Ted Kennedy

Mr. KENNEDY

Mr. KENNEDY. I am reserving my right to object.

Mr. KENNEDY. Mr. President, we had the opportunity to go to this bill last evening. We have been waiting here all day long in order to take action on this legislation. Legislation that can have a direct impact in terms of the cost of prescription drugs and also on coverage. Now at 5 o'clock, the Senator comes here without any kind of notice and makes this request. I think the American people are entitled to know why, since the Senator from New Hampshire was the one who originally objected to bringing up the bill. I would be prepared to vote right now on whether to proceed to the bill if the Senator wants to call off tomorrow's cloture vote. But if the Senator is objecting to the bill on substantive grounds last night, I think the American people are entitled to know where their Senators stand on considering this legislation. If the Senator wants to do it tonight, that is fine with me. If he does not care to do it tonight, we will follow the regular order and tomorrow when the roll is called--as it will be done here in the Senate--when the roll is called, we will find out. The American people will find out who believes we ought to move ahead with this legislation. That is the way it should be. There has been objection raised to the majority leader to moving ahead. Now I think, since this issue has been raised during the course of the debate, during the course of the day, the American people are entitled to know who is going to be for this particular legislation. That is why I have raised that issue.

Mr. KENNEDY. I believe I have the floor.

Mr. KENNEDY. I see the Senator from Michigan has asked to be recognized. I yield to her.

Mr. KENNEDY. I thank the Senator. I intend to yield the floor. I will insist on the regular order so that we have a chance to vote on this tomorrow. I see my friend and colleague, our leader from Nevada, wishes to address the Senate. Obviously, I would follow the leadership in terms of when that vote would occur. If the request is that we move ahead with a vote this evening, I will certainly support that proposal. (Several Senators addressed the Chair).

Mr. KENNEDY. Mr. President, I object.

Mr. KENNEDY. Not all the time.

Mr. KENNEDY. Mr. President, I will just take a minute or two, and hopefully the Senator from Michigan will be able to complete her statement. She has been here all day long. She has yielded to all of the interventions. She has a determination that cannot be matched, but she also has patience and grace that can't be matched either. I will just take a moment, and hopefully she will be recognized. Just as a general matter, this legislation is enormously important. We have all said that during the course of the day. I hope at the start of the substantive debate we can have a sense of civility about how we are going to proceed. If there are legitimate kinds of concerns, as expressed by the Senator from New Hampshire about being unwilling to permit the Senate to move forward, I will take those. I don't agree with them, and I think they are misplaced for reasons I have outlined, but I can understand those. Then we are going to play by the rules. But I would hope, as we begin this extraordinarily important debate and discussion, that we will free ourselves from gamesmanship and surprises. Let's try and deal with this important issue. Let's share our amendments if we are going to call them up. Let's get back to a sense of civility. People have strong views. This is enormously important. The underlying legislation and these amendments are incredibly important. People are entitled to have the full attention and consideration of the Members of this body and to be free of the gamesmanship that too often takes place. I hope at the start of this, we will have that as a basis on the way to proceed. I think the American people expect no less. There has been objection, as has been pointed out, to our considering this. This is too important. The American people will see with tomorrow's vote on the will of the Senate, whether this legislation is flawed in some way or whether we ought to proceed to it. As the Senator from Nevada has pointed out, we are prepared to have that vote this evening as a roll call vote, so that the American people can see, after listening to this debate all day long and after the allegations and charges that were made about the incompleteness of the legislation, whether there are substantial Members of this body who don't feel we ought to go ahead, or whether the majority believe we should go ahead. At the beginning of this debate, which will take some time and is very important, let's hope we can proceed in a way that is worthy of this institution. I thank the Senate.

Mr. KENNEDY. Objection.

Mr. KENNEDY. Mr. President, I am struck by the point the Senator makes again on the floor of the Senate, which I have heard him make many times but which I think is important to understand, and that is that this is actually a very conservative piece of legislation. Effectively, if we accept the underlying legislation, which is just a version of the legislation the Senator introduced with Senator McCain, really we are going back to what the original intention of the Hatch- Waxman proposal was all about. I appreciate the Senator giving the historic perspective because at the time we passed the Hatch-Waxman, we anticipated the breakthroughs in many different areas of new pharmaceuticals to try to deal with the challenges of our time. It has never been more likely than it is now. We are in the life science century. Even since the passage of Hatch- Waxman, we have seen the sequencing of the human genome. We have this extraordinary DNA revolution. We have gone through these extraordinary kinds of basic new research. We have seen this explosion using new kinds of technology matched together with research, which is opening up extraordinary possibilities. We have heard about this in our HELP Committee. So the opportunities are out there in terms of trying to see the day when Alzheimer's is no longer the scourge of so many families in this country. That would empty two-thirds of the nursing home beds in my State of Massachusetts. That is probably true also in the State of New York. We believe the Hatch-Waxman proposal was to try to make sure for the drug companies, the brand companies, that were prepared to go ahead and take advantage of these extraordinary opportunities, building on the incredible investment the American taxpayer has made in the NIH, which has been doubled in recent years. It is an additional reason the Schumer amendment ought to go in. We ought to have the energy of those companies in these breakthrough new opportunities rather than in the ``me too'' drugs. This, I believe, is not only dealing with the abuses that exist, but also, if we let this continue along, it seems to me there will be a continued kind of financial incentive not to take chances for these breakthrough drugs that are out there, in terms of making such a difference in dealing with the health challenges we face, and there will be these financial incentives to game the system in order to deny people the lower cost of drugs by the generics. So I commend the Senator. We will have a lot of debate and discussion about patent and patent laws and timing--30 months, and 180 days, and 45-day windows, and bioequivalency, and the rest. But we are talking about, as the Senator eloquently stated, a major downpayment--the first one that I know in any recent time that will bring pressure to lower the cost of drugs. This is a major achievement and accomplishment if we do it. It is not going to solve the problem, but for the many families who are going home tonight and buying their drugs and finding out that the costs have increasingly gone up so far beyond the cost of living, it will make a big difference, will it not? Secondly, I don't know what the argument is--I have not heard it--for the second provision of the Senator's amendment that deals with collusion between the brand names and the generics, which is taking place out there. That is as bad as the gimmickry we have seen from these corporate scoundrels who have made out like bandits, such as at Enron, getting billions of dollars and then giving short shrift to the workers. What is the difference if those corporations make out like bandits, and in this case, instead of the workers, it is the seniors and sick people who will suffer? I do not see a great deal of difference. The Senator has made such a strong statement. I am as perplexed as he is that we have not had a chance to get to the bill this afternoon and debate it. The Senator has correctly given the interpretation we had of the clarification of language that was raised. I point out to the Senator and ask if he will agree with me, if they do not agree with language, we will be willing to accept the language to clarify those provisions. It is very clear what the intention was in the hearing record. We are not trying to change our position. We are still at that position. If they have language to do that, we will take it now and get on with the bill. We should be under no illusions. That is not it. They want to change other provisions, substantive provisions. All the Senator from New York is saying is, if that is the case, why are we not out here debating those issues and taking votes on them and moving this legislation forward? Does the Senator find any reason this can justify why we are having this delay on this important legislation that can make such a difference to many people? Why is it that on a Tuesday afternoon in July we are not doing the people's business and voting on these matters, debating these matters but instead are caught in tactical maneuvers by those who are opposed to the legislation? I say to the Senator, it is being perpetrated by those who do not want any bill at all. If we do not have any bill at all, there will be brand companies that will make billions of dollars out of the pockets and pocketbooks of the consumers, which is in complete violation of the Hatch-Waxman bill. They are the ones who are behind this delay, and that is unconscionable. I would appreciate any comment the Senator wishes to make on that issue.

Mr. KENNEDY. Will the Senator be good enough to yield?

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I ask unanimous consent to grant floor privileges to my fellows, Stacy Sacks, David Dorsey, and Brian Hickey, for the duration of the floor debate on the bill.

Mr. KENNEDY

Mr. KENNEDY. Madam President, earlier in the debate, there were questions about what was agreed to and what was supposed to be clarified. For those who have any question, I will reference two provisions that were discussed during our markup and also what was included in the bill. As I have indicated, several times last evening and earlier today, if it is technical language, we are prepared to address the technical language now during the lunch break. We were also prepared to address these last evening. But if it is substantive, we ought to have a change in the form of an amendment. That is the way we proceed around here. We agreed with Senator Frist to technical language to clarify one provision. That language is in the bill. It deals with the section: Shall not be construed to alter the authority of the Secretary of Health and Human Services to regulate biological products under the Food and Drug and Cosmetics . . . He was concerned about whether it did or didn't and whether the language was sufficiently clear. We have included that particular section in it. Those who want to look at this can see that. We agreed with Senator Gregg to instruct the staff to make a clarification on another provision stating that a patent can still be enforced against subsequent, future generic applicants. That technical language was added last Thursday. Senator Gregg received it last week but raised no objections. That language is on page 35: The owner of a patent shall be barred from bringing a civil action for infringement on the patent in connection with the development, manufacture, offer to sell, or sale of a drug for which the application was filed or approved under this subsection. That is new language. The last three lines, 18 through 20, are new language. That language was available to the minority last Thursday night. We were not notified Friday or Saturday; we were not notified on Monday. We were notified about 10 minutes after the leader indicated he was going to offer the motion to proceed to the bill. I don't think it really carries much weight. Before we recess for the lunch hour, I want to discuss the abuses of the existing legislation that the proposed legislation will remedy. Also, I would like to discuss why it is important to close these loopholes because of the impact it will have on the costs of drugs to consumers. In 1984, Congress enacted the Hatch-Waxman Act, which provided a framework for allowing generic drugs to come to market while protecting the patents of new medicines that are breaking new ground each and every day. But as recent hearings before our Health Committee and the Committee on Commerce have revealed, there are abuses of the Hatch- Waxman Act by both name brand and generic drug companies that have delayed the approval and marketing of generic drugs. These findings are confirmed by numerous studies by the Federal Trade Commission and other independent experts. The basic structure of the Hatch-Waxman Act remains sound. It has been a tremendous success in promoting competition and innovation. But there are clearly weaknesses in the Act which are being exploited to delay competition and shore up the bottom lines of drug companies with empty pipelines. These abuses force American consumers to pay four times more on average for some prescription drugs. This must be stopped. Everyone agrees that drug companies are entitled to fair profits on their research and innovation. But when patents expire, those companies must innovate to succeed and help patients, not block competition to their old drugs. When we passed Hatch-Waxman, we believed we were going to see a whole series of breakthroughs in new prescription drugs, but that hasn't really taken place. What the drug companies have done is reshuffle the old formulas, put them out, and tried to maintain their privileged position under the patent laws. That is what has happened. We have had these abuses. We have seen the patent abuses, as this chart indicates, where we show the cost to date to consumers, the additional cost to date, and now the various prescription drugs themselves. This delay has benefitted the patent holder. Instead of having the patent expire and the generic being able to come on and offer this drug to consumers at a considerably lower price, the generic is not being made available. Here's what we're talking about. Today, of the top fifteen best- selling drugs potentially subject to generic competition, the basic patents on at least five of them have long expired. Their exclusive rights to market their drugs have long expired. Yet, there is no generic competition. Drug spending rose at double digit rates between 1996 and 1999, and experts expect the growth in prescription drug spending to continue to outpace the growth in health care spending. Some of this increase is due to increased use of drugs. But experts agree that spiraling drug prices have accounted for almost two-thirds of growth in drug spending, especially the higher prices of new, aggressively promoted drugs. Generic drugs are clearly part of the answer. Simply put, a 1 percent increase in generic use can decrease the Nation's yearly bill for drugs by a billion dollars. These savings are easy to understand. For patients and health plans alike, the costs for a brand drug are four times higher than for a generic equivalent. That difference is even higher for the elderly and uninsured, who must often pay full price for their medicines. On average, a month's supply of a generic drug costs a patient $4 and the health plan $16; the costs for a brand drug are four times higher: $16 for the patient, $64 for the plan. For the uninsured, and seniors who lack prescription drug coverage, the full costs are either $20 for the generic or $80 for the brand drug. Prozac is a clear example. This anti-depressant recently went off- patent after generic companies challenged and defeated a Prozac patent. Today, you can buy 30 generic Prozac tablets for less than $30, less than a third of what brand-name Prozac will cost you. There are two key loopholes in the law that our legislation will end. The first is the practice of ``ever-greening'' patents, filing patent after patent, many of them entirely frivolous, to try to bar generic competition long after the basic patent on the medicine has expired. The second is the outrageous tactic used by some drug companies of buying off a potential generic competitor to prevent it from marketing its drug and using a quirk in the law to bar any other competitors from the market. Those are the two loopholes and abuses. This legislation is targeted to the abuses. The abuses result in billions of dollars for drug companies, and that is why many of the major drug companies are so strongly opposed to this legislation. Schumer-McCain closes the evergreen loophole by permitting only one 30-month stay to apply to each generic drug. For the other patents, the drug companies are free to defend its patents the same way any other company does. A second tactic used by the drug companies is to collude with a generic drug manufacturer to block other generic versions of the drug from getting to consumers. Under the Hatch-Waxman Act, the first generic drug company which gets to market has that exclusive right for six months before any other generic can compete. In some cases, brand drug companies have bribed the generic drug company never to go to market. The clock on the six months exclusivity never starts to run, and every other generic competitor is locked out forever. But the ones who pay for these unconscionable sweetheart deals are American patients. Those are the two abuses. Schumer-McCain prevents collusion between brand name companies and generic competitors by opening generic challenges to invalid patents. Closing those two loopholes will make an extraordinary difference. Finally, Gov. Bill Janklow of South Dakota told our committee that the savings for his State's Medicaid Program would be enormous. He added: That's a drop in the bucket compared to what the real costs are out there for the General Motors of this world, and Roy's Blacksmith Shop, and everyone in between. It's some individual or retired person that's paying for their own on Social Security, or a working person. The point is, they all pay more. Madam President, we will all pay more until Schumer-McCain becomes law. That is what we are about with this legislation. That is why it is so important. It is going to have an important impact in calming down the increase in the cost of drugs for the American consumer, and we think the quicker we get on this bill the better. There are other ideas that can also help us in getting a handle on the escalation of costs. Then, hopefully, we will have an opportunity to consider the issues of coverage as well. I know there has been a previous agreement for the lunch break. I yield the floor.

Mr. KENNEDY. Madam President, today is a very important day for all American families, and certainly for families who have suffered and have been diminished in a very important and significant personal way because of the high cost of prescription drugs. The Senate of the United States is debating an issue introduced by our colleagues and friends, Senator Schumer and Senator McCain, to reach out a helping hand to the families of this country in order to get a handle on the cost of prescription drugs. The cost of prescription drugs as well as the accessibility and the availability of prescription drugs are very closely related. We will have an opportunity to debate that issue later in the week. We are hopeful we will be able to work through this process in a way that will command broad bipartisanship on the floor of the Senate. We invite the American people to give focus and attention to this debate. Certainly for me, this is most important because it is related to a commitment that we as a country made to our senior citizens back in 1964 and 1965 when we enacted Medicare. It is an issue which is front and center to every family in America today. It was an issue to families early this morning when many of our seniors went to their drugstores and tried to get the prescription drugs which are absolutely necessary for them and found that the costs have been continuing to escalate and wondered whether they could afford the prescription drugs and the food they need. It will be there this afternoon, at noontime, or this evening when workers return and they need prescription drugs to try to help a sick child. The issues are front and center for every family. I don't think we will debate an issue which is of such central importance to every American family as this one. This issue is not a new issue for this body, but it is a new issue by the fact that we are debating this or have an opportunity to debate it on the floor of the Senate today. Prescription drug legislation has been introduced and referred to committees over the last 5 years which has never emerged from those committees. I won't take the time of the Senate to go back prior to even 5 years ago. In 1978, Senator Thurmond and I introduced prescription drug legislation. We were never able to get it to the floor of the Senate. Now we will have a debate on this. I take a moment of time to respond very quickly to the comments of my friend, the Republican leader, about the process of procedure. Legislation is now before the Senate. It was voted on in our committee 16 to 5. We had a very similar vote on the legislation we just concluded, as a matter of fact. We found after the debate and discussion that we were able to get a unanimous vote on that legislation. We might not end up with a unanimous vote on this, but let us not discount the possibility that we can do something that is important for our seniors. The point has been made about whether this procedure is consistent with the Senate rules. Clearly, it is. The legislation we are considering was reported out in a bipartisan way. I am hopeful and confident that we will consider other legislation to expand the access to prescription drugs. I will not take much time to remind our Republican friends about actions they have taken on important legislation that also circumvented committee action. There were a number of instances. I think that is important. I think the needs of families in this country are by far more important. I regret very deeply that we are going to have to take the Senate's time before we are permitted to actually get consideration of the bill. All Members know we are facing effectively a filibuster on the motion to proceed to this legislation. It is under the guise that some technical language wasn't satisfactory to the members of the committee. I reviewed last night the history on that technical language indicating that if it was just technical in nature, we would be glad to consider those proposals this morning and to clarify the language. If it is substantive, let us get on to the debate and let us get on to amendments. Why delay the Senate of the United States from considering this legislation? We shouldn't be surprised that there are powerful financial interests that do not want this legislation, that are strongly opposed to this legislation, and that want Members in this body to filibuster to their last breath. This is because they have been taking advantage of the existing legislation to expand their profits at the expense of consumers in ways which we will describe during the course of this debate--the greed and collusion with other companies in order to deny quality drugs and generics being available at cheaper prices. What this debate is about in many respects is corporate greed by those companies that are ripping off the public. They are able to get, in effect, a delay by this body in considering this important legislation. Let us make no mistake about what is going on. We will see it over the continuation of this debate. There was a strong belief that we would never have the opportunity to report this legislation out of Committee. We were successful in doing it in a strong bipartisan way. We are grateful to our Republican friends for their support. But we don't underestimate the strong opposition that has been voiced by drug company after drug company that are abusing the process under the old Hatch-Waxman. As a result of that, they are experiencing incomes of billions of dollars more than they ever should, and they are receiving that at the cost of the American consumer. They do not want to lose that privileged position. As a result, they are in support of delay, delay, delay, delay, delay, delay. That is what is happening. Prescription drug legislation is going to be opposed by those that are profiteering. There are many within the drug industry who support our efforts to try to work through a process because they understand the importance of the health factors that are involved in this. We are grateful to them. We hope we can work with them in trying to come up with real legislation that can benefit people. But we should not have to spend a great deal of time in reviewing what has been happening in terms of the escalation of the costs of prescription drugs. The cost of prescription drugs has been escalating and far exceeding the average cost of living. It has been going up at the most extraordinary levels. We see from this chart the fact that the increase in the cost of prescription drugs has been going up and exceeding the cost of living by about three or four times in recent years. In 1996, we had a 3.23-percent rate of inflation, CPI, and the increase in the cost of prescription drugs was 10 percent. The increase in the cost of prescription drugs was 14 percent in 1997, 15 percent in 1998, 16 percent in 1999, 17 percent in 2000, and 17 percent in 2001. Look at the yellow bars that indicate the rate of inflation. Why is it so important? It is important, obviously, for the health and consideration of our fellow citizens. But the fact remains, in 1965, when we passed the Medicare legislation, we went on record--the Congress went on record--with a solid commitment to our seniors and to the American people: Work hard, pay into the system, and at the time you are 65 years of age, you will have health security in this country. That was our commitment, and we did it. We have done it with regard to physician services, and we have done it with regard to hospitalization. But what we have not done this with is prescription drugs. Every single day we fail to enact a prescription drug benefit program that is affordable, accessible, and available to seniors we are violating that solemn commitment and promise to our seniors--every day, every day; today, tomorrow. And that is a solemn commitment. We will hear: We have X provision or Y provision that isn't clarified. The seniors understand what is out there. They understand what is important. We have a responsibility to meet the needs of our senior citizens, and to do it in a way that is affordable and accessible. This legislation that is before the Senate now will have a significant impact in terms of the escalation of costs, make no mistake about it--if we are able to, and when we are able to, get a debate for the consideration of it. But what we are being told now, with only 3 weeks left before the August recess, is: No, we are not satisfied. No, we are not going to be able to take this up. No, we are not going to be able to consider this legislation. If they have differences, let's hear those differences. Let's consider those amendments. Let's debate those amendments this afternoon. Let's vote on those amendments. But let's not just hide behind the questions about clarifications of language. We have seen what has happened in terms of our senior citizens with regard to the coverage on prescription drugs. If you look at this particular chart, you will see where our seniors are now with regard to prescription drugs. Thirteen million of our senior citizens have virtually no coverage whatsoever in the United States today. Ten million have employer- sponsored plans. We will come back to that. But keep that in mind: 10 million have employer-sponsored plans. Five million are under Medicare/ HMO. Two million are under Medigap. Three million are under Medicaid. The only Americans who can be guaranteed prescription drug coverage that will be available and accessible are those under Medicaid. Those are the only Americans who are not at risk today. We are trying to do something about it. But the drug companies say no. They will not even let us begin the debate on it. They say, no, we are not going to permit you to even proceed to the debate on this issue, even though we are finding out what is happening to our seniors. We have 10 million who have employer-sponsored plans. Let's take a look at what happens to those who have employer-sponsored plans. If you take the employer-sponsored plans, the firms that have offered the prescription drug program for our seniors, look what has happened to those 10 million people. These individuals have retired. Let's look at what is happening to their coverage. It is dropping like a stone in a pond. It was 40-percent coverage in 1994; and it is going right on down and dramatically being reduced. That is as a result of the employers cutting that program out. And 13 million do not have any coverage. As I said, 10 million have employer-sponsored plans. And this is what is happening to the employer-sponsored retirement coverage: The coverage is dropping like a stone in a pond. Let's look at what is happening in terms of the HMOs. We said we had about 5 million who were covered by the HMOs. Take a good look at this particular part of the chart. This is Medicare coverage. HMO drug coverage is inadequate and unreliable. A drug benefit is offered only as an option, and 30 percent offer no drug coverage. And 5 percent of Medicare beneficiaries in rural areas have it. But look at this bullet line: Medicare/HMOs are reducing the level of drug coverage. Seventy percent of Medicare/HMOs limit their drug coverage to $750 or less--$750 or less. Fifty percent of the Medicare/HMOs with drug coverage only pay for the generic drugs. So you can say we have all of those who are covered by employers. That is phony because the bottom is falling out for them. You can say you have 4.5 million of them covered by HMOs. This is increasingly phony because they have a limitation of $750. And about 18 percent of all of the seniors will benefit under that particular program. So we go on and see what happens in terms of the next group, which would be the Medicaid coverage. We will find out that some 3 million have that program. And then, finally, you have those who are involved in what they call Medigap, where the average cost has gone up so high that it is increasingly out of range. Our seniors are in a crisis. Our seniors are in crisis with the explosion of drug costs and the failure of coverage, and we are being told out here on the floor of the Senate we cannot even bring up the bill, even though there has been a prescription drug bill for 5 years in the Senate, and we have not had a debate on these issues. So the question is, which way is the Senate going to go? Is the Senate going to go with the drug companies and the wealthy corporations that today are abusing and colluding with some generic companies to deny the lower prices for families in this country? Or are they going to stand up and say: We want to get this legislation passed that can make a real difference in the cost of their drugs? If that is what they want, they should be letting those forces know here in the Senate--the Republican leadership on down--that this is the time for debate and action on this. We do not accept the fact that it is going to be complicated, it is going to be difficult, it is going to be hard to try to reach a coalition. We are committed to getting something done. We believe we have the way to be able to do it. I want to also mention another feature. We know that the House of Representatives took some action recently in order to try to address this issue. We welcome the fact that at least they passed some legislation. We would not be able to get legislation unless, obviously, the House passed it and the Senate passed it. We would not be able to get legislation unless we were able to have the House of Representatives pass legislation. But I want to just review, very quickly, with the Members about what happens in the Republican proposal in the House of Representatives. First of all, there is an assets test. What they have is an assets test. You will hear: The Republican program really covers and reaches out and covers individuals in the lower income levels. That is where the real need is. Right, that is where the real need is. There is a great need when you figure two-thirds of seniors have incomes below $25,000. The average income is less than $14,000. We talk about individuals, wealthy seniors. When two-thirds of them have an income of less than $25,000 and the average income is $13,000, certainly our seniors are hard pressed to be able to do this. It is interesting. It has been suggested that for low-income people, they won't have any premiums. They won't have deductibles. They will not have any copays. That sounds good, but just take a look at the print. There is the assets test. Any senior can't have any more than $4,000 in savings. You can't have a car that is worth more than $4,500 or you are out. You are telling seniors who might be driving around in the cold of winter that they can't have a dependable car in order to go to the drugstore to get their prescription drugs or have a car in the heat of the summer, in the areas of this country that are scorching hot and have a decent car to be able to make sure they get to the drugstores. If they do, they will lose eligibility. Burial expenses worth more than $1,500--isn't this wonderful? If it is more than $1,500, it moves against the assets test and moves to disqualify them. Personal property, a wedding ring, no more than $2,000 in furniture or personal property. A wedding ring counts as personal property. Let alone if it goes over that $2,000, it counts in the assets test, as does $4,000 in savings. In other words, you have to just burn every nickel and dime that you have been able to save over your lifetime in order to qualify for this. Not only is this process unconscionable and it has been rejected by Senator Graham and Senator Miller in their particular proposal, but it is a very important part of the Republican program in the House of Representatives. It is not only that this is demeaning, but what do we ask our elderly people to do? Go in to fill out a little form. Can you imagine how demeaning that is? People who need that prescription drug as a lifesaver have to go in there to try to qualify. They have to count their wedding ring, their furniture, personal property, and whatever is in their savings when they go to qualify for this program. That is when we know from a financial statement that they are individuals in need. Beyond this, you have the paltry coverage benefits under the Republican plan. On this left side you have the percent of seniors that purchase, for example, 18 percent spend $250 or less on drugs; 18 percent spend $250 to $1000; 17 percent spend $1,000 to $2000; 23 percent spend $2,000 to $4,000; and 7 percent spend $4,000 to $5,000. The beneficiary payments and the Medicare benefits, if you are spending $250 on drugs costs, you are still going to pay $658 because you are going to pay the premium and the deductible. So virtually we are telling these 18 percent of the Americans under the Republican program, no benefit, none. You don't get any at all. If you are at 18 percent and you have drug costs of $1,000, you pay the payments and you pay the deductible. You pay your premiums and you pay your copay. That is $808. The Medicare payment is $192. The cost paid by the senior citizen is 81 percent. Some help and assistance that is. The list goes on. The 17 percent with drug costs of $2,000 pay 65 percent of the cost themselves. Those with drug costs of $4,000 pay 83 percent; and the 7 percent with drug costs of $5,000 pay 82 percent. Some drug benefit that is. It is important we have a debate to find out exactly what program does what. But we are denied that opportunity. We are denied that opportunity in the Senate to get on to what is happening with costs. We are strongly committed on our side to try to do something about one aspect of it, and that is the escalation in the drug costs to the American consumer. We have a strong bipartisan proposal sponsored by our friends and colleagues, Senator Schumer and Senator McCain, strong bipartisan legislation that came out of our committee and can save as much as $71 billion over the next 10 years and make a real difference. There are other ideas that our colleagues have in the Senate that can show how the consumers can get an additional break in terms of the high cost of prescription drugs. We ought to have the opportunity to debate them. But no, we can't do that. We can't do it today. We are prepared to get into the debate. We are prepared to get into amendments. We are prepared to have votes in the Senate. But, no, we are told by our colleagues from the other side of the aisle that we can't because there are language changes in here that are not satisfactory. If it is not language, it is substance. I might say that we are glad to work out language. And if it is not language, if it is substance, let's get to it in terms of a vote. We are being denied not only to consider the basic underlying bill, the Schumer-McCain proposal, but we are unable to consider other amendments that can also have a positive impact in reducing the cost of prescription drugs. We are denied that opportunity. There are several of those. I see my friend from Michigan in the Chamber now. She knows a number of those and she will be an effective advocate for many of those. We can have an important debate, and we can have action that can have a meaningful impact in terms of seeing a leveling down of the escalation of the cost of prescription drugs in the future. But, no, we can't consider that. There are certainly those who would say, if we are going to take that very important step, that will be important in and of itself, but what about the coverage? We are being denied consideration of various proposals including those by Senator Ensign, Senator Hagel, and the tripartite group. However, we are unable to even consider and debate those. We are being closed out. We will have to take the time of the Senate this week to just go ahead with what this body has done so well over a long period of time on prescription drugs, and that is to talk and talk about it but not take action. We are prepared to take action. Majority Leader Daschle said weeks ago that we would take up legislation dealing with prescription drugs. He has met that commitment. That is a strong position of those of us on this side of the aisle. We were able to get that legislation out. We don't just say that it is only the Democrats who are interested, as I have said repeatedly; we have strong Republican support for the underlying legislation. If it had been so egregious at the time, I would have expected they wouldn't have supported it. So we have important legislation. It is bipartisan in nature. We agreed, Republicans and Democrats, we want to take action, but we know where many of the drug companies, not all, but many of the drug companies are. They are saying: No, we do not want action on this bill. No, we do not want action on coverage. No, we don't want to have consideration of this legislation. No, we don't want any action whatsoever to protect the seniors and sick people of this country in terms of prescription drugs. There are many of us who reject that attitude and that position. We are strongly committed to having action here in the Senate on this proposal. We believe that the quicker we get to this legislation, the better off we are going to be.

Mr. KENNEDY. Then we will move on the regular order with the presentation of the legislation.

Mr. KENNEDY. We were going to get started. We all are under pressure, but I would be glad to have the Senator from Minnesota speak.

Mr. KENNEDY. Will the Senator yield so I can respond?

Mr. KENNEDY

Mr. KENNEDY. Will the Senator yield?

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I will yield the floor in just a moment. I want to be very clear on the Record; that is, that the language was provided both to Senator Frist and Senator Gregg on Thursday afternoon at around 4:15. The first I have heard there was objection to it was 5 minutes before the majority leader's request. I did not hear any objection to it Friday. There was not any objection to it Saturday. There had been no objection to it today, Monday. It seems to me that if there are objections to it, we ought to be able to clarify the language and move forward it. If people have objections to this legislation, let's hear it. Let's debate it. I pay special tribute to Senator Schumer and Senator McCain. Seniors have been paying too high a price for too long. This is going to make a difference. We have delayed too long in addressing this issue. So I indicate that we are prepared to work on the language over the evening or tomorrow. But we believe we ought to get about the business of dealing with this legislation.

Mr. KENNEDY. I will in just a moment. Then there was another question with regard to the timing and procedures to be able to bring civil action. We added on page 35 a new section for the Senator from New Hampshire. As I mentioned earlier, we don't have a difference. We would be glad to work through the evening, if we had the opportunity to proceed to this on tomorrow. If this language isn't clear--we are not facing a difference on it. What I am troubled by is the fact that there is objection to moving to the legislation and moving to it in a timely way when it is legislation which is of such importance and relevance to every family in this country. I see my friend from Michigan on the floor, but I will yield to the Senator from Arkansas.

Mr. KENNEDY. The reason the Senator objects is in behalf of the Senator from Tennessee who wanted clarification in terms of the ability of the FDA to regulate biological products. We have included a new section on page 52. This section shall not be construed to alter the authority of the Secretary to regulate biological products under the FDA act. So we added that just for clarification. It is difficult for me to understand why that doesn't work.

Mr. KENNEDY. Yes.

Mr. KENNEDY. Mr. President, I will include in this part of the Record the sections relating to the bioequivalence. It is on page 53. The effect of the section is: This section shall not be construed to alter the authority of the Secretary of Health and Human Services to regulate biological products under the Food, Drug, and Cosmetics Act. Any such authority shall be exercised under that Act as in effect on the day before the day of enactment of this Act. Effectively, we are restating the current law. I will also have printed in the Record the language which was questioned earlier--I think an explanation and how it conforms with what we had agreed to in terms of the exchange. If it is necessary, we will be glad to work with our friends and colleagues on the other side during the remainder of the evening and certainly tomorrow to try to find out, if this language is not satisfactory, what language would be satisfactory. We did have areas of differences, but not with regard to these two particular provisions. There was an agreement on it. It was just trying to find the appropriate language which would reflect the opinion of the committee. We believed we had done so, and we are glad to work with our colleagues on the other side. If that is not the case, we are glad to make those adjustments and changes so we can begin the debate on this extremely important piece of legislation. We recognized when this was introduced--and I give great respect to my friends and colleagues, Senator Schumer and Senator McCain, for developing the basic legislation which was the core of the debate we had in our committee--it was modified to try to respond to some of those who had some concerns. We had Senator Edwards and Senator Collins in a bipartisan way develop an approach which had strong bipartisan support. We had good discussion and debate in our committee on this matter and a strong committee outcome. This is a very important piece of legislation. It is one which deals, not so much with the availability and the accessability of drugs but as to the question of whether they are going to be reasonably affordable alternatives to brand name drugs and whether we are going to follow the agreement that was made at the time of the Hatch-Waxman legislation, which was enacted, which really was based upon the idea that we would have new breakthrough drugs rather than rehashing of older drugs. What we have seen is in recent times those who have the patents are using the Hatch-Waxman legislation in ways that work to the significant disadvantage of the consumers in this country. It is to change those abuses that this legislation has been developed. It is very important. We will continue to work with our colleagues to try to clarify any of the language that needs to be clarified. We look forward to the debate at the earliest possible time. I thank the majority leader for giving the attention and priority that he has to this legislation. I think for most of us, as we travel around to our constituencies, we find the availability, the accessibility, and the cost of prescription drugs are on the minds of just about every family in this country. You don't have to be sick, although that is certainly something that every person who is ill understands very well. But it is the total family. So much of the challenge and the burden of health care costs goes to all the members of the family. As we are particularly in the period of what I consider to be the life-science century where we have enormous opportunities for major breakthroughs and extraordinary kinds of positive impact on the lives of people in this country, we must make sure these prescription drugs and the generics are going to be available and accessible. The faster that we have a chance to engage in this debate and pass this legislation, the better the health of the American people is going to be. I note on the floor the prime sponsor, the Senator from New York, Mr. Schumer. He has probably heard that there was objection to taking up this legislation because of certain language clarifications. We reviewed and put in the Record clarifications which, quite frankly, conform to the issues that were raised. They are not areas of difference but areas of clarification. We sent those to our colleagues last Thursday night indicating that we understand they would be satisfactory unless we heard back. We did not hear back until just minutes ago. We want to work with our colleagues. We certainly invite the Senator who has been such a driving force on this issue. We hope that overnight and certainly in the early morning we could have a clarification which would remove the reasons for not proceeding; that at some time tomorrow we could begin the debate in full and move ahead to considering this legislation.

Mr. KENNEDY. Mr. President, in regard to the language to which the Senator has referred on the question of the bioequivalence, a whole new section was added, subsection (C) of section 7, dealing with bioequivalency. It was sent out to the good Senator on Thursday evening. We had indicated if we did not hear back from the Senator or his staff, we would assume that language reflected what was discussed in the course of the markup. We had similar kinds of clarifications with regard to certain procedures and filings. As far as we are concerned, at least on our side, these particular provisions have been dealt with in the legislation and we are prepared to move ahead with the consideration. This is extraordinarily important legislation. It relates to not only the quality of prescription drugs but accessibility and affordability of prescription drugs. We are seeing today the significant abuses of the Hatch-Waxman legislation. If we were able to just go back to the full intent of Hatch-Waxman, conforming with that, this legislation would not be necessary. But it is necessary. The best estimate is it would save consumers $71 billion over the period of 10 years. It is very important. We ought to be about it. I hope we can get to the legislation and start debating it. We had a strong bipartisan vote in the committee, and we are ready to go and consider amendments. If there is further clarification that is necessary, we are glad to consider it, but I regret very much we are going to have to delay legislation which is as important as this to our seniors as well as to other Americans who believe they need to be able to get fairness in the consideration of generic drugs.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I ask unanimous consent that Deborah Forbes of the Labor Committee be given access of the floor during deliberation of this legislation.