Byron Dorgan

Mr. DORGAN

Mr. DORGAN. Mr. President, as was indicated earlier, the Cochran amendment, with cosponsors, is currently pending, I believe, or has been appropriately offered and is pending. I would like to make a couple of comments about the vote we will have at some point in the future on the Cochran amendment. And what I would like to do is go through so that all of our colleagues understand what is in the underlying bill. I indicated earlier that one of my colleagues stood up and said the legislation we had offered would allow drug importation from any country in the world, and that is not true. There is no such debate on a bill that doesn't exist. Mr. President, I have a piece of information distributed by Pfizer Corporation that is opposed to my amendment. It describes various problems with the drugs that are purchased online and counterfeit drugs, and so on. Interestingly enough, all of these problems would be solved by the legislation I have introduced with all of the safety issues involved. You know these are specious issues because the underlying legislation would address all of those issues. Now, let me go through a list--this is the list; you won't be able to read it, but I will go through them--of the safety provisions in this legislation. First of all, with imported drugs, drugs imported from other countries, which, as I have indicated, Europe has done for 20 years with no safety issues at all, so we are as competent as the Europeans are in being able to do this. Our bill would require that all imported drugs be approved by the Food and Drug Administration. So we are not talking about any renegade drugs, all FDA-approved drugs, all of them imported be approved by the FDA. It creates a process to approve medications sold outside the United States which are identical to FDA-approved products. It sets a process by which the FDA may approve medications which differ from the domestic version of the drug; provides that no imported drug may be misbranded or adulterated, and requires compliance with GMP. It requires the FDA to enter into agreements to monitor drug recalls and approval status changes; establishes a set of standards which countries must meet to be a ``permitted'' country. With respect to pharmacies and wholesalers on this list, we say it provides for registration and regulation of exporting pharmacies and importing wholesalers, only by licensed operators in both cases; requires registrants to pay an application fee, submit to evaluation, and post a substantial bond; requires pharmacists and wholesalers to be fully compliant with applicable local, State, provincial, and national laws; requires the FDA to perform inspections of operations, including facilities and records, at least 12 times per year; requires exporting pharmacies to verify prescriptions, to review medications for interactions, to ensure privacy; requires pharmacies to maintain records for 2 years for FDA review. Exporting pharmacies must preserve samples of each lot of a drug for the FDA to utilize for testing. It gives authority to FDA to monitor and inspect the full chain of custody of a drug; sets penalties for violation, including suspension, lifetime revocation, and criminal penalties. It requires every imported drug to have a full record of the chain of custody, which is a pedigree. That is very important. Every imported drug will have to have a pedigree, full record of the chain of custody. It requires every package to have an FDA-approved label affixed, and every product must clearly be identified as ``imported.'' Drug labeling would also include the name of the registrant who handled the medication and the product lot number as a part of that pedigree. Any differences in the imported drug, even in an inert ingredient, must be noted on the label. It requires packaging to include anticounterfeiting or track-and- trace technologies. Exporters must provide the FDA with prior notice of shipments of prescription drugs to the U.S. importing wholesalers. It provides, for the first sale of a drug, it may not be shipped outside of the permitted countries. It requires the FDA to provide information to consumers to identify the safe and legal directed sources of approved imports. It gives Customs Service the authority to seize and destroy any unauthorized shipments; blocking elicit electronic payments to unauthorized foreign pharmacies by Customs; full funding for FDA to facilitate the drug import regulatory operations through a 2\1/2\-percent user fee. It provides implementation of drug pedigrees for domestic medications by 2010, which do not exist now, by the way; requires the packaging of all prescription drugs to incorporate a standardized numerical identifier unique to each package of a drug and counterfeit resistant technologies. When one reads through these safety features and then alleges that this is unsafe, I mean it just--it baffles me how one can reach that conclusion. Tommy Thompson, Secretary of Health and Human Services, said: In order to import drugs from any country, and especially Canada, I have to certify that all of those drugs are safe. That is an impossible thing. If Congress wants to import drugs, they should take out that provision. Well, let me ask this question: Would it be possible for the Health and Human Services Secretary to certify that all drugs sold in this country, FDA-approved drugs, are safe? Does one think the HHS Secretary could certify that? The answer is, no, of course not. I can give you examples of metal traces and things in pharmaceuticals that were sold in this country, FDA-approved, by major manufacturers. Could a Health and Human Services Secretary certify that the existing drug supply is ``safe,'' possess no ``risk''? They can't do that for pet food. They could not do that for lettuce. They could not do it for carrots. They could not do it for celery. They could not do it for imported vegetables. They can't do it for imported meats. They can't do it for domestic production to say, there is no risk. The issue of requiring certification is an attempt to kill the legislation. It is perfectly appropriate for some to say: The current system works fine, don't change it. I don't quarrel with that. I don't agree with it, but I respect those who hold that view. But I do believe it is hard for anyone to, with great merit, make the case that with what we have done in this legislation, on a bipartisan basis, it still renders this to be an unsafe process. The experience in Europe, of course, undermines that argument. They have done it for 20 years. It has been perfectly safe. Also, let me go back to David Kessler's statement. I don't know of an FDA Commissioner who comes to his belt buckle, let alone his shoulders in terms of capability. I thought David Kessler had been an extraordinary FDA Commissioner back for 8 years. I worked with him when he was there. He said this: The Dorgan-Snowe bill ``provides a sound framework for assuring that imported drugs are safe and effective.'' Now, we can talk all day about these drugs being unsafe, but, obviously, that does not change the facts. It does not change Dr. Kessler's opinion. It does not change the circumstances of the safety provisions we put in the bill. They are there. They are there for a very specific reason. We took the interests and concerns of Secretary Shalala and Secretary Thompson. We wrote them into this bill dealing with safety provisions. The fact is, this bill will make our domestic supply of prescription drugs safer. That is the plain fact. Then we will have a pedigree for all prescription drugs, imported or domestic. That is just a fact. Now, the second part of the amendment says it has to be assured that it will save money and pose no risk. Well, ``save money,'' that is easy. The Congressional Budget Office has said it is going to save $50 billion in 10 years. And $6.1 billion--I thought it was 5--$6.1 billion of that is savings to the Federal Government. We just have a new estimate by the Congressional Budget Office that if the Cochran amendment is passed, that savings goes to zero. Why? It undermines the bill. It means this will not have impact. Importing won't happen. Not because anyone wants to import an unsafe drug because, in fact, the safety provisions we have included will make this supply, the drug supply, domestic supply included, as well as imported drugs, safer. That is the point. This issue is not horribly complicated. The question is, should the American people have the ability in this global economy to access a drug that has been produced, in many cases by an American company, with research in many cases paid for by American taxpayers, produced in many cases in a plant here in the United States, and then sent to another country at a much lower price? Should the American consumers be able to access that FDA-approved drug that is sold for a lower price elsewhere? Stated another way, should American consumers continue to accept the notion that they should pay the highest prices in the world? Some say: There is not a problem here. They cite the Washington Post editorial today. That editorial says there is a problem with respect to drug pricing. The first 3 months of this year saw the highest price increases on prescription drugs in the last 6 years. In 2006, it was six times the rate of inflation, the price increase in prescription drugs. In addition, we pay the highest prices of all the other countries. Does that make sense? It doesn't to me. I want to have somebody stand up on the other side of this issue and say: I disagree; I think the American people should pay the higher prices; I think that is fair. That is the alternative, it seems, because that is the reality. I am not interested in debating some fiction. The reality is this: We pay prices that I believe are wrong. I said yesterday, I don't come here with any disrespect for the pharmaceutical industry. I have met many of these people. I know the head of PhRMA, former Congressman Billy Tauzin. I used to serve with him. I like him. I don't come here disrespecting the industry. They do important work. I have a profound disagreement with their pricing policies because they are unfair to consumers in this country. That is my difference and my beef. Their pricing policies are wrong. Why should an 80-year-old woman have to go to Canada every 3 months as she is fighting breast cancer in order to buy Tamoxifen at a price she can afford? Why should you be able to cross an imaginary line into Canada and discover that you could pay one-fifth the price you have to pay for Tamoxifen in this country? The pricing policy is wrong, and we ought to fix it. This is an approach that will fix it. We will have other debate. I do not disrespect the pharmaceutical industry. I have great respect for what they do. I have a profound disagreement about their pricing policy. I don't disrespect those who have a profound disagreement with my amendment. I respectfully think they are wrong. In the end, the question for the Congress is, do you think what is happening with respect to drug pricing is appropriate? My answer is no. The American people are being disserved by a pricing policy that the pharmaceutical industry can make stick. They have the capability to control prices. They do it behind a law that says the only interest that is able to import prescription drugs is the manufacturer of that drug. Europe doesn't require that. Europe hasn't required that for a long while. They allow parallel trading so the consumer can take advantage of price shopping among the countries of Europe. Only this country has decided, no, the consumer doesn't have this right. The manufacturer has the right but not the consumer. I say let's let the consumer, let's let the American people have access to the benefits of the global economy as well. Yes, let's make it safe. We have done that. This legislation with the safety precautions I have described in some detail, if passed, this amendment, if passed, would significantly improve the safety of the domestic drug supply and significantly improve safety of the reimportation that now occurs on an occasional basis by people driving back and forth across the border, those who are fortunate enough to live near a border. We have just gotten a Congressional Budget Office score on the amendment I have offered. It says the amendment, if passed, will save the Federal Government $10.6 billion in a 10-year period. I believe it is a $50 billion savings in total for consumers. I will put in the Congressional Record the specifics. But I do know the Congressional Budget Office has just scored this amendment. It will save consumers tens of billions of dollars. The specific savings to the Federal Government itself, as a result of savings through our programs and expenditures, will be $10.6 billion. I yield the floor.

Mr. DORGAN. I won't speak at length. I do want to make one point. The Senator from Mississippi indicated the amendment I have offered would allow for the reimportation of drugs that are not FDA approved. I don't know where that information comes from, but it is demonstrably untrue. I don't want there to be a mistaken impression on that. I ask my colleague from Mississippi if we could at least resolve that issue. The intent of this, the written version of this, is very clear. No drug will be imported into this country unless it is FDA approved. My colleague indicated this amendment would allow drugs to come in that are not approved. I don't know where that information comes from. If he and I could at least exchange information so that we resolve that, I would appreciate that.

Mr. DORGAN. Mr. President, that is a different issue. The amendment itself, whether there is a regulatory framework or not, will not allow a drug to be imported that is not FDA approved. That is the written provision in the amendment itself. Second, with respect to cost, we may have a disagreement on that, but I again observe that the Congressional Budget Office this morning has given us another score, and the score from the Congressional Budget Office says this will save the Federal Government $10.6 billion in a 10-year period. I believe the global savings--the rest would be for consumers--is slightly over $50 billion in 10 years. So it seems to me it is self-evident. If the Congressional Budget Office is putting out information to the Senate this morning that describes the amount of savings, in this case averaging about $5 billion a year, it is quite clear, someone is going to save something somewhere. I think we also can resolve the cost issue at some point down the road. Let me say, I respect the Senator from Mississippi. He is a very worthy legislator, cares passionately about the things he works on. I do the same. I think the way to resolve this is to talk through what are the safety provisions in the bill. If they are inadequate, demonstrably inaccurate, I will accept that we would make some changes. But I do not believe that is the case. I do not believe it has been demonstrated. As I have indicated previously, Dr. David Kessler, who ran FDA for 8 years, says this bill provides a sound framework for assuring that imported drugs are safe and effective. I understand the pharmaceutical industry does not say that. I understand some others do not believe that. I understand and respect that. But I also believe, very strongly, that the evidence is overwhelming. We have added the safety provisions that were raised by Secretary Shalala. We have added the provisions raised by Secretary Thompson. I believe--and 33 of my colleagues in this Chamber, Republicans and Democrats, believe--we have done a very good job in resolving those issues. This issue almost has a gray beard. It has been around a long time. We have been trying a long time. It is hard to win on this issue. I accept that, and I understand it. But I am hoping that perhaps this is the year in which we might give the American consumer an opportunity to be able to participate in the global marketplace in a safe and effective way, just as the Europeans do, and be able to access a lower price of FDA-approved drugs. Mr. President, I yield the floor.

Mr. DORGAN. Mr. President, one of the observations I made when I was privileged to come to the Senate is that virtually everyone here is a pretty effective communicator. I am reminded of that every day. I hear debate by people who really are effective, and I always appreciate it, and it is always interesting to me. I do think--certainly everybody is entitled to their opinions; I respect their opinions--not everybody is entitled to their own set of facts. We have to deal with a common set of facts. My colleague just made a statement, a philosophical statement, about what he believes. I respect that. But the statement included thoughts like that this piece of legislation would probably abrogate or not respect copyrights. Nothing could be further from the truth. There is nothing in here that would abrogate copyright protection, and so on. In fact, this amendment provides the requirement of serial numbers on lots and samples by those who are engaged in this sort of thing that has been prevented from occurring inside this country. It requires it for importation, and it requires it for domestic medicines. This will dramatically change the safety of the drug supply here and with respect to that which would be imported. With respect to the American people, the American people are not undecided on this issue. Mr. President, 70 or 80 percent of them believe there ought to be allowed the importation of prescription drugs. This is not something the American people are undecided about. It is only in this Congress that it has not been decided. So I think that is something we should understand. Why would the American people believe they should be able to import FDA-approved drugs? Because they believe it is fair for them to be able to do it. Let me describe where the prescription drugs come from by the manufacturers of the drugs. If you are taking Lipitor, that is not made here; that is made in Ireland. If you are taking Toprol XL, that is made in Sweden. Nexium is made in France. Altace is made in Malta. Vytorin is made in Singapore and Italy. These drugs are already imported. Regrettably, by the way, I might say they are imported without the protections that would exist in our amendment. It would require the manufacturer--the manufacturer of the drug--to have serial numbers on the lots, to have samples of every lot reserved, to have a pedigree for every medicine that is moved. That is for domestic consumption. I am not talking about the imported drugs under my bill; I am talking about the drugs that are made in these countries and other countries that ship them into this country, and every drug that is produced in this country will require the same. The fact is we have tried to get that same requirement on domestic drugs and have been blocked for a long time. This legislation will make the drug supply in this country far more safe than it currently is. We all know the amendment that is being offered about risk. Were that amendment to be offered with respect to new prescription drugs that come from research to say, you can't put a drug out there if there is risk, do you think you would have a new drug on the market anytime soon? Do you think a Health and Human Services Secretary or an FDA administrator can say: By the way, I am approving this drug and there is no risk. Of course, they can't. Of course, they would not. We know that. Drugs have risks. In fact, some drugs are put on the marketplace, and we discover later they should not have been there--a substantial risk. Vioxx. An official at the FDA says he believes 50,000 to 70,000 American people died of heart attacks as a result of Vioxx being put on the market. Further, he says--this isn't me, this is an official at the FDA--that Vioxx was widely advertised and widely promoted as some wonderful new drug, when in fact it was not a new class of drugs that had any significant benefit over existing drugs. The point is this: If one were to ascribe this risk category to new drugs, there would be no new drugs. I know all this talk about counterfeiting--and man, have we talked a lot about counterfeiting in this Chamber in the last couple of days-- all this talk about counterfeiting ignores the point that it is occurring under today's laws. The way to fix that and the way to stop counterfeiters is to do what we do in this amendment: You require on every prescription drug that is sold, that it have a pedigree. You require in every circumstance there be serial numbers on lots and samples. It is incontrovertible, in my judgment, that this will dramatically improve the safety of domestic prescription drugs as well as imported prescription drugs. One final point with respect to the issue of research. My colleague said: Well, if we pass this amendment, what the Senate has said is there is no value to research on prescription drugs. I don't have the foggiest idea where that concept comes from. We spend a lot of money on research. I was one of a group of Senators who said: Let's double the amount of money at the National Institutes of Health, and we did, in 5 years, to dramatically improve and increase the amount of research at the National Institutes of Health. I am a big supporter of research. We do a lot of wonderful research, some in the public sector, some in the private sector. At the NIH, by the way, we do the research and often much of that research is used by the pharmaceutical industry to produce lifesaving drugs. But lifesaving drugs save no lives if you can't afford to get them, if you can't afford to have them, and if you can't afford to take them. It is true none of us have a problem, in this Chamber, dealing with the price of drugs; we have health care policies and those kinds of things. But there are a lot of folks all over the country who are taking a lot of different prescription drugs. I think prescription drugs are wonderful. They keep people out of an acute care hospital bed, the most expensive kind of health care. Interestingly enough, in many cases they are taking 10 or 12 different kinds of prescription drugs to manage various diseases. As a result of that, we passed Part D; my colleague is correct about that. Part D provides drug benefits to those who have reached the age of Medicare. Regrettably, of course, there was nothing in Part D that would put downward pressure on prescription drug prices. I would say look at the increase in prescription drug prices in the first quarter in this country. Look at the increase in prescription drug prices in 2006, and then ask yourself whether all of this is working to put some downward pressure on pricing. It is not. It is just not. So as I said earlier this morning, I hate to lose a debate I am not having. I would love to have a debate in which we are both debating the same bill, but a suggestion somehow that this bill allows drugs to come into this country that are not FDA-approved means that you are off debating some other bill someplace. Well, fine. Win that debate if you want. It is not the bill that is on the floor of the Senate. It isn't. The same is true with a number of statements that have been made about respecting copyrights, and so on. In fact, what we have required is a regulatory burden that the industry doesn't like--I understand that-- but it will, in fact, protect them and protect their copyright because it will make it much harder for anyone to counterfeit. That is a fact. One of the interesting aspects of this country is that we are seeing some unbelievably good news. The good news is people are living longer and better lives. In a century, in 100 years, we have increased the lifespan by somewhere around 30 years, from 46 years old to about 76 years old. That is good news. People are living longer and better lives. A significant part of that, I think, is being able to, at an advanced age, manage diseases. A significant part of that is prescription drugs. There are some who don't have that. I have an uncle I have described before who is now 86 years old. He and his wife take no prescription drugs at age 86. The fact is, as I have also described to my colleagues, he is a runner. He runs in the Senior Olympics at age 86. He used to run in his seventies and early eighties the 400 meter and the 800 meter. Now he tells me he is a specialist in the 100-meter dash, at age 86. He has a good life. He is healthy. He likes life. He is very active. He is not riding his motorcycle so much anymore, but he has one of the biggest motorcycles you can get sitting in his garage. He doesn't need to take prescription drugs. Good for him. We have a lot of folks who reach their eighties and nineties. We know about that because in our part of the country, my State of North Dakota ranks No. 1 in the Nation in the number of people 86 years of age or older as a percent of the population. We rank No. 5 in the country in the number of people 65 years of age or older as a percent of the population. So a lot of people are living a lot longer. That is good news. It puts some drain on Social Security and Medicare. A quick way to fix Social Security and Medicare is to go back to the old life expectancy, go back to age 46. We wouldn't have any trouble. I am digressing a bit, but when Social Security was created, on average, people lived to be 63. So we created a system that says: When you retire, you get benefits at 65. Well, I went to a small school, but I understood enough in math to think that works out real well. You pay taxes and, on average, you are going to live to age 63, and when you retire at 65, you get some benefits. That is not a system that is going to have financing trouble at all. But then the problem is people began living much longer. That is not a problem. That is a success. So good for them. At any rate, prescription drugs about 40 years ago became a much larger part of the discussion in modern life, to keep people out of the acute care hospital beds and to manage their diseases. So that is a wonderful thing. I have said before, and I will say it again: The pharmaceutical industry is a fine industry; I have serious problems with their pricing strategy. I think it is wrong. I want them to succeed. I want them to research. I want them to do the research on prescription drugs. I would like them to stop advertising early in the morning when I am shaving and brushing my teeth and getting ready for work, telling me what I ought to go talk to my doctor about. They have all these pills they want me to ask the doctor if they are right for me. I get confused. I am not sure I need them. But there is a lot of advertising going on and a lot of promotion. I want them to find new medicines to unlock the mysteries of dread diseases. I want the Federal Government, through the NIH, to substantially invest in new research and development. I want all of those things. But I also want, even as I compliment the pharmaceutical industry and I compliment the NIH and all those who are spending their days--today, Thursday--trying to figure out how do you unlock the mysteries of ALS or diabetes or cancer or heart disease, even as I do that, I say to the pharmaceutical industry: I think your pricing strategy is wrong and it is unfair to the American people. We ought not be paying the highest prices in the world for prescription drugs. That is unfair. The amendment I have offered with 33 of my colleagues, Republicans and Democrats, would change that. No, it wouldn't shut down research, not at all. No, it wouldn't exacerbate counterfeiting, not at all. The fact is this will be fair to the American people, if we pass this legislation. It will continue, I think, to see substantial research. It will also, in my judgment, contribute to shutting down the counterfeiting of prescription drugs, but most importantly, it will finally say to the American people that we are on your side on this issue. We believe in fair pricing and we finally are going to insist on it. I yield the floor, and I make a point of order that a quorum is not present.

Mr. DORGAN. Madam President, I would like to offer a few comments about this subject. My colleague has spoken on it several times. As I have indicated, we all want to deal from the same set of facts. This is not--let me emphasize again--it is not importing the standards of other countries with respect to the safety of prescription drugs. It does not do that. I want to make sure everybody understands what the facts are. Everyone is entitled to their own opinion; everyone is not entitled to their own set of facts. This does not import the standards of some other country into this country with respect to the safety of prescription drugs. This is simply the question of whether we want to continue to have FDA-approved drugs made in FDA-approved plants; that is, a plant inspected by our Food and Drug Administration, producing medicine and put into a bottle that is approved by our Food and Drug Administration and sold in this country and the same medicine, in the same bottles, sold in France, sold in Italy, sold in Germany, sold in Canada, sold in England, to have the U.S. consumer pay the highest prices of all of those countries. Is that fair to the U.S. consumer? The answer is no. We have a lot of issues that are being raised on the issue of safety. All the things I have heard discussed on the floor of the Senate apply to today--now--when we don't have importation. We are not able to import safely. I should say we are not able to import, rather, prescription drugs because there is a prohibition against it. The only entity that can import a prescription drug is the manufacturer. Lipitor. I held up two bottles of Lipitor on the floor today. Lipitor is made in Ireland. They send it all around the world. They send it to Canada and they send it to the United States. The bottle looks the same, the pill looks the same because it is the same, and it is sold under the same chain of custody--Canada and the United States. There is only one difference. The U.S. consumer is treated to double the price when they purchase their Lipitor. Is that fair? Should we pay twice the price for an FDA-approved drug? I don't think so. My colleagues have said there are counterfeiting issues. Well, all of the stories that have been recounted about counterfeiting issues are occurring under today's schematic of prescription drug sales in America. This has nothing to do with importing. In fact, the legislation I have offered is legislation that would make the supply of prescription drugs in this country and the supply that would come into this country under reimportation much safer. They would be safer because we have put in place safety procedures that have previously been blocked in the Congress, establishing serial numbers on the supply of prescription drugs, samples of the supply of prescription drugs to be held back by those who are manufacturing and moving the prescription drugs, establishing a pedigree for all of these drugs and the bottles in which they travel. It is much safer. It will be much safer for the domestic supply in addition to the supply of imported prescription drugs. That is the point we make. I suppose people will be tired of hearing me say that I respect those who have a different opinion, but I would prefer if they would stand up and say: You know something. Here is my situation. I think the American people ought to pay twice the cost for Lipitor because I believe that. That is a pricing strategy that works for my constituents. I don't hear anybody saying that, of course. They stand up and say there will be big safety issues, or my colleague who in an earlier speech this morning said this amendment would allow drugs to be imported into this country from all over the world. I am sorry. That is not right. That is not debating the bill that exists. We are not letting drugs in from all over the world; only from countries that would qualify, that meet the safety standards. These would only be FDA-approved drugs, and they would only be drugs that are retained under a chain of custody, with a pedigree attached to the drug. There are no safety issues, unless one thinks it is unsafe for the pharmaceutical industry not to make the profits they currently make. They perhaps would see some smaller amount of profit if they passed part of the lower cost along to the consumers. Maybe perhaps the industry could do a little less advertising, just a little less advertising. When you turn on the television at night and you sit down at the end of a long day and you see somebody driving in a convertible with beautiful people and they park under a tree someplace and the Sun is setting, it is a beautiful appearance, and they say: These people are feeling good because of medicine they are taking. You should be asking your doctor whether you might want to take some of that. Get some of this pill. Get some of this medicine. The Sun shines, you get to ride in convertibles, feel better, hang around beautiful people. That is the way advertising works, I guess. I have talked about the purple pill. They say: Ask your doctor, is the purple pill right for you? I don't know what the purple pill is, but I almost feel like asking the doctor, is the purple pill right for me? All of this promotion and advertising, maybe they could back off a little bit of that and reduce the prices to the American consumer. But that is not the strategy. The strategy in pricing prescription drugs is that almost every country has some kind of limitation on what can be priced with respect to prescription drugs, except the United States of America, and here it is Katie bar the door. Whatever they want. We do have price controls in America. Not imposed by the Government; price controls by the pharmaceutical industry. Now, this is a fine industry. They have men and women working, trying to unlock the mystery of diseases, trying to find ways to produce medicines that will manage diseases. I admire all of that. I say congratulations to them. But I have a serious disagreement with them on pricing strategy. They are wrong to believe they have to charge the highest prices to American consumers. That is a fact. They are wrong about that. They say: Well, it is the only way we can do research and development. That is not true at all. That is not true. A substantial portion of research and development is done by the taxpayer through the National Institutes of Health and others, and the product of that is turned over to the pharmaceutical manufacturers in terms of intellectual property that is developed and they manufacture drugs. Good for them. I know they also do substantial research on their own and I appreciate that. I don't appreciate the pricing strategy because I think it is unfair to the American consumer. I don't know how many people I have talked to over the years who have come up to me and told me of their problems: I am 80 years old. I have heart disease. I have diabetes. I take all kinds of medicines, they say, but I can't afford them. The doctor says in Dickinson, ND, one night: I have this welfare woman, and this patient has a pretty aggressive form of breast cancer. He says: You have to be taking this medicine to prevent a reoccurrence when you have surgery. You have to take this medicine to prevent a reoccurrence of breast cancer. She says: What does it cost? He tells her. She says: I can't possibly do that. I can't possibly take that. I don't have the money to do that. I can't buy that medicine. Does this matter? It sure matters to the person whose life is at stake. So price is an issue. It is a big issue. We have all these anecdotal stories. We know the data. The amendment I have offered will save $50 billion over the next 10 years--$50 billion--most of it to consumers, through lower drug prices. That is a fact. It is not going to, in any way, injure the safety of our prescription drug supply. It will, in fact, enhance it dramatically by establishing pedigrees with respect to the movement of prescription drugs in this country and into this country. That is a fact as well. I said this morning I hate to lose debates I am not having, and it happens all the time on the floor of the Senate because someone is debating a bill I didn't introduce. They are welcome to do that. If it is attractive, maybe I will introduce it someday, but I am not interested in having a debate with somebody who wants to reformulate the legislation I have introduced. This addresses safety, all of the issues that Donna Shalala, the former Secretary of Health and Human Services raised, so we have incorporated into the bill, Senator Snowe and I and others have incorporated that right into the legislation. So you can't, it seems to me, make a strong case that there are valid safety issues. Again, I don't have problems with those who come to the floor saying let's continue the current system, but I think the current system is wrong. They have a right to advocate for the current system, but the current system is unfair to the American consumer, in my judgment. I want us to have the opportunity to have good health care and opportunities to be able to access miracle drugs, the opportunity to use those miracle drugs to manage diseases so you can stay out of an acute care bed, which is the most costly health care in our country. But I think it becomes almost a health care rationing in our country when we say we will ignore the situation that exists in this global economy in which the American consumer pays one price and consumers in virtually every other country pay a lower price for their prescription drugs. That, I think, is a horrible disadvantage to consumers in our country. Some will say: Well, you know now we have a Part D in Medicare which offers prescription drug benefits to senior citizens. Yes, that is true. It does. It has what has been defined around here only in the lexicon of politics as a doughnut hole. Only in the political system could we use those kinds of descriptions, but it has a kind of a circumstance where you reach a certain level and then there is no drug coverage on up from that level. Obviously, the prescription drug Part D for Medicare is helpful to senior citizens; there is no question about that. But it certainly isn't perfect because there is a substantial portion of it in which prescription drugs are not covered. At that point, senior citizens who are reaching the declining years of their lives are finding it very difficult to purchase their prescription drugs. There is much to say about this issue. I know there are some who worry that offering this amendment on prescription drug pricing to this underlying bill, the FDA Reauthorization Act, injures the underlying bill. I support the underlying bill. I think my colleagues, Senator Kennedy and Senator Enzi, have done some good work. I support that work. Let me say--and I know they know this--it is perfectly appropriate to offer this amendment on this bill because this is where it belongs. This is exactly where you would offer an amendment of this type. No one should express surprise about that. So we offer the amendment and then we file cloture so we can actually get to a vote on it, and all of a sudden it is like the circus left town. They pull up the tent stakes, fold up the tent, everybody is gone. All of a sudden we can't vote anymore. Why? I guess they are upset that my amendment is now in order to be voted on, and they say: You know, I don't know. We can't do that. As I have indicated before, I would be willing to offer this amendment in a different form--the same amendment but in a circumstance where I had an agreement to be able to bring it up. Four hours of debate, for example, a couple of amendments that would be offered by the other side, I would have the right to offer second-degree amendments, we would go to a vote and decide whether the Senate will pass a proposition that would give us an opportunity to reimport FDA- approved drugs from other countries that are identical to the other drugs we now purchase, except at a lower price. I would be happy to agree with others who would give us that time and that circumstance so that we could have this vote. I don't need to have the vote today or Monday or Tuesday, if I have an agreement that we will be able to get the vote at some moment. This vote has been stalled a long while. Senator Frist, when he was the majority leader, standing right back here at the end of this aisle at about 1 o'clock in the morning, in exchange for my releasing a hold on the nomination of Dr. McClellan, indicated to me and then put into the Congressional Record, in the Senate Record, that we were going to have action on this kind of legislation. It turns out it never happened. Senator Frist, of course, is now gone. For whatever reason, it never happened. I spoke at great length to him about these issues, but it didn't happen. So this is an opportunity for us to advance this legislation, and it is the right place at the right time. This has 33 cosponsors. John McCain is a cosponsor, Ted Kennedy is a cosponsor, Chuck Grassley is a cosponsor, Debbie Stabenow is a cosponsor, and Olympia Snowe is the major cosponsor with me. It is the Dorgan-Snowe bill. Thirty-three Republicans and Democrats are cosponsors of this legislation. This is exactly where it should have been offered, and it was. Now, all of a sudden, apparently there is some kind of gastric distress because we had a cloture vote and we prevailed in the vote that we say, all right, let's have votes on this amendment. So my hope is that, first, while we might form opinions on this amendment, we could coalesce on a central set of facts that represents what the amendment does and says; and, second, that we can begin, on behalf of the American people, to make some movement here and to begin to have votes. I also hope that, as I listen to further debate on the floor, we can stick to what the amendment is. It is not to reimport lower priced FDA- approved prescription drugs from everywhere. It limits it to those areas where we have safe and effective supplies of prescription drugs. I hope we can get all of the facts straight. This amendment has a lot of support. I believe the American people, by 75 to 80 percent, support this. I have seen poll after poll where the American people believe it is wrong and unfair for them to be charged the highest prices in the world for prescription drugs. Why on Earth should they drive 10 miles between two drugstores--one on the Canadian side and one on the American side of the border--only to find that the same medicine, put in the same bottle, made by the same company, FDA approved, has only one difference--the American consumer gets a chance to pay double. How do you justify that? You don't. We ought to change it. I yield the floor and suggest the absence of a quorum.

Mr. DORGAN

Mr. DORGAN. Mr. President, today I am joined by Senators Mikulski, Durbin, Stabenow, Rockefeller, Levin, Feinstein, Johnson, Harkin, Feingold, Leahy, Kohl, and Kennedy in introducing legislation to close an insidious loophole in the U.S. Tax Code that actually rewards U.S. companies that move American manufacturing jobs overseas. Some may think this is a belated April Fools' Day joke; regrettably, it is not. Let me explain how this perverse tax break for these companies works. When a U.S. company closes down a U.S. manufacturing plant, fires its American workers, and moves those good-paying jobs to China or other locations abroad, U.S. tax laws allow these firms to defer paying any U.S. income taxes on the earnings from those now foreign-manufactured products until those profits are returned, if ever, to this country. This tax break is not available to American companies that make the very same products here on American soil. So the U.S. company that decides to stay at home suffers a competitive disadvantage, a disadvantage that our tax laws have helped to create. Multinational companies ought to pay the same taxes that domestic companies pay. At a minimum, U.S. companies that keep their jobs here should not be put at a competitive disadvantage by Federal tax policy. The notion that granting large tax breaks to companies that move their manufacturing operations offshore is good for this country is utter nonsense. Among other things, those who support this half-cocked fiscal policy claim that shutting down U.S. manufacturing operations and moving them abroad will result in more U.S. jobs and increase our exports. However, this assertion is not supported by the facts. According to the latest available data, the number of foreign manufacturing affiliates has grown from 7,420 to 8,490, up some 14 percent since 1993. From 1993 though 2004, U.S. companies moved 1 million manufacturing jobs offshore to their foreign affiliates. Throughout this entire period, this perverse deferral break has been in effect. Has it resulted in new U.S. manufacturing jobs? No. We have lost some 3.2 million U.S. manufacturing jobs since 2000 alone. Has this misguided tax subsidy resulted in higher exports from U.S. companies to their foreign affiliates as the proponents of this tax subsidy suggest? No. In fact, imports into the United States from the foreign subsidiaries of U.S. companies more than doubled from $92 billion in 1993 to $203 billion in 2004. And the balance of trade with foreign affiliates of U.S. firms plummeted to a $72 billion deficit in 2004 as compared to $3.4 billion in 1997. I have been working to end this wrong-headed Federal tax break for many years. Senator Mikulski and I have forced the Senate to vote to repeal this tax subsidy several times. I have described stories on the Senate floor about a number of American companies that have moved production overseas, companies like Huffy bicycles and Radio Flyer little red wagons to China; Samsonite, which went to Mexico and then China; Levi's, which are now made all over the world, everywhere except in the very country that invented them; Maytag, which now makes appliances in Mexico and Korea; and Fruit of the Loom, which moved to Mexico. And I would point out, once again, that this tax deferral break given to companies like Radio Flyer or formerly to Huffy bicycles is not available to American companies that make the very same products on U.S. main streets. But we have run into stiff opposition from many U.S. multinational companies, their lobbyists, and some policymakers who claim our proposal would impede the ability of U.S. firms to compete and grow in the global economy. That is hogwash. This proposal does nothing to hinder U.S. multinationals that produce abroad from competing with foreign firms in foreign markets. The legislation we are introducing today is carefully targeted; it ends the deferral tax break only where U.S. multinationals produce goods abroad and ship those products back to the U.S. market. In more technical language, this legislation would end tax deferral for the ``imported property'' income of controlled foreign corporations. The proposal also adds a new separate foreign tax credit basket for imported property income. The separate foreign tax credit basket is an anti-abuse provision that will stop U.S. multinational companies from using the foreign tax credit to shelter profits generated in a tax haven country by preventing the cross- crediting of high foreign taxes on general income against the U.S. tax on imported property income that is subject to low foreign taxes. The tax experts with the Joint Committee on Taxation estimate that this pernicious tax break will costs U.S. taxpayers some $15.5 billion over the next decade. It is no wonder that the powerful lobby for the largest U.S. multinational firms has fought to keep this tax loophole fully intact. But as I have told my colleagues on the Senate floor a number of times, I intend to offer this proposal again and again until this tax subsidy is finally repealed. I understand that some U.S. companies will still choose, with or without this tax subsidy, to dislocate thousands of workers in America in search of cheaper labor, lax regulation, and greater profits abroad at whatever the cost. They will be free to do so. But at least U.S. taxpayers will not be asked to provide billions of dollars in tax subsidies for those who do. I urge all of my colleagues in the Senate, Democrats and Republicans alike, to take a fresh look at this issue and help us do what Congress should have done many years ago; that is, repeal this ill-conceived tax break once and for all.

Mr. DORGAN

Mr. DORGAN. Mr. President, today I am joined by Senators Mikulski, Durbin, Stabenow, Rockefeller, Levin, Feinstein, Johnson, Harkin, Feingold, Leahy, Kohl, and Kennedy in introducing legislation to close an insidious loophole in the U.S. Tax Code that actually rewards U.S. companies that move American manufacturing jobs overseas. Some may think this is a belated April Fools' Day joke; regrettably, it is not. Let me explain how this perverse tax break for these companies works. When a U.S. company closes down a U.S. manufacturing plant, fires its American workers, and moves those good-paying jobs to China or other locations abroad, U.S. tax laws allow these firms to defer paying any U.S. income taxes on the earnings from those now foreign-manufactured products until those profits are returned, if ever, to this country. This tax break is not available to American companies that make the very same products here on American soil. So the U.S. company that decides to stay at home suffers a competitive disadvantage, a disadvantage that our tax laws have helped to create. Multinational companies ought to pay the same taxes that domestic companies pay. At a minimum, U.S. companies that keep their jobs here should not be put at a competitive disadvantage by Federal tax policy. The notion that granting large tax breaks to companies that move their manufacturing operations offshore is good for this country is utter nonsense. Among other things, those who support this half-cocked fiscal policy claim that shutting down U.S. manufacturing operations and moving them abroad will result in more U.S. jobs and increase our exports. However, this assertion is not supported by the facts. According to the latest available data, the number of foreign manufacturing affiliates has grown from 7,420 to 8,490, up some 14 percent since 1993. From 1993 though 2004, U.S. companies moved 1 million manufacturing jobs offshore to their foreign affiliates. Throughout this entire period, this perverse deferral break has been in effect. Has it resulted in new U.S. manufacturing jobs? No. We have lost some 3.2 million U.S. manufacturing jobs since 2000 alone. Has this misguided tax subsidy resulted in higher exports from U.S. companies to their foreign affiliates as the proponents of this tax subsidy suggest? No. In fact, imports into the United States from the foreign subsidiaries of U.S. companies more than doubled from $92 billion in 1993 to $203 billion in 2004. And the balance of trade with foreign affiliates of U.S. firms plummeted to a $72 billion deficit in 2004 as compared to $3.4 billion in 1997. I have been working to end this wrong-headed Federal tax break for many years. Senator Mikulski and I have forced the Senate to vote to repeal this tax subsidy several times. I have described stories on the Senate floor about a number of American companies that have moved production overseas, companies like Huffy bicycles and Radio Flyer little red wagons to China; Samsonite, which went to Mexico and then China; Levi's, which are now made all over the world, everywhere except in the very country that invented them; Maytag, which now makes appliances in Mexico and Korea; and Fruit of the Loom, which moved to Mexico. And I would point out, once again, that this tax deferral break given to companies like Radio Flyer or formerly to Huffy bicycles is not available to American companies that make the very same products on U.S. main streets. But we have run into stiff opposition from many U.S. multinational companies, their lobbyists, and some policymakers who claim our proposal would impede the ability of U.S. firms to compete and grow in the global economy. That is hogwash. This proposal does nothing to hinder U.S. multinationals that produce abroad from competing with foreign firms in foreign markets. The legislation we are introducing today is carefully targeted; it ends the deferral tax break only where U.S. multinationals produce goods abroad and ship those products back to the U.S. market. In more technical language, this legislation would end tax deferral for the ``imported property'' income of controlled foreign corporations. The proposal also adds a new separate foreign tax credit basket for imported property income. The separate foreign tax credit basket is an anti-abuse provision that will stop U.S. multinational companies from using the foreign tax credit to shelter profits generated in a tax haven country by preventing the cross- crediting of high foreign taxes on general income against the U.S. tax on imported property income that is subject to low foreign taxes. The tax experts with the Joint Committee on Taxation estimate that this pernicious tax break will costs U.S. taxpayers some $15.5 billion over the next decade. It is no wonder that the powerful lobby for the largest U.S. multinational firms has fought to keep this tax loophole fully intact. But as I have told my colleagues on the Senate floor a number of times, I intend to offer this proposal again and again until this tax subsidy is finally repealed. I understand that some U.S. companies will still choose, with or without this tax subsidy, to dislocate thousands of workers in America in search of cheaper labor, lax regulation, and greater profits abroad at whatever the cost. They will be free to do so. But at least U.S. taxpayers will not be asked to provide billions of dollars in tax subsidies for those who do. I urge all of my colleagues in the Senate, Democrats and Republicans alike, to take a fresh look at this issue and help us do what Congress should have done many years ago; that is, repeal this ill-conceived tax break once and for all.

Mr. DORGAN

Mr. DORGAN. Mr. President, I ask unanimous consent that the Committee on Armed Services be authorized to meet during the session of the Senate on Thursday, May 3, 2007, at 9:30 a.m., in open, and possibly closed, session to receive testimony on United States Central Command in review of the Defense authorization request for fiscal year 2008 and the future years defense program.

Mr. DORGAN. Mr. President, I ask unanimous consent that the Committee on Commerce, Science, and Transportation be authorized to hold a hearing during the session of the Senate on Thursday, May 3, 2007, at 3 p.m., in room 253 of the Russell Senate Office Building. The purpose of the hearing is to review pending Corporate Average Fuel Economy legislation and related matters.

Mr. DORGAN. Mr. President, I ask unanimous consent that the Committee on Finance be authorized to meet during the session of the Senate on Thursday, May 3, 2007, at 10 a.m., in 215 Dirksen Senate Office Building, to hear testimony on ``Offshore Tax Evasion: Stashing Cash Overseas.''

Mr. DORGAN. Mr. President, I ask unanimous consent that the Committee on Homeland Security and Governmental Affairs be authorized to meet on Thursday, May 3, 2007, at 10 a.m. for a hearing titled ``The Internet: A Portal to Violent Islamist Extremism.''

Mr. DORGAN. Mr. President, I ask unanimous consent that the Committee on the Judiciary be authorized to meet to conduct a markup on Thursday, May 3, 2007, at 10 a.m. in Dirksen Room 226. Agenda I. Committee Authorization: Authorization of Subpoenas in Connection with Investigation into Replacement of U.S. Attorneys. II. Bills: S. 376, Law Enforcement Officers Safety Act of 2007. (Leahy, Specter, Grassley, Kyl, Sessions, Cornyn) S. 221, Fair Contracts for Growers Act of 2007. (Grassley, Feingold, Kohl, Leahy, Durbin) S. 495, Personal Data Privacy and Security Act of 2007. (Leahy, Specter, Feingold, Schumer) S. 239, Notification of Risk to Personal Data Act of 2007. (Feinstein) S. 1202, A bill to require agencies and persons in possession of computerized data containing sensitive personal information, to disclose security breaches where such breach poses a significant risk of identity theft. (Sessions) III. Nominations: Debra Ann Livingston to be U.S. Circuit Judge for the Second Circuit; Roslynn Renee Mauskopf to be U.S. District Judge for the Eastern District of New York; Richard Joseph Sullivan to be U.S. District Judge for the Southern District of New York; Joseph S. Van Bokkelen to be U.S. District Judge for the Northern District of Indiana.

Mr. DORGAN. Mr. President, I ask unanimous consent that the Seapower Subcommittee of the Committee on Armed Services be authorized to meet during the session of the Senate on Thursday, May 3, 2007, at 2:30 p.m., in closed and open sessions to receive testimony on Navy Force structure requirements and programs to meet those requirements in review of the defense authorization request for fiscal year 2008 and the future years defense program.

Mr. DORGAN. Mr. President, I ask unanimous consent that the Select Committee on Intelligence be authorized to meet during the session of the Senate on May 3, 2007 at 2:30 p.m. to hold a business meeting.

Mr. DORGAN. Mr, President, I ask unanimous consent that the Subcommittee on Public Lands and Forests of the Committee on Energy and Natural Resources be authorized to hold a hearing during the session of the Senate on Thursday, May 3, 2007 at 2:30 p.m. in room SD-366 of the Dirksen Senate Office Building. The purpose of the hearing is to receive testimony on the following bills: S. 205 and H.R. 865, to grant rights-of-way for electric transmission lines over certain Native allotments in the State of Alaska; S. 390, to direct the exchange of certain land in Grand, San Juan, and Uintah Counties, Utah; S. 647, to designate certain land in the State of Oregon as wilderness; S. 1139, to establish the National Landscape Conservation System; H.R. 276, to designate the Piedras Blancas Light Station and the surrounding public land as an Outstanding Natural Area to be administered as a part of the National Landscape Conservation System; and H.R. 356, to remove certain restrictions on the Mammoth Community Water District's ability to use certain property acquired by that District from the United States.

Mr. DORGAN. Mr. President, I ask unanimous consent that the Subcommittee on Water and Power of the Committee on Energy and Natural Resources be authorized to hold a hearing during the session of the Senate on Thursday, May 3, 2007 at 10 a.m. in room SD-366 of the Dirksen Senate Office Building. The purpose of the hearing is to receive testimony on S. 27, a bill to authorize the implementation of the San Joaquin River Restoration Settlement.

Mr. DORGAN

Mr. DORGAN. Mr. President, I would like to announce that the Committee on Indian Affairs will meet on Thursday, May 3, 2007, at 9:30 a.m. in Room 485 of the Russell Senate Office Building to conduct a hearing on S. 310, the Native Hawaiian Government Reorganization Act of 2007. Those wishing additional information may contact the Indian Affairs Committee at 224-2251.

Mr. DORGAN

Mr. DORGAN. Mr. President, I offered an amendment yesterday that a number of my colleagues have spoken on, both in favor and against. When I laid down the amendment yesterday, I did not speak on it, so I wish to take some time to describe what the amendment is, why it is important, and why those who have spoken against it are wrong. Let me describe, first of all, what the amendment is about, and let me do it, if I might, by asking unanimous consent that I be allowed to show on the floor of the Senate two bottles of medicine.

Mr. DORGAN. Mr. President, these two bottles of medicine contain Lipitor. Most people know about Lipitor. It is a cholesterol-lowering drug. This particular prescription drug is produced in Ireland, and it is sent from that production point, in a plant, by the way, that is approved by our Food and Drug Administration. We inspect that plant, as we do others. So they produce an FDA-approved drug--this drug has been approved--in a plant in Ireland that has been inspected by the FDA. These two bottles of medicine containing Lipitor, 20 milligrams, identical bottles with a difference in color, are sent to two different places in this case but sent to many places around the world. This one is sent to the United States to be sold to consumers in the United States that want to lower their cholesterol. This one is sent to consumers in Canada for those Canadians who wish to take Lipitor to lower their cholesterol. There is a difference. Oh, not in the medicine, not in the bottle, and not in the instruction. What is the difference? The American consumer is told: You have to pay twice as much. Let me say that again. The difference is the price. The Canadian consumer is told: You pay half the price. The American consumer is told: You pay double the price. Now, I use the Lipitor as an example only to describe a very significant problem. We have price controls on prescription drugs in this country. Those price controls are not established by the Government. They are not established by the Congress. These price controls are imposed by the pharmaceutical industry. I have a problem with the pharmaceutical industry saying to the American consumer: We have a deal for you; we want you to pay the highest prices in the world for prescription drugs. We are going to sell them all over the world: Italy, Japan, Germany, France, China. We are going to sell our prescription drugs, and in almost every circumstance, in other countries, we are going to give them a lower price. But to you consumers in the United States, we say: You pay the highest prices. Let me give you a couple of examples, and I will use Canada, but I could be using any number of countries around the world. Lipitor. We pay 96 percent more. Plavix, 46 percent more. Prevacid, 97 percent more than if you were to buy it in Canada. Zoloft, 52 percent more. It goes on and on. I said yesterday that I actually sat on a bale of straw on a farm talking to a bunch of folks, and there was a fellow in his 80s sitting on a straw bale talking about life and things, and he said: You know, Mr. Senator, my wife has been fighting breast cancer for 3 years. Every 3 months, we have driven to Canada to buy Tamoxifen because we save 80 percent by buying Tamoxifen to help my wife fight her breast cancer--we save 80 percent by buying it in Canada. So every 3 months, for 3 years, we have been driving back and forth to Canada because it is the only way we can afford that drug. He said: How do you justify that? How do you explain the difference in price? I said: I can't. It doesn't make any sense to me. I don't come here to be critical of the pharmaceutical industry, I come here to be critical of their pricing policy. Their pricing policies are unfair to the American consumer. Yes, the pharmaceutical industry produces miracle drugs; a fair amount of them are produced with research we pay for through the American taxpayer at the National Institutes of Health. Others are produced with the research and development done by the drug industry themselves. But I would say that miracle drugs offer no miracles to those who can't afford to buy them, and that is the point. What is fair pricing for pharmaceutical drugs, and why is it so unfair at this point to the American people? I introduced a piece of legislation with many of my colleagues, and let me read a list of the bipartisan cosponsors, Republicans and Democrats, who sponsored the legislation that we introduced in this Congress, the very legislation I have now offered as an amendment to this bill. Let me go through a list of some of the names. Myself, Senator Snowe, Senator Kennedy, Senators Stabenow, Bingaman, Feinstein, Nelson, Kohl, Schumer, Inouye, Brown, Sanders, Senators Grassley, McCain, Specter, Collins, Durbin, Pryor, Levin, Leahy, Tester, Conrad, McCaskill, Johnson, Casey, Boxer, Salazar, Clinton, Lincoln, Feingold. Thirty-three sponsors for this legislation that I have offered as an amendment here today. Let me now begin to describe a few of the opponents' arguments and then respond to them. My colleague, Senator Cochran, came out and offered an amendment that says in order for this to be effective, the Secretary would have to certify that it poses no additional risk to the public health and safety. Well, that is an amendment that is designed to kill the bill because the Health and Human Services Secretary will not certify to anything. Does anyone think the Health and Human Services Secretary or the FDA or anybody is going to certify that the chicken feed served to 3 million chickens with contaminated material from China, which now goes into our food source that humans are eating in this country today, that poses a risk? Or how about we say that we want them to certify that the vegetables imported into this country from Mexico pose no additional risk? Does anyone think anybody is going to certify to that? Do you, really? I could go on at great length. Does anybody know of any circumstance in which any part of our food supply is certified by anybody saying that the import of this poses no additional risk? No. So this is an amendment designed to make this inoperative. What my amendment does is actually make our drug supply safer with respect to the importation. Because the fact is people are now going back and forth across the border, those who can get there by car. Most Americans can't, but most are bringing prescription drugs back across the border for a 3-month supply. This makes that even safer. I am going to go through a number of the safety areas here, but first let me say this. I understand that the pharmaceutical industry wants to continue its pricing policies. I understand that. It is perfectly understandable. I have some differences with them. In the morning, perhaps while you are brushing your teeth or shaving, getting ready for work, you might turn on the television and what do you hear them saying on television? They say, well, you need to go talk to your doctor. You are brushing your teeth and thinking, why on Earth should I go talk to my doctor? Because the television advertisement says that you need to see if the little purple pill is right for you. You need to ask your doctor whether you ought to take the purple pill. I don't know what the purple pill is, but you get this urge that you think, maybe I should go ask somebody. If everybody is taking the purple pill, maybe I should find out if the purple pill is right for me. Maybe it is right for my colleague from Wyoming or West Virginia. Maybe we all ought to be taking the purple pill. I don't know. If they ever describe what the purple pill does, they also have to then describe what the potential risks might be of the pill. But in most cases, the TV just says, go talk to your doctor to see if it is right for you. So we have a lot of advertising going on, and we dramatically increase the use of prescription drugs. Go talk to any doctor and ask them if patients are coming to them and telling them what kind of prescription medication they want to take because they heard it on television. Go ask a doctor, and I tell you what the doctor will say. Absolutely. Of course, these are medicines that you can only get because a doctor has said you need them and, therefore, I prescribe them. Television advertising is creating a demand. I am not here with an amendment on television advertising, but I am observing that every morning they ask whether the purple pill, or whatever other medicine they are talking about, is right for you and that you ought to be visiting with your doctor about it. In addition to the issue of demand, there is the issue of pricing. I don't know. Somebody doesn't have to give me five reasons or three reasons or even two reasons. I want somebody to give me one reason, just one, that says we think it is perfectly defensible that the American people ought to be charged the highest prices for prescription drugs. Or in the specific case I mentioned, we think it is perfectly defensible that the American consumer taking Lipitor ought to be charged twice as much as the Canadian consumer. Give me one reason. I am not asking for five, just one reason. I can't believe there is one person on the floor of this Senate that has the ability to construct one thoughtful reason in support of that policy. Let me put in the Record a letter the AARP has written yesterday. Let me read a little bit of it: On behalf of the AARP's more than 38 million members, we urge you to support the Dorgan-Snowe importation amendment. This amendment provides for the safe, legal importation of lower price prescription drugs from abroad. In the quest for lower-priced prescription drugs, many Americans are already importing prescription drugs from abroad. [The Dorgan-Snowe] amendment would create a framework for the safe, legal importation of prescription drugs that will better protect the health and pocketbooks of those desperate for lower-priced prescription drugs. We are also very pleased to see that the [Dorgan-Snowe] amendment includes a number of safety requirements including inspections and measures to prevent the counterfeiting of imported drugs. I ask unanimous consent that the entire letter be printed in the Record.

Mr. DORGAN. It is interesting to me that those who have spoken against this come to the floor of the Senate with the specter of counterfeiting. Counterfeiting exists at this point. My amendment will make it less likely. This puts in place the very safety features and the very capability to try to shut that down. But if they are talking about counterfeiting that is existing now, it is existing without these kind of safety precautions on importation. Let me describe a man, a very courageous man named Dr. Peter Rost. He came to testify at a hearing we held on the subject of reimportation. Peter Rost was responsible for a region in northern Europe where they did this routinely. They had an approach in Europe called parallel trading. If you are in Germany and want to buy a prescription drug in France, that is not a problem. If you are in Italy and want to buy a prescription drug in Spain, that is not a problem. They have done this for a couple of decades. Dr. Peter Rost was in charge of a region in northern Europe. He said: I never once--not once--heard the drug industry, regulatory agencies, the government or anyone else saying that this practice was unsafe. And personally, I think it is outright derogatory to claim that Americans would not be able to handle reimportation of drugs, when the rest of the educated world can do this. This from Dr. Rost. He actually paid a price for speaking out and speaking the truth. He actually was working for Pfizer Pharmaceuticals at the time. He has had a little problem with his employer, but that is another story perhaps for another day. But Dr. Rost said it right, in my judgment. Let me, if I might, show this quote from Tommy Thompson, former Health and Human Services Secretary. He says: The law is this: In order to import drugs from any country, and especially Canada, I have to certify that all those drugs are safe. That's an impossible thing. If Congress wants to import drugs, they should take that provision out, because the Secretary of Health and Human Services cannot certify that all drugs coming into America are safe. Let me tell you something about Tommy Thompson. I like Tommy Thompson. He was a Governor from Wisconsin. That's a guy with spirit. I kind of like him. In fact, I think he is thinking about running for President. I probably will not vote for him because I am going to vote for a Democrat in this coming election, but I like Tommy Thompson. Do you know what he said to me at the elevator, right outside this Senate door after he left Health and Human Services? He was getting off the elevator as I was coming on the elevator, and I had been down to see him about this issue of reimportation of prescription drugs. I said: Secretary Thompson, why don't you work with us to get this done? He said: I can't. He explained there are lots of things going on, including the White House makes the call on this policy, et cetera. At any rate, after he left as Secretary of HHS, he was coming off an elevator out here and I was getting on the elevator. We said hello. I like him. I think he was a good Secretary. He turned around and said to me: Byron, he said, keep going on that imported drug issue. You are right about that. You are right about that. That is after he left office. He comes from Wisconsin. He knows. That is a State that borders Canada. He knows his constituents are able to just go miles up into Canada and seek prescription drugs for a fraction of the price. Let me respond for a moment to this issue of safety because my colleague from Mississippi and others have spoken about it. David Kessler, he served for 8 years as FDA Commissioner. He is a terrific public servant. In my judgment, there has been none better than Dr. Kessler over at the FDA. Here is what he said: [The Dorgan-Snowe bill] provides a sound framework for assuring that imported drugs are safe and effective. Most notably, it provides additional resources to the agency to run such a program, oversight by the FDA of the chain of custody of imported drugs back to FDA-inspected plants, a mechanism to review imported drugs to ensure that they meet FDA's approval standards, and the registration and oversight of importers and exporters to assure that imported drugs meet those standards and are not counterfeit. Let me make one with respect to this. A couple of my colleagues stood on the floor and said: Well, you would create a giant bureaucracy in order to do this. That is interesting. The Congressional Budget Office actually scored this bill we have introduced. Do you know what the score was? This will save $50 billion in a 10-year period.

Mr. DORGAN. With a ``b,'' $50 billion; just over $5 billion of that savings is to the Federal Government; just about $45 billion of that savings is to the American consumer. Is that an illusion? No, that is the score we have. We come to the floor of the Senate and the question is asked: Whom do you stand for? Whom do you stand with? Some will say: You know what, we believe--they will not say that. I do not believe they will stand and say: We believe the current surprising strategy is right, by which Americans are charged the highest price. I don't think they will say that. I think what they will see is we think there are serious safety issues with this. Let me again refer back to the expert who would perhaps know more about this than any other American. I have heard things read on the floor of the Senate by the assistant this or the assistant that. The last assistant we had come over to a hearing I held had not even read the bill. That is some assistant. At any rate, we don't have to worry about assistants. Let's worry about Dr. David Kessler, who I think is the preeminent authority. He said we can do this; we can do this, and it will make the drug supply in this country safer. I wish to talk about the issue of safety. It is not as if prescription drugs are not coming into this country from other countries. They, of course, are. Our pharmaceutical industry, and others, manufacture all over the world and then they ship these drugs into our country to be sold here. But there is a law that prohibits anyone other than the manufacturer to ship them in. Lipitor is made in Dublin, Ireland; Nexium is made in France; Tricor is made in France; Actos is made in Japan; Vytorin is made in Singapore and Italy and the United Kingdom. Those are pills made elsewhere, the medicines are made there and they are shipped here. Are they safe? Sure. I believe they are safe. I believe we have an enormously safe drug supply, despite the fright that is discussed on the floor of the Senate about counterfeiting. Is counterfeiting an issue? Sure, it is. It has nothing to do with this subject. Counterfeiting exists now and we have to take action and steps to fight it and we should fight it aggressively. But the fact is, this legislation that we introduce has a range of safety features that will guarantee the safety of FDA-approved prescription drugs that are imported into this country. First of all, we provide that only FDA-approved medicines with a ``chain of custody'' will be sent into this country. Dr. Mark McClellan, who used to head the FDA, and I was very critical of him because he continued to speak as if he represented the pharmaceutical industry instead of regulating it as head of the FDA, he and I had substantial differences, but even he said the chain of custody in Canada is safe, almost identical to the chain of custody for prescription drugs in the United States. If that is the case, and he said it, then tell me with respect to this risk, I go to a little one-room drug store in Emerson, Canada, with a woman named ``Sylvia'' and a number of other senior citizens. We take a little bus up to a one-room drugstore in Emerson, Canada, and they bring their prescriptions. That drug store has a licensed pharmacist, as the drug store a few miles south of the border has, a licensed pharmacist and a chain of custody from the drug manufacturer to the wholesaler to the retailer to the drug store. We go to that drug store and Sylvia and her friends buy prescription drugs at a fraction of the price they would have bought it in Fargo, ND, that morning. Tell me, is there a risk in that transaction? The answer is no. Don't represent there is because there is not. The chain of custody is nearly identical. I am speaking now of Canada. Tell me there is a risk and you are wrong, there is not. All the protestation on the floor of the Senate on this issue is protestation in support of the pharmaceutical industry. I like the industry. I have been helpful to them. I support research and development tax credits to find new prescription drugs. I have done a number of things to say I want us to be able to have a successful pharmaceutical industry in this country. But I am not willing to go so far as to say it is OK to me, I will be quiet if you decide the pricing strategy is we are going to price our prescription drugs at the highest prices for the American consumer. I will not sit in this chair and say it is fine with me. It is not, and that ought not be fine for any Member of the Senate. It should not.

Mr. DORGAN. Let me make some comments on safety. One-quarter of the prescription drugs taken in this country are produced outside this country in foreign manufacturing plants. In the last 5 years, the FDA has inspected more than 850 foreign drug factories in 41 different countries. The drug industry wants to take advantage of the global economy to manufacture their drugs in lower cost countries, but they do not want a licensed U.S. pharmacist and drug wholesalers to be able to take advantage of the global economy to get the best price for the American consumer. Let me say that again. The pharmaceutical industry wants to take advantage of the global economy for the purpose of their manufacture and profitability, but they do not want a licensed U.S. pharmacist or licensed wholesaler to be able to access those same drugs from a licensed wholesaler or pharmacist in another country in order to pass along lower prices to the American consumer. I do not think that is right. We have addressed all the issues that have been raised by two former Secretaries of Health and Human Services, saying in order for me to certify, we need to have this and that. We have addressed those safety issues in this legislation. Yet if you listen to the opponents who stand on the floor of the Senate with the talking points, there are safety and security issues and all these issues--I mean I have gotten the talking points, too, from the pharmaceutical industry. Heck, if I were in their position, I would want to keep this situation as long as possible. You have a good deal, don't give it up. But one of my colleagues yesterday, speaking on the floor, said: The people who are offering this amendment--and again this amendment goes from Senator Kennedy to Senator McCain to Senator Grassley to Senator Stabenow back and forth, Republicans and Democrats. One Senator, one of my colleagues, stood up and said there are political motives. I said I hope you don't mean that, and I hope you will withdraw that. This is a thoughtful serious debate. There are plenty of people who feel strongly in opposition to my amendment. Fine. But then you should stand and debate the proposition that you support. We support the current situation. We support the circumstance in which a pricing policy that prices the prescription drugs higher for the U.S. consumer is already with us. That ought to be the proposition you stand and support. You ought not stand and say there are significant safety issues here because that is not the case. It is not. There is much to say, and a number of my colleagues will continue to debate this issue. My own view is this is a hard issue to get passed on the floor of the Senate. I say that having had some experience with it. I must say I admire the pharmaceutical industry. They have been tough opponents. They feel strongly about their profitability. They say a couple of things. No. 1, this is unsafe. It is not. No. 2, it would somehow exacerbate counterfeiting. It will not. Counterfeiting now exists. We need to address that, but this would in many ways make the supply of drugs safer. They say a number of other things they believe-- that this would cause the American people to change their buying habits in ways that would be unhelpful to them. They believe you do not have a chain of custody that you can control or see that is transparent. That is not true. You know, I mentioned earlier about this issue of the industry itself. I want the pharmaceutical industry to succeed. They succeeded. This has been a very successful industry. They have made a great deal of money. But on this issue of research and development, I want them to engage in research and development. We are doing it here in the public sector of the NIH. We turn that material over to the pharmaceutical industry. They do research and development. Good for them. They spend a massive amount of money on promotion and development. I think that is of some concern for a number of people, but I am not here saying I do not want the pharmaceutical industry to succeed. There are those who also say, in addition to safety and other issues, they will say, all right, if you do not allow a pricing policy that prices prescription drugs at the highest level for the American consumer, it will mean less research and development by the pharmaceutical industry. The fact is, more research and development has gone on in other countries in which they charged lower prices for the same prescription drugs. So how does that hold water? It does not. My hope is, at long last, perhaps, this Senate will stand up for the interests of the American consumer. At long last, we can put to bed these specious arguments about safety because they are not applicable. Read the bill. These arguments about safety are not accurate. Let's put to bed this connection between counterfeiting. It is not accurate. Let's also stop talking about how this would shut off research and development. That is not accurate. Let's talk about what this bill would do, what this piece of legislation, this amendment we have now offered is. It would save about $50 billion over 10 years, $5 billion a year. It would probably require the drug industry to reprice for sure because, the fact is, if they are pricing at the highest levels to the American people, and they say that is the only way they can recover their costs, perhaps others ought to be paying more to recover costs. I don't know. I am saying that the industry, I believe the top seven U.S. pharmaceutical companies, a couple of years ago made $34 billion together. The industry has done very well. But there are a whole lot of folks in this country who haven't. It was about 9:30 one night in a tiny town north of Highway 2 in North Dakota. I had a town meeting. At the end of the town meeting, an older woman came up to me, and she was probably in her early eighties. She said: Mr. Senator, may I speak to you? I said: Sure. She grabbed my elbow with her hand. She began to speak. Her eyes welled up with tears and her chin began to quiver. She said: I am in my eighties. I don't have much money. She said: I have got heart disease and diabetes. My doctor prescribes medicines for me that are too expensive. I cannot afford them. Is there any way you can help me, Mr. Senator? Is there a way you can help me? This woman, with tears in her eyes, was asking: Is there someone who can help me manage this disease of mine because I cannot afford these medicines? We have taken steps to try to be helpful. I might say that some in the drug industry have taken steps by offering programs to low-income people. It is not enough. But I commend those who have and recognize it. But we should not have to do that in this country. We should not have the highest prices for prescription drugs. We should not have an 80-year-old woman driving to Canada to pay four-fifths less in cost for Tamoxifen to treat her breast cancer. That should not happen. So let's do this. Let's create a regime of safety--which we have done. Wonder about it? Go talk to Dr. David Kessler. You find a better expert, you tell me his name. We have created a regime of safety here that will work. Then let us decide to proceed, as Europe has done, as others have done, to allow the global marketplace to work for real people, to work for ordinary folks, not only the big interests. The big interests always do well. At the end of the day, when all of the dust settles, and all of the shouting is over, guess who almost always wins. Yes: Them that's got is them that gets and I ain't got nothing lately. I think that was Ray Charles. Isn't that always the case? When the dust settles, the big interests always win. Let's hope when the dust settles here tomorrow morning, and we have a vote on something that is important, is something that will help a lot of American people, millions, tens of millions, hundreds of millions, let's hope when the dust settles here, ordinary Americans will say, you know what. We won today in the Senate. Hallelujah, we won a vote in the Senate. Let's hope that is the case tomorrow morning. I yield the floor.

Mr. DORGAN. Mr. President, I have listened to some of the debate on the floor of the Senate in opposition to the amendment I have offered with many colleagues dealing with the reimportation of prescription drugs. Especially entertaining was to hear the Senator from New Hampshire, Mr. Gregg, describe North Dakota wheatfields. The Senate is a place of fascinating and interesting debate. I expect we will have more of that in the coming hours, leading up to a vote tomorrow on a cloture motion on this amendment. The continued and insistent reference to this amendment posing safety risks, or risks of unsafe prescription drugs, is at odds with everything we know to be the case. I described Dr. David Kessler, and I suggested if anybody knows a more important, better informed expert than Dr. David Kessler, who was head of the FDA for nearly 8 years, tell me his or her name. I described the statement that Dr. David Kessler made that says this will make the prescription drug supply safer. In fact, the regime of safety we have put into this amendment is appropriate, important, and will mean that we will be able to allow reimportation without a safety risk. Despite the evidence, we continue to hear this issue. I was thinking, as I was listening to this a while ago, about the Lincoln-Douglas debates, when Lincoln became enormously exasperated at one point and he said to Douglas: Tell me, how many legs does a horse have? Douglas said: Well, four, of course. Lincoln said: Now, if you were to call the tail of a horse a leg, then how many legs would a horse have? Douglas said: Well, five. Lincoln said: You see, that is where you are wrong. Just because you call the tail a leg doesn't make it a leg at all. The same principle holds true now on the floor of the Senate. You can say what you want, but that doesn't make it true. Safety issues? That doesn't exist in the amendment we are talking about. This will make the drug supply safer. While I am speaking of Lincoln and Douglas, let me say something else that Lincoln said, which has always been interesting to me. He was describing his opponent's arguments. He said: Your argument is as thin as the homeopathic soup made from boiling the shadow of a pigeon that has been starved to death. Wasn't Abraham Lincoln wonderful? That description can still exist for some of the arguments we are hearing these days on some of these issues. I hope my colleague was not serious a few moments ago when he said this is an amendment that is not worthy and is put out by a bunch of people who want to put out press releases and aren't concerned about the safety of the drug supply. My colleague surely doesn't mean to say that Senators Grassley, McCain, Snowe, and Collins on his side and Senators Kennedy, Stabenow, Brown, and so many on our side--the 33 Senators who have come to a serious issue with a thoughtful proposal-- did so because they want a press release. My colleague knows better than that. He perhaps ought to tell the Senate he knows better than that. I respect those who disagree with this amendment. I hope they will respect as well our determination to correct something we see as a serious problem. When my colleague says we don't want to give up our lead, describing our lead in pharmaceuticals and the development of prescription drugs, I don't want to give that up. Let me tell you another lead we don't want to give up; that is, the lead in providing the highest prices in the world to the American consumer who needs prescription drugs. That is a lead we ought to relinquish right now. I wonder if my colleague would agree with that. Mr. President, this is an interesting debate, a useful debate. It will conclude tomorrow with the vote. My colleague from Michigan, Senator Stabenow, has gone across the bridge that connects our two countries, taken busloads of senior citizens and has been involved in this issue for many years, believing that we ought to insist on fair pricing for prescription drugs for the American people. I am pleased that she was one of the people who helped put together the bill introduced by 33 Senators, and I am pleased that she is a strong advocate for the amendment that we have added to this piece of underlying legislation. I yield the floor.

Mr. DORGAN

Mr. DORGAN. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. DORGAN

Mr. DORGAN. Mr. President, I ask unanimous consent that Senator Boxer from California be recognized for 15 minutes, obviously as the next Democratic speaker following my presentation.