>> if i can for a an announcement i believe on an agreement that's been reached. >> i think so. >> why don't you take the floor. >> thank you very much, mr. chairman. as you know, we had a lot of discussion earlier on the prevention and wellness title. senator gregg brought up the issue of what -- on the variance that we have in law, and the variance allows now i think 20%, if i'm not mistaken, and there was some talk about going to 50%. i had raised some issues about that. anyway, the staffs have been working on this, and evidently we have all reached an agreement on this to support employer wellness programs. i just want to thank all of those who have beening on this. it's been a great effort, the senator from wyoming and new

hampshire and tennessee and connecticut, of course, you have been working on this. what it does is it allows employers to reward employees by as much as 30% of a premium discount and allows the secretary to increase this reward to 50% if deemed appropriate. in other words, taking a look at all the factors that are involved and as long as no one is unfairly discriminated against they could raise that to 50%, so it does include those provisions to make sure that discrimination does not occur, so, again, i want to thank you, mr. chairman, senator enzi, senator gregg, senator alexander and all the staffs who work together on this, and i would ask unanimous consent that the committee adopt the harkin/gregg/ensi amendment as modified. >> senator gregg. >> i want to thank senator harkin for he and his staff's cooperate and senator hagan

played a major role in this. i honestly think that of the things that evolved out of this process this may be the most positive thing that has evolved because i believe if we can create an incentive for employers to promote healthy lifestyles and preventive medicine by giving cash to people which is the way our economy works, people react to money, it's a plus, and we will get peoples -- we will change the way people dial the with their daily lives hopefully and as a result get more preventive medicine in place and get people choosing doctor groups which present better outcomes to them and also live healthier lifestyles so i think this is a huge step forward, and the fact that we've reached consensus on this, no matter what happens on this health care debate, do i hope that this is one of the areas -- i certainly hope this survives because i think this is a huge step forward. >> well, thank you. >> and i thank senator harkin for all his efforts here. >> thank you, senator.

>> i just want to respond in kind and thank senator gregg for all of his work on this. it's been a -- it's been a great effort. i agree with him. i think this is one of the most important parts of this bill. if we can really get employers, as senator gregg, if we can really get employers involved in this in giving incentives to people as we no from pitney bowes and from safeway and a few others, this could be a tremendous, tremendous step forward in keeping people healthy and lowering the cost of health care in this country. >> i agree with that, and i want to commend thom harkin and judd gregg and mike enzi and lamar alexander for their work on this and kay as well. apologize again. i've -- it's a private matter. >> thank you, kay. >> let me start that again. >> let me thank kay hagan. >> very good. >> and let the record reflect that hagan comes first. so i would ask consent that the amendment as described by senator harkin be agreed to.

without objection, it is agreed to, and i commend my colleagues for their efforts on that. it is a very important provision, and it's going to make a big difference, i think we've heard. let me also -- we've been able to dispose of five amendments during the break, and i'll announce these and ask that -- that the following three amendments be agreed to. enzi number 230 as modified, gregg amendment number 209, senator john mccain's amendment number 205 as modified. i'll ask consent that those three amendments be agreed to as modified. without objection, they are agreed to. senator coburn's number 287 and senator ensi's number 225 have been withdrawn, and i appreciate their consideration. that brings us -- and i gather from staff over the break that you've been working as well on the other amendments, whatever that number is that i've been using and 18 was sort of in

play, we've reached some resolution on that, and would i urge that you keep at it and the goal would be that we'll go to about 9:00 and then pick up in the morning again and my hope is, and i know you've all worked hard and i know members on the judiciary committee have responsibilities and i know john is obviously on the floor with the armed services bill so people are very busy, and my hope is that by tomorrow we can at some point tomorrow, whether it's tomorrow afternoon, tomorrow evening, complete our work. it will have been 11 days, 13, 12 days as of tomorrow -- 13 days as of tomorrow. a lot of time and effort has gone into this, and i'm grateful for the patience that people have shown in being here and participating in the debate. it means an awful lot. i was talking to one of our colleagues on the way to one of the votes a while ago. a member on the republican side. we were chatting with each other, and this member has been sort of watching this proceeding, and has said that even though there have been disagreements and back and forth it's been tremendously educational.

we'll had a very healthy and full conversation about a lot of aspects about this bill, even though we haven't reached agreement on these points, i think there's real value in the ability of this committee to be able to move forward and to have the kind of conversation that we've been engaged in and obviously this is one step in a long journey before we get to a final conclusion and that's -- we're all conscious of that as well and so let me stop there and open up the floor for the further debate and amendments. >> senator hatch? >> mr. chairman, i have to be gone tomorrow because of the ju department of fisheries. >> i know that. >> i would like to call up others as well. >> i have to leave in just a moment. could i -- we've got some answers back from cbo on some of our previous work, and i think it's important that we have it. cbo just e-mailed on the bingaman amendment that would reduce the penalty payments at the end insured individuals would have to make. it increases it $20 billion over ten years, and because of the lower penalty the number of people who would be uninsured under the proposal would be

larger than haven't had an answer yet. i spoke to doug elmandorf and

there was a possible number for us this evening knowing you would want to engage in this conversation this evening and i'm fully prepared to go ahead with the understanding that i've tried to get the numbers and he may have them by tomorrow. i think we can have the debate and go forward >> i think we should go forward. >> i normally wouldn't go forward because i would presume you would object if you don't have a score on it but if you don't object i don't have a problem moving forward on it. >> mr. cheryl, i would like to say a few words. >> mr. chairman, sorry, have we decided to go ahead because i object to going ahead without the cbo numbers because the difference between a five or a seven-year follow-on biologic with a limited separate rather than add-on three years is markedly markedly different from a 12 or 13-year follow-on biologic or really no -- almost no generic path. i mean, the score is different enough that i think we're operating tonight under very -- with inadequate information so i would object to moving forward on it tonight. >> well, i -- i want to move

forward because not only does it help to accommodate some of us who really do have the judiciary committee and we have to be there, but -- but it's the right thing to do. we all know that if -- if you have a five or seven-year that you're going to have more budgetary savings than if you have 12 years. i -- i pretty well agree with that, so i'm going to call up amendment number 297, and let's face it tonight and -- and that doesn't mean that you couldn't amend it later if you wanted to, if you thought that the scoring justified that. we -- we're going to be here for a while, but i think we ought to move ahead on it and at least vote on it and i intend to do it so i do call up amendment 297. >> well, there are several amendments in this area. >> right. >> a number of amendments that members have on this subject matter. >> sure. >> and, you know, we've been working our way through this

with a lot of accommodating and want to be careful how we charge ahead and i'm aware of the committee member responsibilities and seek advice and counsel from members on how to proceed on all of this because obviously we want to get the work done as well in the next 24 hours, if i can, because we're going to find this problem even growing as additional responsibilities move forward. >> well, if i could, i -- >> i would like to do this. i would -- i would like to take some time. rather than having separate votes on these matters, would i like to have the amendments maybe be brought up. there are two or three amendments. i know senator brown has one, maybe two, at least one. >> senator hatch has one. >> there's the committee language which we've placed down, and there may be -- is there anything more than that? >> just the two or three. >> senator mccain has one. >> i have one. >> you have one, john, on this as well. >> okay.

let's -- why don't you go ahead, you know, and present your amendment and sharrod, why don't you present yours as well. does that make sense to proceed this way? >> sure. >> no, i think it really makes sense to wait and see the numbers. we've tried to do that in other cases here. we've delayed in the past because members felt strongly about seeing the numbers on the table because i think that really is a major consideration. simply to say that, well, we know it's more at five years than it is 12 really isn't good enough, i don't think. >> well, the numbers -- the real question is what is going to do the best good for our society? what is going to keep investment into the biotechnology world? what is going to get us to these treatments and/or cures that -- that we all know can happen if we allow the incentives to be able to get there, and i'm prepared to vote on this tonight, and i -- and, look, i

can't be here tomorrow, and i doubt that i can be here any day this week because of the judiciary committee. it doesn't mean that i wouldn't try to come over if i could, but it's very, very difficult with the supreme court nomination up, and as you know i take that seriously as well. but i would suggest we -- we move ahead and then, you know, assuming this bill comes to the floor or -- or otherwise is certainly going to be debate d again, there will be plenty of time for people to bring up whatever amendments they want to or to make whatever points they want to. >> well, why don't we do this. why don't you take ten minutes and describe your amendment. >> okay. >> we don't have to offer it at this point. i'll invite other members to be discussed and let me think about how we can proceed in this manner so that we have some way to move forward. >> mr. cheryl, you're suggesting that senator hatch explain his amendment for ten minutes and then i explain mine and senator

explain his. >> and senator mikulski explains hers. >> that gives me a chance? when we brought this up before we already had scores on your amendment and certainly my amendment, and i don't know about senator mccain's amendment, but the fact is we knew where the scores were and that's why i made the comment that i did. i doubt the scores will be much different. >> why don't you go ahead and describe your amendment. >> let me do this. i would comment on amendment 297 and clearly the end of the similar legislation is to save americans in prescription drug costs, but i strongly believe that unless we promote and protect a structure that fosters a strong and vibrant environment for innovators there will be fewer and fewer biologics for the generics to manufacture and all, including patients, are going to suffer. that's why the biologics price competition act and innovation act of 2007 reported out of this committee by unanimous consent was such a classic bipartisan

compromise. i worked very closely with senate health, education, labor and pension committee chairman ted kennedy, the committee's ranking republican mike enzi -- >> orrin, could you speak closer into the mike. >> sorry, bernie. >> the now secretary of state, hillary clinton, senator schumer from new york, senator brown. we all worked together on this, and we -- and we all compromised, and we came together with 33 years of legislative experience in the u.s. senate. i know what constitutes a true compromise. the bill as reported by the senate health committee represents the doable. if we don't do this, i don't think we're going to get a follow-on biologics bill. on the one hand we wanted to create an abbreviated uncomplicated pathway for biosimilars to come to the market. on the other, we wanted to consider the innovator's circumstances including their complex manufacturing practices and the financial risks investors undertake. that's why we all agreed.

let me underscore. we all agreed that the companies 12 years of data of excleesivity and i worked the innovator companies, the innovator companies to that figure because i -- because i did a lot of study on this and it's my strong belief that like hatch/waxman the enzi/hatch/hagan amendment and i'm proud to have the distinguished senator from north carolina one of the proud sponsors of this amendment, will have the support of the consumers, both of developing new biosimilars and by fostering a climate that will lead to lower prices for consumers in the ends. now we had the same arguments as we did in hatch/waxman and by any measure hatch/waxman has been a tremendous success and this will be also. addition al the enzi/hatch/hagan amendment ensures that no product receives no more than one 12-year product exclusivity

agreement this. will ensure the companies can cannot ebb gage in evergreening or the practice of making relatively minor changes to an existing product in order to secure an additional 12 years of data exclusivity. that's a big concession. the approval of a next generation product would not extend the data exclusivity of the original product nor would it prevent or delay a biosimilar from being approved to compete against the original product. now i think this amendment really strikes the right balance, and i really encouraged my colleagues to vote for it. we all did before, and frankly if we do, if we do vote for this, we'll -- we will push this process down the road very, very fast, and the house have done a terrific job, last year there were 108 co-sponsors on the same -- not exactly the same but the 12-year data exclusivity provision, and frankly we'll go a long way towards getting a

biotechnology bill this year, and it's critical that we do, because that costs a fortune to develop these drugs and to get the -- and for especially start-up companies and companies that are just filled with geniuses but no money, they have got to be able to go out there and get the investments that aren't going to be made if there isn't some sort of a methodology that guarantees that there will be a return down the line. this data exclusivity period, the single most important aspect of this bill, and there are plenty over important aspect of this bill and i don't mean to diminish them and it's an important thing and i hope we can all vote for it tonight. i think it would send a tremendous message to everybody in congress and throughout the country that -- that we're serious about biotechnology. i don't know a biotech company that isn't for this bill and for this data -- 12 years data

exclusivity but basically what we're doing is approving what we've already approved before. i could talk on and on but i'll stop at this point. i hope my colleagues will support me and i hope senator brown you will or at least bring up your amendment and senator mccain, of course, has an amendment. happy to vote, happy to do whatever it takes. >> senator brown. >> thank you, mr. chairman. first of all, the -- i appreciate senator hatch's comments. i appreciate his work on hatch/waxman. i obviously wasn't here and didn't know him in those days but i know the public health impact he has has been one of the great public health successes in the last third of a century, and i thank him and congressman waxman for this. congressman waxman is offering an amendment, actually a bill similar to mine actually, identical to the first round before the first compromise. i -- i would like -- i want to call up amendment 200 or at least discuss my amendment 200.

the entire -- the entire point of health care reform, the reason we're here, is to do two things, to improve access to -- to improve access to the system and to contain rising costs, improving access to the system means injecting competitions so that these exorbitantly expensive biologic drugs can be less expensive as hatch/waxman showed it could be on the keck call side of pharmaceuticals and obviously it will contain rising costs, costs to are businesses that underwriting the insurance, costs to taxpayers who spend lots and lots of money for medicare and medicaid and costs for people out of their pockets. we know that biologics are the fastest growing sector of prescription drug expenditures in the united states. costs run anywhere from $10,000 to $200,000 per patient. $10,000 to $200,000 per patient, and yet there's no restraint on

these costs. there's simply no restraint on these costs. there's no path to biologics. there is no followon biologic. i mean, there's no path to generics. there is no followon biologics. we know what happened more than two decades ago with the drug price competition and patent restoration act of 1994, the hatch/waxman act, and we know in 1983, as this was being debated, that pharma, the same group that is pushing very, very hard for the hatch amendment, pharma testified and said that hatch/waxman will substantially reduce the attractiveness of investing in new drug research. it would be a powerful disincentive to investment in the full potential of a new drug. the exact same arguments we're hearing this year from the exact same groups, although you throw in an addition to pharma, you throw in the new biotech groups. in reality the opposite has

happened. prices have come down, of course, with hatch/waxman as they would with my seven-year amendment and even more so with our original five-year bill. prices have gone down and innovation increased under hatch/waxman, the same thing that will happen with a shorter exclusivity period. generic drugs saved the u.s. health care system over $700 billion over the past decade, $700 billion. we know that -- that generic drugs, fda commissioner margaret hamburg talked about how much money generic drugs saved, making the same comments about a shorter exclusivity period for biologics. president barack obama has recognized the importance of creating an approval process for biogen ricks and has advocated for seven years of market exclusivity, not the 12 years but the seven years. now senator hatch has mentioned numerous times about the agreement from -- from two years ago, and let me -- the first chart is that we have up on the right, the first chart illustrates what's changed since we -- sincee@@@@@@ @ @ @ b')'ú

exclusivity period, there's nothing from you the manufacturer. there's no incentive to find a

way to do it with a spray, with what do you call the spray, the -- the -- the aerosol. there's no incentive. you're the manufacturer and you made the 12-year injection drug. there's no incentive for you during the 12 years to come up with an aerosol application of that drug. if you had a shorter period, seven years, you know you would have to innovate more quickly. the 12 years in some sense makes that biologic company satisfied, fat and happy in some ways so the ft c-section actly right. the longer the exclusivity period the less innovation and the whole point of a long exclusivity period, the whole point of senator hatch's action is that a long exclusivity period means companies will innovate more. on the contrary. companies will innovate less. my amendment allows for a very generous seven years of market exclusivity, backing something else that's changed since 2007. we have introduced a bicameral

bipartisan legislation for five years of market exclusivity. representatives waxman, diehl, republican from florida, palone and emerson a republican from missouri and on the senate side, senator schumer and bingaman and i, the democratic side, senator collins and vitter and martinez on the republican side, have argued for five years, even though there was this 12-year agreement of two years ago, so that's a second difference between now and then. a third major difference is the president of the united states is now weighing in at seven years saying that makes more sense than 12 years. the fourth difference is manufacturers continue to dramatically raise prices. the annual cpi 2007, if you can see on that chart, the annual cpi is -- is only a couple of percent. the annual -- on 2007 the annual price increase for -- for biologics was 12.4%.

the average price increase the next year was 23.5%, so we're seeing dramatic price increases, and there's nothing to check those price increases. there's no restraint on -- on these biotech -- these biogen rick companies, these bio companies to restrain prices. med pac talks about medicare savings from biogen rick competition. all these things say what was agreed to, and two years ago it's really outdated for a whole host of very substantive reasons and some political reasons but mostly substantive reasons. now my amendment was -- follows exactly the way hatch/waxman worked. it gives an initial period of exclusivity, seven years, more generous than hatch/waxman which was five and then it gives an additional three years and that three years is not an additive. it doesn't mean if you change your drug and get the three years, it doesn't mean that the first seven years are protected. it means that that three years are protected so there is great incentive to develop a new drug.

you develop that new drug. you have three years of exclusivity. you can get another three years of exclusivity when you develop another new drug but it doesn't protect from -- shield from competition. it doesn't shield the old drug so, in other words, if i have a new drug that i -- that i have a biologic for seven years, i make decent money off of it. i recover my investment often in a couple or three years. i'm making very good profits, as i should if i'm coming up with this new drug, i then at the end of the seven years i've developed something similar but new, maybe a -- a different indication or a slightly different moll kulgs or whatever. i get a new three years but generic competitors can come in for the first seven and compete with me. at the end of the first three i come up with another new drug, look at -- look at how the innovation works here, the sparking of innovation. i get a second three. neither the seven years is protected nor the first three. competitors can kind of come in and compete with me. biogen ricks come in and compete with me so this clearly brings

on more competition than a straight -- a straight 12-year -- a straight 12-year protection that senator -- that senator hatch offers. i won't go into more details than this, but i also wanted to just put on the board what groups support this. senator hatch said he can't think of any bio company that -- that opposed it. that's not supporting this bill. of course pharma supports this bill. the biologic companies support this bill and every one of them -- every one of us have those small companies in our state. it's not like big pharma that are in north carolina or new jersey, not many other places. there are a lot of these companies that i have all kinds of them sprout up around the cleveland clinic and around university hospital and ohio state and cincinnati children's, the second leading children's reach hospital in the country. but even with that, the only people that support the hatch amendment and oppose my efforts and our efforts are -- are the bio companies and big pharma,

but in support, just to run over some of these groups -- >> i might add, yes, the people who actually are most affected by it and who really understand. >> well, i would even dispute that, senator hatch. >> aarp. >> i think we canied. >> families usa and all kinds of disease groups that fight knowing that their patients, the people they serve, the drugs are great, if they are $200,000 a year, $100,000 a year a whole lot of people can't afford them. all kinds of health plans, all the insurance plans oppose -- support this amendment, support the five or the seven-year period of exclusivity. all kinds of businesses, at&t, dow kem calls, xerox, many more than that, almost virtually every organized labor group. all kinds of -- all kinds of pharmacy benefit managers because they are trying to figure out how to get less expensive drugs to their customers, so this -- this bill is pro-consumer. it's good for taxpayers. it's good for employers who pay the bill evidenced by this.

it's good for individual people who want access to this medicine, most importantly it's good for innovation as the ftc report suggests. >> mr. chairman. >> and then i'll go to john. >> look, the people who support me on this are people who deal with these issues over day. i've been here 33 years and i've woerkd on virtually every intellectual property issue that's come before the congress, and when we did hatch/waxman the same arguments. the fact of the matter is it's two types of a bill. hatch/waxman was drug price competition to get drugs more cheaply to the consumer and patent term restoration to treat the innovator companies better so that they will put the money and the investments into this to make it work. i don't have any -- any cause in this thing other than to do a bill that i know will work.

in analyzing this bill we came to the conclusion that this bill would work efficiently like hatch/maxman with a 12-year data exclusivity. it's a little different from patent term restoration, by the way. now to bring under the ftc. let me take a few minutes to discuss -- >> could i propose my amendment? >> i would like john to propose his and then we'll have a discussion. >> why don't i answer the ftc thing. >> if senator hatch is going to answer my discussion and i would like to answer his and senator mccain is left out. >> i hate to be left out. >> i'll tell you what. i'll withdraw -- >> let's let john go ahead and then barbara mikulski has an amendment as well. >> that's fine. go ahead. >> okay. john, go ahead. >> it's nine with me if there's a little discussion here and i'd be glad to wait a minute. >> i think he should go ahead. >> orrin, if you would like to go ahead and finish up your

comments, go ahead. >> that's fine. >> the interesting thing about my amendment is that nobody likes it. >> we should get together, john. i've got one of those. >> pharma -- pharma doesn't like it because it's less than 12 years, and obviously they want that. the generics and biologics don't like it because it's too long, and it adds requirements to the pathway provisions, so i ask for my colleagues' consideration. it gives ten years of initial data exclusivity, and that's what the europeans are doing now, and it seems to be working in europe. that's the direct model that we got from it, and it does add to encourage and reward continued innovation two extra years of data exclusivity of changes in the original product represent really significant therapeutic advancement for the patient.

we all know that the game has been played by changing the color or some minor change in the drug and then the patent has been extended, so we would ask for, quote, significant therapeutic advancement, and i would envision that the fda would be best qualified to -- to make that judgment as to exactly what that definition would be. in other words, to make sure that the changes are significant and not a change in color or et cetera. so also in addition to address patient safety and appropriateness for a patient to be switched from brand to generic, doctors, doctors should be the ones that authorize gener generics substitutability, not a pharmacy or a farmulary and there should be provided clinical data to prove that the follow-on biologic is safe and

effective, and, again, this provision, by the way is supported by the fda. they think that there has to be real clinical data in order that the biologic is safe and effective. the biggest argument as we know against any generic is whether it's safe and effective, and so this provision support by the fda that there would have to be clinical data to -- to prove that the biologic is safe and effective, so the goal of this amendment is to shorten the time frame to a reasonable time frame using the -- use the european model and allow a couple of years -- extra years if there's significant therapeutic advancement, have doctors be the ones that authorized generics' substitutability and also have the fda supporting -- supporting that any generic biotherapy is required to provide clinical

data. i don't think that would slow up the process that much and so i know that we seem to be arguing over some nuances here, 10, 12 years, 7 years, 5 years, but all of these are pretty important issues, particularly the aspect of making sure that any transition to generic is safe as well as effective. thank you, mr. chairman. >> thank you very much, john. senator mikulski has not yet arrived. as soon as she comes in we'll give her time rather to -- to talk about her amendment. meantime, orrin, you had some comments and questions back and forth and others who might want to engage in the debate at this point to please -- to please do so. ? well, thank you. as you can see, this is a very important issue, and we all recognize that the most contentious issue in the fob debate revolves around data protection.

often referred to as data exclusivity, and while there are other aspects of the report that merit comment and criticism with regard to the -- to the federal trade commission report let me focus my remarks on this critical issue. the fair reading of the text suggests that the ftc reached some of its specific finding of exclusivity due to the way the agency generally views the general state of affairs of the key aspects of the biotechnology sector. the ftc report takes the position on the intellectual property front the patent system contains a sufficient set of fr system contains a sufficient set of incentives for innovation. in terms of fda approved products, many experts believe the performance of both the biological and technology sectors han nothing better than treading water for some time. the gao study or the type of factual information it contains carefully considered or

evaluated. perhaps if the ftc carefully considered the type of amount contained in the report and the fda approved data, it might have reached a different conclusion with respect to the sufficiency of the current patented oriented as well leakule property regime to help and provide a strong and growing biologics pipeline. almost shockingly, the ftc provides almost no information about the substantial and increasing cost of finding and developing new biological medicines. it seems to me that any fair reader of the ftc study must ask whether this is a truly a fair and blaelsed representation. >> and despite the growing discussion about the new innovative biologics, the ftc study does find the time and space to compare the development costs of follow-on biologics with small molecule generic @@@

pertaining to costs, difficulties and actual performance of the firms verying

new biological medicines 0 i don't believe that the ftc has made a strong case that the existing system can be characterized as provide robust incentives for innovation. even if we were to conclude the current system is sufficient, i would hope our shared public policy bill will be to improve the sector as it enters the era of greater competition from overseas and emerging firms. there can be no doubt that there are many in india and china eager to take every opportunity to turn current u.s. biotechnology jobs and opportunities for expansion of u.s. jobs into new jobs for their own citizens. these are challenging economic times in which private sector financing is crucial to jobs and financial recovery, one would think the ftc would have factored in the views of those whose function it is on a daily basis to help allocate scares

capital among a range of opportunities. now, in the last congress, this committee reported out this bill which provided biologics innovators with 12 years of data exclusivity. europe allows for 11 years, a guarantee of ten plus the possibility of one additional year for innovators. but we decided 12 was right. to create a pairarity with the hatch/waxman act. under hatch/waxman, traditional drugs don't experience competition for roughly 12 to 14 years on average. that's fact. s 1695, which was our bill, strikes an appropriate balance. we reward medical research to create new therapies and cures and we spur on the development of the biosimilar industry. now, we have to maintain our competitive edge. we want to maintain our world leadership. and if we don't provide the

incentives to innovators we're not going to be able to do that. now, according to nicolas rosseniol who gave the european medicines agency perspective in testimony to the health committee he said this, "this balanced approach has been favored in order to reward companies who develop innovative products without impairing the development of the generics and biosimilar industry." now, he gave the european medicines agency perspective in saying that. the 12 years provides it the appropriate balance. prevents companies from game the rules and it spurs development of second generation products. all i can say is that i hope that all of you will support me on this because i don't have any axes to grind. you know, i don't have any particular industry that i'm trying to help. i've helped the generics.

i've helped the biotechnology people. i've helped pharma when they're right. i've turned them down when they're wrong. my goal is to try and help the american people and people all over the world to have the best therapies that they can possibly have. and the only way you're going to get there is because of drug price competition and patent term restoration in this case data exclusivity period rather than pattern term restoration. if we don't provide theners exclusivity period companies that have to wait 14, 15, 16 years to see a biotechnology therapy putt to fruition just aren't going to put the money in. and if they don't do that, this industry is going to collapse in our country and you know, the big companies might continue to go on. there are a few of those, but a lot of the innovation comes from startup companies, small company who are able to talk enough people into taking a risk to

help them to follow through on getting their biosimilars through. i might add i had one company come to me recently and said they've been working on this drug that is revolutionary. it's not a drug but a therapy. it's revolutionary. they feel like they're almost there and it's been i think almost 16 years. in two or three years, they're going to be there. they have had hundreds of millions of dollars of investment to get them where they are. and frankly, that's what it takes. and anybody doesn't that you understand just doesn't understand the industry. all i can say is that i hope you'll support me on this because i know i'm right on this. and again, i don't have any axes to grind other than to come up with laws that really do work. so all i can do is throw myself on my colleagues here and hope that you'll support me on this. in the end, i know you're going to be happy. i went through the same darn arguments on hatch/waxman in

spades. and finally, henry came in. we were able to put it together and i give him a lot of credit for -- i never forget we had the top people from pharma, the top people from the generics and my office for like 18 days. right in the middle of it, i had a root canal. i was ready to kill anybody by then. in fact, i threatened to kill them if they didn't get started right in the middle of it, right near the end, the pharma guy jumped up and said i'm out of here. and the generic guy jumped up and said i'm out of here. they got to the door at the same time and got stuck in the door together and we all started to laugh, they started to laugh. i said come on back, fellows. shortly thereafter when we cut the deal that has taken the generics from like 18% of the total marketplace to well over 60% today. they have very to gripe about in my opinion because that bill was

worked amazingly well for them. this will work amazingly well, but it doesn't work at all unless they have the investment, unless they have the money, unless they have the time to be able to develop these very difficult to develop therapies. well, i'm prepared to vote, and. >> senator mikulski, barbara. >> yes. >> good evening. could i ask what is the pending amendment? >> what we've done, barbara, just so you can get the lay of the land here, we're trying to. >> that's why i asked the question. >> how to proceed. the committee print has language that talks about losing numbers around here as basically i think it's nine, three, within. >> but is there an amendment pending? >> no, we've been discussing amendments. senator hatch described his amendment to the underlying

bill. senator brown described his amendment. senator mccain described his amendment and you're the fourth amendment. there are four amendments that we've been told anyway at some point we're going to consider. so you are the fourth of that list. >> mr. chairman, i thought my amendment was pending because i called it up. >> we just got these amendments we've been talking about. >> has senator hatch called up his amendment? >>dy. >> no, we're talking about the amendment sunrise called it up. >> there seems to be confusion. >> i thought what i said earlier was the idea to have discussion of the amendments. i'd prefer we didn't bring up an amendment per se at this point because wanted to have a discussion of them and then we'd figure out how to proceed. there was some debate how to proceed. senator brown, in the past i said i would not bring up any part of the bill that we didn't have a score for. so i've done that. we don't have a score on the

follow-on biologics yet. i hoped to get one today but they didn't get it to me. senator brown has objected to us moving to this area without a score. i'm trying to figure out a way we can proceed allowing for everyone to be heard. frank had i, there's a lot of division around this table where people are on this issue. this is one issue that does not have predictability to it. there's a lot of division. trying to create a situation where all can be heard and then figure out a way. >> well, mr. chairman, first of all, i want you to know that i do support the hatch/enzi amendment. i have an amendment that parallels in some ways senator mccain's amendment which goes to ten years, but what my amendment does is really bring in a harm monization with eu. my amendment would simply be available as a fallback in the

event that the hatch amendment doesn't prevail. i would offer my amendment in the spirit of compromise though i'd like to also with the senator from arizona that perhaps we could join forces. what i'm looking for is number one, that we protect consumers, that we also ensure on going and continued innovation in our country, and number three, follow the admonition of the national academy of sciences report called rising above the gathering storm on how america should be competitive in the modern world. this was something that was really brought about through the work of senator doe men nietzsche, alexander and really senator bingaman was where the kind of founders of that. what they said america needed to do to compete was more research, improve education and have and i

novation friendly government. and in the case of biologics and life sciences, though they did not talk about years or timetables, was the fact that we needed to be able to promote patent reform and also acknowledge the need for market exclusivity. so i'm on the side of innovation. and innovation is what will save lives and create jobs. what my amendment would simply do would provide three things. number one, it would create an approval pathway for follow-on biologics that would be -- would be follow-on biologics. it would create a balanced patent process to help determine whether a generic biologic application is inflinging on an innovator's patient rights but the most important thing that it would doo is that it would

provide market exclusivity harmonized with europe. it would provide market exclusivity periods and inknow straighter periods similar to those provided to innovator biologics in europe so that we could continue to be a global competitor. and this would provide innovator biologics with a ten-year base market exclusivity by prohibiting a follow-on generic from being approved by fda till ten years after the reference product was first licensed by fda. it would provide the innovator with one additional year of market exclusivity if within the first eight years after provl the innovator product is found to provide for more than one or more new therapeutic indications. my amendment would also prohibit evergreening which i think we've all agreed is just ends up gaming the system. so i would prohibit that. at the same time, what we would

do is create a regulatory way for approving biosimilar products because right now, fda does not have a regulatory pathway so we would be able do that. that in a nutshell is really what my amendment would do. so, it is not meant to be the premier amendment. it is meant to be if we have to search for a compromise, you offer that we be in symmetry with our allies. with the eu in harmonization and it's essentially i think would be important for us to be able to compete in the global market price and ensure our patient safety, allow for innovation and help our citizens. >> chairman, could i just say i think the similarities between senator mikulski's amendment and mine are such that i would be

glad to join hers or her join mine. >> i think they're the same amendment. >> basically they're the same. so, i'd like mine considered with senator mikulski's amendment. >> i just want to be heard on these. >> so -- mine does deal with pediatrics, which yours i don't believe does, senator mccain. so if we're not going to vote tonight, then perhaps we can work on ours. but i think senator mccain, my position is that i would prefer the hatch amendment to prevail and mine would be ours, ours would be offered as in the spirit of compromise. i would really urge my colleagues if they can't go with hatch to really think about this but also to think about what hatch/enzi is being proposed. >> senator enzi. >> mr. chairman i appreciate the comments senator mikulski. she has worked on this a lot and

we've worked@@mhú$iabãkbúe#ú@ ãb that there is a modification which when we originally draft it had we thought it had to be a

second degree because of the timing but it replaces sub title a of the bill. so people need to know that. i also have a letter from a number of universities and other people that i'd like to be a part of the record. it says on behalf of patients, physicians, researchers and other stakeholders, we have 162 of them that have signed onto the letter in the medical research enterprise, we comment commend your efforts to enact true health reform and a regulatory pathway for biosimilars in the committee's health care reform legislation. we appreciate the difficult balance you're trying to establish between the need to reduce costs and the increased access to biologic while developing new life saving biologics. we jointly support what the

original amendment was in this affordable health choices act and oppose replacing the language with the other options. while we understand additional modifications will be needed before pass and including addition of immediapediatric ins we urge the committee to respect the balance between access patient safety and future medical breakthroughs inherent in 1695. we are willing to do the pediatric addition to it which senator dodd has been the champion of and has worked hard to have in a number of bills and we would want that in the bill, as well. >> other senators wish to be heard on the subject matter? senator hagan. i'm sorry. >> thank you, mr. chairman. i want to echo my support for senator hatch's bill, amendment, and that is, you know, in our country today we have these ashl diseases inflicking terrible problems on citizens.

and we also know that the biologics are much more complicated than the small molecules as far as what they're going to do, how they're made up, how they're researched. we've also got great scientists and researchers that are working so hard today on innovation, on research trying to figure out what we can come up with solutions and drugs to help these people. this amendment is supported by over 100 different groups for patients and physicians having to do with the aids institute, als, the kidney cancer group, nami, national association for mental illness, national association of gynecologists, another group called the national health council made up of the american cancer society, the american diabetes association, the american heart association, the march of dimes, many other groups are supporting the 12-year data exclusivity. what i'm very interested in is

the fact that so many of these drugs, all this research will never make it to the market. never come up. those that do from what i understand only about 30% of them that actually enter the clinical trials that get through will actually receive the fda approval. these individuals were out there look for venture capital to obviously help them get these drugs to market and i think with those odds, it's not surprising it takes about 13 to 16 years of actually being on the market for biopharmaceutical company to break even on those biologic drugs. those are the reasons i think we need to have the 12 years. i'm certainly think that patient safety is first and foremost our concern. and i just feel very strongly that in order for our country to maintain this innovation and this research, we need to do this 12 years of data exclusivity. >> mr. chairman. >> senator.

>> mr. chairman. senator gregg. >> i don't understand a lot of the logic here. we're trying to produce biologics that address diseases of extreme complexity and which require a huge amount of leadtime to produce those. and a massive amount of cash in order to get them to market and to determine whether or not they work. and yet, we're developing a regime, we're proposing a regime, senator brown in my opinion's proposal and even to some degree senator hatches which basically undermines the  incentive to pursue that course of action by making it less likely that the capital investment will be there to pursue these extraordinarily

expensive procedures and medicines. the money comes, doesn't flow in to biologics out of good will and altruism. money flows into biologic research because capital moves there to make money. that's the way a market system works. now, maybe it's the position of the other side or those who support taking away the rights of people who develop these biologics that biologics should all be done, the research should all be paid for by the government. if that's the case, then you might be able to justify a shorter time -- short time periods that don't give a return on capital. but if you intend to have an industry which is viable and which is going to create these medications which will actually save lives and cure people, you have to have the money to, there to invest to produce that.

and all the studies have shown that these are extremely expensive procedures, the numbers have been thrown out of 16 years, 15 years, 13 years, a billion dollars to bring these things to the market. the national venture capital association, which is the investor group has said that 12 years is the minimum basically. that the capital return, the capital investment needed to make this work far exceeds the estimates of, that, we've seen from various groups that have claimed that you can do it for less and that the track record is pretty clear that the capital investment is huge. that the loss leaders are significant more than 40% of these investments go bad. and that as a very practical matter if you're going to get capital to move into these markets you've got to have adequate return and that

requires exclusivivity over what's produced. that's just basic common sense. i mean, nothing more than that. that if you're going to get these biologics produced, you've got to have people willing to invest. if the return isn't there, if the time exclusivivity isn't there to give people a return, they're going to put their money someplace else. into software, into real estate. who knows, but they're not going to put it into someplace where they can't get an adequate return. traditionally our society when you develop something that has a unique intellectual property to it, take for example a book, you give the person who develops that intellectual property a right to that property. you don't tell them that the movie rights are going to be somebody else's and that the playwrights to that book are going to be somebody else's or even that the book rights are going to be somebody else's. the person owns the asset that

they created. the only difference here is that the public good has raised itself to a level where we are as a government going to take that right-of-way after a certain number of ways. what's the certain number of years? it should be determined by what will keep the market investing in these types of products to produce the public good that these products produce. and we know for a fact that that year, that time frame at a minimum is somewhere in the 12-year period. and that to do significantly less than that will cause us basically to reduce the availability of these drugs which significantly improve lifestyle. and i guess my problem with senator mikulski and senators, senator mccain's proposal to harmonize with europe is i don't want to harmonize with europe on this issue. i want to have a competitive advantage over europe. i want the capital that's going

into the marketplace in the area of development of biolonl jiks to come to the united states. and invest in american biologic companies. i don't want it to think, well, maybe we'll go to switzerland because we've got the same period as they've got in north carolina or hopefully new hampshire or maryland. no, i would like maryland, new hampshire and north carolina to have a competitive advantage, have our government give our industry in the bio a competitive advantage. so have i reservations about going to ten years because i don't see harmonizing as being positive to the development of american industry that i think is one of the few industries we lead the world in. we have the intellectual advantage on. that's why i support the hatch approach although i'd like to see a longer exclusivivity period because i want to see these products come to the market. >> mr. chairman, since my name was mentioned by the senator from new hampshire, i'd like to respond very quickly. in europe, the competition is working and that was the reason

why i used the example of what they're doing, not because i don't think there aren't unique circumstances that require an american solution, but the fact is, drugs are generic drugs and biologics are coming to the market with safety and with efficient sit in the european market and there are certain unique aspects about the american solution, but the europe one seems to be working rather well for the europeans. >> senator sanders? >> just the few comments mike enzi said a little while ago, he said something paraphrasing you, everyone said this was the equivalent of hatch/waxman, right? did mr. waxman say that? mr. waxman, congressman waxman as i understand, originally introduced legislation for a five-year period of exclusivity. >> he was originally for zero. >> good for him.

>> even better than that -- >> my point is let's not quote henry waxman when he came forward and said he wanted five years and not 12 years. his views are very different than what senator hatch is talking about. senator huck it, last web when we discussed this issue mentioned how much money the federal government is putting into research. what was the number? >> i forgot what you mentioned. >> 31. >> $31 billion. there's a lot more. we have clinical trials that are paid for by the federal government in many cases, as well. >> you're on to something because i wanted to talk about it. >> go ahead and i'll pick it up. >> again, keep in mind what we're talking about here. we're not talking about patents. everybody gets a 20-year patent. we're not talking about that. ob, people think we're talking about something about your

patents running out in five, six years. when you apply a patent, you get 20 years. i don't care whether you're a drug or a biolonl jik or a new bottle of water or something. you get 20 years. what we're talking about here is data. data. data exclusivity. what does that data mean? it means what you have accumulated during these clinical trials that allow you to get fda approval to sell or administer this drug or biologic. how do you get that data? you'd get it through fda supervised clinical trials. who conducts the clinical trials? mostly private companies. i would frankly admit it is private companies that put the money into the clinical trials.

where do they do those clinical trials? academic health centers. for the large part, academic health centers. who supports academic health centers? our taxpayers. and we put a lot of money into academic health centers every year. this congress does, billions. to go into academic health centers. so you've got this kind of a marriage and quite frankly, i have argued many times in the past it's been a good marriage. i've been involved in this for 30 years. i visited a lot of these academic -- i've been to the research triangle a couple of three times. the way that pharmaceuticals, the private industry and the public have interacted i think has generally been pretty darn good. but to say that they should dakr

biologics. build a basic platform through basic research that we have funded mostly through nih but

through darpa, through the military, we do a lot through the military in this, by the way, a lot a lot of people don't know about in basic research. so should a company, a private company now that has relied upon the platform that's been built through taxpayers' dollars and they have used a system in this country called the academic health centers and other institutions wherein we have put a lot of taxpayers' dollars to support and run them to conduct their clinical trials, if we said private company, you can't conduct your clinical trials in anything except a private hospital out there that gets no federal money. how far do you think those clinical trials would go? about one day. so it's all kind of permeated with taxpayer money. now, talking about here is the data. so they collect the data. what we're saying here is when

should that data be released so that another company out there, some other entrepreneurs, could look the an the data and say, well, gee, this, this and this and they did this. how about if we change this and did this, we might come up with a new formulation that might actually help something else. they're still going to have to go through the clinical trials. they're still going to have to do that, folks. but at least they'll be able to look at the data. if you don't do that, that means a company can sit on that data for 12 years. then they let the data out. clinical trials will take another seven years or more. so you're going to have at least a whole 20-year run in there at least, a minimum. before anyone could ever surface with anything even comparable to what that drug or that biologic is. well, i didn't mean to go on so long but i think there's some

miscon acceptses out there about what we're talking about. if i just conclude on in that i think you know, there should be exclusivity for some of this, but for how long. it seems to me when you've got to go through the clinical trials and everything else and it comes down to something that sherrod brown has said before. there is a balance here. i don't think it's 12 years. i don't think it's five years. somewhere in there where the private sector and the entrepreneurs -- what's he saying? i don't know where it is. someplace in there where you're still going to get the money, you'll still raise the money. but you're not going to stifle innovation. now, innovation argues for a shorter period of time. the shorter the period of time, the more innovation you're going to get because you're going to get more entrepreneurs in there that will get the data and then

say hey, how can we make a new drug or new biologic off of this. a longer time frame argues perhaps for greater krupp front investment of money. so somewhere in there there has to strike a balance. and i don't know where it is. i would just close on this. you're talking about exclusivity. australia has five years, japan six years, canada eight years and eu ten years. i'd say to my friend from arizona that in that ten years, they have price controls on their drugs. if we're going to adopt the eu model, let's adopt the price controls also on the biologics, too. otherwise you've got apples and oranges here if you are going to do ten years like europe, well, maybe we ought to think about the price controls also. so. >> is that an amendment that the senator is offering? >> anyway, i didn't mean to go on. >> i know i shouldn't have yielded to you because you said everything that i was going to

say. but i wanted to reiterate the point suddenly this evening we hear all about europe. every major european country has a national health care program, which provides comprehensive universal health care to all their people. do we think that's a pretty good idea? >> i like that idea about europe. senator harken made the point that in europe, i don't think he made the point but the point to be made is that in europe, prescription drugs in many cases, i know senator mccain would agree with this are substantially less expensive than they are in the united states. and some of us, senator mccain included, would like reimportation so that we can bring those products into the united states at maybe half the price. drug companies don't want that. so i think it's what we're looking at a situation, let's go through it. and let's find out why the drug companies year after year make huge profits, let's look at why

the drug companies have never once to the best of my none lost a political debate here in congress. this is what they get. they get, what is it, $31 billion a year in purchase? that's not bad, $31 billion a year. they have managed to prevent us from having reimportation so the products they produce we can't bring in. we believe in a global economy. we bring in lettuce and tomatoes from every part of the world but somehow can't bring in prescription drugs from great britain or canada. they stopped us from doing that. they sure as heck are going to fight like heck if some of us want to have negotiations on the drugs for medicare part d. they've got government money, no global competition no, negotiations, and now they want 12 years. shock of all shocks are these guys after year make record-breaking profits. some have said some of these companies are small start up companies. they need a break.

i'm sure they are. some of them are some of the largest pharmaceutical companies in the world which make huge. >> thes which pay their ceos 25 or $30 million a year. maybe senator hatch, let me ask you a question. right now in terms of conventional drugs, the prices in this country are by far the highest in the world. is there any reason to believe if we will go forward on biologics that the prices of those biologics this this country will not also continue to be far higher than they are in europe or canada? >> to be honest with you, one reason why they are the highest is because the rest of the world gets our drugs cheaper when they're sold overseas. secondly, i've chatted with some companies recent they're have said if we keep changing the tax laws like has been proposed by the administration, they're going to leave this country.

thirdly, there is no country in the world that is as innovative as this one. especially in biologics. and there's no country in the world that will support the industry as much as this one if the incentives are there. >> right. >> what i am concerned about is making sure that the incentives are there. >> well, i'm sure that you're right in saying that there's no country that supports the industry as much as we do. i would like to see us supporting consumers which apparently we do not do because you didn't answer my question. the bottom line is that today, i live near the canadian border and i can tell you thousands of pilot in my state are getting their medicine from canada at a substantially lower price. and the reason is that every other government in the world is prepared to negotiate prices with the pharmaceutical industry so that they can charge their people a reasonable price. we don't. >> the senator yield on that point? >> i sure do. >> one reason, if you'll notice,

canada has no pharmaceutical industry either. and canada sets its prices. now, i guess we could do that, but that alone would style of innovation. the reason we have such a robust biotechnology industry in this country is because we don't set prices. and we do, we do provide the means whereby they can get the investments to be able to do this type of work. you know, we can argue are philosophically. >> all i would say in response is we have a robust biotech industry. you're right. you know what else we have in one million people who are going to go bankrupt because of medical-related. >> that's another problem. >> it's not an unrelated issue. one of the causes if you have a serious chronic illness and you need a whole lot of medicine out there, you don't have good insurance, you may well go bankrupt trying to buy those drugs. >> might not have the medicine, too. >> pardon me?

>> might not have the medicine if the incentives aren't there. >> clearly we want new medicine. >> there's got to be a balance. >> it doesn't do anybody any good if they can't afford it. and i think for year after year, we've been paying a lot of attention to our friends in far ma who are spending, god, i don't know what they spend on lobbing and campaign contributions. maybe it's time we start worrying about the people who have to pay for this medicine. >> senator mccain. >> i'd like to remove all references to europe from my remarks. and canada. so -- i was just trying to make a point that ten years seems to me of initial data exclusivity for the original product is appropriate. two extra years of data exclusivity if changes in the original product represents significant therapeutic advancement for the patients.

end of statement. >> i thank you. >> mr. chairman. >> mr. chairman. >> i'm sorry. >> mr. chairman, i'm prepared -- just a second. >> senator brown. >> mr. chairman. >> a couple of things to go back and clear up. i've heard statements that we're taking away rights from companies, the government has given the companies the patents. it's given the companies the exclusivity. those are good things, i think we should but we're not taking away their rights when we limit the amount we're giving them. the patent is 20 years as senator harken said. the exclusivity, make sure this is understood, while the approval process goes on, that getting the pennant, going through the approval process at fda, doing the clinical trials, stage one, stage two, stage three all of that does eat away at patent time but it doesn't eat away at exclusivity time. it doesn't begin and until the fda has said yes. then the period of exclusivity

begins. they're not eating away at the seven years that we propose any more than they were eating away at the exclusivity in hatch/waxman. hatch/waxman is five years and it's worked marvelously. i don't think anybody would disagree. the drug companies would like it to be more but it saved $700 billion over ten years, that's a lot of medicare and medicaid dollars, a lot of gm dollars and dollars out of people's pockets they've saved as a result of hatch waxman. it's worked. we're arguing here for 12 years, 2.4 times longer. 12 years, and you know, i hear my friends say there's such a big difference between biologics and chemical compounds. well, they're more complicated. certainly. they're more difficult for us to understand when we go and visit one of these hot shot biotech companies in our states, and i've been to lots of them and i'm excited what they do and all these young people coming

together and they're great jobs and all of that. but they're not more expensive to develop than are the chemicals, the studies show they're almost identical in the cost of development. so why give them 12 years when hatch/waxman has worked so well for five years? it doesn't make sense especially when you consider again, the purpose we're here for this whole markup for the last several weeks we're here to improve access to health care in this country. how you improve in access when people can't afford these biologics in we're here to cut rising costs. how do you cut rising costs if you don't inject competition into this whole process. you know, we sat here for the last, i don't know, hour talking about this. we hear five year biologics. that's the original bipartisan bill with senators big amman and vitter and me and schumer and martinez. we have talked about mikulski's nine years, old europe, senator

mccain and ten years, we talked about the kennedy 13.5 years. you know what we've not talked about, mr. chairman? how much these chemical, how much these biologics are costing patients. let me give you numbers. the whole point that patients have access to these drugs, 192,000 cases of breast cancer will be diagnosed in 2009 in american women. you know how much your septum costs? $4,000. you remember when we were outraged how much tax law costs? $4,000 a year, one of those chemical compounds cost $4,000 a year. we were outraged about that. this is 12 times the cost of that. it's a very good treatment. it's a very good medication but it's $48,000. rheumatoid arthritis, 1.3 million adults have rheumatoid arthritis are affected each year. $20,000 for remicade. 148,000 men and women diagnosed with colon cancer each year.

to spend almost $2,000 a month

or the patient with colon cancer that's got to spend $2,000 a week. what kind of progress is that, mr. chairman? >> mr. >> let me go into order. >> mr. chairman. >> let me go to barbara mikulski who i should have recognized a moment ago. >> a question for senator hatch. senator hatch, isn't it true that current, the current legal situation or law is that there is no market exclusivity and that the kennedy/hatch agreement was a way to bring about compromise between the need for innovation but also to set some type of limit to allow competition to take place? wasn't essentially, wasn't the original so-called 16, s 1695, wasn't that meant to be a compromise framework? >> you're absolutely right.

>> to balance out the issues related for both promoting innovation and also to deal with some of the issues around availability and eventually biosimilar products to enter the market. >> you're absolutely right. ultimately if we do this in a way that there are the incentives for these very expensive therapies, they're not chemicals, they're not drugs, they're large molecule proteins really, if we do that, we're going to have more cures and more treatments than ever before and prices will come down. now, it takes awhile when you develop these industries to get the prices down. but without doing this properly, we're going to have the industry leave this country and i might add that the original industry position, well, we'll have them leave this country and then we won't control it at all. now, i think we can control it. and look, as the author of

hatch/waxman, i really have spent a lot of time on this to come to the conclusion that and it was no simple thing. the industry really wanted 16 years, then 14 years. the original position was 14 plus two. and i went to the industry and said you're going to have to come down from there because i don't think you deserve that much. and i think we can make it. your industries can make it at 12 years. but you got below 12 years and i do believe you're going to have a dearth of products that we would naturally get if the incentives are there. look, maybe i'm wrong. but i can tell you sincerely i've worked on this. i don't have any axes to grind. i get at mad as farm ha as the rest of you. i get as mad at the generics unlike some of you. the fact of the matter is is that i think we've got to bring them all together and the only

way i know how to do that is to do it equivalent in essence from a practical standpoint equivalent to what hatch/waxman did and by any measure hatch waxman has saved consumer no less than $10 billion a year since '884 and much more today if the truth is known. this bill if we can put the 12 years data exclusivity. and by the way, it was a bipartisan agreement. >> i'm going to need to reclaim my time. but essentially, your argument was that kennedy/hatch was the compromise. i want to conclude my remarks by saying i continue to support that compromise. >> so do i. i'm here, yes, i will be speaking up for the 1,000 biotech firms in maryland that employ probably less than 20 people who put their whole future on the line to develop life-saving product for breast

cancer or alzheimer's or aids, even if we look at just the a words. i really don't like them portrayed as robber barons. somehow or another, that they're greece greedy people who are out there going to profiteer off of the miseries of life. many of them, all of them are very dedicated scientists and lots of young people have come in. the fact is that it takes a long time to develop even the idea to take to clinical trials. then you have to go through a series of clinical trials and you're also standing in the patent line. during that time, 90% of all products will fail before getting to clinical trials. once you're in clinical trials, only 20% will be approved by fda. and of those approved products, only 34% will generate profits

equal or greater than the development cost. so they're putting a lot on the line. we're asking them to put a lot on the line. we all want to pay for the research. tom harken and arlen specter have been standup leaders in that area. once you get the research, something then has to be developed into products that then either save lives or improve lives. we all kind of pound our chest now that we want green jobs. well i want those white coat jobs. i've had to say good-bye to steel, to so many things in my state. we're in the process of transforming ourselves and yeah, and people are putting their lives, careers and so on on the line. so i don't see them as robber barons. i see them as the face of the new economy and we also have to know what it takes to develop that product. so i'm going to support the hatch amendment. >> i'd like to be identified. >> senator enzi. >> mr. chairman, i had a whole list of rebuttals from all of

the things that have said but i can't say it better than senator mikulski has just said it. some comments about the difference between patents and exclusivity and i was going to talk about some experiences with chemo and being darn glad that that was there at any price at the time we need it had and one of the things we're doing with health care reform is to make sure that people it can afford it and they don't go bankrupt. but we want to have new products for our problems, our kids' problems and grandkids problems than requires innovation. >> mr. chairman. senator hatch. >> i'm prepared to vote. i chatted with senator kennedy here about a month ago and he promised me that he would be for the 12 years. i think it's fair for me to say that. and i'd like to do this. and i think if we pass this, i think ted kennedy would deserve an awful lot of the credit. and i'm not just trying to appeal to emotion here. i think you all know how deeply

i feel about senator kennedy and what he stands for and the work that all of us have been able to do with him over the years. but i hope everybody will vote for this. but i'm prepared to vote. >> senator hacker. >> mr. chairman, again, keep in mind, i just repeat it again. we're talking about exclusivity of data. collected by private companies. for which they have paid but which has been done on through the environment and on the backs of taxpayers through academic health centers, through doctors and researchers paid by our taxpayers, so the real question is -- is how much exclusivity should they have because a lot of this has already been done. by, i mean, paid for by the taxpayers of this country including the initial basic research. as i said, i don't know exactly where it is. but i just got to believe 12's

too long. you got five for the drugs, if it takes a little bit longer, maybe eight years or nine years it seems to me might be a reasonable compromise. to give it a little bit longer because these are more intricate. but i think 12 years is just going to style of innovation and it's going to allow them to make a lot of money, no doubt about that. a lot of money but a lot of money based upon what taxpayers have already paid for. >> well, let me -- i've noted that we've now had almost two hours of debate on this and that the committee proposal has not received one second of support. written down the 9-3, 1, 6. every other variation offered here but the one we put down i thought was maybe going to be a compromi compromise position. it was three years for inknow vases that have significant therapeutic advance and the second one year for a second,

which was a -- but i didn't hear a single voice and expression of what i thought might bring everyone together. >> i think that's a reasonable compromise. >> as i said, i tried to encourage people to come to that point but you and i are the only two. along the way. but it's been look, this is a -- there are almost as many ideas as there are people around the table. obviously, innovation is terribly important. what's important is trying to bring the cost down. that's what brought us together is the accessibility, afford and the quality of health care. trying to strike that balance. where is that sweet spot that says you've got the right amount of time for innovation and the right amount of time to allow the prices to begin to come down because the development of generics and i don't know if anyone knows exactly where that is. obviously, there's been a significant debate here. what i'd like to do because

sherrod brown has withdrawn his objection about not having a scoring i'm going to prose that the first vote will occur on the brount amendment, the second on the hatch amendment and the third vote be on the backup as you described it. that if hatch did not pass, that the mccain amendment would be the third amendment. and with that -- >> how about the bill. >> and the bill is the underlying amendment. so if they call fail we go to 9-3-1-6. we haven't had a rallying cry around that proposition. >> so we're not going to vote tonight. >> yes, we are going to vote right now. >> the base text. >> i withdraw my objection. >> over the objection, sherrod. >> i'm willing to do this without the score if others are. >> so the clerk will call. >> mr. chairman. >> and the one and 400,000 chance that both senator hatch and my attempt passes do i win?

>>. just one in 400,000 chance. >> that's the same chance a biotech firm has. >> if that ends it means 19 years of exclusivity. all right. the clerk will call the roll on the sherrod brown amendment. >> senator dodd? >> no. >> senator harken. >> ay. >> senator mikulski. >> no. >> senator bingaman. >> aye by proxy. >> senator murray. >> no. >> senator reid. >> no. >> senator sanders? >> yes. >> senator brown? >> senator casey. >> no. >> senator hagan? >> no. >> senator merkley. >> aye. >> senator whitehouse. >> no. senator enzi? >> no. >> senator gray? >> no. >> senator alexander? >> no by proxy.

>> senator burr? >> no by proxy. >> senator isacson? >> no by prox. >> i senator mccain? >> no. >> senator hatch. >> no. >> senator murkowski? >> senator coburn. >> no by prox. >> i senator roberts. chairman kennedy? >> no by proxy. >> vote is five neys, 17 yais. >> the amendment is not agreed you to. the second amendment now is on the hatch amendment. for the record, i want to be sure that modification was included. >> the modification of the six months, is that modification? >> what's this? >> yes.

>> six month addition for pediatrics. >> this is the hatch amendment. >> modification. >> six months for pediatrics. >> okay, i object. i didn't realize that we had a motion to do that. >> i mentioned it at the end of my discussion. >> i didn't understand it was on the floor and there was a chance to object then. >> do you are a right to modify -- >> you are the right to modify amendments. >> second degree amendments. the amendment is on the hatch amendment as modified. which is what? >> so this gives it a 12 1/2 year, the six-month pediatric gives them the first 12 years also? >> that's correct. >> okay. >> so this actually is a longer agreement than the agreement that senator hatch touted as what we had agreed to two years ago? we actually moving the other way even though all these things have changed in the last two years? is that a question? counsel, is that correct?

>> yes, bu@@@@ touched. it's what everybody wanted because we all agreed on. i've heard senator hatch say it 15 times. i've heard others echo it.

all of a sudden, as long as it goes the industry's way, we decide to break that agreement and add something to it. a very good provision. i like senator dodd's provision. i've done that. i included that in my bill. but it seems to me we should do 11 1/2 years plus the six months so we don't violate the agreement that all of us talked about over and over and over ad nauseam. >> i'll just withdraw the modification then. i'm sure i can add it later. >> all right. let's vote. >> all right. >> clerk call the role on the enzi-hatch amendment. >> senator dodd? >> no. >> senator harkin? >> no. >> senator mckulsk snichlt. >> no. >> senator murray? >> aye. >> senator reid? senator sanders? >> no. >> senator brown? >> no. >> senator casey? >> aye. >> senator hagen? >> aye.

>> senator berkeley. >> no. >> senator whitehouse? >> aye. >> senator enzi. >> aye. >> senator gray? >> aye. >> senator alexander. >> aye by proxy. >> senator byrd? >> aye by proxy. >> senator isaacson? >> aye by proxy. >> senator mccain? >> no. >> i'm sorry, i didn't hear you. >> no. >> senator hatch? >> aye. >> senator mckulski? >> aye by proxy. >> nor coburn? >> aye by proxy. >> senator roberts? >> aye by proxy. >> chairman kennedy? >> aye by proxy. the vote is 16 ayes, 7 neys. >> the agreement is agreed. to the enzi-hatch amendment is agreed to. >> thank you. one thing. >> and hagen-enzi-hatch

amendment. listen, it's now approximately 9:00. we've had a good debate. what we want to do is pick up in the morning and let me just notify members that my intention tomorrow is that we'll -- we're going to proceed however long it takes to finish up the bill. we go to our 13th day of a markup. and it's been significant debate of the 13 days, 17, 18 sessions. and we're going to finish tomorrow if we k i thank my colleagues for their patience this evening. the committee stands adjourned until tomorrow morning. >> did you say 9:00? >> i lost track. >> 9:00 a.m.? >> 9:00 a.m.? >> yes.

today. i would like to introduce my panel members. i would like you to meet our congresswoman from california who has an inordinate interest in agriculture. also, a freshman from maine who has a wonderful back ground in

common cause. we were hoping for some other members who may or may not show up. we are delighted to have you here in any case. i represent the 20th congressional district of new york. i cannot stress enough the urgency that our antibiotics to not become obsolete. 2 million americans acquire bacterial infections during a hospital stay. 70% would be resistant to dry dock -- to drugs. as a result, 38 patients died of those infections every day. salmonella causes 1.4 million

illnesses every year. over one-third of all diagnoses occur in children under the age of 10. infants under the age of 1 are 10 times more likely than the general population to acquire salmonella infection. in 1995, 19 percent were found to be multi drug-resistant. that means that our children undergo all commit -- what will treatments because we have allowed treatments to become ineffective. because of these infections and is ineffective treatments is astronomical. resistant bacterial infections increased health-care costs each year. currently, -- issues in

agriculture as animal feed additives. among them are penicillin, tetracycline, and so far--- and sulfonamides. penicillin is used to treat infections from a stripper to meningitis. it also treats the ammonia. tetracycline is used against anthrax. drugs are added to animal feed has growth proponents.

in other words. these are not animals that are ill. this is the most accurate number of all. 70% of the antibiotics and related drugs produced in the united states are given to cattle big bucks and chickens to promote growth and compensate for crowded, unsanitary and stressful conditions. the noun therapeutic use of antibiotic used in poulterer skyrocketed from 2 million pounds in 1985 to 2.5 million pounds in the late 90's. in this kind of habitual non therapeutic use of antibiotics has been conclusively linked to a growing number of incidents of antimicrobial resistant infections in humans and may be -- and may be contaminated groundwater. the national academy of science states that a decrease in

antimicrobial use in human medicine alone will have full effect on the current situation. substantial efforts must be made to decrease inappropriate over use in animals and agriculture as well. resistant bacteria can be transferred from animals to humans in several ways. the most glaring is found in the meat and poultry that we purchase separate haevery day ae grocery store. 84% of those bacteria were resistant to antibiotics used in human medicine. a bacteria can also be transferred from animals to humans by workers and the livestock industry. farmers may transfer the bacteria to their family.

a third method is@@@@@@""8m resistant. the institute of medicine's 2003 report on my car bausch microbial threats clearly saw a decrease in inappropriate use is not enough.

we must decrease the overuse and animals in agriculture as well. as the impact of merce, just look it was a look at staphylococcus aureus. there is little doubt that antibiotic resistant diseases are a growing public health menace. despite increased tension -- attention, the response has been inadequate. although the fda could withdraw its approval for these antibiotics, its record of reviewing currently approved drugs indicate that it would take nearly a century to get these antibiotics out of the feed and into food producing animals. in october, 2000, the fda began

consideration of a proposal to withdraw its approval with therapeutic use of robotics and poultry. it would take five years to complete. under its current regulations, the fda must review each class of antibiotics up early career at the legislation we are here to discuss today shows just the seven class's of medically significant antibiotics that are currently approved for non therapeutic use in animal agriculture. make no mistake. this bill would in no way infringe upon the use of these drugs to treat a sick animal. it simply proscribes they're known -- of their non therapeutic use. when we go to the grocery store and pick up dinner, we should be able to buy food without worrying that eating it would expose our family to deadly bacteria that would no longer respond to our medical

treatments. unless we act now, we will unwittingly be permitting animals to serve as incubators for resistant bacteria. it is time for congress to stand with the scientists, the world health organization, the american medical association and the magic lost academy -- and the national academy of medicine. we cannot afford for our medicines to become obsolete. i think you for coming and i look forward to working with all of you -- i thank you for coming and i look forward to working with all of you. ms. matsui? >> thank you for working so diligently on an important issue. your expertise is beyond question. the congress is fortunate to have someone with your knowledge working on a topic of antimicrobial resistance.

in today's hearing, i will try to present two different perspectives. one as a member of congress and one as a daughter of a farmer. on the one hand, i am serving of the energy and commerce commission as we are working on reform. i have come face-to-face with the immense challenges that our country faces with out of control health-care costs. our economy is reeling in our budgets are out of sync because our health care costs go up and never come down. according to the national academies of science, health care is about $4 billion more expensive every year because of drug-resistant bacteria. here in the house of representatives, we have spent months to try to reform our health care delivery system so that it reduces costs. one of the easiest and most effective ways to drive down costs is to ensure that people do not get sick in the first

place. fighting antimicrobial resistance is part of this strategy. . this is a critical piece of legislation. it will take aggressive action against this resistance. once it does so, fewer people will be hospitalized with fatal illnesses like diarrhea, staph infections and food poisoning. on average, every hospital stay caused by drug-resistant bacteria cost 6000 to $2,000 extra. . .

public health risk. farmers and ranchers are this

country's bedrock. they should be our strength and not our vulnerability. i'm convinced farmers and ranchers can be successful raising high quality natural livestock. they could do so in a way that does not breed what is shoping up in the hospitals and emergency rooms more frequently every day. the preservation of eakts medical treatment act would help reach goals we all share. it would encourage more ranchers to use animal husbandry practices that we know work. it would give consumers confidence that the foods they eat are safe and do not come with a price of endangering public health. and we look forward to working with the people testifying today and hearing their testimony. thank you. >> thank you. >> we're joined by congressman squear -- jerry of colorado.

>> i want to thank you for being able to participate in this hearing. and your professional training is an invaluable asset, thank you for your tireless dedication to protecting our nation's health and well-being. i'm delighted we have the opportunity to be here today and the rules committee to hear testimony on this important issue. we spend so much time here on the regular basis. working with other committee bills. i look forward to hearing more from this bill and the witnesses. this bill, the preservation of eakts medical treatment act would mark a step forward in the fight to protect our nation's food supply. americans are so disconnected with their source of food and fearful and frustrate about what is in it, they participate in growing produce and raising livestock, instead of trusting that the food they buy is safe

for their families. sadly we know all too often this is simi not the case. experts agree antibiotic resistance is a growing problem in the country as wie heard and it is aching its toll on its health and our pocketbook. we spent $8 billion a year and we have lost countless lives in the process. this is crishted in large part to the overuse and misuse of antibiotics as nontherapeutic feed supplements for animals that are not sick. we cannot undo what has been done but restricting the use of antibiotics to people and animals that are truly sick. we can make sure that we have access to a safe food supply and antibiotic therapy. this issue affects all of us. as consumers and grandparents, we have a right to know what is being put in our food. we deserve a government that invests its resources into protecting our health. i must say it is of particular

interest to me, not only as a member of congress but as myself a former organic farmer. and matsui is the daughter of a farmer, i'm a granddaughter of a farmer but i took up organic farming in the state of maine. i graduated with a degree in environmental sciences and spent years selling milk eggs and vegetables to the people in my community. i can say, i hold the blue ribbon and red ribbon in the politician's cow milking contest. if one of them because sick, i gave them an eakt. that's it. that's all we needed to be. i stopped selling the milk and made sure the cow was healthy again and got them back on track. it is a completely unnecessary situation that they're in. i complained to be involved in the organic food movement in our state. i know the griese dairy farmers

in our state are those that are selling milk. some are because consumers want to know what is in their food. we face a time of unprecedented challenges and none more important than reforming our health system. we're considering ways to cut costs and deliver effective care, we must not forget that the regulation of antibiotic use in farm animals has potential to save billions every year and protect americans from unnecessary suffering from resistance and aggressive strains of bacteria. i want to hang the chair woman for holding the hearing and the witnesses for taking time to be here today. i look forward to hearing from each of you. i yield back. thank you. i'm proud to be a cosponsor of 1549. let's put a human phrase on the issues of eakt resistant

bacteria. in my district in boulder colorado, there is dr. eric cornel that teaches at university of colorado. a couple of years, unrelated to his work, he had an infection of antibiotic resistant bacteria in his arm. they had to amputate his arm. he now has one arm because of this fast growing antibiotic resistant bacteria. and several people at the university of colorado have contracted. these unfortunate, beyond, well beyond the greater public health threat, the human toll of this has been felt by many of us right in our own second congressional district. and i hear a lot about these issues. my partner is a vliegen and in doing so, he's constantly critical of our animal husbandry practices of commercial agriculture in this country. beyond the public health arguments, i like to add

additional considerations for why in bill is important and these efforts are important. one has to do with the treatment of the animals themselves, the second emerges from that. when you look at why people are seeking the use of nontherapeutic use of antibiotics, it is so they could crowd animals closer together and raise them in condition that is otherwise would not necessarily be healthy for those animals. this leads to stress among the animals. and unhealthy conditions which can directly lead well beyond the direct public health negative outcomes, to simi poor nutritional profile and the health and nutrition and meat for human consumption. and due to the overcrowding which has been enabled by the nontherapeutic use of antibiotics. my district is home to the holding company of verizon dairy

and aurora organic dairy, the two producers of -- of antibiotic and hormone free milk. which together control i believe over 70% of the market share for those -- for those products. again, the consumers are wising up and are ahead of where we are on these issues. and people are realizing -- that -- to have residual antibiotic content in milk, particularly for children is in fact not only a public health threat but a personal health threat that can lead to antibiotic resistant bacteria, for, for for their children. so, for these reasons, i strongly support hr 1549 and i look forward to hearing the testimony today. i yield back.@@@@@@@ @

and members of the committee. i've seen the commissioner of the f.d.a. and the department of health and human services. i'm pediatrician and until recently a couple of months ago, the health commissioner of baltimore city. i thank you for the opportunity to discuss the important health issue of eakt use in animals.

in my testimony i will provide background information on anti-antibiotic resistance and discuss the involvement of the task force and set up a framework for helping the antibiotics in animals. i'll discuss what is under legislation. >> anti-micronal agents have been used for more than 50 years for tremendous benefit to animals and human health. many diseases are treatable and preventable now. must use and overuse of the drugs contradict to a raped development of resistance. after several decades of the use, we see and continue to see the emergence of multi-drug

resistant path jens which are less responsive to therapy. oftentimes, the infections with those path jens are more search, more likely to cause hospitalizations. and they're emerging due to the combined inpact of micro drugs. we released a report trt rebound corporation and the city about mersa which found from 2000, to 2006 the number of hospitalizations which are almost mersa increased by 45 percent which was increased 1,000 hospitalizations in the city of baltimore.

these been identified for clinical use in human and veterinary medicine. some strains are resistant to multiple antibiotical agents. there has been significant increase in resistance of organize nasms and organizenisms. there's no question this is a series -- serious issue. the task force developed a national plan to combat this resistance. they cochair it along with the c.b.c. and the national institutes of health. this group teg a plan. it includes surveillance to gather information and resistance about the spread and resins of microns.

prevention and control including educational campaigns and development of new therapeutic including vaccines. the and research. and includes research and related fields to improve treatments and outcomes led by the national institute of health and product development. as the drugs lose their effective rchs. new products must be developed to treat rapid infections. the goals and action items include developing new drugs and vaccines and stimulating the development of priority products which market incentives. i'm here on behalf of the f.d.a., and margaret is out of the country, otherwise i'm sure she would be here. this is of personal interest to her. the institute of medicine report that you cited, she was one of the editors of. coming to the f.d.a. working with the staff for the center for veterinary medicine and dr. hamburg and i support

action to limit the use of antibiotics and animals to protect the public health. there are four indications for use of these. growth promotion and efficiency and control and treatment. the vast majority of classes, used in animal agricultural are important in human medicine. a few that are used in animals do not appear to impact human medicine at this time, although there are concerns if you use, a medicine, even if there's no analog, it could trigger development of resistance. protecting public health requires use of those for modern medicine. to protect and limit the spread of antibiotic-resistant pack tieria from the food supply to humans. i want to review these

principles. first i like to talk about growth promotion and feed efficiency. there's increasing evidence that use of antibiotics contributes to the high burden of resistance in bacteria. so to avoid the unnecessary development of resistance under conditions of constant exposure, such as for promotion or feed efficiency, the use of antibiotics should be limited to those situations where human and animal health are protected. purposes other than the advancement of animal or human health should not be considered judicious use. eliminating the uses would not compromise the safety of food. as a result of f.d.a. supports ending the use of antibiotics for growth promotion and feed efficiency in the united states. second, i like to talk about disease prevention and control. f.d.a. believes there are some prevention indications that are

necessary and judicious to relieve animal suffering and death. important factors in determining whether prevention use is appropriate, should include, one, evidence of effectiveness, two, evidence that such a preventive use is consistent with accepted veterinary practice. and though, that the use is linked to a specific agent for bacteria. and four, evidence that the use is appropriately targeted and five evidence that no reasonable alternative for intervention exists. to promote the judicious use and protect human patients, f.d.a. believes that the use -- all use of medically important medications for prevention and control should be under the supervision of the veterinarian. and finally, i like to mention treatment. f.d.a. supports the treatment of ill animals according to appropriate veterinary practice and science relationships. the judicious use of antibiotics

requires a strong commitment to surveillance and research. monitoring, and studdinging the cause and tracking and assessing risk in different settings and evaluating strategies to reduce resistance. i'll mention things that are going on with the f.d.a., and antibiotic drugs in animals. first f.d.a. has risk assessment methodologies during the new animal and drug evaluation to quantify the human impact in animals. we conduct research to understand our resistance and third we reach out to stake holders on all sides of the issue. we assess the relationship between antibiotic use and subsequent human health consequences, using a resistance monitoring system. and it dictates the advantage of

the expertise and resources of a large number of federal agencies and the data provide regulatory officials and the veterinarian community with information about resistance and bacteria. and finally f.d.a. participates in the international dialogue on the use of antibiotics on animals. and let me just mention several comments on h.r. 1549. the f.d.a. supports the idea of h.r. 49 to phase out the growth promotion and feed efficiency use of mike crow -- antibiotics in animals. f.d.a. recommends that any proposed legislation facilitates the timely removal of nod judicious uses of antibiotics in animals. we would be happy to provide technical assistance on the

bill. at the same time f.d.a. believes that there should be legislation allowing the prevention and control as i've previously discussed. this is an important issue for children, as it is for their pediatricians and for the public and public health director and industry and consumers and the f.d.a. we look forward to looking forward to congress on this issue. thank you for allowing me to testify. >> thank you for being here. we're delighted to have you. you worked on the hill. interesting. great henry waxman. that's a good sign. the timely removal as you say this would become, of removing a class of antibiotics from animal feed and in my statement i mentioned that that could take a century. what would you all consider

timely removal? >> i think that -- we would like to see for the for the promotion feed efficiency uses, a much shorter time period than a century but also the ability of the agency to accomplish that without you know having to expend a tremendous amount of resources in the progresses, both time and money. and so, you know, there are mechanisms to accomplish that. we don't want to be in a situation where we have bottled up, you know, many scientists writing papers for things that congress could legislate and make happen if that's what we think that is the right thing to do. >> you're a pediatrician. i'm sure you would not recommend giving our nursery class of 3-year-olds antibiotic every day to make sure they didn't get an ear infection. obviously, you were not recommended for animals. does the f.d.a. control that or

the usda? >> the f.d.a. controls the labels of drugs for how they would be used in animals. >> you can permit it. if legislation were passed. >> it would be under f.d.a. >> that's good to know. and -- one of the things obviously we're concerned about is the conditions under which these animals live. and i noted that, as part of your background that denmark which bodes the nontherapeutic use of eakts in animals, in 1998 found there was no significance. i think that's important. that after the ban corresponding improvement in animal husbandry, such as cleaner barnes and swine mortality and productivity were not affected at all. and i am sure that most of us who -- consumed, i'm sure all of us want to think that they're

raising in clean and healthy s, even though we know better. we're going to a food safety bill here. we would need to talk to you again about other things there you might want in this. thank you so much for being here. your testimony is most important. we look forward to working with you on making this a reality. thank you so much. miss matsui. >> thank you. it is good to see you here. >> prevention of disease whether animals or humans is a high priority of mine. preventing disease before they occur makes sense on many levels. i work hard to make prevention a key element of the -- congress' push on health care reform. and i support the legislation because it doesn't limit the rancher's ability to use medicines in a rational way to prevent line stock disease. prevention is just a word, if not an effective strategy, and if we create more harmful

diseases in the name of preventing minor ones. doctor, in your testimony, i found it compelling because it is really it does tread the fine line between the need to prevent diseases in our animal populations without doing ourselves more harm in the process. and in your testimony you outline how actions taken in the name of prevention can sometimes make things worse, in the case of using antibiotics to fight respiratory infections. would you elaborate on how dangerous it can be for animal producers to assume that simi blanketing their herds with antibiotics can sometimes be counterproductive, both to humans and animals? >> i think the prevention is an area that needs a lot of attention and trying to figure out how to craft a policy, whether by legislation or by regulation.