Michael Enzi

Mr. ENZI

Mr. ENZI. 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. ENZI. 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. ENZI. 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. ENZI. 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.

Mr. ENZI. 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. ENZI. 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. ENZI. 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. ENZI

Mr. ENZI. 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.

Mr. ENZI. 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.

Mr. ENZI

Mr. ENZI. 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

Mr. ENZI. 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.

Mr. ENZI. 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.

Mr. ENZI

Mr. ENZI. I yield 4 minutes to the Senator from North Carolina.

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

Mr. ENZI. 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. ENZI. Mr. President, what is the time situation?

Mr. ENZI. 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. ENZI. 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.

Mr. ENZI. 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.

Mr. ENZI. I object.

Mr. ENZI. I object.

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

Mr. ENZI. Certainly.

Mr. ENZI

Mr. ENZI. Mr. President, I move to lay that motion on the table. The motion to lay on the table was agreed to.

Mr. ENZI. 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.