health consequences are that that they can recall -- require recall, but in that scenario fda must first of the company an opportunity to voluntarily recall products and that doesn't work then the fda can order a mandatory recall and the second time every call is emergency recall if the fda five certainly it presents a threat of serious adverse health consequences are that. you may do that immediately. can you just telling about whether you think that and the need and the approach of the two tiered approach is addressed in a good way in this bill and why it makes sense? >> well, i think the history is that voluntary recall is often an effective and in getting those potentially harmful products off the shelves and protecting consumers, but that you do need of that emergency mandatory recall bond senate as a backup. there certainly have been cases where the mandatory recall of a dangerous product has been delayed because of reluctance on the part of the company to pull the product and there has been a back-and-forth with lawyers involved and delays of weeks putting consumers at risk, so i think to have the

>> yes. >> fda has not been doing an acceptable level of serve valence for research? >> would you agree they have not conducted satisfactory inspections over the years? this figure i got which seems interesting fda conducted 6,562 domestic food facility inspections 2008. the total number of registered facility is 378,000 of many more out there in the world is that a fair statement? >> that is accurate. >> i am sure you agree as you have said fda needs additional resources to do their job? >> yes. >> i want to commend you very much for the way you have been working with us i want you to know we will try very hard to see to it we come up with something that enables industry to work, prosper and have a satisfactory fda that protects the consumer but also does not overburden the industry. we look forward to continuing our efforts on that and i hope you will continue to give us that assistance. again the reporter does not have a nod. >> we look forward to that i thought dr. hamburg at this morning way a good basis for those discussions going forward. >> i am troubled about

it was an fda regulatory limbo when he took over at the company. he tried very hard to get permission to market that and was ultimately successful. host: you write that as part of his tenure at general instruments that company was instrumental in the development of hdtv. guest: that is right. he has an impressive career in business, an agent of change, taking these companies and turning them up around. also bringing to market these very significant products. the early days of hdtv. host: he did not enter private industry until well into his 40's. would he have been happy to have stayed in government service? guest: i think so, but he did not see an opportunity at the end of the ford administration to run for senator or governor. he was not quite ready to run for president. he also believed in people moving back and forth between government and industry. host: let's here from florida on the republican line. caller: good morning. host: rather on the democrats' line, correct? caller: yes. host: will put you on hold. please turn down your television or

which achieves the goal of ensuring safe food for the american people without placing an undue burden and strain on the fda which is already challenged under current food safety obligations. this legislation authorizes an annual pay to play registration fee for domestic and foreign food facilities of $1,000 to supplement appropriations made by congress to fda. in discussion, however, we've not been able to determine from the majority -- from the majority or the fda exactly how much funding is necessary to meet the requirements of this bill. i believe it would be premature to impose significant fees on industry and in turn the american consumers without any reference as to how much funding is actually needed. if the majority remains intent on imposing such registration fees we must also be certain these fees are limited to cover the activities which are such as a minimal fee paid to the fda for an application to cover the cost of review and processing. if the goal is to improve food safety, we must ensure that funds are not funneled into other activities that may or may not have anything to do with improvin

we have a system, an fda, i know senator mclusky and i worked on many times to make sure we get through drugs quickly, but at the end of the day we have a process where safety and efficasy is critical. when our constituents go in a grocery store and buy off the shelves, they need to know it's a gold standard there. i haven't had a chance to look at the mccain amendment. we had this debate before. i want to take everybody's word that is the same language, but i have real concerns about it and i would ask senator brown, this has been dropped on us like a huge two-inch bill here. if we could hold this until the coverage debate, i would really appreciate it. >> i'm trying to explain is senator mccain is in the mark-up on the armed services bill downstairs, i believe, wherever that is occurring so is running back and forth. what he asked is for senator brown to manage this discussion for the amendment. >> i would say to senator brown, if we are going to vote on it right now, i will vote no because i have not had time to read it. it could have a huge impact on the public. >> i, too, am a stro

fda in meeting the inspection challenge. the draft legislation allows the agency to rely on inspections by other agencies as well as state, local and foreign governments. anadditional promising mechanism for international inspections is certification by accredited third parties. fda would like this flexibility to explore the use of accreditation system and on a performance of accredited third parties. with strong standards and robust oversight piatt fda, this approach could help address of the oversight challenge posed by the more than 220,000 registered foreign facilities exporting to the u.s.. this is an historic moment for food safety in the u.s., and moment for a fda and its sister agencies in the federal government to rise to the challenge of the 21st century. success means fewer hospitalizations and deaths, fewer devastating recalls, and greater health to the american people. the draft legislation is a major step in the right direction. i commend the committee for its leadership and on behalf of the hundreds of dedicated staff devoted to food safety as fda, i look toward to assisting with the legislative process. i welcome any questions you may have

we are willing to support a thir registration or user fee provided in is utilized by the fda in a chance and an accountable manner to improve the safety of our food supply through means such as connecting researching consumer education programs. we look for to working with the committee to address our concerns about how the fda and may utilize any fees collected and we support the requirement that every registered for a facility conduct risk assessments and implement and maintain relative food safety plan and identify potential resources of contamination and of proper food safety controls and document those controls that will eliminate potential hazards here and adherence to food safety plans goes a long way toward developing a culture within a company that is critical to ensuring food safety. mr. chairman, thank you for the opportunity to testify, we appreciate the work that has gone into development of the food safety enhancement act discussion draft with the goal of improving food safety. and helping to restore consumer confidence in the food safety system. i look for two questions and remai

fda has been working to support the economic recovery. i want to share some of our accomplishments. we were allocated $8.4 billion. we view that as an extraordinary opportunity. 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

it will enhance fda's ability to trace the origin of tainted food in the event of an outbreak, or foodborne illness. and should be noted that this food drug administration and industry are totally incapable of providing speedy service in this particular. it will enhance the safety of imported food, fda will be allowed to require that certain foods be certified as meeting u.s. safety standards and begin to trace. but also food and drug will be able to finally get enough people at the doors of this country to see to it that safety is properly enforced and that good manufacturing processes are adhered to around the world for the protection of our people. it will provide strong enforcement tools, including mandatory food recall authorities, stronger criminal and civil penalties for bad actors, subpoena authority and it will increase and strengthen food and drugs detention authority. finally and i would argue more importantly the legislation addresses the very important question of the resources of the agency. we will give the agency the authorities it needs and we would do them a grave disservi

nuts and bolts on our health care reform legislation the first hearing is with fda because i believe we'll began not with an overhaul and better resource in a separate and drug administration, from the food safety enhancement act that we're looking at and drafted and and the family smoking and control act of 2009 looking at a new fda and have the talent and the opportunity to make this important institution in ways better serve the health of the american public also fostering, guiding and supporting the bringing a new and better treatment to us as well. i have confidence in a better race doris fda with more authority and one that is not overly prescriptive. i don't want to be overly prescriptive on what we tell the agency to do but hope we can allow to do is john based on a clear authority, adequate resources and sound science. in the case of food safety in this my first three months on this committee by been alarmed to find out what has happened that has put the public's health in jeopardy from salmonella to some questions about even the irb process and several other areas so we're here to help to treat a

comment is you know where i stand on the issue of food safety functions and taking them out of the fda in an agency that has its own commissioner and agency is this an idea you would be open to considering? >> i am enthusiastic about the work, the collaborative work between the department of eckert culture and hhs and certainly appreciate your passion and leadership on this issue over the years. i would suggest that we have a new commissioner of the food and drug administration, peggy hagberg, who's now been affirmed and redoing the inspections and food safety system is essential. it's got to be public-private partnership whether or not it is a stand-alone agency or in the food and drug administration i think is almost secondary to what the system needs to look at. 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 ind

>> there are several agencies in health and human services that don't have an office of minority health. cms? fda? so we want to see it expanded. it's always been that they have been allowed a budget up to 5 percent of the budget of the agency. we'd like to see a line item budget and more coordination, having more of a say in everything that every policy coming out of health and human services, than they to right now. do right now. >> the phrase more money seems to back people off on issues, and i'm -- we're here to tell you that without addressing the gaps in disparities in health, it's going to cost you more money. and to anticipate that we have to plan well, invest well so that the return on our investment is saving lives, the health of our country, and ultimately having money to be able to be expended in other areas such as research. >> you want to talk about interns, does it insure says to care? do you think that the public health option is the best way to insure access? is there anything else, or if there's no public health option that can be done, some sort of carveout for low income? >> w

this bill is much improved what we have seen over the years is the fda has had trouble with identifying food products with major recalls an outbreak. >> it does not go far enough? correct you are nodding your head yes. >> there is such a huge food production chain if there is one. the records are not good if you don't know where the produce comes from you cannot get anywhere. >> mr. ambrosio, mr. stenzel, ms. bailey, you don't object in general to the concept of trees ability comment do you? >> no. >> no. >> no with. >> in fact, in your testimony, you recommended for the secretary be allowed to build systems on information gathered and not be mandated to develop a specific type of system. correct? and ms. bailey endorse testimony, written testimony you talk route the concept of brokers and distributors and ingredients the ingredients to get the trace ability correct? mr. stenzel to produce industry in this country i should not say this you were the ones that gave me courage to believe we could do trace ability because you are doing such a great job. i want to commend do the issue as i heard in all of your testimony today

an animal would work to get their food. by that you understand because that test called self administration, that's the test that the fda used to control substance but the question is how hard the motivation, how hard will an animal works when you do is give them the food that makes them press twice then give them the food than waste they have to press for times, then they have to press 16 times before they get it and 32 times and 64 times, 128 times before they get food so you get a sense of what the break point is. what do you think they will work the hardest for? the answer is sugar. sugar was the main driver but when you add to the sugar you add fact it's synergistic. second piece of science. with my colleagues and italy one of the great pharmacologists he has indicated his career to understanding how drugs highjack the brain. he studies amphetamines, cocaine, and what we know is when you add minister the drugs like amphetamines and cocaine were you see is a bump in the brain's circuitry involving fat amine. tuzee this elevation in dopamine and dopamine is the chemical responsible not for pleasure it means responsible fo

an important role. 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

where he draws on his public sector experience having led both cms and fda and, of course, brings his background as a physician and an economist to that role. mark most recently has been playing a key role in the development of the bill baker daschle plan and an important bipartisan agreement on health care reform and he will describe some of the multi care initiatives that he's involved in that concern as a model for health-care reform. >> thank you. it is great to be here this morning with all of you. how are we doing on the slides coming up fykes okay. this is a very distinguished panel and i'm glad someone had taken time to be here and we're seeing some discussion at around payment from an improving how it works. i'm going to talk about that as nancy mentioned focusing on things like accountable care and multi stakeholder approaches to doing this. but it is very refreshing to see how much of an emphasis there is on getting these kinds of ideas into legislation. this is something that can be bipartisan. a lot of congressional staff are working hard to turn these concept and the legislation that improves benefits a

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 animportance 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 europeans put forward in terms of the european indian negotiations of the european indian fta. and i think that wil

fda. of course he also brings his background as a physician and an economist to that role. mark most recently has been playing a key role in the development of the dolby girt daschle plan, and important bipartisan agreement on health care reform. markle described some of the multi-payer initiatives that he's involved in that also can serve as a model for health care reform. >> thanks, nancy. it's great to be here this morning with all of you. how are we doing on slides? coming up. okay. like i said, this is a very distinguished panel. i'm so glad people are taking time to be here and that we are seeing so much discussion around payment reform and improving health care works as part of health care reform. i am going to talk about that, as nancy mentioned, focusing on things like accountable care and multi-stakeholder approaches to doing this. that it is very refreshing to see how much and emphasis there is on getting these kinds of ideas into legislation. this is something i think can be very bipartisan. i see a lot of congressional staff. i know you're all working hard to a

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 time without any sort of standard be met. >> keira i would like to stress access t

fda to regulate tobacco. guest: susan ferrechio, we will check back in with you in a bit. the new york times has anarticle 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 pointing the fingers at illegal immigrants, but coming from a 22-year old male, i point the

whole process that is used by the fda to regulate 121 and how many of these issues need to be incorporated in it, or whether i the standard is fine, it just needs to be an enforcement issue. those are some very specific recommendations. >> i think we need to somehow get that in some joint letter to the faa to make sure we are at least reviewing those recommendations. the other witnesses, do you agree? >> we wholeheartedly support the points that mr. may pointed out. i think the industry, again, one industry, in concurrence on these type of issues -- let me just point out to specific things in addition. this integrated database a pilot records is something that congress can direct the faa to do and to do it immediately, so that the access to this information is readily available to people as we hire. the better information we have about everybody in the system, the safer it will be. the other issue underscoring the use of c b r's, and as you all talked about in your remarks, it is a tragedy that we are here, and all of the issues that congress and the faa are learning about are from -- in had to be after the tragedy. that is a shame. if there is a tool o

an article in the scientific america and it pulled this case study from the web site. now, i think those of you will follow the food and drug administration know that the fda essentially forces a drug off the market for one of two reasons and they have to be pretty good reasons. one if it is shown the drug simply does not work. the other thing, it's the fda shows that the risk associated with the drug badly up with the benefits. obviously all drugs have chris but of the benefits are small and the rest are great they will after a great deal of turmoil force the drug of the market. the fda proposed translation of registered drug that requires a hearing etc., the weinberg grouper lead to ten additional years of sales before the translation-- cancellation of the traxel whatever this drug was did not work, we had ten additional years thanks to the weinberg group. now they by the way, since i wrote this book, to tell you about the defense industry they have changed their web site. they now call their work private support but i saved all of those screen shots too. i think it hurts all of this, and dill. understand this as well-- people see this all signs turning to scientist