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Senate Proceeding on Jun 3rd, 2009 :: 4:25:30 to 4:52:10
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Richard Burr

4:25:27 to 4:25:50( Edit History Discussion )

Richard Burr: supporting this commonsense legislation. and i yield the floor mr. enzi: madam president? the presiding officer: the senator from wyoming. mr. enzi: madam presi yield 45 minutes of time to senator burrment. the presiding officer: without

Richard Burr

4:25:30 to 4:52:10( Edit History Discussion )
Speech By: Richard Burr

Richard Burr

4:25:51 to 4:26:14( Edit History Discussion )

Richard Burr: objection. the presiding officer: the senator from north carolina. mr. burr: madam president, let me say to my colleague who had his constituent send him a letter and who served incredibly effective fashion the state's attorney general and

Richard Burr

4:26:15 to 4:26:36( Edit History Discussion )

Richard Burr: who was involved in the m.s.a. that the m.s.a. was very states extorted -- that's what i call it -- money from the tobacco industry to pay for health care money that was p master settlement was laid out behalf of the tobacco

Richard Burr

4:26:37 to 4:26:58( Edit History Discussion )

Richard Burr: industry to address the health care costs in those states but also to provide the resources so that those states fact, do cessation programs for adults to stop smoking. what's our experience in the country relative to the recommendations that the centers for disease control told those

Richard Burr

4:26:59 to 4:27:19( Edit History Discussion )

Richard Burr: states they ought to spend on programs to get individuals to stop smoking? well, in the state of new mexico, thief done very well. they've actually spent 44% of what the c.d.c. spend.

Richard Burr

4:27:20 to 4:27:41( Edit History Discussion )

Richard Burr: but i think you'd also find it shocking to believe that the prevalence of marijuana usage in that state is 1% higher than the prevalence of smoking the prevalence of youth marijuana usage is 1% higher than the prevalence of smoking cigarettes by youth. and in addition to that, i might

Richard Burr

4:27:42 to 4:28:02( Edit History Discussion )

Richard Burr: add that the prevalence of alcohol among the youth there is almost double what the usage is of marijuana usage. there are two regulating differently an industry that is currently the

Richard Burr

4:28:03 to 4:28:24( Edit History Discussion )

Richard Burr: most regulated industry in motor vehicle, and the sponsors of this bill have stated it numerous times. one, to reduce youth usage. death. that's the public health component. i agree totally with it. but i think what we have to look

Richard Burr

4:28:25 to 4:28:45( Edit History Discussion )

Richard Burr: at is the experience of what's happening today and what the assessments are of the bill that's being considered that would get -- that would give f.d.a. jurisdiction of this product. today the centers for disease control says that smoking is being 4%. the congressional dget office

Richard Burr

4:28:46 to 4:29:08( Edit History Discussion )

Richard Burr: has looked at the kennedy bill and assessed that over the next ten years, the bill would reduce consumption by smokers at now, let me say it again. currently doing nothing -- not spending billions of dollars, not giving new authorities to the f.d.a. -- we 4% per year.

Richard Burr

4:29:09 to 4:29:30( Edit History Discussion )

Richard Burr: but if we put this bill into effect and we give the f.d.a. authority and jeopardiz of the agency that approves drugs and biologics, medical device, food safety, we're actually not going to reduce smoking usage as much as if we did nothing.

Richard Burr

4:29:31 to 4:29:52( Edit History Discussion )

Richard Burr: now, why is it's he it's very important, because you'll hear me talk over the next several days about reduced risk products. reduced risk products products that deliver the nicotine need for the but reduce the

Richard Burr

4:29:53 to 4:30:14( Edit History Discussion )

Richard Burr: risk of disease because it may be from smoking products to smokeless products. the truth sunday the kennedy bill, we basically -- the truth is under the kennedy bill we basicay eliminate any product that was currently marketed in february of 2007. we put a marker in the says if there's a product that's on the marketplace that was not

Richard Burr

4:30:15 to 4:30:36( Edit History Discussion )

Richard Burr: sold in february of can't be sold anymore. but if it's a product that was sold befor f.d.a., you can't change it one bit. it's grandfathered. so what's c.b.o.'s assessment? what grandfathers every cigarette that was on

Richard Burr

4:30:37 to 4:30:57( Edit History Discussion )

Richard Burr: half years ago and doesn't allow the f.d.a. to the only thing it does is increases the warning which i stated earlier today, if putting a warning label on it reduces the usage of cigarettes, i'm willing to do it today. i'll c

Richard Burr

4:30:58 to 4:31:20( Edit History Discussion )

Richard Burr: but the truth is what this bill does is it locks in these products. therefore, it eliminates the choices that adults to get off of cigarettes and move to a reduced risk product. now, my colleague pointed to the supreme court ruling on the to

Richard Burr

4:31:21 to 4:31:41( Edit History Discussion )

Richard Burr: and he was partially correct. it's just he didn't tell the whole story. the whole sto was the court said in 1998 when the f.d.a. modernization act was written and passed and congress opened of the f.d.a. a, had the opportunity to give the f.d.a.

Richard Burr

4:31:42 to 4:32:02( Edit History Discussion )

Richard Burr: tobacco jurisdiction, and chose at the time not to do it. 11 years ago. 11 years modernization act was passed. i was the lead sponsor of that bill, writing that bill in the united states house of repr took two and a half years to construct it. every member believed that the

Richard Burr

4:32:03 to 4:32:26( Edit History Discussion )

Richard Burr: gold standard of the f.d.a. was so important tha focus of the fact that we had to maintain the integrity of the mission statement of but no member of congress ever attempted to extend to the f.d.a. jurisdiction over tobacco because theyere concerned at the time that to do that would

Richard Burr

4:32:27 to 4:32:47( Edit History Discussion )

Richard Burr: lessen that gold standard at the f.d.a. how can that's got a regulatory responsibility to protect the safety and effectiveness of those products that they regulate that we want you to do it on drugs and biologics and medical devices but

Richard Burr

4:32:48 to 4:33:08( Edit History Discussion )

Richard Burr: you to do it on tobacco? and the risks and fears at the time was this might diminish the f.d.a. what happened in we had a steady decrease in smokers. now we're going to adopt a bill that potentially locks us into just the products in 2007.

Richard Burr

4:33:09 to 4:33:29( Edit History Discussion )

Richard Burr: whyave 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

Richard Burr

4:33:30 to 4:33:50( Edit History Discussion )

Richard Burr: new tobacco product would not be marketed unless things were met: one, it can appropriate for the protection of public health. two, the that existing users of products will stop using such products. and, three, the likelihood that

Richard Burr

4:33:51 to 4:34:11( Edit History Discussion )

Richard Burr: those not will not start. well, let's take the first requirement and sort of 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

Richard Burr

4:34:12 to 4:34:33( Edit History Discussion )

Richard Burr: the use of a tobacco product is appropriate for public health? it's impossible. in other words, this new tobacco product, be it a cigarette, raw tobacco, perhaps an alternative tobacco product, the company would have to show that this new product is appropriate for the protection of public health. mr. president, somebody's going

Richard Burr

4:34:34 to 4:34:54( Edit History Discussion )

Richard Burr: to have to explain to me how a cigarette can be appropriate for the protection of public health. it can't be done. therein lies products before mr. president, even if by some miracle the inventor could show a product was appropriate for

Richard Burr

4:34:55 to 4:35:17( Edit History Discussion )

Richard Burr: 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. well, again

Richard Burr

4:35:18 to 4:35:39( Edit History Discussion )

Richard Burr: somebody will have to show me how you can of the tobacco product currently for sale that would satisfy these standards, that it discourages people from smoking on one, and it deters young people from starting. the bill's manager, the author

Richard Burr

4:35:40 to 4:36:02( Edit History Discussion )

Richard Burr: of the bill us exactly how you accomplish that. how does one go about spwhrelg the data that's needed -- assembling the data that's need for new products when in fact you can't actually ask consumers about a product that

Richard Burr

4:36:03 to 4:36:24( Edit History Discussion )

Richard Burr: has yet to approved. it's a catch 22. it sounds good. let me highlight another problem with the bill as it relates to the harm reduction. you've heard me discuss the harm reduction products, or products that are less harmful. aren't found in

Richard Burr

4:36:25 to 4:36:45( Edit History Discussion )

Richard Burr: i'm sure my colleagues are aware that the underlying legislation would ban several tobacco products. as i february of 2007. one of those products is a product called snoose. it's a swedish smokeless tobacco. it's pasteurized. it doesn't require one to spit.

Richard Burr

4:36:46 to 4:37:07( Edit History Discussion )

Richard Burr: it's a tool that in sweden has been used to get people off of cigarettes. it's still the use of tobacco products, but it meets the threshold of diminishing the risk of death and disease. and some suggest because a wintergreen and there's a spice, that this is attractive to kids. that's not the case.

Richard Burr

4:37:08 to 4:37:28( Edit History Discussion )

Richard Burr: if that were the case, we would see wintergreen marijuana, because the usage or the prevalence among youth is higher. the truth, that has nothing to do with it. as i und does not require the burning of tobacco. it does not require the actual smoking of tobacco. it generates no secondhand smoke.

Richard Burr

4:37:29 to 4:37:50( Edit History Discussion )

Richard Burr: 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 disease associated with smoking. why would you ban this product? the pretext of passing this bill

Richard Burr

4:37:51 to 4:38:11( Edit History Discussion )

Richard Burr: is to reduce the risk and disease. you wouldn't. but we elimi this product to come to market in the future and that that's at market today wean from the market. stpherdz, it's clear that the product is far less -- in other words, it's clear that the

Richard Burr

4:38:12 to 4:38:32( Edit History Discussion )

Richard Burr: product is far less dangerous than cigarettes. it eliminates secondhand smoke. it can move people away from sm it would appear to come close to meeting much of the standards of the bill. but the legislation still mandates the manufacturer

Richard Burr

4:38:33 to 4:38:53( Edit History Discussion )

Richard Burr: demonstrate that snoose will not encourage nonusers to start. well, again, i'm not sure how you communicate with public which is strictly prohibited in the bill until you have an app if you need to communicate with the public in order to understand if the product would cause nonusers to start for a

Richard Burr

4:38:54 to 4:39:14( Edit History Discussion )

Richard Burr: reduced product application, but you can't communicate with consumers until you have an approved application, how would you ever get approval under section 911? the devil's in the details. in fact, you can't communicate, but you've got to communicate to

Richard Burr

4:39:15 to 4:39:36( Edit History Discussion )

Richard Burr: be able to pass the third threshold of allowing a product to come to the marketplace. so it's disingenuous to suggest that this bill is 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

Richard Burr

4:39:37 to 4:39:57( Edit History Discussion )

Richard Burr: are at market today, they would be pulled from the marketplace. mr. president, it would fair to say that what we're doing is freezing the marketplace for in 2007 the "help" committee because this same bill was bught up. the answer i was told then was

Richard Burr

4:39:58 to 4:40:20( Edit History Discussion )

Richard Burr: that it may be difficult to bring a reduced risk product to market, bringing a reduced exposure product to market is much simpler. i said, okay, let's look at it. maybe a cigarette with less benzyne can work, reduced exposure section of --

Richard Burr

4:40:21 to 4:40:41( Edit History Discussion )

Richard Burr: portion of section 911. the language reads in the absence of 25-year study on tobacco products, that if you canhow a reduction in a harmful co can classify it as reduced exposure. but then in addition, those

Richard Burr

4:40:42 to 4:41:03( Edit History Discussion )

Richard Burr: pesky words pop up: additional findings. the reduced exposure language states 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's going to be used by consumers unless you can talk to consumers.

Richard Burr

4:41:04 to 4:41:24( Edit History Discussion )

Richard Burr: therefore, there is no such thing as reduced bottom line: the bill that's being considered to give f.d.a. jurisdiction

Richard Burr

4:41:25 to 4:41:45( Edit History Discussion )

Richard Burr: 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 introduced in over two and a half years automatically goes

Richard Burr

4:41:46 to 4:42:06( Edit History Discussion )

Richard Burr: off the marketplace. and the pathway through f.d.a. for any new technology that mi you might use tobacco in a different way that enables somebody to quit smoking and reduces death and disease, there's no pathway for it to happen because there is no way to communicate with the public

Richard Burr

4:42:07 to 4:42:27( Edit History Discussion )

Richard Burr: until you have an application. part of the application means you have to communicate with the public to meet the test that's been designed. you know this is typical of what the american people think about congress. that we say one thing and we do something else. and that's exactly what we're doing here. i'll offer a substitute with

Richard Burr

4:42:28 to 4:42:51( Edit History Discussion )

Richard Burr: senator hagan tonight, i believe. that substitute will bring full regulatory authority to an entity to regulate this industry. i'm not up here saying that we can't regulate it better than we do today. it is the most regulated produ in america. it is regulated by more agencies than any product that's sold today.

Richard Burr

4:42:52 to 4:43:12( Edit History Discussion )

Richard Burr: can w do it more extensively? sure. can we have better w labels? absolutely. can we be graphic in our description of what these products cause? certainly. but the question is: where is it more appropriate to do the regulation? i would suggest that creating a new entity under the secretary

Richard Burr

4:43:13 to 4:43:34( Edit History Discussion )

Richard Burr: of health and human services, where they have full authority to limit its advertising, to eliminate its advertising is a more appropriate place than to give it to the f.d.a., where their mission statement prove the safety and efficacy of all products that they regulate. but they can never do it on tobacco products.

Richard Burr

4:43:35 to 4:43:57( Edit History Discussion )

Richard Burr: to put it under the same guidance of the secretary of health and human also oversees the f.d.a. what is so magical about putting this at the f.d.a.? i'll attempted to do it years. it i

Richard Burr

4:43:58 to 4:44:18( Edit History Discussion )

Richard Burr: there, over time you able to outlaw this product. or you think. well, i go back to this chart from the c.d.c., the centers for disease c youth marijuana usage is higher

Richard Burr

4:44:19 to 4:44:39( Edit History Discussion )

Richard Burr: than smoking. don't think that just because you outlaw reduce this country's youth from using it. as a matter of fact, you may find out you've increased youth access. the way to do it is to take the money that the manufacturers gave to the states to use the mo

Richard Burr

4:44:40 to 4:45:03( Edit History Discussion )

Richard Burr: provide the cessation programs, to provide products that are reduced risk products that allow individuals to get off of garettes and to go to something that really does reduce death and disease. but if you pass this bill, if you pass the kennedy bill, that's not whate're doing much what we're doing is locking in

Richard Burr

4:45:04 to 4:45:24( Edit History Discussion )

Richard Burr: forever the 21%, 22% of american people that are?? going to in fact the center for disease control said if we do nothing, but 2016, we have reduced from 22% the smoking in% to 15-point 9%. we have actually reduce it had over six percentage points by doing nothing.

Richard Burr

4:45:25 to 4:45:45( Edit History Discussion )

Richard Burr: yet, we're getting ready, if we don't support the substitute to lock in a m us indefinitely into future 21% or 22% of the country's going to choose cigarettes as their means of tobacco usage. it means we're going to continue rate of death and

Richard Burr

4:45:46 to 4:46:06( Edit History Discussion )

Richard Burr: we but we -- we picked the strongest regulatory agency that we could to be in charge of the regulation of this product. tell that to a patient that's waiting for a lifesaving drug and the reviewer that was actually reviewing that application was moved over to

Richard Burr

4:46:07 to 4:46:28( Edit History Discussion )

Richard Burr: the tobacco section because this new responsibility they had made -- mated them take senior reviewers and get them over because they had to regulate this product on day one. te the individual in that's harmed because of mead device that should have never been approved that got through a system of safety and efficacy was no longer adhered to at f.d.a.

Richard Burr

4:46:29 to 4:46:50( Edit History Discussion )

Richard Burr: because they were asked to turn their back on tobacco and not prove that public health was imr important on -- was important on this product and then new reviewers didn't have to be as accurate on device. or will biological companies actually invest billions and billions of dollars to bring a

Richard Burr

4:46:51 to 4:47:11( Edit History Discussion )

Richard Burr: lifesaving biologic to the marketplace that ends or chronic illness? what if that 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 two days of markups on this bill when questions were

Richard Burr

4:47:12 to 4:47:33( Edit History Discussion )

Richard Burr: asked, the answers were ignored. because they were more interested in the speed with which we passed this than the accuracy of the policies that we put in place. since yesterday on facts. i've tried when i made a claim to com

Richard Burr

4:47:34 to 4:47:57( Edit History Discussion )

Richard Burr: the numbers, the c.d.c. is typically a credible source. the congressional budget office is usually a credible source. 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 on the senate floor and use to make our claims every day.

Richard Burr

4:47:58 to 4:48:18( Edit History Discussion )

Richard Burr: don't pass this bill. -- say is don't pass this bill. but they don't say something. tonight members are going to have an opportunity to vote for a substitute, a substitute that gives the same level of authority, that does away of advertising in total, that puts the same

Richard Burr

4:48:19 to 4:48:39( Edit History Discussion )

Richard Burr: so that people can not only read it in plain english, but see in detail. it just doesn't put it at the f.d.a. why? because i spent 2 1/2 years of my life trying to food and drug administration through a piece of legislation that we passed why did it take so long?

Richard Burr

4:48:40 to 4:49:01( Edit History Discussion )

Richard Burr: because the f.d.a. regulates 25 cents of every dollar of our economy. and when the american people go to bed at night they know if they take a drug prescribed by a doctor and filled by a phar hurt them. more importantly, it's probably going to help them. make them better. when they go to the doctor's office or hospital and they use a device, they know it's a

Richard Burr

4:49:02 to 4:49:22( Edit History Discussion )

Richard Burr: device that's been reviewed and that it's safe. they know that when they go the grocery store there's an agency called the food and drug administration that is responsible for food safety and what they buy and what they eat is actually not going to kill them. yet, we've seen instances over the last three years where spinach has snuck through and

Richard Burr

4:49:23 to 4:49:43( Edit History Discussion )

Richard Burr: peanut butter has and as we become a more global economy, what is made and what they put on it, means that the review of food safety has to b as stringent as everything else and the f.d.a.'s struggling today. the their job. the biggest mista make is give them another

Richard Burr

4:49:44 to 4:50:05( Edit History Discussion )

Richard Burr: product and say, regul and say, by the way, regulate based upo the same standards that you do everything else. but that's what we're doing. if you want to reduce youth access, usage, if you want reduce death and disease, vote for the substitute tonight. reject the base

Richard Burr

4:50:06 to 4:50:27( Edit History Discussion )

Richard Burr: if we do successfully done our job. if it, in fact, we fall preyo jeopardizing the goal standard of the this body will be back at some point, fixing a mistake that they made. and my onlyope today i won't be an american that loses their life about the actions

Richard Burr

4:50:28 to 4:50:49( Edit History Discussion )

Richard Burr: that we've taken. i'm already willing to concede that if the f.d.a jurisdiction, the authority, to regulate this industry, we're going to miss 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

Richard Burr

4:50:50 to 4:51:11( Edit History Discussion )

Richard Burr: likely to kill them. the statistics say that th's going to happen. ask yourself knowing that is it really worth risking that you migh at the f.d.a.? that you might lower the bar for drug ail approval or device approval? that we might actually slip on

Richard Burr

4:51:12 to 4:51:32( Edit History Discussion )

Richard Burr: food safety at the food and drug administration. i'm not sure that the risk is worth it. this is about our kids. vote for this is about the status quo, if this is about letting an outside group have a win that's fought this for 10 years because they're in some bat wl an industry, is it really worth it

Richard Burr

4:51:33 to 4:51:56( Edit History Discussion )

Richard Burr: for us to give them a win versus the american people? i don't think so. i encourage my colleagues, support the substitute tonight. reject the base b and suggest the absence quorum. the pr

Richard Burr

4:51:57 to 4:52:02( Edit History Discussion )

Richard Burr: will

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