Byron Dorgan

Mr. DORGAN

Mr. DORGAN. Mr. President, I ask unanimous consent that the Committee on the Judiciary be authorized to meet during the session of the Senate, on December 15, 2009, at 10 a.m., in room SD-226 of the Dirksen Senate Office Building, to conduct a hearing entitled ``Ensuring the Effective Use of DNA Evidence to Solve Rape Cases Nationwide.''

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 December 15, 2009, at 2:30 p.m.

Mr. DORGAN. Mr. President, I ask unanimous consent that the Committee on Homeland Security and Governmental Affairs' Subcommittee on Oversight of Government Management, the Federal Workforce, and the District of Columbia be authorized to meet during the session of the Senate on December 15, 2009, at 10 a.m. to conduct a hearing entitled ``One DHS, One Mission: Efforts to Improve Management Integration at DHS.''

Mr. DORGAN

Mr. DORGAN. Mr. President, I would like to announce that the Committee on Indian Affairs will meet on Thursday, December 17, 2009, at 2:15 p.m. in room 628 of the Dirksen Senate Office Building to conduct a business meeting on pending committee issues, to be followed by an oversight hearing on the Cobell v. Salazar Settlement Agreement. Those wishing additional information may contact the Indian Affairs Committee at 202-224-2251.

Mr. DORGAN

Mr. DORGAN. Mr. President, the Senate voted Sunday on final passage of the conference report to accompany H.R. 3288, the Transportation, Housing and Urban Development and Related Agencies Appropriations Act for 2010. I was unable to vote because I was attending my son's college graduation ceremony at the University of Minnesota, which occurred at the same time as the Senate vote. Had I been present during the vote, I would have voted in favor of the legislation.

Mr. DORGAN

Mr. DORGAN. Mr. President, first of all, I ask unanimous consent that the amount of time by which the other side went over the allotted time be added to our block of time.

Mr. DORGAN

Mr. DORGAN. Mr. President, I came to the floor to speak about a speech a colleague, for whom I have great affection, gave yesterday on the floor of the Senate. He was concerned about a provision in the appropriations bill that is now being considered, a provision dealing with the sale of agricultural commodities to Cuba. My colleague said the provision would undo current law, where the Castro regime in Cuba would have to pay in advance for goods being sold to them because of their terrible credit history. That is not an accurate statement. I expect there is just a misunderstanding. I would be very happy if my colleague would wish to have a colloquy on the floor to set out the law and the provision in the bill so all of us understand the same thing. No. 1, I helped write the law that finally opened just a small crevasse--the ability of our farmers in America to sell their agricultural commodities into the Cuban marketplace. Why did I do that? Because we have an embargo on Cuba that, in my opinion, has failed for 40 or 50 years. At the time that embargo included restricting the sale of food to the Cuban people. I do not think we ought to ever embargo food shipments anywhere in the world. I think it is immoral. I do not think we ever ought to use food as a weapon. Yet that is exactly what has been done. Our farmers could not sell agricultural commodities into Cuba. Canadian farmers could. French farmers could. German farmers could. American farmers could not. I changed the law, along with a Republican colleague, with a Dorgan- Ashcroft amendment. We changed the law. We opened it just a crack so American farmers could sell their commodities into the Cuban marketplace. But it had to be for cash. The Cubans had to pay cash in advance. I support that. I helped write the law. In fact, what I would like to do is put up a copy of the current law. The current law indicates ``cash in advance.'' We have sold about $3 billion of agricultural commodities into the Cuban marketplace since the law was passed, and they have paid cash in advance. What happened was, President Bush decided just prior to an election that he wanted to send a signal that he was really tightening things with Cuba. He decided to change the definition--not by law but by administrative fiat--and he said ``cash in advance'' will mean the Cubans have to pay for the commodity even before it is shipped from a port in the United States. For four years up to then, the government allowed U.S. farmers to ship the goods from the port and then have the Cubans pay cash when the commodity arrives in Cuba. The President made that change as an attempt to shut down the sale of agricultural commodities to Cuba. Here is what the Calgary Herald, a Canadian newspaper, said: ``Cuba to Buy $70 Million of Canadian Wheat.'' Then in the body of the article it says: Cuban food purchases from Canada will increase 40 percent this year due to difficulties buying from the United States which is requiring payment before shipment of the food sales. As I said, President Bush tightened the rules to say that ``cash in advance,'' in a law I wrote, shall be interpreted as meaning you must pay even before the shipment. I have never even considered the phrase could be interpreted like that, but that is the way the law is now being administered. In the pending appropriations bill, there is an amendment I included. It is not, in my judgment, something we ought to debate. It is just there. We ought to understand it. It very simply says this. During fiscal year 2010, for purposes of . . . the Trade Sanctions Reform and Export Enhancement Act of 2000 . . . the term ``payment of cash in advance'' shall be interpreted as payment before the transfer of title to, and the control of, the exported items to the Cuban purchaser. It takes the definition of ``payment of cash in advance'' back it to how it was originally interpreted after I got my bill passed and we started selling into the Cuban marketplace. It restores it to what it was. My colleague yesterday said this would undo the current law where the Castro regime would have to pay in advance. Obviously, that is not the case. It is just not the case. ``Payment of cash in advance shall be interpreted'' to mean ``payment before the transfer of title to, and control of, the exported items . . . '' There is nothing here suggesting credit be offered to the Cuban regime. This only resolves an issue that was created when President Bush wanted to shut off agricultural commodity shipments to the country of Cuba. As I indicated, the result of the Bush administration's interpretation is what the Calgary Herald wrote about: American farmers, watch the Canadians grab your market. Why on Earth should we withhold food shipments anywhere? It makes no sense to me. Why should we say to our farmers who produce foods--and we need to export that food--that the Canadians can have an advantage, the Europeans can have an advantage, they can service that market but we cannot, even though we require cash in advance. Lets make it even harder by requiring payment before shipping even. That makes no sense to me. That is why I wanted to correct it. I wanted to correct it to get it back to what the law reads. My colleague who spoke on this issue yesterday is a good Senator and somebody I like a lot, but he indicates that this amendment of mine undoes current law where the Castro regime would have to pay in advance. That is just not the case. That is not the case. Maybe the best way for us to resolve this is, let's do a colloquy on the floor to put in the Record the exact language, because the shipment of agricultural commodities to Cuba in the future will continue to require cash payments in advance. That is just a fact. Let me say also, my colleagues--I use the term plural--who feel very strongly about this issue, the Cuba issue, we have common cause. I have no truck for the Cuban Government. I want the Cuban people to be free. I have no sympathy for the Cuban Government. But it is interesting to me that our engagement with Communist China and Communist Vietnam, for example, is to say that constructive engagement through trade and travel is the best way to address those issues. We believe that. Except we say in Cuba that we do not believe it. We restrict the right of the American people to travel to Cuba, which is slapping around the rights of the American people in order to poke our finger in the eye of Fidel Castro, I guess. And we do other things that make no sense. My colleagues who have raised these issues actually won on one issue that kind of bothers me. I also put an amendment in this legislation that I understand now has been emasculated. Let me describe what that was. Most people do not know this, but we have airplanes flying over Cuba, at least in international waters, broadcasting television signals to Cuba. I was able to get that shut down in an amendment in the appropriations process because we are broadcasting television signals to Cuba to tell the Cuban people how great freedom is--they can hear that on a Miami station 90 miles away--but we are broadcasting television signals being broadcast by an airplane and the signals are signals the Cuban people cannot see. Isn't that interesting? It is called TV Marti. Here is a picture of what TV Marti broadcasts. That is the television screen for TV Marti. The Cubans block it easily, and the Cuban people do not see it and cannot see it. We started out broadcasting that with aerostat balloons. They called it Fat Albert. This is the second one. The first one got loose. Fat Albert got loose. It was tethered on a big, long tether, hanging way up in the air, to broadcast television signals to the Cuban people that the Cubans were blocking. So we are spending a lot of money broadcasting television signals that nobody can see. In the first case, we had aerostat balloons, huge balloons, tethered way up in the air, spending millions of dollars a year. One got loose and flew over the Everglades, and they had a devil of a time trying to capture Fat Albert. So they got a second Fat Albert and kept broadcasting signals no one could see. But that wasn't good enough. In fact, they decided: You know what, we are going to get ourselves a big fat airplane and we will fly that airplane around and broadcast signals to Cuba from an airplane. And those signals, too, by the way, are routinely blocked and no one can see them. In my judgment we should not waste that kind of money. John Nichols, professor of communications and international affairs at Penn State University had this to say. He is one of the experts on communications policy. TV Marti's quest to overcome the laws of physics has been a flop. Aero Marti, the airborne platform for TV Marti, has no audience currently in Cuba, and it is a complete and total waste of $6 million a year in taxpayer dollars. The $6 million is just for the airplane. They spend much more than that on TV Marti. It is a total and complete waste of $6 million a year in taxpayer dollars. The audience of TV Marti, particularly the Aero Marti platform, is probably zero. We have been doing this for 10 years and more. Since I raised this issue, we have spent $\1/4\ billion broadcasting television signals into a country that cannot see them. Let me continue: TV Marti's response to this succession of failures over a two-decade period has been to resort to ever more expensive technological gimmicks, all richly funded by Congress, and none of those gimmicks, such as the airplane, have worked or probably can work without the compliance of the Cuban Government. It is just the law of physics. In short, TV Marti is a highly wasteful and ineffective operation. I put in an amendment that cut $15 million out of this program. I know it is radical to say you should not broadcast to people who cannot see them. I suspect this must be considered some sort of jobs program. That would be the only excuse for continuing funding. I had an amendment that shut down TV Marti. If ever--ever, ever-- there were an opportunity to cut government waste, this is it. This is just a program that accomplishes nothing and has no intrinsic value at all. But in the middle of a very significant economic downturn, when deficits have spiked up, up, way up, I apparently cannot even get this done. I got it done in the Senate, but it did not get through the conference. I guess for the next year or so--Fat Albert is retired--the airplane will still fly. And here is a television set in Cuba sees of TV Marti snow, static. We will continue to spend $15 million or so so the Cubans can look at static on their television sets. It is not much of a bargain for the American taxpayer, I would say. I only point this out because I lost on this issue. Those who feel strongly that we ought to continue to do this won. I hope that one day, perhaps we could agree that when we spend money, let's spend it on things that work, spend it on things that are effective, spend it on things that advance our interest and our values. This certainly does not. Mr. President, I yield the floor.

Mr. DORGAN

Mr. DORGAN. Mr. President, I have come to the floor to speak about something a colleague of mine spoke about last night, which I think he believes separates us when, in fact, it doesn't. Before I do that, I wish to talk for a moment about the amendment of mine now pending on the floor of the Senate, dealing with the issue of prescription drug pricing. I offered this amendment, along with my colleague, Senator Snowe, with the support of a broad bipartisan group of Members of the Senate-- Republicans and Democrats--at a time when there has been so few bipartisan amendments. The amendment I have offered is, in fact, bipartisan and had bipartisan speeches in favor of it in the last several days. That is unusual, but I think it is also refreshing. The amendment is very simple. It has been around for a long time. It has been hard to get passed because the pharmaceutical industry is a very strong, assertive industry. It is a good industry, but I have strong disagreements with their pricing policies. This amendment simply says the American people ought to have the freedom to access FDA- approved drugs wherever they are sold--as long as they are FDA approved--and offered at a fraction of the price they are sold at in the United States. I ask unanimous consent to show on the floor, once again, two bottles of pills.

Mr. DORGAN. This bottle contained Lipitor, perhaps the most popular cholesterol-lowering drug in the world. This was made by an American company in an Irish plant--made in Ireland and shipped around the world. This bottle, as you can see, is identical to this one. One has a red label and one has a blue label. The only difference in a circumstance, where you have the same pill, put in the same bottle, made by the same company, is the price. Americans pay $4.78 per tablet and, in this case, folks in another country pay $2.05. Why the difference? Again, it is not just one country. This bottle is shipped to virtually every other country, including Great Britain, France, Germany, Spain, Canada, and it is sold at a much lower price. The question is, Should the American people be required to pay the highest prices in the world for prescription drugs and not have the freedom to access those drugs in the global marketplace? Some say: Well, if you did that--if you allow the American people to access that drug from Canada or Germany at a fraction of the price, we would get counterfeit drugs. It is interesting that in our amendment we actually have more safety provisions than exist in our domestic drug supply. There does not now exist a tracing capability, pedigree, or batch lots. That would be a part of our amendment. That doesn't exist for America's drug supply today. We will actually improve the safety of the drug supply with this amendment. I didn't offer this amendment to cause trouble for people. I know this is causing great angst in the Senate. We have been tied up several days now on this issue. I know the pharmaceutical industry has a great deal of clout. This issue revolves around $100 billion, $19 billion of which will be saved by the Federal Government in the next 10 years and nearly $80 billion saved by the American consumers because they can access FDA prescription drugs at a fraction of the price. So I understand why some are fighting hard to prevent this. But this is important public policy. The price of prescription drugs has gone up 9 percent this year alone. Every single year, the price of prescription drugs goes up. Every year since 2002, drug price increases have risen above the rate of inflation. We can't, in my judgment, pass health care reform through the Congress and say: Yes, we did that, but we did nothing about the relentless increases in the price of prescription drugs. We will solve that not by imposing price controls but by giving the American people freedom. They are told it is a global economy. Well, it is a global economy for everything except the American people trying to access prescription drugs at a fraction of the price in most other countries. Again, I didn't offer this amendment to try to cause trouble; I offered this amendment to try to solve a problem. This Congress should not, in my judgment, move ahead with health care reform and decide it ought to leave the question of the American people paying the highest prices for prescription drugs--leave that alone and let that continue to be the case for the next 10 years or the next 20 years. I will speak more about it later.

Mr. DORGAN

Mr. DORGAN. Madam President, the amendment we are now considering is an amendment I have offered that deals with drug importation; that is, the importation of prescription drugs from other countries. One might ask the question: Well, why would we want to import drugs from other countries? FDA-approved drugs are made all over the world and they are shipped all over the world; again, FDA-approved drugs, approved by our Food and Drug Administration, produced in plants that are inspected by our Food and Drug Administration. The difference is--the only difference is--when they are shipped around the world, the American consumer is charged the highest prices in the world by far. Here is an example of the drug Lipitor. There are plenty of examples and I will go through a number of them today, but this is an example of Lipitor. For an equivalent amount of Lipitor, 20 milligram tablets, the U.S. consumer pays $125, the British pay $40, the Spanish pay $32, the Canadians pay $33, the Germans pay $48. We are charged the highest prices in the world for Lipitor. Lipitor, by the way, is the most popular cholesterol-lowering drug. I have a couple of empty bottles in the desk drawer here that demonstrates this drug was produced in Ireland. It was sent all around the world. The same pill put in the same bottle made by the same company, approved by our Food and Drug Administration, this was sent to Canada, this was sent to the United States. The difference? Well, the American consumer was allowed to pay three times as much as the Canadian consumer. I shouldn't say ``allowed,'' I should say forced. But it is not just United States versus Canada. As we can see, it is United States versus every other country. The question is, Should that be the case? Should the American consumer be charged the highest prices in the world? My answer to that is no. Why is it the case that we are charged the highest prices in the world? Because we are the only country in which there is a special little law that prevents our citizens from accessing that FDA-approved drug from wherever it is sold at the most advantageous price. We have a provision in law that says the American people don't have the freedom to import a prescription drug, an FDA-approved drug that they find for half the price or 20 percent of the price in some other country. I say, give the American people the freedom. I hear so much discussion on the floor of the Senate about freedom. This is the ultimate freedom: the freedom of the American people to access those prescription drugs that are sold virtually everywhere else, brand-name prescription drugs at the fraction of the price. I have examples of other prescription drugs as well to show you. It is not just Lipitor, although Lipitor is the most popular cholesterol- lowering drug. This is Plavix. Plavix is an anticoagulant. You will see that we pay higher than all of these countries by far; more than double what the British pay, more than double what the Spanish pay. This is Nexium. If you are someone who has ulcers and you are taking Nexium, for an equivalent amount of the same drug, Nexium, you are charged $424 if you are an American citizen, $40 for the British, $36 for the Spanish, $37 for the Germans, $67 for the French. The American consumer, trying to control their condition of ulcers, pays $424--10 times the amount of money that others are paying for the identical drug--10 times. This kind of what I believe is gouging--that is, a pricing strategy that gouges the American consumer--can largely be resolved by the amendment I have offered. It removes that little sweetheart impediment in law and says to the American people: You may import prescription drugs that are FDA-approved from registered enterprises in other countries. We specifically delineate which countries those are--there are a handful of them--that have a nearly identical drug approval process that we have in our country. Identical. We also put in this amendment unbelievable safety provisions dealing with pedigree and batch lots and tracers that don't exist now in our domestic drug supply, let alone importation. So if we were allowing the American people to do this, the Congressional Budget Office says my amendment will save $19 billion-- $19 billion--for the Federal Government over the next 10 years, but about somewhere around $80 billion for American consumers above that. That is a pretty big savings. Here is another chart that shows what has happened in addition to the fact that we are charged the highest drug prices in the world. What has happened in recent months, in 2009, is that brand-name prescription drugs have increased in price over 9 percent, at a time when there is virtually no inflation. For Enbrel, for arthritis, you get to pay 12 percent more; for Singulair, 12 percent more; and for Boniva, for osteoporosis, by the way, you are paying 18 percent more just this year. That is what is happening. There is nothing in any of the health care plans considered by the Senate or the House that addresses the escalating price of prescription drugs. There are a whole lot of folks in this country who are not senior citizens and are taking drugs to manage their disease. They may take cholesterol-lowering medicine or medicine to lower their blood pressure. They manage their health issues, and they don't have to go to a hospital because they are doing the right things. They are doing it with pharmaceuticals. The problem is, pharmaceutical prices are going up, up, up, way up above what other people in the world are paying for the identical drugs. I am saying it is just not fair. The issue is not that the pharmaceutical industry is a bad one or that they are infested with bad companies. I just think they have bad pricing policies. They are able to, and therefore they do, charge the American people, by far, the highest prices in the world. I wish to talk about a couple of important issues with respect to this issue of giving the American people the freedom to access or purchase that FDA-approved drug in selected countries in which the drug safety regulatory system is identical to ours, which is in our bill. And our bill includes, as I said, the establishment of pedigrees for batch lots and tracers that don't exist today for our drug supply. Some say and allege that you cannot do this safely, that it causes all kinds of problems with counterfeiting and so on. The fact is, the Europeans have been doing it safely for 20 years. For over two decades, in Europe, under what is called parallel trading, if you are a German and want to buy a prescription drug in Spain, you can do it through the parallel trading system. If you are in Italy and you want to buy a prescription drug from France, there is no problem, you can do it. They have done that safely for a long time. To suggest that we don't have the skill and capability to do what the Europeans have been doing routinely for 20 years is, in my judgment, shortchanging our country and certainly our consumers. I think we will, however, have people allege again that this is risky, it is just risky. I would like to make a point about risk because I want to demonstrate something that I think most people don't know. Forty percent of the active ingredients of our existing prescription drugs come from China and India. Again, 40 percent of those active ingredients come from China and India and in most instances from areas that have never been inspected. My amendment doesn't allow drugs to be imported into this country from China or India. I am talking about the ingredients the pharmaceutical industry acquires with which to make their drugs. We don't allow drugs to be imported from China or India as a matter of this amendment; only FDA-approved drugs from FDA-inspected plants in Canada, the European countries, Japan, New Zealand, or Australia. That is all. Why? Because they have similar drug safety standards. That is the basis on which we determine how importation could work safely. I wish to describe a recent scandal that illustrates the double standard some want to apply to this question. The scandal was about a drug called Heparin, a blood thinner that is commonly used by dialysis patients, which was linked to more than 62 deaths last year. Heparin was ultimately pulled from the market. According to Baxter, which markets Heparin in the United States, the allergic reactions to Heparin that caused the deaths appear to be caused by a contaminant added in place of the active ingredient in Heparin somewhere during the manufacturing process, most likely in China. The Wall Street Journal did a very important story on the Heparin contamination. They reported that more than half of the world's Heparin gets its start in China's poorly regulated supply chain. This is what the Wall Street Journal, after its investigation, concluded: More than half of the world's Heparin, the main ingredient in this widely used anti-clotting medicine, gets its start in China's totally unregulated supply chain. The Wall Street Journal published a series of pictures that I want to show--photographs of the intestine encasing factory which processes pig intestines used to make Heparin. I want to show some photographs that came from the Wall Street Journal. This is a photograph of a facility, and that is the outside. Here is a photograph of someone in the facility who is stirring a rusty vat full of Heparin ingredients with a tree branch. So this is the processing of Heparin from pig intestines in a facility in China, in which a worker is stirring this rusty vat with a tree branch. Are the ingredients that are used to make medicine with respect to blood clotting an issue? When the industry and others say we can't have drug importation safely from Canada or Ireland, the point is that they are getting a lot of their ingredients from China and India. All you have to do is simply look at this and ask yourself whether the domestic drug supply with respect to that ingredient and those inputs has sufficient safety. While the record keeping at these Chinese facilities makes it almost impossible to trace the contaminant from this particular factory, these pictures by the Wall Street Journal show the unsanitary conditions in which pig intestines are processed for that particular medicine. Again, by contrast, the amendment we offer would allow the importation of FDA- approved medicines only, with a chain of custody to ensure the drugs are handled properly. It gives the FDA the authority to inspect all facilities in the chain of custody. The amendment mandates the use of anticounterfeiting technology to track and trace imported and domestic drugs to ensure product integrity. That doesn't exist today, but that is required in the amendment. The amendment also requires pharmacies and drug wholesalers to register with the FDA and to be subject to strict requirements to ensure the safety of imported medications, including frequent random inspections. The amendment I am offering would ensure safety and, in fact, provide a much greater margin of safety than now exists with all of our drug supply. We need to have these improvements, in my judgment, because our own prescription drug distribution system is not as good as we think it is. Here is an excellent example of something that took place in the United States. This is a picture of Mr. Tim Fagan, a young 16-year-old boy from Long Island, NY. He received a liver transplant. He was prescribed a drug called Epogen to boost his red blood cells and fight the anemia after the operation. He received daily inspections, but his red blood cell count wasn't improving and the doctors could not figure out why, what was happening. After 2 months, his mom went to the local CVS pharmacy, where she was told: By the way, the Epogen your son has been taking may have been counterfeit. Here is an example of counterfeiting in the existing domestic drug supply--counterfeiting in which this container held the counterfeit medicine and this one held the real medicine. There were subtle differences but not many. It turned out that the vial Tim was injecting was one-twentieth the strength of what he was supposed to be taking and what was disclosed on the label. How did that happen? The weaker drug sells for $22 a bottle, and the high-strength version goes for $445 a bottle. Investigators found that 110,000 of the bogus bottles of that medicine reached the market in this country, and it is estimated that the criminals involved with that counterfeiting in that particular case made $46 million. The manufacturer of that drug, a company called Amgen, had distributed some of the product through a complicated network of secondary distributors. Although nobody knew it at the time, some of the Epogen that was eventually resold had most likely run through a cooler in the back of this strip club, a seedy Miami strip club called Playpen South. Here is a chart that shows the distribution system this particular counterfeit drug went through. Again, this is not an import; this is a domestic drug. You can see this unbelievable and complicated distribution system. At the end of that, it traveled through strip clubs, through homes, and through trunks of cars without proper cooling. This story was told in great detail by some outstanding investigation by Katherine Eban in a book called ``Dangerous Doses.''

Mr. DORGAN. I ask unanimous consent to extend the period of debate until 3 p.m., with the time to be equally divided, with Senators permitted to speak therein for up to 10 minutes each, with no amendments in order during this time.

Mr. DORGAN. I ask unanimous consent to speak for as much time as I may consume.

Mr. DORGAN. Mr. President, again talking about the issue I just described: They traveled through strip clubs. They traveled through homes. They traveled through trunks of cars, without proper cooling. I am talking about a domestic counterfeit drug supply. The amendment we are offering would fix this supply chain problem. It will require a pedigree for all drugs, not just those imported. It should have been done long ago. Some of us have been trying for a long time. It will allow us to track every single drug from where it is made to the pharmacy in which it is sold. My amendment will require a set of anti-counterfeiting measures that are not in place now. If you think of it, I have a twenty-dollar bill here, and most people who have looked at them understand there is sophisticated and substantial anti-counterfeiting technology in new twenty-dollar bills. That doesn't exist today, by the way. That sophistication, that relentless search for the ability to detect counterfeiting does not exist today, regrettably, in our drug supply. The pedigree that we require, the tracing capability, the batch lots will make that a requirement on our entire drug supply. This amendment will make our entire drug supply safer. It will allow Americans to benefit from lower prices--the prices at which these identical drugs are sold in other countries. In many cases they are half the price and in some cases much lower--10 percent of the price at which they are sold in this country. I wish to talk for a moment about the issue of drug price inflation because the drug price--what is happening to us in this country is drug price inflation, the relentless increases year after year, which is the red line here on the chart. It is 9.3 percent this year. This yellow line is the rate of inflation. If we don't do anything to deal with the price of prescription drugs, we will have missed the opportunity to do something to help the American people. Let me describe a few stories about the need for the amendment. In my home State, in Aneta, ND, Maryanne wrote to me: My husband has Parkinson's Disease, so he takes a drug called Mirapex. We have Medicare Part D, but in September, he ends up in the so-called donut hole. In 2008, when this happened, we paid $106 for his medication. It increased to $187 in October and November, $198 in December. Now, in September 2009, the price was $286--a $180 increase in one year.

Mr. DORGAN. Yes.

Mr. DORGAN. The explanation, I suppose, is probably better addressed to the pharmaceutical industry of how and why do they increase these prices this way. My guess is they do it because they can. The fact is, the cost-of-living index--the inflation rate is the yellow line. The price of prescription drugs is the red line.

Mr. DORGAN. I say to the Senator from Arizona, my expectation is the pharmaceutical industry has said this is the time to increase these prices. The most important element is there is no restraint. No one has any capability of restraining them. The only way you would provide restraint on this is if you said to the American consumer: You know what. You don't have to buy it from these people at these prices because it is sold in virtually every other country at half the price. If we say to the American people, we will give them the freedom to access that drug elsewhere, I think quickly the pharmaceutical industry would not be able to impose those price increases because then you would have competition. Freedom equals competition, in my judgment, on this issue.

Mr. DORGAN. I say to the Senator from Arizona, there is not a safety issue here. To the extent there is any safety issue, it is that we intend to increase the safety of both domestic supply of prescription drugs and the imported prescription drugs because the fact is, there is nothing at this point dealing with batch lots and pedigrees and tracing capability. That does not exist at this point. We will insist on it in this amendment. For anybody to suggest that somehow we are going to end up with prescription drug products that are less safe, that is just not the fact. As I indicated before the Senator came to the floor, Europe has been doing this for 20 years in something called parallel trading. For 20 years, they have done it. If you are in Germany and want to buy a prescription drug that is approved, you can. If you are in Italy and want to buy it from France, you can. They do it successfully. I do not believe anybody should tell us we are not capable of doing what the Europeans have done for 20 years, and that is giving people the freedom to access prescription drugs where they are sold at a better price.

Mr. DORGAN. Madam President, the Senator from Arizona is correct. There was a letter from the Food and Drug Administration. The fact is, we have seen this over the years. They say: We don't have the resources or it will pose more risk. The fact is, this amendment provides the resources for them because those who are going to register to ship FDA-approved drugs into this country at a better price are going to have to pay a fee. The people who are selling will pay a fee, and those pharmacies and others in our country that will be receiving them will also pay a fee.

Mr. DORGAN. No additional funding from the taxpayers at all. Those who decide they are going to offer these lower price prescription drugs would be paying a fee for the purpose of being able to do that. This is not a taxpayer-funded issue at all. It will provide the additional resources and pay for those resources without asking the taxpayers to come up with the money.

Mr. DORGAN. The countries that are involved in this amendment--and they are limited--are countries that have nearly identical drug safety standards to our country. These are countries that are accessing the same drugs. I just mentioned--let me do it again--two bottles of medicine. They are empty, obviously. Both of these bottles contain Lipitor. Most of my colleagues know what Lipitor is. This was made by an American company in Ireland and then shipped all over the world. This little bottle was shipped to the United States. This little bottle was shipped to Canada. Same bottle. One was blue, one has red in the label. Same bottle, same company, inspected by the FDA. What is the difference? The price. The American consumer is told: Guess what you get to do. You get to pay almost triple. Why? And it is not just the American consumer, if I can hold up a chart that shows two drugs--one is Nexium. This is advertised substantially. Nexium is an example. I also have one on Lipitor. Here is the price for Nexium. Do you think the pharmaceutical industry is selling Nexium at $37 for the equivalent quantity in Germany and losing money? I don't think they are losing money at that. Instead of $37, they charge the American consumer $424. My point is my beef with the industry is their pricing policy.

Mr. DORGAN. I would say that is also always raised. They say: If you don't allow us to charge the American consumers the highest prices in the world, we don't get to do the research and development that produces the next new miracle drug. Most of the recent studies have shown that the pharmaceutical industry spends more money on promotion, marketing, and advertising than they do on research. I want them to do research. But there is one other piece. The Congress gave, without my support, a proposal that said those American companies that have money overseas should bring it back and we will let them pay a lower tax rate. Guess which industry was one of the largest industries with repatriated profits from abroad? The pharmaceutical industry. If they are making big profits abroad and charging lower prices to those consumers abroad, why can't the American people have access to those prices? It is not because they are going to lose money because they made a lot of money abroad. That is why they repatriated at a lower rate.

Mr. DORGAN. Madam President, the citizens from North Dakota often have to go to Canada to buy a prescription drug. I have told the story about the old codger who was sitting on a hay bale in a farmyard when I had a town meeting. He was nibbling on a piece of straw. He said to me: My wife--he was about 80 years old--my wife has been fighting breast cancer for 3 years. He said: The only way we could pay for our prescription drugs was to drive to Canada once every 3 months because when you buy tamoxifen in Canada, you pay like one-tenth the price or one-fifth of the price you pay in the United States. He said: We did that every 3 months so my wife could keep fighting breast cancer. Of course they do that. What is happening is consumers are allowed to bring back as an informal strategy about 90 days' worth of supply of prescription drugs for personal use only. Most American consumers cannot do that. They do not live anywhere close to a border. The question is, Can the rest of the American people have access to the same prescription drugs sold at a fraction of the price?

Mr. DORGAN. Madam President, the Congressional Budget office says it will save the Federal Government about $19 billion, and then about another $80 billion will be saved by the consumers. That is about $100 billion, nearly $100 billion in savings in total, $19 billion of which will be saved by the Federal Government for its purchases, and the rest by the American consumers.

Mr. DORGAN. I am not a very good advocate for the other side. If one were to ask what is the best argument opposed to my amendment, I would say there are not any arguments that are the best. There is a range of poor arguments or arguments that do not hold much water. I started by saying I do not have a beef against the pharmaceutical industry. I want them to do well. I want them to be successful. I want them to keep finding and searching for miracle drugs. By the way, much of the work they do comes from the National Institutes of Health and the massive investments we make in health. I want them all to be successful. My beef with them is a pricing strategy that says to the American people: Here is what you pay, and you can do nothing about it because we decided that is what you pay, and we are going to offer everything around the world at lower prices. That is my beef. This is a pricing issue. They are wrong about it. The way to correct it is to give the American people a little bit of freedom. We will save money for the government and save money for the American people. I want to raise one additional point while the Senator is here. If the Senator from Arizona is like me, when I am brushing my teeth in the morning, I have a television blaring and I hear all these ads: Go ask the doctor if the purple pill is right for you. I haven't the foggiest idea what a purple pill will do for me. The ads are so compelling you almost feel: I have to get out of here. I have to stop brushing my teeth, go get a phone, and call my doctor to see if my life might be improved by taking a purple pill. I read a whole series of advertisements: Does your restless mind keep you from sleeping? Do you lie awake exhausted? Maybe it's time to ask if Lunesta is right for you. Ask your doctor how to get 7 nights of Lunesta free . . . I read a bunch of these. I will not now. Bladder problems, Flomax, Ambien--you name it and they advertise it all day and every morning. I say knock off a little of that. Give us some better prices. God bless you for doing all you do, I would say to the industry, but give us fair prices. Give fair prices to the American consumer and knock off a little of the advertising. The advertising is only for a product that only a doctor can prescribe. You cannot get this product unless a doctor thinks you need it. Stop asking me if the purple pill is right for me, asking me to ask a doctor if the purple pill is right for Senator McCain. Knock it off.

Mr. DORGAN. Mr. President, let me say that Senator McCain has been a part of this effort for a long time. It is interesting, with all the action on floor of the Senate in recent weeks, this is one of the few examples of a significant policy that is bipartisan. We have Republicans and Democrats--over 30 cosponsors--who have worked with us to make certain we can do this, do it safely, and give the American people the opportunity they deserve. This is very bipartisan. I appreciate that a lot. I wish to say, the National Federation of Independent Businesses supports this; the AARP supports this. We have a long list of organizations that are strong supporters of this amendment, and so I hope, today, perhaps at last--at long last, after 8 or 10 years--we might finally achieve a breakthrough and get this through the Senate. I have said previously that the pharmaceutical industry is a formidable opponent. I understand that. We have had difficulty getting this in a piece of legislation to get it signed and give the American people freedom and give them fair pricing. When we do this--Senator McCain, myself, and others--it is suggested that somehow we have no regard for this industry. That is not the case at all. It just is not. We have no regard for a pricing policy, however, that we believe is unfair to the American people. It has been that way for too long--a long time too long. Perhaps today--with the vote on this amendment, which I expect later this afternoon--will be the first step in getting that changed. I yield the floor.