[Congressional Record (Bound Edition), Volume 148 (2002), Part 9]
[Senate]
[Pages 12981-12984]
[From the U.S. Government Publishing Office, www.gpo.gov]




  GREATER ACCESS TO AFFORDABLE PHARMACEUTICALS ACT OF 2001--Motion To 
                                Proceed

  Mr. DASCHLE. Having disposed of the banking legislation, it is now 
our intent to turn to the whole issue of prescription drugs. We will 
deal with both cost containment as well as Medicare benefits. The bill 
passed out of the Labor Committee, S. 812, Calendar No. 491, will be 
the vehicle for our debate.
  It is my intention now to ask unanimous consent the Senate proceed to 
the consideration of Calendar No. 491, S. 812, to provide greater 
access to affordable pharmaceuticals at 10:30 a.m., Tuesday, July 16.
  Mr. GREGG. This bill was reported out of the committee on which I am 
ranking member. At the time it was reported out, which was last 
Thursday--so it has been a very quick turnaround and no report has been 
filed on the bill--there was an understanding within the committee that 
there would be two issues resolved before it came to the floor. One 
involved bioequivalency and the other involved the 45-day rule.
  There are other issues with the bill. There are other issues which 
may require further work, but those two issues need to be resolved 
before this bill comes to the floor. As I believe was the understanding 
when the bill was passed out of committee, it would be passed with 
those being resolved before it got to the floor.
  I understand it is being moved to the floor quickly to be the vehicle 
addressing the other issues involved in drug coverage.
  The bill itself has some very strong points in it; I have drafted a 
fair amount of it so I recognize that. But at this time I have to 
object to the motion to proceed.
  The PRESIDING OFFICER. Objection has been heard.
  Mr. KENNEDY. Will the Senator yield?
  Mr. DASCHLE. I am happy to yield.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  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.
  The PRESIDING OFFICER. The majority leader.
  Mr. GREGG. Will the Senator yield for a question?
  Mr. DASCHLE. I think I retain the floor. I will be happy to yield to 
the Senator from New Hampshire.
  Mr. GREGG. Yes. That is why I was asking.
  The question is this--rhetorical in nature. Unfortunately, in order 
to reach an agreement, you have to have both sides agree. Senator 
Frist, who is concerned about the bioequivalency, has not agreed to the 
language. I have not agreed to the 45-day language. I am sure it could 
be worked out, and worked out rather promptly, so we would not have to 
go through the exercise of delaying this bill, and I would be happy to 
do that. But until we have worked out that issue, I have to reserve my 
rights and object to the proceeding.
  The PRESIDING OFFICER. The majority leader.
  Mr. DASCHLE. Mr. President, obviously, I am disappointed. I looked at 
the vote. I think it was 16 to 5--similar in magnitude, on a bipartisan 
basis, to the Sarbanes bill that passed out of the Banking Committee. 
We ended up with a unanimous vote on the floor.
  I hope we can get the same kind of unanimity ultimately on this 
legislation. But a 16-to-5 vote would seem to me to indicate very 
strong bipartisan support for this legislation as well. Senators are 
welcome to offer amendments. We oftentimes negotiate issues on the 
floor and accommodate Senators' concerns, both in the managers' 
amendment as well as in individual votes. So we will certainly have 
that opportunity once again.
  I have no doubt if there is an interest in resolving these 
outstanding questions, we ought to be able to do so. But we do need to 
move on. That was my hope, that we could lay the bill down and begin 
the debate and have these discussions.


                             Cloture Motion

  Mr. DASCHLE. Mr. President, I have no choice, of course, but to move 
to proceed to Calendar No. 491. I send a cloture motion to the desk.
  The PRESIDING OFFICER. The cloture motion having been presented

[[Page 12982]]

under rule XXII, the Chair directs the clerk to read the motion.
  The legislative clerk read as follows:


                             Cloture Motion

       We, the undersigned Senators, in accordance with the 
     provisions of rule XXII of the Standing Rules of the Senate, 
     do hereby move to bring to a close the debate on the motion 
     to proceed to Calendar No. 491, S. 812, the Greater Access to 
     Affordable Pharmaceuticals Act of 2001:
         Senators Harry Reid, Jon Corzine, Byron L. Dorgan, Ron 
           Wyden, Maria Cantwell, Paul Sarbanes, Debbie Stabenow, 
           Dick Durbin, Thomas Carper, Tom Daschle, Jack Reed, 
           Daniel K. Akaka, Kent Conrad, Zell Miller, Charles 
           Schumer, Ernest Hollings, and Hillary Clinton.
  The PRESIDING OFFICER. The majority leader.
  Mr. DASCHLE. Mr. President, I ask unanimous consent that Senators 
Lincoln and Hutchinson have the opportunity to speak for up to 8 
minutes each with respect to the Smith nomination, to appear at the 
appropriate place in the Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. DASCHLE. I yield the floor.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  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. SCHUMER. Will my colleague yield for a question?
  Mr. KENNEDY. Yes.
  Mr. SCHUMER. I thank my colleague from Massachusetts who has been 
such a great leader on this issue. I guess, as I understand it, our 
friend from New Hampshire has objected to moving forward.
  We have spent a very long time talking about this issue--of course 
the issue of availability of drugs, and of course the issue of the cost 
of drugs but even the specifics of the generic drugs.
  We had extensive hearings on this bill 10 weeks ago or 8 weeks ago. 
There has been a great deal of discussion. This is not a last minute 
something that someone wrote on the back of an envelope and said here, 
take it. There has been tremendous discussion on this issue. There are 
differences of opinion. That is fair. That is legitimate. That is why 
we have a Senate.
  But to prevent the bill from moving forward when the cost of drugs 
goes through the roof, when the people are clamoring for us to bring 
down those costs, and when there is a proposal that passed in a very 
bipartisan way in Senator Kennedy's committee, it just strikes me as 
missing the forest for the trees--the forest being the great need to do 
something and the trees being the details that we should be debating on 
the floor in open debate.
  I will just say to my colleague that I am as disappointed as he is--
maybe not quite as disappointed; nobody works harder than he does on 
bringing these issues to the floor, but almost as much.
  Is this something that is brand new? Where do these objections come 
from? These are issues that we have discussed and agreed on. It is my 
understanding that the Senator from New Hampshire simply didn't have 
the votes when he decided not to bring forward his amendments when the 
committee marked up.
  Is that a correct or an unfair characterization?
  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.

[[Page 12983]]

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. HUTCHINSON. Will the Senator yield?
  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. HUTCHINSON. I ask the Senator from Massachusetts. I pose the 
question because as a member of the committee and someone who was very 
glad to join in a positive way the bipartisan vote for the legislation, 
it was my clear understanding as we came to that decisive vote that a 
point was reached in working out the two outstanding issues which 
Senator Gregg mentioned in his objection. There is no desire on 
anybody's part to slow this legislation down. But it was with the 
understanding that there would be that agreement.
  While it seems the issues are relatively minor and that it can be 
done in a very expeditious way, the fact is that Senator Frist and 
Senator Gregg have not yet signed off on that language.
  So I can't stand here and listen to my colleagues being characterized 
as obstructing the progress of this legislation when in fact they want 
to honor the agreement that was made at the time that bipartisan vote 
took place.
  I ask the chairman if that is his recollection of the vote that 
occurred.
  Mr. KENNEDY. No. The Senator has not understood correctly. I will 
stand by the record. There was never a conditioning of reporting this 
out for an agreement. I have been either chairman or ranking member for 
some period of time. I know those words are stated. But there was never 
a conditioning of reporting out based upon getting agreement. I would 
not have accepted that. This is too important. There was not a 
difference.
  You will find that the language we have included with regard to 
biologics basically is a restatement of what Senator Frist said. If it 
isn't, I am glad to make that kind of adjustment. What we did say--as 
we say in virtually the passage of all legislation--is that we will 
authorize technical corrections to be made by the staff.
  If you have an agreement in principle, you do not have a difference. 
We have an agreement in principle.
  If this language isn't carried forward--and it is language which I 
believe should be--give us the language, and we will work on it 
tonight. But I think to delay something that is as important as this is 
not justified. This subject matter is too important to families in my 
State, as I am sure it is in Arkansas. That is why I am surprised the 
Senator from Arkansas is standing with the Senator from New Hampshire 
and urging delay of this legislation, because it is of such importance. 
I welcome the fact that he supported it, but we want to get on with 
this legislation. And I think the sooner we can get on it, the better.
  If the Senator wants to work with us and be the agent for the other 
Senators and work through the evening, we would welcome his 
intervention in doing that because we want to get on it.
  I would be glad to yield to the Senator from Michigan. Then I would 
be glad to yield the floor and let the Senator speak.
  Ms. STABENOW. I thank you the Senator.
  First, I commend our chairman, Senator Kennedy, for his work in 
bringing this important bill to the floor. I also commend Senator 
Schumer for his leadership.
  I say to my friend from Massachusetts, it is my understanding the 
leader, because of the importance of the issue of not only lowering 
drug prices for everyone but providing Medicare coverage for 
prescription drugs, has actually allocated up to 2 weeks on this 
subject. I would assume we would have ample opportunity to work out any 
issues and problems that colleagues would have on the other side of the 
aisle.
  But the clock is ticking on the 2 weeks. The sooner we can get to the 
bill, the sooner we can begin to move through a number of different 
amendments to be able to get this bill in good shape, to be able to 
deal with a number of issues, such as those that deal with increasing 
competition and providing Medicare coverage, and so on.
  This is so critical that our leader has, in fact, allocated 2 weeks. 
So I am very surprised that our colleague from New Hampshire would stop 
even the beginning of the debate when he knows that it is not a 1-day 
debate. We are talking about having 2 weeks and as many hours as it 
takes in that time to be able to work out all of the kinks and to be 
able to get it right.
  I know, coming from Michigan today, working and being in Battle Creek 
at a senior center and in Kalamazoo at a senior center, that they are 
watching us very closely. We have had a lot of talk, and if talk bought 
medicine, people would have a lot of medicine.
  It is time to act. I commend the chairman of the committee for 
acting. I am looking forward to working with him.
  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.
  The PRESIDING OFFICER. The Senator from New York.
  Mr. SCHUMER. Mr. President, I will be brief.
  First, a specific point. One of the objections was on the language 
for what we call bioequivalence. In other words, what makes the drug 
the same drug? I am not a member of the committee, but I sat there as 
Chairman Kennedy presided. As I recall, there was a consensus on that 
issue, which was, let us codify what the FDA does now.
  That is what the language was supposed to do. There was not supposed 
to be a change. There was not supposed to be a wrinkle. There was not 
supposed to be anything different. And now, all of a sudden, we are 
hearing an objection based on that provision. I do not quite understand 
it because there was some discussion early on in the bill that the 
Senator from Arizona and I introduced about whether bioequivalence was 
the same. We intended it to be the same, but we were silent. Adding 
this provision just clarified it.
  So there is no new change here, none. To not move forward on the bill 
on that basis, when there seems to be a complete meeting of the minds 
of what to do, does not make sense.
  The second point is this, and both my colleague from Massachusetts 
and my able colleague from Michigan, who has

[[Page 12984]]

been such a leader on this bill, have made it clear: The people are 
waiting. Every day, every minute, someone--a senior citizen, a family 
with a child who is ill--approaches the prescription drugstore counter 
with trepidation wondering what that bill will be.
  They want the best drugs for themselves and their loved ones. Yet 
they are afraid they cannot afford it. They are afraid it means not 
paying the rent. They are afraid it will mean not buying gasoline for 
their car.
  Here we have a solution. I would not say it is the most breathtaking 
solution. I would like to see prescription drugs added to Medicare. We 
are going to have a big fight about that. But it is a solution that 
makes a real difference, that reduces prices on a large number of 
drugs, that has some consensus, that does not get into the free market 
versus price control argument that has plagued us as we have tried to 
come to some kind of agreement.
  So we have a proposal. We are ready to debate it. The majority 
leader, realizing its importance, has given us plenty of time. And the 
first thing we hear is objection to moving forward.
  Again, as Senator Kennedy has said, I am willing, as a sponsor of the 
bill, to be amenable. The more, the merrier. I do not want a partisan 
victory. I want to get something passed. We have spent a long time 
trying to work this out, and it is complicated. We know that. But when 
I hear the first thing done is objection to proceeding--as opposed to 
somebody calling up the chairman or myself and saying, what did you 
really mean by this? Shouldn't we dot the i's, cross the t's, and put 
together an amendment?--I get a little worried.
  So I hope this is not an indication of anything in the future. I hope 
this is an indication that we can try to come together, despite some of 
our differing views, to work on how to reduce the costs of these 
wonderful drugs that are so expensive and together bring up a good 
bill.
  With that, Mr. President, I yield the floor.
  Mrs. LINCOLN. Mr. President, I rise to applaud the majority leader 
for his attempt to bring forward this possible solution to help our 
elderly address the enormous problem that seniors face in drug costs 
and in getting prescription drug care, to use that bill and that tool 
of generics and others to try to assist our seniors in dealing with the 
phenomenal cost and concerns they have in being able to provide for 
themselves the prescription drugs they actually need for the quality of 
life we all know they deserve.
  We all have parents and grandparents, we have neighbors and loved 
ones who are suffering from the unbelievable dealings of the increase 
in cost of prescription drugs. For us in Arkansas, where we don't have 
many tools at all; we have lost all of the Medicare+Choice plans that 
served Arkansas. The last two or three left in December, none of which 
provided a prescription drug package, which means our seniors in 
Arkansas are basically subsidizing other seniors across this country in 
their tax dollars. Other seniors in other areas, where a 
Medicare+Choice plan fits can actually get a prescription drug package 
because our seniors are subsidizing that. So our seniors in Arkansas 
are paying top dollar, more than you or I or anybody else who has 
insurance or who has a program like Medicare+Choice or something else, 
a Medigap program that is helping to pay for that, are paying more than 
anybody else for prescription drugs.
  That is unheard of. Sixty percent of our seniors in Arkansas tend to 
need more prescription drugs because, unfortunately, their availability 
to health care is less. The other thing is their availability to 
prescription drugs out in rural areas is a lot more difficult. These 
are people who need assistance. They don't need, as Senator Stabenow 
mentioned, a lot more discussion, a lot more talk, and a lot more 
promises. What they need is action.
  Unfortunately, what happened tonight was a roadblock that would 
prevent the kind of action we need in moving forward. We have 2 weeks 
to debate and talk about the initiatives here for the generics bill and 
some of the other proposals for prescription drugs but to move this 
debate forward. That is what seniors are waiting on; they are waiting 
on a solution. But more importantly, they are waiting on us to begin 
the debate. Unfortunately, that is what was stopped tonight.
  I hope we can all come together and work out whatever differences 
they may have found from the committee, a bill that passed out in a 
bipartisan way, but work those details out, hopefully tonight, so maybe 
we can bring forward, without having to go through the unusual 
procedural cloture motion to bring something up, that we can begin the 
debate in earnest and begin to honestly look at the ways we can help 
the seniors of the Nation.
  I yield the floor and suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. BROWNBACK. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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