and only 13 parts and chile have fda labs. i hope my colleagues will forgive me but the close the fda in lab empire state of texas located in arkansas. in houston isn't the only import area and texas and cities like laredo is one of the largest block ports of entry in the world imports from mexico literally trailers, thousands of travelers on a weekly basis. it seems unwise and unsafe to have the lab for the empire state of texas hundreds of miles away in another state, the location of labs need to be evaluated and reports submitted to congress on whether the labs are located where they are most needed a. discussion draft allows fda to assess current lab locations and relocate labs as necessary and i like to hear from the fda on whether they have plans to evaluate current locations. congress also is to allocate funds to the building of more fda labs and employees to see the budget allocation of funds for laughs so it insures the food supply of any to build more labs in areas where food imports are arriving such as houston's of

provision that authorizes the fda to issue subpoenas in matters under fda's jurisdiction that are not part of a particular hearing or investigation of a specific violation of the act. there seems to be a fear that it will go on fishing expeditions constantly sending out burdensome on this their request for documents. how to address these concerns? >> well, i think that we have enough work to do without going on fishing expeditions. we would be seeking information and that would be of vital importance to addressing the tasks at hand. it would be of great value to have the ability to access critical information to inform the inspection process as well as to inform outbreak investigations and i think that if we are going to be able to really move forward to ensure the safety of the food supply, this is one of a number of tools that will enable us to really do when needs to be done. >> that is refreshing to hear because i have been pushing subpoena power for the fda for 10 years and to get a witness to agree by the time i got back to my office they would say that is not the official posit

is the fda concern about bpa? and what does the fda plan to do about those concerns? >> well, we are concerned. certainly i am aware of some of the study is that have raised issues in an animal populations in some of the information about bpa in many components of the food supply. we are starting to see activities at the local and state level in terms of action with respect to bpa and i would hope that fda could really be providing leadership on some of these issues of assessing and analyzing resco. we are taking another look at the bpa issue, the acting chief scientist of the fda has been asked to take the lead on this because, of course, this is a decision where we have to bring the best available scientific data to bear. we need to look at all of the studies and examined them. but it is an issue of great consequence for americans. as a mother as well as a physician, it's an issue that i think we need to look as seriously and afford to be able to come back with some reports from a serious look at is being taken and we expect that it is going to be a task for him ove

fda apply to raise three issues about section 105. first, the amount of resources required to achieve these inspection goals would far exceed even the historic increases in the president's fiscal year 2010 budget. moreover, it would be difficult if not impossible for fda to hire and train thousands of additional staff so quickly even while relying on inspections by state, local and other federal and foreign government officials. as a result fda encourages the committee to modify this action to take into account the operational and resource challenges involved. second, as we develop a new food safety system, fda will came better information to guide the agency's approach to inspection and oversight. it will understand where we must as bator frequently because of a higher risk of certain foods, facilities and processing is, and understand where we can protect public health without conducting inspections has frequently. as a result, fda was support flexibility to modify the inspection requirements based on the best available data on risk

however, when it comes to fda's food program, the shortfall in revenues is extreme or the fda's own science board told us that the fda is so starved for resources that american lives are at risk. we cannot realistically expect appropriations alone to provide sufficient resources to close that gap. the recent outbreaks have also taken a major toll on the food industry in the recent peanut outbreak, kelloggs alone lost $70 million. faced with such a dire situation i think it's reasonable to ask the food industry to chip in. robust food oversight system will provide a great benefit to industry by preventing future outbreaks and rebuilding consumer confidence. let me be clear, we are not asking industry to cover the entire cost of the bill or any single part of the bill like the cost of inspections. the bill establishes a set fee of $1000 per year per facility. fda's prohibited from increasing that the future years except to cover the cost of inflation. the bill simply asked industry to chip in its fair share. i also want to address another concern i've heard the presence of fda on forms. fda h

fda has the statutory authority now to regulate the fresh produce industry. we do suggest strongly there be a good coordination with the u.s. department of agriculture and education, enforcement and certainly one of the keys to implementing this bill will be an effective structure with fda working with usda and state and local agencies with compliance, enforcement inspections that needs to be strengthened but not a jurisdictional issue of competing authorities the. >> minder standing at the production level could agricultural practices are the primary preventative tool and mechanism for dealing with it at the production level. do use the perhaps updating or improvement on those agricultural practices standards as they apply to fruits and vegetables is important and is there anything hear that will prevent that from taking place? >> yes, sir, that is an extremely important part. the fda agricultural practices are called to be updated with this draft legislation. we support that as a baseline guidance. for those specific commodities which fda has determined a s

in working with the fda on this legislation, one thing was abundantly clear. the administration is absolutely committed to overhauling fda's food safety program. i think we'll all see that commitment today when we hear from commissioner hamburg. the recent food outbreaks have exposed glaring holes in fda's basic food safety authorities. fda does not have routine access to any records kept by the food manufacturers. fda cannot require companies to conduct a recall of unsafe foods. the agency could only ask

the recall is no small issue both in terms of resources and efforts on the parts of the fda and also implication on industry and consumers who want access to those products. it is an area we would like to work with you on four language. we would not want it to be to overwhelmingly prescriptive because you want the flexibility for the potential emergency situation to move forward. >> i agree. this is an area we should look at because we know the ramifications of a recall. the extent and fault and certainly we want to have a balance of protecting the public verses undue expenses to companies as well. ironclad to see that at least is an area that you would be willing to talk about. i might also say the same thing would apply to the access of records. there really is no standard at all in this bill but on the senate bill if the fda has a reasonable belief it prevents a threat of serious adverse health consequences or death the fda would have access to copy all records and so forth and so forth. under this bill it appears the fda would have blanket authority to request any records at any

host: du think it is of to the fda to relate -- do you think it is up to the fda to regulate tobacco? caller: yes. it should be done. i am so glad it is done. i hope the president does it as soon as possible. host: our next call is from sarah on the democrats' line from right here in washington, d.c. caller: i would just like to say that i think, indeed, the fda should regulate the tobacco industry. tobacco has called -- has caused serious, serious health problems in this country from second-hand smoke and from those who actually do smokeless cigarette. -- who do smoke the cigarette. i know people that smoke the pipe, the cigar, and they do not inhale. but the cigarettes are just absolutely -- they have to be controlled. people have died in my family from cigarette-related illnesses, and something has to be done. i do not know if -- it has got to be maybe the chemicals and the other garbage in, garbage out that is placed into the tobacco. but something seriously has to be done, and i appreciate that, you know, people are recognizing this now, and the fda -- they regulate everything el

obama for doing this, and the fda. it's about time. it's probably 30 years too late but thank god they've done it. host: buffalo, new york on the democrat line. caller: good morning. i don't know if you've ever been a smoker. i have. many other listeners this morning who have been smokers in the past have found it a living hell to attempt to give up cigarettes after they've been smoking them. the reason for that, as you know, is the addictive drug which many scientists say is ever bit as strong as heroin. my question is this. i assume congress will pass this and mr. obama will soon sign this giving this the fda authority to regulate the context. my question is this, this is the real $64 question americans should pay attention to. will obama direct the fda to regular the amount of nick owe teen in cigarettes. if that nicotine was reduced, americans could kick the habit easier and perhaps we could faster arive at a smoke-free america. guest: you raised a couple of good points. one being, you are right, this bill doesn'to+3 ban nicotine

they'll argue fda doesn't have the resources to ensure the safety of imported drugs, but let's be clear. the almighty pharmaceutical industry's real concern is competition. any claim that imported drugs will be dangerous is inaccurate. safety of imported drugs is of utmost concern and this would require drug wholesalers to register with the fda and institute strict safety requirements including manufacturing site inspections. additionally the amendment requires chain of custody rules to ensure only authorized persons handle any medications. the amendment would provide the fda the resources and authority it needs to ensure the safety of imported drugs and to stop illicit sales. mr. chairman, i don't know whether this amendment will pass on this bill, particularly since we, i think it may have some additional urgency given the fact we are trying to find ways of paying for the universal health care or making health care affordable and available to all americans. i have watched the pharmaceutical industry and pharma and their powerful lobby block it in the past. they may be able to do so ag

they give the rod dated to the fda said the fda can analyze it for themselves because the fda does the interpretations done by drug companies are not of interest to them but their problems with the rod data. there been a number of scandals were physician seven roll patient's essentially to look away when they are sending in results. within of turmoil, it would think industry would want this. the model is not a bad model. it is bureaucratic and-- when the company once a drug tested or chemical tested they say the agency will say this is what it will cost you and the agency will find independent scientists to do the studies. that is a big step toward but certainly it is a discussion we are having now that ten years ago would be unthinkable and there been a number of editorials in leading medical journals calling for this because the editors are so furious about essentially what they see as being lauded to buy the drug companies. as the scandals continue i could see how there would be some industry acquiescence especially in the drug industry where you do want the best information and com

the government knows-- biax was approved by the fda in 1999. when you go back and look at this you can see in the early days the for studies that were done led them to conflicting interpretation but not so conflicting when we look at independent scientists disagreed with mark scientists. benchley the truth was reached because in this case the for studies involving biax involve comparing biax to leave ornack person because essentially they were done as a painkiller, but later study was done comparing biax to a placebo because it was assisted to see of biax traded call on polyps. so, at the very beginning, this is 2001, the journal of the american medical association published a review by three respected cardiologists to look that the data and said look, it is pretty clear the patients taking vioxx had more than twice the risk of heart attacks as the ones taking a leave. powerful findings. merck scientists working not just for mark but paid by merck and working some of the major medical centers replied, no you conducted the studies to different w

voted 79 months amateurs in the affirmative and 307 members of the house of representatives in favor of fda regulation of tobacco. there are people here, i can't name all of you who spent much of your adult lives working on this and my hat goes off to all of you. thank you for what you have done. [applause] let me tell you the journey tobacco took 15 years since the day we started it took 15 years to get where we are, and along that path it's a long time and but if you're unwilling one of you in the audience i still remember to this moment we went around the table and i asked people what they thought and you heard what you would expect to hear, it's the big money, it's political suicide. yes, it's the right thing to do. but if you do with its quick to take all the energy and everything you have and then one of you looked at me and said if you're willing to take on tobacco i'm willing to spend dressed of my career working on this. that taught me more than anything else one could imagine. and along the way in the 15 years you will excuse me but we had the opportunity to do a couple of other t

fda is stepping up -- fta is stepping up six different programs. together, they will serve no fewer than 695 grantees with the potential of 1300 separate recovery act grants. these grantees exhibit drastically different levels of strength, staffing capacity, and range from the largest rail system that serves more passengers annually than amtrak to the smallest world transit providers that may have a flight of three or four minivans. florida's dot plans to use the money to construct a greyhound -- it will provide improvements to safety to the environment and economic benefits. by contrast, in south carolina, the government plans to support its "united we ride initiative. it will have a travel coordination center. it is focused on rural residents and the elderly and helping them get the medical -- get to medical appointments and elsewhere. reaching the challenge of reaching all that -- given the challenge of reaching all of the grantee's, we have put the funds to work. we are using website, whether dinarweb diinars, and sometimese get on the phone to

let's ask fda first identify cost benefit because resources are finite. >> my time has expired but i really hope all of you will come in and work with us on this trace ability when gray's because from the very days of working on this issue you are saying my view which is we need to have trees ability throughout the industry but we cannot have a one size fits all trace ability system or technology the key is to be interoperable so if you have peppers and tomatoes and mixed in a salsa that is one level of complexity but if this also is incorporated in a process food, that is another layer then put into a restaurant or any place that is another layer. we have two work on that. i am amazed we do have the technology we just need to work on it i hope you work with us to improve the language. thank you for your indulgence mr. chairman. >> i had to take a deep breath because mr. mathisen and chairman dingell, we have tried -- tried to educate the committee with the electronic pedigree with regard to drugs now there is an interest to do something expansive with pedigree with food is so stop a

of products, why in god's name cannot import prescription drugs on the very heavy regulation of the fda whose job it will be to say any product comes into this country has to pass the highest safety ratio. of course, we can do it in if we do it will lower the cost of drugs for the government for millions of american people. now i would say strongly support this amendment and hope we can pass and now appear know i think mr. chairman you can correct me if i am wrong but majority leader read indicated this would come to the floor of the senate -- a couple weeks ago it was taken out, so i think we will have another shot on the floor but i hope we could pass it today. >> mr. chairman it without the more careful safety language in there i can to vote for it. the examples always given of the safe low-cost ones are people that shoveled up to canada and bought their drugs in person. the difficulty is with the people that get them through mail-order and if you think that you are going to a lincoln canada and getting the pharmacist in canada chances are much better than you are getting a pharmacis

i have a particular concern with fda. we have a measure which congress has twice passed legislation to direct the fda first three initially change the law then we pass legislation to direct fda how they are scored into which projects go and never e merge and we feel strongly house and senate the measures are not being followed. two questions since the president is proposing a status quo continuation of the bush era policies across the board for 18 months, what will we do about the cost effectiveness? and then i hear bizarre rumblings from the secretary that someone has a bright idea for some new cost effectiveness measure that would be applied to all transit and highway projects whenever that might be they could not explain that concerns me because we have never managed to get rid of tease of and get the fta to follow the law with the existing process in the agency now we're hearing that is the one policy change they want to add another bureaucratic step in the process but not reform anything else. we have some concerns a

just a general note and then a question about your time at the fda if you wouldn't mind. i think a lot -- i appreciate you talking abut the symptoms and not just the problems but if i could add a caveat i think a lot of this is about loneliness and foreigners have come and written books about america, [inaudible] robert frank referenced the loneliness and america and i'm wondering what this is rhetorical, not free to necessarily answer, but in society no other society in history has been founded just on the individual and i think it's the pressure the average american has put on to solve regulate is unheard of in human history including comparing modern day other societies. and having lived outside this country allot over and over again you hear as other societies pick up the fourth and fifth gear lifestyle the fast food -- the value of efficiency versus nurturing human relationships which is usually food brought us together but in this land efficiency value in other words it is a basic biological thing called food as opposed to nurturing part minds, convert mess and a lo

it would provide the fda the resources and authority to ensure the safety of imported drugs and stop illicit sales. i don't know whether this will pass on this bill particularly when it may have some additional courtesy given the fact we're trying to find ways of paying for the universal health care making an affordable to all americans. i have watched the pharmaceutical industry and a powerful army and they may be able to do so and again, but i have been around this kind of issues where we taken on the special interest for a lot of times over the years. we will do what is right in the long run. maybe not in this committee or on this bill but as some point in time because it benefits the american consumer and 50 percent of the american people that have to take prescription drugs everyday and to their benefit and sooner or later they will prevail. with that i know we will go to the same discussion and i would request a recorded vote on the amendment but i also wouldn't take too much of a time because we have a ventilated this in the past. >> i presume this is the same amount offered a

this bill for the first time will allow us to step up and require fda regulation of tobacco products. that is a great accomplishment for the people of the country and i'm grateful to the colleagues. madam president, i know the absence of a quorum. >> madame president? >> will the senator quote is the quorum call? >> i withdraw the request. >> senator from illinois. sorry, senator from north dakota. >> madame president, the senate is not in order. >> the senate will be in order. senator from north dakota. >> madame president i asked senator durbin be recognized following my presentation. >> without objection. >> madame president i just want to compliment senator don for his work on this bill and senator enzi and so many others. i want to make sure the record notes something we just agreed to today. symbol wondered what has happened to the legislation i indicated i would offer on this piece of -- on the bill of which we had a cloture vote. the real importation of prescription drugs. now, i intended to offer on this. i have received from the majority leader a commitment that put on the c

in a project to a the reforms that occur if the fda authorize legislation over the last 50 years have all been driven by concerns about children when children have been killed eventually congress says we need more legislation. we do not care is much about workers unfortunately. we have had some scandalous examples the last few years of worker exposure uncontrolled that i read about one chemical but has killed or crippled dozens of people in microwave popcorn factories we could not get osha to protect them even the popcorn industry to take it seriously there was one case of one consumer that was brought to the public's attention and i was on good morning america then it became a major issue this man has damaged lungs but not as badly as the workers and every major popcorn company has removed this chemical from the flavoring of microwave butter popcorn. we need to focus on workers they are the canaries. they get a lot of exposure first. we will never be able to do the studies to that see the effects of breathing chromium of people that live near the factories but we have to go into the

[applause] we have our fda commissioner, dr. peggy. we have our cdc director, and we have some extraordinary members of congress here on stage, senator dodd, senator bourbon, senator harkin, representative waxman, rep christiansen, and rep platz, all who did a big part to move this legislation forward. [applause] i want to thank all of them. there are three members of congress that i have to especially thank, representative waxman, representative dodd, -- senator dodd, and most importantly, senator ted kennedy who cannot be here today. [applause] and the legislation i am signing today represents a change that has been decades in the making. since the middle of the last century, we have known about the deadly effects of tobacco products. more than 400,000 americans now die of tobacco related illnesses each year, making it the leading cause of preventable deaths in the united states. more than 8 million americans suffer from at least one serious illness caused by smoking. these health problems caused us all more than $100 billion a year.

it is a big step for the fda to regulate tobacco. guest: susan ferrechio, we will check back in with you in a bit. the new york times has an article about posting bills online before the president signs them. the white house changes the terms of a campaign pledge about posting bills online. obama during the campaign promise that once the bill was passed by congress, when there is a bill that ends up on his desk, you the public will have five days to look on line to find out what is in it before it i signed it, so that you know what i am doing. five months into the administration, mr. obama has signed two dozen bills but has never waited five days. on the recent credit card legislation, he would do just two days. there's watchdog groups were repeatedly failing to live up to the pledge, the fact checking arm of the st. petersburg times has branded it a promise broken. grand rapids, mich. on the independent line. caller: i am calling in regard to a standpoint from a college graduate last may. i am calling because i feel like everyone is

they are called fda. those washington bureaucrats are called the institute's of medicine. i do not happen to think they are washington bureaucrats. i happen to think they are very capable research people who devote their life to try to come up with evidence that would support initiatives that could save lives and improve lives. could we get off of this washington bureaucrat stuff? i am beginning to find it offensive. i have represented people who work at the national institutes of health. i represent people who work at at the. they are doing their best -- at fda. they are doing their best to save and extend the lives. he gave the example above virtual colonoscopy. where do you think that came from? that came out of government sponsored research so that the private sector could value from it. when we talk about how we are the latest and greatest, we are the top five of medical expenditures in the world, but we are in the bottom 37 in terms of health outcomes. the whole idea of what is coming out of the effectiveness is to enable more evidence informed to occur. evidence inf

it is not interfere with the fda. i would never prevent the fda from fulfilling its mission of insuring the safety of our medical products. it for him is the government for rationing health care based on this research. it is to protect patients and protect seniors. i would ask that people would support this amendment. i might add something here from personal experience. i apologize for going on. i said before that i have had the privilege of public service for a long time. i have said before that healthcare seems to be -- i do not know how it ends up under my jurisdiction in terms of a committee or working for a previous member or where ever in my career -- but that has been the case. i've also expressed considerable frustration dating back to the chairman hew and what used to be hippa. i do have a little blood pressure. i've not been down to the agency recently. i would like to pay a visit and indicate to them that i am not exactly a total critic. they do have a very important job. i can remember that we were in the

we need revolution of the fda. we need the fda to be more than it has been. it has to become involved in finding answers to diseases. it is not just to make things safer. is to helped develop things that will solve problems. they have got to be brought into the process. this translation research thing has got to be done. we have got to explain that to people. finally, we have to get health care reform. in 1993 we fail. we were pigheaded, including myself. we said it has got to be this way or we're not going to do it. that was stupid. that was really stupid. i don't want them to do that this time. i want them to compromise, find common ground. when you go into the emergency room, you are not republican or democrat, you are just sick and you want to be well. that is what people want. this is a huge. we cannot miss this opportunity. this year it has to happen. if it goes into next year it won't happen because there will be an elections. we have to do it this year. [applause] >> he is not running any more. >> never again. >> i am up their many days talking to my

those of you who follow the fda know that it essentially force is a drug off of the market for one of two reasons and i have to me pretty good reasons. one is that it does not work or the other if the show's the risk associated with the drug badly outweighed the benefits. obviously all drugs have risks but if the risk is great eventually will force off the market. does not happen much but it does this post 58 proposes cancellation of a new drug the one group says it is an extensive process with a written appeal leads to 10 additional years of sales whatever the drug was it did not work we had 10 additional years thanks to the average bigger. since writing this book talking about the practice they have changed their website they now call it product support. [laughter] i think it hurts all of us. gilbert understands this as well who he writes about having weasels to write articles casting doubt. we are being seen by the accountants at arthur andersen. one thing i began am deeply involved with teaching a course in a bar mental health policy at george washington, osha issued a proposed ch

fda estimates based on grants currently in process that approximately 4,000 new transit vehicles will be purchased or on order by this september. all vehicles will comply with the "buy america" act and will serve as an important shot in the arm for our manufacturing sector. in fact, minnesota is a good example. in that case the metro counsel in minneapolis has requested funds to purchase 31 standard 40-foot buses, 30 hybrid buses, 26 articulated buses and 15, small 13 foot buses. links in orlando, florida, requested funds to buy 61 buses at a cost of $8.6 billion. that's part of what's missed. you talk to the sand and gravel folks calling people back to work. we have a situation where we have bus manufacturing lines that are hot and staying hot, knowing that these grants are coming. knowing the orders are coming. when we purchase a bus, we don't ask the grantee to give the money up front. they outlay the money to the grantee when the bus is delivered. that's not to say that people aren't working on that manufacturing line. the outlays come when the bus is delivered. i think that's an

we do not intend actually to displace the decision of the fda, we're telling them to study this for a year, if this propose it go forward, they have a year to pro mul gate the rule. i think it is entirely consistent. >> senator -- >> i thank the senator for working on this and i don't think that the current presentation of drug labeling is technical rkts i think senator reed is on to something with the study and the study proposed, i'm pleased they were able to work out the solution and i'm pleased we've been able to reach agreement on the provision. i co-sponsored it and i want to thank senator reed and senator hatch for working on the issue and coming up with a solution. >> any further comment on this amendment. we're missing the necessary votes we'll have to lay this amendment aside until the requisite number of voters show up. any additional amendments you want to propose? >> there were amendments to be suggested by senator greg when improving data collection, which i know we would also -- that we could proceed on. >> mr. chairman, if you would indulge me, there are two amendments

. >> the fda administrator rogoff mentioned several spta projects are assisted by recovery act funds including, correct me if i get the pronunciation incorrect but the station project that has a business component to it can you tell us more about the project and how what benefits spta? >> i submitted copies of some of the pictures with my testimony. you can see the station i don't think any person would go near that station in the current condition but it is critical we have facilities so that they feel safe on the system that also has the ability for transfer four bus routes so they can take the bus to the station and take the train into downtown philadelphia and demand number of stations a mentioned earlier in my testimony will also have the ability for multi transit purposes. >> and there is activity that goes around the transit station? >> yes. we're looking at economic development as everyone knows in the public transportation world if you have public transportation it increases the value of the us real-estate around the station. >> thank you. i would note also you also spoke ab

i represent people who work at fda. they are doing their best to come up with those ideas that either will save lives or extend lives. the -- given examples about cancer and virtual colonoscopies, versus all that. but where do you think that all came from? that came out of a lot of it government-sponsored research or government doing the research so the private sector could benefit from it. we talk, about aren't we the latest and greatest. we're in the top five of medical expenditures in the world but we're in the bottom 37th in terms of health outcomes. so the whole idea of what is coming out of comparative effectiveness is to enable more evidence and form practice to occur. evidence informed, not evidence or practice mandated. so that's number one. number two, the people who are going to be providing the aye lot of this research well be coming from the iconic institutions in our country. they are iconic. they are known around the world as incredible institutions. and we find it convenient to turn to the institute of m

and i am eager to restore the fda to the gold standard which it is a long way from right now. >> thank you, mr. chairman. historically, health insurance programs have been driven by the individual states. new york state law used to dominate this entire arena. commissioners across the state's played a significant role. you have indicated by way of your statement for the record that you intend to begin building on the system that we have. in doing that, d.c. the federal government's role core operating with the state's or do you foresee a more centralized federal government system? >> i met with my former colleagues the other day. the insurance commissioners were here, dealing with this very issue. i am most vote -- i am a strong supporter of the consumer protection rule that states play in the health insurance area. i was engaged in that, myself. sthand theindividuals covered individuals covered by the erisa plans to have nobody to turn to if the benefits were denied or the claim wasn't paid or if the company suddenly ceased offering insurance. so i am a strong believer that there is an

trade policy and stopping and going back and looking at fda's before going forward. now, i understand, you know, congressman can sign built and doesn't cost them anything but i think it is an importance of what the obama administration will face. in that regard let me shift from their to the regional questions, but before i do so, a place where it's going to come to trade policy and certainly will be to the floor in the administration when it besides do so, go forward with regional initiatives. and that is the pressure to increase the u.s. demand in terms of labor and the environment. the most recent demand in the house are for countries to really, small countries at any rate, to accept an office of the ilo which will dictate to them their changes or revisions, particularly in their labor laws and the same thing would be true with environmental, environmental laws in terms of multinational treaties. i mention this because this has already come up in terms of india. and that is the indian government reacted very negatively to a much looser set of goals that the europe

it does not interfere with the fda's ability to rule a medical treatment to be unsafe. i would never prevent. i don't think any member here would prevent he fda from fulfilling its mission of ensuring the safety of our medical products. it simply prohibits the federal government from rationing health care based on this research. so it is to protect patients and to protect seniors. i would ask that people would support this amendment. i might add something here from personal experience. and i apologize for going on. i said before that i've had the privilege of public service for a long time. and i've said before that health care seems to be -- i don't know how it ends up under my jurisdiction. at least in terms of a committee or working for a previous member or wherever in my career. but that's been the case, and i've also expressed considerable frustration and angst dating clear back as i indicated to the chairman to joe kalifano and h.e.w. and h2 s, cms. and i do have a little blood pressure. i have not been down to the agency recently. i would like to pay a visit, jus

relevant standard of care comes from professional societies, medical schools, studies done at nih and fda and other government agencies, learned treatises and journals and no reason to exclude information from one source if a court determines it to be relevant in a particular case. neither the center for health outcomes research or any other source of medical research sets the legal standard of care. no organization or national academy sets it. many sources are considered relevant about what information was available to providers regarding a particular condition or treatment. also, staff reviewed this. it points out there's another flaw in the amendment as written, which might have been unintentional. the rules of evidence created by the amendment wouldn't apply to both sides. it says that the conclusions and recommendations of the center should not be used for the purposing of establishing liability. thus could not be used as evidence by an injured person to show malpractice. does not prohibit a defendant, a defendant, from using the same information as evidence to rebut a claim of malpr

if a drug is not safe, the fda needs to say that the drug is not safe and we would not pay for it. this comparative effectiveness research should not be used by the government to delay or ration care. the reason for it is that we all want to be in charge of our own health care with our doctor. we want the choice. if a doctor says that we think you need this kind of treatment and we can get coverage for their from their insurance, we want to get that care. if we cannot, we want to provide in-find insurance that can provide that for us. what we do not want is for the federal government to say that it does not matter if you want to pay for it. it does not matter if you are covered, and you cannot get it because the federal government says so. if that is what could happen if we have a government run insurance. the president has said that he wants a public auction. there will be a government insurance company that will be a place where everybody could go for coverage if they do not have it. i think that there are better ways of getting everybody covered. there are some people that need

recently fda's risk committee recommended the fda adopt standards to disregard the change, the essential changes that would apply to promotional labeling and printed advertising so it would not a and sustanon beyond the model itself would be promotional advertising, the magazine circulars etc. and this has been agreed to with ranking member. we do not intend angelina to this place in the decision. if they propose this before than the have a year to promulgate the rules so i think this is entirely consistent with a reasonable approach to adopt in this immense senator and see. >> i think the senator for working on this and i don't think the current presentation of drug labeling is helpful, it's a highly technical document designed more for the trial lawyers and the patience and i think that's senator reid is really onto something with steady and the report and i am pleased our sows are able to work out this bipartisan solution and i'm pleased we been able to reach agreement on a provision so i co-sponsored the amendment and i want to thank senator reid and senator hatch for working on this

chairman, i cannot overstate how proud we are be extremely hard work of the fda staff in putting this money to work, especially in our 10 regions but around the country they have been working morning, noon, and like to make sure these dollars are being put to work properly. this constant collaboration between fda and transit providers is implementable in keeping us on track. of the 8.3 billion funded 1.74 billion, or to what one person has been obligated so far. and another for .1 billion, or 50%, are in process of obligation in the near term. i'm informed as i was coming over here that we are hopeful of obligating another couple hundred million dollars just today. these figures equate to about 19000 jobs, currently obligated and another 45000 jobs for the grants in process. in addition, $55 million in recovery act funds have been transferred from the federal highway administration to fta for public transportation projects. these transfers reflect local decisions by state and municipalities to use recovery act highway funds or transit projects instead. tranter estimates based on the g

there is a good study published in 1996 by a former fda commissioner and future fda commissioner by the name of kesler and mclellan. here's what it showed. if in fact you did do this, this is in '96, you would save between $60 billion and $109 billion a year. $60 billion and $109 billion a year. that was in '96. that equates to about $300 billion to $400 billion right now. >> savings in what? >> in terms of the cost of defensive medicine. tests that are ordered that nobody needs except the doctor fearing they are going to get sued for something or extorted. it's really, you know, i'm going to be really frank with you. we have half the lawsuits filed in the hopes that somebody will get scared and have to spend more on lawyers than it will cost them to settle it. that's the system that we have today. so there's no basis to the claim other than to make you spend money on your own lawyers so you settle for $60,000 or $100,000 so you don't end up having to spend more on that on lawyers. so what that study said published in 1996 is back then, between $60 billion and $109 billion a year just i

let's ask fda to first identify cost benefit because in the end resources are finite. >> right. let me just say because my time is expired. i really hope that all of you will come in and work with us on this particular traceability language because from the -- from the early days of my working on this issue, what you're saying is exactly my view and that we need traceability throughout the industry but we can't have a one size fits all traceability or technology. those things be interoperable and if you have tomatoes and sauces mixed in a salsa and if you have that salsa incorporated in a processed food that's another layer of complexity and then if you have that put into something at a restaurant or any place that's another layer. we do have the technology and we just need to work on it. i hope you all will work with us next week to work on this. thank you for your indulgence, mr. chairman. >> mr. boyer? >> i had to take a deep breath because mr. matheson and i and i guess now chairman dingell and gene green -- you know, we've taken this -- trying to educate the committee here

obviously if the drug is not say, fda needs to say the drug is not sapan the government is not going to pay for it. the point here is that this compared the effectiveness research should not be used by the government to deny it or delay or ration care. the reason for it is obviously we all want to be in charge of our own healthcare with their doctor. we want a choice. at the doctor says we think you need this kind of treatment and we can get coverage for that from our insurance we want to get that care. if we can we want to find insurance that will provide that kind of coverage for us. 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 if you want to pay for it, it does not matter whether you are covered, you can't get it because the federal government says. this is especially important if we have a government run insurance company which is what many on the other side of that aisle is talking about. the president has said he wants the so-called public auction so that there will be a gover

the fda can't even control or do a good job at the food supply, and is a revolving door. what i would caution you, sir, is -- it is coming. that should be defeated. if you believe in choice and the american citizen, a defeat that. that is coming out of europe, part of nafta. lastly, i have been watching the senate proceedings and they talk about malpractice -- that is the problem that drives up the insurance costs. yes, it does, and insurance doesn't drive up the cost, but i was subject to a medical accidents and unless you died or you are severely in a,, you tried to sue them, you need money to sue the system. guest: ok. host: talk about medical malpractice. guest: i just want to make a reference, something coming out of europe, i do not see how that will relate to north american free trade agreement but i will try to circle back on what the caller mentioned because it is new territory for me. merkel malpractice is cited as one of the major -- medical malpractice decided as one of the major factors, but one article about a city in texas having the highest medicare costs

[unintelligible] there was a predecessor the year before the court held eight-one that the fda's regime for medical devices pre-empted all state lawsuits and was allowed to be marketed but caused physical injuries. i was the lone dissenter in that case. dan another case involved drugs rather than devices and the absence of a pre-emption clause in that statute proved this positive. tort suits could be maintained another case kid with a record resembling john grisham's novel, "the appeal." they charged that the coal companies predatory practices drove him out of business. the west virginia supreme court divided 3-2 and reversed the judgment and declared victory for the coal company. and there was one problem. justice benjamin, who cast the deciding vote was nearly elected to the court and the coal company's ceo had spent $3 million to defeat the incumbent. dividing five-four, we continued that his participation in the case violated the right to due process. a justice kennedy's opinion for the court, joined by justice stevens, souter, ginsburg and brier, found that it was disproportionate

the fda has assembled experts to discuss and vote on ways to prevent overdosing. the pain relieving. the reducing ingredient in tylenol and others medications. those are some of the latest headlines on c-span radio. host: we want to hear from you. the numbers are on the screen. republicans, 202-737-0001. democrats, 202-737-0002. independents, 202-628-0205. send us an e-mail or a tweet. on the front page of "the wall street journal" -- dick cheney is on the front page of "the washington times." from "the washington post" -- the "chicago tribune" -- and the front page story in "the star-ledger." rarely in memory has a man become such a planetary pariah. not a single person, no member of his family, no friend of a lifetime stepped forward to attest to his character. humanity has written off bernie madoff. also, "the new york post." inside "the new york daily news" has this photograph. from inside "the new york post" -- they reprint his remarks. he said, "there's nothing i can do, but i will live with this pain for the rest of my life. i apologize to my victims. i am

the law allows the fda to reduce nicotine in tobacco products and candy flavorings and black label such as low tar and light. you can see live coverage of that on c-span3. a look at this morning's headlines from today's washington journal. host: 1 spending bill is under their belt, what is ahead? guest: 2 more in the house and one in the senate. a bill to promote tourism and the senate, and a lot of committee work on health care reform. that will take care of the whole week. two bills for appropriations, homeland security funding and the interior environment fund in the house. also the tourism bill in the senate. host: we are covering the health committee markup. this must be the fourth day they've met. guest: that's right. in the house, they came out with their own plan, similar to the kennedy bill. it will be marked up this week in the house. every day there will be committee work on health care in both the house and the senate on different plants. host: susan ferrechio, we will check back with you. to bloomfield in west virginia, our democratic ally. where are the jobs in your commun

former fda commissioner david kessler explains how americans can control their eating habits. . . chair daniels. ogata, creator of universe is -- oh, god, creator of universes, we're here to recognize a friend, a patriot, a leader, a lover of our country. in this moment, as we should in all moments, we recognize your presence in the work of our hands, your light, and the clarity we attain. your spirits, and the wisdom we achieve. your inspiration, and the good that we seek to do. we ask for continued guidance and a blessing, even as we know that we often merit them not. we thank you for our many guests. -- figts. -- gifts. so many across the nation and the globe are not here this evening. our tradition teaches that five years old, the person should study scripture. at 13, the commandments. at 20, one is ready for 1's life pursuit -- one's life pursuit. at 50, one is ready to give counsel. at 60, one becomes an elder, and with your grace, a sage. one would ask, what is the proper course that a man should choose for themselves? he would then say, that which is an honor to him. gila'