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Public Statements

Prescription Drug and Medicare Improvement Act of 2003 - Continued

Location: Washington, DC



    Ms. STABENOW. Will the Senator yield for a question?

    Mr. DORGAN. Yes, I am happy to yield for a question.

    Ms. STABENOW. I appreciate that. I wanted first to compliment my friend from North Dakota, who has worked so diligently on this issue. I am very proud to be a cosponsor of the amendment.

    The PRESIDING OFFICER (Mr. Coleman). The Senator can only yield for a question.

    Mr. DORGAN. I was yielding for the purpose of a question.

    Ms. STABENOW. I was in the middle of saying I wanted to ask is it not true that even though the report you just indicated made it clear the safety provisions, the oversight, is the same between Canada and the U.S., isn't it true that even in light of that, you have gone the extra mile to put into place basically a 1-year provision for reimportation, and then at the end of that time the program would stay in effect, unless the Secretary submits a certification that in fact there is a problem, that based on experience, based on evidence that the benefits do not outweigh the risks? Isn't that correct that you in fact have gone that extra step, that extra mile to make sure even though we know it is safe, it is the same, that we give a safety valve so that the Secretary in fact could step in and certify if there was a problem?

    Mr. DORGAN. Mr. President, Senator Stabenow has done a service by pointing out something in the amendment I did not point out. The other change is that this would be a 1-year pilot program, when approved by the Senate. The certification will still be that this is safe because, clearly, we have identical systems in the U.S. and Canada.

    In addition, after a 1-year pilot project, there will be a 6-month period in which the Secretary of Health and Human Services will certify if there is a problem, if in fact there is one. I expect there will not be. At that point, this program will continue. At least it creates a specific 1-year pilot project and an evaluation, so there is a fail-safe system if there would be any problem at all. I would not expect a problem—particularly because we have narrowed this—with respect to Canadian drugs.

    The PRESIDING OFFICER. The Senator from Pennsylvania is recognized.

    Mr. SANTORUM. Mr. President, I rise in opposition to the Dorgan amendment, although as modified by Senator Cochran's amendment, I will not oppose it.

    Senator Cochran's amendment goes to the whole point here, which is that reimportation of drugs is unsafe. I am not the one saying that. I think most Members here are very concerned about the safety aspects of reimportation. We have three Secretaries of Health and Human Services, 10 former FDA commissioners, the U.S. Customs Service, the White House, DEA, CMS, Canadian Pharmacy Regulatory Agency, U.S. Pharmacy Regulatory Agencies, and 44 U.S. pharmacist groups, voicing safety concerns about the reimportation of drugs.

    I am satisfied Senator Cochran's amendment will sufficiently reflect the concern of Members of this body and of these organizations about the issue before us. So I am going to set that aside. I could argue until the cows come home how this is an unsafe and unwise practice to engage in. But with this amendment, we will leave it up to the Secretary to determine as to what he believes—and he was here a minute ago. We have a statement from him already saying he does not believe it is safe. I am comfortable leaving it in the hands of someone who will study this issue in depth with respect to safety.

    I want to dispel a couple of myths that have been created during this debate. One of the myths is that American pharmaceutical companies spend more money on advertising than they do on research. As most people who have followed the pharmaceutical industry and followed this debate know, the pharmaceutical industry is the most research-intensive industry in our country. I have always said I find it remarkable that we are here on the floor of the Senate all the time beating up on the pharmaceutical companies, saying they make too much money or they spend too much money on advertising or they don't spend enough money on research and development, and we need to whack them here and whack them there until they become like the steel industry, where they become—or other industries—less and less profitable, and then we pass loan guarantee programs to prop them up. That is sort of the way we do things here. If anybody is doing well, whack, we are going to take a shot at them and say they are doing too well for everybody's good.

    Let me just suggest the pharmaceutical industry is doing well because they are leading the world in curing disease and treating very serious health problems. They are doing it because of the enormous amount of research they are doing, not because of the money they are spending on advertising. General Motors spends more money on advertising—some $4 billion every year. That dwarfs almost all of the spending by the pharmaceutical industry with respect to advertising. Yet I don't hear the Senators from Missouri or Michigan or any others out here complaining we pay too much for cars. Cars are as much of a necessity for most people as pharmaceuticals. Why don't we hammer General Motors, Ford, and those other folks for wasting this money on advertising.

    Companies spend money on advertising because they have an obligation to sell their product. The way you sell your product is by promoting the value that product hopes to bring to an individual's life—the positive attributes of the product. Pharmaceutical companies have the right to do that through advertising to the general public, which may not be informed about new therapies that are available, as well as through direct advertising to physicians who prescribe the medicine. That is a proper role, I believe, in informing the public. We want them to be informed.

    I cannot imagine we would want a public that would not want to know what some of the more recent developments and potential improvements to their lives that are available to them. Some have suggested their spending on advertising is more than they are spending on research and development. That is not true. I know that was said in passing. Someone said: I think this is the case. Let me clarify for the record so we do not have this common misstatement that I think this may be the case. Let me tell you what the facts are.

    I have a chart. It is just a piece of paper. I do not have it blown up. The black line is the spending on research and development, and the light gray line is the total promotion. Total promotion means, yes, advertising, but it also means the free samples of drugs many receive when they go to the doctor's office. That goes in promotion. That is actually, in a sense, free drugs for the purposes of advertising and promoting the product. All that is included in here.

    You can see that research and development while, yes, advertising is going up, research and development is going up even further. In 2001, $30 billion was spent on research and development and a little over $10 billion on advertising—three to one. I daresay General Motors does not spend three to one on research and development versus their advertising. I daresay most companies and most industries do not come close to spending that amount of money. But you know what. They are the bad guys. They are the guys we have to hit upside the head. Why? Why do we have to hit them upside the head? Because they are increasing their prices too much. It is too costly, and we need these products.

    Let's look at why they are increasing their prices and why you can go to Canada, Germany, or other places, and receive these drugs for less money. There are a couple of reasons.

    No. 1, there was an excellent article in the "Weekly Standard" just the other day talking about the incredible cost of getting drugs approved by the FDA.

    For a company which starts out with thousands of compounds with which they are experimenting, researching, trying to work themselves through the process to determine what is a viable compound to experiment with and to move forward with, they start out with thousands, tens of thousands. They narrow it down to a few hundred. They do some more intensive research on those. They get to about four or five they do some trials on and some tests on and even further research. They come down to usually one drug where they go through the extensive process of clinical trials and testing.

    By the way, the reason Europe, Canada, and other countries around the world get drugs years before we do, in some cases, is because of the incredible costly process the very people who are complaining the drugs cost too much have supported, the extensive approval process that jacks up the price of those drugs in this country.

    It costs $1 billion on average for a drug to go from that basic research of compounds all the way through the process of determining whether it is effective, whether it is safe, what conflicts there are. All the issues they have to deal with, it costs about $1 billion in this country.

    It does not cost $1 billion in Canada. It does not cost $1 billion in Europe. It does not cost $1 billion in Mexico. It costs $1 billion here because of the extraordinary lengths to which we go to make sure the drugs here are, what? Let's hear that word again. Safe. That those drugs are safe. We put a premium value on, yes, efficacy. They have to be effective. They have to treat what they say they are treating, and do so effectively, but they also have to be safe. So we put a high value on safety, and we require these companies to go through enormous hoops to make sure, in this country, before a drug is sold, we know it is safe.

    We are suggesting two points: No. 1, safety is a highly valued commodity when it comes to drug use, and that reimportation is unsafe. No. 2, one of the reasons reimportation is so popular is because the cost of the drugs are cheaper. One of the reasons they are cheaper is because they do not have to go through the safety measures they are put through in this country.

    You require them to prove it is safer, and then you say: Gee, why are you charging us more money? Why don't we just get them from this other country, that, by the way, does not require you to go through those hoops. So they do not pass on the costs to these other countries.

    There is another reason. The other reason is because in Canada, Mexico, most of the world, they set prices. They set prices. They say: You want to sell drugs in our country? Fine. Pfizer, you want to sell a drug in our country? No problem. Here is what we will pay you.

    Pfizer says: Wait a minute, we have all these costs. I want to make a profit.

    Fine, if you want to make a profit, here is what we will pay you.

    We charge $3 for this drug in the United States. You are only offering to pay us $1.

    Well, we have looked at it and your manufacturing costs are 50 cents; $1 is a pretty good price. You will make 50 cents on every pill.

    Pfizer says: That is our manufacturing cost. We have hundreds of billions of dollars in research costs. We have litigation costs we have to be concerned about. We have advertising and other related costs that are built into the cost of this drug. You are only giving us the manufacturing cost.

    If you don't like the deal, you cannot sell your drug. So if you want to sell your drug and make your 50 cents, sell your drug. If you don't, see ya.

    The drug company has to make a decision: Do I agree to sell based on the price the Government wants to give me or am I shut completely out of that market?

    A lot of drug companies say: OK, I am not making the money I could in this country because we do not have those kinds of price caps on our drugs yet, and they say: At least I am making some margin. OK, I will agree to sell there. If they say no, they do not have any market share at all.

    That is a best case scenario. A worst case scenario in Canada is: I have a breakthrough drug, and there are no other drugs like it in the world. It is a new class. It is, in fact, one of these great discoveries that we hope for every day. They go up to Canada and say: We spent over $1 billion researching, coming up with this great breakthrough drug for a cure or for a treatment for this illness.

    Canada says: Great, we would love to sell that drug. There isn't any other drug out there that does this. Yes, you want to charge us $10 a pill, that is nice; we will pay you $5.

    The drug company says: Well, that is nice, 10.

    Canada says: No, you didn't hear me, 5.

    The drug company says: I am just not going to sell the drug.

    A lot of drug companies will sell it anyway. Why? Because they feel a social responsibility to have that drug available, as we see with the AIDS drugs in Africa that are being sold at well below the costs in any other country in the world. They may feel a social responsibility to sell it, and, in many cases, they do.

    Let's assume for some reason this company says: No, I do not feel any social responsibility here; I am going to play hard ball. What does the Canadian Government do? What do they by law have the right to do? They have the right to steal that patent, make the drug in Canada, and sell it for whatever price they want.

    That is a pretty strong bargaining position. It is wonderful to stand out here on the floor of the Senate and beat up on these companies for selling drugs for less money in Canada, for less money in Mexico, for less money in Germany. Why?

    No. 1, it is a one-sided bargaining situation. You either take the price we give you or you are out of the market. If we want your drug anyway, we will steal your patent. Not a lot of bargaining power. Plus, by the way, the United States costs so much more because of the FDA process, not to mention the litigation costs on top of the research and development costs.

    The litigation costs in this country, because of runaway malpractice suits and liability suits, product liability suits, class action suits, the costs associated with drugs are higher here on top of that.

    So what do we do? We blame the pharmaceutical company. We blame them because Canada sets prices. We blame them because we have an extensive and very costly FDA process. We blame them because we cannot put our tort liability system in place. It is their fault because they want to advertise their product. God forbid that someone knows what my product is. This is the bad work that is being done.

    Now what are we going to do? We are going to say that, yes, well, maybe you are right, Senator, maybe it does cost more to bring a market here. I think everybody would admit that, yes, our litigation system is more costly; yes, Canada sets prices and blackmails them if they do not go along. We agree with all of that, but you know what, it is still not fair, because our seniors—and not just seniors but anybody—our people in America deserve the same price they get in Canada.

    Okay. Let's make a decision. Let's make a decision that, in a sense, we are going to set prices in this country, that we are going to adopt the Canadian formula. Now, obviously not every drug is sold in Canada. So there are a lot of drugs that will not be affected by this reimportation because Canada does not pay for every drug. There are certain drugs that just are not sold up there. Why? Because the drug company decided they were not going to play ball and sell at a price that is well below what they believe is a profitable price for them to sell. So we are only talking about a certain group of drugs. We understand that.

    We saw an amendment earlier today that is going to make sure these research-oriented drug companies, the ones that are creating the new therapies for the future, now that their patents expire on time, they have no patent extensions, even though some may be worthy or not; we are going to tighten down on that so generics can get into the business. Generics, by the way, make no breakthrough drugs, do no research on new therapies to treat diseases that are heretofore untreated or not sufficiently treated, but we are going to squeeze down these drug companies that are making these research investments and doing these kinds of innovative therapies. We adopted that earlier. Now we are going to whack them again and we are going to basically take the Canadian prices that were set in Canada and have them apply in the United States, so there will be free trade.

    I heard people say free trade, free trade with a country that sets prices. Now, I would suspect the Senator from North Dakota would not be for free trade if they set the price of wheat in Canada at 50 percent below the price of wheat in the United States. I do not think the Senator from North Dakota would call that free trade—I could be wrong—or if we set the price of timber at half, by law, in Canada, of what the product was here. I do not think the Senator from Iowa would consider that free trade if they set the price of corn or the price of milk in Canada, by law, at half the price of the product in this country. I do not think we would be up here extolling the virtues of Canadian free trade. I know for a fact the Senator from North Dakota would not because he is on the floor with great frequency extolling the evils of free trade in Canada, particularly when it comes to wheat. They do not set the price of wheat in Canada, but he is for free trade on a product that is artificially priced below the market to come into this country. Interesting economic theory but certainly not consistent economic theory.

    So what happens? We now have this product coming into this country at below what arguably it could cost to get that product approved and researched, with the liability costs, all the other costs associated. Now what would be the result? If it is that pervasive, we may force the drug companies to lower their prices. It could happen. In either event, we are going to take a significant piece of the market share away from the pharmaceutical companies selling drugs in this country.

    What is the effect of that? Well, the effect of that is obviously lower profits for pharmaceutical companies. There are a lot of folks, I guess, who do not want people to be profitable, not at the expense of our consumers who want to buy pharmaceuticals. In the end, the result is this: We have to make a decision as to whether we want an industry that is going to spend 30-plus-billion dollars a year in finding the next cure, in doing the next level of research for that disease someone in our family may have or some neighbor may have, or whether we are more concerned with having cheap drugs today.

    Let's understand, with eyes wide open, what we are balancing. We subsidize the world's research. Admit it. I accept that. People say we pay more for drugs here than everybody else in the world. All we are doing is subsidizing the drug companies in this country and the rest of the world is riding along on the money we give drug companies by paying higher prices for drugs. They piggyback on us, and that is not fair. Okay. You are right. What do you want to do about it?

    Well, one thing we could do is talk to our trade officers and get them to pound away at these other countries so they do not set formularies and artificially low prices. We could do that. Do we tell Canada they cannot blackmail our companies by threatening to make the drug and steal the patent? We could do that. Short of that, which is not happening right now and this debate is happening right now, we have to make this decision, and the decision is this: Do we want to eliminate the research and development of new drugs and new therapies to solve new problems or problems that exist, diseases that exist, and, yes, subsidize the world in the research and development or in exchange for that next generation of drugs coming on line next year, are we willing to trade cheaper drugs today for no cure tomorrow or cheaper drugs today instead of the cure tomorrow, 3, 4, or 5 years from now?

    That is a legitimate debate. I say to the Senator from North Dakota if he wants to enter into that debate—and the Senator from Michigan who is going to speak next, if she wants to enter into that debate—I will accept that debate. I will truly accept the integrity of people who say it is worth it to have cheaper drugs today to get more drugs to people today who need them than to develop the next generation of drugs down the road for people who will need them then. That is a legitimate argument to make.

    I assume many Americans would agree with that argument, particularly if they are the people who do not have the money to afford the drugs they need today. There are probably a great number of Americans who would say that is a good tradeoff.

    I come down on the other side. I do not believe it is a good tradeoff. The reason I do not believe it is a good tradeoff is I think there is a better way to solve what seems to be an intractable problem: either research, innovation, new disease treatment, or cheaper drugs.

    Interestingly enough, the solution is what we are talking about in this Chamber this week and next week, and that is drug coverage. The solution is, let's provide drug coverage to lower the cost out of pocket to the consumer, particularly catastrophic drug coverage.

    In my mind, the most important thing we are doing, not some of what I consider very broad coverage that we have in this bill, but most important is including the catastrophic coverage. If we have a high drug user or the low-income subsidies in this bill for low-income individuals, those are the people I am most concerned about. They are the ones who, I argue, are the most compelling cases for saying we need cheaper drugs now as opposed to cures later.

    If we can solve those compelling cases of the low-income individual and the high user of pharmaceuticals, if we can solve those two problems, then we take a lot of pressure off this issue of cures tomorrow versus drugs now.

    This amendment does not belong. It is an anachronism. We get to the heart of the problem that this amendment attempts to solve. I believe it solves it in the wrong way.

    I also believe reimportation is unsafe. It is unfair to an industry in this country which is much maligned—until, of course, you get that diagnosis. Once you get that diagnosis and you find out within the last few years a little white pill that keeps you alive, that keeps you walking, keeps you breathing, keeps you eating, once you find out there is an industry out there that you never had a good word for up until that moment, who you thought were bad people because they were raking these people over the coals with all this money they were making, until you found out because of the research and development that went on, your life will continue and you will be able to see your children grow up or you will be able to see and play with your grandchildren, all of a sudden these companies are not so bad after all.

    I know this is not a popular view for Members of the Senate to hold. I have been told on numerous occasions defending drug companies is not a term extender for Senators. I understand that. This is not a populist issue. I accept it. But I have the gift in my State of having thousands of employees who go to work every day with the focus on creating the next little pill, the next little serum that will save somebody's life. They are proud of the work they do. They have a right to make money and do it. They have an absolute right to make money and do it. I will stand by their right to do that. It is an industry that not just makes money, but we are saving people's lives. We are changing people's lives. We are giving that grandson the opportunity to know his grandma. We should be willing to pay for it.

    We should not be blackmailed by other countries that want to use us for their research ground. We have some work to do. In my opinion, we have work to do in the international trade arena to go after these countries that do use us as the funding of their laboratories. But the mistake is not to adopt their policies. It is to get them to change their policies. What this does is adopt a flawed, fatal system for far too many people.

    I yield the floor.

    The PRESIDING OFFICER. The Senator from Michigan.

    Ms. STABENOW. Mr. President, it is hard to know where to begin. I would like to talk about some of the facts and realities for folks who are struggling to pay for those medications that are being developed or being advertised on television.

    I hope we will remember in these debates we are not talking about automobiles or tennis shoes or peanut butter or any other optional product. We are talking about lifesaving medicine.

    I celebrate the fact we have lifesaving medicine and that we have those who have dedicated their lives to that research. We have a lot of such individuals in Michigan. I am very proud of them and the work they do.

    At the end of the line, if you cannot afford the medicine, it does not matter. So price does matter. Affordability does matter. Competition to bring prices down does matter.

    I am very pleased a little earlier this evening we voted together in a bipartisan way to close loopholes the brand-name companies have been using to game the system, to keep competition off the market, and generic drugs. We passed a very important amendment to this bill. I commend, again, all who have worked very hard on that. The system has been out of whack. I suggest it is out of whack in a number of other ways.

    First, it is absolutely true that the most profitable, successful industry in this country is the pharmaceutical industry. No question about it. It is great they are doing well. Any other business in this country would love to have their situation. They are, arguably, the most highly subsidized industry by taxpayers in this country. They have a set of rules that up to this point have been highly in their favor to allow them to keep the competition off the market. It is a great deal if you can get it.

    I know we have hundreds if not thousands of folks working here, lobbyists, making sure we keep that good deal for them. I appreciate that. Unfortunately, that good deal for them, that great deal for them, has been at the expense of every other business trying to provide health care for their employees, every other employee trying to keep their health care and not lose their job because of rising health care costs, every senior, every family in this country. The debate about pricing is about not only making sure we have a healthy pharmaceutical industry but we have other healthy businesses and consumers who help pay the tab for that research and can afford to buy the product at the end of the line.

    What do I mean by that? I have said this before. We start with a lot of the basic research in this country being paid for by American taxpayers through the National Institutes of Health. I am proud we have greatly increased the amount of money going into basic research. We have done that on a bipartisan basis. It makes a difference. We are very close on many different illnesses from Parkinson's to Alzheimer's to diabetes, critical research. We need to be doing more. But that is done by American taxpayers, investing our money. Because we benefit, we understand how critical this is.

    That information, that research, is then given to the pharmaceutical companies who then develop it. We give them a writeoff for their research, tax deductions, tax credits for new research, all of which I support, as well as deductions for their advertising, their marketing, their administration, their other business expenses. Tax deductions, tax credits, are subsidies from American taxpayers. So we have a real stake in this operation. We are already helping pay for it.

    Once the drug has been developed, because it is very expensive for new breakthrough drugs, because it is very expensive, we have a policy of creating a patent for up to 20 years to limit the competition so that company can, in fact, be covered at cost, because with new lifesaving drugs it is very expensive.

    We have a stake in this. We have a stake in it. We helped pay for it. We helped create rules that are favorable to the companies, so that, in fact, they can succeed. The deal, though, I believe, is that at the end of that process the American consumer, the American senior should be able to afford to buy that product that they helped pay to develop, to research, to make happen. That should be the deal.

    That is the point. In too many cases right now that is just not happening. We get to the end of the line, and there are many ways in which the companies sue currently to keep generics off the market or keep the border closed so we can't buy them from Canada or do a variety of other things to make it difficult for the competition to come in and to keep the prices low. They make sure Medicare doesn't negotiate on behalf of all the seniors of the country to be able to force a group discount. There are a wide variety of methods to make sure the rules stay the way they are and we are all paying a big price for that, I believe.

    We certainly want this industry to be successful. I think it is clear by the rules, the subsidies, the support that has been there and will continue to be there. But this is not a pair of tennis shoes. It is not an automobile, as much as coming from Michigan I want everybody to buy a new automobile every single year, an American-made automobile. But if you don't, you will not lose your life. But if you don't get your cancer medicine, you might. This is very different.

    Let me speak to the issue of advertising. Since 1996, the FDA has taken the cap off of direct consumer advertising, as we know, radio and television, other direct consumer advertising. We know, we have seen advertising skyrocket. We do not have to debate that. All you have to do is turn on your television set. If not every commercial, it is every other commercial—they are very nice commercials—but they are commercials for prescription drugs. We do not have to argue about whether advertising has gone up. Every single person in this country knows that advertising has gone up.

    You do not have to tell a doctor that marketing has gone up. My doctor talks to me about the line of drug reps at the door to come in and promote particular medicines.

    We know from studies that have been done, and FCC filings, that about 2.5 times more is claimed under the line item for "advertising, marketing, and administration" than is claimed under research.

    What I find very interesting is that I keep hearing that more is spent on research than on advertising and marketing. Last year, I offered legislation to say OK, if that is true, then let's just cap the amount you can write off for advertising and marketing to the same level you can write off for research on your income tax form. It should not matter to anybody because they spend more on research. You would have thought I had proposed the worst thing you could possibly propose. It was adamantly and is still adamantly opposed by industry. It should not matter if they are spending more on research than on advertising and marketing.

    I would like to speak to the business at hand here, the question of allowing Americans to buy American-made drugs, subsidized by Americans, the research funded in part by Americans, at the price they are sold in every other part of the world—half the price we pay here.

    This particular amendment is a very conservative, cautious amendment. It focuses only on Canada. We know, in fact, there is importation already back and forth from Canada. Drugs are already frequently imported into this country but predominantly by manufacturers. They are already bringing them back across the border. In fact, according to the International Trade Commission, $14.7 billion in drugs were imported into the United States in the year 2000, and $2.2 billion in drugs sold in Canada were originally made in the United States.

    It is ironic that the drugmakers are saying drugs cannot safely move between the border between the two countries. What they are saying is they don't want individuals to be able to do it or pharmacists to be able to do it or wholesalers to be able to do it, but they do it every day.

    Also, we hear there is a difference in terms of oversight and inspections. According to the CRS, our Food and Drug Administration already inspects pharmaceutical production lines in Canada for 341 prescription drugs run by about 30 drugmakers. So they are already doing it for the pharmaceutical industry. We pay to send FDA inspectors to Canada to inspect already.

    Another report dated September 2001, a report by our Congressional Research Service—again, the nonpartisan Congressional Research Service—confirms that:

    The U.S. and Canadian systems for drug approvals, manufacturing, labeling and distribution are similarly strong in all respects. Both countries have similar requirements and processes for reviewing and approving pharmaceuticals, including ensuring compliance with good manufacturing practices. Both countries also maintain closed drug distribution systems [which is very important] under which wholesalers and pharmacists are licensed and inspected by Federal and/or local governments. All prescription drugs shipped in Canada must, by law, include the name and address of each company involved along the chain of distribution.

    So that is the reason this amendment is narrowly focused on Canada because we are talking about a system that is very similar, almost exactly the same in terms of the safety and the rigorous oversight. We are also talking about a process that is already going on, it is just going on by the manufacturers and not by licensed pharmacists or by individuals or by wholesalers.

    I think this amendment is very conservative because the amendment not only has Senator Cochran's provisions in terms of certification, but this is an amendment that would affect 1 year. We are going to affect things for a year, to open the border to Canada. After that 1-year period, the program would stay in effect unless the Secretary submits a certification to Congress that, based on substantial evidence and the experience of the 1 year, the benefits of reimportation do not outweigh the risks. So there are multiple protections in this amendment, and strict FDA oversight is in this amendment.

    I think this is particularly important to do in the context of the prescription drug legislation that we are working on and that will be passed by this body because the bill in front of us to provide a Medicare prescription drug benefit does not take effect until 2006. So other than a discount card, which is not new to seniors, those who have been listening to the debate we have been having all week and anticipating help right away are going to be sorely disappointed because there will not be a prescription drug benefit until 2006. In the meantime, we can help not only seniors but families and businesses and everyone who is involved in paying for prescription drugs right away, immediately. It doesn't cost anything to open the border to Canada for prescription drugs for pharmacists and for individuals. We can do it now. If there is an evaluation that there is a problem, it can stop. But we know, based on information about the inspection systems, based on what is already occurring, that it is highly unlikely that there would be a problem.

    I think it is critically important that we give major help now. We can cut prices in half; in some cases much more. I have had the opportunity to go with a number of different seniors to Canada where they have met with a Canadian physician and received a prescription and gone to a Canadian pharmacy. We have been shocked at the difference in prices for literally the very same drug. It is particularly significant in Michigan where we can look right across the river which you can swim across, and go from Detroit to Windsor and see that kind of a price difference. We have many seniors now looking to Canada for opportunities to see Canadian doctors because they are so desperate to get help.

    Let me mention just a couple of things. Again, we are not talking about some optional product where people are advertising and making good profits. We wish them well. That is the American way. That is the capital system. Good for them. But we are talking about a health care system where we are not seeing doctors being reimbursed, nor hospitals, nor nursing homes, nor home health agencies. The only part of the system that is exploding in cost and which is driving up the cost of the health care system is in the area of pharmaceutical drugs. This is not optional. It is medical. It should be viewed as part of the health care system. That is what we are debating today.

    Let me mention Tamoxifen. Tamoxifen is a very important drug in battling breast cancer. I had an opportunity to visit with Barbara Morgan from Michigan when she went to Canada and visited a Canadian doctor and going through the process there where she was able to get her monthly Tamoxifen for $15 instead of $136. That is a huge difference for her. She and her husband are retired on average means. She did not expect to get breast cancer after retirement. They had, like many others, been saving up to do things in their retirement. They now find themselves spending money on her treatment and on her prescription drugs. These are not theoretical discussions about people. This is not a theoretical debate about allowing Americans to get American-made, American-subsidized prescription drugs from Canada. This is very real. It can literally make the difference between life and death for people when they are struggling for critical lifesaving medicines.

    That is why I feel so strongly about this amendment. That is why I am hopeful the Secretary will look at the evidence, will look at the narrow construct of this amendment and be willing to work with us, be willing to allow the borders to be opened for 1 year. We are asking for 1 year with all of the safety precautions that are in this amendment—just 1 year to allow our seniors and others to be able to see a dramatic cut in the prices they have to pay for their medicines; 1 year to try this and to evaluate the issues that have been raised by those who are opposed.

    I appreciate the time. This is, I believe, a very serious part of this debate. If we want to make the difference right now for people, right now doesn't involve money in the budget resolution. It doesn't involve waiting until 2006. If we want to help folks right now, the way to do that is to give them the opportunity to get their prescription drugs at the lowest possible price. That is what this amendment will do.

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