[Congressional Record Volume 143, Number 123 (Tuesday, September 16, 1997)]
[Senate]
[Pages S9360-S9363]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 
                                  1997

  The PRESIDING OFFICER. The Senate will now resume consideration of S. 
830, with the time until 10 a.m. to be equally divided.
  The clerk will report.
  The assistant legislative clerk read as follows:

       A bill (S. 830) to amend the Federal Food, Drug, and 
     Cosmetic Act and the Public Health Service Act to improve the 
     regulation of food, drugs, devices, and biological products, 
     and for other purposes.

  The Senate resumed consideration of the bill.
  Mr. JEFFORDS addressed the Chair.
  The PRESIDING OFFICER. The Senator from Vermont is recognized.


            Modified Committee Substitute Amendment No. 1130

  Mr. JEFFORDS. Mr. President, I yield myself such time as I may 
consume.
  Mr. President, we are here to discuss yet again the need for cloture 
on S. 830, the FDA Modernization and Accounting Act. We have already 
had 14 hours of floor debate on this measure and we have not yet 
discussed this amendment. This will be the second time that cloture has 
been voted on regarding this measure. The first vote was 89 to 5 to 
invoke cloture. The Senate has spoken. And, yet, we are here to repeat 
ourselves again and again.
  My colleagues have already heard repeatedly from both sides of the 
aisle about the strong bipartisan commitment to crafting this measure, 
about the months of negotiations, deliberation and collaboration with 
the administration, the minority, and outside groups. Literally dozens 
of accommodations have been made and agreements reached. No one 
disputes that this is a good bill. No one should dispute that we have 
moved forward, or that we should move forward, with our debate on the 
remaining issues. Now we should move forward on that debate.

  This measure accomplishes two very important objectives. First, it 
modernizes the way that the Food and Drug Administration accomplishes 
its mission. It streamlines the review and approval process for medical 
devices, pharmaceutical, and biological products. In so doing, it helps 
to ensure that the best and safest medical technology available in the 
world would be available to the American people. In so doing, it helps 
ensure that the best medical technology jobs will continue to be 
available for the American people.
  Second, this measure authorizes the Prescription Drug User Fee Act--
or PDUFA, as it is known. Everyone agrees that PDUFA has been immensely 
successful in helping FDA do its job better and more efficiently.
  Mr. President, congressional authorization for PDUFA expires in 15 
days. At the end of September this successful and innovative program 
will be at serious risk. It is the height of irony that a program like 
PDUFA that was designed to reduce delay at the FDA is now at risk of 
becoming bogged-down in a procedural delay on the Senate floor.
  I would argue that the time for delay is over, and that the time for 
the Senate to do its work it was sent here to do is now.
  Almost 50 amendments have been filed on this measure. And, frankly, 
virtually all of them are nongermane, or they have been worked out, or 
they can be worked out. A single provision remains that may require 
some extended debate, and we should move to its consideration and an 
up-or-down vote on it as soon as possible.
  Last week we spent almost 15 hours talking about uniformity for 
cosmetics. We have an agreement on that provision, thanks to the 
efforts of Senator Gregg.
  I say that we should move on. I say we complete this debate, and 
finish this measure, and let's vote.
  Mr. President, I yield the floor.
  Mr. KENNEDY addressed the Chair.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, with all due respect to my friend and 
colleague, the majority leader, the fact of the matter is by the votes 
that we had last week requiring that we have some opportunity to 
examine a very important provision--and that is the preemption of 
various States' ability to protect their public--we have seen a rather 
dramatic change in the language of the provision that will continue to 
permit the States to protect their public. That was very important for 
the protection of the American public. I know that there are some 
people around here who want to see the trains run on time. But some of 
us--not only those of us here but the National Governors' Conference, 
the public health organizations, the women's network organizations that 
deal with women's health issues--a wide range of consumers believe, 
quite deeply, that we are absolutely within our rights to make sure 
that this provision was offered and changed, and we did so. And, by 
doing so, the public health interest is preserved.
  Now here we are on the floor of the U.S. Senate the morning after 
having seen the headlines from two national journals--yesterday in the 
Wall Street Journal, talking about a particular prescription drug 
called fen/phen, that had been moved through, rushed through the FDA. 
It has been linked to everything from brain damage in animals to 
primary pulmonary hypertension; a rare but fatal lung disease; millions 
of Americans tried the drugs to slim down; some 60 million people 
worldwide were estimated to have taken the drug; the straw that broke 
the camel's back was a heart valve problem which now has been widely 
recognized.
  Here is an item in the Washington Post. Two diet drugs are pulled off 
the market. Why? Because the products were used for purposes for which 
the drug was not approved.
  We are talking about an identical provision in this body with regard 
to medical devices--the use of the medical device for purposes for 
which it has not been approved.
  We have seen the whole world being awakened to this particular health 
problem. Some of us are trying to making sure that we don't have 
headlines like this in 3 months, 4 months, or 6 months with regard to 
the medical device issue. That is what we are talking about.
  Mr. President, I would just point out that there are about six little 
words that, if the majority would be willing to accept, would move us 
right ahead, and get us very short time agreements on the other 
elements.
  Let me just point out. Mr. President, there are the two provisions 
with regard to medical devices--one they call class II--devices which 
represent about 5 percent of the devices. Those are the new devices.

[[Page S9361]]

  In the language of this bill, it says, whether or not there is 
reasonable assurance of safety effectiveness, if the proposed labeling 
is neither false nor misleading.
  ``Neither false nor misleading,'' that is in regard to class III 
devices. But, if you look at class I and II devices with regard to the 
representations that are made involving the FDA, there is no such 
language.
  If the majority will take the language that we propose for class III 
and apply that to class I and II, we will call this cloture vote off. 
What person in the United States of America wants to permit medical 
devices to be approved if we cannot have agreement by the manufacturers 
that their statements to the FDA reflect the true uses for the devices?
  My goodness, are we in that big of a hurry? That is why this issue is 
important. Now, the majority leader says we have just one more item. We 
are glad to deal with this issue, and we have offered compromise 
language to deal with it. It is of vital importance and we will have a 
chance later to discuss the health hazards associated with it. The 
medical device industry, which has been enormously cooperative in 
working out other provisions on this, had refused to go along with our 
proposed language. Medical device labeling has important health 
implications.
  You can rush this through and say the rest of the bill is fine. It is 
fine. Senator Jeffords and his Republican colleagues deserve great 
credit. My Democratic colleagues deserve great credit. But do we have 
to be reminded again that the FDA has the responsibility for the 
protection of the public health. If we do, we don't need to look any 
father than reading this mornings newspapers. All we are saying is 
let's not do with medical devices what was done with regard to these 
diet medicines. I think that is an important health matter. So do the 
overwhelming majority of patient coalitions and public health 
coalitions.
  If the industry wants to debate that, we are going to take the time 
to debate it. If there are Members on the floor of the U.S. Senate who 
want to take the position that we don't need this change in the bill 
language on medical device regulation, let them make that case on the 
floor of the U.S. Senate. Because that is the case they are going to 
have to make, because the amendment has been filed. If the majority 
indicates they will accept that, that's all fine and well. Our 
amendment will ensure that FDA is able to comprehensively examine the 
safety of medical devices. We will move through this legislation very 
rapidly indeed. But this is one Senator who is not prepared to roll 
over on that issue. We will have the opportunity during the course of 
this morning or this afternoon or tonight or tomorrow, or however long 
it takes, to go through the various instances where medical device 
labeling could pose an important and significant public health threat, 
a threat to the American people.
  There may be those who do not think this is an important issue. I 
believe the overwhelming majority of the American public will think so. 
As they are reading their papers this morning and listening to those 
who say, let's rush this bill on through, I would think some Americans 
would say, let's take another look at what we have in this legislation, 
particularly with regard to the medical device provisions.
  Mr. President, with all respect to my friend and colleague, we have 
talked about this. Senator Durbin has talked about sections 404 and 
406. This particular issue is the key issue.
  If we can get the language in the bill ensuring that we will not 
permit the medical device industry to restrict the FDA's ability to 
make a full study of medical device safety, I think we would move ahead 
with the legislation.
  I withhold the remainder of my time.
  The PRESIDING OFFICER. Who yields time?
  Mr. JEFFORDS. Mr. President, I must answer that charge.
  The PRESIDING OFFICER. The Senator from Vermont.
  Mr. JEFFORDS. To inflame this issue into being one of false 
information and filing of misleading information is totally incorrect. 
The issue here is not that. The issue here, on each of these medical 
devices, is whether or not they must file every conceivable, possible 
use that FDA thinks might be made of it. FDA should focus rather on the 
use that it is intended for or any other use that the manufacturers 
know it will be intended for. There is nothing involving false or 
misleading information. That, of course, is under the control of the 
FDA and that would be a serious matter with the FDA. It could, and 
should deny approval of a device where a manufacturer deliberately 
files false and misleading information.

  Let us set the record straight. Manufacturers cannot file false and 
misleading language. To raise that as the issue is to really differ 
from what the important issue is, and that is how long do Americans 
have to wait to get access to important, new medical devices. In Europe 
it takes much less time and it is much more expeditiously handled. We 
can have the same kind of treatment here while ensuring that they are 
safe and effective for their intended use. For any device that is 
intended for a particular use and it is known by doctors to be 
effective for another use, that's fine. That is the practice of 
medicine. Doctors sometimes find other, valuable uses for medical 
devices. That is how medical practice and innovation proceeds--and we 
don't want the Federal Government telling doctors how to practice 
medicine.
  But for the manufacturer to search out every conceivable use and then 
to study every conceivable possible use ends up in delays of these 
devices coming onto the market. That means that Americans, doctors and 
patients, are unable to utilize medical innovations that are more 
readily available in Europe. So I wish we would get away from making 
this into a ``false and misleading language'' filing. There is no such 
issue here as that. The question is how much right does the FDA have to 
require a manufacturer to understand and get involved with the practice 
of medicine where some other use might be made. That is the issue.
  I think there are ways we can solve this, but not just by raising it 
to the issue of emotionalism. That is not the solution here. There is 
no problem having false or misleading information filed on a medical 
device approval application, because that is against the law. I yield 
the floor.
  Mr. KENNEDY. Mr. President, how much time do we have?
  The PRESIDING OFFICER. The Senator from Massachusetts has 2 minutes 
32 seconds remaining.
  Mr. KENNEDY. I yield the remaining time to the Senator from Iowa. I 
think we will have more time later.
  Mr. HARKIN. I thank the Senator for yielding. Let me agree with 
Senator Kennedy on this issue. The stories in the paper this morning 
ought to alarm us all about the need to proceed very cautiously and 
very carefully about what we are doing. I spent a lot of time looking 
at devices. I had amendments on the bill itself, when it was in 
committee, on devices. The FDA has the authority now, if a device is 
used for a certain purpose, to make sure that there are not misleading 
or false advertising proposals. But when they want to use the device 
for a purpose for which it is not intended, there is nothing in the 
bill to prohibit that. That is what we are talking about, and I think 
we have to proceed very cautiously and carefully here.
  Mr. President, I did want to talk about another issue. I thank 
Senator Jeffords and Senator Kennedy for their hard work and leadership 
on this bill. I think we all agree we need some reform of FDA. I have 
been in favor of that. We need to streamline the processes. I agree 
with Senator Jeffords in that regard. There are many positive 
provisions in this bill.


 Amendment No. 1137 to Modified Committee Substitute Amendment No. 1130

  (Purpose: To establish within the National Institutes of Health an 
    agency to be known as the National Center for Complementary and 
                         Alternative Medicine)

  Mr. HARKIN. Mr. President, I am disappointed, however, that an 
essential element was not included. A major goal of FDA reform was to 
include access to medical innovations without compromising public 
safety. I have an amendment, amendment No. 1137, which speaks to that. 
I would like to call up that amendment at this time and ask for its 
immediate consideration.
  The PRESIDING OFFICER. The clerk will report.
  The legislative clerk read as follows:

       The Senator from Iowa [Mr. Harkin], for himself, Mr. Hatch, 
     Mr. Daschle, and Ms.

[[Page S9362]]

     Mikulski, proposes an amendment numbered 1137 to modified 
     committee substitute amendment No. 1130.

  Mr. HARKIN. Mr. President, I ask unanimous consent that reading of 
the amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (The text of the amendment is printed in today's Record under 
``Amendments Submitted.'')
  Mr. HARKIN. Mr. President, further, I ask unanimous consent that this 
amendment be in order, notwithstanding any vote on cloture.
  The PRESIDING OFFICER. Is there objection to the request?
  Mr. JEFFORDS. I reserve the right to object. What is the regular 
order here with respect to amendments?
  The PRESIDING OFFICER. Amendments are in order to both the substitute 
and the bill.
  Mr. JEFFORDS. At this time, prior to cloture?
  The PRESIDING OFFICER. Amendments may be called up prior to the 
cloture vote.
  Mr. HARKIN addressed the Chair.
  The PRESIDING OFFICER. Is there objection to the request?
  Mr. JEFFORDS. I object at this time.
  The PRESIDING OFFICER. Objection is heard. The Senator from Iowa has 
the floor.
  Mr. HARKIN. Mr. President, how much time do I have remaining?
  The PRESIDING OFFICER. The Senator has 15 seconds.
  Mr. HARKIN. Mr. President, this is cosponsored by a number of 
Senators on both sides of the aisle, Senators Hatch, Daschle, Mikulski, 
myself, and a number of Senators on both sides of the aisle. I don't 
believe it is going to be objected to.
  However, we are facing the problem of cloture. That's why I asked for 
unanimous consent. I am sorry the manager of the bill would not allow 
this amendment to be in order.
  The PRESIDING OFFICER. The Senator from Vermont controls the 
remaining time.
  Mr. JEFFORDS. How much time do I have remaining?
  The PRESIDING OFFICER. The Senator from Vermont has 5 minutes 26 
seconds remaining.
  Mr. JEFFORDS. I yield the remaining time to Senator Coats.
  The PRESIDING OFFICER. The Senator from Indiana.
  Mr. COATS. Mr. President, I don't need all the 5 minutes. I would be 
happy to yield back to the Senator from Vermont to wrap up before the 
cloture vote. It is unfortunate that we are in this position again. We 
had a substantially bipartisan, overwhelming vote to invoke cloture on 
the motion to proceed. I believe the vote was 89 to 5. I think that 
indicates a very broad level of support for the need to move forward 
with this legislation that was 2\1/2\ years in the making. There is 
obviously a widespread, general consensus that FDA reform is necessary 
to provide better protection for the health and safety of Americans and 
to provide access to drugs and devices that Americans have been denied 
due to delays at FDA. We are trying to expedite that process. We are 
trying to bring in expertise from outside to help FDA, whether it is 
through the tax that is levied on prescription drug companies that goes 
to hire additional workers and provide additional resources for FDA, or 
whether it is for outside agencies, certified by FDA, to help them in 
the process of reviewing this tremendous backlog of applications for 
health-improving, and in many cases lifesaving, devices and drugs.
  What we are trying to do here is give FDA the kind of support and 
resources it needs, along with a pretty good shove in the right 
direction, to bring our agency up to world class standards and up to 
the task of effectively dealing with this exciting explosion of 
technology through which the American people can reap great benefits.
  I regret once again we have to go to a cloture vote. We just ran into 
a problem here, procedurally, with the amendment, the Senator from Iowa 
fearing that cloture would cut off his ability to offer a relevant 
amendment under cloture. I would say to the Senator from Iowa, none of 
us really wants to go to cloture. But in order to move this bill 
forward, it appears that we have to invoke cloture once again.
  I know under the rules of cloture, it limits the amendments as to 
relevancy. No one in favor of FDA reform wants to keep going through 
this process of invoking cloture, but unfortunately we have to do it in 
order to move the bill forward.
  Again, 2\1/2\ years in the making, there were extensive hearings in 
the Labor Committee, efforts on a bipartisan basis to resolve problems 
and disputes, votes in committee, negotiations post-committee action, 
30-some concessions or modifications in response to concerns that were 
raised postcommittee on this. So, none of us here supporting and 
promoting the movement forward of this legislation is trying to delay 
anything. We are just trying to expedite it. Nor are we trying to say, 
``Our way or no way.'' There has been extensive negotiation, extensive 
accommodation, extensive work to move this bill forward in any way that 
we possibly can.
  So I urge my colleagues, as we did a week or so ago, I urge my 
colleagues to vote with us on cloture. We have no other choice, other 
than lengthy debate over items and issues that have been discussed over 
and over and over and voted on and negotiated. Clearly, we know where 
the Members of the U.S. Senate stand, both Republicans and Democrats, 
liberals and conservatives. There is about as widespread support for 
this reform bill as any major legislation that has come before the 
Senate as long as I have been in here, for 9 years. It is time to move 
forward. Regretfully, we have to do it once again with a cloture 
motion.
  I urge my colleagues to help us move this very needed and very 
important legislation the next step forward.
  I yield back any remaining time I have to the Senator from Vermont.
  The PRESIDING OFFICER. The Senator from Vermont.
  Mr. JEFFORDS. Mr. President, as to the Senator from Iowa, I apologize 
that we are in an awkward situation this morning. I have assured him 
that we will have a hearing in October on NIH with respect to 
alternative forms of medicine. I look forward to that because I agree 
with him on that issue.


                      Unanimous-Consent Agreement

  Mr. JEFFORDS. Mr. President, I ask unanimous consent that the 
previously scheduled cloture vote be postponed to occur at 12:15 p.m. 
today, and further, that second-degree amendments may be filed up to 10 
a.m. this morning. I further ask consent that following debate this 
morning regarding the FDA reform bill, the Senate resume consideration 
of the Interior appropriations bill until the cloture vote.
  The PRESIDING OFFICER. Is there objection?
  Mr. KENNEDY. Mr. President, reserving the right to object, I do not 
object to moving the vote to 12:15 today. I understand the leader wants 
to get to the Interior appropriations bill. I do not want to unduly 
delay that provision. However, it says under the proposal, ``I ask 
consent that following the debate this morning regarding the FDA reform 
bill, that the Senate resume * * *.'' We would like to have at least a 
limited period of time. I know the Senator from Iowa wanted to speak. I 
was wondering if we can at least get a half hour debate on the FDA 
reform bill before finishing. It says here, ``I further ask consent 
that following the debate this morning,'' I was wondering whether 
``following the debate'' could go until 10:30?
  Mr. LOTT addressed the Chair.
  The PRESIDING OFFICER. The majority leader.
  Mr. LOTT. Mr. President, under the circumstances, I reserve the right 
to object since an additional proposal has been made here. Can I 
inquire of the Senator from Massachusetts exactly what he is proposing 
to add here?
  Mr. KENNEDY. The Senator from Iowa wanted to be heard on a matter. I 
wanted to speak just briefly to clarify the record. I was wondering if 
we can divide  that  time  between  now  and 10:30--we took up some of 
the time between 9:30 and 10 for debate and discussion--and then go to 
Interior.
  Mr. LOTT. Mr. President, further reserving the right to object, we 
are moving at this time to accommodate one of our Senators who has a 
health problem right now. It does disrupt the whole schedule. We have 
work we need to do on Interior appropriations. If we delay it further 
and then come back to it and have to go off it at 12:15, it just 
confuses and complicates the whole process.

[[Page S9363]]

  We have asked the managers of the Interior appropriations bill--now 
we have interrupted them--to come to the floor. They are scheduled to 
be on the floor. I know the Senator from Iowa is working to try and get 
an amendment included. I feel confident that will be done at some 
point. At this time, I have to object to the expansion of the unanimous 
consent request that was offered by the Senator from Massachusetts and 
support the request that was made by the Senator from Vermont.
  The PRESIDING OFFICER. Is there objection?
  Mr. KENNEDY. Mr. President, under those circumstances and to 
accommodate the Member, I will not press this, although I do think we 
will have an opportunity to address these issues later in the morning.
  The PRESIDING OFFICER. Without objection, it is so ordered.

                          ____________________