Richard Burr

Mr. BURR

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 President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. BURR

Mr. BURR. Senators come to the floor and speak about the $13 billion in marketing the tobacco industry spends. They fail to tell you that 95 percent of that money goes to retailers and coupons against the competition and to make them more attractively priced at retail. Only 3 percent actually went to advertising in adult venues and point of sale displays. That doesn't make it a good point. What makes it a good point is that the tobacco industry spends a tremendous amount of money making sure that their industry is protected for those who choose to use it and are of legal age. Last year, we taxed the tobacco industry to fund the children's health insurance program. There is a proposal on the table to tax them to pay for universal health care. Senator Dodd admitted yesterday that the industry would be taxed to pay for this bill. But that is not a good story. A good story is placing tobacco products in the candy aisle by a news organization just to make a point and then portray to the American people that these are the tactics of the tobacco industry. I have, over 4 days now, come to the floor not to defend the tobacco industry, but to defend the FDA, because I don't believe the American people deserve us to discredit the gold standard of the FDA by putting this product under their jurisdiction and asking them to do something they have never, ever done. When I showed the flow chart of jurisdictions, the one missing out of the current regulatory architecture for tobacco is the FDA. Nobody can claim to me they have done this before and, therefore, this is an appropriate thing to do again. Simply, I have come to the floor in the last 4 days to debate the policy. At the end of the day, I hope Members of the Senate will weigh the policy, the points that I have made, the statistics I have produced, the evidence I have brought to the table, and if, at the end of the day, what you are attempting to do is reduce death and disease, reduce youth usage, I hope I have made the case to you that you should not pass H.R. 1256. This afternoon, before there is an opportunity to vote, I hope to make the case that you should support the Hagan-Burr substitute. I hope I have made the case to most that even if the choice comes down to passage of H.R. 1256 or nothing, that the CDC report says if you want to address a reduction in death and disease, the fastest way to get there is to do nothing if, in fact, your only choice is to pass H.R. 1256. Once again, I thank my colleagues for their patience as I come to the floor to try to educate and provide facts. I yield the floor.

Mr. BURR. I thank the Presiding Officer. Mr. President, later this morning, today, we will go back on the tobacco FDA bill. As one who has tried to educate Members on why this is a flawed bill, let me state I am fighting an uphill battle. I have been all week. I wish to thank my friends and colleagues who have come to the floor over the last days to support their belief that this is misguided, not the regulation, but the fact that we are concentrating this in the Food and Drug Administration, an agency that has the trust and confidence of the American people that the gold standard of proving safety and efficacy for all drugs, devices, biologics, and cosmetics, and food safety is their No. 1 mission. But my colleagues know this has been an uphill fight, too. I have tried over the course of those days to highlight for the American public why it is bad policy. I have highlighted portions of the bill that I thought were flawed. I haven't come out and said this is the wrong thing, even though, let me remind my colleagues, this is the current flowchart for the Federal regulation of tobacco before we do anything. So for Members who come and say this industry is underregulated, let me remind them it is the Department of Transportation, the Department of the Treasury, the Department of Commerce, the Department of Justice, the Office of the President, the Department of Health and Human Services, the Department of Education, the Department of Labor, General Services Administration, the Department of Veterans Affairs, the Federal Trade Commission, the Department of Agriculture, Environmental Protection, U.S. Postal, and the Department of Defense. Now we are going to take all of those areas of Federal regulation and we are going to condense them all into the Food and Drug Administration, which has a mission statement of proving the safety and efficacy of every product over which they have jurisdiction. Twenty-five percent of the U.S. economy is currently regulated by the Food and Drug Administration. Americans go to bed at night after taking pills prescribed by a doctor and filled by a pharmacist with the comfort of knowing they have been approved to be safe and effective. Through this bill, we are going to dump on the Food and Drug Administration a product that is not safe and it is certainly not effective. I have tried to point out the flaws. Heck, I have tried to point out the good things in the bill. I haven't been one-sided on it. But every time one of my colleagues from the other side of the aisle has come to speak, we have either seen charts that are 10 years old or data that is 10 years old. We have seen products that they have painted in a light that didn't even exist 10 years ago. I haven't heard a single question I have asked in this debate answered by the other side or even their opinion of what is wrong with the substitute. It has all been rhetoric. I wish to share a story with my colleagues. This story is a news report. It was a report CNN ran on a product that is new to the market. It is called Camel Orbs. It is not a cigarette, and it is really not smokeless tobacco; it is a dissolvable tablet. As I pointed out to my colleagues yesterday when I showed them the chart for continuum of risk, nonfiltered cigarettes have a 100-percent risk factor and filtered cigarettes have a 95-percent risk factor. As you introduce new products into the marketplace that allow individuals to move from cigarettes to other products, you reduce the risk. You reduce the risk of death and disease, and that is one of the three objectives of tobacco legislation. Youth usage should go down. Death and disease should be reduced from the standpoint of risk. Let me come all the way over here on the chart to dissolvable tobacco. The risk is 2 percent. To bring these to market is to reduce the risk from 100 percent to 2 percent--98 percent better. CNN ran this article on Orbs. It is a smokeless product, but I will get into that in a few minutes. For now, what you need to know is Orbs falls under the same age restrictions all tobacco products do. That means it contains no cartoon images. It must be shelved behind the counter where it is out of reach of children. Heck, it is out of reach of adults. They have to physically ask for the product. By the way, you must show photo ID to buy tobacco products today. Let me say that again. You must show a photo ID to purchase tobacco products. When CNN did their story, take a guess on the angle they took. They labeled it as candy--candy--even though it is not candy flavored. They said it was candy. They didn't mention death or disease. You would think a story on tobacco would lead with that. I haven't been shy to come to the floor and say that is the result of tobacco usage. But they didn't even go to death and disease. No, they said it was candy. That is how they labeled it. Even though they mischaracterized the product and took people down the path they wanted to go, that wasn't the bad news of this story. The bad part of the story was they took tins of the product and they actually placed them in the candy aisle at the convenience store, right there beside the Reese's Cups and the chewing gum. Then they took footage of a young boy, I think, reaching over and picking up one of the Camel Orbs, even though this is highly illegal. Even though the convenience store could be prosecuted, and therefore they don't put tobacco products in the candy section, still CNN wanted to make their point. What a better way to make the point than to stage what the picture was. Let me say that again. What a better way to make the point than to stage that every retailer in the world out there is putting Orbs, a tobacco product, in its candy section. They portrayed Reynolds America as being deceptive and luring children. No candy. It is not going in the candy section. It is in the tobacco section where smokeless and stick smoke products are. That is why it is so difficult. That is why the job I am on a quest for is an uphill battle. It is because nobody on that side wants to come down and talk about the policy. The bill we are considering was written 10 years ago. No wonder we are using 10-year-old charts and 10-year-old statistics. The truth is, if you look at the statistics today, if you want to address death and disease, then accept the fact that there has to be an opportunity to reduce the risk. But what my colleagues need to know is that H.R. 1256 gives the FDA full jurisdiction over tobacco products, and it takes this category right here and it locks it in. It cements it because it grandfathers FDA from ever doing anything on the existing products that are in the marketplace: filtered cigarettes and nonfiltered cigarettes. FDA is forbidden from changing anything. The products that were sold continue to be sold. No new products can be sold. They say there is a pathway for these products to come to market. It is a three-pronged test they have to meet. I won't dwell on the first two prongs. Let me dwell on the third one. The third one is this: You have to prove that people who don't use tobacco products aren't likely, when this new product is introduced, to actually use this product. But the way the bill is crafted says this: You can't communicate with the public unless you have an approved product. So I ask my colleagues, if you can't communicate with the American people to find out whether they are likely to buy a product that is new to the market until that product is actually approved, then how can you fill out an application and make the claim that the American people aren't likely to use that product when they don't use tobacco products? So it is disingenuous to suggest that there is a pathway for reduced-risk products when, under the construction you make anybody go through, you can't possibly make the claim they ask you to make because you can't communicate with non- tobacco users as to whether this product would be something they would choose to use. So any claim based upon that, that this is a bill which addresses death and disease, is disingenuous at best because what it does is it locks this category. It cements those people who currently use smoke products--cigarettes--the 19.8 percent of the American people who currently smoke. So far in this debate, I have seen charts, like everybody else, that would make your skin crawl and I have heard stats that would make your head spin. I even heard Senator Sanders come to the floor yesterday and say tobacco manufacturers want to get you addicted to heroin. I think he misspoke, but I have to tell my colleagues I am not absolutely positive of that. All of this follows the same conclusion: Under H.R. 1256, which is the base bill, the sponsors claim that the FDA will stop everything, that all of this will go away. And let me concede for a minute that maybe they are right, then they would have to concede that I am right-- with the exception of locking this product in forever. If you lock that product in forever, then you can't make the claim that you are reducing death and disease. I think, as I have gone through this debate and pointed out that when you look at the CDC study of 50 States and you look at the percentage of smoking prevalence in our youth, what you find is that in 48 States out of 50, the prevalence of marijuana usage is higher than the prevalence of smoking. Let me say that again. In 48 out of the 50 States, the prevalence of marijuana use is higher than the prevalence of smoking. One would conclude from that, since marijuana is illegal-- it is not age-tested; it is illegal--that the usage prevalence among youth would be zero. Well, the American people aren't that foolish. They realize nothing goes to zero. But they also realize it is foolish to suggest that if you concentrate tobacco jurisdiction at the FDA, the smoking prevalence is going to go below that of marijuana because marijuana is illegal. The fact is, putting tobacco regulation at the FDA is not going to have any impact on youth usage. What is going to have an impact on it? Actually taking the master settlement dollars from 1998, the $280 billion the tobacco industry committed to the States, all 50 of them, for two things: one, to defray their health care costs, and two, to fund the programs of cessation to get people to quit smoking and fund the programs to make sure children never take it up. But as I pointed out, we have some States that, when the CDC annually makes its recommendations, spend as little as 3.7 percent of what the CDC told them they needed to spend of this tobacco money to make sure kids got an educational message: ``Do not smoke. It kills.'' Now we are blaming it on the fact that they are not regulated enough today and that we can concentrate this under one Federal agency, the Food and Drug Administration, and by some magical, mythical thing that happens, youth prevalence of smoking is going to go down. No. It is going to go down when States take the money the tobacco industry gave them and they actually use it to reduce the youth usage, to make sure they never take up tobacco products, to make sure people switch from smoking products to some other form that has a better effect on death or disease. I would love to say that my State of North Carolina devotes 100 percent of what the CDC recommends to use on cessation and youth education, but we only spend 17.3 percent of what the CDC recommended of the money we got. When you look at all of the States, though, 17 percent is pretty good. I don't know whether it was used in other States for sidewalks or for greenways. I know one thing for certain: It didn't go to try to educate young people in this country not to use tobacco products. If we want to get the youth usage down, then we have to use the tools we know work; that is, education. I have listened to my colleagues come to the floor for weeks and make unbelievable statements. All of this has followed the same conclusion: FDA will stop all of this and FDA will put the evil tobacco out of the hands of kids. I think I have made a pretty good case that it is not going to happen, not with this legislation. The sad reality is, maybe Congress could pass a bill that does all that. That is why Senator Hagan and I have offered a substitute. That substitute will be debated over the first half of this afternoon, and every Member will have an opportunity before the afternoon is over to vote on that substitute. I encourage all Democrats, Republicans, and Independents to read the bill. You will find that it provides all the regulation in H.R. 1256, and more. The base bill limits print advertising to black-and-white ads. What does our substitute do? It eliminates print advertising. That magazine that mom buys that a 14- or 16-year-old daughter may like to look at in the afternoon--under our substitute, they cannot advertise there anymore. Under H.R. 1256, they are allowed to advertise, but in black and white. In some way, they believe kids cannot read in black and white, they can only read in color. That probably tells you more about how misguided the legislation is. It is not solving the problems--death, disease, and usage. The tools are in place. We can reinforce them in a more effective way. That is what the substitute amendment, I believe, will do. My friend from Connecticut yesterday stated that I was misguided in my belief that the FDA was not the right agency to regulate tobacco. He said the FDA was the only agency in America that had the scientific expertise to do the job. I only have one question: Does the FDA have the expertise to make tobacco safe? Again, does it have the expertise to make tobacco safe? I think the answer is, no, it doesn't. Therefore, it doesn't meet the mission statement of safety and efficacy. But that is what they are vested to do. That is what the American people believe the FDA accomplishes. To suggest that we would regulate a product that doesn't meet that threshold is, to some degree, disingenuous to the American people. My friend from Connecticut also pointed out that my downplay of CBO's estimate on smoking reduction was misplaced. He said that while I kept using the 2-percent figure--which is all the population over 10 years-- and CBO had estimated that if we pass the bill, we will reduce smoking by 2 percent over 10 years--that was 900,000 fewer smokers over 10 years, and that number was impressive. I agree that it is impressive. I think he said there would be tremendous health care savings with 900,000 fewer smokers. I am not sure if Senator Dodd heard the statistics I gave that were the result of the CDC study. I said numerous times that the CDC said that if we do nothing, there is a reduction in smoking of between 2 and 4 percent per year--not over 10 years, but per year. I ask my friend from Connecticut, what is more impressive, 900,000 or 9 million fewer smokers? By doing nothing, as CDC has said, we eliminate 9 million smokers. By passing this legislation, CBO says we eliminate 900,000 smokers. Nine million fewer smokers is what we would have if we pass the substitute, but it is not what we would have if we pass the base bill. I ask my friend from Connecticut to truly think about the health savings realized without passing the base bill and realize that, with the substitute, we might actually get to more than 9 million. My colleague went on to say that I purposely ignore CBO's estimate that youth smoking rates will reduce by 11 percent over the next 10 years under the bill. That is the CBO projection. Obviously, he didn't hear me earlier in the morning on this issue. I think it is great that smoking rates would decline by 11 percent over the life of the bill. I think it is much better that they would reduce 16 percent if, in fact, the bill weren't enacted. That is what the CDC says--16 percent if you do nothing, and 11 percent if you pass H.R. 1256. We are not saving lives with this bill. We are not reducing youth usage. If you want to save lives, you need to follow where Senator Hagan and I are and create a harm reduction center--one that will promote harm reduction products. If we go back to the continuum of risk chart, if you look at the 100 percent risky and 90 percent risky, it is hard to believe you reduce death and disease. The only way to do that is if you get people to give up these products and you make available products that are on this chart, but also some products that are not on this chart. In the absence of doing that, there is no way you can claim that you have actually affected death, disease, or the cost of health care. I listened to my friend from Oregon make statement after statement about those dissolvable tobacco products that I pointed out in the CNN expose on tobacco. He repeatedly called it candy, also, even though you cannot buy it unless you are 18, and it cannot be put in the candy section--unless you are CNN and you are doing a story. He said the packaging was intentionally shaped like a cell phone to attract kids. If a cell phone doesn't work, children don't want it, let me assure you. But I will make the pledge to him today that if he will offer an amendment to outlaw any packaging that looks like a cell phone, I will cosponsor it with him. If he were right, I think every manufacturer of anything in the United States would make it look like a cell phone today, if it were that effective. My friend went on to call Camel Orbs dangerous. He had no scientific basis for that claim. He quoted an 8-year-old Surgeon General warning on smokeless tobacco that said it caused cancer, but the last time I checked, Camel Orbs didn't exist back then. He said that I called harm reduction products, such as Camel Orbs, safe. I have been on the floor 4 days, and I spoke for 2 hours 37 minutes yesterday. I might have slipped, but I don't believe I have ever referred to any tobacco product as ``safe.'' If I did, let me retract it. I have frequently said there are products that are ``less harmful.'' I have constantly described and made the point that if you don't move people from cigarettes to other tobacco products that allow them to make that transition, you will not reduce death and disease. I don't think tobacco is safe, but I do believe there are products that are safer than smoking. I believe that for adults who choose to use tobacco products, they should have every option available to make sure that that product is something they can access. Compared to smoking, they do reduce death and disease. Camel Orbs and Sticks represent a 99-percent reduction in death and disease associated with tobacco use compared to cigarettes. They don't cause lung cancer, cardiovascular disease, emphysema, or COPD. The American Association of Public Health Physicians states that those Orbs are the most effective way to fight death and disease associated with current tobacco users. Yes, much to my amazement, the American Association of Public Health Physicians came out and endorsed the substitute to H.R. 1256. Again, yesterday, the Association of Public Health Physicians endorsed the substitute amendment to this bill. Unlike my friend from Oregon, I have the science to back up my claim. I have the studies from Sweden, and I have looked at the documented evidence. Alternative tobacco products work in harm reduction. I will tell you what doesn't work--current cessation programs, especially the ones that are not funded in that money that was supplied to the States. The current cessation programs don't work; they have a 95-percent failure rate. So 95 percent of the people return to smoking. Why in the world would we continue to support that as a pathway for reducing death and disease? Why wouldn't we acknowledge the science that currently exists and accept, in new policy, a policy that would in fact embrace this? May I inquire how much time I have left?

Mr. BURR. Mr. President, I ask unanimous consent to speak for up to 30 minutes.

Mr. BURR. Mr. President, I understand we are in morning business.

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

Mr. BURR

Mr. BURR. Mr. President, when I yielded the floor to allow Senator Brown to speak, I was in the process of describing the substitute amendment to the base bill, H.R. 1256. Before I go back to that, let me share with my colleagues the response to a letter from the Campaign For Tobacco-Free Kids. They assessed the substitute bill and they provided in a letter to the committee why they found the substitute to be wrong. I will use that word. Let me take on some of the things they raised in that letter. One, they said that the Burr-Hagan bill would create a new bureaucracy that lacks the experience, expertise, and resources to effectively regulate tobacco products. I think I made it abundantly clear earlier today that under the current regulatory framework for tobacco, every Federal agency in the United States has jurisdiction in it, except for the Food and Drug Administration. So to suggest that the Food and Drug Administration has the experience or the expertise or the resources to effectively regulate this would be disingenuous. They have no experience, because they haven't been involved in regulation. They do have expertise, but expertise to prove safety and efficacy of products, not to come to the conclusion that a product is unsafe and kills. Yet they are not going to do anything to restrict its access or provide resources to effectively regulate tobacco products. Incorporated in this base bill H.R. 1256 is, in fact, a surcharge on the tobacco industry of $700 million over the first 3 years to fund--to provide the resources--for the FDA to regulate the industry. And it doesn't stop there, because they can't hire the folks, they can't set up the regulation until they have the ability to do the surcharge it requires, in putting it in the FDA, that you come up with $200 million to fund the initial effort to set up the infrastructure to regulate this product. So, in fact, there were no resources. Within H.R. 1256, it creates the resources to create the framework, to create the personnel, to regulate a product they have never regulated before. I remind my colleagues that in the substitute amendment, we set up a new Harm Reduction Center under the guidelines of the Secretary of Health and Human Services, within Health and Human Services, the same place that the FDA is. When we asked the Secretary of HHS how much does it take to fund that, they gave us a number of $100 million a year; $700 million for the baseline, H.R. 1256; $100 million for this new Center of Harm Reduction, overseen by the same Secretary of Health and Human Services. Granted, I will be the first to say that if we are creating a new agency, the agency for harm reduction, it does not have the experience, the expertise, or the resources yet, but it can search within the global marketplace to find the individuals, and the Secretary of HHS has already said $100 million will permit us to do that function in a harm reduction center. So the first complaint, hopefully, I have disposed of. The second complaint from the Campaign For Tobacco-Free Kids as to why they would not support the substitute amendment: The Burr-Hagan bill does not give the FDA any meaningful authority to require changes in tobacco products. Well, I do hope somebody from Campaign For Tobacco-Free Kids is watching, because what the base bill, H.R. 1256, does is it locks in these products, nonfiltered and filtered cigarettes, and legislatively says to the FDA: You can't do anything with those products. They are grandfathered. As you heard me say, H.R. 1256 does not allow these reduced-risk products to come to market. So the tobacco industry, based upon how the legislation is written, would basically limit tobacco uses to these two categories, the 100 percent risky and the 95 percent risky. I misspoke. Let me correct it, because within H.R. 1256 it does state that any product that was sold prior to February 2007 could, in fact, be sold. Some, not all, smokeless products fall into that category of having been sold prior to February of 2007. One has to ask: Why February of 2007? Why is that magic? It is very simple. That is the last time they updated this bill. I am sure they updated before the markup in 2009, but they weren't even careful enough to change the effective date that cut off when a product could be sold. There can't be any other reason, because there is nothing magical to February of 2007, except that U.S. smokeless products were included, and if you include U.S. smokeless products and filtered and nonfiltered cigarettes, you might have one manufacturer that then controls about 70 percent of the market. And because you have grandfathered it all in and you have forbidden FDA from ever changing it, you have basically given an unbelievable market share to one company, and you have not allowed any other company in the world to participate because if they weren't sold before February of 2007, they can't be sold in the future. Because, as I discussed earlier, to bring a new product to the marketplace, you have to make the claim that no nontobacco user would use the product. Yet how can you make that claim if the same provision disallows you from talking to a non-tobacco user about whether they would use the product? It is a catch-22. Yes, we created a pathway, but we also designed it in a way that you couldn't meet the threshold needed to have an application approved. It is very simple. Two was that the Burr-Hagan bill doesn't give the FDA meaningful authority to require changes in tobacco products. They are 100 percent correct. Nor does H.R. 1256. As a matter of fact, not only does it not allow for changes, it legislates there cannot be changes to products sold before 2007. If the Campaign for Tobacco-Free Kids is trying to reduce the risk of death and disease and usage, it has supported the wrong bill. Third, the Burr-Hagan bill will harm public health because it perpetuates the consumers' misconception that they can reduce their risk of disease by switching to so-called low-tar cigarettes. Our bill goes further than the Kennedy-Waxman legislation by banning the use of terms such as ``light,'' ``ultra-light,'' ``medium,'' and bans the use of candy, fruit, or alcohol descriptors on cigarettes even if not characterized in the legislation. In addition, the risk reduction center is required to establish a relative risk ranking for tobacco and nicotine products annually and disseminate that information to the public. This preempts any unsubstantiated lower or reduced-risk consumer communications by a tobacco manufacturer. In other words, under H.R. 1256, the FDA does not have to inform the public about the relative risk of the products they regulate. So they are not going to share with the people that if you smoke filtered cigarettes, it is a 100-percent risk, and unfiltered is a 90-percent risk. In the substitute that is being offered, we require the harm reduction center to annually print a list of what the risks of the products are that are tobacco related and that they regulate. The fourth complaint by the Campaign for Tobacco-Free Kids is that the Burr-Hagan bill doesn't strengthen warning labels in a meaningful way. Well, actually, our bill incorporates the same warning levels for cigarettes contained in the Kennedy-Waxman legislation and requires they be placed on the bottom 30 percent of a cigarette pack, including Senator Enzi's graphic warning label language. Also, our amendment goes further than H.R. 1256 by requiring the disclosure of ingredients on the back facing of a tobacco product packaging. Let me state what the claim was: The Burr-Hagan bill doesn't strengthen warning labels. The only thing I can think is that the Campaign for Tobacco-Free Kids didn't read my bill or it doesn't know the difference between identical language in H.R. 1256 and the Burr- Hagan substitute because the wording is actually the same. In addition, we require that the ingredients in those products be listed on the pack, which I think is beneficial to consumer choice. Fifth, the Burr-Hagan bill doesn't adequately protect consumers from misleading health claims about tobacco products. Well, once again, our bill requires the same rigorous standards used in H.R. 1256 for reducing the risk of tobacco products. Furthermore, it requires the harm reduction center to establish and publish the relative risk of tobacco and nicotine products on an annual basis. Unlike Kennedy- Waxman, this legislation also requires disclosure on individual packs of all ingredients. The sixth complaint by the Campaign for Tobacco-Free Kids is that the Burr-Hagan bill gives the tobacco industry license to create ways to market to youth. We have covered this. Our bill is much more comprehensive. It eliminates print advertising. There are marketing prohibitions and restrictions over and above what H.R. 1256 does. Last, the bill gives the tobacco industry undue influence and creates gridlock on an important scientific advisory committee by giving the tobacco industry the same number of voting representatives as health professionals and scientists--a 19-member board with 10 health care experts, 4 members of the general public, 2 representatives of tobacco manufacturing, 1 representative of small tobacco manufacturing, 1 representative of the tobacco growers, and 1 expert on illicit trade of tobacco products. Somehow, 14 health care experts and 1 trade expert can be depicted by the Campaign for Tobacco-Free Kids as being the same number as 4 tobacco-related members of the advisory board. So clearly, 15 without a tie to tobacco, 4 with a remote tie to tobacco, and the Campaign for Tobacco-Free Kids said that by giving the tobacco industry the same number of voting representatives as health care professionals and scientists--Mr. President, the American people deserve an honest debate. They deserve the information on one side of a bill or another to be factual. I am not sure how you can look at 15 individuals in one category and 4 in another and portray for a minute that is the same number. But that is what the Campaign for Tobacco-Free Kids does. If, in fact, they have misled in the letter to the committee about H.R. 1256 and the substitute, what else haven't they told us or what else have they told us that is not accurate? It brings into question that effort and, clearly, in 1256, the effort is not to reduce the risk of disease or use of tobacco products. Mr. President, how much time do I have?

Mr. BURR. When I ended talking about the substitute, I held up this can of Camel Orbs and I told the Members of the Senate that this was a product that currently is rated at about a 1-percent risk, or an 89 percent reduction from typical nonfiltered cigarettes. It is an 89 percent reduction from nonfiltered cigarettes. I will hold one up. It is a dissolvable tobacco. You don't get lung cancer or COPD from it, and it doesn't cause heart disease. There is a 1-percent risk. But under H.R. 1256, this product is outlawed. Why? Because it wasn't sold before February 2007. Let me say to my colleagues, if the intent of passing Federal regulation of the tobacco industry--and I am supportive of it--is to reduce death and disease, why would you exclude a product that has a 1- percent risk but then grandfather in products with a 100-percent likelihood of killing you? Even if you are not debating whether it is in the FDA or in the harm reduction center, how in the world can a Member of the Senate say it is OK to eliminate the ability for an adult to choose to use this and to be locked into a certain death? We are supposed to pass policy that makes sense and that works for the American people, that actually reduces the risk of death, disease, and usage of tobacco. When you lock them into the highest risk and likelihood of death, you haven't fulfilled that. When you don't require States to use the money they were given for cessation programs, how can you expect that you are going to reduce youth usage? When you see that 48 States have a higher prevalence of marijuana use among youth than they do of tobacco, how can you conclude that by giving the FDA jurisdiction to regulate tobacco, somehow that means you are going to have a reduction in youth usage? It is just not going to happen. The American Association of Public Health Physicians states that this product, Orbs, is the most effective way to fight death and disease associated with current tobacco use. Again, the American Association of Public Health Physicians states that these are the best tools we have to get people to quit smoking. As a matter of fact, I am proud to say that yesterday the American Association of Public Health Physicians endorsed the substitute amendment and not the base bill because they recognize that the base bill does nothing but provide a pathway to certain disease or death. Just so I am clear, under the base bill, H.R. 1256, Marlboro is cemented on the retail shelves. Camel Orbs, which reduces death and disease associated with tobacco use, is banned, can't be sold; It wasn't on the market before January 2007, and Marlboros are on the shelf. Snus is banned. In the past 25 years, Swedish men showed a notable reduction in smoking-related disease, a decline in lung cancer incidence rates to the lowest of any developed nation, with no detectable increase in the oral cancer rate, improvement in cardiovascular health, and the tobacco-related mortality rate in Sweden is among the lowest in the developed world. But in our infinite wisdom in this austere body, we are getting ready to pass a bill that takes a product that Sweden used to get people off cigarettes, to reduce lung cancer, to bring down cardiovascular disease, to reduce mortality by tobacco products, and we are going to eliminate it and we are going to lock them into everything Sweden is trying to get rid of. Think about this before you do it, for God's sake. Once you pass this, it is too late. Mr. President, the current cessation programs don't work. I said earlier that those products have a 95-percent failure rate. Giving current smokers an opportunity to migrate to a less harmful product--it is a public health initiative, and not creating a pathway to reduce harmful products is not a public health bill. But those products are banned in H.R. 1256. Senator Hagan's and my amendment allows these products to be marketed and regulated correctly. Our amendment establishes a tobacco harm reduction center within the office of Health and Human Services. We provide the harm reduction center with the regulatory authority to better protect our children from tobacco use and significantly increase the public health benefits of tobacco regulation. We require tobacco manufacturers to publish ingredients of products. We require the harm reduction center to rank tobacco products according to their risk of death and disease associated with each type of tobacco product in order to inform the American public more fully about the risk and harm of tobacco products. We ban candy and fruit descriptors of cigarettes. We ban the use of the terms ``light'' and ``low tar.'' We give the Harm Reduction Center the authority to review smoking articles and adjust accordingly to what is in the best interest of public health. What we don't do is give an already overburdened agency the responsibility to regulate tobacco. We have a change in administrations. As supportive as I am of the new Commissioner of the FDA, Margaret Hamburg--she will do a wonderful job--let me turn to the former Commissioner of the FDA. Two years ago, Andy von Eschenbach gave his opinion on the FDA regulation of tobacco. You might say: Gosh, this was 2 years ago. I think I already made a credible case that most of what is in this bill was written 10 years ago. Even some of the deadlines that are in the bill have not been changed since the bill was updated 2 years ago. So I think it is very credible to use the comments of the former FDA Commissioner 2 years ago: The provisions in this bill would require substantial resources, and FDA may not be in a position to meet all of the activities within the proposed user fee levels . . . As a consequence of this, FDA may have to divert funds from its other programs, such as addressing the safety of drugs and food, to begin implementing this program. All of a sudden, we are right back where I started 3 days ago. Why in the world would we jeopardize the gold standard of the Food and Drug Administration, the agency that provides the confidence to every consumer in the country that when they get home at night, after having a prescription filled, they don't have to worry about whether it is safe or effective; that if they go to a doctor or hospital and they use a device on them, it wasn't something crafted in the back room and nobody reviewed that it was safe or effective; that it had the gold standard, the seal of approval of the Food and Drug Administration; that as biologics were created that did not exist 10 years ago, that we could feel certain that the FDA looked at this new product and approved it for use in humans; that when we went to buy food, our food would be safe. Do we want to jeopardize the FDA having to divert funds from food safety right now when we have had Americans who have been killed? Do we want a reviewer at FDA, whose gold standard is to prove safety and efficacy on all the products they regulate, except for the tobacco, to lower their guard and let something through that did not meet the threshold of safe and effective? I am not sure that is in the best interest of America. I am not sure it is in the best interest of the American people. My colleague from Connecticut came to the floor and said the Food and Drug Administration is the only agency that has the experience, the expertise, and the resources. The Commissioner of the Food and Drug Administration said: I don't have the resources, and if you give this to me, I might have to divert funds from other programs. As a matter of fact, they would have to divert people from reviewing the applications for new drugs, new biologics. It could be that somebody who is waiting for a new therapy dies before the therapy is available because we had to divert funds or people to take care of regulating a product that the FDA has never regulated and for which Commissioners of the FDA told us they did not have the funds. I am not sure how clear we need this. I said when I started on Monday this was an uphill climb, the deck was stacked against me. I understood the threshold was come to the Senate floor and to spend as much time as it took to convince my colleagues--Republicans and Democrats and Independents--that this was not a bill where one party trumped the other. Senator Hagan is a Democrat; I am a Republican. We have come to the floor passionately with our substitute amendment because we think it trumps H.R. 1256 from a policy standpoint. The American people expect us to pass the right policy, not any policy. If the FDA is not the appropriate place to put it, the American people expect us to find something else that meets the threshold of the right regulation but does not encumber the gold standard of an agency on which we are so reliant. I am hopeful we are going to have a vote this afternoon on the substitute. It will be next week before the base bill is voted on. I say to my colleagues, they are only going to have one opportunity to change this bill. That one opportunity is to vote for the substitute amendment. If they vote for the substitute amendment, they are going to vote for a bill that actually reduces the risk of death and disease for adults who choose to use tobacco products. If they vote for the substitute, they are actually going to vote for a bill that actually reduces youth usage in a real way. If they pass on supporting the substitute--and it will be a close vote--if they pass on supporting it, they are going to have to live with what they do to the FDA. They are going to have to live with the consequences. When I came to the Congress, the House of Representatives, in 1995, I was given the task of modernizing the Food and Drug Administration. We opened the Food and Drug Administration in its entirety. It took 2\1/2\ years to produce a bill. It was a bipartisan bill. As a matter of fact, I think in the Senate and in the House it passed by voice vote. Why did it take 2\1/2\ years, two Congresses? It is because we understood, at that time, the delicacy of what we were attempting to do. We were attempting to modernize the Agency and to maintain the gold standard. At the end of the day, no Member of the House or the Senate offered an amendment to give the FDA jurisdiction over tobacco. In 1998, that bill became law. Why didn't they? It is because every Member knew it was not worth the risk of giving them the responsibilities of tobacco when we had spent 2\1/2\ years trying to protect the gold standard. We are not that forgetful. Don't forget our commitment to make sure the gold standard of the FDA is intact. Don't jeopardize it by giving them tobacco. Don't let our kids be sold short by producing a bill that does not do the education they need so they never pick up a tobacco product. Don't lock the adults who choose to use risky products to risky products forever. Give them an opportunity to have less harmful products. That can only be done one way. That can only be done if Members of the Senate vote to support the Hagan-Burr substitute. It does keep kids from smoking. It does preserve the core mission of the FDA. It does reduce the risk of death and disease. I yield the floor.

Mr. BURR

Mr. BURR. Mr. President, I ask unanimous consent to be recognized for up to 30 minutes.

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

Mr. BURR

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

Mr. BURR. Madam President, I needed to come to the floor and apologize for a misstatement I made yesterday on the current bill, the Kennedy tobacco bill. In yesterday's debate, I stated that the CBO, the Congressional Budget Office, report on the bill revealed that if enacted, smoking rates would decline 2 percent annually. In fact, I was wrong. I prepared a chart yesterday that showed, based upon what CBO said, that we would reduce by 2016 the smoking rate in the country to 17.8 percent, and also the CDC's projection, which if we did nothing, we would reduce it to 15.9 percent, clearly showing the CBO estimate under the current bill we are considering would not bring the smoking rate down as much as doing nothing. The mistake I made yesterday was I assumed the way I read it that the CBO estimate is it would reduce smoking 2 percent per year. In fact, what the CBO report actually said was it would reduce by 2 percent over 10 years. So, in fact, I have been way too generous to the current bill that it would reduce smoking to a point of 17.8 percent, which was figured based on a 2-percent-per-year reduction. In fact, the gap between doing nothing and passing this bill clearly is much bigger than I had anticipated; that by doing nothing, we get much more value, if the objective through passage of this legislation is to reduce the smoking rate in the United States. The bill that is being considered does not change existing products. Let me restate that. We grandfather in all the tobacco products that are currently being marketed. What CBO has concluded is that then you have to permanently figure that about the same rate of Americans will continue to smoke because they do not have new options to turn to. Let me make this pledge to my colleagues. If the CBO report that smoking will decrease by a scant 2 percent under the bill is because of new warning labels and graphic warning labels that are mandated in the bill, then let me say the substitute Senator Hagan and I will offer provides for the same warning labels and the same graphic warning labels. If that is what gets the 2 percent reduction over 10 years, which clearly it has to be, then I am willing to cosponsor that bill right now and substitute it for the entire Kennedy bill, so we get the full 2 percent we get in the Kennedy bill over 10 years of reductions. A simple warning label would be a tremendous improvement over this legislation--$787 million, a new mandate to the men and women in our military to pay for it, and it has been portrayed as an effort to reduce the usage of tobacco products with our youth. I covered for all our colleagues yesterday the fact that when you go down and look at the CDC proposals to States on part of the $280 billion of MSA payments that the industry made to States, that the States had spent a pittance of what CDC projected on cessation programs to get people to stop smoking. But more alarming than the fact that States use the tobacco money to fill their budget gaps and build sidewalks rather than to fund programs to get people to stop smoking is the fact that in practically every case of 50 States, the marijuana prevalence use among youth was higher than the tobacco prevalence. Let me say that again. Marijuana usage by our youth is projected by CDC to be higher in practically every State than what they have projected youth prevalence of tobacco use. It is actually smoking. That does not necessarily include smokeless. For my colleagues, including myself, I have spoken on the fact that we must keep tobacco out of the hands of our children. It has an age limit. I would agree it has some problems on enforcement. But marijuana is illegal. It is supposed to be enforced in every community. It is supposed to be enforced in every State. Yet more kids use it than they do tobacco products. In 1975, Congress commissioned the University of Michigan to track youth smoking rates. At that time, youth smoking was at an alltime high. However, those rates have started to come down and leveled off around 30 percent, all the way up to 1993. For some unknown reason at the time, youth smoking rates started to increase around 1993, peaking at close to a new alltime high in 1997. In 1998, 12th graders who said they tried cigarettes in the last 30 days was approximately 36 percent, according to the University of Michigan. Congress did not have a good sense of why this was happening. Opponents of the tobacco industry started blaming all this on the alleged manipulation of young people by tobacco manufacturers through sophisticated marketing and advertising campaigns. I heard a Member on the floor last night of the Senate basically blaming everything on these very creative marketing techniques. Trust me, if they were that effective, every company would be figuring out how to adopt those techniques. The tobacco industry has a checkered past, at best, when it comes to marketing and advertising. But what I am suggesting is, it may not have been all due to tobacco. There was another trend occurring in the 1993 to 1998 period that virtually mirrored that of youth smoking, and it was the increased use of illicit drugs by teenagers. Something much broader was happening among youths in our society during that time period. The Senate's answer to smoking rate increases was to pass a massive FDA tobacco regulation bill, the exact bill we are debating today. Congress said nothing else would work to save our kids and bring down youth smoking rates. Senator Kennedy made the following remarks during the 1998 Senate floor debate to emphasize the need to protect our children. I quote: FDA Commissioner David Kessler has called smoking a ``pediatric disease with its onset in adolescence.'' In fact, studies show that over 90 percent of the current adult smokers began to smoke before they reached the age of 18. It makes sense for Congress to do what we can to discourage young Americans from starting to smoke during these critical years. . . . Youth smoking in America has reached epidemic proportions. According to a report issued last month by the Centers for Disease Control and Prevention, smoking rates among high school students soared by nearly a third between 1991 and 1997. Among African-Americans, the rates have soared by 80 percent. More than 36 percent of high school students smoke, a 1991 year high. . . . With youth smoking at crisis levels and still increasing we cannot rely on halfway measures. Congress must use the strongest legislative tools available to reduce smoking as rapidly as possible. Senator Kennedy, on the Senate floor, May 19, 1998. Of course, the Senate told the American public that passage of the massive FDA tobacco regulation bill back in 1998 contained the ``strongest legislative tools available'' to address youth smoking issue. Congress did not pass the FDA bill we are debating today. What happened with youth smoking rates? They decreased since 1998 to current alltime lows. I am talking about record lows over a 34-year period. In 1998, we were told by some in the Senate that youth smoking rates would not come down absent a major bureaucratic expansion over tobacco at FDA. Those Senators were wrong, dead wrong. Today, we continue the same debate over basically the same bill, and we are debating this as if nothing else has happened or changed. Obviously, something we are doing across this country is working, and it has nothing to do with what Congress is talking about doing. It has to do with the passage of the Master Settlement Agreement, advertising restrictions, awareness campaigns, and education. None of these things are enhanced in H.R. 1256, the Kennedy bill. It is about design, not about keeping kids from smoking. CBO recently stated that if it was enacted, youth smoking would reduce, over the 10- year period, 2 percent--excuse me, 11 percent for youth, 2 percent overall. But according to the University of Michigan, youth smoking rates have declined by 5 percent over the last 5 years and 16 percent over the last 10 years. If this is an indication of how youth smoking rates will go over the next 10 years, we will actually slow the decline by passing this bill. Let me say that again. My colleagues do not understand. We slow the decline of youth usage by actually passing this bill. It is the University of Michigan, it is the Congressional Budget Office, all very reputable agencies. I know I have a colleague on the floor who wants to speak. I am going to yield the floor to him. But let me remind my colleagues, we are talking about a massive expansion of regulation for the FDA, not a massive expansion of regulation over tobacco. There are a host of agencies currently that regulate tobacco. It is the most regulated product in the United States of America. Now we want to centralize that regulation into the FDA. Let me read the FDA's mission statement: The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our Nation's food supply, cosmetics and products that emit radiation. Just in the first phrase, ``protecting the public health,'' you are not protecting public health when you allow cigarettes to be sold. So the fact that we have constructed a bill that grandfathers every existing product but makes it practically impossible to bring to market reduced-risk products that allow Americans to give up the cigarettes and to move to something else, the CBO was right, it will slow the reduction in smoking rates. We do nothing for disease and death. We do more for disease and death by not passing legislation than we do by passing legislation. If the authors of this bill are, in fact, honest and the effort is to reduce youth access and youth usage, then the Members of the Senate should do nothing. Hopefully, tonight Senator Hagan and I will offer a substitute that brings as much regulatory authority to an entity outside the Food and Drug Administration but one under the Secretary of Health and Human Services. Why? Because I spent 15 years in Washington trying to protect the integrity and the gold standard of the FDA, so that when every American goes to bed at night and they take that prescription they got from a pharmacist prescribed by a doctor, they don't have any question as to whether, one, it is safe, or, two, it is going to work; that when they go to the hospital and all of a sudden a doctor shows them a procedure they are going to have and a medical device is involved, they are not sitting wondering: Is this going to work? Is it going to hurt me? Because the FDA has already said it is safe and effective; as we bring on this new line of biological products that are going to cure terminal illnesses that are very expensive, we are not going to do it in a way that hurts our health because the FDA's gold standard is in place; that when we go to the store and we buy food, we are going to be assured it is safe, something we haven't been able to do for the last few years--spinach contamination, salmonella in peanut butter. The list goes on and on. Why, with an agency that is struggling to meet their core mission, would we ask them to take on a product that in legislation we say we know you cannot prove it is protecting public health or it meets safety and efficacy, but on that we want you to turn your head, we want you to ignore the core mission for this new jurisdiction we are going to give you, but for everything else, we want you to apply that gold standard, we want to ensure drug safety, device safety, food safety but not with tobacco. To my colleagues, it is very simple. Read the bill. You won't vote for this bill. You want to reduce youth consumption of tobacco? It is real simple. We reduce it faster by doing nothing. Again, I think there will be a substitute that all Members can vote for tonight. It accomplishes further reductions of youth usage, because we don't constrict less harmful products in the future from coming to the market. We don't lock an adult population in to only being smokers because they are addicted to nicotine. We give them options, such as Sweden gave their citizens, where they have reduced adult tobacco smoking at incredible rates because of innovative new products that deliver nicotine in a way that reduces the risk of disease and reduces the rate of death. If the objective here is to reduce disease, to reduce death, to reduce youth usage, then I would encourage my colleagues tonight, when Senator Hagan and I introduce the substitute, to listen very carefully and support the substitute. But at the end of the day, if your objective is to reduce youth consumption of cigarettes, in the absence of passing that substitute, it is very clear--the CBO and the University of Michigan says: Pass nothing. Madam President, I yield the floor.

Mr. BURR. Madam President, let me say to my colleague, who had his constituent send him a letter and who served in an incredibly effective fashion as State attorney general and who was involved in the MSA, the MSA was very clear. States extorted--that is what I call it--money from the tobacco companies to pay for health care costs. That money that was part of the Master Settlement Agreement was laid out on behalf of the tobacco industry to address the health care costs in those States but also to provide the resources so those States could, in fact, do cessation programs for adults to stop smoking. What is our experience in the country relative to the recommendations given by the Centers for Disease Control to those States in terms of what they ought to spend on programs to get individuals to stop smoking? Well, in the State of New Mexico, they have done very well. They have actually spent 44 percent of what the CDC suggested they spend. But I think you would also find it shocking to know that the prevalence of marijuana usage in that State is 1 percent higher than the prevalence of smoking by youth. The prevalence of youth marijuana usage is 1 percent higher than the prevalence of smoking cigarettes by youth. In addition to that, I might add that the prevalence of alcohol among the youth there is almost double what the usage is of smoking or the prevalence of marijuana usage. There are two objectives to regulating differently an industry that is currently the most regulated industry in America, and the sponsors of this bill have stated it numerous times: No. 1, to reduce youth usage; No. 2, to reduce disease and death. That is the public health component, and I agree totally with it. But I think what we have to look at is the experience of what is happening today and what the assessments are of the bill that is being considered that would grant FDA jurisdiction of this product. Today, the Centers for Disease Control says smoking is being reduced annually by 2 to 4 percent. The Congressional Budget Office has looked at the Kennedy bill and assessed that over the next 10 years the bill would reduce consumption by smokers at 2 percent. Let me say that again. Currently, doing nothing--not spending billions of dollars, not giving new authorities to the FDA--we reduce smoking by 2 to 4 percent per year. But if we put this bill into effect--at $787 million annually--and we give the FDA authority and jeopardize the gold standard of the agency which approves drugs and biologics, medical devices and food safety, we are actually not going to reduce smoking usage as much as if we did nothing. Why is that? This is very important because you will hear me talk over the next several days about reduced-risk products. Reduced-risk products are products that deliver the nicotine needed for the addiction but reduce the risk of disease and death because it may be moved from smoking products to smokeless products. The truth is, under the Kennedy bill, we basically eliminate any product that wasn't marketed in February of 2007--over 2 years. We have put a marker in the bill that says if there is a product in the marketplace that was not sold in February of 2007, it can't be sold any more. But if it is a product that was sold before February 2007, the FDA can't change it one bit. It is grandfathered in. So what is the CBO's assessment? What the Kennedy bill does is it grandfathers every cigarette that was on the market 2\1/2\ years ago and it doesn't allow the FDA to change it in any way. The only thing it does is to increase the warning label. I stated on the floor earlier today that if putting a warning label on it reduces the usage of cigarettes, I am willing to do it today. I will cosponsor it with anybody. The truth is, what this bill does is it locks in these products; therefore, it eliminates the choices adults have to try to get off of cigarettes and move to a reduced-risk product. My colleague pointed to the Supreme Court ruling on the tobacco industry, and he was partially correct. He just didn't tell the whole story. The whole story was the Court said, in 1998, when the FDA Modernization Act was written and passed and signed into law, Congress opened the entirety of the FDA Act and had the opportunity to give the FDA tobacco jurisdiction and chose at the time not to do it. That was 11 years ago; 11 years ago, the FDA Modernization Act was passed. I was the lead sponsor of that bill, writing that bill in the House of Representatives. It took 2\1/2\ years to construct it. Every Member believed that the gold standard of the FDA was so important that we never lost focus on the fact that we had to maintain the integrity of the mission statement of the FDA. But no Member of Congress ever attempted to extend jurisdiction over tobacco to the FDA because they were concerned at the time that to do that would lessen that gold standard at the FDA. How can you tell an agency that has a regulatory responsibility to protect the safety and effectiveness of those products they regulate that we want you to do it on drugs and biologics and medical devices, but we don't want you to do it on this new product of tobacco? The risk and concerns and fears at the time were that this might diminish the effectiveness of the FDA. What has happened in 11 years? For 11 years, we have had a steady decrease in smokers. Now we are going to adopt a bill that potentially locks us into just the products in 2007. Why have we had a reduction? Because new reduced-risk products have come to the marketplace. We ought to continue to bring new reduced-risk products to the marketplace. Unfortunately, this bill does not do that. As a matter of fact, in section 910 of this bill, a so-called new tobacco product would not be marketed unless these three things were met: No. 1, it can show the marketing is appropriate for the protection of public health; No. 2, the increased likelihood that existing users of tobacco products will stop using such products; and No. 3, the likelihood that those not using such products will not start. Let's take the first requirement and put it into English. Before a company could market a new tobacco product, it would have to show that its use is appropriate for the protection of public health. Who in the world can show that the use of a tobacco product is appropriate for public health? It is impossible. In other words, this new tobacco product--be it a cigarette, raw tobacco, perhaps an alternative tobacco product--the companies would have to show that this new product is appropriate for the protection of public health. Somebody is going to have to explain to me how a cigarette can be appropriate for the protection of public health. It cannot be done. Therein lies why I grandfathered products before 2007. Even if by some miracle the inventer could show a product was appropriate for the protection of public health, this would only meet a third of the qualifications for a new product to come to market. It would also have to show that the product will make smokers or those using chewing tobacco less likely to smoke or chew and will prevent new people from starting. Again, somebody will have to show me how you can provide an example of a tobacco product currently for sale that would satisfy these standards: it discourages people from smoking, and it deters young people from starting. The bill's manager, the author of the bill, could not share with us exactly how you accomplish that. How does one go about assembling the data that is needed for new products when, in fact, you cannot actually ask consumers about a product that has yet to have an application approved. It is a catch-22. It sounds good. Let me highlight another problem with the bill as it relates to harm reduction. You heard me discuss harm-reduction products or products that are less harmful. These are not found in H.R. 1256. I am sure my colleagues are aware that the legislation would ban several products not sold in 2007. One of the products is a product called snus. We have seen the can. It is a Swedish smokeless tobacco, it is pasteurized, and it doesn't require one to spit. It is a tool that in Sweden has been used to get people off of cigarettes. Yes, it is still the use of tobacco products, but it meets the threshold of diminishing the risk of death and disease. Some suggest because there is a wintergreen and there is a spice, that this is attractive to kids. That is not the case. If that were the case, we would see wintergreen marijuana, because the usage or preference among youth is higher. The truth is, that has nothing to do with it. As I understand it, the product does not require the burning of tobacco. It does not require the actual smoking of tobacco. It generates no secondhand smoke. It will not affect the children near a user. According to the research done by a host of reputable scientists and public health organizations, use of this product instead of cigarettes can actually reduce death and disease associated with smoking. Why would you ban this product if the pretext of passing this bill is to reduce the risk of death and disease? You would not. But we eliminate the ability for this product to come to market in the future, and that which is at market today we ban from the market. In other words, it is clear that snus is far less dangerous than cigarettes, and it would be appropriate for the protection of public health because it eliminates secondhand smoke, it moves people away from smoking cigarettes. It would meet much of the standard of the bill, but the legislation still mandates that the manufacturer of snus demonstrate that snus will not encourage nonusers to start. Again, I am not sure how you communicate with the general public-- which is strictly prohibited in the bill until you have an approved application. If you need to communicate with the public in order to understand whether the product would cause nonusers to start for a reduced product approval application but you cannot communicate with consumers until you have an approved application, how would you ever get approval under section 911? The devil is in the details. In fact, you cannot communicate, but you have to communicate to be able to pass the third threshold of allowing the product to come to the marketplace. So it is disingenuous to suggest that this bill is for the purposes of reducing death and disease when, in fact, those things that are proven to reduce death and disease have strictly been forbidden. And in the case of those that are at market today, they would be pulled from the marketplace. It would be fair to say that what we are doing is freezing the marketplace for cigarettes and chewing tobacco. In 2007, I raised the issue with the HELP Committee because this same bill was brought up. The answer I was told then was that it may be difficult to bring a reduced-risk product to market. Bringing a reduced-exposure product to market is much simpler. So I said: Let's take a look at it. Maybe a cigarette with less benzene or nitrosamines can work, so I read the reduced-exposure portion of section 911. The first part of the reduced-exposure language reads that in the absence of conducting a 20- to 25-year study on tobacco products, if you can show a reduction in a harmful constituent in the product, you can classify it as reduced exposure. That seems reasonable. Then, in addition, those little pesky words pop up: ``additional findings.'' The reduced-exposure language states that you must show how the product would actually be used by consumers. Once again, catch-22-- you can't talk to consumers until you have an approved application. You can't show how the product is going to be used by consumers unless you can talk to consumers. Therefore, there is no such thing as reduced exposure. The bottom line? The bill that is being considered to give FDA jurisdiction brings no new harm reduction to tobacco users in America. It does to smokers exactly what the bill states, it locks in place all the cigarettes that were sold prior to February 1, 2007. Any of the reduced-risk product that has been introduced in over 2\1/2\ years automatically goes off the market, and the pathway through FDA for any new technology that might not burn tobacco or that might use tobacco in a different way that enables somebody to quit smoking and reduces death and disease--there is no pathway for it to happen because there is no way to communicate with the public until you have an application, and a part of the application process means you have to communicate with the public to meet the test that has been designed. You know what this is typical of what the American people think about Congress, that we say one thing and we do something else. That is exactly what we are doing here. I will offer a substitute with Senator Hagan tonight, I believe. That substitute will bring full regulatory authority to an entity to regulate this industry. I am not up here saying we cannot regulate it better than we do today. It is the most regulated product in America. It is regulated by more agencies than any product that is sold today. Can we do it more extensively? Sure. Can we have better warning labels? Absolutely. Can we be graphic in our description of what these products cost? Certainly. But the question is, Where is it more appropriate to do the regulation? I suggest that creating a new entity under the Secretary of Health and Human Services, where they have full authority to regulate this product, to limit its advertising, to eliminate its advertising, is a more appropriate place than to give it to the FDA, where their mission statement is to prove the safety and efficacy of all products they regulate, but they can never do it on tobacco products; to put it under the same guidance of the Secretary of Health and Human Services, who also oversees the FDA. What is so magical about putting this at the FDA? I will tell you, because they have attempted to do it for 10 years. It is because when you put it there, over time you will be able to outlaw this product--or you think. I go back to this chart from the CDC, the Centers for Disease Control, where in 48 out of 50 States the prevalence of youth marijuana usage is higher than the prevalence of youth smoking. Don't think just because you outlaw it you are going to reduce this country's youth usage. As a matter of fact, you may find out you have increased youth access. The way to do it is to take the money the manufacturers gave to the States and use the money to provide the education, to provide the cessation programs, to provide the reduced-use products that will allow individuals to get off cigarettes and go to something that really does reduce death and disease. But if you pass the Kennedy bill, that is not what we are doing. What we are doing is we are locking in forever the 21 or 22 percent of the American people who are going to smoke. In fact, the Centers for Disease Control said that if we do nothing, by 2016 we will reduce, from 21 or 22 percent, the smoking rate in America to 15.9 percent. We will actually reduce it over 6 percentage points by doing nothing. Yet we are getting ready, if we don't support the substitute, to lock in a measure that assures us indefinitely into the future that 21 or 22 percent of the country will choose cigarettes as their means of tobacco usage. It means we will continue the rate of death and disease. We may look back and say: But we picked the strongest regulatory agency that we could to be in charge of the regulation of this product. Tell that to a patient waiting for a lifesaving drug and the reviewer who was reviewing the application was moved over to the tobacco section, because this new responsibility they had made them take senior reviewers and get them over because they had to regulate this product from day one. Tell the individual in America who is harmed because of a medical device that should have never been approved but got through the system because the gold standard of safety and efficacy was not adhered to at FDA because they were asked to turn to tobacco and not prove that public health was important on this product and, therefore, new reviewers looked at it and said: We don't have to be 100 percent accurate on devices. Or the biologic companies, when they see a delay in the approval of an application, that actually invest billions of dollars to bring a lifesaving biologic to the marketplace that ends a terminal or chronic illness, what if this product doesn't come because of what we do? These are questions we should be asking ourselves. The American people deserve us to fully vet this. But in 2 days of markup on this bill, when questions were asked, the answers were ignored. They were more interested in the speed with which we pass this than the accuracy of the policies that we put in place. I have tried to keep the debate since yesterday on facts. I have tried, when I made a claim, to produce the numbers. The CDC is typically a credible source. The Congressional Budget Office is usually a credible source. The University of Michigan, many have come on the floor and used it as a credible source. This is not industry hype. These are institutions that we come to the floor and use to make our claims every day. What all of them say is: Don't pass this bill. But they don't say not to do something. Tonight Members will have an opportunity to vote for a substitute, a substitute that gives the same level of authority, that does away with advertising in total, that puts the same descriptive labels on so that people cannot only read it in plain English but see it in detail. It just doesn't put it at the FDA. Why? Because I spent 2\1/2\ years of my life trying to modernize the Food and Drug Administration through a piece of legislation we passed in 1998. Why did it take so long? Because the FDA regulates 25 cents of every dollar of our economy. When the American people go to bed at night, they know if they take a drug that was prescribed by a doctor and filled by a pharmacist, it will not hurt them. More importantly, it is probably going to help them. It will make them better. Or when they go to the hospital or the doctor's office and they use a device, they know it has been reviewed and it is safe. They know that when they go to the grocery store, there is an agency called the Food and Drug Administration that is responsible for food safety. What they buy and what they eat is actually not going to kill them. Yet we have seen instances over the last 3 years where spinach is sneaked through and peanut butter is sneaked through. And as we become a more global economy, our concerns about where it is made and what they put on it mean that our review of food safety has to be as stringent as everything else. The FDA is struggling today. The biggest mistake we could make is to give them another product and say, regulate this, and don't regulate it based upon the same standards you do everything else. But that is what we are doing. If you want to reduce youth access, youth usage, if you want to reduce death and disease, vote for the substitute tonight. Reject the base bill. If we do that, we will have successfully done our job. If, in fact, we fall prey to jeopardizing the gold standard of the FDA, mark my words, this body will be back at some point fixing a mistake they made. My only hope today is that there won't be an American who loses their life by the actions we have taken. I am willing to concede that if the FDA gets the jurisdiction, the authority to regulate this industry, we will miss the opportunity to take a lot of Americans off of cigarettes and move them to other products, other products that are better for their health and not as likely to kill them. The statistics say that that will happen. Ask yourself, knowing that, is it worth risking that you might change the gold standard at the FDA, that you might lower the bar for drug or device approval, that we might actually slip on food safety. I am not sure the risk is worth it. This is about our kids. Vote for the substitute. This is about the status quo. This is about letting an outside group have a win that has fought this for 10 years because they are in some battle with an industry. Is it worth it for us to give them a win versus the American people? I don't think so. I encourage my colleagues to support the substitute tonight. Reject the base bill. I yield the floor and suggest the absence of a quorum.

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

Mr. BURR. Mr. President, while the Senate is in consideration of a bill to regulate tobacco, I think it is extremely important that Members of the body understand that tobacco is not an unregulated industry today. Let me preface this by saying that I am not proposing that we do not do something additionally in the Senate. I think we can regulate more effectively. But what I have put up--I know it is hard for the Presiding Officer to see--is the current regulatory structure of the tobacco industry in America. It shows every Federal agency that currently has a regulatory jurisdiction over tobacco: Department of Transportation, Department of Treasury, Department of Commerce, Department of Justice, the Executive Office of the President, Department of Health and Human Services, Department of Education, Department of Labor, General Services Administration--the GSA--the Department of Veterans Affairs, Federal Trade Commission, Department of Agriculture, the Environmental Protection Agency, the U.S. Postal Service, and the Department of Defense. These are all Federal agencies that currently, today, regulate the product of tobacco. For any person to come to the floor of the Senate and claim that there is not sufficient regulation of this industry right now is ludicrous. As a matter of fact, this is the most regulated product sold in the United States of America currently. The proposal Senator Kennedy has introduced is a proposal that concentrates all the regulation of tobacco in the Food and Drug Administration, an agency that was created for the sole purpose, by its mission statement, of approving the safety and efficacy of drugs, biologics, medical devices, cosmetics, products that emit radiation, and responsibility for food safety. We are going to shift from all these Federal agencies and all the flowcharts underneath them of different aspects of regulation currently for the tobacco industry, and we will concentrate this in the Food and Drug Administration. It probably makes a lot of sense from the standpoint of consolidation, but what I want my colleagues to understand is that this truly today is the most regulated product sold in America, when we look at the expanse of the regulatory framework that exists today. The authors of the bill have suggested we have to allow the FDA to have jurisdiction because there should be two objectives. One is to reduce death and disease, and the other is to reduce youth usage of tobacco products. These are two goals I embrace wholeheartedly. Let me share this chart. It starts with a product I consider to be the base: 100 percent of these products presents a health risk. What is the product? Nonfiltered cigarettes. I know the President of the Senate probably remembers when all his friends smoked nonfiltered cigarettes. The truth is, we probably still have some friends who do it today. The continuum of risk goes down in the next category, filtered cigarettes. The industry introduced filtered cigarettes at some point, probably before I was born. The risk is only reduced by 10 percent. It meant it was 10 percent less likely to have a risk involved in it. But still, clearly, 90 percent of users having the risk is pretty unacceptable. Then we go to a category that never hit the market, except for experimentally through market testing. That was tobacco-heated cigarettes, a product that didn't actually burn tobacco, but it had a ceramic disk in the front that glowed and got hot. As that hot air was pulled through the tobacco, the nicotine was extracted and delivered, but the product never burned. It never created secondhand smoke. In fact, it never had any smoke that actually was emitted afterward. Whatever was emitted was a vapor, and it dissipated. Then we have a new category called electronic cigarettes, a fascinating product, rather expensive. It actually runs off a battery. It extracts the nicotine and delivers it into the system in a totally different way than the tobacco-heated cigarette. But, clearly, we see that in two new iterations, we have gone from 100 percent risk to 90 percent risk to 45 percent risk and now, with this new electronic cigarette, to a risk of less than 20 percent. One would say, moving from here to here from the standpoint of risk is an advantageous opportunity for people who use nonfiltered cigarettes. If we could get them over here, we have reduced the risk of death, and we have reduced the risk of disease. Let me move out to the next category, which is smokeless tobacco, U.S. smokeless tobacco. I need to draw the distinction because globally there are new types of smokeless tobacco. But U.S. smokeless tobacco all of a sudden reduces the risk to 10 percent. We have gone from 100 percent to 10 percent. We have reduced by 90 percent the risk presented by the use of tobacco products. Now we move to the next category, which is probably hard to see. I would equate this to about 2 or 3 percent risk. This is Swedish smokeless snus, a pasteurized product. It is actually spitless. It can be swallowed because of the pasteurization. But, again, products that deliver the nicotine need to allow somebody to go from a nonfiltered product all the way over here to a U.S. smokeless or to a Swedish smokeless. We have now gone from 100 percent risk to 2 or 3 percent risk. Now a new category, not even on the market, a category already targeted as a product that should not be: dissolvable tobacco, a product that dissolves in the mouth. That delivers what this person needs over here from the standpoint of being addicted to nicotine but puts the category of risk somewhere down in the 1 percent category. As innovation has taken place, we have allowed the opportunity for people to come off products that had 100 percent risk down to products that reduce the risk by 99 percent. Then we have therapeutics, such as gum and patches and lozenges, that have minimal risk and pharmaceutical products that allow people to actually either reduce or quit the habit of tobacco usage. When we look at the goal of a tobacco bill--and the authors have said the goal is to reduce disease, death, and youth usage--I ask the Presiding Officer, if you reduce from 100 percent the risk to 10 percent for U.S. smokeless or 2 percent for Swedish smokeless, does that embrace the spirit or intent of what the author of the bill is trying to do? I say yes. But what I have to share with my colleagues is this category that is at 2 percent, under the current bill being considered, would be banned. Why? Because of an arbitrary date that they have chosen to say if the product wasn't sold in the United States before February of 2002, then this product is not allowed to stay on the marketplace. My point is, if the authors say the objective of the legislation is to reduce the risk, as you reduce the risk, you reduce the likelihood of disease, the severity of death, isn't this the category we would like more smokers to move to? I think the answer is obviously yes. We would like to move people away. We would like to reduce the health cost. We would like to reduce death. If we can do that by bringing this new age of products to the marketplace, this is beneficial to everybody. It makes a lot of sense. That is not what the legislation does. I have spent this day coming to the floor trying to emphasize with my colleagues that what the legislation does is grandfathers two categories, nonfiltered cigarettes and filtered cigarettes. It says these are the only products that will be allowed to stay on the market. It means the 20 percent of Americans who currently have chosen to smoke, hopefully adults, are not locked into these categories from the standpoint of choice. Yet in Sweden, they created this new product, and they have had a massive movement of people from these two categories to this category. This is not something I have made up. The data is there to show. The authors of the bill would suggest we allow this product to be created, but there are three thresholds they have to meet. The three thresholds they have set are absurd. Let me focus on the third threshold. They suggest that the manufacturer would have to prove this product wouldn't be used by a nontobacco user. For you to accumulate data to know whether a nontobacco user would be interested in using this product, you would have to go out and present the product to them and explain it before they could comment on whether they would be inclined to want to try it. But the bill forbids any communication about a product that hasn't been approved. So I ask, how do we get a product approved if the threshold is to tell them what the likelihood is of people who haven't used tobacco products using it, if you can't talk to people who haven't used tobacco products about using the product because the product hasn't been approved? In Washington we call this a quite crafty way of making a claim but reversing in the bill the ability to use it. In essence, the bill that is under consideration creates these two categories indefinitely and says: It is OK if we have 20 percent of the American people who choose to use those products. Hopefully, over time, more adults won't choose to use them. We are willing to accept that 20 percent are using them, and they are going to die or have severe disease. If that is the case, then how can you come out and claim that this is a public health bill, that we are going to pass this bill because of the responsibilities we have to public health? Since 1998, smoking rates in America have dropped from approximately 23.5 percent to 19.5 percent. The Centers for Disease Control and Prevention, the agency that many come to the floor and quote with great frequency because of their expertise, says if the Senate does nothing, if we don't pass a piece of legislation, by 2016, the rate of smokers in America will drop to 15.7 percent. But if we look at the Congressional Budget Office that has had an opportunity to see the Kennedy bill, they estimate the Kennedy bill will reduce smoking 2 percent over the next 10 years. Meaning in 2019, the rate will fall from 19.5 percent to 17.5 percent. You get where I am going? By giving the FDA regulatory authority, we are going to increase by over 2.5 percent the number of smokers in the country than if we did nothing. That doesn't make much sense, does it? Let me explain. When we lock in these two categories and we eliminate the ability for somebody who is a smoker to find one of these products to move to, we have now locked in the category of smokers. When we explain it to somebody, it makes tremendous sense. The question is, Why would we do this? I expect Sweden to be up here arguing that this is the right strategy. Yet Sweden is the one that is the most progressive. Why? Because they are truly focused on the health of Swedes. The fact that we claim that we are doing this because of death and disease isn't true. We are doing this because 10 years ago somebody wanted to do something punitive to an industry. As a matter of fact, the date that is set in the Kennedy bill is February 2007, meaning if the product wasn't sold before 2007, it is banned from the marketplace. Why did they use February 2007? Because they wouldn't even change the bill they passed out of committee in 2007 to reflect 2009, which is the current date. There was so little attention paid to this piece of legislation that they didn't even go through to purge the date and change it. They printed the same page of the bill they had last time. I have said several times throughout, the only thing I ask Members to do before they vote on this bill is to read it. I don't think that is too much to ask. If they read the bill, they will never vote for it. If they read the bill, they will understand that, one, this makes a lot of sense. But, two, remember, when I went over the current regulatory structure, I didn't mention the Food and Drug Administration. I did mention the Department of Health and Human Services. As we go down this flowchart of things under the HHS, there is no FDA. We are choosing an agency of the Federal Government that has never regulated tobacco. How can that possibly make sense? Maybe if you claimed you were going to put it at the Centers for Disease Control, they actually have some responsibility within the framework currently of regulating tobacco. But not the FDA. We may have taken the only piece of the Federal Government that doesn't currently have any jurisdictional responsibilities to regulate tobacco, and we are giving them 100 percent of the requirement to regulate tobacco. The truth is, we don't need the FDA to do it. We can do it by creating a new entity under the Secretary of HHS, the same person who is over the FDA today, and we would suggest doing that by creating a new center. That new center would be responsible to regulate in total tobacco products throughout the industry. It is a Harm Reduction Center. Think about that: Harm Reduction Center. Let me go back to this chart: The continuum of risk. If the objective is to reduce death and disease, then you have to drive the risk down. To drive the risk down, you have to bring less harmful products to the marketplace. So you have two choices. You have a bill that will do that through creating a Harm Reduction Center that regulates with all the authority the FDA has or you can choose the Kennedy bill, which basically isolates these two categories of 100 percent risk and 90 percent risk; and you put that into statute that the FDA cannot touch products that are over here, as shown on the chart, but, more importantly, you structure it in a way that the FDA could never approve any new products that are less harmful. The Harm Reduction Center actually has two responsibilities. One, it is to regulate the entire tobacco industry and, two, to facilitate smokers moving over to lower risk options because we want to reduce the harm that potentially can be caused. I am going to speak later tonight, as I offer this substitute, which I hope every Member will take the opportunity to read on behalf of Senator Hagan and myself. I am sure we will both speak tonight and throughout the day tomorrow as we get ready to have a vote. It is my hope Members will take the opportunity to review the substitute. Let me put Members on notice right now, some will come to the floor and claim: Well, this is a substitute that the HELP Committee considered and they rejected it 12 to 8, 13 to 8--I cannot remember exactly what it was. Let me put Members on notice before they come down here and make claims on it, it is not the same bill. It is not the same substitute. I am sure staff now is going to scramble to figure out what is in this new bill. We listened to criticism. Where we thought we could better the bill, we did that. The fact is, there are still going to be Members who come and make claims tonight, tomorrow--before this is all settled--that are not accurate. I put them on notice now: I will come to the floor and expose exactly what you say. This is not a debate where we are going to use the charts we had 10 years ago and say they are relevant today. This is not a debate where we are going to have information that was produced in 1990 for an issue we are discussing and debating in 2009. It is not right to do that to the American people. In concluding--because I see my colleague is here wanting to speak--I pointed out earlier that in 1998 the industry made a massive payment to the 50 States of this country. It was called the Master Settlement Agreement, MSA. Mr. President, $280 billion that the industry, over a fixed period of time, was paying out to States. It was for two purposes: No. 1, to subsidize health care costs--the Medicaid costs in States--that might have been from the direct cause of tobacco usage; and, No. 2, so States would have the resources they needed to create cessation programs so people would move from this category, as shown on the chart, to this category or quit tobacco use all together. I came to the floor yesterday--and I will say for the purposes of the Presiding Officer in the Senate, who is from Illinois--CDC made recommendations to every State to do this every year: How much of the money they got that year should be used for cessation programs. Well, in Illinois, Illinois devoted 6.1 percent of what the CDC recommended for cessation programs to cessation programs--6.1 percent. Mr. President, 19.9 percent of the youth in Illinois have a prevalence to smoking--way too high. In Illinois, though, 43.7 percent have a prevalence to alcohol use. In Illinois, 20.3 percent have a prevalence of marijuana use. I am not picking on the Presiding Officer of the Senate, and I am certainly not picking on Illinois. I will have used all 50 States before this is over with. As I said, one of the shocking things to me, as I explored this chart, was that I found that, I believe it was, 48 out of the 50 States have higher youth prevalence in marijuana use than of smoking. Well, some are going to claim the reason you have to give FDA jurisdiction over this is because the age limitation of 18 is not working, that youth are getting products. Well, you know what. There is no age where it is legal to buy marijuana, especially for youth. Yet in 48 out of 50 States, the prevalence of marijuana usage is higher than the prevalence of smoking. Do not believe for a minute you are going to construct a regulatory regimen here that is going to take a product that is legal to people over 18 and it is going to allow a framework where people under 18 are not going to get it, when a higher percentage of them can get a product that is illegal for everybody in America. I might also say to the Presiding Officer, his State is not the lowest from the standpoint of the percentage they chose of the CDC recommendation to devote to cessation programs. As a matter of fact, one State had a commitment of 3.7 percent. Now, $280 billion--paid for by the tobacco industry to cover health care costs and cessation programs--I would suggest to you, if the States had all spent 100 percent of what the CDC told them they needed to spend, we would not be here talking about the regulation of the tobacco industry because cessation programs would have worked and the rate of 19.6 percent today of smokers would have reduced drastically. I would remind you that the CDC says, if we do nothing, by 2016, we reduce the rate to 15.7 percent of the American people. But when CBO looked at the Kennedy bill, they said, in 10 years, in 2019, the Kennedy bill would reduce smoking to 17.5 percent. If we do nothing, we get to 15.7 percent. If we pass this bill, we get to 17.5 percent. If the objective is to have less smokers, the answer is: Do nothing. But tonight, sometime around 6 o'clock, Senator Hagan and I will come to the floor not to suggest to our colleagues that we do nothing but to suggest to our colleagues we do the right thing, that we find the appropriate place to put regulation, that we give it the same teeth the FDA has, that we give them the ability not just to have black-and-white print advertising--such as the Kennedy bill does--I suggest in my substitute we eliminate print advertising, we do away with it in total. We do not worry about whether Vogue magazine, which is typically bought by an adult woman, might be looked at by a teenage girl. If we just eliminate print advertising, we do not have that problem. The Kennedy Bill limits it to black and white. We ban it in total. If Members will take the opportunity to read both bills--to read the substitute, to read the base bill--they will find out we are actually more expansive from the standpoint of regulation. We actually accomplish the task of reducing disease and death. I believe, by some of the things we do, we actually reduce the amount of youth usage, such as by eliminating print ads. But there is a big difference. I do not turn it over to the FDA. I do not do that for a selfish reason--purely selfish. I spent 2\1/2\ years, 15 years ago, when I got to the U.S. House of Representatives, where I was tasked by the chairman of the Energy and Commerce Committee to write a bill that modernized the Food and Drug Administration. It took 2\1/2\ years to do. It was signed into law in 1998. We opened the entirety of the Food and Drug Administration and revamped all the ways it worked to make sure we could reach new efficiencies in the approval of lifesaving drugs, biologics, which were new, devices. We spent a meticulous amount of time going through this with one goal in mind: Do not lower the gold standard the American people have come to expect through the FDA; do not lower the standard an applicant has to reach so we can assure the safety and efficacy of the products we regulate. Well, I thought that was important, and in 1998 it became law. And you know what. When we had the entirety of the FDA bill open to every Member of the House and the Senate, no Member of Congress offered an amendment to give the FDA authority over tobacco because they knew, at the time, the integrity of the FDA was more important than who controlled it from a regulatory standpoint. They did not want to jeopardize the integrity of what the FDA core mission was. But here now, 11 years later--I might also say, the Supreme Court ruled in a court case that the FDA did not have jurisdiction over tobacco. The reason they chose was, in 1998, the Congress opened the FDA Act and did not give FDA authority. Therefore, it was not the intent of Congress for FDA to have authority. So those who claim this is part of the FDA--should have been, always would be--it is not the case. Because Members of Congress had the opportunity and did not do it. Why? Because of the integrity of the Food and Drug Administration. Why in the world would we have changed, in 11 years, to where we would risk the gold standard of drug approval, of biologic approval, of medical devices approval? Why would we risk at a time where, every year for the past 3 years, we have had an issue on food safety--we have had salmonella in peanut butter; we have had tainted spinach; we have had imported products that have killed Americans; and the FDA is the agency responsible for the regulation of food safety--why would we dump on an agency today that is struggling to meet their core mission of food safety a new product such as tobacco? Why would we take an agency, such as the FDA, that regulates 25 cents of every $1 of the U.S. economy, and say: You know what. You have never regulated tobacco before, but we would like you to do it now. We would like you to take senior reviewers who are approving lifesaving applications for drugs, and we would like you to move them over to the tobacco area. What else can they do? You cannot go out in the world and find people automatically at the FDA who have ever regulated tobacco. So they are going to take their most senior folks. What does that mean? The likelihood is, we are going to wait longer for that lifesaving drug. We are not going to reduce health care costs because chronic disease is not going to have new therapies because the applications will not be acted on. Heaven forbid we do this and all of a sudden somebody dies as a result of an FDA reviewer who looked at it and said: Well, you know, I know our core mission is to prove the safety and efficacy of all the products we regulate--with the exception of tobacco because you cannot prove it is safe and effective--so if I am going to turn my head on tobacco, maybe I will turn my head on this medical device because it does not look too bad, and all of a sudden somebody dies from it. This is a huge mistake for the Senate to do. I urge my colleagues: Read the bill. You will not vote for it. Read the substitute, it will supply the sufficient amount of regulation to an industry that can be better regulated, should be better regulated--more importantly, a substitute that goes much further from the standpoint of reducing youth usage of tobacco, which gets at the heart of death and disease. In fact, the substitute is the only bill that accomplishes what the authors of the current base bill suggest is the reason we are debating this issue. This chart I have in the Chamber proves it. It does it in the most visual of ways. If we do not allow these products to come, you have now locked it into this. That is not what the authors suggest is the objective. I urge my colleagues, tonight, when given the opportunity, listen intently, read the bills. Tomorrow, when you are given an opportunity to vote, vote for the substitute. Do not support the base bill. Mr. President, I yield the floor.

Mr. BURR

Mr. BURR. I ask unanimous consent that reading of the amendment be dispensed with.

Mr. BURR. Mr. President, let me say it is shocking that the argument as to why we should do this is because the Food and Drug Administration regulates cat and dog food, what we have just heard. The truth is, the FDA regulates every pharmaceutical product, every medical device, every biological product, lifesaving drugs, chronic disease, treatments, therapies. It is in charge of food safety, of products that emit radiation. It is the gold standard of the world from the standpoint of the approval and assurance of safety and efficacy of things Americans take that are prescribed by doctors and filled by pharmacists. They know when they go home, they can take it because it is safe and effective. Now we are talking about giving that same agency a product for which they can't prove safety and efficacy--their core mission statement for every product they regulate. They will have to turn their head on tobacco because it kills. It causes disease. It isn't safe. This makes no sense. What the substitute does is create a tobacco harm reduction center. It locates it at the Department of Health and Human Services, under the Secretary--the same Secretary who oversees the Food and Drug Administration. Within that tobacco harm reduction center, it gives the authority to the center to regulate all cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and other tobacco products that are deemed by the Secretary to be necessary for regulation. We don't lessen the regulation of this industry. As a matter of fact, as Members have an opportunity to hear tomorrow about this substitute amendment, we increase the regulatory authority. We do it under the same guidance of the Secretary of Health and Human Services. We define what adulterated and misbranded tobacco products are. We give the tobacco harm reduction center the ability to pull products directly from the market and to prevent those products from going to market. Misbranded product would be a label that is false or misleading, labels that don't contain all the information, are not in compliance with section 109, and tobacco or ingredients are not disclosed. It requires tobacco manufacturers to submit extensive lists of ingredients, substances, compounds, and additives by brand style to the tobacco harm reduction center. It requires the center to determine and make public a list of harmful constituents, including smoke constituents and by brand styles. It requires annual registration and submission of additional information by the manufacturers to the center. It requires establishment of tobacco product design standards and establishes tar and nicotine ceilings for cigarettes. It eliminates candy and fruit descriptors on cigarette advertising and marketing. It gives the center the authority to remove tobacco products from interstate commerce if such products pose an unreasonable risk of substantial harm to public health. This is about public health. The objective of any bill should be to reduce youth usage, to reduce disease, to reduce death. If we put it in the FDA, we grandfather a tremendous amount of smoking products, but we don't allow a pathway for new, less harmful products to reach the marketplace. In our case, we allow reduced-risk products to come but under the supervision, the direction of the harm reduction center. It requires all tobacco manufacturers of imported tobacco products to establish and maintain records, make reports, provide information as the Secretary requests, not as we prescribe. It requires premarket approval of new combustible tobacco products before entering interstate commerce. It bans the use of such descriptions as ``light,'' ``ultra- light,'' and ``low tar'' on packaging, advertising, and marketing of cigarettes. It requires testing and reporting of all tobacco product constituents, ingredients, additives, including smoke constituents and by brand styles. It creates a scientific advisory committee of 19 people. It establishes a new warning label that communicates the health risk of cigarettes, with placement for cigarettes on the front of the packaging. It requires ingredient disclosures and other information on all tobacco packaging. It has the graphic warning labels required. It establishes new warning labels that communicate the health risks of smokeless tobacco. It requires ingredient disclosure and information on tobacco products. The list goes on and on. The authors of the base bill and the substitute that has been offered in its place suggest that they do a better job of making sure that youth don't access tobacco products. That is just wrong. Every State sets an age limit. One bill does not police the process more than the other. The one thing this substitute does, this amendment in the nature of a substitute, is we ban print advertising except in a publication that is an industry publication. So every general print ad, every general print publication, a publication that a mom might buy but a teenager might look at, we eliminate advertising. What does the base bill do? It limits it to black-and-white advertising. Don't come to the floor and suggest one does a better job than this substitute. When you ban advertising, you have banned the ability to market to the youth. When you ban descriptors and other items such as candy and fruit descriptors, we do that as effectively, we just do it through a harm reduction center. Why? Because it is under the same leadership of the Secretary of HHS. I don't want to jeopardize the gold standard of the FDA. I don't want to compromise the gold standard that it has to meet the test of safety and efficacy so the American people have trust in products. We jeopardize that when we give the FDA this mission. Some will claim the FDA is the only one that can do it. As I showed before, there is the regulatory chart for tobacco today in the United States. Every Federal agency is listed up here, including HHS. FDA has no current jurisdiction. They have no expertise to regulate tobacco. It is the most regulated product sold in America today. But I am not on the floor arguing that this is enough. We can do better. We can consolidate that regulation. We can build on the strengths of all of these underneath the heads. But to add FDA is a huge mistake. We just got faxed to us the endorsement of this substitute amendment, No. 1246, by the American Association of Public Health Physicians. The Association of Public Health Physicians endorses the Burr-Hagan amendment. All of a sudden, health care entities are looking at these two bills, and they are saying: The amendment in the nature of a substitute, No. 1246, actually does accomplish what is best for public health. And public health physicians are willing to put their name on it. We are going to have an opportunity tomorrow to talk at length about what is in the substitute. My colleague, Senator Hagan, cosponsor of this bill, will have an opportunity to address it either tonight or tomorrow. I look forward to the opportunity to do that. I yield the floor.

Mr. BURR. Mr. President, I ask unanimous consent to call up an amendment in the nature of a substitute, No. 1246, and ask for its immediate consideration.

Mr. BURR

Mr. BURR. Mr. President, as I stated earlier today, I will be back time and time and time again to help my colleagues, one, understand what bill is being considered this week in the Senate but, more importantly, the ramifications of doing the wrong thing. I think most Americans would agree that we should do everything we can to regulate tobacco products as relates to the youth of our country. By the same standard, I think that we have an obligation as Members of the Senate to make sure we don't in fact limit the choice of adults who choose a tobacco product. I believe that you don't limit that if you responsibly regulate the product. I believe you do limit it if in fact to make something fit you design a regulatory scheme that by default limits the future options adults might have. I left off earlier talking about the core mission of the Food and Drug Administration being to protect the public health by ensuring the safety and efficacy of pharmaceutical products, biologics, medical devices, cosmetics, and the food supply. God knows we have been challenged over the last couple of years with the food supply. Whether you talk about contaminated peanut butter or spinach in California, a number of things have come into play, and I think many of us would agree the Food and Drug Administration has been deficient in the area of food safety. As a matter of fact, the people now authorizing bills to dump on the FDA the responsibilities for tobacco were very critical of the FDA as it related to their food safety oversight, so it shouldn't shock any of us that I think they are misguided in where they have chosen to focus their efforts toward regulating this industry. Let me add to that the former--just recently former with the change in administration--FDA Commissioner's statements about this bill. The provisions in this bill would require substantial resources, and FDA may not be in a position to meet all of the activities within the proposed user fee levels. As a consequence of this, FDA may have to divert funds from its other programs, such as addressing the safety of drugs and food, to begin implementing this program. This is not something I have schemed up. This comes from the former Commissioner of the FDA, who says that within the framework of the Kennedy bill, the user fee levels alone may not be enough for us to set up this regulatory framework and, therefore, we might have to divert funds from other programs, such as addressing the safety of drugs and food to begin this program. Let me explain. To implement this program, it will cost $787 million a year--$787 million a year. I will propose, along with Senator Hagan, a substitute--that when HHS was asked to tell us how much they needed to absolutely fund that new entity to regulate the tobacco industry they told us they would need $100 million. So there is already an option on the table that allows us to take user fees from the industry to fund a $100-million-a-year program to regulate the entirety of tobacco; or we can choose to put it at the FDA, where we are basically going to do the same thing and the former FDA Commissioner said the $787 million devoted to user fees may not be sufficient to meet the regulatory requirements set forth in this legislation. It is actually a little bit worse than that, because the CBO stated that before the Kennedy plan can be implemented--which is paid for by a shell game of requiring military servicemembers to mandatorily participate in TSP, the savings plan, the 401(k) of the Federal Government--to pay for the program you have to come up with $200 million to kick the program off. You know, it is a catch-22. The Kennedy program can't even be implemented from the shell game of funding they have set up, but more importantly it is going to cost almost eight times more than if we were to regulate tobacco in a separate entity under the guidance of the Secretary of Health and Human Services--the same person who has the guidance of the FDA; the same Secretary. What we are going to propose is that we set up a new agency to in fact regulate the tobacco product, but not get it confused with other core missions, such as the safety and efficacy of drugs and biologics and devices. That would be a huge mistake, I believe. Let me, if I could, quote Jack Sullum's April 2008 op-ed in Reason Magazine in talking about the Kennedy bill. He said: A consumer protection bill that reduced competition, raised prices, restricted choice, blocked information, and made products more hazardous could not really be counted as a success. The act imposes new regulatory burdens and advertising restrictions. The compliance costs and reduced competition are likely to raise prices. The bill not only authorizes the prohibition of safer tobacco products in the censorship of potentially lifesaving information about relative risks; it gives the FDA permission to make cigarettes more dangerous by ordering reductions in nicotine content. Such a mandate aimed at making cigarettes less attractive to new smokers would force current smokers to absorb higher levels of toxins and carcinogens to obtain their usual doses of nicotine. According to supporters, this bill, backed by the biggest tobacco company, will enable the FDA to protect smokers from big tobacco. But who will protect smokers from the

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

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

Mr. BURR. Mr. President, I come to the floor because the Senate this week is considering a new regulatory bill for the tobacco industry and there will be Members who will come to the floor to say: We have tried to do this for 10 years. This is well past due. Well, in part they are right. This bill was produced 10 years ago. It has not changed. It is exactly what was produced. But let me try to fill in some history for the Members of the Senate. In 1998, we passed the FDA Modernization Act. I was the lead sponsor of that bill in the House of Representatives. We spent 2\1/2\ years developing a bill to modernize the Food and Drug Administration. Most Americans do not even realize what the Food and Drug Administration is. It is an agency in the Federal Government that regulates 25 cents of every dollar in our economy. It is what assures every American that when you go to the pharmacy and you get a drug, there is a Federal agency that has determined that drug is, one, safe, and, two, effective; or that when you go to a hospital or a doctor's office, and they take a medical device--maybe it is something that permits them to go inside your body without cutting you open--that device has gone through an extensive review by the FDA. In some cases, pharmaceutical products take up to 12 to 14 years for approval--the amount of clinical trials to prove safety and efficacy that we go through, not just on animals but on humans--but it assures every American that the gold standard in the world exists right here in the United States of America. We put manufacturers and their products through a test at the FDA like no other country does. As a matter of fact, when the European Union was created and there were efforts to try to harmonize our approval process in the United States with that of Europe, what we found was that Europe's adoption, then, of 15 countries was that they take any of the 15 countries' approval process. What we found in the United States was it was hard for us to find one country that had as rigid a requirement as the United States of America; therefore, we didn't harmonize. For that reason, there are drugs that are approved in the European Union that are not approved in the United States because they either haven't met the test of the FDA or they have chosen not to go through the test. The reason I share all of that with my colleagues is that for 2\1/2\ years, there were two focuses of those of us who worked on FDA modernization: one was to make sure we had an agency that could perform its task of efficiency, and two, that we did nothing to change the gold standard--the assurance the American people had that every time they got a prescription, every time there was a device, that the gold standard was intact, that it was safe and effective. It says on the FDA's Web site--and this is just part of their mission statement: The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our Nation's food supply, cosmetics, and products that emit radiation. For the most part, I think we would agree that we do set the gold standard on the approval of products. We do have some questions about the Nation's food supply. This body has taken up three or four different pieces of legislation because of the fact that the FDA has not had the preview process they needed, and because of that, there have been contaminated foods--some produced here in the United States, some things were shipped in from out of the country, but it was FDA's mission to make sure that did not happen. Well, when we passed that piece of legislation, we all of a sudden accelerated the application process, the review process of drugs and pharmaceuticals. In the next year, we approved 81 new applications because that FDA Modernization Act was in place but, more importantly, the gold standard was still in place. I wish to ask my colleagues, what are we here today to do? The legislation that is on the floor is to give the FDA the jurisdictional responsibility of regulating tobacco. I want my colleagues to think hard about this. The FDA's responsibility is for protecting the public health--well, tobacco is bad for the public health; it causes disease and it causes death--``by assuring the safety and effectiveness.'' Well, how in the world can you certify that tobacco is safe? It can't be done. So to say we are going to allow the FDA to become the agency of regulatory jurisdiction is to say to an FDA reviewer: We would like you to do this on drugs, we would like you to do this on devices, we would like you to do this on foods, and we would like you to do this on cosmetics and products that emit radiation, but when it comes to tobacco, we don't want you to hold tobacco to the core mission statement of the FDA. We want you to ignore that it kills people, we want you to ignore that it causes disease, and we want you to just regulate it based upon how Congress said regulate it. It is not making much sense to people who are listening. Why would you do this? You could find any agency or create an agency to do exactly what Congress laid out in law. But no, we are laying it out in law and we are saying to the FDA: We want you to take that on as your jurisdiction, as your responsibility. But what is the likelihood of this, that by putting this new burden on the FDA and surging reviewers who are currently working through applications on drugs and devices, working on food safety, and we surge them over to this new area of responsibility called tobacco, that we are going to put more junior employees working on applications of drugs? It might be the next lifesaving drug that is on the marketplace. It might be a device that is actually a device that is inserted into your body, and maybe a young reviewer either delays the approval of that device or that pharmaceutical or makes the wrong decision because the senior reviewer has gone over to do tobacco. Some will come to the floor and claim that tobacco has to be in the FDA. The FDA, since its inception, has never, ever regulated tobacco. We regulate it through what was the ATF, Alcohol, Tobacco and Firearms; the Federal Trade Commission has regulated the labeling; and the industry on its own eliminated most of the concerns the American people had when they had a master settlement with States years ago. We are going to be debating this for days. I am going to be down here frequently until this debate is over with because what I want is for the Members of the Senate and the American people to understand that it is not as black and white as what some people would come to the floor and say: Just give it to the FDA and let them handle the responsibility. Feel comfortable doing that if you are willing to jeopardize drug safety, food safety, and device safety because they can't prove the safety and efficacy of this product. As a matter of fact, the bill that is being considered by the Senate doesn't do anything to regulate existing products that are on the marketplace. Think about that. Think of all of the cigarette brands you see behind the counter. The Kennedy bill actually says they are grandfathered. You can't touch them. You have to allow them to continue to be sold. But to a new product, one that might be a reduced-risk product, meaning less harm to the user, the pathway to try to be approved through the FDA is impossible. It is estimated that without doing anything, we will have a 2-percent reduction in cigarette usage per year in this country. That is a statistic the CBO came out with. But if we enact this bill, according to the--excuse me, CBO estimated that it is currently being reduced at 2 percent annually. According to the Centers for Disease Control, smoking rates declined among Americans annually at 2 to 4 percent. Think about this: CBO says this bill will reduce cigarette smoking by 2 percent annually. CDC says we are currently reducing cigarette smoking use 2 to 4 percent in the United States. In essence, what CDC says is, if you do nothing, we are going to reduce it more than what this bill is going to do. Why? Because CDC--the Centers for Disease Control and Prevention--realizes that when you grandfather all of these products, where FDA has no ability to go in and say, do this, do that, what you are doing is you are locking in the American people. When you say to the FDA: Have this jurisdiction, but we are not going to give you any real way to bring reduced-risk products or reduced-harm products to the marketplace, all you are doing is assuring that people are going to continue to smoke cigarettes. The marketplace at least has brought smokeless tobacco into the marketplace, and through that smokeless tobacco, it has generated a 2- percent reduction in smoking. We can make the claim that smokeless tobacco is not good for the American people. It is certainly not good for our youth. But the statistics show it is not as bad as smoking. You don't have the degree of death and disease from smokeless tobacco. We will get into that because there are studies around the world, many of them done in the country of Sweden, where we find exactly that, that they have been able to reduce smoking drastically in Sweden by allowing new, reduced-harm products to come to the marketplace, and through the ability of the public to decide that they would like to switch, they have drastically gotten off of cigarette products. No, that is not the course we are going to take. We are going to take one that is typical Washington. We are going to pick an agency and we are going to say: Let's dump this responsibility on them, no matter what the cost is. We forget the fact that the FDA is the gold standard. It is responsible for protecting the public health. How are you protecting the public health when you grandfather every cigarette product that is currently on the marketplace to exist just as it is? How do you prove safety and efficacy? How can this be effective? We are headed in the wrong direction. As one of the authors of the 1998 act, this troubles me greatly because I spent 2\1/2\ years trying to figure out how not to change the gold standard, that balance at the FDA that assured every American that it had gone through a grueling process of review, that it had passed every test that had been set to prove safety and efficacy. Why would we jeopardize this? Why would we risk the fact that we might change this gold standard? These are the questions that are going to be asked over the next several days. They are questions I hope to answer for people, not with what I believe but with the facts, with the truth about what is going on around the world, why we are headed in the wrong direction, and why we can have an effective regulatory entity in Washington without jeopardizing the future of drug and device safety, food safety, cosmetics, and products that emit radiation. These are things we need to take very seriously. I will make this last request, as I see my colleagues are headed to the floor and wish to speak as well. I only asked one thing a week and a half ago of the committee members, and that was to read the bill. Well, the fact that attitudes haven't changed much, that we are on an accelerated pathway, I can just about assure my colleagues they didn't do what I asked. I didn't expect them to. I think the American people believe we read every bill before it is considered. I think most Members attempt to do that through staff or themselves. This is one that, quite frankly, had they read it, we wouldn't be here today. We wouldn't be doing what we are attempting to do. This is not about a quest of 10 years. In 1998, when we opened the Food and Drug Administration to do the Modernization Act, we opened the entire thing. Every Member of Congress had an opportunity to amend that bill in the House and the Senate at the time and to give the FDA jurisdiction over tobacco. No Member exercised that ability. So in 1998, there were no Members who thought it was important enough to put that responsibility in the FDA. We have seen steady reductions in smoking among adults and, more importantly, smoking among youth. Youths are always the ones we point at and we say we have to make sure we do this because children shouldn't have cigarettes. They are right. They shouldn't. That is why we have age limits and advertising limitations. Can we do better? Yes, we can. Let me assure my colleagues, I will offer a substitute that not only is effective regulation, but it will protect the gold standard of the Food and Drug Administration. It won't put in jeopardy what we have established as the most crucial regulatory body we have that controls or regulates 25 cents of every dollar of our economy. I don't believe that is responsible of the Members of the Congress. They have already made the mistake in the House. I hope we don't make the mistake in the Senate. We can come up with effective regulation but not doing it through the Food and Drug Administration. Mr. President, I yield the floor.

Mr. BURR

Mr. BURR. Mr. President, I rise today to speak on the pressing issue of health care in America. Millions of Americans go without health insurance each year. Especially during these tough economic times, many families are looking to Washington to fix the health care crisis in this country. This year, Congress is poised to make significant changes to our health care system. Ultimately, the American people want solutions that work. In that vein I am pleased to join today with my colleague, Senator Coburn, to introduce, S. 1099, the Patients' Choice Act. It will start to build a health care system that is responsive to patients' needs and conscious of their budgets. As we developed the framework of the Patients' Choice Act, we had to think about what would truly transform the failing health care system in America right now. Typically, the problems with our health care system relate to cost, quality, and our inability to make important lifestyle interventions before treatable symptoms become chronic conditions. With that thought in mind, Senator Coburn and I set out to reform our health care system so it met the following requirements. We believe that any truly transformational health care plan must guarantee that every American can get affordable coverage. It must demand more value for our health care dollar instead of imposing a new tax or passing on a new obligation to future generations. It must transform the health care system so that we focus on keeping people healthy and well instead of only treating them when they are sick. It must make health coverage affordable for those with pre-existing conditions. It must end the current discrimination in the tax code that benefits the wealthy and corporations but fails the poor and those who can't get coverage through their employer. It must ensure that health care is accessible when people want it, where people want it. It must be sustainable so that it will be there for future generations. We believe the Patient's Choice Act will meet all of these requirements. The bill focuses on 6 key areas: preventing disease and promoting healthier lifestyles; creating affordable and accessible health insurance options; equalizing the tax treatment of health care; establishing transparency in health care price and quality; and ensuring compensation for injured patients. S. 1099 transforms health care in America by strengthening the relationship between the patient and the doctor and relying on choice and competition rather than rationing and restrictions. In doing so, we can ensure universal, affordable health care for all Americans.

Mr. BURR

Mr. BURR. Mr. President, I rise today to speak on the pressing issue of health care in America. Millions of Americans go without health insurance each year. Especially during these tough economic times, many families are looking to Washington to fix the health care crisis in this country. This year, Congress is poised to make significant changes to our health care system. Ultimately, the American people want solutions that work. In that vein I am pleased to join today with my colleague, Senator Coburn, to introduce, S. 1099, the Patients' Choice Act. It will start to build a health care system that is responsive to patients' needs and conscious of their budgets. As we developed the framework of the Patients' Choice Act, we had to think about what would truly transform the failing health care system in America right now. Typically, the problems with our health care system relate to cost, quality, and our inability to make important lifestyle interventions before treatable symptoms become chronic conditions. With that thought in mind, Senator Coburn and I set out to reform our health care system so it met the following requirements. We believe that any truly transformational health care plan must guarantee that every American can get affordable coverage. It must demand more value for our health care dollar instead of imposing a new tax or passing on a new obligation to future generations. It must transform the health care system so that we focus on keeping people healthy and well instead of only treating them when they are sick. It must make health coverage affordable for those with pre-existing conditions. It must end the current discrimination in the tax code that benefits the wealthy and corporations but fails the poor and those who can't get coverage through their employer. It must ensure that health care is accessible when people want it, where people want it. It must be sustainable so that it will be there for future generations. We believe the Patient's Choice Act will meet all of these requirements. The bill focuses on 6 key areas: preventing disease and promoting healthier lifestyles; creating affordable and accessible health insurance options; equalizing the tax treatment of health care; establishing transparency in health care price and quality; and ensuring compensation for injured patients. S. 1099 transforms health care in America by strengthening the relationship between the patient and the doctor and relying on choice and competition rather than rationing and restrictions. In doing so, we can ensure universal, affordable health care for all Americans.

Mr. BURR

Mr. BURR. Madam President, I send an amendment to the desk and ask unanimous consent for its immediate consideration.