it does -- does not pass safety and efficacy, it does not receive approval of the f.d.a. let me say it like i said it a couple of hours ago, mr. president, tobacco products are not safe. tobacco products cause disease and death. there is no way that the food and drug administration on their current mission statement can regulate a product they can't prove safe and effective. if you try to put a square peg in a round hole, you will have reviewers at the food and drug administration that say, you know, the gold standard is no longer important, because congress has legislated that it's not important. if i turn my head on tobacco products, i can turn my head on this medical device, because it doesn't look like it's going to be dangerous, and, you know what? all of a sudden something will slip through the crack. we're going to have a pharmaceutical product that will do damage, a device that will do damage because we have lowered the threshold that every product must meet to get f.d.a.'s approval. i'm not advocating for the f.d.a. to do nothing. we need to reduce death an disea

that would be based on value, efficacy and evidence to be able to inform. now i'm going to ask unanimous consent that the counteroffer that i propose which would say they're prohibited as being used as mandates for payment coverage or treatment and be considered for adoption. >> reserving the right to object and i do so and i will not object. i just want to respond if i can, and i'm sorry, i'm not keeping time on this debate and i want it to be equal and dire. i respect this senator greatly and i know we'll work together on this vote and i know you're going to win and we'll be coming back and trying to make some accommodation here. the difference between private insurance, i would tell the chairman and he knows this and medicare is that under medicare's balanced billing requirement, a patient can't even use their own money to get treatment that is prohibited by medicare. so even though you would want to do it and pay for it as a sort of a co-pay, with your patients you can't do it. so that's one of the problems. the other thing is this business of assuming

that would be based on value efficacy and evidence to be able to inform. now, i am going to ask unanimous consent that the counteroffer that i propose, which would say senators are prohibited from being used mandates for payment covered church treatment be considered for adoption. >> reserving the right to object and died will not object, i just want to respond if i can and i am sorry. i don't know who is keeping time on this debate and i wanted to be equal. i respect the senator greatly and i know that we will work together down the road after this vote and i know you are going to win and we are going to be coming back and trying to make some accommodation here. the difference between private insurance i would tell the chairman, and he knows this, and medicare is that under medicare's balance billing requirements the patient can't even use their own money to get treatment that is prohibited by medicare so even though he would want to do it and pay for it as a sort of a co-pay, with their patients to can do it so that is one of the problems. the other thin

in i support the mccain imminent but i don't believe people are worried about the safety and efficacy necessarily tools of the drug industry. >> i apologize if people thought my comments indicated. >> senator sanders. >> i don't often agree with senator mccain but he is absolutely right on this issue and i concur with what senator brown says. many years ago i was an hour away from the canadian border in vermont and was the first member of congress to take people over the border and i will never forget because we will with a busload of women dealing with breast cancer who did have a lot of money. the purchase tamoxifen a widely used breast cancer drug, this was 10 years ago, they paid one-tenth the price that they paid in vermont than in the united states. i will never forget with tears in their eyes, working-class woman struggling for their lives did not have enough money to buy medicine and they paid in one-tenth the price an hour from where they were living in the saint albans area in vermont. so i think there is little doubt in my mind that if we as a nation think we can eat fruits

quote, the security of the american people and the efficacy of the missile defense are not enhanced by continuing to put money into programs that in terms of their operational concept are fatally flawed. or research programs that are essentially sink holes for taxpayers' dollars. we would not invest in civil war era technology that doesn't work to defend our country. we would invest in the 21st century technology that does work and that is what we are doing. we should oppose this amendment. i yield back the balance of my time. the chair: the gentleman yields back the balance of his time. the committee will rise informally. the speaker pro tempore: the house will be in order. the chair will receive a message. the messenger: mr. speaker a message from the senate. the secretary: mr. speaker. the speaker pro tempore: madam secretary. the secretary: i have been directed by the senate to inform the house the senate has passed s. 962, cited as the enhanced partnership with pakistan act of 2009 nrning which the concurrence of the house is requested. the speaker pro tempore: the committee will

there are much more efficacious and easy to take. part of the answer also lies in the and in the stigma -- i can say this enough. ending the stigma associated with these disorders. that somehow seems to remain whether we call them severe mental illnesses where brain diseases or mental health problems or emotional disorders. we still seem to have a stigma and sadly while moving closer to the answer is we have a long way to go but i also want to say i think we've come a long way. i really do appear, i think that a lot of the efforts, listening to, him speaking to 7,000 young people, all the work that you all do, all the time, helps to educate and education displaces ignorance and fear and that is what we have to do this illness. and so i do think it is getting a lot better for this dittman is concerned. so to fight our scientific breakthroughs, the shame and years of nontank mental illnesses still do exist. said that is our challenge even though i think we have made a lot of progress and will continue to. as was mentioned when al becam

agency whose primary job is to determine safety of food and drug and medical devices as well as efficacy. as a matter of fact, many people have been tempted to buy prescription drugs, let's say, over the internet but not knowing where they were actually manufactured, whether they were actually counterfeit drugs. so there's not only the question of safety -- in other words, if you put it in your mouth, is it going to poison you. but it's also if you put it in your mouth taking it spefbgting it to actually be effective against the medical condition that you want. the f.d.a. is a regulatory agency that's supposed to determine not only safety of food and drugs, but also their efficacy. now there is a certain anomaly in giving the f.d.a. regulatory authority for something that we know will kill people and does, in fact, kill hundreds of thousands of people when used as intended by the manufacturer. but i think this is a step in the right direction. i think the world would be a better place. we'd all certainly be healthier if people chose not to use tobacco, and many have made that choice due

that they have the same efficacy of their counterparts in the u.s. all of that is in this bill. all of that is in this mccain amendment. all the commentary about fraud is commentary about fraud. that is importation outside the structure of law. by the way, i'm sure members of this committee understand there is a lot of fraud within the boundaries of the united states of america, cases that have occurred where the drugs that are delivered have been prepared in someone's garage and are simply not the chemo treatment it is supposed to be, but just a bag of saline solution with just a label on it. so the issue of fraud is neither bounded by the boundaries of this country and it is not about whether or not there is a structure. it is about the lack of a structure. so just as we have established a system within the united states to combat fraud, this amendment is about extending that structure and in the process restoring a coherent market so that the citizens of the united states can benefit from fair pricing of pharmaceuticals. it is ironic, and i think a point to dwell on, that man

every year, half of their efficacy passes away. they are not speaking american. once the nomination happen, and john mccain got it, republicans like to say the only win elections by being conservative. they always win presidential elections by appearing to be magnanimous, a kinder gentler america, to thousand points of light. it is never, i will shrink government and stopped work. -- stop war. it is a different part of the republican machine. it is what they say to each other. i talk radio hosts in cincinnati warm up the crowd at a john mccain event. he spoke the dreaded name barack hussain obama. that particular week in the campaign, the pundits had decided this was beyond the pale. calling him by his middle name was not correct. they took john mccain to task. john mccain said, i don't know this guy. he is just some guy from cincinnati. the next morning, this talk show host bill cunningham was on the today show saying what does he mean he has never met me? i met him three or four times. they told me to warm up the crowd. i knew it. i knew that the machine had de

extensive and arduous enterprises for the public benefit and for the people to be able to judge the efficacy of the programs. this office is set up in structured a certain way. it has various powers and duties given to it. the veto power was initially conceived as a way of defending the executive from invasions' by the congress of its constitutional rights. he used analysis to describe the various functions. he formulated a new understanding. when the president takes an oath of office, he is taking an oath that tries to reflect this understanding of the office. it is the only a oath as spelled out in the constitution. it encompasses more than the duty to faithfully execute block -- the law. if we were to be purely republican, we would say that is all the president should do, enforce the law. the constitution spells out the oath. it speaks of the duty to faithfully execute the office and preserve and protect and defend the constitution of the united states. our presidency was unique in its creation. there is not another one like it. it can be strong. he can also be weak. it is designed to do

there of memos that speak to the efficacy of waterboarding i would like to read them. >> i agree. i think that other issues -- [inaudible] >> i don't understand -- >> right. >> suck all the air out of the white house when i read it. >> so many things in there that i think that should be investigated. >> very well. you would be interested to know there's a chapter in the book that says all the 9/11 commission recommendations should be implemented. >> okay. >> not just that. i was always for it. never understood why the administration was an impediment and never wanted you to do your job. how can you fix things unless you know exactly what went wrong? always my view. john lehman is a friend of sorts. he has been on my friends often and i enjoy him. >> great guy. >> he invited me -- i had a crush on patrick. >> thank you. >> i think i have. marina has been great and it's a fun experience. i've done it before and i always ebb joy it. thank you. i hope you like it. nice to see you all. okay. >> i'll let you mingle. >> i'm going to go find chris. >> how are you, bud. >> is this a suburb

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're not going to do anything to restrict its access. and resources to effectively regulate tobacco products. incorporated in this base bill, 1256, is, in fact, a surcharge on the tobacco industry o of $700 million over the first three years to fund -- to provide the resources for the 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 serv

whose gold standard is to prove safety and efficacy on all the products they regulate except for tobacco, lower their guard and let something through that didn't meet the threshhold of safe and effective? i'm not sure that's in the best interests of america. i'm not sure it's in the best interests of the american people. my colleague from connecticut came to the floor and said the food and drug administration is the only agency that had the experience, the expertise, and the resources -- well, the commissioner of the food and drug administration said, i don't have the resources. 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 applying -- from reviewing the applications for new drugs, new biologics. it could be that somebody 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 the f.d.a. had never regulated and that commissioners of the f.d.a. told us they didn't have the funds. i'm not sure how clear we need this. i s

over again, including the same language, the same case examples and whatever, i'm puzzled by the efficacy of that. if it were appreciate debate or new ideas or different things, fine. giving me language on little pieces ever paper on which i'm going to commit the sacred fortunes and hest the united states for decades, this is not the way to go. we can't do this on the back of envelopes. so i'm for debate. i enjoy the debate. i love the interaction of the legislative process. but i think we havepppppp0 >> good evening everyone. if i could quiet the crowd please. i am john podesta, the center -- president of the center for american progress. it is a great honor to be hearing this panel. on behalf of the american constitution society, i would like to welcome all of you to tonight's plenary panel, which is entitled the levers of change, how progress is made in today's policy environment. i would also like to extend special thanks to all of our panelists who have been generous enough to donate their arrival time to participate in this discussion. we have several members of the administra

and getting our own message out but also a is very, very real concern and the other issue is the efficacy of the african government which the people of african stan government do not believe in and -- afghanistan government do not believe in and the best is to go local because the afghan people are more ikely to trust their local tribes and work with their governments than wind up with whatever a national government looks like, not to say we shouldn't make the national government there better as well. but balancing that going forward, how do you see the best approach to striking that balance. and the second question with regard to pakistan, this issue affects pakistan as well. in fact, there was a summary of that saying that the strikes, the drone strikes are actually fairly well thought of in the fattah because the people who live there who have been dealing with these psychopaths in their communities is in pakistan itself and where the people see this as a threat to their sovereignty and less likely to be supportive of us. but pakistan needs to learn counterinsurgency. i won't go throug

government that's -- whose responsibility for protecting the public health by ensuring the safety, efficacy and biological products, medical devices, nation's food safety and products that emit radiation, that it is impossible to take an agency that that's their core mission and give them a product where you ask them to ignore the standard that they follow on everything else that they regulate. i think the american people would say it seems reasonable to create a new entity to regulate tobacco. if for no other reason, if you didn't believe any of

is there a clear understanding of the efficacy and current status of agreements relating to the six party talks in the north korean nuclear program? in essence would any new negotiations be starting from square one? the united states and china have cooperated closely in the six party process about our priorities are not identical. with regard to north korea. while the united states is focus on eliminating north korea's nuclear weapons program, china's primary concern relates to regional stability. a point not lost on the north korean officials. given recent provocations have prospects for more concerted chinese actions been improved. facilitate the broadest possible basis moving ahead i encouraged the obama administration officials two actively consult with congress as they proceeded in developing a comprehensive north korea's strategy. i am joined with chairman kerry in welcoming our ambassador, nancy lindborg, and leon sigal today's hearing. we look for to there in size and hopefully their inspiration. thank you mr. chairman. >> thank you very much, senator lugar, as always they are tho

about, i believe patients and providers should better understand their care and be confident of its efficacybut never lose sight of the fact or of the basic understanding that medicine is simply not an exact science. we're all different beings and we sometimes need different therapies, some drugs work for some people, some work for others, some don't work for some people as well. there's a varability that affects their treatment outcomes and only within the confines of the physician/patient relationship should treatment decisions be made. we must preserve and protect that physician/patient relationship. what might work for one person or even many patients does not mean it will work for every patient. allows physicians to practice medicine without the fear of frivolous lawsuits and add more medicine through frivolous liability lawsuits. in my earlier life, much earlier life, i did some medical liability defense work, defending doctors and hospitals and nurses and health care providers, et cetera. and once they came up with the doctrine of informed consent, rather than the standard of practice

or her life but provides a way to kind of make sure that others can and do something that hasn't efficacious ending. >> you know why bill has been so successful and i had to dig out of it. [laughter] >> what we take a couple of questions in the audience. i don't know if there is a mike but of people are interested in asking questions. >> [inaudible] [inaudible] >> the question is about the use of media and identify the problems in defining these problems and why there is in better and more coverage really of these issues here. >> i think part of it is you have a culture -- patient privacy is important and i think the culture of their pre and psychology is the patient privacy are huge concerns and a creates among practitioners and a per. out deeply rooted sense of an aid for her personal privacy and packin spill over in terms of how much they feel comfortable because it is hard when you are a position to tell these personal finance because a lot of them here themselves and talk about them. so my guess is that could be a contributor and i think was interesting michael talked about the explosio

core mission is this: they're responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biologic products, medical devices, our nation's food supplies, cosmetics, and products that emit radiation. nowhere in there does it say tobacco, nor has it ever. as a matter of fact to lay person they would look at it and say: if there's an agency that's responsibility is to prove safety and effectiveness, for god's sake, you couldn't give them tobacco because they could never prove tobacco is safe. it kills. there's no dispute on that. but we're trying to take a round -- a round peg and put in a square hole. we're trying to find an agency that we think has punitive steps that they can take, but we're actually going much further than that. you see, not only is there experience or expertise at the f.d.a. to regulate tobacco, they're not. we're going to ask the f.d.a. to surge with their resource, with their personnel, with their expertise away from things like lifesaving drugs, effective medical devices, a responsibility to food safety at

difference but this may simplify the logistics of reaching kids in sub-saharan africa with more efficacious vaccines and also in the conflict affected areas of afghanistan and pakistan to get the job finished more quickly. you can see from this map the complexity of the situation we are facing. many countries are still affected with polio. very few districts in the world have polio as you can see. the challenge of these practices and outbreaks in west africa, with the range of new tools, political commitments, etc. i believe we can indeed accelerate the progress we're making to reaching all children and eventually eradicating this disease forever. if there is one last lesson i might close the presentation with, it is this one. if we have learned one thing, it has been that in this battle as in any, no plan is going to survive contact with the enemy, you have to constantly be revising it as necessary to reach the kids, which indeed we can as shown through this program. thank you. [applause] >> coming up on c-span 3, house hearing on regulating the insurance industry, particularly in the fina

while the draft legislation before us attempts to improve the safety and efficacy of the nation's food supply it appears a there is still a lot of room for improvement in am appreciative that we're having the hearing and i am hopeful that we are going to be able to work in a bipartisan way on this issue. i appreciate the majority's attempt to improve the food safety system, but i think that we all know especially those of us who are mothers, we know that you can't inspect your way to food safety. we know that this legislation is going to have to do more than be reactive. this legislation broadly increases the speed to authority to make it one of the largest federal agencies in the existence. my concern is the growth of bureaucracy and what is going to happen in and that bureaucracy and groce. what i do think is necessary and i think it is necessary that our system be at risk based, that it be preventative and take that approach, and that it attractively targets bad actors. it's imperative that resources are focused on high risk in a innovation and, however, this bill places undue burde

as secretary gates told our committee, and i quote, the security of the american people and the efficacy of the missile defense system are not enhanced by continuing to put money into programs that in terms of their operational concept are fatally flawed or research programs that are essentially sinkholes for taxpayer dollars. with all due respect, mr. chairman, i find myself here trying to rescue the missile defense program from its strongest advocates because all they want to do is spend money. we spent $120 billion over the last 10 years on missile defense. i'm a strong supporter of missile defense. but unless you have oversight, and unless you have an operationally effective system to protect against the existing threats and deploy those systems to protect our four deployed troops, the american people and our allies, it's just money after money after money. now, the advocates of missile defense that just want to spend money don't want to seem to deal with the fact that in this bill we authorize $1 bill to test, sustain -- $1 billion to test, sustain, and improve the existing system.

thanks having spent a few years doing this i've gotten good at realizing there hasn't been a lot of efficacy on the hill, consistent advocacy on disaster response and recovery and to the .1 of the things we have seen with the ready come emt initiative is i know the you are focused on hurricanes your constituency, that's your geography, that's one of the biggest threats that you face but over the course the last 60 days have a little bit of a shake in the los angeles region and we've had a scare from pandemic and the one recognition and the one thing i strongly encourage you to do is let's make this about the need for better capabilities to deal with catastrophic events particularly housing in respect of the cause is because the senator from illinois appointed out he's more concerned about tornadoes or whatever we are calling them or microbursts these days and we've got to make sure we are designating the argument with the people who are here. >> i will tell you what i am going to do because i want to support the white you just made on and going to call a hearing for earthquakes particularly

nor will but mere himerely judgment and must depes open the aid of the executive arm and even the efficacy of judgments. the court is to have judgment. a judge is to have judgment. not writing the law. in hamilton's view judges could be trusted with power because they would not resolve divisive social issues. that is for the legislature. short circuit the political process or invite rights which have no basis in the context of the constitution. now, i've long believed the judicial branch preserved its legitimacy with the public and has its strength with the public through refraining from action on political questions. this concept was perhaps best expressed by justice frankfurter, a steadfast democrat, appointed by president franklin delano roosevelt. justice frankfurter said -- quote -- "courts are not representative bodies. they are not designed to be a good reflex of a democratic society. their judgment is best informed and therefore most dependable within narrow limits. their special quality is detachment founded on independence. history teaches that the independence of the judiciary i

>> even if it were efficacious, i still think that it is completely wrong because it puts 100% of the cost of this social problem on the woman who's coming home from the hospital with a disabled baby who she's going to have to take care of for the rest of her life, with the woman who is coming home from the hospital with a disfiguring injury that she will carry for the rest of her life, the woman coming home from the hospital, coming home from the doctor's office, being told that she's dying of cancer because of a missed diagnosis. those are the people who are going to suffer when their damages for physical and emotional pain, suffering, inconvenience, physical impairment, mental anguish, i'm reading the amendment now, disfigurement, loss of enjoyment of life, loss of society and companionship, loss of consortium, et cetera, et cetera, et cetera can't be adequated ely compensated. why we have to put 100% of the cost on that woman, i don't understand and even if we did save millions in texas, guess who paid? >> i thank my colleague. this is an issue where -- there still is the issue of

of course the other issue is the efficacy of the afghan government which the people of afghanistan do not believe in. i think certainly the best approach there is to try to go local as much as possible. the afghan people are far more likely to trust their local tribes and work with their local provincial governments than they are to fly off on whatever the national government winds up looking like, not to say we shouldn't try to make the national government a little better as well. in balancing now afghanistan going forward, how do you see the best approach to striking that balance and with regard to pakistan, this issue affects pakistan as well. in fact, david kill cullen testified before our committee a while back. saying that the strikes, the drone strikes in the in a that are actually fairly well-thought-of in the fattah because the people who live there have been dealing with these violent psychopaths who have been running their communities. it's in pakistan itself and in afghanistan where the civilian population sees this as a threat to their sovereignty and therefore is less li

it is about the efficacy, and sometimes it is about what are the good stuff, not about to smile, but by approval. >> this amendment would not eliminate that. i would remind my colleagues there is one fact with medicare, if medicare denies the benefit, you cannot legally buy it with your own money. how many are aware of that? if there's a procedure to save my life and medicare says we don't cover the procedure, i am prohibited by law from spending my own money to buy that procedure. that is medicare law. so, not only do we have that preclusion, we are talking about now we are going to judge it in terms of age adjusted quality of life. quality and we are going to have somebody decide what the quality of life is. so, i would strongly ask you to it please consider something along the line of senator enzi's the amendment and i will make the point again. rediker it is denying a drug today in the procedure today that has great indications for certain people, but they decided it cost too much so we can't, you cannot have it. so, for five people are going to die this week because of medicare'

again including the same language, the same case examples, the same one ever, i am puzzled by the efficacy of that. if it were fresh debate, new ideas or different things, a fine and then giving the language of little pieces of paper in which i'm going to commit the sacred fortunes in honor of the united states of america for decades, this is not the way to go. we can't do this on the backs of envelopes. and, so, i am for debate. i enjoy the debate. i love the interaction of the legislative process, but i think we really have to say, what is full debate and what is just really running the clock? >> i agree. the meeting will stand adjourned until monday. [inaudible conversations] today the chairman of several key house committees discuss their drafted legislation to overhaul the nation's healthcare system. speakers include representatives george miller of education, charles rangel of grain the beans and henry waxman of energy incomers. from capitol hill, this is 40 minutes. >> i'm congressman george miller, chair of the education and labor committee and co-chair of the democratic policy com

own message out but also it is a very, very real concern and, of course, the other issue is the efficacy of the afghan government, which the people of afghanistan do not believe in. i think certainly the best approach there is to try to go local as much as possible. the afghan people far more trust their tribes and the local provincial government other than what the government winds up and not to say that the national government will be better as well but balancing afghanistan in going forward, how do you see the best approach in striking that balance? and the second question, you know, with regard to pakistan. this issue affects pakistan as well. in fact, david kilcullen testified before the committee a while back saying the strikes -- the drone strikes in the fatah are actually fairly well thought of in the fatah because the people who live there have been, you know, dealing with these violence psychopaths who have been running their communities. it's in pakistan itself and in afghanistan where the civilian population sees this as a threat to their sovereignty and, therefore, is less l

would fall under the state department and i'm wondering if you could comment on the feasibility and efficacy of such a corps and how soon we might see it? >> first thing, thank you for your service. there's been a lot of discussion where the civilians and there have been successive attempts within the state department to increase the number of field-deployable civilians who can get in the higher risk environment and do civilian jobs but in a more dangerous context. is eric here? i think he is somewhere. eric was the first aid officer in afghanistan. and he went out individually, you know, carrying a weapon, working with special forces patrols delivering all the aid capability of a normal aid officer but in a much more high risk environment. at that time he was probably a foreign antibody in the aid structure and people were very nervous about that. similarly, i know a number of state department officers, dan green, who worked in afghanistan who undertook some extremely dangerous activities to do the political reporting and get the sort of state department job done. but again, those guys were

hamilton called the expense of an arduous printer price for the benefit of the people to judge the efficacy of these programs. and so we see that this office is set up and structured a certain way and has these various powers and duties given to eds and even the veto power which was as originally conceived as a means of defending the executive against the haitians by the congress of what hamilton called the president's constitutional rights. in hamilton used to the following nouns to describe behavioral aspects of the executive decision come activity, the secrecy, dispatch, a figure come expedition. he formulated a new understanding and firmness. and so on the presentation of the oath of office is taking enough that tries to basically reflect this understanding of the office. it is the only oaf spelled out in the constitution and encompasses more than a duty to faithfully execute the law if we were simply to be purely republican about this we would say that is all the president should do, force the laws written. but that is not what they.com the constitution spells out this oath in this pie