please join me in the pledge allegiance to the flag i pledge allegiance to the flag of the united states of america and to the republic for which it stands one nation under god indivisible with liberty and justice the clerk will read a communication to the senate washington d c may ninth two thousand and seven to the senate under the provisions of rule one paragraph three of the standing rules of the senate i hereby appoint the honorable benjamin l carden a senator from the state of maryland to perform the duties of the chair signed robert c byrd president pro tempore as president the majority leaders recognized this morning of the sixty minutes for morning business republicans control the first half democrats control the second half the following morning business the senate w today i compliment their hard work and the many individuals who work to accomplish this especially senator brown who's an absence the chairman was here throughout the day to assist moving the process along in center has worked very well with some candy in the entire process of getting us legislation through the committee to the floor and now toward completion through the hard work of these that i've mentioned we have only three amendments that are in order a circuit court judge upon the use feeling back of that time then a vote on confirmation will occur once a judge has been confirmed i have every belief the senate will the end and complete process of going to conference and how many motions to instruct that the minority will require some member should be prepared to work into the season and evening on this most important item finding the cloture vote on the most of the water resource legislation will not occur before tomorrow morning throughout the busy day there will be votes occurring so members should plan accordingly on the f d a legislation it's my understanding there will be three votes is that right mr president three votes three votes and then final passage the senators correct to be i would ask again that they there is no time that well the votes all occur at one time ok do many minutes between each vote ok i would ask consent that be the case and i would also ask that there be ten minutes votes on the after the first under the previous order the leadership time is reserved under the previous order there will be a period for transaction of morning business for up to sixty minutes of senators permitted to speak for up to ten minutes each with the first time under control the republicans and the second half the time under control of the majority mr president senator from missouri mr president i'm pleased to report to my colleagues on a trip and intelligence committee trip that  i led to iraq this past weekend with senator snowe chambliss and congressman i said and we found some very amazing things we've visited to create area an area so hostile heavily armed u s units could not even successfully go when it was it was extremely dangerous on sunday as a result of the changes that have happened in ramadi in the last several weeks we the four of us members of congress with the general in charge of the aerial general gaskin troops around us no helicopters flying overhead we got out and walked downtown baghdad firecracker corner so named as one might guess because of the tremendous number of rounds that perpetually were going off in that area it was quiet at the time we went from there into the former and bar college which has become the  security force headquarters for the area of that building is manned by iraqi police units iraqi army units and u s marines they were living together conducting missions together and apparently they have been extremely successful because ramadi has changed significantly and the last three months attacks in ramadi have decreased by some seventy four percent i have a chart here probably not i can't see it too well but this first one shows weekly attacks going from have one hundred thirty five in february down to about twenty four per week in april twenty third twenty through twenty six indirect fire attacks went from one hundred month which in last july were over three hundred twenty came down in march to fifty seven were month sixty seven per month april to twenty eight per month what's going on here it's quite simple the surge and clear and hold counterinsurgency strategy is beginning to work mistakes that we made previously were to go in and take out al and leave well al qaida would come right back in and anybody who had cooperated with the coalition forces would be subjected to death or other severe penalties now w significant noon numbers of iraqi police and army backed up by u s military we were able to go in and clear and hold that's why the marines  iraqi police and army were stationed in downtown baghdad this is becoming and it's not yet a denied zone for al qaeda by one of the amazing most important things an amazing things that's happened having had their family members killed businesses disrupted they have decided that the coalition forces american australian british in cooperation with the iraqi army and police are far better hopes for security and i are making a commitment to go in there they have made a commitment as well and now they are turning over a large there for voluntary in large numbers of young men to serve in the iraqi police and the iraqi army in just a couple of weeks twelve hundred all rocky young men signed up for the army are now over ten thousand iraqi policemen they're being trained and they're taking over the area as you look at the entire scope of ramadi their twenty three tribal areas and they are joining the military in the police force to help keep the area clear the u s military has gone in and was able and downtown ramadi to repair and help reopen the largest most important to broadcast security messages in addition to messages from locally mommas this is just one example that we saw in baghdad we learned that the clear and hold strategy was working in their areas which had been a highly dangerous highly had a high number of attacks daily now because of the presence of the joint security forces iraqi u s and coalition forces have seen the incidence declined by more than two thirds what does this mean well it means that  significantly degraded significant numbers of about god had been killed and detained and others have been forced out of baghdad in al anbar and our coalition forces with the help of a rocky military are i understand doing a very good job tracking them down and eliminating them now this is not conclusi this is only the first results of the surge and the affected counterinsurgency strategy that was recommended by the baker hamilton commission last year and it's being implemented by general petraeus who is an expert on counterinsurgency and i would say that marine general gaskin was running out and bought he was doing a magnificent job and i was impressed with what we heard from general and general mcchrystal and others who are working to make sure that they complete their job we also met with the most influential leader of the shia in iraq solutions and bring together a unity government of sunni kurd shias to ensure their safety and stability of their country so they would have an opportunity to go back to normal lives and prosper we've given them that opportunity need to take that take that opportunity we need to do a better job of telling people the difference and our military is doing that but the same time when we met with our troops they kept asking us why we are getting the money they know they're doing their job and they asked us a question which was rather difficult to answer you're sent us over here to do a military mission we're accomplishing that mission why are we not getting the money we need where are the mine resistant ambush protection vehicles that can reduce injuries and deaths so significantly and there was no and there was no answer other than it's been delayed well the president may i ask for one more minute without objection recognize for additional minute let me let me just conclude by saying that we are making great progress and we cannot afford to tell our troops that we're not going to support them by sending in a bifurcated budget funding a month at a time a month at a time because they've got a they've got a month several months long game plan and when they hear people say that the war is lost they say we're risking our lives every day because the war is not lost what are people in congress thinking we cannot tell the iraqis and our troops that we're going to cut out of here in a couple of months because we will lose the cooperation of the tribal sheikhs and the others who are helping us against al qaida if they think we are about ready to leave and leave them at the mercy of al qaida which will come back again if we leave prior to establishing strength in the iraqi security forces that will enable them to prevent al qaida from taking over their country and make no mistake about it mr president that is the take the remainder this president yesterday i came to the floor with senator from arizona in the month senior senator from texas to talk about rising gas prices this is the sticker shock at the pump is something that all americans are noticing and you know we can talk and esoteric sorts of ways about national energy policy but when people drive up and have to fill up their car to be able to drive their kids to school or to drive to work that's when they begin to understand that the consequences of congress's failure to act in a number of respects you know last year about this time o friends on the other side of the aisle held a press conference over here on massachusetts avenue and we're decrying the lack of action on the part of the then majority of congress to bring down gasoline prices but mr president since that time the average retail price of gasoline has gone up by thirteen cents and i saw today's daybook on the for  that are the new majority the democrat majority is now going to have another press conference over at the same gas station talking about high gas prices but i would suggest this president that the responsibilities of being in the majority are to act not just to hold press conferences and i think our friends haven't quite recognize the fact that they're in charge now they have a responsibility to act and stead of using the same old shopworn tactics of holding a press conference and and launching new investigations and fact the the food the federal trade commission and the department of justice have held extensive investigations already and basically concluded that the problem is we don't have adequate supply and because we don't have adequate refinery capacity to keep up with the demand and as i noted yesterday congress can pass a lot of laws we can even repeal civil laws but we can't repeal the laws of supply and demand and we know that in a booming world economy where there's competition  in india and china countries with more than a billion people each as the economies of other countries become more developed they are going to demand more and more of the same limited supply of oil and that's why we've seen the price of oil go up and gasoline and rather than hold press conferences my hope would be that ark colleagues on the other side of the aisle the new majority that's in charge would work with us to pass legislation which would actually have an impact and bring down gasoline prices bring down or oil prices and enhanced our national security at the same time it's no secret to any of us that most or not most but a lot of the oil that we import comes from troubled regions of the world it comes from other hugo chavez in venezuela comes from the middle east and i don't need to say more about that and how how much of that supply is threatened at times by the bellicose actions of countries like iran arising hope they hope a nuclear power i hope they do not acquire a nuclear capacity because they're a state sponsor of international terrorism but my point is we need to develop more of our domestic resources we need to look for alternative forms of energy that are clean we need to continue our scientific research into things like clean coal burning technology we about three hundred years supply of coal in this country and we all know that  coal can burn dirty but the fact is that by using the technological advantages that that we have in this country we can conduct the kind of research that will allow us to use this  coal in a way that does not pollute and does not endanger the environment and the fact of the matter is we simply can't turn a blind eye to any source of energy and remain competitive in the world economy but the fact of the matter is  that we're simply not going to solve these problems by holding press conferences as our colleagues are going to do apparently this afternoon i think at two thirty or three thirty i can't remember when they did that last year when they were in the minority but you know  they have not quite yet i guess accepted the fact that on november the seventh they won the election and they are now responsible and it means more than just holding press conferences it means action i would tell you mr president that that the republicans are willing ready and able to work with our colleagues to try to solve the energy crisis the gasoline price crisis in this country it's not going to be easy but for sure none of us can do it in a partisan way the only way we're going to be able to do it is by working together in the best interest of the american people and i think the american people are more than a little tired of some of the hollow rhetoric when people talk about problems but you know what when you're in a position to actually do something about it that nothing gets done there is as our leader on this side of the aisle senator mcconnell has noted divided government actually provides an opportunity for us to take on some of these big problems some of these big challenges that are harder to tackle when there is a single party in charge but it takes a spirit of cooperation it takes a desire to actually work together to try to solve these problems the best we can and the energy problem is just one of them i would say that the spiraling debt being accumulated by growth and entitlement programs is another one of them i'm really very very disappointed that this new budget that's going to come to the floor this week later this week does nothing about passing the bu on on entitlement spending and matter of fact it imposes additional debt and burden on our children and grandchildren when we have the responsibility to pay our own bills not use social security to pay for the general debt which we're doing now and other bookkeeping tactics that if we were in the private sector would probably mean that somebody would end up in jail but the federal government plays those sort of budget gimmicks and they need to end so mr president let me just end by saying that this is an opportunity for us to work together but not if we're going to have press conferences and do nothing to talk tough but fail to use the tools that are available to us here in congress as representatives of our respective states to work together in a bipartisan way to try to solve them i think that's what the american people want and that's why i came to the senate i wanted to do something i wanted to actually have it make a difference and i think that all of us feel roughly the same way but somehow we've fallen into these bad habits of partisanship and avoiding the solutions that are readily at floor the senator from wyoming is recognized thank you mr president i want to join my friend from texas and talking about the interest in energy i don't think there's anything frankly when we really look at it that impacts our future and our jobs and our families any more than energy and availability think about for a moment what we actually use each of us every day we drove here in our cars energy lights up here energy air conditioning our heat energy and then of course in the whole economy so i want to talk about some of it in the context of high gas prices in the course americans are experiencing that right now we have passed them on the energy committee and we have passed good energy policy in the last couple of years we've already begun to see some of the benefits of  of that passage there's no question about that but there is much more that can be done and unfortunately we've gone along here a good deal of the time this year and haven't really done much about it so we really need to accomplish some things and the high price of gas of course is touches all of us but it's particularly important in a state like mine where people have to travel so far for school or work or other obligations yesterday the energy committee of which i'm a member scheduled a hearing on the short term energy outlook for oil and gas this hearing will be held next week but that's not enough just having hearings is not enough as having press conferences is not enough we need to we need to move forward and what is the answer to high gas prices of course the simple economics of it is supply supply and demand one option is to drive less of course and we can do some of this we can have more efficient cars and those kinds of things but we must drive to we must drive we have to have energy and we do that so there are some things we can do that but the other one and the one that we can deal with is increasing supply my friend from texas makes a good supply and demand and that's where the impact is on the price the economic factor must be informed in this debate we're certainly  consume our energy in more efficient ways and we should we should do that and i support those efforts and i'm glad to be a co sponsor of a bill out there as ninety nine two that does that but we also have to pass alternative fuels and i am for that but i think we have to be really honest on alternative fuels as to what kind of an impact that's going to have in the relatively short time i'm all for these kinds of things but there's wind or whether it's sun or whether it's whatever but it's years down the road before it will be able to do the kinds of volume that's necessary for energy so i think my real point is that in the meantime as we look for alternatives as we look for various things there are things we can do now and that's what we need to do to deal with our needs in the interim well these other things are being decided so i'm hopeful the majority will bring the legislation to the floor that allows us to provide americans with secure affordable and a responsible supply of energy and i'm convinced that unless we move forward the majority however these fuels raise the cost of corn they raise the cost of livestock feed and subsequently meat groceries they cannot be transported in our existing system you can't put ethanol into pipelines and mov the advanced technologies are not commercialized anywhere in the world so along with senator bunning i offered an amendment to add coal to liquids and coal to liquids does not suffer from the shame same shortcomings as as ethanol it will have no impact on the affordability of food you can be delivered through just in pipelines coal is available is one of our our most abundan t resources as a matter of fact it's the most plentiful supply of fossil fuels that we have in this country is coal and coal has the potential to be converted to liquids into fluids and  electricity on the spot so these are the things that need to be done and we spent most to most of two hours talking about this amendment and we see seemed a great deal of support however when it came down to the bottom line it was a party line vote twelve to eleven and defeated that so i'm going to bring it to the floor when this energy bill comes because i think we need to look at the short term impact and here's one the conversion of coal to liquids that can work we're doing some of it now in a very small in my home state of wyoming we're developing a new refinery that's going to take coal and turned it into diesel fuel but until we get out there with real long industrial union council air transportation association all these people know i'm important you have energy you have available there's a list of about fifteen groups of this kind that are supporters of this they're boil supporters necessarily they are business people who know how to meet our needs we have to have energy so let me read the letter that they wrote in this century america cannot be secure unless its energy supplies are secure fostering greater reliance on domestic energy is a national security imperative the nation's abundant and affordable coal reserves matched with a proven technology can put america on the path to energy independence by dramatically reducing our growing dependence on imported oil and reducing our burgeoning trade deficit messed the production of coal to liquids you will see billions of dollars invested in new investments made in united states and create thousands of new jobs so that's not the end of the letter but that's the message from groups that are not directly involved in energy but know the impacts of the shortage of energy and what it will do so i could not agree more with the role that these folks see in the future  refrain from offering our amendment but we did not wait we believe strongly in the purpose of the energy committee is to develop the best possible approach we have to dealing with the energy problem and to dealing with it not only in the long term but in the shorter term foyle we reach those long term goals that may be there so we did not achieve our goal there and that's why we want to move forward with this and to see if we can get coal to liquids in our energy policy and get some incentives there to move forward with this i want to work in a bipartisan way to address the current concerns that our members have i'm hopeful that we'll have the opportunity to revisit americans are suffering from high fuel prices and we should do everything we can to remedy that situation and we have to do more than just talk about it more than have press releases more than have those kinds of things we need to make a move to take our largest fuel resource fossil fuel resource and make it available for domestic gumption mr president thank you and i yield the remainder of my time a after the koran call be dispensed with without objection when i'm president i ask to speak as if in morning business for five minutes without objection thank you madam president come to the floor this morning really with a lot of enthusiasm for where we are making progress in various committees in the united states senate towards a policy that we can discuss on the senate floor in regards to energy independence and i'm very excited about that have been having participated in the two thousand and five energy legislation that was a great bipartisan effort by my colleagues to work together to pass what was a basic energy bill in two thousand and five that i think my state reaped many benefits of the new technology and wind and solar giving tax credits for a short period of time and working ahead on bio diesel in the great production of what is now a hundred million gallon biodiesel facility that's under construction in washington state so there were many great things about the two thousand and five energy bill and the fact that it was a bipartisan effort albeit i wished it had been a much more aggressive effort on energy and i think that's where we are today on the precipice of a great energy opportunity now senator reid has been very specific since the beginning of this legislative year that he wants energy independence to be a key priority and wants to see great success on that legislation in fact there are six different committees that are working on energy legislation the agricultural committee the finance committee the commerce committee the e p w committee the homeland security committee and the energy committee and so all of those committees are working on legislation and they're working on legislation in a bipartisan fashion in fact two of those committees have reported quite significant energy legislation working across the aisle to make sure that we are getting the best ideas out here to the senate floor and continuing to discuss those ideas that obviously at the committee level we haven't been able to reach consensus so just in the last few weeks i have to say yesterday was quite a historic day because it's the first time in twenty years that we've been able to in a very bipartisan effort put a cafe bill on to the senate floor that i hope we will be discussing soon to lower to actually increase the fuel efficiency standards of automobiles and hopefully lower our consumption of foreign fuel if we can move from the current mpg standard of twenty five miles today to thirty five miles in a ten year period of time that will be a great accomplishment attached to that legislation is also very important consumer protection legislation to really give the federal trade commission the tools that it needs to protect consumers against price gouging currently our statues that the f t c have ability to look at are based on antitrust laws they're based on whether we think oil companies are colluding to set price what we really have questions about is whether the individual companies may be doing activities that actually take supply offline and thereby increase the supply because there are shortages so let's give the f t c the authority that it needs to have strong consumer protection laws and to make sure consumers are protected so that legislation passed out u nanimously as part of a package out of the commerce committee yesterday because of the good bipartisan efforts and more by the chairman of that committee senator in a way in the ranking member senator stevens working together to pass bipartisan legislation and again not everything complete they're not everything everybody wants to see but at least legislation that is historic and will come to the senate floor for all of us to discuss and just recently we passed out of the energy committee again i think very positive landmark legislation as it relates to setting a higher mandate on biofuels that is in the last energy bill that we were able to pass we said that we should have a goal of producing seven point five billion gallons of bio fuel a year by two thousand and twelve now both the president and the congress are trying to chiva higher goal and we have just in this legislation passed out a goal that by twenty twenty twenty two we would actually have a mandate of having thirty six billion gallons of alternative fuel produced in this country so that's quite significant  goal and mandate for us to achieve that will really start producing alternative fuels that we can use in this country in addition that legislation had money for what we call a biofuels infrastructure how do we actually get this product out there into the corridors of transportation so the public doesn't have to worry about their cars and filling them up they actually will have the infrastructure to do that in the commerce committee legislation we actually produced a legislation focusing on flex fuel cars so that we can actually have by two thousand and fifteen eighty percent of the cars being driven on our roads be flex fuel cars those are cars that could either use gasoline or could use an alternative fuel and we also have passed legislation out studying plug in hybrids and making sure that the plug in hybrid research continues to move ahead and in the energy bill there was also language about carbon sequestration and making sure that we move ahead on making sure that carbon see question is a reality again very important bill as it relates to my senator bingaman for working so closely together because that legislation also passed out on a bipartisan effort and was a great complement to those two distinguished senate hers who had worked so closely on the last energy bill to produce another energy bill so we're well poised for a very positive impact on what i think is one of the biggest challenges that we face getting off our overdependence on foreign oil giving us cleaner sources of renewable energy and we are well poised to take up that debate here on the senate floor with a landmark legislation out of two different committees in a bipartisan effort so we'll have a lot of work to do across the aisle we still have great opportunities to see legislation out of those other four committees that i mentioned that will contribute to how we see our way through this energy package but we should embrace the opportunity that the president laid out in his state of the union when he said he wanted to make sure that we had a fuel efficiency standard that we set a higher renewable fuel standard and that's exactly what we've passed now i'm sure we're going to have other debates where we don't agree i personally think we should set a renewa standard for amount of electricity we use from our electricity grid to get off of fossil fuel so those will be things that will be debated and i'm sure later in the year we'll have a debate about climate change or sometime in the near future but for now we are making great progress and i hope that my colleagues will focus on the fact that this legislation that is moved out of committee on a bipartisan basis gives us another opportunity to work together here on the senate floor to continue this great effort and really put some solutions before the american public right now with gas prices reaching four dollars americans want to know that we are going to have an aggressive policy not only in giving them consumer protections but better planning for the future so that our economy can benefit from alternative sources of fuel i thank the president and i yield the floor business is closed under the previous order the senate will resume consideration of senate bill ten eighty two which the clerk will report telling number one twenty s ten eighty two a bill to amend the federal food drug and cosmetic at reauthorize and then the prescription drug user fee provisions and for other purposes not to present under the previous order there be sixty minutes for debate to run concurrently on the bill and remaining amendments with ten minutes under the control of the senator from iowa grassley or his designee five minutes under the control of the senator from illinois illinois mr durban or his designee and the remaining time equally divided between the chairman and ranking member of their or their design of this legislation we have some important matters to consider which we will and just a very short period of time but as we're coming into the closing at times for this a minute i think it's  appropriate that we just review very very quickly what this legislation does but it does not i'm a strong believer that this legislation which has a strong bipartisan support and i'm enormously grateful c and to the members on our side of the aisle as well as on the other side for all of their help and assistance in getting us to the point where we're going to take a final action on something that makes a major difference in terms of families in america ensuring the safety of our prescription drug system and also doing very important making very important progress in terms of the safety of our food supply so this is real i think in a very important way breakthrough legislation and just to review very quickly what it does and then we'll come back to the amendments that are before the senate and how we think of the senate should dispose of them why this legislation safer food and safer descriptions safer medicines for the families in this country we spelled out at the earlier part of our presentations the elaborate scheme that we have supported to make sure that we are going to have the safest kind of prescription drug program the safest day in the world and using the modern range of different kinds of technologies and also modern of surveillance systems to be able to detect it post marketing surveillance which will ensure that in the future we're going to have the safest prescription drug program in the world and we're doing the same so we have we will have safer medicines well also have safer food for families and their pets i think all americans have been alarmed as they should have been what has been reported in the news in the very recent times and the many families have lost their pets in these recent times because we did not have an agency that had the kind of authority that this agency will have and that is in this legislation will have the earlier warnings on drug safety problems with the extremely elaborate systems that we have on the post marketing surveillance and using both public and private senses and modalities that collect information and that the f d a will be able to draw iran to make sure that if there are only warning systems the agency will be able to take expeditious de wine who's not here but others on the republican side to try and make sure and understand that children are not just little people the children are children and therefore they react to their bodies react as they're developing differently in terms of various kinds of prescription drugs and to both get the reaction on children as well as to provide incentives to try to meet some of the children staleness is diseases we build on that mr president and that is enormously important we've made important progress we believe that this legislation will help even to a greater extent we're going to have much more transparency and stronger science at the f d a the wonderful work that has been done by sen others in terms of the transparency so we have greater awareness the public is more involved in what is happening at the at the agency and the greater focus and attention in terms of making sure that the agency is going to have the best in terms of the new sciences where in the light science century at the present time this is a been impressed again i think in the country with the extraordinary convention and bio sciences that took place in boston in the last few days and listening or reading about the various panels that they have in the potential that the life sciences have not only in terms of energy not only in terms of agriculture but also in terms of medicines and the united  absolutely poised to lead the world with all of its implications of althea families air and all that we can do for other countries around the world and we need to make sure that we're going to have the best kind of science at the f d a we try we do public and private funding that will seek out the best and the newest in terms of modalities to be able to review various prescription drugs to make sure that they get advanced quicker and safer in terms of evaluations in the future and that's going to be enormously important because time means cost if we're able to get matters on with newer kinds of modalities the cost will be more understandable and reasonable to consumers and we will get  function that ought to be considered in tandem mr president i know there be those that want to think that we ought to separate those functions i feel to myself another another two minutes they that they ought to separate those we can imagine a circumstance for example that we have the side reaction of a particular drug is that individuals lose all of their hair and they become noxious on that well clearly i'm describing the impact of met they could have on an individual that is a basis for many anti cancer drugs you wouldn't approve that for athlete's foot because the side effects are so dramatic but you would prove that as part of a not a kind of regime to try and deal with the problems of cancer and that is the kind of that we believe that we have been able to pass them here i respect those that think that those ought to be separated and we also have the items on civil penalties for the first time there's a question about how what those civil penalties would should be i kind of like it to be higher but i'm mindful as well that this is the first time we have the civil penalties we're going to be working on those matters on the with the house i basically think they should be a little higher but i i listen to my colleagues on this issue and we're going to try and make sure that we get something that's going to be fair and to do the job i'm also mindful mr president of the concern that we have in terms of the potential of conflicts of interest and i'm going to reserve my time to be able to deal with this issue this is a very very important issue we want to make sure on the one hand we're as we have these breakthroughs in terms of science that we're going to be able to have  best that we have in terms of the country participating in these review groups but we also have to be sensitive to the issues of the conflicts of interest i know the senator from illinois has a proposal on this and i'll reserve the  of the rest of my time to be able to discuss that the late late if the president feels time man approached her from illinois i have an amendment pending and scheduled for a vote this morning on the conflict of interest provision a food and drug administration advisory committees make important decisions life and death decisions they decide whether the drugs and medical devices which are going to be used in america are safe and effective in other words if a person in america has a prescription from a doctor and takes this drug is it going to be good for their health or bad this is a really critical decision if they make the wrong decision if this advisory committee turns a drug loose on the market that's dangerous it could have terrible consequences so these advisory committees literally have life and death decisions in their hands on approving drugs and deciding what the warning labels say deciding what to have to say in advertising might be a danger of this drug these advisory committees are the juries of experts scientific experts who have to make these calls one of the most important decisions in our government and they're not just life and death decisions they are decisions involving millions and millions of dollars drug companies spend a fortune and a long period of time trying to bring a drug to market they would hope that this will be a drug very popular and profitable for them and their shareholders that's a natural inclination of a business so the advisory committee not only decides the safety and efficacy of the product it makes a decision which has a direct impact worth millions of dollars to the drug companies involved but you know we found out we found out over the last ten years that many people sitting on these advisory committees those who are actually sitting on the so called juries deciding the fate of these drugs have a conflict of interest some of them were already receiving from the companies that make the drugs tens of thousands of dollars and consulting fees and speaking fees it turns out that they're on the payroll some of them of the very companies that they're being asked to stand in judgment of that's a conflict of interest which people just can't accept and i can accept the food and drug administr argues you know there are so few experts that we really have to sometimes turn to those who have a conflict of interest there's no place else to go so occasionally we have to put a waiver in and allow someone to sit on an advisory committee panel who frankly has a financial interest in the company that they're making a decision about now that worries me because if you're going to have truly objective decisions that are right for the consumers of america that approve drugs or disapprove them on the merits not because of some inclination or prejudice which you might bring to the table you don't need these conflicts of interest so basically what senator bingaman of i and i have said is let's strengthen the conflict of interest provisions on advisory committees let's make certain that there is confidence in the process we know what happened with vioxx there were ten people sitting on the advisory committee who had a financial conflict of interest had they been removed from the deliberation the drug would not have gone back on the market in danger in the health of thousands of americans how can you ever justify that kind of conflict of interest our language tightens it up what we're trying to do is to make sure that the food and drug administration with this amendment limits the number of waivers to one for each advisory committee meeting allows it buys very committees to receive information from guest experts who have a financial conflict but prevents those experts from participating in the deliberations they can come in and express their point of view and then leave the room before the deliberation and the vote take place and strengthen the provisions to increase the outreach for new experts the food and drug administration has to do a better job of cultivating this new qadri of trustworthy experts who can serve on these advisory committees we have one hundred twenty five medical schools in this country ninety schools a pharmacy forty schools a public health if the f d a is more aggressive filling the slots on the advisory committees we can remove the shadow of doubt which is over the this process now some will argue well the f d a has come forward with draft regulations to improve this they are draft regulations they are suggestions this is law this tells them that they will have to follow the law to avoid these conflicts of interest this isn't just a an idea that senator bingaman i bring to the table without support i'd like to ask unanimous consent madam president to close and  the record here with my remarks letters from the consumers union the union of concerned scientists and a broader letter with eleven different organizations that support this amendment that would reduce and eliminate the conflicts of interest when it comes to approving new drugs and medical devices what's at stake here is the integrity of the food and drug administration the integrity of the process and making certain that we can say with a straight face to american consumers the products that are coming to the market the life and death decisions that are being made to bring them to the market are being made by people that don't have a financial conflict of interest when they're healthy is decide minute i urge my colleagues to support the durbin bingaman amendment as can animate and sent these letters me into the record after my remarks without objection to yield time senator from wyoming madam president i want to thank the senator from massachusetts senator kennedy for the statement that he made a little bit earlier but mostly for the two and a half years worth the effort that he and have put in on this this bill it's been a very cooperated process between he and i and between the members on both sides of the aisle on the committee there have been a lot of things raised about food and drug safety particularly drug safety and it has been acquired process as i mentioned we've had a lot of questions we've had some disagreements but what that's resulted in is going back and getting more information finding a way that we can come up with a solution that will provide more assurance to americans that they are drugs will be safe and i also want to thank the people at the food and drug administration for their participation in this lengthy process and providing answers it's been a long road for this bill and i do strongly urge my colleagues to vote yes on final passage and endorse the most comprehensive drug safety overhaul in more than a decade completion of this bill march yet another significant step in the process but there is more work to be done the house needs to pass their version of the legislation and then the two bodies need to work out differences in the conference committee my hope and expectation is that the house will act in a reasonable manner and soon because this is widely considered to be must pass legislation this key f d a package includes for reauthorization that must be done this year along with the central new authorities for the f d a to be able to react in a timely way to safety problems that arise after a drug has been brought to the market i'd like to take a couple of minutes to recap for my colleagues the path this legislation is taking that's far the senate committee on health education labor and pensions conduct a top to bottom review of the f d a as drug safety and approval processes over two years ago we did that at the same time that the finance committee was doing a review of the f d a is safety approval processes we use that information plus information from other senators to do this bill this bill is a culmination of that review and our continued evaluation and analysis of the f d a the changes made in the drug safety components of this legislation are critical to restoring the peace of mind to americans who want to be assured that the drugs they purchased to treat illnesses and chronicle medical conditions can be relied upon and trusted giving the limitations we identified during our review of the f d a i strongly felt it was necessary to correct those problems and ensure that the f d a has the right tools in the tool box to address drug safety after the drug is on the market that's why this bill creates the risk mitigation strategy or rams the rams gives f d a the full toolbox of options for dealing with potential safety problems even if they're discovered after the drug is first marketed our goal is to get drugs to market quicker and to discover problems faster and get them corrected with this new tool box f d a has the ability to identify side effects after the drug is marketed through active surveillance f d a also has the authority to request a separate study or a clinical trial to learn more about a particular potential safety problem f d a can also obtain timely label changes for the first time under this risk evaluation and mitigation strategy system through the rems process the bill also makes several key improvements to how patients get their information through advertising and labeling and i want to thank my colleague senator roberts for his tireless efforts to provide an appropriate balance for direct to consumer advertising it was not an easy task to reconcile some very different opinions and i am so pleased that we were able to reach a resolution on this issue that we could all support i also thank my colleagues senator hark and senator kennedy for their hard work on this issue senator roberts had planned to vote for s ten eighty two that cannot be here today because in kansas showing the president the damage from the tornadoes i wish him all the best in helping his state to recover from that tragedy the f d a currently has very little authority to require labeling changes after a drug is brought to market we have included provision that ensure that discussions between f d a and the drug manufacturer regarding the labeling changes come to a close quickly and effectively rather than relying on f d a as nuclear option which is pulling the drug completely off the market this legislation gives f d a the tools needed to get drugs to the market quickly and efficiently and to respond to potential problems the same way especially when lives are on the line and people need new drugs and therapies f d a currently has no mechanism to active routine surveillance  potential safety problems it cannot easily detect safety problems after a drug has been put on the market this legislation fixes that challenge and ensures that f d a has the right tools to address drug safety after the drug is on the market the legislation allows for routine active safe monitoring using a large linked databases with what i call health i t for drug safety i want to thank senator gregg for being the champion of this provision  ensuring that we crafted this provision appropriately not every drug will need a ram's however every drug will need a very active f d a and the f d a with all the necessary tools to identify and quickly manage additional risks title four of the bill before us contains a number of critical provisions to improve children's health up to seventy five percent of drugs used by kids have not been tested in kids without information from pediatric studies kids are often overdosed underdosed or receive an effective treatment they may suffer needlessly or even die the best pharmaceuticals for children act makes drugs safer for kids by creating incentives to perform pediatric drugs steadies the incentives have produced astonishing results in seven years before the p c a incentives a total of eleven pediatric studies were performed seven years eleven studies in the ten years since incentives were authorized at least one hundred thirty two studies have been completed and more underway as a grandfather i am very happy that the laws in place if my grandson trey is sick i want the drugs he needs to have been tested for kids all of us want that for our children and grandchildren the bill also out reauthorized has a companion statute the pediatric research improvement act which enables the f d a to require a pediatric st if it's not done under the incentive program or through the national institutes of health these two laws work together as a carrot and a stick and i strongly support their reauthorization and continuing to keep them together and so far i've only talked about drugs for kids the bill will also make medical devices safer for kids devices designed for adults might not fit in kids a scaled down device might fit at first but the child grow out of it so doctors have to jury rig adult devices improvised or use more invasive treatments in addition the market for kids devices is small and the development costs are very high so few kids devices get made that bill before us creates new incentives to grow the market for kids medical devices and i'm hopeful e's new incentives will be as successful as the kids drug incentive i'd like to thank senator alexander senator allard senator bond senator dodd senator clinton and others for their leadership in behalf of kids a number of other f d a issues were also addressed during the debate of this legislation that legislation was improved when the senate adopted a food safety amendment by a vote of ninety four to nothing this amendment adds additional food safety provisions for to better protect our pet food supply and track when food is adulterated my colleagues and i also reached consensus that the issue of follow on biologics will be addressed in the health committee earlier this summer as my colleagues know i have some concerns with the dorgan amendment on drug importation that was adopted last week and i supported the cochran safety of minute that was also adopted i didn't support the dorgan approach to foreign drug importation because i don't believe that adequately ensures the safety protect prescription drugs and play i was pleased to work with my colleague senator dorgan to add some very significant added counterfeiting language to the bill in the manager's amendment but a lot of work still remains i support the process moving forward and i'll continue to work with my colleagues and senator dorgan and senator snowe to improve this language during the conference process finally i'd like to thank senator hatch for his work on the antibiotics and other  follow on biologics senator hatch was responsible for the first f d a revitalization act in one thousand nine hundred before i was even elected a member of the senate and i'd like to thank him for helping me to bring that full circle and for the mentoring he's and for working with us to address these issues in appropriations bills during the past year there are many includes many thought proposals i support their their right to call for an f d a to improve its outreach to experts that have no conflicts of interest and their right to call for greater transparency in the process of the waves but where i just disagree with my friend from illinois and new mexico is on the idea that there should be an inflexible cap on the number of wages for conflicts of interest that are biased recruit committee can grant no matter what the expertise of the science scientists involved memo would impose a one size fits all one waiver for conflict per committee relegating any additional members with conflicts to a secondary guest status on the committee the f d a has recently issued a policy not to grant a waiver for a financial interest that exceeds fifty thousand dollars and will allow those who receive a waiver for a lesser conflict to serve only as members who can participate in committee discussions but not vote the hallmark of this proposal is the flexibility it gives to ensure the committees will have the adequate expertise if one or more expertise with financial conflicts in excess of fifty thousand have expertise this essential to a committee the commissioner can grant the needed waivers this is expected to be rare but it can happen if needed and under the durban amendment by contrast the f d a can grant only one waiver for meeting and that's no flexibility on this point mr president experiencing difficulty in filling vacancies on advisory committees and the durbin amendment no matter how well intentioned would worsen the problems making it hard to pale critical vacancies and slowing the process of reviewing new medicine let's look at the problem f d a is facing now the antiviral drugs advisory committee needs six experts with specialized knowledge in the fields of clinical pharmacology internal medicine infectious diseases microbiology respiratory therapy devices panel has nine vacancies the op balik drug advisory committee is needed nine experts the advisory committee on peripheral and central nervous system drugs needs six members on and on down the list the stories of same critical vacancies missed opportunities and miss expertise i'm not for conflicts of interest i'm against them but they are a fact of life we can't wish them away we need policies that reflect the current reality of research in the life sciences we have increased the transparency in this legislation so they'll be wide understanding of is exactly how decisions are made and this is we all failed is that the most important in the time of the life sciences we're talking about the cross fertilization of different ideas visit the institute of medicine they're talking about the life sciences and the work that is taking place flip a molecule and it can be relevant to alternative fuels flip it again and again to be relevant to agriculture flip it again and it can be relevant to the health sciences we need all of these kinds of disciplines working together and to take one particular  requirement and to exclude the possibilities of getting the best in terms of future scientists we need integrity and the f d a integrity and that decision making integrity when they grant those waivers and the public ought to have the right to know i think we have a balance in this amendments important because asked ten eighty two does not sufficiently address the underlying problems that i have found existing at the food and drug administration during my ten as chairman of the senate finance committee looking into the problems of the food and drug administration with the goal in mind that the federal government should only be paying for drugs that are safe that problem that i just expressed is the lack of equality between the office a new drug which reviews drug applications and decides whether or not to approve a drug for marketing and the office of surveillance and epidemiology the office which monitors and assesses the safety of drugs post marketing the institute of medicine now many times institute of medicine for justification for my amendment they recognize this problem the institute of medicine recognizes joint authority between these two offices for post approval regulatory action related to safety even the consumer union support system and having a quality between the pre approval and post approval offices at the f d a is fundamental to real reform concentrating on the entire lifecycle of drugs is critical after all the vast majority of a drugs life cycle is spent post approval in essence the bill before is promotes a status quo when it comes to the specific role played by the office of surveillance that means the office or surveillance and epidemiology will remain nothing more than a mere consultant to the office a new drugs and this is not acceptable amendment ten thirty nine gives the office of surveillance sign off authority they are experts and post marketing safety even the institute of medicine recognized that through their recommendations let me be clear this is not the amendment that senator dodd and i originally proposed i still believe and independent post marketing safety center would be best to solve this problem but under the process that is not going to happen at least joint then through this amendment at least joint post marketing decision making between the officer surveillance and the office of new drugs will allow the office w post marketing safety expertise to pay have a say in what drug safety actions will be taken by the f d a the problem here is not only that the f d a having enough tools this bill gives additional tools it's about f d a managers disregarding the concerns raised by its own scientists in the office or surveillance and not taking prompt action th amendment makes common sense when you weigh the evidence that i presented over the last three years about these problems at the f d a opponents to this amendment say that this amendment is on necessary because the bail includes a dispute resolution process was strict guidelines deadlines but that process is for disputes between the f d a and the drug company not internal disagreements between f d a offices getting down to brass tacks when the office that looks at post marketing surveillance is under the thumb of the office of new drugs the office of new drugs said this drug would say they else time madam president senator from wyoming myself such time as i need i do rise in opposition to the amendment offered by my colleague from i was under grassley number ten thirty nine regarding the joint signing authority under the office of new drugs and the office surveillance and even epidemiology this amendment would add an unnecessary layer of bureaucracy that we designed into into an agency that we've designed to be  responsive in their process to deal with emerging drug safety issues that before the bill is passed the option after market is to suggest changes or pull the drug off the market kind of a nuclear  option the underlying bill has surveillance and techniques to notice problems quicker that's why we'll be able to get drugs onto the market faster and the underlying bill does have a dispute resolution process with firm and t deadlines and there is both one with companies and with staff disputes and it requires its very nature close call it a collaboration between the two offices there's a man with only serves to separate out what should be a together process and delay what should be a rapid process so i would urge my colleagues to oppose this this amendment i think that the tools we put in the tool box will do what the senator from iowa wants to have done which is a quick response when there's a problem and i hope that we don't add this extra layer of bureaucracy we looked at this problem through a number of hearings and a number of concerns by people and again on the committee on both sides and came up with this third way for being able to do it that hadn't been polarized and that had some agreements and so i hope people will stick with what's in the bill  and preserve the balance of my time provides for the application of stronger several monetary penalties for violations of approved risk evaluation and medication strategies currently the bail before us contains penalties but those penalties won't mean much to large global corporations in fact the penalties amount to the cost of doing business this amendment is intended then to give the food and drug administration the watchdog some bite along with this bar there is opposition to having strong civil monetary penalties but that just does not make sense to this senator even the consumers union supports this man the reality here is the drug companies provide life saving farmers because throughout the world the pharmaceutical companies make miracles happen before a drug is approved a drug company has an incentive to provide evidence of a drug's effectiveness to the food and drug administration without it they can't sell drugs in this country however once a drug is already being sold in the marketplace drug companies have almost no incentive to look for and evaluate the safety issue the bottom line is that sometimes market forces guide businesses in a way that may be contrary to the public interest we have seen this happen many times for the food and drug administration's new authorities to be meaningful in this legislation there must be stronger civil monetary penalties that are in the underlying bail hence my man if fines are nothing more than the cost of doing business we can't change behavior more importantly you can't even deter bad behavior after all if a company does what it is supposed to do a drug company doesn't need to fear any penalties it's just that simple i asked members of the to just make this bill even better and they have already included several ideas that senator dodd and i have shared with them i reserve the balance of my time t time myself such time as i need i want to thank the senator from iowa senator grassley for his participation in this bill it has been tremendous i mentioned the hearings that he held as as we were holding hearings as the recent crisis with food and drugs and the valuable information that he shared with us as well as amendments as as he has correctly stated are already a part of the bill safety plan and i appreciate my colleagues comments earlier senator kennedy the level of senator civil penalties in the underlying bill was carefully crafted to reflect existing f d a policies for other regulated products but this is the first time that we've had civil penalties in this portion covering covering this area of food and drugs and it was no small feat to be able to get again  consensus position so that we could have civil penalties in the bill and i do think that that is necessary and there is a precedent for the levels that we've selected the current levels the medical devices has the same levels and i want to reiterate again that that's never before been available to the f d a as a tool on drug safety issues but we're providing it as a tool for the more i believe that the very threat a penalty is sufficient to deter bad behavior this is the name and shame principle the fine may be affordable to the company but the loss of their reputation isn't and i would urge my colleagues to oppose this amendment as well this is not the end of the process and i suspect that the house will have something to say on it as i've mentioned to the the senator from iowa before and yes there will be additional negotiations i'm certain civil penalties  and i would i would hope that we would stick with the civil penalties that have the basis in the medical devices as some basis from which to do the negotiating and i would hope that that the senate position would be the one that's in the president i'm going to support the comments of senator enzi as mentioned about the fines we're going to have to look at this in conference and it's clear that the house is going to have raised the fines it does seem to me as the  had pointed out so we'll have a chance to look at it in conference i think that's probably the best way to do it let me just point out two other items mr president and that is something that i think most americans have been concerned about in recent times that was being reported today that china has detained managers from two companies linked to contaminated foods as a first step we needed to do turn in the extent of the contamination and see how far into the food supply this internal adult ration is gone yesterday's report from the f d a that contaminated wheat flour from china was fed to fish raised for human consumption is another example of the need for a comprehensive examination of our foo safety system we also found out yesterday that what we thought was contaminated highly processed we've gotten was actually just on process wheat flour spiked with melon i mean to make it appear to be higher quality months ago the f d a war that certain types of pet food were suspected being contaminated then there were more kinds of pet food that it was hard being fed the contaminated food but that those had been a quote before human consumption and then we found out the tens of millions of chickens eaten by people have been fed the tainted food yesterday were informed that fish raised for human consumption had been put to bed contaminated food the incremental expansion of this crisis raises serious concerns about the f d a s ability to rapidly identify the source of food related problems and bring to bear the effective tools we know that issue food safety is divided into different kind of committees but it is has to be of concern to the american families we have included strong new protections allow f d a to better ensure the safety of human and pet food but this is just a first step send to n z and sent to durban to join with me and others and we are committed to taking a comprehensive look at the safety of our food supply and we are committed taking the actions with our colleagues here to needed to ensure that the foods of our families and pets are as safe as possible as part of the manager's package adopted last night we included important new provisions to allow the f d a to oversee the safety of farm raised different agencies in the the what they call the health research and quality art has responsibility in this and we will be in touch with them to examine this issue  provide better guidance of recommendations to doctors and patients the f d a does not practice medicine but we this kind of action has to be of concern because it reflects itself an increased cost to the american consumer and it does raise health issues as well so this is just illustrative mr president of the range of different areas of concerns that the american families have we believe that we've made a very important  center from miami mr president i have to i have to make some comments in regard to the other amendment that will be voting on this morning which i also hope people will oppose that's number ten thirty four offered by my colleague from illinois senator durbin  a relies on thirty thirty advisory committees to provide independent expert advice which lends credibility to the product review process and informs consumers of trends in product development given the complex issues that are considered by the f d a outside help is needed and beneficial and it's just advisory the decisions are not made by the committees they advise but any scientist who is expert enough to merit interest by the f d a has almost certainly merited interest by other entities such as granting agencies and companies involved in the field this amendment would seriously limit the f d a as ability to access the best experts in the field to assist the agency with its decision making process it would restrict f d a to granting only one waiver per committee meeting now how would the f d a decide who gets that one wave or who's more worthy of the toxicologist the drug safety expert the specialist in women's health these aren't easy answers in march released a guidance document outlining strict new limits on evaluating advisory personnel committee members for service the comment period on this and says not even close it's premature to void that guidance before we even know whether and how it will work let's take a step back and think about what might happen if we don't allow people who have worked with or for industry to be involved in an advisory committee meeting louis past two or was a brilliant microbiologist who revolutionized human food and health safety every time you buy milk in the grocery store you're benefiting from his contributions to society but under the durban amendment passed through or would probably not have been able to serve on any advisory committee you see pastor's research was funded by the wine industry now do you really want to prevent the f d a from benefiting from the advice of the best and the brightest that they have to offer we do want to move so that there are not conflicts of interest i think that the guidelines that are out there if finalized will will do that and the bill the amendment almost gets into a position of not conflicts of interest but bias is much harder to determine and if we're going to do that we'll never be able to have anybody on any of the committees particular with expertise that we need so i would i would ask that we oppose that amendment as well and i would i would yield time compromise on this important measure up to go on a note senator roberts was unsure metal in working out the problems with direct to consumer advertising provisions i know he would have i've been here today to support this bill but he's out in kansas with the president during the hurricane damage and his and his state and also i want to commend senator cochran we appreciate his efforts to ensure that any proposal to bring drugs down from other countries must be certified by the secretary of health and human services a safe for the american people so again i thank the senator from wyoming for his extraordinary accomplishment in moving this important bipartisan legislation  own myself such time as i might consume and i won't have two and a half minutes left on the very important amendment about making sure that there's adequate cooperation and and  dialogue between the office a new drugs in the office a postmark of surveillance i want to make clear that this amendment is not as some have characterized it as being about process it seems to me that this is the ultimate of insurance to do the right thing to protect the american people on the safety of drugs and it's based on so many examples that i found over the last three years where there was not the respect for the office of post marketing surveillance that there ought to be from the office so new drugs and and and a lot of safety issues would not have gotten out if we had not had a lot of red blooded patriotic whistleblowers that would come to congress like dr graham for instance in the case of vioxx like dr marshall or in the case  of drugs for depressants for children who are committing suicide this ended up and vioxx coming off the market this ended up in black box safety measures in the case of the anti depressants and the institute of medicine has recognized the importance of these two groups within the f d a working very closely together on making a determination on post marketing surveillance and that's what my amendment does it make sure that this process works the way the institution of medicine indicated that it should so i ask as you consider voting on this amendment i ask my colleagues himself or herself one basic question before voting since the institute of medicine recommends a quality between propre approval process and other words before drugs marketed and post approval and we are enormously appreciative and grateful i will personally appreciative of the work of my friend and colleague senator from ohio senator brown who was here yesterday until then i had the opportunity to travel to ireland where they signed and put in place after four hundred years of struggle the democratic institutions over there in a very moving ceremony which president bush should supported and very special recommendations by and large after they had months and months of hearings the american people ought to understand that the legislation that reflects the bipartisan support here in the in the senate is really a reflection of the best judgments that we could have as a result of months and years of working on this and of the membership of it and we are enormously grateful this legislation is going to make the prescription drugs that our families take safer and our  that is very important and is going to ensure that the agency has resources to do follow on reviews to continue its important function to be the world's lead up a gold standard for safety for the for our people in the example for the rest of the world so this is very important legislation we are constantly reminded every day of the additional kind of challenges that we're facing in terms of safety for our families we are very aware of it on sunday and  members of our committee are going to continue our study our review and they continue to our activity to ensure that we're going to have the best in terms of a safe and secure food supply pharmaceutical supply and take advantage of this li science century so that every american is going to have the best and hopefully at the riposte reasonable price so that they can have healthier and stronger families mr president i'm prepared you'll  president senator from wyoming i have a number of people that i that i need to think for their efforts on this bill and i will do that following following the vote so that we don't hold up the vote but there's just been a tremendous cooperation effort knowledge capability thats been involved in this not just with the senators but also with the staffs and the staff folks on on staff on both sides of the aisle have spent countless hours on this even on weekends in fact i know one weekend when one one day on one weekend they were about twenty hours together to pull this thing to together and get of the final things worked out but they worked the entire weekend for at least the last three weekends and they'll look forward to a little time to rest will probably give them a day but that's because we have so many things happening in the committee and senator kennedy and i are determined to get a lot of things done that will help the american people with their health and with their education and also in the area of workplace safety and before us this morning ninety one back down to my time under the previous order they will be two minutes for debate equally divided prior to a vote in relation to amendment number one zero three nine for the scientific process but it's involved in the issue of this amendment as well is whether or not the scientists in the f d a that are that have the responsibility of post marketing surveillance get the respect that they  to have from the office of new drugs that previously had approved a drug we have found in the case of vioxx in the case of antidepressants for children and a lot of other areas as well that this is just not been the case management will follow the institute of medicine recommendation and make sure that there is adequate just adequate time and consideration given to post marketing surveillance  same as there is to the approval of the drug in the first place so i asked for this amendment and it's backed by the institute of medi been here for a tool box for post approval which never existed before for the f d a that this amendment would have been necessary in light of the tool box that we provide and the dispute resolution that we have in we want to know about anything goes wrong faster than we think that's built into it we do have a dispute resolution in the in the bill that's the type guidelines and will happen will result in rapid approvals and we don't need the additional process the amendments separates out what should be together and delay is what should be rapid so i urge my colleagues to oppose the amendment is there sufficient second on the remaining amendments on the remaining amendments appears there is pretty days and they are ordered rule on the range remaining amendments as well the question is on amendment number one zero three nine the clerk will call the roll mr akaka mr alexander mr carden mr carper mr casey mr chambliss mrs clinton mr coburn mr cochran mr kennedy mr kerry mr mccain mrs mccaskill mr mcconnell mr menendez mr reid of nevada mr roberts mr rockefeller mr salazar mr sanders mr schumer mr sessions webb mr white house mr wyden and mr menendez any senators wishing to vote or change their vote if not on this vote the yeas are forty six the names are forty seven and the amendment is not agreed to is the majority leader this president i have a unanimous consent request for committees to meet during today's session the senate they have the approval of the majority and minority leader so i ask unanimous consent these requests be agreed to and then it will be an order please take your conversations out of the well i ask unanimous consent these requests be agreed to these requests be printed in the record without objection under the previous order they will be two minutes for debate equally divided prior to a vote in relation to amendment number nine ninety eight mr president that it will come to order then or from iowa one man it that we have item senators i want to tell you that the senate is not the issue is the level of civil and monetary penalties if the fines are nothing more than the cost of doing business you can't change behavior and you can bad behavior and my feeling is the levels in this underlying bill are not just high enough to get the attention of the drug companies after all if a company does what it is supposed to do a drug company letter from wyoming i have to oppose this amendment in keeping with having a balance in the bill that we've agreed on this is the first time that civil monetary penalties have been assessed for violations of the drug safety plan that's what's in our bill we do have civil penalties in the bill the civil penalties are the same as for the medical devices that's how we decided what level to do it so we've added civil penalties i would hope that and they'll be more work done on this probably as we get to conference but i'd like to establish the fact that civil penalties are in there i'd like to arrive at the level that the senate opus the civil penalties are assessed with more consideration and with  debate with the house so i would ask ninety seconds just this one could burden small businesses and create problems there and it's part of the bill that we put together with such compromise i have future vote against the amendment the question is on a member number nine nine  of florida no mr rockefeller thing mr is there any senator wishing to cast their vote so any senator wishing to change their vote if not on this amendment the i's are sixty four the nays are thirty and the amendment is agreed to went out objection under the previous order there will be two minutes for debate equally divided prior to a vote in relation to amendment number ten thirty four mr president said it's not norton or from illinois and it is not an order the senate will be in on or ask all members to take their conversations off the center from illinois president two years ago when advisory committee of the f d a sat down to judge painkiller drugs and whether they were safe to sell to america they made the decision about selling buyouts to america was safe ten of the members of that advisory committee had a financial conflict of interest when they made the decision that those ten members with a conflict not been there those drugs would not have gone on the market causing harm to americans this amendment that senator  offer will take the conflicts of interest out of the advisory committees we will allow one waiver for someone with a conflict of interest and we will say that others who participate as guest experts have to leave the room before any deliberation or boat you will hear from the other side the food and drug administration has an idea of how they're going to change this rule at some future time this is not an idea we're proposing it's a law a lot to protect the integrity of the advisory committee and the drugs and medical devices which are sold across america i urge my colleagues to support this women senator from massachusetts mr president we didn't have a head of the f before the last five years you have a new policy got a new policy out there basic what the durbin amendment says one size fits all that concept has been rejected by the europeans rejected by the canadians and basically rejected by the institute of medicine and the reason is because we're dealing with a life science century in terms of trying to have breakthroughs in cancer if you're looking at cancer drugs you're looking at fifty different puppets are going there you know we're going to say because of one of those devoted they financial limitation of fifty thousand dollars out at the f d a now everyone is going to know it's a new day out there we have the transparency but virtually everyone that understands where the life science center he says we have to have the best science and the institute of medicine said don't go with a one size fits all which the durbin amendment does time has expired the question is on a member number ten thirty four the azan age have been ordered the clerk will call the ms collins mr conrad lugar martinez murkowski nelson of nebraska shelby smith specter stevens thomas been born a bitch and warner am was there any senator wishing to cast a vote joining senator wishing to change their vote if not on this amendment the eyes are forty seven the nays are forty seven and the amendment is not agreed to under the previous order the committee substitute as  amended is agreed to the motion to reconsider it is considered made and laid upon the table and the cloture motion on the bill is withdrawn under the previous order the clerk will read the bill for the third time caller number one twent mr sanders voted in the negative amendment the i's are ninety three the nays are one and the amendment the bill as amended is passed under the previous order the motion to reconsider is can the motion to reconsider is considered made particularly the majority leader who after some difficulties last week helped to smooth some things out and make it possible for us to move on a little bit of the bill he has his coordination and leadership was indispensable in this i want to thank the republican leader for the way that he participated in the bill and again made sure that we are working across the aisle and getting difficulties smoothed out  i definitely want to thank the chairman of the committee for the outstanding work that he did through the entire process and as we mentioned a number of times it's been a very lengthy process but he's always been so so forthright and knowledgeable on this and willing to work under all kinds of circumstances and difficult things and because of his dedication and abilities i've learned a lot about running the committee from him and i've learned a lot about getting a bill passed from him and i'm enjoyed working with him for the last two years on a number of bills but i do want to thank the staff people that have worked on this late spent many evenings and even weekends away from their homes they  work virtually through the night to get some of these things worked out the way we work a bill it's a work in progress until it's finished it isn't finished yet we've got to work with the with the house side yet but and we'll do that because this is such an important bill for the for the country my health team worked overtime to get this bill to the floor and passed in the senate and i'd first like to thank my health policy director shauna christopher sean i was promoted to our leadership position in january of this year took a hold of the reins a incredible knowledge dedication and negotiating experience that and expertise that helped bring this bill to fruition i also want to greatly thank amy moberg our crackerjack expert who knows all things f d a her knowledge and drafting skills were central to this bill i want to thank you flanagan for his work on the children statutes in this bill and dave mechelle for who is our resident drug patent expert for his ongoing work on follow on biologics others on my team i'd like to thank you todd spangler and brittany moore who provided the required backup that goes with building a bill of this magnitude and finally i want to thank my staff director kathryn mcguire who has steady hand the negotiating and communication skills and ability to senator kennedy's staffers were reasonable negotiators throughout the process and open and patient hearing all sides of any issues as i mentioned before senator hatch was responsible for the first f d a revitalization act and i'd like to thank this concept a reality and they did it with class grace patience kindness and i can't thank them enough i would feel the floor senator for senior senator from massachusetts is recognize d mr president one of the great joys and serving in the senate has been a working with my friend and colleague from wyoming sunday and on different to legislation he he he does it the old fashioned way he believes that to what we ought to do is have hearings on the problem and then listen to various alternatives and then try to work out a solution and carry the process forward that was the old fashioned way today people look at the different the issues pile  we always try and find common ground and we have been able to find it certainly on this legislation and and many other pieces of legislation and i sort of look forward to to that tradition i'm normally personally grateful opinions strong arguments and different ways to do it but we have legislation and it's good legislation solid and we're proud of it and i think the over overwhelming virtually unanimous vote of the united states senate on both sides is a real moment i was necessary absent that when i left monday night there was a certain element of chaos surrounding this bill and coming back early this morning under the great work of ascent to n c and senator brown we had a orderly poppet be able to proceed and he's knowledgeable about health issues has a very distinguished record on health policy before he came to the senate and has missed a beat on it and working through these issues and it's been invaluable to me personally to our committee so i think  center roberts and harken on this direct to consumer issue involves a lot of different policy issues a lot of motion and feeling they worked very hard with again with our staffs and we had i think very solid recommendations on this neglected to diseases this is something that to the united states should be doing more of they've been a very creative in coming up with an idea many people talk about it they've come up with a very good suggestion sent a coburn on the doctor patient relationship allerton that food safety issues again send a link link and on the food safety on that raised fish issue so these are just some of the items again we think those are the staff members we find different people find they can try and find solutions rather than perpetuate differences it makes an enormous difference and we find that that was certainly true i think of all of the staff on our committee koppel and if we will sure might have missed some one on this but we'll make sure to include inflator in the record so we thank all of our colleagues and friends we look forward to get meeting with the house of the senior senator from vermont is recognized as president i asked and sent the call that one day dispensed with without objection so ordered under the previous order the senate will proceed to executive session to consider executive count number one o four which the clerk will report nomination the judiciary deborah and livingston of new york to be united states circuit judge for the second circuit under the previous order there will be three hours for debate equally divided between the chairman senator leahy and the ranking i'm speaking about jack valenti jack and his wife mary margaret first time my wife myself and i under their wings right came here is a at least one italian dish and watch a first run movie i jack would be reading by the by name and for those of us to sometimes have to remember talking about kids there in that case there had a grandchild i could not happen to think this man who by all rights never should have made it to world war two he was a highly president kennedy's death on a plane back was president johnson and sharing those taxes from the it said that i'm working with him i think from a personal point of view of it she called me once and said i i saw that nice young man on television and i said mother what are you talking about she said why jack funny that nice young man i said mom jack is almost twenty years older than i am she said really well he doesn't look at any gave a killing shot she said patrick you should take better care of yourself when jackie had one of the many retirement parties and i was picked that one i told that story to his great play and i'm afraid more than one person in the audience all of us would like to think we could master with the best of all speech writers i know but he couldn't he did he was all the speechwriter nobody else could begin to match asked i've been bothered since the name of bothered by something not so much what they said but what has happened in the last few days this present every one of us we turn on our television sets they see the devastation in kansas by tornado about the equipment levels available to our national guard for dealing with such emergencies at home as this horrible disaster i spoke of the big fellow greensburg kansas and contrary to what the white house has said the governors have done about the governors republican and democratic governors alike and they're active in generals those with the heads of the national guard in their respective states are reporting something quite different than the blood's a attitude of the white house state after state reports missing i'm these and medium size trucks generators dump trucks communication systems and these are not planes and just any observer of guard issues these are the leaders have been elected by the people to provide for their security and deal with the sometimes terrifying sta is equally ridiculous because it's been clearly documented there's a very real twenty four billion dollars equipment shortfall in army national guard equipment all those reports courts don't take into consideration the shortfalls within the or national guard and the both the active army and the national guard agreed in this figure it was developed together with the national guard bureau working closely with the army staff thousand medium sized trucks no plans to purchase the twelve thousand required generators no plans to purchase the sixty two thousand communication said the list goes on and on is ministration as for a blank check to resupply the iraqi national guard they don't have one cent in their budget to resupply the american national gu when it comes national guard equipment car design have adequate stocks to deal with emergencies like massive full potential on a smaller scale disaster they can respond as quickly as for the first responders disasters god's going to be hard pressed respond as well as it did along the gulf coast almost two years ago to present me just show you and you can see an airplane breakdown of fire retardant that's a national guard airplane here you see a little boy or a little girl child being rescued carried up to a helicopter in the arms embracing arms of safety in the arms of a national guard member here you see the rescue of somebody in an accident here you firefighters try going through the rest of their own lives put out a forest fire who are they that actually guide members secretary of defense maintain this morning is apparently for the defense i figure contradicts everything i've heard from other responsible to shows that the figure close to thirty five percent frankly thirty five percent or fifty six percent is not adequate by any means directly for dealing with that twenty four billion dollars shortfall  that's been vetoed but we're going to work together in a bipartisan fashion to get back into whatever spending  what bothers me is you don't do it you can't do that unless we work together unless we work together this is a case becomes almost a cliche to say we can't afford to let our guard down but we can we don't have tornadoes in vermont having a homeland security is paramount a vision is still not responded to that but we did respond when the governors called out the national guard but this one i couldn't pass up they know what the numbers are they know the governor of kansas was speaking the truth they know the guard is woefully under supplied they know they've been governors take instead their input and respect their thoughts of a god given their place to commanders in the national guard and there's daily turn a situation where i must come up with a new place replenish present the senate continues to make significant progress today with another confirmation of another lifetime appointment to the federal bench the judicial nomination we consider anational security law she previously probably university of michigan law school and prior to academic career she served as a federal prosecutor deputy chief of pills for the u s attorney's president clinton's nominees did this for years they do years before the end of this tour but the idea is should they get a republican they could have some people in  of being independent jurors might damage whole politicize the courts now my time as chairman for the middle of two thousand why did the end of two thousand and two i worked sixty or more of his judges i would succeed in confirming one hundred nominees and seventeen months including seventeen to the circuit courts certainly a record of recent years process as part of all our progress in all our efforts we're still confronted by very shrill complaints more ominous of the signals and rumors that the white house is again gearing up to dominate more extreme nominees the previous six year cycle for doing office u s cordless forty seven judicial vacancies presidents us only twenty four nominations twenty three of them almost half have no nominee five of fifteen judicial emergenc tenth congress even the for this congress convened injured in january of zervos were predicting that you dishful nominations would be one of the most contentious issues that we face but i think that by taking forward looking approach the senate managed to avoid an unnecessary confrontation and i think that by and large we've started off on the right foot earlier this year the washington post los angeles times both applauded the president for difficult concessions he made in shoes and not choosing to renominating certain previous nominees that it generated intense opposition but i thought some of that opposition was mostly unfair and  warranted i respect the president's decision to extend an olive branch to the new democratic majority in the senate those two newspapers also encourage the new democratic majority to reciprocate with cooperation and fairness and that spirit of cooperation with senate republicans received assurances earlier this year from the democratic majority of a fair and reasonable pace for the confirmation of nominees to the u s courts i was pleased to hear the majority leader pledge his cooperation and leadership to help this congress and i quote at least meet the standards of congress is similarly situated as ours close quote and we saw progress in the first couple of months of this year with the confirmation of two circuit court nominees today the senate will vote to confirm a third circuit court judge and i welcome today's vote and hope that it will be an indication of the majority's intent to keep working with us on a pace necessary to meet the historical average that the majority leader has in doors yesterday the distinguished chairman of the judiciary committee commented on how he views this progress and i'd like to briefly discuss this oracle analogy that he cited but first i should note that i'm proud to continue to closely work on several significant pieces of legislation with the senior senator from vermont senator leahy he and i have found common ground on among other things historic changes to the freedom of information act and much needed reforms to the u s patent system and i look forward to working with the distinguished chairman to help these make these important bills become law but the chairman and i do tend to be part on some issues related to judges and so i just want to take a moment to comment on the remarks he delivered yesterday on the pace of judicial nominations in particular i'm i'm wondering why he chose the year one thousand nine hundred six as the appropriate measuring stick for progress on judges made by this congress of course there is one obvious parallel between  hundred six and the present year and that parallel is divided government in one nine hundred ninety six president clinton a democrat sat in the white house in the senate majority was held by republicans but i'm submit that we ought to be in the business of comparing apples with apples we must look at congress similarly situated to this congress point in fact looking to similarly situated congresses is the very comparison cited by the majority leader mr president you'll recall that the majority leader's commitment on judicial nominations in his own words to quote at least meet the standards of congress is similarly situated as ours close quote this president by any reasonable measure the proper comparison in the one day but jordie leader has apparently endorsed it's not a single year but an entire congress specifically with the congress the final two years of the presidency and  majority of the opposing party in fact we were fortunate to be looked at historical parallels during the last three presidents he's not just one the landscape we face in the one hundred tenth congress was similarly faced by president clinton in one nine hundred ninety nine in two thousand during the one hundred sixth congress president clinton worked with the republican controlled senate during the final two years of his presidency to confirm fifteen circuit court judges in one thousand nine hundred one in one thousand nine hundred two the one hundred second congress president george herbert walker bush worked with the democrat controlled senate during the final two years of his presidency president bush and the democrat control majority in the senate president reagan and the democrat controlled senate work together to confirm seventeen circuit court judges again mr president i submit that we we have to compare apples to apples and when we do that we see that somewhere between fifteen and twenty circuit court judges were confirmed during each of those final two years of our last three presidents that mr president is the standard that is relevant that does discussion the facts are what they are this congress has confirmed to circuit court nominees will shortly conform confirm our third and that's a good thing but the fact is that we're not yet back on pace to reach the output of the last two years of the clinton presidency when fifty five member republican majority the senate confirmed fifteen circuit court nominees there's no satisfactory reason that i have heard as to why no circuit court nominees were confirmed in april or even reported out of the committee the reasons that have been offered that the vacancy rate is not that bad that the president needs nominate more circuit court judges that president clinton was treated worse are all irrelevant to the majority leader's representations on the senate floor that this said it will quote at least close quote if the historical average i urge my colleagues on the other side of the aisle to work with us as we must and work with the president to get back on track that is our is interesting when i hear this talk by the struggle averages they work only when you bring them to the number of times that there is a democratic majority of the republican president and a republican president is treated dr better  than the republicans did with a democratic president no time for the democrats ever part of filibuster sixty of the president's nominees i was been talking about president bush withdrawing some of these nominees you had last year i pointed out you had a republican majority throughout the year and then passed one was opposed by organizations have never taken a position to judge before gotten a majority i know a republican controlled committee wouldn't have gotten out of the committee because both republicans and democrats would have opposed it so no big no big deal i must admit to their credit they were drew his name after he was indicted and pled guilty to fraud it probably kind of happy i didn't let him go for it now so i'm from texas assistant united states attorney in the southern district of new york i was a commissioner for the new york city civilian complaint review board for some nine years nine hundred ninety four to two thousand and three and has been on the columbia law school faculty since nine hundred ninety four as associate professor professor in the year two thousand and vice mean in two thousand and five and two thousand and six she has been rated you know and a mostly well qualified by the american bar association and i believe that she is an extraordinary prospect to go to the court of appeals for the second  do not have nominations from the white house and toward that end there has been a leadership meeting with the white house counsel and we have tried to structure a plan which would enable us to go forward to confirm or circuit judges and to fill a vacancy as of this court court judge many of these courts are in the category of judicial emergencies and as a practicing lawyer for many years i can attest firsthand to the importance of having judges on the bench so that litigants can have a speedy disposition of their trials there is an adage justice judicial issues the talk very very briefly about the immigration question which is front and center in the congress today second only to the concerns about the iraq war current funding impasse which we have in the constitutional confrontation between the congress and the president and the sustaining of the veto in our efforts to try to work that out i believe that there is a universal agreement that the immigration situation in the united states today is an unmitigated disaster strong language but  strong enough for what is going on with immigration we have a forest border i'm documented immigrants are coming into the united states they pose a security terrorists are really afraid to wander across our borders and come into our country and post potentially great threats to our national security we find a significant incidence of crime among documented emigrants crime does not have a sole source but it is a it is a problem we definitely need to get a handle on immigration we work very to the floor and it passed the united states senate it was comprehensive reform which is what was called for by the president a bill which would deal with the eleven million undocumented immigrants would provide for a guest worker program would provide as a preliminary to secure our borders provide for employer sanctions if the employers hire illegal immigrants the house of representatives chose to get from course to provide only for border security and it was embarrassing in my judgment that we were unable to have a conference and pass an immigration bill last year with a congress both houses senate and house of representatives controlled by the republicans and president bush a republican in the white house but we find ourselves this year with the undead again a disaster of immigration worse and now than ever there have been major major effort to try to fly the consensus legislation to present to the united states senate for consideration the first meeting was held on february thirteenth of this year and the meetings have been held continuously right up to the present time almost three months and these were abbreviated meetings where these meetings were held every tuesday wednesday and thursday from four to six o'clock and they were attended by all the average of eight to ten to twelve senators they were attended also by the secretary of commerce republicans meeting separately and then we moved into a bipartisan meetings and last week the last trick of the way we had twelve senators meeting off the senate floor for two and a half hours pretty hard to keep twelve senators in one room for two and a half hours but we did we have come to what has been categorized as a grand bargain that's a term that one of our most active participants senator lindsey graham gave to it because we had the overall structure of an immigration bill that ought to have all of the aspects of it worked out but we worked our first seating to provide for real border security border security which will increase the number of border guards from twelve thousand to eighteen thousand border security which would encompass a fence it can't have one across the entire border but a fence to secure our major metropolitan areas tough sanctions on employers so that we would reduce the magnet to bring people to the united states for jobs where they were not legally in the united states we have provided the mechanism for dealing with the eleven million undocumented immigrants we have structured a program so that it would not be fairly or accurately characterize amnesty requirement so that the immigrants learn english requirements of the immigrants have roots in the united states that they have held a job for a protracted period of provided for a guest worker program which is really one of standards that is people come to the united states for the purpose of filling jobs that return to their they get homes were provided that if there are people living in the united states legally citizens or legal immigrants that they would have the first opportunity at these jobs we have held some twenty three meetings over the course of the past three months so i was a little surprised to see the statement by the majority leader i had a press conference yesterday and perhaps it was said partially in jest but senator reid pointed out that there had been notice for some two months that the immigration bill would be taken up in the last two weeks before the morial day recess and then he said quote and anyone but thanks that two months is not enough time to get ready should get has elected to have the matter go through the negotiating process which i've just described so he doesn't have to seek another occupation but there are many people on both sides of but if we are to find the realism of enough grain cars to accommodate the undocumented immigrants who are going to come through the process at the end of the line there has to be immigration bill but the hill publication reports today opposition from members of the house of representatives for senate legislation when we don't even have legislation it existed one member of the house is quoted the saying it is important the senate knows that there will be strong bipartisan opposition to amnesty but we don't even have a bill that can be accused of being amnesty and outlined which we are considering and contemplating it is certainly not amnesty by any fair interpretation of the majority leader has intends to file under rule for change today and go to the legislation on monday and as i said yesterday there is strong opposition to such a practice at least on this side of the aisle and it is my hope that we will not face a contested motion to proceed it is my hope that we will not face the threat of a f buster against a motion to proceed which would do much immigration reform we have capsulated our views in a letter following the majority leader's news conference of today where we are asking a number of us are asking that we rethink the schedule which we have if we bring last year's senate pass a bill to the floor it's going to have substantial opposition that's already been announced on both sides of the aisle both that republicans who supported last year are opposed to if we start there the floor action is likely to break free for all now i understand the problems of sense of scheduling about i also understand  hope that the current process can be allowed to continue there has been a massive good faith effort by republicans and democrats meeting for a very protracted periods of time to come to agreement on a bill to reduce its written form i will come see but there has been a lot of wheel spinning in the process which we have undertaken a perhaps it was an error interested in bringing eleven million undocumented immigrants out of the shadows that's the main benefit that comes from those who want to proceed in the traditional american way to welcome the emigrants under a system of tribes plan that if we don't have proper answer reform we're not going to provide the border controls and the  remaining how much time as the senator from vermont has forty nine a half minutes as far as i know and the senate set up on the fence when it has a poor but i know th i would like to thank my colleagues in prescott in the coffin as well since he made the grand bargain once before and it didn't work out so well so i would say to my colleague from pennsylvania i hope that his grand bargain works out better than resco macof frank grand bargain anyway mr president i rise to speak on our nominee the confirmation of deborah livingston she is a legal superstar from my home state of new york and she's nominated to the second circuit court of appeals let me say that we in new york have a system in place for nominating federal judges that works the president and i work together to name highly qualified consensus candidates to the federal bench there is often rancor when it comes to judges from other parts of the country but there's been very little when it comes to new york and it shows you where both sides wish to compromise we can probably get there it's that's because in new york we have an effective and bipartisan way to select qualified and almost without exception moderate candidates for the bench mrs livingston ms living's been to squarely in that mold her career so far is spanned private practice criminal prosecution and academia so she has a deep understanding of the law again from many perspectives from the courtroom for the classroom mrs livingston is a graduate of princeton university received her j d from harvard law school also my alma mater where she served as an editor of the harvard law review from eighty nine hundred eighty six to nine hundred ninety one mr livingston was an assistant u s attorney in the southern district where she prosecuted public corruption cases and sir as deputy chief of the peals before and after her time as a prosecutor miss livingston was an associate at one of the very prestigious law firms in new york is currently the vice dean and paul j kellner professor of law at columbia university where she focuses on criminal procedure evidence and national security i think it's great that we'll have an appellate judge who has both scholarly mind and practical courtroom experience it's a perfect combination in my view for an appeals court judge i hope that my colleagues will join me in voting for confirmation and in keeping with the coburn's mr cochran mr coleman ms collins