it's clear that this administration and f.d.a. itself are more than ready to take this on, and we just need to give them the law that will allow them to begin. in the bill we have provided everything necessary to take this historic step. a comprehensive and flexible set of new authorities and full certain funding. the final ingredients is the political will to do the right thing. for the first time in many we have final -- years we have got that too. it includes over 1,000 medical, public health, faith and community groups from aarp to the american academy of pediatrics. from the southern baptist convention to the islamic society of north america. it's supported by the american lung association, the american heart association, the american cancer society, the groups that are best situated to understand the damage caused by tobacco and to recognize that a renewed f.d.a. can and must take on this new authority. the diversity of support for this bill shows just how critical it is to all americans. tobacco does not discriminate when it

because you grandfathered it all in and forbidden f.d.a. from changing it to 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 2007, they can't be sold in the future because as i've discussed earlier, to bring a new product to marketplace, you have to make the claim that new nontobacco user would use the product. yet how can you make that claim if the same provision disallows you from talking to a nontobacco user about whether they would use the product or not? it is a catch-22. yeah, we create add pathway, but we also designed it in a way that you couldn't meet the threshold needed to have an application approved. so, very simple. point two of the burr-hagan bill does not give the f.d.a. meaningful authority to require changes in tobacco products. they are 100% correct. nor does h.r. 1256. as a matter of fact, not only does it not allow for changes, it legislates there can't be changes to products that were sold bef

now, we're going to turn to the f.d.a. and say, we want you to regulate the tobacco product so we take the gold standard of the f.d.a. now and apply it to tobacco, and now there is this inference that somehow the f.d.a. has said -- now, tobacco is a safe product. that is something we should not be doing. it's why i sought to create a separate agency rather than the f.d.a., creating a mission that is counter to their present mission. you see, if you use a cigarette and follow the instructions and you do that every day it will kill you. now, think about that? it will kill you. we don't want the f.d.a. to create some time of inference into society that somehow that it's ok. president obama stated on march 14 of this year that 95% of america's 150,000 food processing plants and warehouses go uninspected each year. wow. each year 74 million people in the united states are sickened by tainted food and about 5,000 die, according to the c.d.c. that's on food alone. then, with regard to drugs. i look forward to working with chairman wa

f.d.a. regulation were good in theory and practice, several things, including the f.d.a.'s competence in tobacco policy and science, it's public imimagine, it's fit with the tobacco file and its available resources and overall current competence argue strongly against giving it regulatory responsibilities for our nation's tobacco policy policy. this is a scholar. the f.d.a. regulation of tobacco need not be a public health tragedy, however. by bringing the crafting of tobacco policy into the light of day by taking it out of the hands of special interest and most importantly by keeping it away from the f.d.a., there is every opportunity to begin to create a policy that not only seasons the interest of non -- that not only serves the interest of smokers and nonsmokers but it is a policy that might really work. to senators of the united states senate, if you want a policy that really works, do not adopt h.r. 1256. consider strongly the merits of the substitute amendment which does focus on the public health of this country. mr. basham writes on a variety of topics and when he

both senator klobuchar and myself are cosponsors of the f.d.a. food safety modernization act, a bipartisan measure to enhance current food and drug administration authority to better protect our nation's food supply. whether produced domestically or imported, americans must be able to trust that the food sold in their grocery stores and restaurants is safe and secure. it is critical to ensure that the food and drug administration has the tools it needs to properly monitor and inspect the food that is consumed in this country. the f.d.a. food safety modernization act affords regulators the authority they need to better identify vulnerabilities in our food supply while maintaining the high level of food safety most americans enjoy and take for granted. the legislation calls for an increase in the frequency of f.d.a. inspections at all food facilities, grants the f.d.a. expanded access to records and testing results and authorizes the f.d.a. to order mandatory recalls should a private entity fail to do so voluntarily upon the f.d.a.'s request. the fo

and what this bill doesn't do is ban cigarettes or tobacco products or these new smokeless products. it is giving the f.d.a. new regulatory authority over these products in order to be able to inspect manufacturing facilities, over the warning on the package. and there will be warnings on the front and back. it gives them power over marketing claims. but this does not ban cigarettes or any other tobacco product. people can still buy them. host: the "new york times" says that tobacco will be -- mentsdzle will be studied. guest: mentsdzle is a really controversial issue. it bans a lot of other flavoring in tobacco products, but it did not outright ban men thol. it did give the f.d.a. that power to look and they're going to have a new advisory committee meeting. it's an issue because a lot of experts say a lot of younger people, a lot of minorities also prefer men thol cigarettes. and so there's a lot of debate about this issue. on one hand, if congress were to ban men thol, the people who prefer those cigarettes would no longer be able to get them and only the other cigarettes they don't prefer would be aven

f.d.a. commissioner at the time. and he said: the provisions in this bill were to require substantial resources in the f.d.a. -- and the f.d.a. may not be in a position to meet all of the activities within the proposed user fee levels. as a consequence of this, f.d.a. may have to divert funds from other programs, such as, addressing the safety of drugs, food, to begin to implement this program. this is not richard burr. this is the former commissioner of the f.d.a. saying that we may have to divert funds from other programs, such as, safety of drugs, food. you know, if the american people are given this choice, they would say uphold the gold standard of the food and drug administration. let me go to bed at night as i take that medication that my doctor prescribed and my pharmacist filled, and let me feel confident that the most qualified reviewer looked at that application, that they looked at the clinical trial data, that they made a determination that this drug was safe and effective for me. make sure that when i go to

she's reports play an important role in establishing the health of the programs and f.d.a.'s performance in carrying out the law. i want to make sure the agency is doing what it's supposed to do and that the fees really are paying for f.d.a.' f.d.a.'s tobacco-control activities. these reports will help do you say just exactly that. i've always stood against tobacco. the footing would have been better if changes such as my phaseout amendment to reduce tobacco use over a hundred years were accepted. i know how addictive it is. i didn't want to make it too short a period of time. i thought a hundred years was plenty reasonable. we didn't have a chance to debate that or look at it now and i actually introduced that a little over a year ago -- a little more than a year ago. it was as a new amendment then. new amendments have trouble getting traction except in new zealand. new zealand liked this comment, this -- this approach to stopping smoking and looked at it in their legislature. they even called it the enzi bill. of course, you have to realize that that's how it sounds and th

i'll also mention how this bill further burdens the f.d.a. and its core mission while at the same time the majority is talking about how the f.d.a. cannot protect the american people with regard to tainted food and adulterated and counterfeit drugs. i'll also like to mention that how this bill actually locks the marketplace to prevent innovation and competition. we are truly on the waive of of socialism in this country. so first let me refer to the first amendment. the kennedy bill directs the secretary of of h.h.s. to promulgate an interim final rule that is identical f.d.a.'s 1969 rule which legal experts across the political spectrum have stated would violate the first amendment. while these views should carry great weight, even more dispositive of the fact that the united states supreme court has also weighed in on various provisions of the rule finding them already unconstitutional. they have already ruled. yet we are going to put them right back in legislation. not very responsible. so before members get down here and start pounding their c

and promote. the reason that, madam speaker, if we just turn this over to f.d.a. like chairman waxman has recently just suggested and let them come up with these strategies, it's not going to be able to get into the hands of the american people because of the two-tiered standard that has been set in this legislation. i reclaim my time. the speaker pro tempore: the gentleman reserves the balance of his time. the gentleman from california. mr. waxman: madam speaker, i yield three minutes to my esteemed colleague from the state of minnesota, mr. oberstar. the speaker pro tempore: the gentleman from minnesota is recognized for tea minutes -- three minutes. mr. oberstar: i thank my friend for yielding, my friend and colleague of 34 years ago we entered the congress together. i do not propose to read this entire document, but it is the report of the hearings and committee report conducted by my predecessor in congress, john blot nick -- blotnick in 1957 on false and misleading advertising among a number of products and the failure of the federal trade commission to inter

and i think by providing for disclosure of all the ingredients of these products to the f.d.a. and, thus, to the american people, we can give people at least as much information as we can possible to make wise choices with regard to their use of tobacco or not preferably. it would require larger and more -- and stronger health warnings on tobacco products. this bill would also protect our young people and taxpayers as well. smokers will pay for the enforcement of these regulations through user fees on manufacturers of cigarettes, cigarette tobacco and smokeless tobacco products. nonstphoerbgs will not have to pay any additional -- nonsmokers will not have to pay any additional taxes or fees as a result of this bill. madam president, i hope this bill does some good. i think it will. but the key to reducing smoking is for individuals to make better choices and for our culture really to change, as it has already changed, when it comes to consumption of tobacco products. and i think about other examples over time where our culture has really changed to where we now do things that ar

it forbids the f.d.a. and 1256, even though it creates a pathway to less harmful products, it's a pathway that can't be met because one of the conditions of new products entering the marketplace is you have to prove that people don't today use tobacco products won't be enticed to use these products. but it also says in 1256 that you can't communicate with anybody in the public unless you've got a product that's approved. so i ask you, mr. president, how do you meet the threshold of proving that somebody that doesn't use tobacco products is not going to use this product if you can't communicate with them until you get the product approved by the f.d.a. i've come to the conclusion since nobody who is a cosponsor or author of the bill has come up with an answer to me, that it can't be done. so to claim that this is a public health bill, one would have to make a reasonable claim that these products are going to be available and maybe potentially products in the future. but what h.r. 1256 does is it cuts off the av

and died. under this legislation by empowering the f.d.a. to regulate tobacco products, we will not have to wait until the deaths and millions more americans to learn whether a so-called safer cigarette is really what it claims to be. the bottom line, we have an interest in making sure our constituents know the facts, all of them, before making potentially deadly choices. america must also be made aware of the dramatic health risks associated with smokeless tobacco. many still believe that chewing tobacco and snuff are safe alternatives to smoking cigarettes. this bill will require warning labels that indicates that smokeless tobacco causes mouth and gum cancer, serious oral disease and tooth loss. a few weeks of chewing tobacco can develop lucolasty of the cheeks and gums which is the formation of leathery patches in those parts of the mouth. one in 20 develop into oral cancer. the american dental association, who strongly supports this legislation, calls tobacco use the number one cause of preventable disease in the united states. should be

labeling changes, to artificially and unreasonably extend a company's patent protection, if we elevate the stature in the place of the office of generic drugs within the f.d.a. again, it was an obvious opportunity to do just that in a bipartisan consensus way as we debate and act on this major f.d.a. bill on the floor of the senate now. i'm sorry that door has been closed to us. i'm sorry we've lot that opportunity. it's a shame. but we need to move on that issue just as we need to move on reimportation now in the next few months, this year, in this body, and in the u.s. house. we desperately need important health care reform. we need savings in the system to make costs of the overall health care system more reasonable without sacrificing patient care; without telling seniors they can't get this treatment; they can't get that operation. these are commonsense achievable ways to do that by stabilizing the cost of prescription drugs. that's one of the most significant costs in our health care system with one of the most significant growth patterns. so let's act. let's act on reimportation, let's act on generic reform in a bipartisan way, acting for the best in

minute to my friend, the chair of the appropriations subcommittee on agriculture, rural development and f.d.a., the gentlelady from connecticut, ms. delauro. the chair: the gentlelady is recognized for one minute. ms. delauro: according to the army, 143 soldiers committed suicide in 2008, the highest rate since the army began keeping records three decades ago. after asking our men and women in uniform to sacrifice so much, the least we must do is ensure they get the care they deserve. this amendment, based on the sergeant john schultz military mental health improvement act is about making sure our troops receive adequate fre pre-and post-deployment mental health evaluations. they need to provide face-to-face screenings between a mental health provider and the veteran. within 120 to 100 -- 120 to 180 days after the soldier returns. a case manager will follow up. let me say thank you to chairman skeleton, his collaboration, his commitment to this issue. we have no excuse for failing the soldiers who have given this nation everything. let's give them long life, good health and quality care. mr.

f.d.a. 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've got the ability to do the surcharge it requires in putting it in the f.d.a. 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 1256 it reyates the resources to create the framework to create the personnel to regulate the product that have never regulated the product before. i remind you in the substitute amendment we set up a new harm reduction center under the guidelines of the secretary of health and human services, within the health and human services, the same place that the f.d.a. is. and when we asked the secretary of h.h.s. how much does it take to fund that? they gave us a number of $100 million a year. $700 million for the base bill, 1256, $100 million for this new center of harm reduction. overseen by the same secretary of health and human services. now, granted, i'll be the first to sa

food and drug administration to evaluate any health claims for scientific accuracy and public health impact. we give the f.d.a. the power to require companies to make changes to tobacco products to protect public health, and we require larger, stronger warning health notices on tobacco products. these are just commonsense reforms that will start to reduce the terrible toll that tobacco has taken on families all across this nation. the f.d.a. is the right agency to do this. it's the only agency that can bring together science, regulatory expertise, and the public health mission to do the job. and through a user fee on tobacco conditioners the bill gives the agency -- tobacco crngz the bill gives the agencies the money to needs to conduct its new responsibilities. this is a strong public health bill and it is a bipartisan bill. after more than ten years of effort, we have never been close to giving the f.d.a. the authority it needs to regulate tobacco. i urge my colleagues to resist any amendments that would weaken this bill or add provisions that might stop it from becoming a law. f.d.a. regulation of tobacco

so far, i believe it will be possible for us to accept their bill and send it right on to the president. we are talking about the f.d.a. tobacco bill. thank you all very much. [captioning performed by national captioning institute] [captions copyright national cable satellite corp. 2009] >> and the house should be gaveling in in the next 10 or 15 minutes or so. when they come back they'll have a vote on the republican motion to instruct conferees on the 2009 war spending bill. and debate ahead on u.s. aid to pakistan. you heard the speaker there also say that the house likely to consider a resolution later today on the house floor condemning the shooting that occurred at the holocaust museum yesterday in washington, d.c. while we wait for the u.s. house, a discussion on health care from this morning's "washington journal." you can contact us at twitter. here is a preview of president obama's trip to green bay today. this writer writing that when president obama touches down he will be landing in one of the highest value help communities in the nation. it has managed to control medical spending while steadily improving

and so, again, the f.d.a. with the authority to regulate the production and marketing of tobacco products is the most viable answer. our approach would also ensure that scientific expertise of the f.d.a. is applied to appropriately regulate tobacco. current smokers deserve to learn more about the products they consume. additionally, we must have much-improved marketing oversight so that children and adults are not targeted with false or deceptive advertising of a dangerous product. to that end, i was pleased to join with senator lautenberg in sponsoring legislation to end the fraud of allowing the tobacco industry to perpetuate the orwellian idea of the safer cigarette. the truth in cigarette labeling act was a bill senator lautenberg and i introduced to prohibit the cigarette companies from using the f.t.c. method for measuring tar and nicotine which has been found to be a deceptive method of presenting data on tar and nicotine exposure through smoking. thankful, the f.t.c. agreed to implement the lautenberg-s

f.d.a. bill currently before the senate, but actually acting on in that context. and so i have to say, madam president, as i speak about these two issues, i'm really disappointed we're not taking this obvious major opportunity of acting on a major f.d.a. bill to, again, not only have me speak, but all of us act together on the crucial issues of, number one, the re-importation of prescription drugs. and, number two, meaningful generic drug reform so that we get generics to market sooner as a lower cost alternative for american consumers. i want to touch on each of these in turn, madam president. madam president, i was glad to support my friend, the distinguished senator from north dakota, and many democratic and republican colleagues in introducing an amendment to the f.d.a. tobacco bill to enact comprehensive re-importation of prescription drugs. this is long -- this has long been an issue that has truly united in a sincere bipartisan way democrats and republicans, many democrats, many republicans have agreed on this. i think it's important at a time when, unfortunate

and the end of overeating, former f.d.a. commissioner, david kessler. and on "after words," from the garden of eden to today. recollection of 600 stories and talks to a are columbia university professor. we have the entire schedule and great new features and streaming videos, archives and simple ways to share your favorite programs. booktv.org. >> president obama was the featured speaker at last night's radio and tv correspondents' dinner. it was held at the washington, d.c. convention center and lasts about 15 minutes. [applause] >> thank you so much. thanks to all of you. have a seat. before i get started as the father of two girls, can i just say how incredibly impressive those three young ladies were. dad would be proud. to heather and all the others who have made this evening possible, thank you so much. it is wonderful to be here. i want to express my appreciation for the opportunity to tell jokes that weren't funny enough for me to use when we did this five weeks ago. [laughter] >> the jokes may not be as good, but neither is the guest list. [laug

it certainly is important on this bill and the functions of the f.d.a. concerning the importation of prescription drugs into this country. i believe the senator from north dakota's amendment and i would agree to a time agreement within an hour -- hour equally divided or half-hour equally divided and vote on it. but i think the american people ought to know whether we're going to be able to import prescription drugs into this country so to save them billions of dollars every year rather than take so much of their hard-earned money, especially retirees. mr. reid: madam president? the presiding officer: the majority leader. mr. reid: w we have been trying for two days to move forward on germane amendments. i have had several conversations with senator dorgan. i know how important he feels. i voted with him and you every time this matter has come up. and i would be happy, ace indicated here earlier, to work out some kind of an agreement on this. but at this time, until we get some ability to vote on the germane amendments, it just doesn't seem like the right

power, the authority to regulate the sale, production, and marketing of tobacco products particularly to young children. so for the first time, the f.d.a. will have this authority and put in place tough restrictions for families that for far too long have been absent when it comes to how cigarettes are market to their children. i'm sure my colleagues are tired of hearing me say over the last several weeks about the number of young people who start smoking every day. we've been at this matter now for about two or three weeks, considering the floor action as well as the action in the "help" committee, which is the committee of jurisdiction. you can do the math yourself. 20 days, 3,000 to 4,000 children every day starting to smoke while we've been deliberating this piece of legislation. needless to say, i don't know of a single person in this country with an ounce of sense that -- that wants that rate of -- of children beginning this habit to continue. i don't know of anybody with any sense at all who believes that our country is better off if day after daye

if we pass the legislation that senator snowe and i have introduced with broad bipartisan support that allow the reimportation of f.d.a.-approved prescription drugs by american consumers, it will require the pharmaceutical industry to reprice their drugs and to allow our consumers to have fair prices for the prescription drugs they take. and by the way, our legislation is actually a winner. it's a half -- nearly a half a -- a half a billion dollars, nearly $500 million in cost savings and deficit reduction. according to the c.b.o. evaluation. so the fact is, there's a lot of things we can do, and a lot of things that represent common sense. i know that some will want to put together a health care proposal that will look like a rubix cube, you know, with all kinds of moving pieces. it needn't be that complicated. i've just described some of the things that we can do that in my judgment represent common sense. let me make one more point. when medicare was started, medicare has been a very successful program. but when medicare was started, the fact is they established a base funding for medicare that represented the cost

and prescriptions are best. but it cannot be used to deny treatment or service. we obviously make an exception for the f.d.a., which has the bill in the food and drug administration which can say a certain drug is dangerous to your health. obviously that would be exempted from this prohibition. otherwise we say you can't ration health care with comparative-effectiveness research. the bill pending before the "help" committee actually creates an agency to use this research for that purpose. so there is a blatant attempt in the "help" committee to use this research to ration care. our legislation would stop that. and we think we ought to pass it now to instruct the "help" committee that we don't want that to happen. in the finance committee, it's more indirect. a private entity would conduct the research, but there's nothing to prevent the federal government from using the results of the research to delay or deny your care, to ration care. so for the bills that are being written in both committees, our legislation would provide direction that americans are not -- whatever other reform we have, americans are no

f.d.a. needs to say the drug is not safe and the federal government isn't going to pay for it. that's obvious. but the point here is that this comparative effectiveness research should not be use bid the government to deny, delay or ration care. the reason for it is, obviously, we all want to be in charge of our own health care with our doctor we want a choice. if the doctor says we think you need this kind of treatment, and we can get coverage for that from our insurance, we want to be able to get that care. if we can't, we want to find insurance that will provide that coverage. at a minimum, we want to be able to pay for the treatment, if nothing else. what we don't want is for the federal government to say it doesn't matter whether you're covered, you can't get it because the federal government says so. this is especially important if we have a government-run insurance company, which is what many on the other side of the aisle are talking about. the president has said that he wants a so-called public option so that there will be a government insurance company that will be a

f.d.a. approves a medical device that is it and there's going to be no tort suits and there's a bill here very strong to overrule that will create more costs than you can imagine and meanwhile, juries around the country, well meaning, redesign your heart monitor, redesign your catheter, or redesign everything, and they have absolutely no idea what they're doing. and there's a bill up here to do exactly that. medical screening timets sometimes work if they're staffed the right way and their results are told to a jury. it's not a total solution. eliminating double payment for the same injury can work, but usually in medical liability, it doesn't, because it's a right of resured or recover. i'll mention a simple reform. rewrote about it. it's in the outline. this is what trial lawyers do all the time. if you stop them, it will sure reduce those crazy, multizillion dollar settlements. trial lawyers more and more are using evidence of wrong doing, punishment, evil, they are very good at this. i did it for years. to lift up that pain and suffering award. what the defendant did or doesn't do has noth

and jay richards on why he thinks [inaudible] is the best way to end poverty. >> the end of overeating. f.d.ammissioner david kessler says americans can control their eating habits. much more books and author this weekend on book tv. the website has the entire schedule and great new features including streaming video. archives that are easy to search and simple ways to share your favorite programs. booktv.org. >> "washington journal" continues. >> nelson smith is the president and ceo of the national alliance for public charter schools. first up, what is a charter school? why have the populations grown over the last couple of years? guest: that is first of all a public school. it is a public school that is in lieu of a traditional school district. it is held through performance of a contract, which is called a charter. it is subject to the federal laws that other public schools are. they're free are to integrate for the high accountability, they can make quick decisions and move nimbly to serve the kids. as a result they're freeing to try things and try strategies that other public schools ca

have seen so far, i believe it will be possible for us to accept their bill and send it to the president. talking about the f.d.a. tobacco bill. thank you all very much. >> house republicans put forward their health care proposal on thursday. john bohner is joined by members to have group which crafted their plan. this is about 20 minutes. >> on every major issue addressed by congress and the white house this year, it is the american middle class that has take an hit from the trillion dollar stimulus bill to the fiscally irresponsible budget to endless bailouts. washington has asked the middle class to bankroll trillions in spending that we can't afford. now it appears that democrats are ready to lead us off the cliff again, this time with health care. we're here to engaged and be on alert for what congress is about to do to rush a health care bill through this congress and into law. they want to rush it through congress as quickly as possible so that no one will understand the implications of what's about to happen. president obama is in wisconsin today pushing for rough passage of a bill that is going to make

f.d.a. at a lower cost. that's what this is all about, mr. president. it's the special interests versus the american interests. and special interests, in this case, phrma, has won rounds one through nine. we won't quit this fight, mr. president, because the american people deserve it particularly in these difficult economic times. so, mr. president, we may be blocked on this bill. we may be blocked on the next bill. but we'll come back and back and back and keep coming back. my message to the other side and those at phrma, and we will succeed in allowing americans to acquire the much-needed, in some cases lifesaving prescription drugs at a lower cost to themselves and their families. that's what this amendment is all about. mr. president, i suggest the absence of a quorum. the presiding officer: the clerk will call the roll. a senator: mr. president? the presiding officer: the senator from nebraska. a senator: mr. president, i ask that the quorum call be set aside. the presiding officer: without objection. mr. johanns: mr. president, today i rise in solemn remembrance of the life of a fallen hero: sergeant justin

f.d.a. allowed to be marketed caused physical injuries. i was the lone dissenter in that case. wyeth v. lavigne involved drugs rather than devices, and the absence of a preemings clause in that statute -- pre-emption clause in that statute proved as positive. tort laws and the state law could be maintained the court held 6-3, claims for inadequate warnings on drug labels. caperton v.a.t. massy coal company came with a record resembling john grisham's novel "the appeal." the case involved a $50 million jury verdict in favor of caperton, who charged that the coal company's predatory practices drove him out of business. the west virginia supreme court, dividing 3-2, reversed a judgment for caperton and declared victory for the coal company. there was one problem. justice benjamin, who cast the deciding vote in west virginia's highest court, was newly-elected to the court. the coal company's c.e.o. had to defeat -- had spent $3 million to defeat the incumbent whose seat benjamin won. dividing 5-4, we concluded that benjamin's participation in the case violated capertop's right to due process. justice kennedy's opinion for the court, join

to preempt and therefore allow even more room for states >> just to elaborate on this very interesting -- the pharmaceutical labeling case. what really was the problem here is that the f.d.a. had long taken the view that a federal label was simply a floor, not a ceiling, and the states could regulate through their tort system within that. the bush administration changed that position in a preamble to a regulation, not through notice and comment, and made that the new policy. and justice stevens says in the wyeth opinion that this change is entitled no no deference under chef ron. it was really an extraordinary supreme court reaction to that kind of administrative lapse. >> there is one justice's answer to my question about deference. no deference. now, let's move on to an area, which is, of course, year in and year out a staple of the court's document. criminal justice cases, especially fourth amendment cases regularly appear. i thought for discussion of that, january crawford greenberg. >> thanks, dick. we have quite a few, obviously, as you would expect, fourment cases this term, as we do every term. those are in your materials. instead of just going over every single o

f.d.a. allowed to be marketed caused physical injuries. i was the lone dissenter in that case. wyeth v. lavigne involved drugs rather than devices, and the absence of a preemings clause in that statute -- pre-emption clause in that statute proved as positive. tort laws and the state law tort laws and the state law could be maintained the court held 6-3, claims for inadequate warnings on drug labels. caperton v. a.c. massy

and therefore allow more groups to regulate. >> quickly, to elaborate on what john said about this very interesting pharmaceutical labeling case, what really was the problem here is that the f.d.a. had long taken the view that a federal label was simply a floor, not a ceiling, and the states could regulate through their tort systems within that. the bush administration changed that position in a preamble to a regulation and made that the new policy, and justice stevens says in the wyatt opinion that this change is entitled to no deference under chevron. it was extraordinary to the supreme court's reaction to that administrative lapse. >> my question is about deference. no deference. now let's move on to an area which is year in an year out a staple of the court's docket, crim gnat justice cases, especially fourth amendment cases, regularly appear. jan crawford will lead the discussion on that. >> well, we have quite a few, obviously, as you would expect fourth amendment cases as we do every term. those are in your teerms, but instead of going over every single one, some are interesting factually but not that ground breaking. i will pull out a few that i think are ploafts intere

f.d.a. adopt standards in this regard. the the essential change is that it would apply to promotional labeling and print advertising. so it would not, as i understand it, beyond the bottle itself, but it would be the promotional advertising, the magazines, circulars, etc. this has been, again, agreed to with the ranking member. we do not intend, actually, to displace the decision of the f.d.a. essentially telling them to study this for a year. if they propose it, they have a year to promulgate the rule. i think this is entirely consistent with a reasonable approach to adopting this drug box. >> i thank the senator for working on this and i don't think that the current presentation of drug labeling is helpful. it is highly technical designed more for trial lawyers than for patients. i think senator reed is really on to something with the study and the report he proposed and i'm pleased we've been able to work out this bipartisan solution and been able to reach agreement on the provision. so i co-sponsored the amendment. no senator hatch has co-sponsored it as well. i want to thank them for working on this issue and c

f.d.a. is 100 years old. it creates a completely, on his bill, a completely new agency, a new and untested acknowledge to oversee tobacco products. the food and drug administration is the right agency, mr. president, because it's the only agency that regulates, has the regulatory experience, the scientific experience, and the combination of that with the public health mission. unlike the kennedy bill, which is the underlying bill we're dealing with here, senator burr's substitute fails to provide adequate resources to do the job, as well. in the first three years, senator burr's substitute would be adopted, unquarter of the funding that is allocated in senator kennedy's proposal of the underlying bill. in addition, the burr substitute provides far less authority to remove harmful ingredients in cigarettes that the weapon difficult bill would do -- that the kennedy bill would do. it does not go far enough to protect children from marketing and has less effective health warnings. i say respectfully to my friend from north carolina, the setting up or creating a whole new age, providing a fraction of the funding nec

leaves rule making to the f.d.a., the systemic risk council would leave most of the day to day rule making with the financial regulatory agency. but the systemic risk council -- and i understand criticisms of the council's approach today. we don't want to be debating at a moment of crisis. that is why it needs independent staff and resources. it would have the authority to review every bit of information that the individual day-to-day financial regulatory agencies possess, to require those agencies to collect information from the institutions they regulate. it would also have an independent staff capable of analyzing this data, understanding how the pieces of the regulatory system work together, and then at that staff level feed that information up to the council so we could identify weaknesses or caps within our system or potential systemic that might be arising outside the purview of the individual financial regulatory agency. the council would also have the authority to require the federal regulators to develop clear written plans for dealing with potential financial crises. in effect it would have the potential to ask any institution to come forward with a wi

and they're just as deadly. like cigarettes, they don't have any f.d.a. regulation, and the consequences are dire. i want to show a photo here of a young man named gruen von barons. he's an oral cancer survivor. he's had more than 40 surgeries to save his life, including one radical surgery, and you can see how it left him in this picture. it removed half his neck muscles and lymph nodes and half of his tongue. like too many teenagers, he first tried spit tobacco at age 13 to fit in. by age 17 he was diagnosed with cancer. how can we let this happen. the tobacco is targeting our children, and it's our job to protect them. this legislation is vital to our children and to our nation's health. it will prevent the tobacco companies from marketing to children. it will require disclosure of the contents of tobacco products, authorize the f.d.a. to require the reduction and removal of harmful ingredients and force tobacco companies to scientifically prove any claims about reduced risk of products. the f.d.a. is the proper place to have this authority. it's responsible for protecting consumers from produc

and it will give the f.d.a. the ability to make the cigarettes currently available less toxic and less cars know gentlemen nick and less add -- less carcinogenic and less addicting. for example, a study by david burns and christie anderson, both of the university of california, san diego school of medicine, suggest that cigarettes smoked today may double the risk of lung cancer compared to cigarettes smoked by americans 40 years ago. now that's amazing. remember all the unfiltered cigarettes of yesteryear? so you would think those cigarettes would be stronger, right? no, they're saying. they attribute this to a change in the chemicals which have been added in recent years to cigarettes. the researchers compared cigarettes in the united states with cigarettes in australia, and here's what they found. that cigarettes smoked in australia have a much lower level of a compound known as tobacco specific nitrosone ph*e s. it causes a type of lung cancer called adeno carcinoma. rates of this lung cancer are much lower in

preventive medicine and giving the authority to the f.d.a. to vigorously enforce strict new laws about gets is going to make a big, positive difference. so clearly i'm very proud to be here in support of this important legislation. i want to say again to senator kennedy if he's anywhere near watching this debate how much i respect, admire and miss his presence here on this bill. miss him. because if he was here he would be roaring from the back of the chamber. roaring at us. in the budget of ways. and challenging us to move forward on this bill as quickly as we can. the house has acted. once the senate acts, we can have a conference or, maybe, the house will take the senate bill and this bill will be on the president's desk before we do health care reform. imagine what a great preamble this would be to health care reform. taking this incredible rob thism in our set, tobacco use, causing so much suffering, so much dependence, so much addiction, so much cost, if we're able to tackle this as a preamble to our health care reforeig care reforo pro