application would not be required for

the difference to be made to the U.S. label drug, or that

states that there is no difference.

And then a whole bunch of requirements again for the Secretary, which goes down the line to the FDA. So I think we can conclude we are not just going to bring in U.S. drugs. If there is anything you would like to have, you can.

Then there is a section called ``Importation by Individual.'' This covers the portion where each person can get on the Internet or telephone or whatever way and order drugs. There are requirements in this bill for exporters, which are the people who are sending drugs to other countries; there are requirements in here for importers, which are companies receiving drugs--and those could be pharmacies, probably would be pharmacies, although there could be some wholesale--but there is also this section about importation by the individual.

I hope everybody takes a little look at that, because in the United States I have been working a lot on financial literacy, trying to get people to understand finances and how they can stay financially sound and hopefully financially secure, and it is a huge job. With regard to the No Child Left Behind Act and in Education, we keep talking about plain old literacy; just being able to have people read, and read at grade level, and hopefully read well enough to have a good job and to protect themselves. They better be literate, because look on page 62 and read what the importing individual is responsible for. Because if they are not responsible for this, they could easily be getting something that is not an approved drug or that is not from the source they think it is. It could be a counterfeit drug, and particularly as this opens up on the front end. How many people doing counterfeit drugs now are going to want to jump into the breach and catch people before they understand any of this? I suspect there will be a huge escalation of companies getting into the counterfeit business. There are a few dollars in it--quite a few dollars.

I would encourage people to look on page 62. There are things scattered

throughout the bill an individual would have to know to be sure what they were getting was safe, if they ordered individually. But that is kind of the point of the bill, because most of them probably will be ordered individually.

On page 64, Request for Copy of Special Labeling and Ingredient List. I think that probably would be handy.

Then, on page 65, it goes into the question of adulteration, where it says a qualifying drug that is imported or offered for import shall be considered to be in compliance if the drug is in compliance with all these other sections.

There is also a section titled Standards for Refusing Admission. There are quite a few ways it can be denied, but in order for these adulterated drugs to be denied, to be refused admission, somebody has to find them. So what kind of force are we going to add to the FDA to make sure these things can be found?

I am particularly fascinated with item (F), which gives the Secretary some extra capability if the drug is counterfeit or if the drug may have been prepared, packed, or held under insanitary conditions. Now, the fact that they mention it has to make you believe there is a possibility--maybe a probability, the way it is put in here--that they will be prepared, packed, or held under insanitary conditions.

The United States has a little different level of sanitation than a lot of the countries around the world. Of course, all of these aren't going to come from all around the world to begin with, or will they?

Let's see. They do not have to be bioequivalent. There are a whole bunch of things the individual has to watch out for themselves. It doesn't have to be the same drug that was manufactured in the United States or from a United States company, and if it gets into the EU, it can come to us. That is EU now; EU later. The EU is expanding. We ought to take a look at some of the countries that are being brought into consideration, particularly if you might be worried about them being packed, held, or prepared under insanitary conditions.

Then we get to page 71. Again, there are a lot of things I would like to mention in between, but this is all boring detail stuff, anyway, so I will highlight a few of these things and let people think about them a little bit.

On page 71, we give the Secretary some more responsibilities. They have to:

. . . enter into an agreement with the government of the

country to receive information about recalls and withdrawals

of qualifying drugs in the country; to monitor recalls and

withdrawals of qualifying drugs in the country using any

information that is available to the public in any media.

There are requirements for notice and changes in the labeling, packaging, and that sort of thing.

That is all additional. We are asking them to do some more things in the United States to make what we have here and are relatively certain about even safer. That is the purpose of the bill. Now we are adding these additional sections, 140 pages, which bring the problem from other countries to our country. I grant it, a lot of those are made in the United States or by companies from the United States.

Page 72, again, has a whole bunch of requirements for what kinds of things ought to be included with the drug. You need to know those because if they are not, you maybe ought to suspect there may be a problem. You have to be able to check the packaging and note whether it has the proper seals and whether there could have been any damage to them. It is your problem--unless, of course, the consumer consents to waive the requirements after being informed the packaging does not comply. There is fascinating stuff in here.

Here is one of the parts that really ought to interest us. When we get to page 76, page 76 says you have to play the game: You can't win, you can't lose, and you can't get out. Here is how that works.

Canada has price fixing. There is no doubt about it. That is how they get some of the lower prices on some of the drugs. You can't buy all of the drugs in Canada at lower prices. In fact, I have a friend in Afton, WY, who is a pharmacist. He had a fellow come in who was from Canada but he could not get back to Canada and his prescription had run out, so he relied on an American pharmacy to get his prescription refilled. All the time they were filling the thing, he is complaining about how this darned prescription is going to cost him an arm and a leg because it is in the United States and the cheap drugs are in Canada. The pharmacist gave it to him, told him what the price was, and he said: But that is cheaper than I get it in Canada.

That is a little bit of financial literacy. Just because you heard everything is cheaper in Canada doesn't mean it is.

You should particularly pay attention if there are generics because U.S. generics do not translate to Canada nearly as quickly, if at all. The companies had to go through this bidding process. The bid doesn't take into consideration the change, and that is part of the deal, that you get a little bit of exclusivity with your pill.

I was interested in Zocor. It is a big drug in the United States and a big drug in Canada, although Canada has one-tenth the population of the United States. The Health Minister called me and said: You cannot be considering this import thing. We do not have the capability to supply the United States with their drugs. We will be inundated with prescriptions, and we do not have that big of a supply because we have a tenth of the people the United States has.

Getting back to my Zocor story, that has gone generic. In Canada, you still have to get Zocor, and it is $33.64 for 30 pills. That is a 1- month supply of 10-milligram pills. That would not, of course, include the cost of shipping and handling.

In the United States, there is a generic Zocor, simvastatin. The statins are all designed so that part of the label talks about doing similar things. But the generic Zocor in the United States costs $29.99 for 30. So that is $3.50 less. It is not a lot, depending on what you consider a lot to be, but it is less. But if you are willing to use provostatin or lovastatin, we are talking about $4 a month--$4 a month as opposed to $33.64 a month.

People need to be aware that just because we say Canada is cheaper, it is not always cheaper. But for those drugs which are cheaper, page 75 has a little provision.

I need to explain how Canada gets this price fix. It is called negotiated price. How do you negotiate a price if there is a sole supplier? You really do not have much luck negotiating if it is a sole supplier, so you have to take similars. I use the example that if there are five heart medicines, you make those five bid against each other. That is your leverage. If you make them bid against each other, you have to drop somebody to get the price down, and probably several to get the price down, so maybe you have one or two heart drugs instead of five. But you tell your doctors--who in Canada work for the state--that is their choice, and they make it.

But in the United States, we are used to having our doctor make the decision. And because of television advertising, we are able to make some of our own decisions on what we think would be the best one and tell our doctor what he better do for us. Sometimes that is another little problem.

At any rate, that is how Canada gets lower prices. We can probably do that in the United States, too, but people in the United States really expect to be able to get the drug their doctor says they ought to have. I think we would have a large-scale revolution if we started suggesting that the Government could figure out which drugs they could have so we could get lower prices.

Page 75, section (b), that is where they say if a company has a drug that is in Canada, it has to be sold in the United States at the same price. So you really do not have to go through Canada. That will just move Canada's price fixing down to the United States.

I have to mention a little thing on pricing when the Government gets into that business. Back in 1975, I got married, and my wife and I started a shoe store in Gillette, WY. You will recall at that time that the Government decided they would put some prices in there. This really shows that it was 1975. We always made sure there were several styles of men's shoes that were under $10. I don't know if you can get the laces for $10--yes, you can. But you

cannot buy $10 leather shoes, leather lined, particularly not made in America. That has disappeared, too.

But they decided, for a whole range of products in the United States, that the Government would set the price to keep down inflation. The companies, as soon as they heard about that, said: This will really affect our profitability, and we are not going to be allowed to raise them except at set particular times and for set amounts. So what they did was raise their prices right away. A $10 shoe became a $15 shoe overnight. Then the price setting went into effect and they were allowed to raise it again, and they raised it again to the maximum there. And every time they were allowed to raise it, they raised it. It made a huge difference in the price of shoes, as it did with everything that was being attempted to be controlled. People wound up paying a lot more than if there had been no Government pricing.

How will that work here, if you are a pharmaceutical company and they say that you are not going to be able:

. . . to discriminate by denying, restricting or delaying

supplies of a prescription drug to a registered exporter or

other person in a permitted country that exports a qualifying

drug to the United States under this section. . . .

And you can't:

discriminate by publicly, privately, or otherwise refusing to

do business with a registered exporter or other person in a

permitted country that exports a qualifying drug to the

United States under this section . . .

And so on. I am reading from the bill here. What it says is that if you are selling it to them now, you can't change at all.

If I am the company that is about to find out that the price I have in this deal with Canada, which is just a small part of the deal, and I am doing it--I am the only accountant in the Senate. For accounting purposes, sometimes these companies will sell to another entity a ways away--in this case, another country--for a lower price because they cover the costs and make a profit on what they are doing. But by picking up peripheral sales, there is less cost involved in them, so there is still the same amount of profit. Granted, that is kind of an accounting technique, but it is the way a lot of businesses have to pick it up. That is why they keep going for additional sales and looking for ways to get additional sales. They have gotten additional sales in Canada by going through this bidding process which fixes the price.

But what we are saying on page 75 of this bill is that if you sell to Canada, you have to keep selling, you have to keep selling at the same price, and you cannot get out of the game unless--and here is the ``unless'' that I bet you kicks in--unless you are not selling to them. So unless there is some kind of ironclad contract that requires them to continue to do that, Canada is just about to lose its drug supply because they are not going to continue to sell up there at a rate that is below cost--if you are doing it at U.S. costs--if you can jerk that drug.

That is why Canada is a little bit concerned about what we are doing here. First of all, they don't have enough drugs in the pharmacy and enough pharmacies to supply 10 times their population, for the people in the United States, and second, they are worried because their supply will be cut off before this bill goes into effect, so it really doesn't go into effect. That would be the effect of it, that this would be 140 pages of wasted trees.

You have to believe, unless there is an ironclad contract, that is what a business would do. It is a terrible thing to have happen to Canada or the other countries. But that is what happens when you fix prices.

I would mention that on page 115, it begins a section on Internet sales of prescription drugs. I will give them credit for giving it a try. I will not give them credit for having a very complete or safe job on it, but it is a try. It is important for them to try because most of the people in the United States will be ordering their drugs, probably, through the Internet--perhaps over the telephone but not in person.

The examples we have heard of everything working fine have been of people going across the border in a car and buying at a pharmacy. That makes sure the trail of concern and safety is more likely to be there. But the Internet is a little bit more universal. Things can go around the world in a matter of minutes. They can go from one server to another server to another server--you are now covering three countries--and it looks as if it came out of the last country, perhaps, if you want it to look like that. There are a lot of things that can be done. I know the kids would probably understand that more than I would because they are able to do a lot more things on the Internet than I am able to do on it.

I know there are some difficulties with the Internet because the FDA has already intercepted problems and been able to confiscate some drugs that were tremendous problems. They are pretty sure some got into the country and didn't wind up in a situation of death, but they did find out they wound up in a situation where the person was not getting what they thought they were getting and it wouldn't digest and problems such as that. But they have also confiscated a huge amount of drugs which have been sold over the Internet which came into this country and which have a lot of problems.

I had a display up here on the desk. The Senator from North Dakota likes to hold up two pill bottles and say: What is the difference between these two pill bottles? One is the United States and one is Canada. What is the difference in price? And he goes through the pricing difference. But one of the things he ought to go through at the same time is: Can you tell which was made in the United States and which was not? Can you be sure the one you say was made in Canada was made in Canada? I will tell you, there are some absolutely marvelous counterfeits out there.

The box I have here has a couple of examples of confiscated drugs from the FDA. You cannot tell by the box, you cannot tell by the packaging, you cannot tell by the pill. I am even told that if you grind it up, you will wind up with the same components; they are just not put together right, so they don't work. But as long as it is not a lifesaving drug for you, you can get along with it, anyway, you just will not be getting the benefits from the drug. Something to think about.

There is a possibility of improving that section, because one of the amendments that has already been filed is by the Senator from New Hampshire, Mr. Gregg, who has been working this Internet problem for a long time. He has an amendment that is a vast improvement over this section and might be able to greatly enhance and perhaps correct some of the problems that can happen there.

I would mention one more. Page 131, a restricted transaction. See if you have the pharmaceutical literacy to know exactly what is happening here. A restricted transaction means a transaction or transmittal on behalf of an individual who places an unlawful drug importation request to any person engaged in the operation of a registered foreign pharmacy.

Now we have got to know who the registered and unregistered ones are and whether it is lawful or unlawful drugs. Again, there is so much literacy that has to go into this, as opposed to what you get in the United States, that you know it was from the United States.

We probably do pay a premium for our safety. Most people want to be sure they are safe. There is also a little bit of a problem with the bill the way it is written and being able to tell about the wholesale licensure and the pedigrees that go with that licensure. There will be another amendment that will be submitted that hopefully can clear up some of those problems. I hope people will work with us.

As you can see, one of the things we are trying to do is to make a problem better. I think it would have been a lot better if we could have gone ahead and had the drug safety taken care of today, which we were on a track to do, because Senator Kennedy and I had already worked through all of the amendments that had been turned in, with the exception of the importation one. We had been able to resolve or have them withdrawn for almost everything and could have wrapped it up with a few more votes. But it will take us a little longer now. We are hoping there are opportunities to improve the bill. I know under the procedure of the Senate there are ways to keep people from being able to have votes.

I mentioned a number of times the success Senator Kennedy and I have

had with the Health, Education, Labor, and Pension Committee, a big bite of the apple, the success we have had in the previous 2 years. Some was because we did not follow an exact procedure of going to a markup and arguing until things were polarized. We took what we could and worked with people through the process, and they trusted us enough to work through the process, so by the time it came to the floor, we had a managers' amendment that covered a lot of the difficulties people had with the bill.

When you put in an amendment, technically the amendment is one way or the other. Oh, yes, there are ways to do second-degree amendments, but you will not see many of those around here, because that is putting in another very concise set of words that is accepted or rejected. They can change the original bill a little, or perhaps a lot. Some of them can be complete substitutes. But they are polarizing, and they do not take care of the technicalities. The advantage of running the bill through this sized body, then through the other end of the building with 435 people, is to get 535 opinions of what ought to be done. Out of 535 opinions, we can usually come up with a pretty good bill. But when an amendment is put in and there is no way to do any correcting, or the only way you can do correcting is another take-it-or-leave-it bill correction to it, it is a very difficult way to get any legislation done.

Our success over the last 2 years of getting legislation done was because we worked this process of continually working until we got to a final product, which meant cleared through conference committee.

But evidently we are not going to do that this year with this piece. It was a significant victory for someone who has worked very hard on it. Senator Dorgan has worked hard on it for a long time. He did an outstanding job of presenting it. Now I am hoping he will work to see that it gets perfected a little bit more. It cannot be perfected in the way we normally perfect it, but a little bit more as we go through the process, and perhaps by about next Thursday we can finish with the bill. It is an extra week of work, but I think this could have been brought up in a separate bill, handled individually, and had some of the same mechanisms for improving it we would normally have in a bill. But that is behind us now. So we continue to work on the bill, and we hope by a week from today we can have this concluded.

Mr. President, I yield the floor, and suggest the absence of a quorum.

Mr. President, I rise today in support of this amendment by Senator Allard which would strike a cap on pediatric research incentives for blockbuster drugs with more than $1 billion in annual sales. That sounds like a lot. We are going to quibble here about whether they get 3 months of additional time or 6 months of additional time. They have had 6 months of additional time.

Incidentally, this is one time per drug. This is not every time they can come up with a child's use they can extend another 3 months or 6 months; this is one time on any drug, they can get an extension of 6 months.

Now we are going to decide that a company that comes up with a really great drug is only going to get 3 months versus 6 months because they make $1 billion in annual sales? Three months' worth would be $250 million in annual sales, and that sounds like a lot, but when you figure out what is profit out of that, it is a much smaller number.

I congratulate Senator Dodd for originally coming up with this incentive. He came up with the idea for 6 months, and it worked. You have seen the chart that shows how dramatically there was an increase in the number of drugs that were studied for kids and how proper doses were derived for kids. The Allard amendment ensures that pediatric studies that are essential to our children's health and well-being will continue to take place, that they

will continue the same as they have with the same incentives and the same requirements. Under current law, in exchange for performing a pediatric study, a manufacturer can receive an additional 6 months of market exclusivity, one time per drug. This is a powerful incentive to ensure pediatric studies are completed. The substitute amendment we are debating today limits this exclusivity to just 3 months, and I am concerned that this will reduce or limit the number of pediatric studies. Senator Allard's amendment would revert back to current law. If we support and pass the amendment of Senator Allard, we go to current law, so manufacturers can receive the additional 6 months of market exclusivity.

Before incentives, there were very few pediatric studies. In the 7 years before Congress authorized incentives, only 11 pediatric studies were completed; 7 years, 11 studies--embarrassing. But at least 132 pediatric studies were completed, and more are ongoing. The current incentive system works.

This is not an abstract policy issue. Pediatric drug studies can mean the difference between life and death for our children. For example, initial research indicates that Viagra, which is a blockbuster drug, can work miracles for children with pulmonary fibrosis, a rare and potentially fatal lung disorder. Viagra seems to relax and expand blood vessels in afflicted children's lungs. Incentives spurred Pfizer to perform studies that are now underway and could save approximately 28,000 children who might otherwise die or suffer greatly. Without powerful incentives, such studies might not get done.

The Democratic witnesses at the HELP Committee's--the Health, Education, Labor, and Pension Committee--recent hearing agreed that caps are a risky experiment. The number--zero incentives, 11 studies; strong incentives, 132 studies--that speaks for itself. Reducing incentives will certainly reduce the number of pediatric studies. We should not undercut a system that is proven to help kids and then say we are improving the program. I don't think so.

I strongly agree we need to do everything we can to make health care more affordable and accessible, but harming a worthwhile program that saves kids' lives is the wrong way to do it. It is wrong to play the politics of drug pricing at the expense of our kids. We should protect these incentives which are proven to work.

Again, I congratulate Senator Dodd for coming up with the idea of providing these incentives. I wish to note for the record it was at 6 months that we provided that. I ask that you support the Allard amendment.

I yield the floor.

One of the things we are trying to do is keep the debate on the children's amendment so we can get a conclusion to the children's amendment before time deadlines come up. So if those who wanted to speak on other issues can reserve their time until later, that would be very helpful.

Mr. President, I, too, encourage people to get their amendments to us, so we can talk about the amendments. The amendment process is a difficult thing around here because it doesn't allow for some of the tweaks noticed by people who have expertise in that area. If we get to talk about them first, sometimes there can be modifications to them before they are put in. We want to move this along and have some things to vote on at 4 o'clock today. I hope everybody will cooperate on it.

I thank Senator Kennedy and his staff and my staff who have been working together with anybody who has an amendment. They were working at 3 and 4 o'clock this morning on different things, trying to get them ironed out so that it would be possible to move the bill forward.

Mr. President, what's wrong with limiting exclusivity for blockbuster drugs? It is the exact opposite of what we should do. The whole point of the law is to leverage the large adult market for the benefit of the smaller kids' market. The effect of the cap will be to discourage companies from studying the effects of the most-widely used drugs on kids. Seventy-five percent of the drugs are not being studied under the current incentive. We need more studied, not less.

Are not companies only studying blockbuster drugs that make the most money, not the drugs needed most in kids? No. According to a Tufts University study, only about 10 percent of drugs with pediatric exclusivity are blockbusters. GAO says most products obtaining exclusivity have annual sales of less than $200 million.

Do companies get to choose the drugs they study? What is to stop companies

from ``cherry picking'' to make money, not help kids? No drug is eligible for pediatric exclusivity unless FDA requests, in writing, a pediatric study of the drug. FDA's decision is based on whether more information about safety and efficacy for children is necessary.

Doesn't the Duke/JAMA study demonstrate that 6 months of additional exclusivity is a windfall? It's been said that a cynic is someone who knows the cost of everything, and the value of nothing. That applies here. The Duke/JAMA study concluded that the financial benefit of exclusivity for blockbuster drugs often exceeded the cost of the pediatric study. This completely misses the point. This law is not about micromanaging drug company profits. It's about helping kids. In fact, the very last sentence of the study reads: ``Clearly, however, the greatest return of the exclusivity program is the benefit derived in obtaining new information relevant and applicable to the care of children, and this benefit should not be compromised.''

Companies can spend only a few million dollars on a study and get many millions in return. Shouldn't the reward be equal to the amount spent on studies? The incentive is designed to raise the priority of pediatric studies among all the competing research priorities for drug development within companies. Just covering the cost of the studies will not do it--the drug company knows it can put those same dollars into the development of a drug for adults that will earn much higher profits. Incentives work by making pediatric study more attractive than other studies for drug companies.

Aren't windfall profits unfair? No. The benefits to kids, and to society in general, from pediatric studies far outweighs the cost.

What are workability issues with the exclusivity cap? FDA says the cap has ``serious workability issues.'' It is unclear how FDA will obtain the right type of sale data or how the data's accuracy can be verified. FDA would spend lots of time litigating the validity of exclusivity decisions, and less time making drugs safe for kids.

Why shouldn't we restrict excessive drug company profit? The problem is not excessive profits. The problem is that most drugs aren't tested for kids. It is wrong to play the politics of drug pricing at the expense of kids.

Mr. President, I will have a lot more comments on this bill at a later time. In light of the comments by the Senator from North Dakota about the importance of reading the bill, I wasn't sure that I had read the most recent copy of it. I think I have the most recent copy of it now. It is a fascinating 140 pages that is being attached to our 300-page drug safety bill. The reason I am checking it is because in the past we have noticed some strong implications for safety problems with drug importation, and I want to make sure we are not opening the door for even more safety problems. I had hoped that the bill on safety wouldn't have to get into the safety of imported drugs, but I can see that is not the direction we are going. I am more than happy to address it.

I am fascinated by the discussion today because the people who normally are talking about free trade are now talking about some restrictions. That would be my side of the aisle. Those who normally rail at any kind of opening of the market to anyplace outside of the United States are the ones who are supporting this bill. It is kind of a reversal of situations.

I have heard the Senator from North Dakota talk about the way the Canadian Government is subsidizing the grain in that country and how that gives them an unfair advantage in the United States market and how we have to be sure that doesn't happen. Yes, the Canadian Government subsidizes. Yes, the Canadian Government gives an unfair advantage to their citizens. On drugs, the Canadians do some interesting things, too. They are a very small, limited market compared to the United States.

Sometimes in business when you are trying to price things, you say: I could pick up a little bit more in the market if I changed my price a little bit. But I am only willing to go after the fringe in order to do that. That is kind of what has happened in Canada. Canada has made it a little more difficult for the drug companies because they say: We are going to negotiate the price. I love that word ``negotiate.'' Normally that means there is a little give and take on both sides and some advantages that are picked up on both sides in order for the outcome that is derived.

In terms of pharmaceuticals, usually ``negotiation'' is the code word for ``price fixing.'' That is what they have done in Canada. They have fixed the price. If you want to be able to sell your drug up there, they will tell you what bid you better come in at and they are willing to have various pharmaceuticals bid against each other for the right to enter that fringe market, a small portion of what is in the United States but a potential customer. If you can cover your costs and pick up a few more sales, perhaps you can increase profits. It is a little accounting trick, but it happens. But they negotiate the price.

There are five drugs for heart that do similar things. They make the five drugs for heart bid against each other. That means one or two of them will win the bid. If your doctor prescribed one of the other three in Canada, you are out of luck. The decision by the doctor is taken away because you will get a good price on the pharmaceutical that may not be quite right for you, but it will be cheaper than what you could have gotten. That is not the way we work it in the United States. We try to have competition between all of the different products and hope that brings the price down.

There is some positive indication that it does bring the price down. We have the Medicare plan D. When they did the calculations on how much that was going to cost, it was considerably higher than what it actually came in at when there was competition among the providers, who in some cases represent more people than Medicare or Medicaid or the veterans and negotiate prices, but they negotiate realizing that we are forcing them to provide all of the pharmaceuticals, not just one or two out of five. If they are providing a plan, they have to provide for the prescription drugs.

When I was doing hearings across Wyoming, I had a little surprise almost at every meeting that I had to explain Medicare Part D. That was somebody saying: I can't get the prescriptions I really want. I was doing all of this promotion before Part D even went into effect. So I knew something was wrong with that kind of a response. It occurred to me that maybe those were veterans. We negotiate the price on drugs for veterans. That means when the Government is doing it, they have to say: You know, I don't think your price is low enough so we are just not going to make that available to our people.

Did you know that a whole bunch of veterans are taking prescriptions under plan D because they can't get what they want under veterans? It is an interesting situation. When you negotiate these things, you change some of the dynamics and you do not make everything available. I don't think we in the United States are going to settle for just having some, although if we can tap the cheap one in Canada where they fix the price, that will lend an advantage to people in the United States. I am ready to admit that. I am ready to admit if we didn't have restrictions on ethanol and subsidies in this country, we would bring in a whole bunch of ethanol from Brazil. But we are going to protect the ethanol. Again, it is a different group of people who are talking about that than are talking about drug importation.

Let me get back to drug importation because that is important. The Senator from North Dakota several times--in fact, all the time--used to say ``where are all the dead Canadians'' when he was talking about safety. That is what my colleague from North Dakota used to come down to the Senate floor and say when he was talking about importation. He always asked that question. It may have escaped the notice of those of us in this body that he didn't ask that question anywhere in yesterday's debate or today's debate. Why not? Because two summers ago, five people in Hamilton, Ontario, died from taking counterfeit Norvasc. Norvasc is a blood pressure drug taken by millions upon millions of people who rely on it for their health and well-being. Since so many people take it, it is a target for counterfeiters looking to make a quick buck. I know he did say that counterfeiting is going to happen anyway. Probably. It happens in virtually every industry, and there are some countries that actually specialize in it. But imagine opening an opportunity for counterfeiters, an opportunity for them.

In the portions of the bill I have gotten through already, I know there are some pretty tight restrictions on who can be an exporter and who can be an importer and how packages will be labeled and all of those sorts of things. It is a marvelous effort to try to tighten it up so that what you buy is what you think you are getting. But how many of us, when the program was to first start, would know what to look for or even who to order from in order to be sure the drugs we are getting are safe? How do you do that? It is a tremendous opportunity for counterfeiters. We already have a problem with counterfeiters. There is no way you can write off the counterfeit argument.

I ask unanimous consent that I be able to show some three-dimensional objects on the Senate floor, the same as the Senator from North Dakota.

I will leave this on the desk so people can take a look at it. This is the Norvasc product with which the Canadians had a problem. It killed people. I want Members to take a look at the packaging. I have the external packaging. I have the internal packaging. I have the pills themselves. I challenge anybody to see the difference. We are going to put some special labels on anything that gets shipped into the country. I am sure nobody would ever be able to counterfeit any labels that were coming into the

country. It just couldn't happen. There are now dead Canadians, and it saddens me to say that I believe there will be even more. These unfortunate individuals got their fake pills from a brick-and-mortar pharmacy. If that is what is happening when you buy drugs in person in Canada, who knows what you might get when ordering from a Web site that says it is in Canada but could really be based anywhere in the world.

In fact, some of the drugs that have been intercepted by the FDA have come through Canada but actually were from Saudi Arabia. Communication worldwide is transparent these days. Whom you think you are ordering from is not always whom you are ordering from. Right now that practice is referred to as hiding the maple leaf.

I would like to invite my colleagues to visit with me when I am finished my remarks. I have these pills I would like them to take a look at. There are other examples, too.

So anybody who holds up two bottles and says, this one is this and this one is this, they can't be sure if the one that is being imported is really from the country they are talking about. It has to be a concern. That has to be tightened up. There have to be some ways people can really tell.

There is also a difference between whether you are importing for an individual or you are importing for a pharmacy. If you are importing for a pharmacy and they get a counterfeit load, it is not just one person who dies. It is the whole community, everybody who is taking that medication. So there needs to be some concern with these things.

As I said earlier, we all want to have affordable drugs. We would like to bring down the cost of medicine every way that we possibly can. But a counterfeit or tainted drug is unsafe at any price.

I want to add another thing on the counterfeit drugs. You can take the pills and you can grind them up and do a chemical analysis of one pill against the other, and they will come out identical. Now, part of the problem is the way you put these together to make them dissolve properly so what you need in your bloodstream gets into your bloodstream.

A number of the imported drugs that have been confiscated are shown they will not even dissolve. If you take a pill, and it goes completely through your whole system, you could die. It is a serious problem. It looks good, it even checks out good, but there are processes for putting these things together.

From my brief reading of the bill, I am also worried about some of the biologic information that may be in there that could be imported as well.

The Food and Drug Administration Revitalization Act is about restoring the trust of the American people in the FDA. That is where it belongs. We should have a lot of concern.

There is an amendment that is going to come up everybody is working on right now to make sure it would work, and it talks about some increased safety with food. Now, food, some of it, such as tomato packaging, is pretty well there. It is not put in another container. It is hard to fake. But there can be problems. We had problems with spinach in this country. We have a big problem with pet food right now, and it is because of China.

China--how much do you trust them with your drugs? We have been trusting them with our pet food, and they are killing our pets. It took a little thing called melamine that increases the protein count in the food. It does not increase the protein, it just increases the protein count. It makes it look like a much richer food than it is. Unfortunately, it kills. Unfortunately, they have not just been using it in pet food; they have it in their regular food chain, and children--young children--got it, and the children died. When they checked on it, they found out they died of starvation, even though they had what should have been a good protein diet. There was a little melamine in it, and it was starvation rather than poisoning.

But if they do that to food products, how much would we worry about drug products that come in from there? I know there are some limitations on where they can come from, but if they get into the European Union, there does not appear to be any constraint on it then, and it could be transferred on over to the United States. So throwing our borders open to drug importation would, instead, falsely place trust in criminals trafficking in illegal pharmaceuticals.

I think the American people deserve better. I hope we do not make this move at this point in time, and that we constrain the bill to those things we know will add safety to our pharmaceuticals and medical devices and things for children in this country.

I yield the floor.

Madam President, I thank the Senator from Illinois, Mr. Durbin, for his tremendous work and creativity and willingness to make revisions to his amendment so that we can clear up outstanding concerns or clarify outstanding concerns people might have had with it. I think we are at the point where that is the case. I would like to make a few comments on it myself.

Food safety is an issue that affects us all. It is not a partisan issue. We all want the safest food supply possible. It is, instead, our shared goal, a goal that requires cooperation and teamwork through a complicated process, and we have had that.

For many of us, the safety and reliability of our food system is something we all too often take for granted. Day by day, we consume our favorite beverages, enjoy a quick snack, or sit down to a meal at a local restaurant. We rely on a system of checks and balances that takes place behind the scenes that we are often unaware of until something goes wrong. Then and only then do we realize how dependent we are on the food safety system that is supported by the activities carried out by the Federal, State, and local government agencies, as well as by the food industry itself. Together, they inspect, test, research, and monitor our food supply from the farm or ranch where it is produced to the family dinner table where it is consumed. The type and amount of oversight they exercise depends on the food product, and the degree of regulatory scrutiny they demand is commensurate with the degree of risk.

In addition to these longstanding authorities and the activities of food safety, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 required the Food and Drug Administration to register food processors, inspect their records, and detain adulterated food. It also requires the Food and Drug Administration to issue regulations to ensure the safety of imported foods.

Food safety has been making news lately. From E. coli in fresh spinach to salmonella in peanut butter to melamine-contaminated pet food, we hear a constant drumbeat of food safety problems.

The United States has one of the best food safety systems in the world, but even in the best of systems, there is room for improvement. Those improvements can take many forms. For example, we can address how food becomes contaminated in the first place, and we can make advances in the processing and handling of food. Our surveillance, testing, and reporting systems represent areas we should evaluate, as well as internal and external communications. Interagency cooperation and coordination between Federal and State officials is critical in identifying, tracking, and responding to outbreaks of foodborne illness.

The amendment offered by my colleague, Senator Durbin, contains several important elements in that response, but it is the beginning, not the end, of the process of food safety. This amendment does a number of important things. It establishes standards for pet food and sets up early-warning systems for any problems with pet food. The amendment improves communications systems about all food recalls, and it coordinates State and Federal activities on fresh and processed produce. Finally, the amendment creates a database of instances of adulterated food so that the FDA can better track patterns of problems and target its limited resources where they are most needed.

I am pleased we are able to work across party lines to develop an amendment today that we can all support, and I ask unanimous consent to be a cosponsor, along with Senator Allard.

However, there is much more work to be done. This amendment is a good first step on the road to a comprehensive response to food safety.

In March 2005, Senator Kennedy and I announced that we were working to develop a comprehensive response on another FDA issue, which is drug safety. The bill on the floor this week is a direct result of that announcement and

that pledge to work together. So when I pledge today to work to develop a comprehensive response on food safety, you can have some sense that I do mean that. I want my colleagues to work quickly and diligently to get this amendment to the point where we can accept it. I know we have it scheduled for a vote at the moment, too.

Madam President, I yield the floor.

I thank the Senator from Louisiana for his patience on this amendment, and also his understanding that he would work with my staff and the staff of Senator Kennedy to see what can be done to make our drug supply safer. I appreciate that.

I also thank him for all the efforts he has made on behalf of the Louisiana turtle farmers, which was a new industry to me--although they have been exporting turtles all over the world for years--for the work he did drafting and putting together a mechanism for eliminating salmonella in turtles so they can be, once again, pets in the United States.

The heart of the debate is how to construct a regulatory framework so that biologic drugs can be safely available under an accelerated pathway. It is more difficult to approve biosimilars than to approve generic versions of typical drugs. The balance we are trying to find is a compromise that promotes access with innovation, while also maintaining the high standards of safety at the Food and Drug Administration.

Biologics are complex molecules modeled after key processes occurring daily within the human body. One analogy is that if a typical drug was a 3 bedroom, 2 bath starter home, a biologic would be a skyscraper. The size, scope and complexity are completely different. The nomenclature is, too. As key scientists stated at our HELP Committee hearing on this topic, these are not generic biologics but biosimilars.

With many drugs, we can describe their structure with a high degree of precision--but not with follow-on biologics. You can't make an exact ``copy'' of a biologic, like you can for most typical generic drugs. For example, if I was to try to build the skyscraper of a biologic without the blueprints, as any generic company would need to do to create a follow-on biologic, I would have to ensure that every copy was identical or there could be fatal results.

Because of this, science must be an essential part of any safety standard.

One piece out of place would cause the entire structure to fall.

But to be clear, a safe pathway for an accelerated approval process for biologics, that also preserves innovation, is possible. It is not just me who believes it--the FDA, generic and pharmaceutical industries have all said so as well. I have been working across party lines with Senators Hatch, Kennedy and Clinton to develop legislation that does just that. Our staffs have been working tirelessly on this topic: individually meeting with experts and stakeholders; and as a group, talking with experts from the United States and global leaders. After all, we want the same end result--legislation that ensures medicines are safe and affordable, and that medical innovation continues to flourish.

I have a track record of working across party lines to build consensus and find common ground on tricky legislative issues. I know that with a little more time, and through regular order, we will develop a bipartisan package that accomplishes our common goals.

I concur with the chairman and am committed to moving a bipartisan bill through the HELP Committee in the near future with the goal that it can be joined with the conference on the FDA Revitalization Act.

Mr. President, I move to lay that motion on the table.

The motion to lay on the table was agreed to.

It might be helpful if I explained the provision you are discussing, as my office has received many calls as well and I believe the callers are not informed about this matter. Subtitle B of title II of S. 1028 establishes the Reagan-Udall Foundation for the Food and Drug Administration. That simple purpose of that nonprofit Foundation is to lead collaborations among the FDA, academic research institutions and industry designed to bolster research and development productivity, provide new tools for improving safety in regulated product evaluation, and in the long term make the development of those products more predictable and manageable.

Yes, we took great pains to make certain there would be no conflict with DSHEA. Regarding foods, and dietary supplements are generally regulated as foods, the general directive of the Foundation is to identify holes in the evaluation of food safety and identify ways to address those deficiencies through collaborative research with industry.

I agree with Chairman Kennedy's assessment.

Mr. President, I rise to speak about the Student Loan Accountability and Disclosure Reform Act which I, along with Senators Alexander, Burr, Isakson, Allard and Murkowski, am introducing today. In this era of rising college costs, it is more important than ever to make sure that the colleges, lenders and guaranty agencies that provide loans to help students pay for college operate in a fair, accountable and transparent manner.

In fiscal year 2007, the Federal Government, through the Federal Family Education Loan, FFEL, and Direct

Loan programs is expected to back and provide $65.9 billion in new loans to students and their parents for attendance at over 6,000 schools. The FFEL program accounts for about 79 percent of new student loan volume. There are approximately 3,200 FFEL lenders. Thirty-five State and private, nonprofit guaranty agencies back the FFEL loans.

Overall, the programs are expected to provide financing to 14.3 million students and their families this year. These students and their families are depending upon us to protect them from those individuals who are using the financial loan programs to benefit themselves to the detriment of students.

The focus of this bill is to make colleges, lenders and guaranty agencies accountable, by prohibiting lenders and guaranty agencies from offering inducements, and colleges from accepting them, and by requiring disclosures to students, their families and the public.

There are a lot of ethical, hard-working financial aid administrators and lenders who have spent their lives helping students go to college. It is a shame that a few bad actors have cast a shadow over the whole student loan industry. However, in light of recent revelations about the behavior of a few college officials and a few lenders, it is clear that we need to take steps to protect students and their families from any actions and arrangements that are not fully disclosed.

A key part of this bill is a Code of Conduct for institutions of higher education. It prohibits colleges and their employees with responsibility for student financial aid from receiving anything of value from any lender in exchange for advantages sought by the lender. The prohibition applies not only to gifts and trips, but to compensation for service on advisory boards and consulting contracts.

Colleges are prohibited from designating ``preferred lenders.'' However, they may collect information from lenders, at the college's invitation or upon the request of a lender, including interest rates, payment of origination and other fees, discounts, services and terms and conditions of the loans, and the lender's contact information, on a standard electronic template. All templates submitted will be made available to current and prospective students and their families. Colleges will provide students and parents with a guide that enables the students and parents to do their own evaluation of the loan products, benefits, and services offered by the lenders. An annual attestation of college compliance by a high level college official with the Code of Conduct is required.

The bill expands prohibitions on guaranty agencies and lenders, including provisions that prohibit the offering of any premiums, payments, prizes, and tuition payments. Guaranty agencies are precluded from performing any services for colleges without compensation. Lenders may not provide information technology equipment at below market value. Both lenders and guaranty agencies are prohibited from sending unsolicited electronic mailings to potential borrowers.

Finally, the recent revelations of questionable relationships between colleges and lenders have led to new calls to eliminate any areas of potential conflicts of interest. For this reason, it is time to phase out the ability of colleges to act as lenders in the FFEL program, a provision commonly referred to as ``school-as-lender.''

Higher education is crucial to maintaining America's competitiveness. Education at all levels, including lifelong education opportunities, is vital to ensuring that America retains its competitive edge in the global economy. In this global economy, learning is never over and school is never out. If students and families are to make informed decisions about how to pay for college, they must have clear, accurate, comprehensive information on which to base their decisions.

We must help and protect the 14.3 million students and their families who will seek student loans this year to pay for the education they need. Therefore, we must maintain the integrity of the student loan programs. Let's fix the system and restore the confidence of students that they are being treated fairly from the beginning, and through the time they are repaying their loans and realizing their goals.

I want to thank Senators Alexander, Burr, Isakson, Allard, and Murkowski for joining me in this effort.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, I rise to speak about the Student Loan Accountability and Disclosure Reform Act which I, along with Senators Alexander, Burr, Isakson, Allard and Murkowski, am introducing today. In this era of rising college costs, it is more important than ever to make sure that the colleges, lenders and guaranty agencies that provide loans to help students pay for college operate in a fair, accountable and transparent manner.

In fiscal year 2007, the Federal Government, through the Federal Family Education Loan, FFEL, and Direct

Loan programs is expected to back and provide $65.9 billion in new loans to students and their parents for attendance at over 6,000 schools. The FFEL program accounts for about 79 percent of new student loan volume. There are approximately 3,200 FFEL lenders. Thirty-five State and private, nonprofit guaranty agencies back the FFEL loans.

Overall, the programs are expected to provide financing to 14.3 million students and their families this year. These students and their families are depending upon us to protect them from those individuals who are using the financial loan programs to benefit themselves to the detriment of students.

The focus of this bill is to make colleges, lenders and guaranty agencies accountable, by prohibiting lenders and guaranty agencies from offering inducements, and colleges from accepting them, and by requiring disclosures to students, their families and the public.

There are a lot of ethical, hard-working financial aid administrators and lenders who have spent their lives helping students go to college. It is a shame that a few bad actors have cast a shadow over the whole student loan industry. However, in light of recent revelations about the behavior of a few college officials and a few lenders, it is clear that we need to take steps to protect students and their families from any actions and arrangements that are not fully disclosed.

A key part of this bill is a Code of Conduct for institutions of higher education. It prohibits colleges and their employees with responsibility for student financial aid from receiving anything of value from any lender in exchange for advantages sought by the lender. The prohibition applies not only to gifts and trips, but to compensation for service on advisory boards and consulting contracts.

Colleges are prohibited from designating ``preferred lenders.'' However, they may collect information from lenders, at the college's invitation or upon the request of a lender, including interest rates, payment of origination and other fees, discounts, services and terms and conditions of the loans, and the lender's contact information, on a standard electronic template. All templates submitted will be made available to current and prospective students and their families. Colleges will provide students and parents with a guide that enables the students and parents to do their own evaluation of the loan products, benefits, and services offered by the lenders. An annual attestation of college compliance by a high level college official with the Code of Conduct is required.

The bill expands prohibitions on guaranty agencies and lenders, including provisions that prohibit the offering of any premiums, payments, prizes, and tuition payments. Guaranty agencies are precluded from performing any services for colleges without compensation. Lenders may not provide information technology equipment at below market value. Both lenders and guaranty agencies are prohibited from sending unsolicited electronic mailings to potential borrowers.

Finally, the recent revelations of questionable relationships between colleges and lenders have led to new calls to eliminate any areas of potential conflicts of interest. For this reason, it is time to phase out the ability of colleges to act as lenders in the FFEL program, a provision commonly referred to as ``school-as-lender.''

Higher education is crucial to maintaining America's competitiveness. Education at all levels, including lifelong education opportunities, is vital to ensuring that America retains its competitive edge in the global economy. In this global economy, learning is never over and school is never out. If students and families are to make informed decisions about how to pay for college, they must have clear, accurate, comprehensive information on which to base their decisions.

We must help and protect the 14.3 million students and their families who will seek student loans this year to pay for the education they need. Therefore, we must maintain the integrity of the student loan programs. Let's fix the system and restore the confidence of students that they are being treated fairly from the beginning, and through the time they are repaying their loans and realizing their goals.

I want to thank Senators Alexander, Burr, Isakson, Allard, and Murkowski for joining me in this effort.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

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.

Mr. President, I rise at this moment to support the substitute that has been put into S. 1082, the Food and Drug Administration Revitalization Act. I have said a lot about this important bill, and I do intend to say more. The most important thing I can say right now is this is the product of a lot of bipartisan work by members of the Senate Committee on Health, Education, Labor, and Pensions. We have a great process that wound up with a work in progress, which wound up with this substitute bill.

Now we do have one major outstanding issue to figure out; that is, the direct consumer advertising for prescription drugs. I do believe we will work something out, but we are not quite there yet. So I would ask my colleagues' indulgence to work that out, and I hope I have the assurance of the

chairman that we will engage in a serious dialog about the various provisions that are included in that direct consumer issue. That will be a real key to finishing up.

I congratulate the Senator from Massachusetts, Mr. Kennedy, for the outstanding way he and his staff have worked with all the Members on our side of the aisle to clear up. As he said, in some cases, clarifications were needed, and in some cases it was the expansion of wording; in some cases, a reduction in wording. But, at any rate, we got it to where I think both sides understand and agree on many of the issues that are included. I hope we can have other amendments brought to the floor so we can debate them and get them worked out.

Of course, it would be nice if any Senator thinking about offering an amendment would share their idea with us prior to filing it. We might be able to save some time that way and make sure debate flows in an orderly process. We are trying to keep the bill to relevant amendments.

Madam President, I am going to make even briefer remarks than the Senator from Massachusetts did.

One of the questions I had been asked over the weekend was: Why hasn't the President already vetoed the supplemental appropriations bill? He promised he would veto the bill because it has all this extra spending in it, with directions on the war from people who really are not even involved in administering the war.

Of course, what I found out is the bill has not even been sent to the President yet. He cannot veto a bill until he receives a bill. So to chastise him for not having already vetoed the bill when there is a hold card keeping him from being able to veto the bill I think is unconscionable. Hanging on to that bill and not getting it there so the decisions can be made on it one way or the other just is not right. That is not the way to run the Senate. It is not the way to run the country. And it is not the President's fault if he does not have the bill to make the decision.

There can be a lot of debate on what that decision ought to be made and how to carry them out. I am certain the President will veto the bill; he has been very clear on that. There is a differing philosophy on how a war ought to be run. There are a lot of people throwing in the towel. It is kind of hard to win at anything if your opponent knows the point at which you are going to give up.

That is where we are in this battle, with the complete direction to give up, to throw in the towel, to say what has been done over there has not done any good, won't do any good, and to keep calling it a civil war. It is not a civil war. It is a religious war that is brewing. There is a tremendous difference. It is a religious war that involves the entire Middle East, not just Iraq. And in preparation, for what the other people in the Middle East have heard said on the Senate floor, armies are gearing up in Saudi Arabia and Syria and Israel and Iran, ready to move into the vacuum that would be caused by a U.S. departure.

That will not be the first time there has been a religious war in the world. If we do not step in, it would probably be the first time we had the chance to stop a religious war and did not help.

So we could leave, have a regional religious war, and then try to decide what we are going to do about that.

Religious wars are not easy things to solve. We have seen that with Kosovo with religious genocide. We got to see what happened in Kosovo. We helped out in Kosovo just as we are helping in Iraq.

So, Madam President, I hope we would actually debate the Food and Drug Administration bill, which is what we were set out to do this week. I hope people who have amendments would bring the amendments to the floor.

Madam President, I thank the Senator from Massachusetts for his comments. I'll make a slight addition to what he said. For some, it may not look as if there is a lot of progress being made, but I assure you there is a lot of progress being made. One of the secrets to our committee operation--which used to be one of the most contentious committees in the Senate, and now it works productively on issues such as this to get things done--is that we recognize if somebody brings an amendment to the floor and we have not heard about it before, it creates difficulty. When the amendment is filed, we don't have a real good process for amending an amendment. Technically, we can, but it requires a lot of time and votes. In the meantime, it polarizes people. Instead, we take a look at them, talk about them, and we use the body of knowledge we have gained from a lot of hearings on the issue to show where there could be inconsistencies and problems with the amendment. We get the problems ironed out so the amendment can have a logical chance for inclusion if it adds to what we are doing.

That is what is going on as we are speaking. The Kennedy staff and the Enzi staff, and those Senators with amendments are meeting together and working out difficulties. We will accept many of them. Some of them are already in the substitute bill we have. So a lot of progress has already been made on this bill. We want to get the remaining things cleared up. We would like to get it done tonight and tomorrow, if possible. I think we are getting a long way down the list now on problems that people had with it, and we are getting those cleared up in a way that I think both sides can agree on.

So that is why this is not quite as controversial as some people might expect or perhaps even want. I thank the Senator from Massachusetts, Mr. Kennedy, for all his cooperation on this and the tremendous effort of all the staff. We need people to come down with amendments, particularly if they have something new that we have not heard about.

I yield the floor and suggest the absence of a quorum.

Mr. President, I wish to thank the Senator from New Hampshire, Mr. Gregg, for the tremendous effort he put into this bill. He spent years on the committee. He became chairman of the committee. He used those years with the institutional memory and the experience with a great deal of diligence and creativity which he has always used on that committee to provide us with fuller explanations and wording for several of the provisions that are in this bill.

I thank him for helping us to perfect those and the diligence he always has on all of the issues we bring up in the committee. I also appreciate the work he has done on Internet safety. This is not something he just developed now. He has been working on it for at least 3 years that I am aware, to make that as safe a system as possible if we ever have to put it into place.

I am hoping we will not have to have that full debate at this time and appreciate his submitting it in case we need to have that debate.

I also appreciate the explanation he gave on the follow-on biologics. It is a hard thing for people on the committee who have been through a number of hearings to understand. I am sure the public as a whole has an even greater difficulty with it. But it is a whole new phase of medications. By the name, ``biologics,'' it is alive. That makes it a lot more complicated than a set of chemicals that are ground up and put together in a particular order. Even with the chemicals that are ground up and put together in a particular order, if they aren't done quite right, they would not dissolve and people do not get any benefit from them. That is why we are doing the bill. Then we will be working on biologic similars to see if there is some way that that can be done effectively and safely. I thank the Senator for his comments and his tremendous work.

I yield the floor.

Madam President, I wish to thank the Senator from Massachusetts, Senator Kennedy, for his outstanding presentation on what is in the bill.

I rise to speak about S. 1082 as well. It is a comprehensive bill to enhance drug safety and provide key resources to the Food and Drug Administration--the FDA--for the review of new drugs, for the review of medical devices, and to ensure that drugs and devices for children are safe and effective. It has been a long and careful road for this bill.

The Senate Committee on Health, Education, Labor and Pensions embarked on a top-to-bottom review of the FDA's drug safety and approval process over 2 years ago. This bill is the culmination of our review and the input of hundreds of stakeholders. I wish to speak for a few minutes discussing why the drug safety components and the changes that are being made are so critical to restoring the

peace of mind to Americans who want to be assured the drugs they purchase to address illnesses and chronic medical conditions can be relied on and trusted.

``Bipartisan'' is a word that is kind of thrown around in this Chamber a lot, and sometimes it means that one person from one party joins several people from the other party. For Senator Kennedy and me, bipartisan means you actually work together to find out what the problem is, what the potential solutions are, and how you can meet those needs. I mentioned it has been a long process--over 2 years--and it is still a work in progress--and we are making progress.

We held hearings on the FDA. A lot of those hearings were held in the heat of the moment, when certain drugs were having problems, and we recognize that is a problem. One of the problems with Congress is we usually see that if it is worth reacting to, it is worth overreacting to. We have always taken a very careful view in our committee to make sure that was not the case.

Other committees held hearings on the FDA, even though the FDA is under the jurisdiction of our committee, and we have no problem with that. We have taken the suggestions we have gotten through those hearings and considered them for this legislation. Then we drew up a list of principles, and we took that to the stakeholders to see what all the people involved thought about the principles we had. Then we did the tough part. We drafted the details. It is easy to sell concepts, but details are tough. Until you have those details put down in writing and have people look at every word that is in them, you can't tell whether you have a bill. But we went through that process. We took it back to the stakeholders. We redrafted. We filed the bill. We had more hearings. This year, we have had more hearings on FDA, and we have had a markup. That is when all the Committee Members are offered a chance to request or suggest amendments to the bill.

We probably had about 50 amendments and we worked on the 12 major categories of amendments. Some of those were worked into the bill as part of the markup. Some of them have been put into the manager's amendment. I mentioned this is a work in progress. We are still looking at some of those, figuring out what is needed and how to get there. I appreciate the cooperation we have had from the Members with their suggestions and the staffs of the Members with their suggestions, because throughout the last weekend, there were hours and hours and hours spent by Senator Kennedy's staff and my staff and the interested Senators and their staffs to arrive at the best possible solution. We are not there yet. We are close. That is the way we work on bills--a long process with decisions being made up to the last possible moment so that we can have the best possible solution for the people of this country. That is bipartisan.

It was mentioned there have been some hearings on food safety. Recently, there has been some real criticism of the FDA on food safety. We held hearings on food safety. I don't want the people of this country to think it is all bad. In fact, I was amazed that three Federal agencies have to work together on a food problem. The CDC, the Department of Agriculture, and the Food and Drug Administration have to work together because each of them has a role in discovering whether there is a problem. I was amazed to find out that with as few as 50 cases spread out across the whole United States, they can diagnose and determine there is a problem and get products off the market. If you are not amazed with that, you are not paying attention. We have agencies that work together, and they work together in critical times to solve problems for the people of America. They can notice, with a real small sampling--when you consider the millions of people in this country, the millions of people who are being fed every day,--they can recognize a problem with the food supply and get the harmful product off the market. It would be nice if they could prevent that. They are working on that.

But when you consider the number of producers in this country and other countries, they have a tremendous job, and we have to be sure they have the tools to do that job as well. But that is a job that is in addition to the drug approvals. This bill concentrates on the drug approvals.

Vioxx was one of the triggers of these discussions. As we saw with Vioxx, the FDA doesn't have enough tools to deal with newly identified risks when those risks become evident after a drug has been on the market for some time. Most of the FDA's current authority is based on information and plans available at the time of approval. They have a massive job determining if a drug is ready to go to market. What is amazing is that once they have given that approval, their options are very limited. Now, that creates a little bit of a dilemma for them. They don't know everything that will happen with that drug. Yes, it has been through clinical trials. What is a clinical trial? It is a controlled study of people taking the drug, and sometimes people who are not taking the drug--a controlled study. Once that drug is approved, it goes out to the whole market--not controlled people, not people that we know what other drugs they are taking or what other kinds of things they are doing. That can have a different result than under a controlled situation.

The FDA's choice has been to take the information and approve the drug and then monitor the drug, but have relatively few tools after that point. What can be the result of that? The FDA can say let's really be careful before we approve this because we will have expended our toolbox. They have said: If you will give us a bigger toolbox for after the approval, we can approve the drugs quicker. We can have some assurance that because of the controlled study things will be fine. But we won't have to worry quite as much about preapproval because we will have tools after approval--tools for quick recognition of additional problems as it goes out to the major markets.

We need to have that happen if we are going to have safe drugs in this country. We have always relied on that, and we expect that. The FDA, for the most part, has delivered.

So much more needs to be done to clarify the FDA's authority, to give them the bigger toolbox so that FDA can proactively react to additional safety information whenever that safety information is discovered. That is the purpose of this underlying legislation. The FDA does have some authority to manage the risks of drugs--for drugs such as novel cancer therapies approved under subpart H for accelerated approval. Is that faster approval? The FDA has the authority to apply restrictions on distribution and use for those drugs at the time of approval to provide further safeguards against misuse and adverse reactions. However, if such a risk is determined after the drug is on the market, the only option FDA has now is to pull the drug from the market, disrupting patient care.

Some of the people who have that drug are deriving a tremendous benefit from it and are not having the adverse reaction and would feel hurt if it is pulled away from them as the only option that the FDA has. The FDA does not want to disrupt patient care. The FDA just wants to protect patients. Those who need the protection they want to help; those who don't need the protection ought to be able to get the continuing patient care. The option now, I repeat, is to pull the drug from everybody. Then, of course, they can put it back on the market so it can apply those special risk management tools. We have chosen to give the FDA in this bill the authority to impose those restrictions after a drug comes on the market, too, so there is no disruption in patient care.

The bill also makes several key improvements to how patients get their information through advertising and labeling. The changes ensure that patients get access to new and changing information in a timely manner. As Vioxx made clear, FDA has very little authority to require labeling changes postmarket. Those changes are primarily negotiated and they don't have any time limits on the two parties coming to agreement to the labeling change.

Now, we have included provisions that ensure that those discussions between the FDA and a drug manufacturer come to a close, rather than relying on the FDA's ``nuclear option,''

which is pulling the drug from the market. It hurts a lot of patients and disrupts their care.

Imagine a system that gives the FDA, through sound science and remarkable innovation, the tools to get drugs to the market quickly and efficiently, especially when lives are on the line and people need new drugs and therapies. Imagine a system that gives the FDA new authority to take swift, appropriate, and decisive action to ensure patient safety and protect consumers when new information comes to light to expose unexpected risks. We can make this a reality with the passage of this bill.

FDA doesn't have a current mechanism for active, routine surveillance of potential safety problems. Thus, it cannot as readily detect safety problems after a drug has been put on the market--short of a catastrophe. FDA has minimal authority to require additional observational studies or clinical trials after the product is already on the market. FDA cannot even make companies finish studies they have agreed to pursue concerning safety impacts on patients.

Given the current FDA limitations, I strongly felt it was necessary to correct those problems and ensure that FDA has the right tools and toolbox to address drug safety after the drug is on the market. That is why this bill creates the risk evaluation and mitigation strategy, or REMS. The REMS gives FDA a full toolbox of options for dealing with potential safety problems, even if they are discovered after a drug is first marketed. I hope you are noticing a trend.

With this new toolbox, FDA has the ability to identify side effects after the drug is marketed through active surveillance. FDA also has the authority to request a separate study or clinical trial to learn more about a particular potential safety problem. FDA can also obtain timely label changes for the first time under the new REMS system.

How does this all work together? A house cannot be built without a foundation. Routine, active safety monitoring using large linked databases--what I like to call ``health IT for drug safety''--is the foundation. Risk evaluation and mitigation strategy, or REMS, is the house.

I thank the Senator from New Hampshire, Mr. Gregg, for all of his work on health IT for drug safety and his emphasis on being able to have the right surveillance and the right triggers to be able to put these things into place at an appropriate time. In designing that house, you can have a small, simple house, or you can have a big fancy house. The size and complexity of your house should match your needs. The REMS is customizable, buildable to address whatever risks are present for the drug in question. The REMS allows you to build an addition for your house if your family grows, for example. You can also move into a smaller home if you find you don't need so much space.

Let's talk about how this would work. Let's say drug A treats high blood pressure, has very few side effects. Therefore, the label and use of routine, active safety monitoring will be enough to manage the risk. Drug A doesn't need a REMS. However, drug B, which also treats high blood pressure, has serious side effects, including occasional liver failure. The label and use of routine, active safety monitoring is not enough to manage the risk. Therefore, drug B needs REMS.

The REMS will include extra warnings on the label, perhaps periodic letters to doctors to remind them of the risks, and require testing and a system to test patients for liver enzyme levels before they are allowed to fill a prescription. As I said, not every drug needs a REMS. However, every drug will need a very active FDA with all of the necessary tools to identify and quickly manage additional risks.

Like everyone else, when I purchase a product for myself, my children, or my grandchildren, I want the assurance that the product is safe and beneficial. This bill gives the FDA the necessary resources and tools so that moms and dads are able to trust that product at the pharmacy counter and know that it is safe and effective.

As I mentioned, this bill is still a work in progress. There are a dozen amendments, several of which have been in the managers' amendment, and several are still being worked on. We do want faster drug approval, but we want assurances that as the whole population becomes a clinical trial, connections can be made quickly to any problems without the need to pull the drug off the market and away from those who could benefit. I will have more to say about other potential things that will not be in this bill that I think would complicate the bill or maybe be adverse to what we are trying to do in the bill, and some of them that have not had enough study yet. I will comment on those as they come up, if they come up.

At this point, I yield the floor.

I thank particularly Secretary Leavitt and those people on his staff. We had discussions over the weekend. They had some suggestions for changes. We asked for more detail on those changes. We also asked for them to be prioritized. I was pleased they were delivered within a matter of a very short period of time. That shows people in Government can work together and that they do work on the weekends to get these things done. A lot of people think when we go into recess for a weekend, all work around here stops. But there are dedicated staff who put their best effort into getting together and working together, sometimes in very tense situations and long hours, mostly through the night--last night. Then they have to draft what has actually been decided. It is a very difficult process. We owe them a great deal of credit. I want the American people to know that, too.

I yield the floor.

I also request unanimous consent, on behalf of one of my staff members, to have the privilege of the floor during discussion on this important bill. That will be David Schmickel.

Mr. President, I would like to speak about community spirit. In the Senate, we work day in and day out to pass good policy that will provide for the safety, security, and health of

the Nation, but we are not alone in our effort to make our country better. In fact, we are but a small part. There are great events taking place every day in our country that are examples of neighbor helping neighbor, people who do not wait and do not ask for help but take it upon themselves to act. I would like to tell you about one such example that has been going on for years in Wyoming right in the small community I call home.

When people think about my hometown of Gillette, WY, many images come to mind--sagebrush as far as the eye can see, coal trucks, and cattle herds. We have deer, antelope, and some buffalo in the neighboring community of Wright. Our kids are great basketball players, and we work hard to get the methane gas and minerals that power this country. The list goes on. But after living in Gillette for more than three decades, what stands out about home are the people themselves, their character, their sense of community, and how they come together to help each other. And then there is the crawfish. Yes, I said crawfish.

This week, Gillette will be kicking off a 24-year tradition of flying in 10,000 pounds of crawfish for the annual Crawfish Boil. The event raises money for local families with medical hardships and was started in 1983 by the Society of Petroleum Engineers. The event raised $117,000 last year to help people get medical treatment. This weekend we hope to top that number.

Wyoming may be small in population, but our families know how to help each other out more than any other State in the Nation. Wyomingites do not just rely on government for help--they talk to neighbors, they come up with a good idea, they organize, and they follow through. The crawfish feed is an example for the Nation on how to pull yourself and your neighbor up by the bootstraps and have fun doing it.

Gillette not only raised $117,000 at last year's Crawfish Boil, the Festival of Trees raised $51,500 for hospice and lifeline services, the Chili Cook-Off raised $28,800 for the Council of Community Services, the Black Cat Ball raised $26,000 for the Hospice Hospitality House, the Chuckles for Charity event raised $24,000 for the Gillette Area Refuge, and the Rotary Ball raised $40,000 for education and other programs in Gillette. Mr. President, $287,000 in 1 year, in one community with roughly 25,000 residents. I could not think of a better place to call home.

Mr. President, I wish to speak about the importance of supporting and passing the America COMPETES Act.

It has been 50 years since Sputnik was launched by the Soviet Union. The United States was quick to react with a flurry of activity and investment to spur innovation. Its launch also had a dramatic impact on education in this country. Students wanted to be the best and wanted to prove that the United States was a better and stronger country. Today the need is just as great, but we don't have a catalyst, like Sputnik, driving the need. The need is driven by our economy and companies that need bright and innovative workers. This need is driven by the competition the United States now faces from across the globe.

Last year I was in India and saw firsthand what Thomas Friedman discusses in his book, ``The World is Flat''. It does not take long to figure out that by numbers alone, India has to educate only 25 percent of its population to have more literate and educated people than the total population of the United States. This trip reinforced my belief that we need to ramp up our efforts in the areas of education and labor to keep our country competitive.

Add to this perspective the fact that China has 20 percent of the world's population and has sharply increased the proportion of its college-age population participating in higher education from 1.4 percent to over 20 percent in just a generation. It should not be surprising that a substantial portion of our workforce now finds itself in direct competition for jobs with highly motivated and often well- educated people from around the world. Unless we pay attention to these facts, this competition will only increase in the future.

Here are a few of the facts that I find paint a compelling picture and show why this legislation is needed: Business is spending billions each year to train new employees and remediate the educational skill gaps of those already in the workforce. The American workforce is aging--77 million baby boomers are set to retire over the next several decades.

Reading proficiency among 12th graders has declined to the point where just over one-third of them are even considered proficient readers. In addition, 47 percent of those with a college degree are not considered proficient readers according to the most recent National Assessment of Adult Literacy. Only 68 of every 100 ninth grade students graduate ``on time,'' in other words, within 4 years. America's high school graduation rate is among the lowest in the industrialized world, and the impact on our minority students has been especially severe, where this rate hovers around 50 percent.

Nearly one-third of entering college freshmen need at least one remedial course. The United States has one of the highest college enrollment rates, but a college completion rate average to below average among developed countries in the world.

Four out of every five jobs will require postsecondary education or the equivalent, yet only 52 percent of Americans over the age of 25 have achieved this level of education. Seventy-five percent of today's workforce will need to be retrained just to keep their current jobs.

Median earnings of a high school graduate are 43 percent higher than those of a nongraduate and those of a college graduate are 62 percent higher than those of a high school graduate. Two-thirds of the 7 million worker gap in 2010 will be a skilled worker shortage.

If our students and workers are to have the best chance to succeed in life and employers to remain competitive, we must ensure that everyone has the opportunity to achieve academically and obtain the skills they need to succeed, regardless of their background. To accomplish this, we need to build, strengthen, and maintain our educational pipeline, beginning in elementary school. We must also strengthen programs that encourage and enable citizens of all ages to enroll in postsecondary education institutions and obtain or improve their knowledge and skills. The decisions we make about education and workforce development

will have a dramatic impact on the economy and our society for generations to come.

This legislation is the product of bipartisan negotiations and input from members of 3 Senate committees--the Senate Commerce, Energy, and HELP Committees. Work on this legislation began last year in response to the ``Rising Above the Gathering Storm'' report, the ``Innovate America'' report, and the President's American Competitiveness Initiative. I want to thank all those who worked on this bill for their hard work and dedication and commend them for the collegial manner in which this bill was crafted.

This bill includes provisions that improve math, science, and critical foreign language education in our Nation from elementary school through graduate school. It supports improvements to teacher preparation, establishes stronger links between graduate schools and employers, provides funding to support students trained at the doctoral level in science, technology, engineering, and mathematics, and enhances Federal programs that support students in graduate school.

It should come as no surprise that I particularly support the education components of this bill. Education at all levels, including lifelong learning opportunities, is vital to ensuring that America retains its competitive edge in the global economy. In this global economy, learning is never over and school is never out. Every American can and should be part of our Nation's success. The education and skills of today and tomorrow's workforce were a high priority for me even before I became chairman and now the lead Republican of the Health, Education, Labor, and Pensions Committee.

The America COMPETES Act is a good starting point, but we need to do more. Maintaining America's competitiveness requires that all students have the opportunity to continue to build their knowledge and skills. We need to find ways to encourage high school students to stay in school and prepare for and enter high-skill fields such as math, science, engineering, health, technology, and critical foreign languages. For many, including those at the cutting-edge of science, technology, engineering, and mathematics, acquiring a postsecondary education or training will be the key to their success. Therefore, I remain committed to reauthorizing the Higher Education Act.

Individuals in the workforce often need retraining to keep up with our fast-paced economy. Businesses also need help in finding well- qualified individuals to meet their needs. The Workforce Investment Act and the system created to support it provide those needed services. We must reauthorize the Workforce Investment Act this Congress.

Finally, our children need a strong foundation of knowledge to succeed in both education and knowledge. The No Child Left Behind Act provides funds to States and local school districts to support our neediest and most disadvantaged students. Those students need a hand up in order to succeed in the future. I look forward to working with Chairman Kennedy to reauthorize the No Child Left Behind Act this year.

Fifty years after Sputnik, the United States is in another equally important race that will define our leadership. This race is fueled by innovation, education, and skills. Its success is measured by jobs and prosperity for American families. It is a race we cannot afford to lose.

I ask my colleagues to support the passage of the America COMPETES Act.

Mr. President, today I wish to speak in opposition to the bill currently before the Senate.

First I would like to briefly review the status of the new Medicare law that Congress passed in November of 2003. That landmark legislation enacted the first major benefit expansion of the program since 1965 and placed increased emphasis on the private sector to deliver and manage benefits. It created a new voluntary outpatient prescription drug benefit to be administered by private entities. The legislation also expanded covered preventive services and created a specific process for overall program review if general revenue spending exceeded a specified threshold.

I am pleased to be able to report that this new program is working. All across the country, seniors are expressing their approval of the new benefit. In my State of Wyoming, the new Part D prescription drug benefit has been a huge success. Last year, I traveled around Wyoming and visited with seniors in Cheyenne, Douglas, Sheridan, Casper, Powell, and Rock Springs. I talked to folks all over the State and told them about the new program as I encouraged them to sign up for it. I also talked to a few of the pharmacists in Wyoming that worked so hard to make this program a success. I believe I can speak on behalf of many of my colleagues in saying thank you to the thousands of pharmacists throughout the country that did so much to implement this great program.

Today, about 89 percent of Wyoming seniors are receiving prescription drug coverage, an increase of 16 percent from last year. They remember what it used to be like when they tried to get their prescription medications and they don't want to go back. I have received hundreds of calls and letters from Wyoming seniors who like the way things are and don't want Congress interfering with their prescription drug plan because it is working for them. Five separate surveys show that more than 75 percent of all beneficiaries are satisfied with the way the program works.

Not only are about 90 percent of seniors now receiving prescription drugs, the program is costing less than originally expected. When is the last time a government program cost less than was estimated? I came to Washington in 1997, 10 years ago, and I don't know that I have ever seen a government program that spent less money than we expected. Private competition is working better than we envisioned and it is saving seniors and the government more and more money every day. Why should we change that?

For some reason my colleagues on the other side of the aisle have decided they need to ``fix'' a program that isn't broken. We have implemented a plan that is working and before we change it, we need to be sure about what we are doing and the effect it will have on the program and the impact it will ultimately have on seniors from coast to coast.

The bill now before the Senate would strike the noninterference clause from the Medicare law. The ``noninterference'' language in the Medicare law prevents the Federal Government from fixing prices on Medicare drugs or placing nationwide limits on the drugs that will be available to seniors and the disabled. I support this language 100 percent. Decisions on what drugs should be available should be made by seniors and their doctors, not by some central committee in Washington.

Under the Medicare Part D law, each prescription drug plan has its own list of preferred drugs. Each plan's list is different--some are broader, some are narrower. Each list, however, has at least two drugs from each therapeutic class of medications and everyone can find a plan that is advantageous to them.

The ``noninterference'' bill before us is not only unnecessary, but it could also prove to be harmful to the health of our nation's seniors. The ``noninterference'' language protects seniors and the disabled from having the government decide which drugs their doctors can prescribe. It maintains the sacred relationships that seniors have with their doctors, who know best about what particular drugs are right for their patients. Patients support this language, and they want us to maintain it.

I would like to repeat, we have already implemented a plan that is working. Yet the majority party wants to ``fix'' the Medicare drug benefit. It is ironic to me that they use the word ``fix''--fix is exactly what this bill will lead to, the government ``fixing'' prices on drugs. It is not a bill about negotiating prices; it is a bill about fixing prices. As most Americans know, the Government doesn't negotiate in the Medicare program. It sets the prices that the Government will pay doctors and hospitals for serving seniors.

Setting the price is the same as price controls. And we saw what happened in the 1970s when we tried to control the price of gasoline. Do you remember the long lines at the gas pumps? Trying to control the price of gasoline was a complete disaster. Let's not experiment with giving government the ability to control the prices of prescription drugs.

Despite what some folks are reporting, the nonpartisan Congressional Budget Office has said over and over again that removing this language would not save the Government or seniors any money. It wouldn't save money because the Medicare prescription drug plans will have strong incentives to negotiate drug price discounts that would be as low--or lower--than anything the Government could negotiate. Additionally, many plans represent more people than Medicare, Medicaid, or the Veterans Administration, so the plans have greater purchasing power than the Government. To effectively negotiate, you need competing products, or you have to be willing to do without one of the products on which you are negotiating.

How many times does the Congressional Budget Office have to say that this bill will not save the Government any money before it starts to sink in? When will my friends on the other side of the aisle acknowledge that this bill will not save any money?

We do, however, know of something that will save the Federal Government and seniors money--competition among private plans. What has been proven to reduce costs--especially for seniors with low incomes-- is the new Medicare drug benefit that we passed in 2003.

The competition among private plans is driving the cost of the program down. The average monthly premium has dropped by 42 percent, from an estimated $38 to $22--and there is a plan available in every state for less than $20 a month. So let me suggest letting competition work to drive the prices even lower instead of instituting government price controls that have failed in the past.

Also, because the program has choice, if the price of one plan goes up, beneficiaries can switch plans. It is important to remember that sometimes the prices will go up, because medical costs will go up as long as new technologies are invented that allow people to live longer, healthier lives.

Democrats want to change Part D to resemble the drug benefit program of the Veterans Administration. In the VA system, the Government sets a price on a drug it can get at the cheapest rate and limits or restricts access to those it can not get at cheap rates. As a result, the VA benefit excludes three out of four drugs available through Part D. Changing the Medicare Program to be as restrictive as the VA system is completely illogical.

Another thing about the VA system is that it can take a long time for new drugs to be included on the formulary--sometimes as long as 3 years. Let me repeat that. It can take as long as 3 years for new, life-saving drugs to be included on the VA formulary.

Lastly, the VA owns the whole system, so you have to order your drugs from them or you have to fill your prescriptions at one of 350 government-run facilities nationwide. In contrast, seniors signing up for a Medicare prescription drug plan can choose their plan based on the pharmacy they want to use to fill their prescriptions. As a result of all of these things, more than 1 million retired veterans have signed up for Medicare in the last year. I talked to many veterans in Wyoming and they all told me that they signed up for Medicare Part D so they could finally get the drugs they needed that they couldn't get from the VA.

Unfortunately, my colleagues on the other side of the aisle want to make the Medicare Program more like the VA program. They want to take away a senior's ability to choose. The real thing we should be talking about is how we can change the VA program to be more like Medicare Part