bottles. i don't pretend to do as persuasive a job as senator dorgan of north dakota does, but we will hear arguments from the pharmaceutical industry of why the and then it should not pass. the most powerful lobby in washington today is a pharma who exercise their muscle with great frequency in contribute millions of dollars to campaign coffers. so, i understand the opposition here. we had a little intercepted e- mail from than the other day when senator dorgan and i were going to try to get on the floor and the arguments were that we needed, they needed to contact various people in order to stop this. they will argue they are not safe and that the fda does not have the resources to ensure the safety of imported drugs, but let's be clear, the almighty pharmaceutical industry's real

concern is competition. the almighty pharmaceutical industry's real concern is competition. any claim that imported drugs will be dangerous is inaccurate. safety of imported drugs is of utmost concern and this would require drug wholesalers to register with the fda and institute strict safety requirements including manufacturing site inspections. additionally the amendment requires chain of custody rules to ensure only authorized persons handle any medications. the amendment would provide the fda the resources and authority it needs to ensure the safety of imported drugs and to stop illicit sales. mr. chairman, i don't know whether this amendment will pass on this bill, particularly since we, i think it may have some additional urgency given the fact we are trying to find ways of paying for the universal

health care or making health care affordable and available to all americans. i have watched the pharmaceutical industry and pharma and their powerful lobby block it in the past. they may be able to do so again, but i've been around these kinds of issues where we've taken on the special interests for a lot of times over the years. we will. we will do what's right in the long run. pain not in this committee. maybe not on this bill. at some point in time because it benefits the american consumer, it benefits 50% of the american people that have to take prescription drugs every day and it's to their benefit and sooner or later they will prevail. with that, mr. chairman, i know we'll go through the same argument and discussion and obviously, i would request a recorded vote on the amendment, but i also wouldn't want to take too much time from the committee because we have pretty well ventilated this issue a number of times in the past. >> mr. chairman, mr. chairman?

>> senator mccain, this is the same amendment offered as the mccain-dorgan-snow language? >> i think the senator from north dakota would prefer to call it dorgan. >> i apologize but that is the same amendment. i know the issue has been raised by senator enzi. that is the question of whether or not, whether it was the cochran or roberts language -- is it part of this bill or not? i don't know the answer to that? >> according to senator mccain's staff, it is not in here. they put safety provisions in there. they always mention that. i have gotten a copy of the cochran-roberts language which places some requirements for safety certification before the bill can go into effect, which is what we've always passed when this bill has come up.

at some point they figure that with that amendment in there, it's a worthless bill. but i would ask unanimous consent to be able to offer this second degree amendment to the mccain amendment. >> mr. chairman, it's fine with me. let's have no doubt who wrote that, pharma and no doubt about the effect of it. it will kill the bill. you can vote for it, but it kills the ability to re-import drugs. let's not have the charade. i would be glad to do whatever the committee's wishes are. have no doubt it would have the effect of killing the legislation and the amendment before us. >> mr. chairman? >> let me finish the thought. i supported this proposal in the past. 108th congress we had this matter up. i think the case has been made

on re-importation. >> sorry? >> is this on? >> just pull the mike closer. >> i supported this in the past. 108th congress we had a vote on this and i supported it. i would again today. i think this is an important provision moving in that direction. obviously, members here -- i also, i disagree with john at this point. i don't think the cochran or language necessarily kills the bill at all. it does raise the iue many of us have concern about the effectiveness, but nonetheless, i want to be on record as being supportive of this effort. i know there's been an effort in the past to talk about this and different vehicles and so forth, but this is certainly a major cost factor in dealing with health care. i'll leave my colleagues to express their views on the matter. that's where this senator stands on the issue. senator brown. >> thank you, mr. chairman. i support mccain amendment and

oppose any second degree amendment. i've been through this as john as 1 1/2 decades working with john on these and patent issues, too, that pharma seems to, even when we went to battle they seem to win the war. any weakening language does two things. one, it denies these cost savings to consumers and second, it's got something about public safety as john points out. it denies savings to consumers and only doesn't save us the money it would save if we were to do this right. for years, several years when what is in the house of representatives, i represented a district in northern ohio about four hours from windsor, ontario. i used to take bus loads of ohio consumers, mostly elderly, but not all, to canada to buy drugs. it was a peculiar thing for a federal official in one country to take people to another country to buy prescription drugs, the same prescription drugs they could have bought in a local drug store, same brand

names, same box even, the same -- this exact same drug, same inert or active ingredients. the price was 1/3 or 1/4. that's the only difference. that's not because of their single-payer health care system but the government did what the ba does this this country, negotiate drug prices on behalf of 38 million consumers and directly negotiate the drug prices on behalf of them with the drug industry and got price savings of 50, 60, 70, 80%. the mccain approach is the right approach in cost savings that are so important will be contributed to this bill if we pass the mccain language without the weakening language. i would add those same kinds of cost savings we can see in the biologics section of the bill later.

when we do a generic, we know how generic drugs have cut the costs of chemical pharmaceuticals. we also know the same process and biologics will save some $10 billion over ten years plus, way more than that. that is a good score. senator gregg is always concerned about the score keeping the costs down. this is one element of doing that. senator mccain's language, not to be weakened by the cochran pharma language as senator mccain suggested, and coupled with what we can do in biologics and other things. i think it will bring prices down for consumers, hospitals and private payers and tax payers. >> mr. chairman, i am going to apologize to my committee member and to the chairman, the ranking member did not do an adequate job here. i am not going to ask for the uc

for a second degree amendment because i think it's a terrible precedent for us to set -- we'll never get our committee work done if we start having second degree amendments on amendments. we do need to get committee work done. i am not going to make that request. i am going to make a request of the -- where did he go? it's a little hard to make a request of him if he is not here. >> senator mccain left me a note asking me to manage the amendments because he has to go back to armed services. >> my request is for him to defer this to the coverage section. it is coverage. it could be voted on there. i suspect it won't change a single vote, but that would allow us to put in an amendment without changing the precedent for the committee for second degree amendments.

i suspect it will get the same result at that time that it would right now. i would just ask for that courtesy, partly because i have no way to know what the proxies would be on my committee for either the, what would be a second degree amendment or the mccain amendment. i'm not prepared for that. >> why don't we do that. why don't we have -- senator mccain's staff is here. no? oh, there you are. >> they would object and i would object. we vote on this. >> mr. chairman -- >> let me hear from other members, as well. >> mr. chairman, i would ask senator brown to hold on this to do it under the coverage section of senator enzi. this clearly impacts everybody. i have sympathy making sure all our constituents get the best possible price on drugs, but i also have a concern and we had a lot of news in the past couple of years about things that have

been imported into this country that had tremendous health impacts. we have a system, an fda, i know senator mclusky and i worked on many times to make sure we get through drugs quickly, but at the end of the day we have a process where safety and efficasy is critical. when our constituents go in a grocery store and buy off the shelves, they need to know it's a gold standard there. i haven't had a chance to look at the mccain amendment. we had this debate before. i want to take everybody's word that is the same language, but i have real concerns about it and i would ask senator brown, this has been dropped on us like a huge two-inch bill here. if we could hold this until the coverage debate, i would really appreciate it. >> i'm trying to explain is senator mccain is in the mark-up on the armed services bill downstairs, i believe, wherever that is occurring so is running back and forth.

what he asked is for senator brown to manage this discussion for the amendment. >> i would say to senator brown, if we are going to vote on it right now, i will vote no because i have not had time to read it. it could have a huge impact on the public. >> i, too, am a strong advocate of consumer opportunity, but i have to be in up here for consumer protection. what i'm going to put on here is not my health hat, but appropriator of health care. we have risks of counterfeit drugs coming into this country. we know this from sources and the mcmafia around the world exploiting us. this is real. i really have to insist on a

certification from the secretary of hhs on safety. i can only do it as a matter of really good conscience. i want our consumers to get the best deal. i would love for them to be able to import inexpensive prices. everything i know from both classified and unclassified briefings, i really would have some enormous amount offing anxiety as voting for this amendment as constructed. >> senator roberts? >> i would like to echo the remarks from the distinguished senator from maryland. i was chairman when she was most helpful on the committee when this first came up. i don't think we are leaking anything classified here when we say we did have hot spot hearings and basically with

focus on the i did not realize, and i apologize to the senator, i did not know that she had an amendment -- that is another thing. i thought we would do this next week under the coverage section of the bill. >> the mccain amendment. >> yes, but i had an amendment or modification to that one. it was not filed. his is but - 9. i thought the deadline was next week. last week the deadline came and went. some of those were confused about that process. my modification is very quick. i would just rita. some others have shown the same concern. -- a i will just read it. some are concerned about drugs coming in from eastern europe

and the baltic. the new move over to the mideast and gets a little shaky. we have had that one case. senator mikulski of that -- had that prescription bottle from iraq of all places. it is a very real threat. my modification -- but since i missed the deadline on the amendments -- but again i thought we would do this under the coverage section. that my deadline on that would be next week. it simply says, this act shall become effective only if the secretary certifies to the congress that the implementation of it will pose no additional risk to the public's health and safety and result in a signal the direction of the cost of coverage products to the american consumer. a significant reduction in the cost of covered products to the american consumer. it's that section a that is

absolutely essential if i'm going to support this amendment, although i know exactly what the senator from arizona is trying to do. i respect that. i don't mean to throw a clinker in here or be a johnny-come-lately, but i did want to share the concern of the senator from maryland. i would like to ask the chairman some guidance here. i know senator mccain is busy in the armed services committee. i understand that. i thought this was going to be next week. i was going to offer an amendment prior to the deadline for next week, which i think i understand is next week. and that that would be an order. i'm also more than happy to let senator from maryland take the lead or distinguished senator from washington or whoever else would like to do this. i need some guidance here. >> my guidance would be, as i thought of my job here is to count noses. as i count noses at this point,

i would say senator mccain is not here, that my view is the mccain amendment if offered without the roberts-cochran, whoever else is offering the language on the safety and effectiveness will fail. i happen to be in support of the mccain amendment. i am also in support with the amendment to do with the safety and effectiveness issue. i would tell people as i look around my job is to get some sense of where my colleagues are in these matters. right now if john is interested in adopting this amendment, he's going to be better suited in accepting the amendment or having a vote that deals with these other issues, otherwise it will not make it. my advice would be, i want to offer amendments or not offer them is wait until title one of the bill. allow the amendment to be offered then the amendment carries. that's my judgment on the matter. obviously members have a right to offer amendments when they want to.

if it were offered at this point, that is the conclusion. >> mr. chairman, senator mccain wants to go ahead with the vote. i think he snows sometimes we tilt at windmills here. he knows sometimes you lose. he also knows that as i do that the so-called safety language is language that really does restrict re-importation. we've all seen this. >> that's right. >> you've seen the drug industry every year. every time there is a spike we have the re-importation language and the drug industry comes in with their amendments and they usually win because they are darn good at this and we don't get anywhere on it. i hear members cite a united nations roll call raising fears in people that we are going to start importing drugs from places with no strong safety net, safety regimen like fda has. that's not what's going to happen with this.

we have worked on this language for years. the mccain amendment, understands that and embodies that. gives the secretary the power to figure out the authority to figure out where the safe drugs come from. there's a lot we need to do on food safety. there is a lot we need to do on a lot of things. the fact is that i have confidence that when i take my constituent, i took my constituents ten years ago to windsor, ontario and went to hunters drug store and they bought lipitor and other prescription drugs in the same boxes with the same brand name, same dosage, same inert ingredients and the active ingredients that the candidate equivalent of the fda protects the government in canada. those fears aren't real. the drug industry will probably have its way on this vote. i hope senator mccain tries it again in the next section. he wants to go ahead on the amendment. i ask for a roll call.

>> senator brown, really, i take offense at what you are implying here about those of us who worry about safety. you know my affection for you. >> i know and it's mutual. >> we tend to be on the same side 99% of the time, but this counterfeit drug thing is a real thing. i'm grad you went to canada and bought drugs if we could all go to canada and go to their drug stores, it would be a different gig. this is not what importation is. importation will come through a variety of trade routes for which there will be inspection and there is a lot of counterfeiting. if you want to vote on it and think it's so, don't imply those who are voting for safety are showing for the drug companies. >> let me echo that point, as well. it's always a dangerous ground when we get into attributing motivation why people cast votes. i do support the mccain

amendment, but i don't believe people necessarily worry about safety and efficasy are cools of the drug industry. >> i apologize if that's what people thought my comments indicated. >> senator sanders? >> i don't often agree with senator mccain, but i think he is absolutely right on this issue and concur with what senator brown just said. i live an hour away from the canadian border in northern vermont. i think i was the first member of congress to take people over the border. i will never forget as long is a live. we were with a bus load of women and dealing with breast cancer, and they did not have a lot of money. they purchased tomaxafin. they paid 10% of the price. with tears in their eyes, working-class women struggling for their lives didn't have enough money to buy medicine and paid 1/10 of the price about an

hour away from where they were living. if we as a nation think we can eat fruits and vegetables that come from developing countries, that come from farms in mexico and in china, the idea we cannot properly import medicine from canada, from the united kingdom, in major developed countries with the help of the fda, that you can't have a paper trail to make sure these products are safe is inentrepreneursible to me. of course we can do it. i've been involved in the struggle for 15 years. i think this is one way -- i am not a great exponent to free trade. senator mccain is. if you can import food from all over the world. if you can import all kinds of products, why in god's name can you not import prescription

drugs under very heavy regulation from the fda whose job will be to say any product that comes into this country has to pass the highest safety rations? of course we can do it. if we do it, we can lower the cost of prescription drugs for the government and millions of people. i strongly support this amendment. i hope we can pass it now. i think, mr. chairman, you can correct me if i'm wrong, but majority leader reid indicated this andment would come through the floor of the senate. remember a couple of weeks ago it was taken out? i think we have another shot of it on the floor. i hope we can pass it today. thank you. >> without the more careful safety language in there, i can't vote for it. the examples that are always given of the safe low-cost ones are people that shuttled up to canada and bought their drugs in person. the difficulty is with the people that get them through mail order and if you think you

are going through a link in canada and actually getting a pharmacist in canada, chances are much better that you are getting a pharmacist in saudi arabia through greece through canada to you. the examples that they found sometimes these chemicals, the compound is exactly the right compound, but it won't dissolve in the body. so we have store rooms full of stuff that people thought they would get that would be good that will not work for them if they were to get it. that's a safety concern. we have to be concerned about the safety of the stuff. and we worry about dog food and everything else, i don't know why we wouldn't worry about prescriptions. we've got lots of examples of bad medicine that's come in. the labels are exactly the same. the cartons are the same. everything looks the same. the packaging is the same, but the pill won't work.

how many people would die taking a pill that won't dissolve or that just because it has the right chemical compounds hasn't been put together right to be useful? i don't think that is a big request. some assurance that would be met. i can't vote for it. >> thank you very much, mr. chair. as we've been sitting here i've been paging through this amendment. thinking about the broad debate. much of the conversation has been about examples of bad medicine, as the senator from wyoming has pointed to. that's occurring under the existing structure. this is fraud outside the existing structure of the law. it would make sense to have an amendment that sets up a

structure for importation that says that the importers and exporters have to be qualified, they have to be licensed, they have to be reviewed, and if they break the rules they are kicked out. that the medicines are checked. that the medicines are of the same chemical format that they claim to be. that they have the same efficacy of their counterparts in the u.s. all of that is in this bill. all of that is in this mccain amendment. all the commentary about fraud is commentary about fraud. that is importation outside the structure of law. by the way, i'm sure members of this committee understand there is a lot of fraud within the boundaries of the united states of america, cases that have occurred where the drugs that are delivered have been prepared in someone's garage and are simply not the chemo treatment

it is supposed to be, but just a bag of saline solution with just a label on it. so the issue of fraud is neither bounded by the boundaries of this country and it is not about whether or not there is a structure. it is about the lack of a structure. so just as we have established a system within the united states to combat fraud, this amendment is about extending that structure and in the process restoring a coherent market so that the citizens of the united states can benefit from fair pricing of pharmaceuticals. it is ironic, and i think a point to dwell on, that many of these drugs, many of these drugs were developed with research funded by the tax payers othe united states of america and that we turn around and create a framework where those same tax payers have to pay the highest price in the world in order to

utilize those drugs. we fund the research and then we have to pay the highest price on the back end. i certainly embrace the conversation with my colleagues about safety. i think that we need to observe that there is a lot of this bill in this amendment that mccain has put forward that addresses safety. it's not that we can't do more. i certainly would fully entertain that conversation. i would encourage, since there is going to be a vote on this, i would encourage my colleagues to embrace the mccain amendment, the core principle he set out a structure of registration of licensee of supervision of excluding those. i would point, for example, on page 20 of this bill, that notes that folk whose violate the rules get thrown out of the system. i'm sure there is more that can be done. i gather additional commentary would be appropriate in a subsequent section of the bill

for the conversation that came forward. the follow-on section we'll be considering down the line, will this, mr. chair, still be relevant if a memo is brought forward under this section to further address safety? >> i'd have to check on that. i don't know if that is the case or not, but it could be. >> i would simply encourage my colleagues to say, yes, to fairness to the american consumer who has funded the research, with the understanding we are going to have a follow-on >> anyone wish to be heard on this matter? >> let's call the roll. >> i would ask that the mccain amendment be sent to the secretary of hhs for comment in preparation for the debate. i'm ready to vote no, but if we will do it on the floor like to have more information.