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Mr. COBURN. Madam President, I wish to speak for a few minutes on the bill we are proceeding toward and to ask a few questions of the American public.
We have a bill that is going to regulate tobacco, and I am OK with us regulating tobacco. I do not have any problems with it. I think we should do it. What we should be doing is banning tobacco. Nobody up here has the courage to do that. It is a big business. There are millions of Americans who are addicted to nicotine. And even if they are not addicted to the nicotine, they are addicted to the habit.
But we have a bill, we are trying to do something positive, and we find ourselves constrained by our own shortsighted vision. We have an agency called the Food and Drug Administration. I have had a lot of experience with them. I manufactured medical devices in the 1970s and had several investigational new drug permits under them. I know the rigors under which INDs are managed and the care that is put forth by the employees of the Food and Drug Administration, as well as their advisory councils, as we go through that.
But if we go back and look at the charge of what the Food and Drug Administration is, the Food and Drug Administration is about safety and efficacy--``safety,'' meaning they are responsible to make the judgment that if we are going to approve this medicine or this device that is within an acceptable risk--there is always going to be down sides to anything they approve, but within an acceptable risk, in total, it is going to be better for the country.
In this bill, we allow existing tobacco products not ever to be eliminated. So we are going to take products that we know are not safe and we know are not efficacious and we are going to apply the resources of an agency that is having trouble meeting its demands right now, as well as meeting the demands of food safety right now, and we are going to take resources and put them there.
The first problem with that is we send a totally mixed message to the Food and Drug Administration: Your job is no longer about safety and efficacy; your job now is to warn everybody about the downside of tobacco.
We know that. What we have to do is stop new addiction. We know that. If we really want to make a difference in health and we want to eliminate dependence on tobacco, what we have to do is to stop the addiction. We have had all of these lawsuits through the years where billions of dollars have gone into attorneys' coffers, and about 40 percent of it has gone into, supposedly, stop-tobacco-use programs, and we are going to say to the Food and Drug Administration: Your job is about safety and efficacy, making sure that what it says it does, it does, and we are going to turn them into a different kind of agency. I believe that is where this bill is misdirected.
We ought to have an agency that does control tobacco, that does heavily regulate its advertising in terms of the warnings on the packages, in terms of limiting what young people can get to, so we can actually stop this trend toward addiction. But to do it in the Food and Drug Administration sends a mixed message: No longer is our job efficacy, no longer is our job safety; our job is to control advertising, we are going to control packaging, we are going to control and have them report to us on the contents of all of these thousands of bad products that are associated with tobacco, that are in tobacco--not just nicotine and not just the effects of the tobacco, whether it be inhaled or chewed or sucked on. The fact is, we are going to change the direction of the agency.
So what should we do? We should regulate tobacco. We should set up a way for us to do that which will effectively stop new addiction, especially among young people because that is where it starts. It starts with the young, and there are certain personality types as well as certain genotypes that, even with some of the medicines we have today, cannot wean themselves from the addiction to nicotine.
So why wouldn't we go another way? We have the Department of Health and Human Services, of which FDA is a part. Why wouldn't we create a smaller agency that is just about tobacco, just about regulating tobacco, so that we can see clearly--and we can also do it, by the way, for about a fourth of the cost of what it is going to cost to do it under the FDA. So for one-fourth of the cost, we can create a new agency within HHS that will be solely focused on this and this only, that will have one primary objective, and we will force and guide and direct and measure whether they are accomplishing their purpose. Instead, we are going to hide it in another agency that is struggling today.
We are at $400 million to get a new drug through the FDA right now. That is the cost of processing. That doesn't even talk about the research costs, but the new drug. That is just the cost to get it through the trials and get it through the FDA. We have all of these drugs today that aren't approved, that could be saving people's lives, because we can't get it through the FDA. And now, what are we going to place on the FDA? We are going to place the regulation of tobacco on the FDA.
Tobacco is not safe. In no way is it efficacious for any individual. Yet we are going to put a segment within the FDA and say: Run it the way you are running the rest of the business. It makes absolutely no sense to me. It doesn't mean that the goal behind this legislation isn't a good goal. It is. It is a good goal, but how we are doing it and where we put the control of this is totally counterintuitive.
I think if you would ask anybody in America, you want the people who are approving the drugs that are good for you to also control--why don't we put alcohol under them? Why don't we put the DEA under them, under the FDA? If, in fact, we want a controlling agency, then let's move it to the DEA--the Drug Enforcement Agency--or Alcohol, Tobacco and Firearms, right? Why don't we put it in ATF? We already have other agencies. But to put it in the FDA, when the total goal of the FDA is to approve new products for our benefit, our safety, and to cure health needs--tobacco creates health needs; it doesn't cure them. The only thing I know that it cures is if you get a wasp or a red hornet sting and you take some chewing tobacco and put it on the sting, it takes the pain away. I experienced that a lot as a young boy. My grand dad would pull it out and put that plug right there, and the pain would go away very quickly. That is the only efficacious thing I know about tobacco.
So I would just ask my colleagues to think again about what we are doing. Let's do the intent of the bill, but let's do it in a way that makes sense, that doesn't send a cross signal, and either put it into one of the other organizations we already have that is handling products that are bad for Americans--not products that are good for Americans--or let's put it into a separate agency where we can see it transparently and clearly.
I wish to make one other point. Inside this bill is the banning of any new nicotine products. I wish to tell my colleagues that is totally shortsighted. If you are a smoker today and we could get you off of smoking even though we still give you nicotine and we can do that through a new product, such as a dissolvable flavored lozenge, where we supply the nicotine addiction to your body but you are no longer creating lung disease, chronic obstructive pulmonary disease, bolus emphysema, or increasing your chances for heart disease and hypertension, markedly increasing your chances for lung cancer, if we could convert that to something that would satisfy the demand yet wouldn't harm the rest of your body--we ban that in this bill. We stop all positive movement through commercial products to create a nicotine source that is other than chewing tobacco or cigarettes or cigars.
So why would we want to do that, especially if, in fact, we could take these millions of smokers today who, most of them, their habit is--there are two addictions they have. One is the nicotine craving that actually hits at the intercellular level. It is called a nicotinergic interface in terms of receptors on certain parts of the body. If we could do that in a way that would allow us to put nicotine in there to solve it but not cause all of the other disease, why would we say with this piece of legislation that we are never going to let that happen? Yet we are. I don't understand it. We could do that in a way where that could be highly restricted to only people who had a prescription, where they were already nicotine addicted.
So there are things we are missing in here from a general health standpoint that are going to be very harmful because what we are saying is: You can use the nicotine patch, you can take some of the new drugs that work in the brain to relieve the nicotine addiction, but rather than supply something in a harmless way that has no other ill health effects--I don't understand why we would not do that.
So I would appreciate my colleagues considering my comments. I believe the FDA is the last place we ought to put this. I think we ought to do it. We ought to change some of the things on how we are going to do it. We ought to create a capability to have nicotine supplied other than through chewing tobacco or cigars or cigarettes so that we can take the effects of it that we know are very harmful today and lessen them for the citizens who are addicted to nicotine.
My hope is that we wake up before we pass this bill because what we are really going to do is we are kind of shooting ourselves in the foot. If we really want to stop and help those people who are already addicted and really want to prevent new addictions, then we have to allow for some of these new products, and we ought to do it at an agency that doesn't have purposes counter to what the charge of that agency is.
With that, I yield the floor to my friend from Oregon. I also thank him for being so kind to allow me to go first.
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