Judd Gregg

Mr. GREGG

Mr. GREGG. I understand there is a desire not to have us go to a vote until 5:40 or so. So there is extra time here. I would suggest that I take 12 minutes and the Senator from Michigan take 12 minutes, that we equally divide the time between now and 5:40, and then, at 5:40, proceed to a vote.

Mr. GREGG

Mr. GREGG. Mr. President, if the Senator will yield, at this time we cannot agree to such an understanding. As the Senator has noted, this amendment has generated a very significant interest. Debate has been, obviously, substantive and there is still a fair amount of debate that has to flow under the bridge before we can close the game, if I can mix metaphors.

Mr. GREGG

Mr. GREGG. With no intervening action?

Mr. GREGG. As long as the position of the Senator from Mississippi is protected as being the next amendment offered, I certainly have no objection, but it is the call of the Senator from Mississippi.

Mr. GREGG. Mr. President, it is appropriate to address again the issue of why this bill should have been vetted--not this bill we are hearing about, the big bills that are coming at us, the drug bills for drug benefits under Medicare--why they should have been vetted by the Finance Committee. The Senator from Massachusetts represents that it didn't happen the last 5 years. There was no bill reported out of the committee. So why should the committee have to take it up this year? Why not just write it in the office of the majority leader, which is what has happened here? We haven't seen the bill. It is ironic. We have had all the representations as to what the Democratic bill is. We haven't even seen the bill. It hasn't been scored. It doesn't exist, as far as we know. Yet there are people out here puffing its strengths. The reason you have to take this to committee is that if you don't take it to committee, you guarantee, almost, that you will not pass a bill. You are certainly not going to pass a bill that was drafted in some back office around here. If the bill does not go through the Finance Committee, it requires 60 votes to pass this body. It is subject to a point of order under the Budget Act. It appears that the reason Senator Grassley, being ranking member on the Finance Committee, Senator Breaux, Senator Snowe, being members of the Finance Committee, and Senator Hatch is supportive of this bill and is a member of the committee--it appears within the Finance Committee there is a working majority to pass a bill out, specifically the tripartite bill. Senator Jeffords is a member of the committee who is on this bill. There is a working majority to pass the bill out of the committee right now. If that happens, when the bill comes to the floor, it only needs 51 votes to pass and you actually get a drug benefit for senior citizens. The way this process has been set up by the Democratic leadership is to create a hurdle that makes it virtually impossible to get a bill off the floor of the Senate. That is the difference. That is why you need to go through committee. The difference is that simple. If you want to pass a bill, you go through the committee so you only need 51 votes to pass it. If you don't want to pass a bill, don't take it through the committee, because then you create a hurdle of 60 votes, and it makes it virtually impossible to pass the bill. This is a process which has been set up to fail, as has been mentioned by innumerable speakers. It has been set up to fail. It has been set up to create a political issue as we go into the August recess before the November elections. That is unfortunate. It is cynical. The Senator from Maine has, in terms of considerable outrage, expressed her frustration with that type of process. She has worked conscientiously with the Senators from Iowa and Louisiana, and other Senators in this body, to develop what is a consensus piece of legislation which will give seniors who are in dire need of it a very significant benefit in the area of drugs, for purchasing the drugs they need to live a decent life. It is a bill which is fairly expensive. We are talking, I believe, about $400 billion. That is a lot of money. Maybe it is $350 billion over 10 years. Whatever it is, it is a very expensive bill. We are talking about taking a large amount of money from working Americans out of their paycheck through taxes and using it to support a seniors drug benefit, a very reasonable approach. Because it is such a large amount of money, it is outside the budget which we presently have in place. We have a $300 billion number which we put in place as a Congress last year to try to address the drug issue to help seniors. The plan, bipartisanly reached, tripartisanly reached, exceeds that number, as does every other plan being proposed, except for the Hagel-Ensign plan which is below that number. All the other plans, with the exception of Hagel-Ensign, are subject to a point of order and, thus, subject to 60 votes. And it is extremely unlikely, considering the nature of the Senate, that you will get 60 votes for a final package. There are three different competing packages on our side, and there is this phantom package on the other side being written in an office, or a cloakroom, or a closet somewhere, and which we will see someday. In any event, we know it has not been adequately vetted and we know the number is very high, over $600 billion minimum, maybe as high as $1 trillion if it is honestly scored. That is why you have to go through committee. The committee has the expertise on it. That is important. More importantly than that, the committee gives the imprimatur of budgetary action, and if a bill is reported out of the committee, it meets the budgetary guidelines; it is not subject to a point of order. So the misrepresentation that if it didn't happen the last 4 years that the committee reported out a bill on this issue, why should the committee have to report now, is a bit of a red herring. The issue isn't that you didn't do it 4 years ago. The issue is, do you want to pass a drug benefit package today or do you want a political issue? If you want a political issue, don't run it through the committee, bring it out on the floor and guarantee it fails because it can't get 60 votes. If you want a drug benefit package, put it through committee, and the committee comes out with a package, which would probably be the package outlined by Senator Snowe, and it gets 51 votes at least. I suspect it will get more than 51--in the midfifties, probably. Then you have a package with which you can turn to your senior citizens and say: This will be a significant benefit to you as you deal with the issue of prescription drugs. That is the difference. That is why you need committee action on this bill. As long as there is no committee action, I suspect you are guaranteeing failure.

Mr. GREGG. The Senator characterizes my views accurately, and I agree with the Senator that this bill should be moved independent of the drug bill. Unfortunately, the greater issue, or game, of the drug fight has been set up to lose so that nothing will happen, as the Senator from Arizona so appropriately pointed out. I do think this is important legislation. I hope we will pass it somehow. My concerns go to the expansion of lawsuits under the new cause of action. Much of the rest of the bill--in fact the vast majority of the rest of the bill--I think is excellent. I appreciate the work of the Senator from Arizona in bringing it forward.

Mr. GREGG. Will the Senator yield for a question?

Mr. GREGG. With the time equally divided.

Mr. GREGG

Mr. GREGG. I yield the remainder of our time to the Senator from Pennsylvania.

Mr. GREGG. Yes, that is correct. That happens to people from New Jersey.

Mr. GREGG. If the Senator will yield a second, I want to clarify. I wandered in in the middle of the discussion and misunderstood the issue. I believe the Senator from New York is correct in his assessment of the bill on the 30-month issue. It was the 180-day rule to which I was referring.

Mr. GREGG. I simply ask the Senator if he is aware that under the bill brought forward to us, as amended, the 30-day rolling exclusivity would be able to continue to roll over, that under this bill it is potential--and in fact likely--that second and third 30-day periods could be driven under this bill--and even fourth 30-day periods. There was actually language that would have eliminated that opportunity completely.

Mr. GREGG. Well, it is New Hampshire, but we are all in the East.

Mr. GREGG

Mr. GREGG. Mr. President, I ask unanimous consent that Madhavi Patt, with Senator Hatch, be granted the privileges of the floor during consideration of S. 812.

Mr. GREGG

Mr. GREGG. The bill wasn't passed until last Thursday.

Mr. GREGG. I am willing to give you a victory. I am saying: You win. Proceed to the bill.

Mr. GREGG. I ask for regular order. Either objection should be or not be made.

Mr. GREGG. My question is, Why do you need a vote?

Mr. GREGG. If the Senator will yield for a further question, I think the Senator's knowledge of process around here certainly exceeds mine and, obviously, it borders on genius. And, therefore, I suspect the Senator knows there are ways in which to get one's point across in this institution which involve procedural activities. My purpose in raising this issue was to get my point across, that I believed the bill was coming to the floor without having been adequately structured as to how it was going to leave the committee. Now, I made my point. I am happy to move on without a vote. There will be a vote tomorrow, if you wish to have it, and it will probably be 98 to 0.

Mr. GREGG. Let me make the point, we do not need a vote because I am willing to agree to go to this without a vote. But if we are going to have a vote, let's have it when it was originally scheduled, which is tomorrow at 10:30 or 9:30, whatever it was. So I would object.

Mr. GREGG. Reserving the right to object, I would actually note I am actually the junior Senator from New Hampshire. But independent of that subtlety----

Mr. GREGG

Mr. GREGG. Does the Senator consider it tortured that a Senator feels a representation made in markup is not being pursued?

Mr. GREGG. Will the Senator yield for a question?

Mr. GREGG. Mr. President, there have been a lot of representations by the Senator from Massachusetts as to why we are in this position. He need only turn to himself to answer that question. When we marked up this bill in committee, there was an unequivocal, unquestioned agreement, in my opinion, that we would reach accommodation on two parts of this bill. There was significant discussion about the 45-day rule and about the fact that what the language in the bill represented, what the sponsor of the bill represented the language to do, was the opposite of what the language did. It was agreed to by the Senators there--both Republican and Democrat--that that language would be corrected. There was an agreement between the Senator from North Carolina and the Senator from Tennessee that the language dealing with the bioequivalency issue, which is critical in this bill, would be corrected before it got to the floor. The essence of this bill was presented to the committee on Thursday and marked up. Now it is on the floor. That is rather prompt action, to say the least. But the understanding was that, before it got to the floor, these two items would be corrected so that the bill would be in the proper form when it reached the floor. The reason there is delay occurring is that there continues to be a stonewalling of the agreement that was reached in the committee as to correcting those problems. It is pretty hard to reach an agreement in the committee and suddenly find it means nothing when you get to the floor. It makes it very hard to do business around here when that happens. But that is the reason for the delay of this bill being available for amendment. The debate is going forward rather intensely. The Senator has numerous charts, and I am sure other Senators will be down here with numerous charts to discuss this bill. But I thought it was important we make the point that when an agreement is reached in committee during a markup that the bill will be corrected before it gets to the floor, on two specific and important points, that agreement should be upheld. Now, obviously, at some point we are going to go to this bill and we will start amending it. It doesn't look as if the agreements that were reached in committee are ever going to be fulfilled, which is regrettable and inappropriate, in my opinion. It makes future markups very tenuous, because how can you mark up something and have an understanding, and then suddenly find that the understanding was meaningless once you agreed to move forward with the bill? It changes the whole tempo of how you do things around here. So it has nothing to do with greedy drug companies. I am sure there are a lot of greedy companies out there. We have seen that everywhere. It has to do with the appropriate process in the Senate and the movement from the committee to the floor, as to why we are delaying this specific bill's ability to be amended. We are not delaying the ability to discuss the bill. There is a great deal to discuss, and I will take a few minutes to do that. I am talking about the underlying bill, not the drug bills that are going to be coming as amendments to this bill. The underlying bill, which was Hatch-Waxman and has been amended by Edwards-Collins, has a very legitimate purpose: To get generics to the market quickly but at the same time protect the incentive of brand name companies to do research and have protection in the research and the products they produce, but at the same time allow generics onto the playing field quickly. It is a very technical bill, with technical language, which will have a big impact on the ability of Americans to buy drugs more cheaply and also to have new drugs come to the marketplace, which drugs will be able to save lives. You have to remember that. I think something is often forgotten in the demagoguery of ``let's reduce the price of drugs,'' which dominates the political marketplace today, as buses drive to Canada and people claim they can buy this or that at cheaper prices. The basic benefit that we as the American society have is that we have a vibrant research community in the area of producing new drugs. That has taken us from being a society where people were operated on all the time, and put under the risk of a knife, to a society where in health care drugs are able to take care of many of the issues that were not able to be cured before; and if they were not, you were put at risk of being put under a scalpel. We need to continue to expand that, to have an expanding research base in the area of drug production. But in doing that, we see the costs going up. So how do we address that? The hope is that, as the drugs come on the market and after the people who have developed the drugs have a reasonable period of time to get a return on that so that they recover the costs--and it takes about 12 years and $500 million to bring a new drug to market--that was the last number I saw; maybe it is higher. But once the costs have been recovered at a reasonable rate in a typical market system, then you allow other people to produce the same drug. That is called the generics. They come in and produce it at a much lower cost. What we don't want to do, as we are making those lower cost drugs available, is wipe out the incentive of people to go out and produce new drugs for the marketplace. So it is a very delicate balance, and it cannot be effectively handled by suddenly going to the Canadian system. The reason the Canadians are able to offer low-cost drug prices is that they take our research and they basically don't pay us back for it. They sell the drugs in Canada without the research factor as part of the cost. Of course, there are other things we can do in this area--and, hopefully, we will get into those debates--such as marketing drugs and how you control the cost more effectively. Those are other issues. But this question of how we balance bringing generics into the marketplace versus creating continued incentive to research is absolutely a critical question of maintaining a healthy society and getting more drugs to the market, which will benefit more people within our society. Hatch-Waxman has been an extraordinary success. When it was drafted by Senator Hatch and Congressman Henry Waxman, I don't think they would have anticipated they would produce something so successful. It has accomplished its goal very effectively. But, unfortunately, as so often happens, as time has gone on, we have seen some holes in it. It has mutated a bit, and smart lawyers have figured out ways around it. As a result, unfortunately, both the brand companies and the generic companies have found ways, in some instances--not all but some--to game the system. Brand companies are keeping generics out of the market longer by using the mechanisms available under Hatch-Waxman, and keeping other generic companies off the playing field by also using the mechanisms under Hatch-Waxman. So there has been an attempt to reform it. It began with a bill called McCain-Schumer, which mutated into Collins-Edwards, which actually took as its base a significant amount of language that I developed for an amendment within the committee. So the underlying bill is basically moving in the right direction and is a good bill. It has four major problems, however, two of which I thought had been fixed before we got out of committee--at least I think it was pretty clear that everybody at the markup believed there was an agreement that they would be fixed before it got to the floor. Two of the others still require amendment activity--or they are all going to require amendment activity now, but they should not. Only two of them should have to require amendment activity. Where are these problems? They are technical in nature, but they have a huge impact on the process. The FDA has looked at the bill, and it has found these problems to exist. They are not my creation. They are not some brand name drug company's creation. They are not even the generics companies' creation. They are a problem which is highlighted by the way the language is drafted. I want to read now the FDA's concerns because they basically make the case for these problems. The FDA, I believe, is the fair arbiter of this issue. In a memo dated July 10 from Frederick Ansell of the FDA to Diane Prince and Patrick McGarey, he points out a variety of issues. I will highlight the ones I think are the most significant. The introductory paragraph: This memorandum follows up on my July 9 memorandum on technical issues with S. 812's substitute amendment. This memorandum addresses substantive concerns-- Substantive concerns-- about the legislation. The first point they make deals with something called civil actions. This is a change in patent law which is rather dramatic. It deals with the 30-month stay issue and how that works. Civil action to correct or delete patent information. The civil action can be brought against patent holder to ``correct'' patent information required to be provided under the bill. Since there is no requirement that the plaintiff have filed a par. IV certification, does this mean there is an alternative available to an ANDA holder to file suit in lieu of certifying under par. IV? That language also means that a suit can be brought not only to delete a patent that should not have been listed, but over whether the listing was ``correct.'' If the incorrect or missing information means that the NDA or patent holder ``fail[ed] to file information on or before the date,'' (even if it is later ``corrected,'' since the correct information was not filed as of the due date), then a potentially technical failure to provide information will make the holder ``barred from bringing a civil action for infringement of the patent against a person'' who filed an ANDA. Skipping a few sentences: This is a change in the patent law that would provide pharmaceutical patents less protection than any other category of patent and would presumably harm innovation in drug research area. I reemphasize this point: This language ``would presumably harm innovation in drug research.'' That is the FDA evaluating the effects of the 30-month rule as it is structured in this bill. Going on to another section, the 45-day rule. This was something on which we thought we reached an agreement in the committee. It is a complicated issue, but the 45-day rule means that under the bill as it is drafted, if the holder of the patent, the brand company, the primary developer of the patent does not bring a suit in 45 days, they essentially lose their ability to bring suits against anybody, not just the generic company that filed a plan against their patent--against anybody. This is a radical departure and would essentially mean that for most brand companies, they would just have to file suits interminably or else be put at risk of losing any rights to their patent. To quote the FDA, which is summarizing their view of this language: The same considerations raised about barring patent lawsuits altogether raised about an earlier provision of the bill apply to this language concerning patents that would not, following the notice and suit, permit a 30-day stay. Skipping down again: That may make preparing an infringement case sufficient to obtain a preliminary injunction difficult, making illusory the ability to protect the patent or forever be barred. Making illusory--emphasizing ``the ability to protect the patent or forever be barred.'' Essentially this language, which we had thought we had agreement to correct, in the FDA's view would make ``illusory the ability to protect the patent or forever be barred''--obviously not constructive to creating new research in the area of drugs. The third area is the 180-day issue, which is a major issue. If a generic company files a challenge under the present law and comes on the playing field, so to say, then they get 180 days exclusively to put their product in the marketplace. This is an attempt to encourage generics to come into play. The Edwards-Collins bill has an incredibly complex new system to try to address this issue. The language I proposed would have essentially eliminated the 180 days if there had been collusion between the brand name company and the generic company. One way the system is gamed is a brand name company and a generic company get together. A generic company comes in, files, and, as a result, with the consent of the brand name company, essentially locks down the product for another 180 days, and then they continue to roll that out. In an attempt to address that, I proposed language which would basically be use-it-or-lose-it language. In other words, if they came in and did not produce their product, they would not get their 180-day exclusivity. The Edwards-Collins bill sets up a very convoluted system where you can have a rolling 180 days and can actually end up with this going on forever. The FDA memo describes this, and then it says in conclusion: And if in that circumstance, the second applicant cannot go to market within 60 days, then the third applicant obtains 180 day exclusivity. Talking about how this becomes a rolling event. Then it says: This does not seem to make a great deal of sense, given that the supposed purpose of exclusivity is to encourage a challenge to a patent by a generic. It is also possible that exclusivity could roll and roll on forever. It also means that it will not be clear which applicant if any should receive exclusivity. Finally, whereas under current law, only one applicant (the first) or none can receive exclusivity, the ability of one of multiple applicants to receive exclusivity means that there will be more instances of exclusivity, delaying the date that the public will be enabled to obtain generic versions of a drug generally, and at a cheaper price, than during the duopoly of the innovator and the generic with exclusivity. In other words, the language actually works against bringing generics to the market according to the FDA view. We have these four major issues, the fourth one being the fact that a new cause of action is created under this bill which is a private cause of action and which, in our opinion, is a very bad idea and very poor policy, and I will enter into the Record a number of letters, including one from Susan Estrich, reflecting the view that this is bad policy, to create this new cause of action. The reason I raise these points is to make clear that this bill, which was first introduced on Thursday, which came out of committee on Thursday and which is now on the floor, has some substantive problems with it. Some of these substantive problems could have been corrected if the markup procedure had been followed. They were not. But I do believe it is appropriate we have a few days to air the issues so people can get a little window of knowledge on this bill before we suddenly jump into it. That is what we are asking for as a result of this delay in the ability to amend the bill. The Senator from Massachusetts made the statement, or at least he was reported to have made the statement, that the first he heard of these concerns was 5 minutes ago--or to quote, ``the first I heard there was an objection was 5 minutes before.'' I presume before the objection, quoting Senator Kennedy. That was in an AP story by Janelle Carter. The fact is, that is not accurate. We had made it very clear that we expected the agreement in the markup to be followed, and one would presume if the agreement was not followed there would be an objection. How else would one proceed? So the 5 minutes either implies that he was not at the markup, or that if he was at the markup he did not hear the agreement. The fact is, there was an agreement. So it is not reasonable to say that we were delaying this bill when, in fact, all we are trying to do is accomplish what was represented to us was going to be done originally, when the bill was ran through committee. To lay the blame for this delay at the hands of greedy corporations is to throw red herrings and smokescreens over a process which, in my opinion, is being abused from the standpoint of the markup process. It has nothing to do with winners and losers under a delay. As a practical matter, this delay is probably going to have virtually no impact on this bill, or on the drug bill, because the debate is going to go forward today and we are going to discuss all the different issues, as I have outlined the problems--the FDA memorandum and the other issues which are of concern. Then when we get to the amendment process, people will be up to speed. Hopefully, a little more light will have been shined on this bill, which needs light on it, and then hopefully we can pass it. Of course, this bill is going to be totally overwhelmed by the actual bills that are going to deal with the overall drug bill. While we are on that topic, let me make a couple of points. The Senator from Massachusetts held up a chart which showed a line that went straight down about drug coverage and other coverage that insured individuals are getting. He also held up another chart with a line that went straight up about people being added to the marketplace who were uninsured. I suspect he will probably refer to the fact there are so many uninsured. It is a little like that story of the fellow who kills his parents and then goes to the court and throws himself on the mercy of the court because he is an orphan. The fact is, the reason the amount of coverage is going down and the reason the number of uninsured is going up is because this Congress continues to pass mandates on to the price of the premium, all sorts of different things which feel good, sound good, are good ideas but each new mandate significantly increases the cost of insurance for everyone. As a result of increasing that cost, either the other items of insurance have to be reduced in order to keep the price stable--which sometimes is what happens in reducing the availability of drug coverage or dental coverage or something else that one might have had before the new mandate hit--or you have to increase the price of the insurance, thus people and businesses cannot afford it, especially small businesses, so more people become uninsured. We are complaining coverage is less and that more people are uninsured while we are basically creating the problem by adding more and more mandates into the marketplace, which inevitably forces up the price of insurance and inevitably forces people out of coverage. In the end, it may be the goal of some in this body and in the other body to accomplish that so there will be more pressure to generate a national health care plan along the lines of what was presented by Senator Clinton back when she was First Lady, a plan which would basically have the Federal Government take over all health care so everybody would have some form of coverage, much like the Canadian or the British system. If more uninsured are created, there will be more pressure created, obviously. That may be the goal of some. The goal of others may be: I am especially concerned about this ailment or that ailment and I really want it to be covered by insurance; I have an anecdotal experience in my life that says this part of health care definitely needs to be covered because I know somebody who did not have coverage and who had this problem. So we add that as a mandate. Whatever the reasons are, the facts cannot be denied: Every time we add these new mandates, we increase the cost of insurance or we reduce the other coverages under insurance, and the result is we are adding more uninsured to the marketplace, or alternatively we are reducing the availability of various types of coverage in other areas that are not mandated. And that is why that chart occurs. That is why we are seeing drops in coverage; it is us. It is like the famous Pogo cartoon: We know the enemy, and he is us. On that issue, the Senator from Massachusetts attacked aggressively the House-passed plan. The House plan does not happen to be the Senate plan--and that would be the Senate Democrat plan or the Senate Republican plan or the tripartite plan or bipartite plan, or however many different plans we have floating around. There are some very legitimate plans that have been proposed in the Senate, though, and if we are talking about procedure and how we get these plans discussed and properly voted on, one must ask the question: Why is the Finance Committee being bypassed? Why is this new drug plan being written in an office across the hall instead of in an open committee room where it should be written? The answer is very simple. Because if the Democratic leadership went to the Finance Committee, it is very likely that a bipartisan bill would be reported out and it would be the tripartisan plan which has been offered by Senator Breaux, Senator Jeffords, and Senator Snowe. That plan, I suspect, has a majority vote--I do not know because I do not serve on the committee, but I certainly heard this from a lot of members of the committee--that plan has a very reasonable chance of having a majority on that committee. That is why the committee is being bypassed, because the Democratic leadership does not like that plan for some reason. I guess it does not cost enough. That plan costs about $400 billion. That is still over the $300 billion we had in the budget, but it is nowhere near the pricetag of what I suspect will be the plan we will see proposed by the Democratic leadership, which may be scored as high as $700 billion, which is a huge amount of money, which leads me to the next question: When Senator Kennedy talks about how little coverage the House plan had--or maybe others in this body do not feel the Snowe-Jeffords-Breaux bill has enough coverage and they want to expand that coverage dramatically by reducing copays or reducing deductibles or essentially reducing the catastrophic threshold, and so they get up to a number of $700 billion in their scoring of what their bill ends up costing, which is a huge amount of money. The $300 billion is a lot of money, I think; $700 billion is two and a half times that, almost. So that is really a lot of money. Somebody has to ask the question: Where does it come from? We do not have a surplus. Where is the $700 billion going to come from, this extra $400 billion on top of the $300 billion that we have? It comes from the younger generation. It comes from those Americans who are working today, going to be working tomorrow, and going to be working 10 years from now, and who are going to have to support the baby boom generation when it hits retirement--my generation, the generation of Bill Clinton, the generation of George W. Bush, the generation of the Senator in the chair, the Presiding Officer. Our generation is huge, absolutely huge. We know that. In every segment of American society that we have impacted, from when we started a dramatic run on baby carriages and cribs back in the early 1950s, to when we pushed the limits of our educational systems in the 1960s and 1970s, to our music in the 1980s--we have changed fundamentally the way this society has worked, simply by our size. When we hit retirement we are going to have a huge impact on this society and the impact, the most significant impact we are going to have is that we as a massive generation that will be in retirement will have to be supported by the smaller generations that are younger than us who are working for a living--our children and our grandchildren. We are going to end up passing on to them huge costs to maintain the standard we have set and which we think is reasonable as a society for senior citizens to have, both in the area of health care and in the area of retirement benefits--Social Security. We know the Social Security system is headed toward a crisis because of this generation, because of our generation, and the demands we are going to put on the system. When we add a new drug benefit, of which we are basically going to be the biggest beneficiaries--obviously people who are in the system today will benefit significantly, too, but the big cost of the benefit is going to kick in when we start to retire, beginning in the year 2008, which is not that far away--that cost is going to be passed on to our kids in the form of taxes. Their taxes are going to have to go up. They are going to have to work harder or they are going to take home less in order to support their young families so we can get that drug benefit. When we start throwing out these new benefit ideas on the floor of the Senate, and we start to malign other programs--whether it is the House program or whether it is the tripartisan program put forward by Senator Grassley and Senator Breaux and Senator Collins and Senator Jeffords, or whether it is the proposal put forward by Senator Ensign and Senator Hagel--when we start to malign these programs because they do not cost enough, they do not give enough benefit, somebody should be asking the question: Who is going to pay the bill for the increase to bump these programs up above what they are proposed at? They are all extremely generous, $300 billion being the floor for these programs. Who is going to pay the cost? It is going to be younger Americans; our children and our grandchildren who are going to pay that cost. We need to be careful about what we do to them because if we continue on this path as our generation retires, we are going to significantly impact their quality of life. We are going to reduce it because we will have put so many burdens on them to support us. Let's put some balance into this debate. Let's not just talk about how many new benefits we can put on the books. Let's talk about how many new benefits we can afford to put on the books, how many new benefits can our children afford to pay so we can help in the area of drug coverage. Yes, we need a drug package. We need a Hatch-Waxman reform package absolutely--in fact, I drafted a large part of the package we are debating today, the Collins-Edwards package. That was borrowed from language which I was successful in putting in. I appreciate the fact the Senator from North Carolina and the Senator from Maine chose to use language which I had developed because I believe very strongly that we need a strong generics industry and we need to have the capacity of generics to compete aggressively in the marketplace, coming quickly--or as quickly as reasonable--after you have a reasonable return to the brand companies, to accomplish the goal of reducing prices of drugs. The basic bill is a good bill with some significant reservations, the most significant being the ones I have outlined. Of course a new drug benefit for senior citizens is critical. We have gone from a society where, as I mentioned earlier, we treat people by putting them under the knife to where we treat people by giving them these miracle drugs. They are expensive. If you are a senior and you are trying to make ends meet and you get hit with a drug bill, it can be very difficult, in some instances. So we need a benefit. Low-income seniors especially should be completely covered--and all these programs do that and do it effectively. Middle-income seniors should have some sort of relief. Certainly anybody who has a catastrophic event which involves the cost of drugs over a threshold of any significance should have coverage. We can design a plan to do that. But in doing that, let's be sensitive to the fact that it is costing somebody something. This is not money that grows on trees. This is money that comes from somebody's hard day's work. And that hard day's work is going to be done by our children and our grandchildren. They would like to have that money to maybe help them educate their children or their grandchildren or buy a new car or live a better life. So we have to be judicious in our approach, not simply be political. Let me, for the record, put in the record, parts of the record of the markup so that it is clear at the markup there was an understanding, I believe, reached that this language would be corrected. The first issue went to the ``use it or lose it'' language. I quote Senator Clinton. My staff at least believed that it was intended to be as I have described it, that generic ``X''---- And then Senator Edwards intervened and said: Edwards saying: Why don't we just clarify it--Mr. Chairman, if we can just clarify this language. I think Senator Gregg is right about intent, and I actually read the language the same way he does-- Then I speak and I say: Well, that is a major step in the right direction. That went to that issue. Then on another issue--this may be the same issue actually--Senator Clinton said: --so I think we need to go back to the drawing board to clarify this. Senator Edwards said: Yes, we can fix this. Further to this issue why we--I, not we--have delayed going to this bill until tomorrow when cloture ripens, and the point about the representation being made by the Senator from Massachusetts that it was because of the greed of some corporations out there, that they want to delay, my representation is that there was an understanding in the markup--in the markup that was very clear, in my opinion--that two items in the bill would be corrected, two major items, one dealing with the 45-day rule, and the other dealing with bioequivalency, and that had to do with Senator Frist, that those would be corrected before we took the bill to the floor. Because of the rapidness of the bill coming to the floor without a report, within less than a week of its being actually filed in the committee, it seems to me that it was reasonable to shine some light on these two issues before we move to the bill--to actually amending the bill. So I want to return to the language here of the markup to make it clear why I believe my presentation is correct on this point. The first item I quoted was Senator Edwards saying: Why don't we just clarify it--Mr. Chairman, if we can just clarify this language. I think Senator Gregg is right about the intent. . . . This deals with the 45-day issue, and the question of whether or not it cuts off all lawsuits, all rights of remedy if you do not bring a suit; it cuts off all rights of remedy under the patents so that a person--the company basically loses its patent if it doesn't bring a lawsuit against filing generically in that 45 days. You lose your patent against everybody. Nobody wanted that, but that is what the bill ended up doing in its present language. Then the second part of that discussion went to--Senator Clinton: --so I think we need to go back to the drawing beard and clarify this. Senator Edwards says: Yes, we can fix this. Then I said: Good. The Chairman said: All right. Now we are going to instruct the staff to make that clarification, along with the rest of the bill. That is my point. There was, at the same time, some discussion of language which Senator Collins was straightening out. I believe that was actually straightened out. Then I went on to say: I think that significant progress has been made here in these discussions, obviously on the 45-day issue and on Senator Collins' proposal. I believe there is middle ground that can be reached on the new cause of action, and much of this bill is excellent. In fact, it came out of ideas that I strongly endorse and was supportive of and hoped we could reach agreement on. With the cause of action language in its present structure, I cannot vote for the bill, but certainly I hope that by the time we get to the floor and as we move through the floor that we can adjust it enough so that I can feel comfortable with voting for the bill. I was talking about cause of action. That is really a point on which I still hope we can reach agreement. If we can, the bill becomes, in my opinion, a very workable piece of legislation that should be passed. Then wrapping up, I said: I would also note for the record that we do wish to have our procedural days which are available to us to review this, and I would hope during this time we could work out the few--obviously, get the language straightened out--but work out the few substantive kinks and get this to a point where it could have unanimous support. The Chairman. We will certainly work with you and your staff in working out the language on this. That is more vague and not as much to the point as the 45-day exchange. But the point I was making there was that the traditional way we bring a bill to the floor is we do a report. The minority then has 3 days to file. Then there are 3 more days. You usually have 6 days after a report is filed under a bill before the bill comes to the floor. That has been totally shortened. By not filing the report, the majority was able to put themselves in the position where they can call up a bill after 1 day. That is their right. That is the rule. But it is not the traditional way things have happened when you report a bill out of committee. You usually have the report and then have 3 days to respond to it. I was under the assumption, wrongly obviously, that we would have 3 days to work this out, put some light on the bill, and address the issues which were highlighted by me here. There was another exchange--unfortunately, I don't have a copy-- between Senator Frist and Senator Edwards in which Senator Frist raised the point about the bioequivalency issue that goes to whether or not the generic drug comes to the market and is actually equivalent to the drug that it claims to be copying. If it is not, you have significant health questions. I don't want a drug out there that comes to market claiming to be equivalent but is not equivalent, because then you have different absorption rates. As a result, you could have serious medical problems. This was the point that Dr. Frist made very well. Obviously, he is a doctor. Senator Edwards said to Dr. Frist rather specifically: All right. We will work that out. I understand your concern. I am paraphrasing. We can work that out. Unfortunately, that was also not worked out. Those are the reasons. Those are the issues that lie here on the question of why we are holding this bill over for 48 hours before we proceed to the amendment process, which will begin occurring tomorrow after cloture is voted, or cloture is vitiated. Either way, I do think it is appropriate that we have this time to discuss the bill because it is a complex bill and it needs to be aired. I yield the floor.

Mr. GREGG

Mr. GREGG. Reserving the right to object, is the Senator going to be debating the drug issue?