Thank you very much for that question. I absolutely believe, we as an organization believe it is an important incentive. It puts a spotlight on research and children. It they risks it at a certain level because there is an incentive and that becomes a very important issue as Companies Look across their portfolios and decide where to make investments to battlers la health of the nation. That in my mind is a big deal. How it could be made better, right now is it is provisional or temporary trial. It could be a stronger statement if it was permanent. We the people want to invest and make incentives and opportunities for research with children. While i have the money there is one of the eighth thing i would like to comment, particularly impressed with the comment about the voice of the patient. And i think as do many of my colleagues within shire and across the industry, though rare disease world, is hugely informative. Often times patients and organizations who represent them know more about their disorder and what really matters than any of us. How School Physicians for regulators or whoever it they are, are well informed and sophisticated. As industry engages with regulators, with the fda, bringing that voice to the table, not every time but in certain situations that the pathways have never the road was never laid out before. That voice is just critical particularly in the selection of an end points, etc. The efforts that efta and congress have gone through to enable dialogues between industry and the agency are commendable. I think they are superb expedited programs, fasttrack, special protocol assessments, all of this but they dont incorporate that voice. Personally as to my colleagues, i think it would really facilitate moving things a little more rapidly. Thank you. I appreciate all the comments, and witnesses we can listen to, we end up with a good product and that is what this is about. Your comments are right on. I want to help you on those as we appreciate but i am only interested in exploring the genomics education issue, Great Strides in the last 30 or 40 years as we move forward on that and i had what i consider a good conversation several months ago as we talk privately about where we should go with 21st century viewers and jim had an idea that the federal government would be the only one that could pursue this and that is to come up with a nationwide study. All types of demographics and be able to use that by interface, advances that we saw on the genomics to help industry find faster skewers to yield to you, to have better details sent me but in essence we get the comments from those of us at the table at that particular side, how that would be useful and constructive. As an entryway to this, think about oldtimers, alzheimers. Everyone knows that is the tsunami of suffering particularly my generation aging out. The industry has spent hundreds of millions of dollars and almost without exception very expensive trials have failed, yet these tsunami still comes at us. Part of a reason we failed is by the time patients develop symptoms of alzheimers disease they have such neurological damage is impossible to reverse. What is clear is that disease as an example we need your earlier, to understand at a much earlier date, we need to seize the subtle changes in body chemistry that can enable us to predict the vulnerability towards alzheimers and intervene sooner with the drug. In order to do that, this is applicable to any disease you can think of. In order to do that kind of thing what we need, i talked to a lot of folks about, is a large, long longitudinal study on order of magnitude of 100,000 people by age and in the 21st century version in 1948. And all of these people we would apply every test to fluids and air bodies, probably due and m r i, cognitive and functional tests for these people over time. And what happens is when people develop those symptoms, using all that data, and go back and correlate these precursors and learn from hazmat howitzer intervenes. I entered this with alzheimers in mind and parkinsons and cast vascular, as you mentioned this is a project of such magnitude, private sector can do it and leave the federal government can do it and i argue the federal government shouldnt. I would say i have read dr. Collinss mind on this subject and he says in one way or another as soon as you take care of the rest of my needs we will talk about the next big project. As i said to both of you earlier we need to be advocates of meeting his academic needs as well. Having said that, this is the mother ship, a big project of Data Collection. So many other enterprises, academic, commercial, private sector investigators could dock in to this matter should end up load their data to enrich the consistency and Download Data from this set to enhance their abilities to further their Research Projects wherever they may be. This is not a project that would be a lowcost project. Probably order of magnitude, 100 million a year but when you think of the trillions of dollars of cost that could eventually be avoided with alzheimers monroe and other diseases, it would pay for itself in spades and people who participate in this project would learn to better can to their own health and thereby saving the Health Care System dollars. And i would argue in not the very distant future, everybody will be doing this. Everyone will have the genome sequence that first, everyone will have this diagnostic would you like to elaborate . I throw my arms enthusiastically around my colleagues. I have talked about this on several occasions and i do believe this would require an upfront investment but over the course of time in terms of providing a platform for all kinds of clinical research, currently we have to set up one office you have an infrastructure that would allow you to pose all sorts of interesting questions on to this longitudinal cohort at lower cost. This has real potential of being set up in a way many of us would like to see and having patients right in the center of how this was organized and patients would be empowered as being part of this to learn more about their health care. There are so many gadgets but i will waive this one which is and be cagey attached to the back of my iphone. It would give a read out in to my electrocardiogram and lots of other socalled mobile health applications. You imagine with this cohort providing those kinds of applications, a lot of private sector producers of such applications would be interested in having them tested. You could in addition to genomics have monitoring of individuals on a realtime basis, so called quantified Self Movement which allows people to learn about themselves in real time on going, this could be transformative. The only thing i would say is wrong with this proposal is 100,000 is too small and i think if you want to have power, when you see the reduction in costs that is happening, we should go for 1 million. Would you like to respond . Your e cagey on my heart and now it is fluttering. We will let dr. Burgess way in. That is the future but that is where it is going and that is where we need to go. Embracing something of that magnitude when it is time something that to new level. So very exciting proposal. I thought i would endorse that in a slightly more mundane day. Some of the barriers we are facing today with innovation, with new breakthroughs with new treatments and medicine are really practical. The types of things that foster innovation in this country, very disparate data sets and different providers and health care settings, they dont speak to one another so they are not interoperable and we have selective access in different groups for taking advantage of the potential of bringing statuses together and it is not just technical, there are incentives differences. We have to bring together large sets of data, clinical and biological in a way that can be mined most productively and respectfully for patients at hand. Such an endeavor would provide a mechanism where we have to solve those problems along the way or else the project would succeed and that by itself would be a great benefit to society. I am very enthusiastic about this proposal but it is reminiscent of the National Childrens study and by interest in hearing your comments about the National Study which has stalled and wonder about where this fits in as we prioritize federal funding for research and funding for individual investigator wars versus studies like this. Very appropriate question. The National Children study authorized by congress in the year 2000 has had a challenging period of design and redesign over the course of more than a decade with the goal to follow 100,000 children, ideally, at the beginning of the pregnancy to assess what might have happened in prenatal life that would be important to know about and following these kids to age 21. It has had lots of challenges in terms of what is included. How would dissembling be done . Most recently the institute of medicine asked to undo the current plan raising questions whether the plan would achieve necessary goals which is why isnt a good moment. And push start on what could be a long and expensive 21 year program. And special working group, a retired dean at stanford and a pediatrician and russ altman to try what the alternatives might be. The design of the children study could in fact take greater advantage, things that have happened more recently particularly the advent of Previous Technology like Electronic Health records in ways to do this kind of study which i am totally committed to make sure we invest in in a way that will be more efficient and less costly and the designs that are mostly put together years ago. I take your point that when you talk about longitudinal cohorts studies there are all kinds of ways to stubbier oto and all kinds of ways to be successful. Is a good example, we need to learn from those lessons. I think the we are again building and jim greenewoods vision, an exceptional moment where we have for the first time the ability to design such a cohort that taps into Electronic Health records that are available for many individuals who could then participate which much less trouble in terms of getting information about their medical histories and experiences with health care and we have Technology Like janelle makes which used to be prohibitively expensive which are now becoming remarkably cheap and we have a lot of public momentum behind this and an argument to be made that ultimately while this is hard is going to save money in hong kong delegation along one. Put those things together and it seems like we would not be doing the leadership we should without taking that seriously. Other countries, china for instance, gets this and are making investments of this work but i dont think we will learn everything we need to know about American Health by waiting to see what the chinese look like, not even a shoe with a will necessarily be made immediately available. We should have an american effort of this sort to teach us about our own population. Dr. Hanlon . This will allow us to analyze nubile markers but also that we dont lose sight of what we have already accomplished as a Scientific Community, datasets that ethics on medicines already approved that are contained in the databases. The u. S. Is the only country and the fda the only agency that requires primary data sets where every other country in the world will be requires Clinical Study reports. We are sitting on an enormous amount of data that is not accessible to the Scientific Community in any agra that way. Congress could act by expanding the freedom of information act to include the primary data from these studies. In addition to that there are many studies that are done every year in the process of molecules that make approved drugs, failed studies. We have more to learn from failed studies that we do from our studies that have succeeded and having a way of having access to this data that the Scientific Community can mine would add tremendous insights on study designs, appropriate end points and how well they provided the assessment for new drugs in the review. I applaud the idea of looking forward. That is important but we shouldnt forget the enormous amounts of data that already exists that we are not mining in a meaningful way. Somewhat more pessimistic about the ability of a large federal government run trial. Something that i wanted to ask about because you showed eric cantor redeye came here months ago and you showed us things you with doing with 3 purposing from failed drug trials that you actually had a couple things that have been quite intriguing to. Can you speak to that a little bit . I certainly will. Thank you for the question. There are hundreds of molecules that get tested for therapeutic benefit in a particular disease over the course of a decade that dont turn out to provide the benefit everybody hopes for. The failure rate in phase 2 and phase 3 on basis of lack of advocacy, over 50 . Those are compounds for which this has been an enormous investment in terms of understanding they are safe, knowing what target they hit, knowing what those to give to achieve appropriate blood and so on. And those compounds, and that particular drug happens to hit exactly the right network or pathway, that you know have been involved in that disorder and as we learn more about molecular pathways and those 7,000 diseases that were mentioned you start to play matchmaker here and identify new use for an old drug. We set up a program many people thought would be pretty difficult because of the ip issues and ultimately was successful. To invite companies to basically open their freezers and make available compounds that had been through phase 2 and three and known to be safe but never received fda approval because they didnt get the advocacy or change in the business plan, 58 such compounds were made available by eight Different Companies and we are now about a year and lead to months into the effort of seeing with is those will in fact turn out to be of great benefit for other diseases based on crowd sourcing of new applications. Inviting people and universities and Small Businesses to say that compound might work for this disease, lets try it. I dont know what the home runs will be but there will be one or two but the idea of trying to build on this profound investment that was made in these molecules and see if some use could be found will be helpful. Theres one hitch, because of the intention by the 21st century cures to look at obstacles and as many compounds are near the end of their patent life, so if we were successful actually in finding a new use, it might be difficult to convince the company to do the definitive phase three title because where they will recoup investments going downstream with the patent already expired, there may be some way to deal with that bat is an area where creativity thought about in terms of providing greater incentive and repurchasing to succeed. Thank you for that. That is intriguing. On the concept of a large governmental study, we had the discussions with dr. Collins before. There are private sector entities that are working on the same problems. This is an example of that. For full disclosure, when they started email me and saying will you fill out this survey i thought what a nuisance, but you spend a few minutes filling out one of their surveys and realize that over time you are making a lot of information available, genomics information and filling in some of those backgrounds for them. The protection for the data, i also offer that people are concerned about privacy but it has to be a 2 way street. We are willing to give up all kinds of products on twitter and facebook and my constituents do and all the time. The primary method of communication. People are willing to give up information as long as it is a 2 way street. The thing that concerns me about a governmental structures study would be it is almost impossible, almost impossible to get data back out. Whatever happens the interface has to be userfriendly to allow participants, recipients that is critical to them. Participants, full participants and have some benefit being able to provide access to the jaded that generated upon them and 23, we talked about this on numerous occasions. It might well be if we went for a million individuals many of them would be recruited from 23 and they have a positive experience with this kind of connection with their gino make information. And one of the advantages, might be an insistence on of and data access. That would be the model you have to follow. That is the norm for everything we are doing. I grant you that is not going to be trivial and people may be skeptical about the idea the government is running this enterprise and it might make more sense to contract it out. This has to get started and in our long history of success of medical research from framingham to solving hiv aids in terms of being able to treat people in the developed world successfully the governments role has been essentially and it needs to be here as well with partners of course. They are not here today. Cms is one of the largest repositories of data out there, almost impossible for the average person in the average position, and get information back out. Thank you. Just to respond to dr. Burgess for a moment, only the federal government could do it this. This is something the private sector the afford having said that, and great advantage to figure out how to set this up in a way that avoided bureaucracy induced problems, and the Public Private partnership is probably in order. There are ways to partner the costs. Users of the data could be charged to use the data and they could pay for that data with dollars or in contributions of their own data into the system. In terms of it is already being done, those are microcosmic by comparison, not at systematic testing, i remember 23, an mri, no one is testing those and so forth and fluids and as i said, this is a mother ship in which other concepts can dock and trade data and that is why after being funded, managed in some regard by the federal government. I was originally going to comment on dr. Hanlons comments but theres a lot of rich discussion. One additional would make that has already been said more broadly is whether it is a big longitudinal study or a smaller study taking advantage of existing data what is critical is we know which questions need to be asked and we designed the study in such a way that would get meaningful answers to tell us what we need to know and that is so important and theres a lot going on in the area of Clinical Trial designs, trying to ask and answer questions in ways that require smaller numbers and shorter trial design using bio markers and adaptive approaches and also using existing data. The point i was originally going to make in addition to the wheat purposing effort dr. Collins was talking about, as the science advances and we learn about subgroups and responders within a given disease category we know diseases are not quite as homogeneous as we once thought, there are huge opportunities using existing data bases, once we know more to go back and reexamining and get important new a series, studies that might have looked at a given condition with a mixed population even though they technically have the same disease you might wash out your effects but if there is up by 0 markers that tells you that there is a subset of people more likely to respond or more likely to suffer serious adverse events, then you can start to tease it out, take advantage of what already exists to get new important information. I also think the importance of being able to learn from failures is important is frustrating to me and i talked about this on many occasions, sometimes we, working with the company, know why something hasnt worked but we havent been able to share that information more broadly. Some work with legislation and companies that need to be part of this process and dr. Hardins company this is an important time to look at the barriers to more transparency and the huge opportunities for more transparency and access to existing data. I want to comment on the barriers with this large study which are not restricted to alzheimers or pediatric, the harmonization of Electronic Health records. This is a major problem. If you one vigilance, to know when a drug goes awry you can go to norway and get this done because there is harmonization of the Electronic Health records and the Health System we have disparate, there is a way to in since different private sector is to harmonize Electronic Health records, that is the only way to achieve those big goals. I turned to the Ranking Member for questions. It is hard to spend the day on this issue of resources and concerns at the federal level and of course comparison with other countries and you mentioned keeping up with china. What i wanted to ask you, dr. Collins and other is, how bad is it getting when we talk about cuts at the federal level and maybe have to add cuts at the state level or at the private level i am not just talking the federal government but overall, in terms of keeping up with china and other countries do we continue to deteriorate looking at not just the federal government but also collectively u. S. Expenditures on research and cutting edge. Thank you for the questions site. Cutting edge is getting on little dull. To give you an anecdote, a previous trainee of mine who went back as a professor, work with me because theres more money for research in the last month. The sense of the chinese investigators being well funded is fair, and getting people to go back to and dope up the the research empire. Our country has been built on a number of immigrants that came from vietnam. That is how we can keep the competitive resources to attract talent, and the issue we have confronting in the academy are young people. We have a lot of good young scientists who are getting discouraged because of the type of funding cuts that are being posed, many of the talents go somewhere else or do something else. Many ideas buried in these young people will be gone. Innovation in terms of the immune cells, again, a Young Investigator didnt stick with it, that idea would have been gone, but shortterm fixes have longterm consequences. I really think we need to continue to invest in our research enterprise. Thank you for that question and adding to the private sector to this issue the highest respect for the and i h n i h, cutting their funding will her private enterprise, 78,000 medical Device Companies that just begin and lots of funds to a large part, in the medical research. Getting a project approved in the United States costs much more then in any other country. They are not available for Product Research and development. We are working in the United States, sometimes on firstgeneration products that the europeans are using in their second and third generation. I have been on so many panels and so many Startup Companies not to start the United States with your new Product Research. Go to europe first endure Clinical Trials there, earn money there, get reimbursement there. You did not depend on investment funding, go to the United States. Really concerns me, it is taking us off the forefront of medical innovation. These basic things i love these dreams, hopes will turn to a reality. I sure do. There are some basic things to work on that i hope will find the initiatives attention. That task is on total revenue. It is a real excise tax. Money is still paying him. Even if you dont make money you pay this tax, mr. Chairman. I just want to emphasize the point that i think we are at risk of losing a generation of investigators in Biomedical Research. Building on the point about young faculty, we are seeing an increase in lot of junior faculty who are unable to make the transition from the mentored Career Development award to an independent Investigator Award because of the funding challenges. Younger individuals seek that, so we have a slower stream of individuals into medical research so the bottom line is we have a decrease in number of young investors and as we think about by a medical research that is a critical issue. The nih has made efforts to accommodate investigators by making special allowances on their first indicated investor awards. The bottom line is we do not have enough money allocated to the n i h. Of we want to support ongoing research, if we want a future of Biomedical Research in this country we need to think more about junior investigators. We have three, lets go down the line. Dr. Collins . Another one over here. Some numbers to backup a conversation which is clearly the one that wakes me up in the middle of the night. If you look at and i ages spending potential for research which is the appropriation plus the affects of Biomedical Research, inflationary index, comparing 2003 to right now, at nih has lost 93 of its purchasing power. Almost a quarter. Numbers that reflect the time for a young scientist or mid career scientists, it relates to what your chances are if you send your best ideas to and i age nih, and as the best. The system in the world to review it and what priorities you assigned to it, will you get funded or not . Karl june sent a proposal that in the past would have been considered innovative and risky and might have got a priority score that reflected some ambiguity in terms of belief of the peer review people whether this could work but would have gotten funded. Pretty sure e did get funded. Now because of this loss of purchasing power, your chance of getting funded shrunk to one of six. About 16 is the success rate whereas virtually all of the last 50 years until 2003, that success rate ran around 30 . I have looked at grands the sport at the 20 or the 10 for the 25 . I cant tell the difference between the mention either can anybody else. We have done that experiment. That says we are leaving half of the good science in the United States on the table. And the people who have proposed it go away discouraged and some of them gave up. 18 of young scientists in recent query were considering leaving the United States to go to another country and other countries as you heard are increasing their support in some instances dramatically, china going up 20 a year. Compound that and you can imagine predictions in another four years china will spend more on Biomedical Research than the United States not as percentage of gdp but absolute dollars and consequences will be very close. Listening well, i want to point to you this obvious break, we are out, i spent a lot of members on a bipartisan basis to china. I dont know if you talked dont know if that is a good or bad things. I look forward to hearing back from joe and some of our staff the went with him, what are the chinese doing that we are not and how we can make up for this. That will be part of our equation and one of the reasons we need priority to send a number of colleagues there in the last two weeks, thank you. Respond to congressman pallones question and echo some of the previous speakers, the past way to curing the sick person is with basic Research Congress funds and dr. Collinss organization distributes into academia. It then goes as necessary to some billion dollars and 23 shortfall needs to be made up and i dont think theres a number wouldnt support in terms of funding the nih and then comes 50 billion a year my industry spends on research and development to take the basic technology and convert it into a real medicine to save a real human life and where does that many come from . Essentially in two sources, sales of products, existing products and investments by venture capitalists and people who buy stocks on the open market. Those investors dont make those investments for the most part because they want to cure disease but do it for return on investment. This enterprise is among the most risky enterprises there is. To most projects fail over and over again, expenditures of money is enormous and most of the products dr. Hamburgs organization approves overturned their investments so in order to continue to attract all of those resources in the process we have to make sure that those investors have confidence that this is a good product, it will be approved in a timely fashion and will be reimbursed in a reasonable fashion and i hate to do this but if you look at the case that is still evolve in which cures hepatitis c, no more liver transplants, it will save American Society enormous dollars it will cost to pay for that drug but in the long run it is because of successes like that that investors will say put more money into this enterprise. I want to bring us back to the idea of Electronic Medical records because i think this idea has multiple layers of benefit to health care and the development of medicines. If we had a Truly NetworkElectronic Medical record system in the u. S. It would not only benefit from saving patients but it would also be a network for Health Care Providers to find nations similar to their and patients in terms of demographics and characteristics to collaborate in terms of treatment and health care and finding out what has worked and what hasnt worked and how can that be done in a more systematic way and also allows to follow patients treated with different drugs according to labels and not according to labels to see what adverse events are related to things that they were intended for or otherwise with the way physicians are treating their patients but in addition it could benefit the cost of Clinical Trials. Right now in Clinical Trials you had your medical record whether electronic or niosh and a data collector that pharmaceutical companies or Biotech Companies use to collect data for the trial and data entered separately it is verified by individuals to go to the site to verify the transfer for verification. Of the medical record was the primary source of official data entry there would be no need for that. Data would be easily upload it and you would be the primary data and no need to clean data which is part of another process of looking for data that is missing so this would have tremendous impact not only on health care in the u. S. But causes of Clinical Trials. Just before we move completely off of the question of nih funding and where it stands in relation to the rest of the world by thought i would raise one point in support of that from an industry perspective. Virtually every major pharma reduced its resources over the past five years and all those same companies are trying to find as quickly as they can better ways to work with academic investigators so both sides play their strength in collaborative way and to bring what pharma does well, chemistry, Clinical Trials and interacting with regulators and works with those investigators to bring basic science. Among those creative ways to Work Together are emerging some three way partnerships with venturecapital community so we are creating companies, creating jobs with those basic scientists to the extent that and i age funding goes away we go from job creation to a static level and job reduction because the investigators no longer have an outlet so everyone loses in this case. The pharmaceutical industry loses, patients lose innovations that comes with Creative Partnerships and the investigators have fewer outlets moving forward. Thank you. I just wanted to chime in. Lets see if we can reach. I wanted to chime in and discussion regarding funding for investigators because i lived through the scenario that is being described and the federal government spent considerable amount of money to train me to become a physician scientist and it is very difficult to secure funding earlier in my career so i went in an entirely different direction and a number of colleagues that were extraordinarily talented. To pursue different career paths with the difficulty of securing funding early in their careers. I wanted to bring that point home. While we are talking about funding, one thread that i keep hearing through all the discussion is cost. The cost of regulation. We can talk about Electronic Health records giving data through that for compared to this and predictive analytics, but the hippo law is going to restrict access to that. It started out as Health Insurance portability and protection act. For the purpose of moving from one Insurance Company to the other and protect that, and so that the information was available, the regulation has come from strangling research as well as the ability to compare the health analytics. It is like a Patient Protection and Affordable Care act, a few thousand pages, it has spun more than 700 regulations and the regulations exceed 21,000 pages. When you look at funding also think about the ability to reduce costs, we are able to use the dollars better than what was in the past. It was the end of july, communicating on how drugs are working in the real world, and we learn all about it. How can we ensure truthful realworld effectiveness, doctors and patients as soon as possible. What role do you see for companies that develop these projects. Let me comment on how important the ability to monitor products in the post market setting is and whether it is the drug lord device, the ability to have that life span approach was enormously valuable and congress has worked with us for more robust market vigilance of roche. And the importance of the interoperability of Electronic Health records. And the post market surveillance in as effective away as possible, but we have systems in place under drug side, the device side to be able to monitor nations experiences with products in the post market setting on the device side, we are in the midst of expanding those activities and it will make a difference. As you are looking at the premarket approval to follow in the post market setting where you learn much in the free market period. And Clinical Trials, they dont give what the real world experience does. That is very important. And monitoring to do studies, how do you communicate, that is a bigger question in many ways because it really does involve partnership of having the information and making available, in the Health Care Delivery system this helping get the information now. One thing that is important is the fda has increasingly realized our Critical Role and rather than operating in isolation trying to work more closely with our stakeholders and partners to get information out whether it is patient groups or Health Care Providers and professional society where the media but that has to be the communication issues become ones where there is two way communication. We need to provide the best possible information as quickly and clearly as possible and using different tools of the media that are now available to us but we need to get that feedback back to us about where the problems are and the gaps in understanding about appropriate usage and if they are not effectively used they dont provide benefit and provide harm. I took your question, and i right about that . I didnt. It might not have been but i will read it in any way. When the drug is approved it has a label and is clear the company that makes the drug is permitted under law to promote the product, positions and patients consistent with the labeling and not because the product has not been approved for the use. With cancer drugs and others to use a drug off the label and beyond the label and sometimes companies, enthusiastic sales forces, commit violations of osha limitations and for that they are frequently find huge numbers, billions of dollars in fines, and a system where a former employee or current employee can blow a whistle, you can get a lawyer and under that situation, the lawyers and whistleblowers can take huge percentages, 10 of what could be a 1 million fine and there are huge incentives and the Company Mitigates and loses they get the list and can no longer have their drugs reimbursed by Government Programs so that is death to a company. That settles a huge amounts. Something we need to protect against bad behavior here. We need more clarity from congress, the fda as to where the lines reasonably should be drawn to avoid the ills that are derived from inappropriate promotion and the ills that are derived from overpenalizing behavior by some portion of the company. To elaborate not speaking from a legal point of view but a medical point of view, very much a reality, we all know that in many areas medical practices especially important and prevalent, you could speak to an apology and awfully believe this and if we could really move towards what we are talking about, more integrated medical records and open means of communication we could learn a lot about off label use that would be very valuable to advance medical practice. The way the system currently works is not an unaccompanied interest to do the Data Collection and studies to bring a product approved for one use before the fda for a second or third off label use but in fact it is important from the perspective of medical care to know as much as we can about those drugs and their use in other medical treatment settings than what it originally came for the fda for approval for. Mr. Chairman, for my intense compliance there are no new words in my world. If that was not your chance let me go back from a safety perspective for the patient the fda is doing the best job in the world when it comes to Patient Safety and theyre Warning Systems with or without post surveillance where appropriate is a new tool to be used in this manner but i do not think we have a Patient Safety issue in this country. The fda is doing an excellent job keeping risky product off of the market taking them away once we found out what was associated with it. Venture capital going to the e. U. What is their record . It depends on how you measure it. There are not more recalls in the European Union than there are in the United States. We have a different recall system but all in all i claim to say i dont have any Scientific Data to support that, we are not riskier in the European Unions and we are here. The company for the industry, i would not have data to support that. My ideal thing is when i look at these two nations with their scientists and regulatory agencies we would work closely together. The products that are already proven in europe we have of fasttrack approval situation in the United States, we are working on let bids, three generations behind and bringing the next generation lipids inches this country instead of working on the next generation, we are working backwards to get the next generation in. If there were a way to fast track and use that data and experience to get these products faster approved, that would make a dream come true for me. Is important to clarify this, the device world is different than the drug world in terms of approval speed and first in where world approvals are happening. On the drug side it really is the United States and we are the model others strive for. There are very different Regulatory Frameworks and i would say that in europe as you well know, after some very prominent safety issues there has been discussion about their Regulatory Framework but the goal is not to look at whos system is better but to look at what is the best system we can move towards the overall and we work closely with our european colleagues. I came back from up meeting where i had an opportunity to be with many of them and what is crucial is that weve really look at the science that needs to drive decisionmaking and when you need Clinical Data and you mentioned the Device Consortium which is a Public Private partnership. Looking at things like developing computer models for doing testing so you dont have to have more expensive and risky Clinical Trials in humans. Using various other kinds of markers, and surrogate end point. There is a lot that is going on and i do think you have to look at the reimbursement framework in europe. This is a discussion we should have more offline. Many products that are approved first in europe with less safety and efficacy data are not reimbursed by the National Authorities but available to patients to support the mandate it is collected. We often use data from europe for approval here but it is a different reimbursement is quite different with the private insurance system. I am glad to hear what you are saying. I dont think we have this sent there. Working together and finding common ways and using each others knowledge to get a product faster but safer to the patients we have a common mission. Progress is being made. I have been asked to save for those folks watching on cspan we want to hear from you. Please email your ideas to cures mail. House. Gov. This has been a tremendous forum. This is a wonderful, and lightning and interesting discussion. Members are going to be having forums like this all over the country in the next month and when we get to washington we will meet together, share the insights we received at these round tables, recommendations and ideas and i would like to thank all the members, panelists for attending today. I would like to thank each of you for taking time to be here and we look forward to working with you in a collaborative effort tomorrow on this. Thank you end this round table is adjourned. [applause] cspan2 providing live coverage of the u. S. Senate floor proceedings and keep Public Policy events and every weekend booktv, for 15 years the only Television Network devoted to nonfiction books and authors. Cspan2 created by