center will come to order the chaplain dr barry black will lead the senate in prayer let us pray oh mighty and everlasting god the protector of those who put their trust in you on this national day of prayer we thank you for the gift of intercession when in need we can enter your throne room with our praise and petitions and when tempted to despair we have an antidote in prayer transform the lives of our lawmakers as they see you in prayer freed them to live life more fully through their ups and downs help them to love you with a decisive loyalty the lord draw them to a relationship of grateful trust in you as they seek your wisdom in solving the challenging questions which trouble our world a communication to the senate washington d c may third 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 robert p casey jr a senator from the commonwealth of pennsylvania to perform the by ten o'clock this morning now of other members are still pending and today will be a busy day with votes occurring throughout the day another issue which will need the senate's attention is going to be the conference on the budget resolution house again the act either today or monday appointing conferees which will mean that we'll act shortly there after chairman of the budget committee senator conrad in the ranking member senator gregg have had a national conversations about the likelihood of there being motions to instruct the conferees or under the budget act there is a maximum of ten hours of debate to get to the conference so i would hope that the two managers of that budget resolution centers  can make a determination as to how many motions to instruct your well the to give some idea as i understand the rule we have ten hours a day no matter what if there are motions construct that have been filed and not enough time to debate them their votes will take place with no debate so i hope that there would be adequate time to debate whatever motions to instruct and basic conversation about that most important a budget resolution that we need to complete so we can get to the pr bills so i'll be discussing this matter with republican leader and may have more to say during the day mr president we have if there's a lull in the schedule today we have a number of judges we can vote on and so we may do that we we to senator kennedy answer and see have done a masterful job in moving this matter along we would hope that they can continue their masterful work and complete this legislation but i do say as i have said but it's worth repeating senator kennedy some would say are not a matched pair but they have different political philosophy they come from different parts of the country but that really is what the senate's all about and they have set i think an example of how individual senators can work together and they are really exemplary as far as i'm concerned of being able to move a very difficult complicated piece of legislation my understanding that this isn't the last word there's going to be a conference that the center can he has has told senator enzi that he would be a part of that conference so they trust each other and i think that's important and i think it's not we finished a competition bill last week this is another step forward i hope we can complete by the previous sort of the leadership time is reserved under the previous sort of the senate resume consideration of s one zero eight two which the clerk will report calendar number one twenty s ten eighty two until two in the federal food dr cosmetic act to reauthorize and then the prescription drug user fee provisions and for other purposes under the previous order there will be an hour for debate prior to a vote on the motion to invoke cloture on amendment number nine nine zero with the time equally divided between the senator from north dakota mr dorgan and the republican leader or their design just to bring our colleagues up we've made very good progress during the evening both the center and see staff and our staff just clearing through with the members we've made very good progress has still a number of items  to probably four or five important areas where we may very well have the votes during the day of rest we will announce the agreements that have been made with a particular colleagues the areas and the content of the seven agreements as we move on through the day we are in touch with a couple of senators so that we'll be able to make a judgment decision at the conclusion of this vote on the co chair will center from iowa i have not had an opportunity to speak with the senator from north dakota so i hope i'm not abusing my privilege of working with him and having some time this morning so i would yield myself seven minutes mr president the dorgan amendment is a moment americans consumers have been waiting for so i'm here to urge my colleagues to vote for cloture so that we can finally legalize drugs importation as i said yesterday the dorgan amendment is the result of a collaborative effort by myself with senator dorgan snowe and candidates to finally make drug importation legal in this country this is a golden opportunity that we have been waiting for years to accomplish the bill before us is the big the vehicle this year to get it done the bill we are debating is  must pass food and drug administration fail the senate should send a strong message that we are committed to finding getting it done this year and that is what we have been working for to do this very day making it americans to import their prescription drugs is a top priority at the grassroots of america and needs to be a top priority here in washington it's something that shows up in my almost every one of my town meetings around iowa i've long advocated them allowing americans consumers access to safe drugs from other countries i've always considered this more a free trade issue than i have a health or prescription drug issue imports create competition and keep domestic industry more responsible to consumers in the united states so that i explain why i consider this a free trade issue more than a health issue we import everything we allow everything that consumers might want to buy based upon the quality that they choose and the price that they choose we've allowed it to come into the country if americans want to buy from hopefully they want to buy american made products but we've considered free trade something that is going to giving consumers free giving consumers the best deal that they can get so why not do it for pharmaceuticals as well as any other product people want to buy so mr president consumers in the united states now pay far more for prescription drugs than those consumers in other countries pay if americans could legally and safely access prescribed drugs from outside the united states under a regulation that we  guarantee safety then drug companies will be forced to re evaluate the price strategies that they have for americans consumers they have no longer be able to get out american consumers by making them pay more than their fair share for the high cost of research and development ice sort of research and development out because i think canadians getting a better deal from american pharmaceuticals germans getting better deal from american consumers and that they get such a low price they don't pay the fair share then the american consumer of pharmaceutical products pay for most of the research and and  while the research and development benefits the entire world not fair to the american consumer now it is true that farmer pseudocode companies do not like the idea of opening up  american consumption of drugs to the global marketplace they want to keep the united states close to other markets in order to charge higher prices here now they'd argue we've got to charge higher prices here the government  directs what we pay the consumers of our charge to consumers of of the german well that's not fair to the american to pay for that sort of research however with the dorgan amendment now and this is what we're talking about on this important vote just coming up priest christian drug companies will be forced to compete forced to establish a fair price here in america now some don't want this to happen and i want to reiterate that there is an attempt to this amendment requires all imported drugs to be improved approved by the food and drug administration that's the right thing to do the amendment sets transient set of safety requirements that must be met before americans can import drugs into this country and there are staff penalties for violations don't we fold by this poison pill amendment voting for that amendment is a vote to kill drug and for patients and that amendment surely will be up if we get beyond the cloture vote t it's important that people vote for cloture with the dorgan amendment we are getting the job of safety done we need to make sure that americans have even greater more affordable access to wonder drugs by further opening the doors to competition in the global pharmaceutical industry we must make sure that they have access to affordable prescription drugs so i are origen my colleagues to vote for cloture vote one additional editorial comment that's a legitimate to maybe criticize grassley for voting this amendment but a criticism that i think i would now explain and that is that comes from a very good fellow member and friend of mine in the united states senate came up to me yesterday and said well then wouldn't i be for having all restrictions against ethanol coming into this country done away with because i represent a state importantly there is already free importation of ethanol in this country up to seven percent of our production and we have not even said seven percent importation  debate that issue when the when the leeway within present law allows so i don't think there's an inconsistency on my part in what i said about the free and free from my mentor industry of pharmaceuticals without objection the clerk will call the ro is a vote that will determine whether we can proceed to have a vote on my minutes a call cloture vote shut up debate so that we can move to the amendment that i have offered i want to just remind my colleagues again of what this amendment is this is a bipartisan amendment sponsored by thirty three united states senators republicans and democrats senator grassley who just spoke mysel senator snowe senator mccain senator kennedy  senator stabenow wide range of senators republicans and democrats who believe that united states citizens ought to be able to purchase f d a approved prescription drugs the identical f d a approved drugs that are sold in other countries for a fraction of the cost of what they're sold in this country and the believe that the american people ought to be able to make the global economy work for them and ought to be able to access those same prescription drugs as long as they are in a chain of custody that  safe and as long as they are f d a approved i described yesterday and let me again ask consent to describe to my colleagues these two bottles these are medications called left or is made in ireland it is a common cholesterol lowering drug taken by a good many americans and as you can see when made in the plant in ireland it is put in these bottles identical bottles with a label that is blue in this case red in this case otherwise identical the difference in this situation is that this bottle is sent to canada from ireland this bottle is sent to the united states same pill same bottle made in the same manufacturing plant f d a approved the difference well the american consumer is told you get to pay twice as much for the identical drug you get to pay twice as much it describes a serious problem what i believe is i sing a prescription drugs in this country who pay the highest prices in the world subscription drugs i don't know of anyone in this chamber who stands up and says let me sign up for that let me tell i think it's right i think it's fair and i think it's important that the american consumer pay the highest prices in the world for prescription drugs i don't think anybody stands up here and claims that what they claim is if they don't get that kind of money they will shut down research and development and they are they are forced to charge lower prices overseas because those governments overseas won't allow them to make money let me show you what happened a while ago this chamber without my support because it was a foolish thing to do that you know what we want to say to the biggest economic interests in our country the biggest companies that have moved american jobs overseas and make investments overseas we want to say to them that if you make profits overseas we'll allow you to repa triate those profits into this country back here and you get to pay a special tax rate normally when a company would repatriate its profits made elsewhere it pays normal income tax rates but this congress said to them you know what we'll give you a special deal a big fat tax break you repatriate your foreign profits you get to pay five and a quarter percent income tax nobody gets to pay a five and a quarter percent income tax rate i'd love to pay that everybody else would as well but they got that the biggest companies in our a massive amount of money saved i estimate about a one hundred billion dollars in taxes that should have been paid because they got a five and a quarter percent sweetheart deal so  let me just turn to one drug company pfizer that company one of the world's biggest drug makers this is new york times june twenty fourth two thousand and five it said it would return eight point six billion dollars in overseas profits so that by and repatriation of thirty six point nine billion dollars it had already announced twenty eight point three billion so that makes it pretty thirty six billion dollars they're repatriating in profits they've made overseas that's four times what pfizer spent on research and development last year the new york times says but isn't it interesting that they charge lower prices for prescription drugs in other countries they say they don't make money in other countries and yet when they get a big fat sweetheart deal to pay a five and a quarter percent income tax rate they repatriate thirty six billion dollars that's the profit they made in other countries looks to me like profitable selling these drugs at lower prices in foreign countries so much for that argument the price discrepancy i have indicated previously i'd use canada as an example but i could use france italy germany spain would matter lipitor ninety six percent higher prices for americans prefaced it ninety seven percent higher prices for americans  nexium fifty five percent higher prices zocor i mean the fact is we are paying the highest prices for brand a prescription drugs in the world and it's unfair and we're trying to change that what we're saying is that it's not the global economy work for everybody not just the large pharmaceutical industries how about allowing it to work for regular folks to buy a safe f d a approved prescription drug for example from the canadian pharmacy can anybody give me one reason s pharmacist license pharmacist should not be able to go to a licensed pharmacist in winnipeg canada both licensed both with an identical chain of custody why a u s license pharmacist should not be able to go to a license pharmacist in canada and acquire an f d a approved drug such as to moxon at one fourth one fifth of the price that's charging that is states and pass the savings along to the consumer i'm not asking for five reasons i'm asking can anybody give me one reason that should be prohibited i think the answer is there is no good reason to prohibit that sort of thing so we will have a vote on this amendment my hope will be that we will be able to invoke cloture so that we'll be able to proceed to the minute there will be a cochran amendment to miami to second degree and then a vote on my amendment my hope is that we can do that today mr president i feel the floor cloture this is a very serious amendment the senator from north dakota has has proffered and is being considered by the senate and it should attract the attention and careful review of  senators and i noticed in the washington post in an article thursday may three the editorial writer says that  the amendment the senator of north dakota has offered which would allow importation of prescription drugs from other countries which he claims and other supporters claim would a cut rate pharmaceuticals flow into the united states allegedly saving ailing americans untold amounts of amounts of money but here's the catch and i quote from the editorial this is a mirage importation will not solve the problem of drug pricing u s drug firms sell prescription medications to countries such as canada low prices a situation that would quickly change if canadian distributors started to recycle large quantities of drugs back to the united states another factor in this debate that shouldn't be overlooked is that president bush is threaten to veto the bill if it contains this language so to achieve our goal of helping to ensure safe and unadulterated prescription drugs marketed in the united states are safe we need to have the federal agencies that have the responsibility of  steering that safety to be in charge of certifying that and so i've offered an amendment to the dorgan amendment if closure isn't in vote it will be subject to consideration that says unless the food and drug administration or the department of health and human services can certify and vouch for the safety of imported drugs this amendment would not be operative and we have been told by administration officials that they cannot make that certification and they could try we all try we all try to help by working together ensure that what the consumers are buying is what the labels on the drug say they are but we have seen in in recent years a growing threat from counterfeit drugs that are made in other countries not canada necessarily but other countries and transshipped which could be transshipped through canada or could be mailed directly to purchasers in the united states that aren't what they say they are some are even dangerous some contain nothing at all nothing that's effective do what the drug is supposed to do so we are already confronted with a serious problem this is going to make it much much worse exceedingly difficult for those who are charged with certifying the efficacies of drugs protecting our citizens from dangerous drugs counterfeit drugs to do their job this is going to make it much much more difficult this is not the first time the senate has been asked to make a decision on this and then our amendments like it on three different occasions the senate has without objection or on a vote that one vote was ninety nine to nothing rejected this amendment there have been votes that have been closer but recently i think senators have gotten the message that this is not an amendment is going to achieve the goals that the proponents who are offering it say it will there will be some cheaper drugs coming into the country but maybe just temporarily for the reasons that have been pointed out by others and in the washington post editorial this morning so i'm hopeful that senators will carefully look at the situation that we face the intent of course is certainly laudable but we have an overriding responsibility to make sure that medications purchased by american citizens in the united states are safe and that that is a decision made by the regulators and the inspectors here in the united states to have the responsibility of making those decisions so i'm hopeful the senate will not vote  cloture if it does we'll well talk a little more about the situation but up until that point i hope senators will review the history of the senate on this subject and vote against the motion to   thank you mr president we have an interesting challenge in front of us data how do we know that is all of us support drug availability at affordable prices and the challenge it brings us to the floor today of how to ensure that prescription drugs used by americans are both affordable and safe and that's the goal for all of us i believe in the united states senate we trust that the drugs that we get at our local pharmacy our neighborhood pharmacies are safe because they go through a rigorous a approval process and a series of tests and inspections are done before they reach our medicine chest those drugs improve extend and save lives and i'm proud so many of these drugs originate in my home state in fact more than half of the medicines approved by the f d a in two thousand and one were developed by seventy thousand hard working people employed in the pharmaceutical companies of new jersey these companies have received more than a levon thousand patents for their products since one thousand nine hundred eighty five for their innovative work many of these products are life extending and limited often painful and debilitating conditions and when we look at prospects that these companies are offering we want to encourage the research and i heard this morning about a and inoculation that could be sufficient given one time two women that could prevent i asked you  wonderful thing and recently we've had a a product come to market called sera so it says that young women who receive an injection of gardasil can be protected against cervical cancer for their lives what a wonderful thing that is and the fact our lippert are as has been known for some time to reduce plaque gathering heart and the valves and the veins that lead to the heart of the president we want to encourage that kind of development and our goal is to make sure that these workers continue developing lifesaving medications at the same time lower costs and increase access to these drugs that i support the efforts to lower prescription drug prices i understand the appeal of rei as long as we are absolutely assured of the safety and efficacy of these products so if we're going to trust drugs and for good from other countries we need to be sure they're just as effective and completely say we cannot put our citizens in the position of buying medicine they think will lower their cholesterol or prevent heart disease only to find out years later that the drug was a fake according to the world health organization up to ten percent of all drugs sold across the globe are counterfeit and we heard the bait about the countries that some of these drugs come from now if we want to give consumers the chance to buy drugs imported from other countries we've got to insist that these drugs are reliable and safe and that's why mr president the senate has three prior occasions required the department of health and human services to certify that and for taishan be without additional risk to the public health and will reduce while it reduces costs and that's why i intend to support the cochran second  degree amendment and i courage my colleagues to do the same thing let's make sure that what we're it's telling the public to buy is absolutely safe harmless and can improve lives qualities this amendment for and about right acronym that would require the same certification that this body has approved three times before to guarantee the safety of imported prescription drugs and providers time has expired if i may have thirty seconds more without a guarantee the safety of imported prescription drug drugs part me and provide consumers the peace of mind knowing that the drugs are taking safe and effective no matter where they originated  be printed in the record and i thank the distinguished senator from new jersey for his excellent statement we urge the senate to reject this motion to invoke cloture without  that the ranking member mr president i find it somewhat ironic that we're on the floor and an amendment to a drug safety bill is an amendment to allow drugs to be imported freely from any country around the world maybe i'm the only one that finds some irony in this that we co mechanism in this country to set up of a system of surveillance to recognize red flags that may suggest to us that we need to look deeper into the unintended consequences of drugs that have already been proven safe and effective and that we go even further than that and codified into law a very regimented process for the food and drug administration to go through if in fact it's triggered that there might be a problem and in the same bill because of the outrage over the concerns that we have for prescription drugs now we're going to say to the chinese continue to manufacture continue to ship in and these products may not even have an active ingredient we just adopted senator durbin's amendment that related to pet food safety standards well what this suggests to me is that for us to consider the of drugs is to say that we put food above the drug jane for the american people that we're willing to put more standards on pet food today than we are on the importation of these drugs passage of the medicare prescription deep plan which which was just a year ago lowered significantly the pressure that was needed for drugs over the internet or drug from other countries why because in the first year we've seen a thirty three percent reduction in the price of those pharmaceuticals for our medicare eligible population it's not that all the pressure is all but i'm not sure that the remaining pressure is going to be alleviated by providing them with a drug supply that have no active ingredient that lets them have the security of knowing they're going home and they're taking their drugs but the consequences of ended up in an emergency room because they didn't get the active ingredient they needed mispresent last year one point seven million tablets of counterfeit viger were uncovered one million tablets of lipitor or that were in fact counterfeit and a half million tablets of novak which were seized in china and the unfortunate thing is china is not the only country in the world where we have created a cottage in your story of producing drugs that look just like the ones that we sell in a pharmacy but that we regulate at a gold's sander that many on this floor have tried to protect every time we open legislation that is about the food and drug administration this president we're here today to assure the american people that were raised in the gold standard that it's not just the bar of where we determine safety and efficacy but where where he's in the standard when the population at large is exposed to that medication to make sure that in fact unintended consequences are fully investigated to accept the importation of foreign drugs is to open the door that a cottage industry today becomes a mag industry tomorrow at supplying counterfeit drugs with no active ingredient with the potential that there's products in it that are adulterated that not that will just not solve the health problem but as has been proven in the pet food supply killed pets now when people died we put the standards higher than we do the standards of importation of dropped i would urge my colleagues at least except the cochrane amendment which puts a safety standard in but do not pass this importation legislation from any country around the world i mean i don't know of that piece of legislation but if it exists i would be happy to vote against it that's not what this bill is this bill doesn't allow imported drugs from anywhere around the world at all so you know i'm not interested in losing a debate i'm not involved in the debate is about a piece of legislation carefully constructed in which we talk about imported drugs from countries that are judged to have a safe supply of drugs let me give you an example of  testimony from david kessler i would say if you if you can find an expert better on these subjects and david kessler i'd like to hear the name he ran the a for eight years was identified by everybody as an outstanding f d a commissioner here's what he says quote a sound framework for assuring that imported drugs are safe and effective most notably it provides additional resources to the agency to run such a program oversight by the f d a of the chain of custody of import to the f d a inspected plants a mechanism to review imported drugs to ensure that they meet f d a approval standards and the registration and oversight of importers and export is to assure that imported drugs meet these standards and are not counterfeit all this discussion about counterfeit that's happening today under today's rules without importation that's a spaces issue dr david kessler says it provides a sound framework for assuring th imported drugs are safe and effective and let me show you a chart dr roast i mentioned earlier they've been doing this for twenty years in europe dr roast peter roast one vice president marketing at pfizer said this during my time responsible for a region in northern europe i never once not once heard the drug industry regulatory agencies the government or anyone else saying that this practice was unsafe he's talking about importation of prescription drugs here in germany want to buy a prescription drug from france no problem you can do that through something called parallel trading here in spain want to buy it from italy no problem you can do that they have parallel trading not once he said  has anybody raised that the issue that this practice was unsafe for nearly twenty years in europe and personally he says continue to quote i think it is outright derogatory to claim that americans would not be able to handle reimportation of drugs when the rest of the educated world can do this that's the fact one of the things the congressional budget office says this amendment will save fifty fifty billion dollars that's  b fifty billion dollars in ten years that's five billion dollars a year forty five billion dollars to be saved by american consumers the leading expert says there's no safety issue we have a regime in this bill that provides for safety and so the question isn't on all of these ancillary issues and by the way the washington post doesn't take on this issue with respect to safety it says there is in fact a problem with drug pricing let me read the sentence i agree they don't want this passed but the reason they don't want this passed is they're worried that it will undercut the underlying bill because the president will veto it well here's what the president said when he was running for president two thousand and four they said what about importing drugs he said well if it's safe then it makes sense obviously telling those in attendance at that debate that he thinks it makes some sense if it saves about consulting dr david kessler who says it is safe and effective as we've described it in this legislation and so what the washington post says they're worried about because the president's threaten to veto this with the underlying bill but they say this is they're talking about importation will not solve the problem of drug pricing and the washington post think there's a problem in drug pricing what is that problem well to respond to my comments are they my colleagues comments in the first quarter of two thousand and seven the largest price increase in prescription drugs in this country in six years american association retired persons a r p said that in two thousand and six the price of prescription drugs rose four times the rate of inflation there's no problem thanks so think there is a problem washington post says there is the numbers show that there is a problem the question is are we going to solve it and we're just going to decide no that's what's put this down the road the more time it's present i yield four minutes to five minutes to my colleague from vermont senator from vermont thank you mr president and i want to congratulate my colleague from south dakota for the extraordinary and comprehensive outline of this issue that he has made not only today but in the past by the straight with my colleague north dakota i am sorry mr president not that it bothers me very much but i with the president every single day in this congress and throughout america people sit down and they eat their lettuce and their tomato and their salad and their tom mexico from latin america their lettuce comes from latin america all the food that they eat they come from as far away as china and billions of dollars of food imports come into this country but i don't hear anybody in the spotty standing up and say all we have a problem we have a problem about food safety of food coming from other countries they come in there is a problem i don't hear too here but somehow mr president the united states government with the f d a cannot regulate a small number of drug companies so that we can safely bring in prescription drugs from canada and other industrialized countries so that as a result we can substantially law the cost of medicine for millions and millions of america this is absurd of course we can safely regulate the flow of medicine coming in to this country the real issue here is not the safety of medicine the real issue here is the power of the pharmaceutical industry the most powerful industry in terms of lobbying impact in the united states of america i think the oil companies up our full take a look at the drug companies think the banks a powerful take a look at the drug companies today we are living under a medicare part d prescription drug program that was written by the drug companies for the drug companies today billions of dollars of taxpayer money goes into research and development for new medicines that go to benefit the drug companies while the american people do not get reasonable prices for the products that they helped to produce mr president since nineteen ninety eight the pharmaceutical industry has spent over nine hundred million dollars on lobbying activities nine hundred million dollars that is more than any other industry mr president today there are over twelve hundred per script for drug lobbyist right here on capitol hill and throughout this country and you know what their job is what their job is is to make sure that in the united states of america we continue to pay by paul the highest prices in the world for the medicine that we use if you have a chronic illness there is a strong likelihood that you will be paying two times as much for the same medicine as all friends in canada pay or our friends in europe pay why is it that the same medicine manufactured in the same factory costs ox in some cases two times in some cases three times as much money as it does cost ou canadian and european friends and the answer is pretty simple the answer has everything to do with the power of the pharmaceutical industry and the enormous amounts of money that they spend on law being on campaign contributions on advertising on pressure that they put on members of the united states congress the  president i have been involved in this issue for a number of years and i've been involved in it in an emotional way because i was the first member of congress to take constituents over the canadian border the purchase in that case  cancer drug that ended up costing vermont women one tenth the price that they had to pay in the united states of america in our country today there are people struggling very h terrible illnesses who have no health insurance and who need their prescription drugs and some of them simply cannot purchase their prescription drugs some of them are taking money out of their food budget to buy their prescription drugs we are a great nation in many respects but the time is long overdue for members of the senate for members of the house to reclaim this institution from powerful special interests today is a day of reckoning this is very important legislation this can drive the price of prescription drugs down by twenty five to fifty percent let us stand together senator from wyoming has ten minutes senator from north dakota has three minutes three and happens mr president i do rise today to oppose cloture on the amendment i do find it ironic that in the midst of the work on the biggest drug safety reform in the last decade perhaps longer than that we're even considering the issue of drug importation our drug safety bill is an acknowledgement that we don't have things quite right now our domestic drug safety system i'm baffled that we want to take on all the hard work and effort to fix our drug system problems and then throw it all away opening it up to foreign drugs and when i was chairman of the health committee we held three hearings on drug importation the witnesses at the hearing raised a number of problems and questions about importation in general and this bill in particular in fact one of those hearings was entirely about this bill at that time i asked my colleague north dakota if he would work with me to develop a state based pilot program for drug importation he turned me down i was convinced then as he is now that his bill is the way to  go i'd like to take disasters in the small chunks if we're going to have to take disasters and i hope we're not going to take disasters and i respectfully suggest that this bill is not the way to go even if it were this isn't the time for it to go there  we've had a lot of comments about the wall street the washington post editorial and i do refer people to that washington post editorial they cover and a number of factors but they do emphasize that the main bill the safety bill the safety reform bill that we're working on is a very important bill and they do recognize that this amendment would add some very strong complications to it they the senator from north dakota suggested that we read the bill you know that's really a good suggestion for anything that we cover around here and i make an effort to read all of the bills that we that we do i hope everybody takes a look at this one and i think you will vote against if you read the bill it's a road map to loopholes yes every time somebody brings up a potential safety thing they stick another clause in there that might cover that gap but it shows where the gaps are most likely and they keep adding paragraphs we have an amendment that would have been given an amendment that would have been a second degree but it was too late to be a second degree so it's a first degree amendment that would deal with counterfeit and counterfeiting that's another area that has to be looked at and this the senator from rot talks about taking people across the border into canada to buy drugs you know they're going to the the exact pharmacy at that point they're not going through the internet they're not doing it through the telephone these things are interest cep did their fault sites that are set up out there and people are thinking they're getting drugs from canada or getting them from saudi arabia and other places in the world it is so easy to get information as though it were a particular location imply that it's a particular location get the confidence its particular location and not be that location to try and solve some of that senator gregg has has has an amendment that would perhaps tighten up the internet problems but look at that one too and you will see that there are problems if you're not getting a direct i'm a strong supporter of people getting it from their local pharmacist the local pharmacist the one that's going to help you interpret all those sheets of paper that come with the prescription they're the ones that are going to know what other drugs you're taking and if there are some possible interactions local pharmacists are the most valuable asset that we have in the entire pharmaceutical chain and we're working very hard in other ways to try and put them out of business and that's going to be a tragedy for  america so i have read the amendment i encourage people to read the amendment look at the complexity of the amendment look at the loopholes that they're suggesting that they have fixed see if you think that's fix them but i ask that you take a look at what the washington post and i'm not one of the ones that normally advocates that you take a look at what the washington post says but it's definitely food for thought on this bill it will it will take away a major reform that we could have  by throwing something else in that that we need to discuss more so i would ask my colleagues to oppose cloture for the sake of the safety of our drug supply let's get it fixed at home before we try to open it up to the world be i would in order to allow the senator from north dakota to have the final word on that since his bill i would ask people to vote against cloture and i would yield to balance my time senator from north korea mr president  thank my colleague from wyoming i regret that he cannot be a supporter of cloture and the bill but i respect and understand his position we just disagree and i do so respectfully i want to die i do want to mention one thing with respect to a pilot  program following that hearing i did put together a pilot project and went to tommy thompson went down to his office made a presentation of a northern plains pilot project on prescription drugs and he felt like he couldn't move forward with but i do want to say what he said to me after he left the health and human services i met him in the elevator just outside the senate chamber one day after he left being secretary because i had bad him a lot about the issue reimportation and as i got off the elevator and he was getting on and we greeted each other i liked him i thought he was a good health and human services secretary he said by the way byron he said you keep working on that important drug issue you're right about that you're right about that that was after he left the health and human services let me let me again respond with respect to david katz where all this talk about safety first of all this is where this amendment belongs on this bill this improves the bill it doesn't detract from safety issues at all it does address something not addressed in this bill and that is a serious pricing problem with prescription drugs in our country there's no answer to this that i have heard in all of the discussion david kessler head of f d a for eight years i think he's the expert here on these issues the dorgan snow bill quote provides a sound framework for assuring that imported drugs are safe and effective he says they will be safe and effective why would someone go to some fraudulent web site as it was just discussed by maybe somebody go to a bad web site why would somebody go to a bad web site in order to import prescription drugs if that web site by the f d a exists that describe that will describe where they can access these prescription drugs safely i mean that's those are spaces arguments congressional budget office says that this amendment will save fifty billion dollars over ten years now why would they say that precisely because the washington post acknowledges there's a pricing problem with prescription drugs in our country fifty billion dollars savings over ten years now i just mentioned that in the first quarter of this year the price of prescription drugs the largest increase in six years in this country last year two thousand and six according to a r p it rose four times the rate of inflation there's a pricing problem with prescription drugs the identical drug f d a approved same pill put in the same bottle made same company f d a approved and sent virtually every other place in the world at a lower price and the american consumer is told you know what we've got a special deal for you you get to pay the highest price in the world the question is whether this congress will decide that that special deal of the highest price in the world ought to stop i hope this congress will decide we're going to stand with the consumers yes we're going to insist on safety we're going to stand with the consumers there is a pricing problem this amendment is one way to fix it in a manner that is safe and effective and finally mr rhodes says for twenty years they did this in europe he said i think it's out derogatory to claim that americans would not be able to handle reimportation  prescription drugs when the rest of the educated world can do this of course we can do this of course we can allow someone to go to canada and buy from a canadian drug store that has this as safe a chain of custody as ours do and buy prescription drugs in this case lipitor for half the price that's being charged five miles south across the border why on earth should the global economy not be able to work for average folks the pharmaceutical industry imports all of these drugs why should the average person this country not be able to put downward pressure on prescription drug prices by being able to access f d a approved drugs from other countries canada other countries that have a safe supply of drugs that's all our member does it's the right thing to do how much time remains well then let me roll back my time mr president kennedy to the f d a revitalization bills signed by sixteen senators by unanimous consent the mandatory quorum call has been waived the question is is it the sense of the senate to debate on amendment number nine ninety offered by the senator from north dakota to provide for the importation of prescription drugs shall be brought to a close the s and days are mandatory under the rule the co mr sessions mr shelby mr smith ms now mr spect mr stevens is just a new name mr tester mr thomas mr warner mr web mr thomas no gregg no mr specter mr specter  mr alexander  voter who want to vote or want to change their votes mr craig no mr craig  the senior senator from mississippi is recognized mr president i have an amendment we have order in the senate please take conversations out of the chamber a senior senator from mississippi is recognized as president i have an amendment at the desk it is  senators senators amendment is already pending i thank the chair senator may proceed mr president this present the purpose of this amendment is to require before can be undertaken a certification by the secretary of health human health and human services for the food and drug  importation of the drug will indeed have an economic benefit to the consumers who buy those drugs and that it is safe and not harmful for human consumption we have had discussions with the please be in order we have had discussions over the last several years really with administration officials who have been very concerned that the importation of drugs that would be permitted by the dorgan amendment needs to be balanced by the interests we have in protecting the integrity of the marketplace so that no counterfeit drugs are imported creating the impression that they are something that they are not this is a very real problem and recall having meetings here in the senate with members of the committees with jurisdiction learning about the growing problem and the continuing increase in instances  where postal inspectors others who are charged with the responsibility of inforcing our laws and protecting american swimmers are finding that drugs that are manufactured in other countries not canada necessarily but in india in asia in south america are counterfeit they look like the real thing the labels look like the legitimate and our din labels you see on the drugs being purchased but they're not what they say they are this is a very difficult thing to deal with so what we're asking in this amendment is that the senate insists that if drugs are going to be imported then there has to be a certification by the f d a or the department of health and human services that they're safe for human consumption that they haven't been tampered where that they are not counterfeit so i hope the senate will approve this amendment to the dorgan amendment and i don't know of anything else to say i submitted in earlier comments a washington post dot com  article which is printed in the record now which supports this effort and talks about the importance of certification to the consuming public we have a lot of information in i'd be happy to discuss the details with any senators who are who are undecided about approving this amendment but i hopes the senate can adopt this a senator from wisconsin is recognized thank you mr president i ask unanimous consent to set aside the pending amendments so that i may call my m m at number nine ninety one and i ask for its immediate consideration subject ordered objection is  but there's still a lot of work being done on this amendment and senator kyl and others are involved in it and would not want to debate until we have more chance to work on it for the amendment after that president of wisconsin i do rise at this time to offer a member number nine ninety one this amendment is supported by senators grassley and leahy and i think my colleagues for their support this amendment is in almost all respects identical to  three sixteen to preserve access to afford evil generics act which did pass to do gerri committee earlier this year in a unanimous fashion this amendment will prevent one of the most egregious tactics used to keep generic mar competitors off the market which leads consumers with unnecessarily high drug prices the way it is done is simple a drug company that holds a patent on a brand name drug pays a generic drug maker to not put a competing product on the market the brand name company profits so much by delaying competition that it can easily afford to pay off the generic company and a generic company can also make much more money by simply accepting to pay off  by settlement losers or the american people who continue to pay unnecessarily high drug prices for years to come this amendment is basically very simple it will make these and i competitive and i consumer pat payoffs illegal will thereby end the practice seriously impeding generic drug competition competition that could save consumers literally billions of dollars in health care costs despite the  is opposition recent court decisions have permitted these backroom payoffs and the effect of these courts decisions have been stark in the year after these two decisions the f t c has found half of all p settlements fourteen of twenty eight did it evolve payments from the brand name to the generic manufacturer in return for an agreement by the generic to keep its drug off the market in the year before these two court decisions not a single patent settlement reported to the f t c contain such an agreement when brand name drugs lose their pet monopoly this opens the door for consumers employers third party payers and other purchasers to save billions of dollars sixty three percent on average by using generic versions of these drugs a recent study released earlier this year by pharmaceutical care management association showed that health plans and consumers could save twenty six point four billion dollars over the next five years by using to generic versions of fourteen popular drugs that are scheduled to lose their patent protections before the year two thousand and ten and we've heard from some in the generic drug industry that on occasion these patent settlements may not harm competition that is why are amendment includes a new provision not contained in s three sixteen this new provision would permit the c the guardians of competition in this industry to exempt from this amendments ban certain agreements of the f t c discernment determines that such agreements would benefit consumers this provision will ensure that  does not prevent any agreements which truly benefit consumers it is also important to note that contrary to the arguments made by some this amendment will not ban all patent settlements in fact this amendment will not ban any settlement which does not involve an exchange of money this amendment will do nothing to prevent parties from settling patent litigations with an agreement that a generic will delay entry for some period of time in return for ending its challenge to the validity of the patent only the agreed just pay off settlements in which the brandname company also pays a generic company a large sum of money to do so will be banned we understand that several of our colleagues will prefer alternative versions of this proposal as we said all along we continue to be willing to consider modifications to this measure as long as this legislation will be effective to ensure that these and i consumer pay off settlements stop to work with my colleagues to find an effective manner to do this i've directed my staff to work with the staff of other interested senators in this regard and i am willing to continue to engage in this short of such an effective alternative being presented to me we will ask for a vote on adoption of this amendment so in closing we cannot profess to care about the high cost of prescription drugs while turning a blind eye to and i competitive backroom deals between brand engineer drug companies i believe it's time to stop these drug company payoffs that only serve the companies involved and deny consumers to affordable generic drugs i  rewarding generic drug makers who enter the market first for some companies have subverted this balance system instead of allowing market forces to bring medicines to consumers at lower prices companies collude to the benefits under these arrangements except consumers so the brand drug companies get further protection from competition generics get payoffs and a guaranteed market only consumers get left behind stuck with the higher prices and lesser competition judiciary committee reported legislation on this important issue and i commend senator coles for leadership i know that senator specter senator hatch have important recommendations and i'm sure we can work this these matt is out o death senator from north dakota is recognized mr president as the president indicated earlier the cochran amendment with co sponsors is currently pending i believe or has been appropriately offered in this pending like to make a couple of comments about the vote that we will have some point in the future on the cochran amendment and what i would like to do is to go through so that all of our colleagues understand what is in the underlying bill i indicated earlier one of my colleagues stood up and said that the legislation would offer it would allow drug reimportation from any country in the world well that's just not true i mean you know there's no sense to be think a bill that doesn't exist so  mr president set aside in order to send a come to order will the senators and staff evil take your conversations out of the chamber center from north dakota deserves to be heard senator from north dakota's recognize i have a piece of information distributed by pfizer corporation that is opposed to my a describes it describes various problems with drugs that are purchased on line and counterfeit drugs and so on interestingly now all of these problems would be solved by the legislation that i have introduced with all the safety issues involved now these are spaces issues because the underlying legislation would address all of these issues now let me go through a list and this is the list you won't be able to read it but i'll go through them of the safety provisions in this legislation first of all with the imported drugs drugs imported from other countries which as i have indicated europe has done for twenty years and no safety issues at all surely we are as competent as the europeans in being able to do this recall this my bill our bill would require that all imported drugs be approved by the food and drug administration so we're not talking about any renegade drugs out there all f d a approved drugs all of them imported be approved by the a it creates a process to approve medications sold outside the united states which are identical to f d a approved products it sets a process by which f d a may approve medications which differ from the rest of version of the drug provides no imported drug may be misbranded or adulterated or require and it requires compliance with g m p requires the f d a to enter into agreements to monitor drug recalls and approval status changes a stab this is a set of standards which countries must meet to be a quote permitted country with respect to pharmacies and wholesalers on this list we say it provides for registration and regular state regulation of exploiting pharmacies and importing wholesalers only by licensed operators in both cases requires registrants to pay an application fee submit to evaluation and post a substantial bond requires pharmacists and wholesalers to be fully compliant with the local state prevention of the national laws requires the f d a to approve inspections perform inspections of operations including facilities and records at least twelve times per year requires exploiting pharmacies to verify prescriptions review medications for interactions to ensure privacy requires pharmacies to maintain records for two years for f d a review exploiting pharmacies must preserve samples of each lot of a drug for f d a to utilize for testing gives authority the f d a to monitor inspect the full chain of custody of a drug says penalties for violation including suspension line to lifetime revocation and criminal penalties it requires every imported drug to have a full record of the chain of custody which is a pedigree that's very important every imported drug will have to have a pedigree full record of the chain of custody requires every package to have an f d a approved labeling affixed and every product must clearly be identified as quote imported unquote drug labeling would also include the name of the registered to handle the medication and the product a lot number as a part of that pedigree with prior notice of shipments of prescription drugs to the u s importing wholesalers it provides that first sale of a drug that may not be shipped outside of the permitted countries requires f d a to provide information to consumers to identify the safe and legal directed sources of approved imports gives customs  a two and a half percent user fee provides implementation of drug pedigrees for domestic medications by twenty ten which do not exist now by the way and requires the packaging of all prescription drugs to incorporate a standardized numerical identifier unique to each package of a drug and counterfeit resistant technologies when you want when one reads through the safety features and then alleges that this is unsafe i mean it just it baffles me how one can reach that conclusion tommy thompson the secretary of health and human services said in order to import drugs from any country and especially canada i have certified that all those drugs are safe that's an impossible thing if congress wants to import drugs they should take that provision out well let me ask you this question what it means possible for the health and human services secretary to certify that all drugs sold in this country f d a approved drugs are safe there's could certify that the answer is no of course not i can give you example of metal traces and things in pharmaceuticals that were sold in this country f d a approved by major manufacturers could a health and human services administrator secretary certify that the existing drug supply is quote say poses no or quote risk unquote they couldn't do that for pet food they couldn't do that for letters they couldn't do it for carrots they couldn't do it for celery they couldn't do it for imported vegetables they can't do it for imported meats they can't do it for domestic production to say there is no r the issue of requiring certification is an attempt to kill legislation and it is perfectly appropriate for some to say the current system works fine don't change it i don't quarrel with that i don't agree with it but i respect those who hold that view but i do believe that it is hard for anyone to with great merit make the case that with what we have done in this legislation on a bipartisan basis still renders this to be an unsafe process the experience in europe of course undermines that argument they've done it twenty years it's been perfectly safe and let me also go back to david kessler statement i don't know of an f d a commissioner that comes to his belt buckle let alone his shoulders in terms of capability david kessler i think it's been an extraordinary f d a commissioner back for eight years i worked with him when he was there he said this the dorgan snow bill quote provides a sound the imported drugs are safe and effective now you know we can just talk all day about these drugs being unsafe but obviously that does not change the facts does not change dr castro's opinion it doesn't change the circumstances of the safety provisions we put in the bill they are there they're there for a very specific reason we took the interests and concerns of secretary shalala and secretary thompson we wrote them into this bill dealing with safety provisions and the fact is this bill will make our domestic supply of prescription drugs safer that's the plain fact then we will have a pedigree for all prescription drugs important domestic that's just a fact now the second part of the amendment says it has to be assured that it will save money and pose no risk or save money that's easy the congressional budget office has said it's going to save fifty billion dollars in ten years six point one i thought it was five six point one billion dollars of that is savings of the federal government we just have a new estimate by the congressional budget office that if the cochran amendment is passed that savings goes to zero why it undermines the bill it means this will not have impact importing won't happen not because anyone wants to import another state drugs because in fact the safety provisions we have included will make the supply the drug suppl domestic supply included as well as imported drugs safer that's the point this issue is not horribly complicated question is should the american people have the ability in this global economy to access a drug that has been produced you know often cases by an american company with research in many cases paid for by the american taxpayer produced in many cases in a plant here in the united states of america and then sent to another country at a much lower price should the american consumers be able to access that f d a approved drug that is sold for a lower price elsewhere stated another way should the american consumers continue to accept the notion that they should pay the highest crisis in the world some say well that's not a problem here cite the washington post editorial today the washington post editorial actually says there is a problem with spector drug pricing in the first three months of this year highest price increases on prescription drugs in the last six years last year in two thousand and six six times the rate of inflation price increase and prescription drugs in addition to that we pay the highest prices of all the other countries and that is that makes sense  to me and i'd like to have somebody just stand up on the other side of this issue to say you know what i disagree i think the american people should pay the higher prices i just think that's fair i mean that that's the alternative it seems to me because that's the reality and i'm not interested in debating some fiction someplace the reality is this we pay prices that i believe are wrong and i said billy i don't come here disrespecting the industry they do a lot of important work i have a profound disagreement with their pricing policies because i think it's unfair to this country unfair to the consumers of this country that's my that's my difference and my beef their pricing policies are wrong why should they as i said yesterday why should an eighty year old woman have to go to canada every three months as she's fighting breast cancer have to go to canada in order to  this is an approach that will fix and i will have other debates here and i do not let me say again as i said just moments ago i don't disrespect the pharmaceutical industry of great respect for what they do i have a profound disagreement about their pricing policy i don't disrespect those that have a profound disagreement with my amendment i respectfully think they're wrong in the end the question for the congress is you think what's happening with respected drug pricing is appropriate and my answer is no i think the american people are being disturbed by a pricing policy the pharmaceutical industry can make stick they have the capability to control prices they do it in this country behind a law that says the only interest being able to can that is able rather to import prescription drugs is the manufacture of that drug europe doesn't require that europe has been required that for a long while they allow parallel trading to exist so the consumer can take advantage of some price shopping among the countries of europe only this country has decided no the consumer doesn't have this right the manufacturer has the right but not the consumer and i say that's what the consumer let's let the american people have access to the benefits of the global economy as well yes let's make it safe we've done that this legislation with the safety precautions that i have described  and significantly improve safety of the reimportation that now hers and ok janelle bases by people walking back and forth or driving back and forth across the border those who are fortunate enough to live near a border let me just i just passed a piece of in from a we have just gotten a congressional budget office score on the amendment that i have offered and it says that the amendment if passed will save the federal government ten point six billion dollars in a ten year period and i believe it is a fifty billion dollar savings in total which is something like a forty billion dollar savings globally or something i will in any event put  congressional record the specifics but i do know that the congressional budget office has just scored this amendment and it will save consumers tens of billions of dollars and the specific savings to the federal government itself as a result of savings to our programs and expenditures would be ten point six billion dollars mr president with that i will yield the floor mr president senator from mississippi mr president for the information of senators i think out seek to defang in more specific terms exactly what the dorgan snow prescription drug amendment mr president the dorgan snow bill which is pending before the senate as an amendment a lemonades language the food drug and cosmetic act that allows importation to take effect only if the secretary of health and human services can demonstrate to congress that it will pose no additional risk to public health and result in a significant reduction in the cost of covered products to them their american co amendment that i have offered to the dorgan snow bill would restore this language the senate has overwhelmingly voted on three occasions to include a safety and savings certification provision in prescription drug importation legislation for the purpose of protecting the public health following passage of this safety and saving certification requirement no secretary of h h s democrat or republican has been able to demonstrate that importation is safe or will lead to cost savings but secretary shalala in the clinton administration and secretary thompson in the bush administration could not demonstrate that importation poses no additional risk to public ale or would lead to significant cost savings back into the year two thousand secretary shalala concluded and i want to quote it is impossible to demonstrate that it meaning your protection is safe and cost effective in quote secretary thompson reached a similar conclusion in the next year two thousand and one by saying he could not sacrifice public safety for uncertain and speculative cost savings  oregon's no bill contains numerous provisions that would expose americans to harmful or adulterated imported drugs could expose in particular the bill permits the importation of drugs that originate in such countries as latvia estonia slovakia greece hungary and the czech republic the are outside the control of the manufacturers and app side of the jurisdiction of the food and drug administration some of the drugs that could be imported under this provision would violate food and drug and cosmetic act requirements against adulteration and mis branding canadian law all has been discussed here it permits the trans shipment of unapproved prescription drugs from any country in the world through its borders to the united states they shipments move across borders free from examination from canadian regulators who have said their government will not ensure the safety and effectiveness of exported drugs the f d a and customs officials have seized counterfeit drugs entering the united states from alleged canadian pharmacies that are established for the purpose of permitting trans shipment from other countries outside of canada into the united states these places originated include countries such as india pakistan china and thailand if mom and that is not adopted the underlying bill as amended sen north dakota would permit transshipment and severely restrict the ability of border officials to stop suspected drug shipments in or ing the united states naaman would not allow him for taishan to began unless the safety concerns are resolved and the government gena sure the american public that imported drugs will not in danger they their health there's no guarantee that american consumers will experience reductions in their prescription drug costs if the dorgan takes effect because middleman have shown they may keep the savings the amendment have offered insurers that consumers would benefit from importation before weakening consumer protections against potentially unsafe  program would take effect only after a regulatory system has been put in place to protect american consumers i hope the senate will approve my amendment second the senator from north dakota mr president i won't speak at length i do want to make one point the senator from mississippi just indicated that the amendment i have offered would allow for the reimportation of drugs that are not a approved i don't know where that information comes from but it is demonstrably untrue and i don't want there to be a mistaken impression about that i would ask my colleague from mississippi if we could at least resolve that issue the intent of this the  written version of this is very clear no drug will be imported into this country unless it is f d a approved so my colleague indicated that this amendment would allow drugs to come in that are not approved i don't know where that information comes from and if he and i could at least exchange information so that we resolve that issue i'd appreciate it mr president i am advised if the senator will you know that the f d a is that it would not have a regulatory framework in effect could not put a regulatory framework in effect to guarantee what my amendment says it should guarantee and that is the effectiveness of the drug the fact that there will likely be savings that will result for american consumers if the dorgan amendment is adapting well must present that's a different issue the the amendment itself will not allow whether there's a regulatory framework or no regulatory framework it will not allow a drug to be imported into this country that is not f d a approved that is the written provision in the amendment itself second with respect to cost i respect that we may have a disagreement on that but i would just again observe the congressional budget office just this morning has given us another score and the score from the congressional budget office is that this will save the federal government's ten point six billion dollars in a ten year period and i believe the global savings the rest would be for the consumers is just slightly over fifty billion dollars in ten years so it seems to me that it's self evident if the congressional budget office is putting out information to the senate this morning that describes the amount of savings in this case averaging about five billion dollars a year it's quite clear someone is going to save something somewhere so i mean that i think that we also can resolve the cost issue at some point as we get down the road you know again let me say i i respect the senator from mississippi he's a very worthy legislator cares passionately about the things that he works on and i do the same and i mean i think the way to resolve this is to talk through what are the safety provisions in the bill and if they are inadequate demonstrably inadequate i will accept that we would make some changes but i don't believe that is the case i don't believe it's been demonstrated and as i have indicated the previously dr david kessler who ran f d a for eight years says this bill provides a sound framework for assuring that imported drugs are safe and effective i understand the pharmaceutical industry doesn't say that understand some others don't believe that i understand respect that but i also believe very strongly that the evidence is overwhelming we have added the safety provisions that were raised by secretary shalala that at the provisions that were raised by secretary thompson i believe and thirty three of my colleagues in this chamber republicans and democrats believe that we have done a very good job in resolving those issues you know this issue almost has a great beard i mean it's been around a long long time we've been trying a long time it's hard to win on this issue i accept that and understand it but i'm hoping that perhaps this is the year and we might which we might give the american consumer an opportunity to be able to participate in the global marketplace in a safe and effective way just as the europeans do and they will be able to access a lower priced f d a approved drugs the senator from north carolina mr president i think cali that this issue has been around for a long time and one of the reasons we continue to debate it is that we continue to have real live examples of product that comes in that's adulterated i'm not sure that we've done anything to a lemonade the ability to counterfeit other than than to confuse it even because in fact today we basically say that it's almost impossible unless you're an individual crossing the border to bring in drugs from another country are challenge that customs today with immigration well we're just as challenge to custom said day on the shipment of pharmaceutical product that comes in this country from abroad and it's not held to a single country and i don't believe that the reason that we embrace this bill is because the europeans do it there are a lot of things that europeans do today that i wouldn't necessarily suggest are right for america as a matter of fact we've got some international treaties that suggest that we should harmonize our drug standards with the european union and what we found was the european union of harmonization is with twenty two members they accept which ever country the application was applied for and if that country approves it then it's good for the e u well if you look at some of the standards throughout the twenty two countries it would be dismayed aniline the gold standard of the f so for those that suggest that what we would do in this is to maintain our gold standard it wouldn't happen the reality is that a view except what they do which doesn't come close to the gold standard of the f d a for safety and efficacy over time would bring further deterioration to the confidence of our drug supply when every american goes to their local pharmacy and they have that prescription that's written by a doctor they go in with one hundred degree confidence of knowing that there is an active ingredient in it that it isn't adulterated that their health isn't going to be affected adversely when they take it now we're on the floor today this is part of a drug safety bill why because in some cases when products are approved and given to a much larger population that larger population experiences different side effects because every person is genetically different they're no two alike unless we change the colonials in this country and the reality is i don't think we're going to do that so we don't have it to worry about but we're here trying to strengthen the safety of the product that we currently can maintain the chain of custody because it's manufacture it's distributed and every product has a case a lot number what we experience with counterfeit drugs they've been able to make a pill at dental to the pills we go to the pharmacy and buy adenike all in not just the pill but the packaging and as we shift packaging so do those who are trying to game the system the ality is that the person who's on the receiving end and i sympathize with exactly what the senator from north dakota has claimed that in many cases pharmaceuticals aren't affordable for some people that's why we created that's why over thirty million americans that are medicare eligible now have coverage coverage that has brought down the price of pharmaceuticals thirty three percent in the first year any other area that we would propose legislation if we saw a trend like this we would be embracing the fix that we put in but no we're going to dilute it even further and confuse seniors across the country and say you know now just go on the internet and b because we've said it can only come in if it's an f d a approved product will f d a approved products are the only things we write prescriptions for in the country and the reality is that the only counterfeit product that counterfeiters are making are after lookalikes there is nothing in the dorgan bill that says somebody can't counterfeit anymore there's nothing in the bill that says if we don't catch it it does us airport when it flies and in fact we test it immediately to find there's no active ingredient that we haven't put somebody's life in danger there's no assurance in this bill that if there's an adulteration of some kind that affects somebody's health that unless we in the host of may years of pills that come in if we don't catch it there's somebody on the receiving end that's going to be adversely affected health wise so i appreciate the fact that everybody wants cheaper drugs we all do but there's a reality about the united states of america that we protect intellectual property therefore we attract companies not just limited to pharmaceuticals  i guess the next thing we're going to do is claim that microsoft software is too high so we're going to now allow that to come in from somewhere else well we protect handbags we protect clothing we protect the copyrights the intellectual property there's even more reason to do it in pharmaceuticals it's because there's a safety component i think when many people think they might be buying a counterfeit handbag if they bought it on the streets of this town or some and they probably think well if i get a years use out of it based on the price that's ok i don't think you can apply the same standard to pharmaceuticals but doesn't have the active ingredient somebody might that in fact we in the drug safety bill dog food higher than what this importation provides for pharmaceutical supply in this country we're going to have plenty of time to talk about it and just as the senator from north dakota brings a lot of facts and figures to the floor there are a lot of facts and figures from the eight years maybe more that we've debated this issue and it hadn't been congress it's turned it down it's been the american people at the end of the day they send us here to make decisions that are positive as it relates to their health and their future i don't think i don't think americans want to take a pig in a poke on pharmaceuticals but that's what this  we're vantage by that there are many countries in the world where you you don't have access to the drugs and biologics and devices that we have in this country yet they're expensive because they're expensive to develop but we put more value on the quality of life the ability for us in this country to treat things that others aren't able to treat because we believe that in the overall scheme of our system that we save more money on health care if in fact we give somebody a pill that wasn't the case we would have programs for a chevy eight but every time we supply that therapeutic for that a chevy age patient we know that they're not going to have one case a year with some type of retinal infection we know they're not going to be admitted to the hospital for a week because an ammonia we know that the savings over that incident is probably going to be fifteen or twenty thousand dollars that we've saved and that's before we put any cost on the quality of life of the patient that's affected by the disease i would imagine mostly counterfeit you have a product because it's expensive you know it's one of those diseases that doesn't stay in the same place it's smart it changes self within somebodies body and it means over a period of time you can take a drug that's very effective or a combination of drugs it's very effective and after two or two and a half or three years the disease is now changed and if you don't change with new therapies the reality is that there are going to be a tear aeration of that person's quality of life and a further advance of the disease right now we've got companies that are excited about working on the next product that will continue to take a disease that we can't cure today but that we can stop the progression right in its tracks and what we're going to say to those companies that spend hundreds of millions if not billions of dollars is one of the the united states doesn't put any value on that any more say that to the population that's affected by saying to the population of any group of americans that are affected by disease that we're not going to have the policies in place that stance the development of drugs biologics and devices when we do this that's what we're saying and again i appreciate the author's attempts to try to assure us that safety is at the forefront but that's only there if we're smart enough to catch it if we were that smart we would have an immigration problem in this country are choosing an illegal immigration problem in this country if we were that smart we'd know that we caught one hundred percent of what was coming in the country but i don't think there's anybody that's going to take this floor and suggest to the american people we catch one hundred percent of the adulterated or counterfeit drugs there's certainly nobody that can come to the floor even with our food safety standards that where they are where the f d a is in charge and u s d a is in charge and the h s now has some responsibility for and suggest to the american people that we catch one hundred percent of the contaminated food before it found its way to the shelf or to a plate in our house the reality is we've had twelve examples just in the last year where we're just not that good we're not perfect and i would suggest to you to try the system by setting up a program that cannot be policed and i think that's what my colleague from mississippi would say and time and time again we've had the debate we've polled in the experts and they've said this is just something that's undeniable for us we can't do it my hope is that as this debate goes on more and more members will realize you know it sounds good but not a risk we should take in this country it's a risk that affects people's lives  by people who really are effective and always appreciated and it's always interesting to me i do think you know certainly everybody's entitled to their opinions i respect their opinions not everybody's entitled their own set of facts we have to deal with a common set of facts my colleague just made a statement a philosophical statement about what he believes i respect that but the statement included things like you know that this piece of legislation would probably abrogate or not respect copyright nothing could be further from the truth nothing in here that would abrogate copyright protection and so on in fact in fact this amendment provides the requirement of serial numbers on lots and samples by those that are that are engaged in this sort of thing that have been prevented from occurring inside this country it requires it for importation and requires it for domestic medicines this will dramatically change the safety of the drug supply here and with respect to that which would be imported before i forget i was asked by our cloakroom to say that we have ten unanimous consent requests for committees to meet during today's session of the senate they have the approval of the majority and minority leaders i ask  with respect to the american people the american people are not undecided on this issue seventy eighty percent of them believe that there ought to be allowed the importation prescription drugs i mean this is not something the american people are undecided about it is only in the congress that it has not been decided so i think that is something we should understand why would the american people believe that they should be able to import f d a approved drugs because they believe it's just fair for them to be able to do it let me describe where the prescription drugs come from by the manufacturers of the drugs well if you're taking lipitor that's not made here that's made in ireland if you're taking  that's made in sweden next it was made in france i'll tases made in malta vytorin made in singapore in italy i mean these drugs are already imported regrettably by the way i might say they are imported without the protections that would exist in our bill that would require the manufacture the manufacture of the drug to have serial numbers on the lots of samples of every l reserve they have a pedigree for every every medicine that is that is moved that's for domestic consumption i'm not talking about the imported drugs under my bill i'm talking about the drugs that are made by these companies and other countries have shipped them into this country and every drug that is produced in this country will require the same the fact is we've tried to get that same requirement on domestic drugs and have been blocked for a long long time this legislation will make the drug supply in this country far more safe than it currently is we all know that the the amendment that is being offered about risk where that amendment to offer and to be offered with respect to new prescription drugs that come from research to say you can't put a drug out there if there's risk well do you think that that you'd have a new drug on the market any time soon you think a health and human services secretary or an f d a administrator can can say by the way i'm approving this drug and there's no risk of course they can of course they won't we know that drugs have a risk in fact some drugs are put out in the marketplace and we discover later they should not have been there a substantial risk vioxx of an official at the a says that he believes fifty to seventy thousand american people died of heart attacks as a result of vioxx being put on the market and further he says this isn't me this is an official the f widely advertised and whitely promoted as some wonderful new drug and in fact it was not a new class of drugs that had any significant benefits over existing drugs point is this if one were to ascribe this risk category to new drugs there'd be no new drugs but i know that all this talk about counterfeiting and manically talked a lot about counterfeiting in this chamber in the last couple days all this talk about ignores the point that that's occurring under today's laws and the way to fix that and the way to stop counterfeiters is to do what we do in this amendment we require on every prescription drug that is sold that ha pedigree we require in every circumstance there be serial numbers on lots and samples in the it is incontrovertibly in my judgment that this will dramatically improve the safety of domestic prescription drugs as well as import prescription drugs one final point with respect to to the issue of research my colleague said well if we pass this amendment what the senator said is there's no value to research on prescription drugs i don't have the foggiest idea where that idea comes from we spend a lot of money on research i was one of a group of senators who said let's double the amount of money at the national institutes of health and we did in five years to dramatically improve and increase the amount of research for the national institutes of health the big sport of research we do a lot of wonderful research some in the private sector some in the public sector at the and i by the way we do the research and often much of that research is used by the pharmaceutical industry to produce lifesaving drugs but lifesaving drugs save no lives if you can't afford to get them if you can't afford to have them can't afford to take them it is true that none of us have a problem here in this chamber with dealing with the price of drugs we have you know health care issues we have health care policies and you know those kinds of things but there are a lot of folks out in the country that are taking a lot of different prescription drugs and i think description drugs are wonderful they keep keep people out of an acute care hospital bed with the most expensive kind of health care and they are interesting early enough in many cases taking ten or twelve different kinds of scription drugs to manage various diseases and  as a result of that we passed a part d my colleague is correct about that and a party provides drug benefits for those that are have reached the age of of medicare and but regrettably of course there was nothing in party that that would put downward pressure on prescription drug prices i would just say look at the inflation prescription drug prices in the first quarter in this country look at the increase in prescription drug prices and two thousand and six and then ask yourself whether all of this is working to put some downward pressure on pricing it's not it's just not so you know as i said earlier this morning i hate to lose a debate i'm not having you know i'd love to have a debate in which we're both debating the same bill but the suggestion somehow that this bill allows drugs to come into this country that are not f d a approved means that you're off debating some other bill some place well fine when that debate if you want it's the bill that's on the floor of the senate and the same is true with a number of statements have been made about respecting copyrights and so on in fact what we have required in here is a regulatory burden that the industry doesn't like understand that but it will in fact protect them and protect their copyright because it will make it much much harder for anyone to counterfeit that's just a fact president one of the interesting things about this country is that we are seeing some unbelievably good news the good news is people are living longer and better lives in a century and one hundred years we've increased the lifespan by somewhere around thirty years forty six to about seventy six that's that's really good news people are living longer better lives and a significant part of that i think is being able to at an advanced age to manage diseases a significant part of that is prescription drugs there are some that don't don't have that i have a an uncle i've described before who is now eighty six years old he and his wife take no prescription drugs at age eighty six factories i've also described my colleague he's a runner it runs in the senior lympics and age eighty six he's he is to run in his seventies and early eighties the four hundred meter in the eight hundred meter now he tells me that he's a specialist in the one hundred meter dash and age eighty six so he's got a good life he's healthy likes life is very active it's not writing his motorcycle so much anymore he's got one of the biggest motorcycles you can get sitting in his garage and he doesn't need to take prescription drugs good for him but we got a lot of folks who reach eighty's and ninety's and we know about that because in our part of the country in my state of north dakota ranks number one in the nation in the number of people eighty five years of age or older as a percent of the medicare to just go back to the old life expectancy go back to forty six you would have any trouble in fact when medicare i'm digressing a bit when medicare was created or i should say social security was so scared it was created on average people live to be sixty three and so we created a system says when you retire you get benefits at sixty five well you know i went to a small school but but i understood enough and mass to think that works out real well you say you pay taxes in on average are going to live to sixty three and when you retire at sixty five you get some benefits but you you know that's not a system it's going to have financing troubles at all but then the problem is people begin living much longer that's not a problem that's a success so good for them at any rate prescription drugs about forty years ago became a much larger part of the discussion in modern life to keep people out of the acute care hospital beds and to manage their diseases and so that's a wonderful thing and i've said before and i'll say it again the pharmaceutical industry is a fine industry i just have serious problems of the pricing strategy i think it's wrong i want them to succeed i want them to research i want them to do the research on prescription drugs i'd like him to stop advertising little in the morning when i'm shaving and brushing my teeth and getting it ready for work tell me what i have to go talk to my doctor about it all these pills on me to ask the doctor if they're right for me i get confused i mean i'm not sure i need them and i'm not sure how to ask my doctor if they're right for me but as about advertising going on and a lot of promotion i want them to find new medicines to unlock the mysteries of dread diseases i want the federal government to the and i to substantially invest in new research and development i want all of those things but i also want even as i compliment the pharmaceutical industry and compliment the and i each and all those who are spending their today thursday trying to figure out in a research laboratory how do you unlock the mysteries of ai less or diabetes or cancer or heart disease or even as i do that i say to the pharmaceutical industry i think your pricing strategy is wrong and i think it's unfair to the american people we ought not be paying the highest prices in the world for prescription drugs that's just unfair image that i have offered with thirty three of my colleagues republicans and democrats would change that no it wouldn't shut down research not at all no it wouldn't exacerbate counterfeiting not at all the fact is this will be fair to the american people if we pass this legislation it will continue i think to see substantial research it will also in my judgment contribute to shutting down the counterfeiting of prescription drugs but most importantly it will find a say to the american people that we're on your side on this issue we believe in fair pricing and so we've been waiting for senators to come back to the floor here you can see right on your screen what this underlying bill is about this food and drug federal food and drug and cosmetic dact what's going on now there's been an amendment offered by senator dorgan a vote was taken to limit debate on that so debate will be limited on his amendment that would deal with reimportation prescription drugs also enemy and meant to the amendment what's known as a second degree amendment offered that would require the health and human human services secretary rise in strong opposition to the cochran amendment and we should be very clear off anybody who is interested in prescription drug reimportation for anybody who is interested in lowering the cost of prescription drugs in this country from twenty five to fifty percent for anybody who is interested in standing out of the working families of this country who are getting ripped off every day by outrageously high prescription drug costs that cochran amendment is a poison pill the vote for the cochran and then that is the vote against prescription drug reimportation is to kill the dog and amend the ideal bill of asking permission from the secretary of health and the bush administration welfare already gone on record rather firmly and decisively in opposition to reimportation is to simply massed your vote bush administration represents the pharmaceutical industry they will kill for scripts from drug reimportation at the simply ask their permission to go forward is to kill prescription drug reimportation so anyone who is serious about lowering the cost of prescription drugs will not be supporting the cochran amendment mr president the unfortunate reality is that in the united states of america today we continue to pay by fall not even close the highest prices in the world for prescription drugs because of the escalating cost of medicines many of our hello america many working people many people with chronic health problems simply do not get their prescriptions filled with the president i am sure that in montana the experience is the same as it is a month people say i walked into the drug so i could not believe the price that they are charging me i can't afford that price i have to walk the pharmacist i suspect you have talked to a pharmacist who have been in barracks they have seen tears coming out of people's lives when they told them the cost of the medicine meanwhile as a result of the power of the pharmaceutical industry we have the highest prices in the world and those prices are rising every single day in fact tomorrow if an american walked in to a pharmacy and the pharmacist says to that person i'm sorry to have to tell you about the cost of your medicine went up fifty percent seventy five percent we can do nothing about it unlike the rest of the industrialized world canada europe where they understand the prescription drugs are an integral part of the whole strategy regarding health care we let the drug companies do anything they want to do the president is the first member of congress to take constituents across the canadian border to enable them to pay substantially lower prices than they were paying in the united states i have seen firsthand what it means the people's lives when they get the drugs that they need at a price that they can afford and i will forget never forget when in one nine hundred ninety nine i bought a bus load of miners over the canadian border many of the women there which drug dealing with breast cancer fighting for their lives and they don't have all a lot of money and they went to montreal they were able to purchase a mock safin a widely prescribed breast cancer drug for at that time at that time one tenth the price they were paying in the united states for your matches not fighting for your lives not having a lot of money needing a drug and suddenly they look at the price they were paying they literally could not believe it mr president i ask permission to be made as part of the wreckage of a chart which companion prices in the year two thousand and five so the prices may be different today but as of april two thousand and five a price comparison between united states is a drug for diabetes and solve two thousand and five in the united states of america the price of the drug was a hundred and sixteen dollars for the same number of pills and the same milligram it was fifty dollars and sixty two cents in germany fights the price same product same company same factory less than half the price seen germany for selecting a drug for depression eighty five dollars in the united states thirty five dollars in germany same company same product clarinex seventy seven dollars in the united states thirty eight dollars in germany and on and on it goes sometimes more sometimes less but often half the price in germany and different prices in canada but often the same end result the very simple question that the members of the united states senate have to ask themselves today is why is it why is it that in the united states we have to pay the highest prices in the world from medicine why is it that at a moment in history when we are eating food products manufactured on the produce in farms in mexico and in latin america produced in china and they're coming on to our kitchen tables that day why is it that anybody here can say with a straight face it is ok for products all over the world to come into this country from thousands and tens of thousands of farms that's ok but in terms of a handful of major drug companies somehow we cannot regulate the flow of those medicines from canada but goodness sake is to the united states of america give me a break that augment is so totally absurd as to be almost beyond the laugh test mr president this debate has nothing to do with safety with your with food safety with drug safety all of us are concerned about drug safety the dog going to mehmet has page after page after page of regulations making sure that the f d a approved medicine that comes in to our country will be safe and what saddens me very much mr president is that in many ways the american people have given up on this issue in terms of the ability of their own government to act and they've taken matters into their own hands i don't know what goes on in montana but i will tell you that in the state of vermont thousands of people and i would say they just over the canadian border they go to world drugs suppose they buy the products they need not a big deal save substantial sums of money there was an estimate a few years ago and i don't know what those numbers thought today but there was an estimate several years ago that a two million americans were buying their medicine in canada what the dog an amendment is about the simply say that it's a little bit absurd for americans have to get in there cocked it's right that canada get the drugs that they need that maybe it might make more sense for our pharmacists to be able to purchase that medicine out prescription drugs distribute is to be able to purchase that medicine so in fact americans could take advantage of the low prices at their on local drug store that's what we want to do we don't want all of america to have to go to canada will have to go to germany to buy reasonably priced medicine we want that product sold those products sold in this country at an affordable price now i think many americans are wondering how does that happen let's see products made by an american drug company at a time when the taxpayers of this country by the way spend billions of dollars in research and development for drugs that go to the drug companies that in the midst of all this how does it happen that we pay two or three times as much as our neighbors in canada or a friends in germany or throughout europe how does that happen well the answer is pretty simple the answer is pretty simple and the answer is has everything to do with the way we do politics in this country and the enormous power of logged multinational corporations and the  p s who represent those corporations mr president let me quote from a washington post article pride a january twelfth two thousand and seven was a front page article and this is what it said this is january twelfth two thousand and seven and i quote this month alone january the pharmaceutical research and manufacturers of america  spent more than one million dollars on full page newspaper ads pouting the success of the existing medicare drug system and i continue to quote in the washington post drug companies spent more on l than any other industry between one nine hundred ninety eight and two thousand and five nine hundred million dollars according to the nonpartisan center for responsive politics they donated a total of eighty nine point nine million dollars in the same period to federal candidates and party committees nearly three quarters of it to republicans quote this is within the article you can hardly swing a cat by the tail in washington without hitting a pharmaceutical lobby and of quote said senator charles grassley republican of iowa a key sponsor of the two thousand and three legislation that created the current program course that's what we're dealing with today and we should not kid ourselves the pharmaceutical industry year after year turns out to be all financially successful industries in our country according to fortune magazine the top nineteen pharmaceutical companies in two thousand and five by two thousand and five made forty two point one billion dollars in profit in two thousand and four their profit margin was almost sixteen percent three times higher than the average fortune five hundred company three times  some of the president that is what you've got you have a situation where millions of america ns are struggling to pay their prescription drug costs we have a situation where many americans simply can't afford the medicine that they desperately need you have a pharmaceutical industry which year after year enjoy some of the highest profits of any industry in this country you have an industry which pays its c e o s very absorbent it salaries you have an industry which has an estimated twelve hundred paid a lot of us in this country many of them formal leaders of the republican and democratic party you have an industry that makes huge amounts of campaign contributions and we end up with a situation in which we pay by fall the highest prices in the world for prescription drugs senator dorgan quoted a study from the c b o i believe it was that suggests that we could save some fifty billion dollars over a five year period if we moved the prescription so the idea that in this body we have people who get up every day and tell us how wonderful they perceive unfettered free trade to be it is not a problem when american workers are thrown out on the street because factories moved to  people pay thirty cents and i'll say that's part of the global economy no problem there no problem when food stuff comes into this country and all farmers lose money not a problem that's a lot of the global economy but somehow amazingly enough when an aspect of free trade works for the average american and not for a lot of multinational corporations suddenly we don't like unfettered free trade suddenly we just cannot reinforce prescription drugs from canada from canada which neighbor was us obviously from a handful of drug companies we just can't do that i think that argument is very very absurd so let me conclude a vote for the cochran amendment is a vote to kill prescription drug reimportation pure and simple the bush administration has said they will not go forward with  reimportation let us defeat the cochran amendment let us pass the dog an amendment let us lower prescription drug costs in this country by twenty five to fifty percent and perhaps even more important let us show the american people would allow re importation of prescription drugs they were telling you before in the last quorum call about a so called second degree amendment that's an amendment to the amendment by senator dorgan this one offered by a senator cochran that would require the health and human and human services secretary to certify safety and cost effectiveness of any drugs imported into the u s so that's the situation here on the floor of the senate majority leader reid has said he wanted to finish up this bill this week so looks like the senate has some work to do throughout the rest of the day along that line we have a story for you can read at our website c span dot org go to our home page and click on the feature link section to see today's washington post editorial talking about this bill and to read you just the highlights of that editorial which you may have seen some of the senators said quote from on the floor today the editorial says to you in its concluding paragraph that complicating the bill's prospects for package is an amendment from senators byron l dorgan and olympia snow that would allow the importation of prescription drugs from other countries a proposal that supporters claim would let cut rate pharmaceuticals flow into the united states saving illing americans untold amounts of money the washington post editorial goes on to say this is a mirage importation will not solve the problem of drug pricing u s drug firms sell prescription medications to countries such as canada at low prices a situation that would quickly change of canadian distributors started to recycle large quantities of drugs back to the u s and the editorial finishes up by saying further president bush has threatened to veto the bill if it contains such language with the sake of common sense and to enhance the chances of urgently needed legislation the senate should reject the importation amendment before passing the bill and again you can read that entire article that entire editorial and other information at our website someone who was not to participate in shaping this bill i rise to let everyone know that we it's very important that we pass this bill this legislation is perhaps one of the most important bills that had been passed in more than a decade to improve our drug safety i'm very distressed that for a variety of it illogical reasons this bill is being impeded and yet drug safety should not be improved impeded drug safety is one of the most important issues we face and listening to testimony recently two former f commissioners one appointed by republican most recently dr mark mcclellan and the other appointed by a democrat dr david kessler talked about this guy just question and the need for  some of the most important things they felt would come before us and i'm some water and no ice please  i have allergies and but i'm certainly not at large or to talking about this bill congress has a unique opportunity to change the way that we monitor the safety of drugs in america we can't afford to miss this chance we owe it to consumers with vision and patients who are lying on f d a to be the gold standard to really pass this legislation this is about protecting the american people and there are countries all over the world that can afford an f d a so they want to watch to see what drill what drugs can be approved now i have been a long supporter of the food and drug administration it is in my state and i'm very proud of it i fought for the resources for it to have to do the job they do but they're still inadequate we've done a variety of things to improve f d a but nothing as important as this bill when we began to work on this legislation i wanted to know what was the impact that we could make that i could make i was very concerned about the fact that came to boston's way it seemed not to have the right leadership and it certainly didn't have the right monitoring for drug safety and particularly post drug surveillance so we ended up with the vioxx situation we ended up with the and direction to to the larger community they published a report called the future of drug safety it had been commissioned by the f d a itself and  read report i was struck by its common sense provisions but i was also struck by the fact that we have reports we have lots of commissions that this congress asked to be developed but we never but no one's going to act on it well i acted on it i took the right prescription for f d a and our readership to senator kennedy and then we're working on a comprehensive bill are for it to their attention these recommendations by working on a civilized and were adopted not about my amendment it's about the institute of medicine recommendations this in a great when we can take the best thanking work on a bipartisan bas and put it into action to protect the american people to me that's what it's all about so today when i look at this bill on the floor i am so proud of the provisions that we included it strengthens science and terms of strengthening science they were very clear and said that science must be strong to protect the public and also they have to be very still uncertain in science to keep the best and brightest scientists at a so what did we do one number one we created the office of chief scientist at the f d a a single scientist will now oversee all of the offices to be sure that they have a very excellent science advisory board and they're the director or commissioner is getting the best advice can you imagine yes i didn't have a chief scientist we have a scientist at the national space agency we should certainly have a chief scientist at the nation's drug safety agency then we created certain committees to review all new drugs now means all new drugs will receive apprehensive review you might say well then they now know most got an advisory committee review but under this legislation they'll be an things safety and efficacy to make sure it does no harm and also that it does good well right now we have to make sure it does no harm and then also work to make sure it does good we also want to reinforce the ability of scientists to publish scientific articles you might say why don't they now you know if you work at the f d a you can't really publish articles unless your boss says it's ok can you imagine that we're talking about peer reviewed scientific journals that's kind of want to but it's important to morale there the other thing we do is improve transparency transparency at the is critical especially throughout the drug approval process where all scientific views even dissenting views should be made public we move to make sure that will happen we under the legislation that i had and corporate it in the bill we're going to make summaries of the drug approval process available to the public on the internet and if there are dissenting scientific  that's also going to be made available if you're a scientist if your research or even if you are a consumer you'll be able to know the history of this particular drug and its approval and where there are flashing lights raised by an alternative view that you can talk to your doctor this is very big it will not violate i know the distinguished senator presiding is an attorney with the attorney general for the great the state of colorado and i know he would also be very concerned about protecting proprietary information this isn't going to be about that it's about the safety issues and they'll be made public we're also going to make sure that  consumers will be able to also have a way of more directly communicating the public throughout the approval process it's important that scientists know how to follow the drugs after they are approved which  takes us to most of all my important consideration this legislation will require to make sure it will strengthen the office of surveillance and efforts epidemiology to make sure that it's part of the drug process from the beginning and all the way through it's going to generate but also th would add up to a nudge an additional five million dollars for drug safety so what we've done by implementing vientiane and i could go through there's over fifteen of these recommendations which you know by working together we've improved safety we've improved transparency we've improved morale we've improved resources i think this is a good bill i say to my colleagues on the other side of the aisle i don't know what you're cranky about i don't know why you're holding up this bill you know after what i'm printing about i'm real cranky when a drug goes out into clinical practice and all of a sudden kids have problems kids have problems because they're trying to be like other kids and they're taking the medication and this triggers some biomedical thing in their brain and gives them very dark thoughts and we don't want them to do dark things to each other i'm cranky when we have a drug that a doctor working in a rural part of my state who can't doesn't have the time to read every journal but is rolling on the fact that this drug has been approved by the improve the drug safety of this bill so we want to talk about that we have to get back to mission and to purpose it is the mission of the f d a to stand sentry over our food supply and our drug supply to ensure safety and efficacy and it's incumbent upon us to give them the right policy framework and the right resources and i think you want to get into some right action pass this bill let's work together to make sure that much is talked about defending america or let's defend america by passing this bill mr president i