[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.
____________________