[Congressional Record Volume 143, Number 128 (Tuesday, September 23, 1997)]
[Senate]
[Pages S9737-S9754]
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 (Mr. Hutchinson). Under the previous order, the 
Senate will now resume consideration of S. 830, which 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 foods, drugs, devices and biological products, 
     and for other purposes.

  The Senate resumed consideration of the bill.
  Pending:

       Jeffords amendment No. 1130, in the nature of a substitute.
       Harkin amendment No. 1137 (to amendment No. 1130), 
     authorizing funds for each of fiscal years 1998 through 2000 
     to establish within the National Institutes of Health an 
     agency to be known as the National Center for Complementary 
     and Alternative Medicine.
       Durbin amendment No. 1140 (to amendment No. 1130), to 
     require that entities and individuals accredited to conduct 
     review of device notifications be subject to the conflict of 
     interest standards that apply to employees of the Food and 
     Drug Administration.
       Durbin amendment No. 1139 (to amendment No. 1130), to 
     eliminate provisions relating to the discretion of the 
     Secretary of Health and Human Services to track devices or to 
     conduct postmarket surveillance of devices.


                           Amendment No. 1140

  The PRESIDING OFFICER. The Senate will now resume consideration of 
the Durbin amendment No. 1140 with 2 minutes of debate prior to the 
vote.
  The Senator from Illinois.
  Mr. DURBIN. Mr. President, thank you for recognition this morning and 
the resumption of our consideration of this important bill.
  Amendment No. 1140, which I have offered, is an amendment that I 
think is absolutely essential if this bill is to be airtight. We are 
giving to outside laboratories the authority to review and approve 
medical devices, medical devices which literally could mean life or 
death for millions of Americans.
  When these approvals are given, these companies stand to make 
substantial profits because of FDA approval. The Durbin amendment 
corrects a serious error in this bill by making certain that there will 
be no conflict of interest by the third-party reviewers. We say in 
specific terms that those reviewing the medical devices cannot receive 
gifts from the company that is the owner of the medical device, they 
cannot receive or own stock of the company that they are reviewing, 
they cannot have been offered a job or solicited a job from the company 
that they are reviewing, and there must be a full financial disclosure.
  If we are going to maintain the integrity of the process, protect 
American consumers, and avoid this sort of conflict of interest, I urge 
my colleagues to adopt the Durbin amendment.
  Mr. JEFFORDS. Mr. President, the Senator's amendment at best 
duplicates the third-party conflict-of-interest protections in the bill 
and at worst unnecessarily constrains the agency. The ranking minority 
member, Senator Kennedy, and the FDA join me in opposing this 
amendment.

[[Page S9738]]

  Section 204 of the bill provides a full statutory directive to the 
agency adopt measures within 180 days of enactment to prevent conflicts 
of interest that may be involved with both an individual reviewer and 
with the reviewing organization. As with Senator Durbin, this was a 
critical concern for members of the committee.
  Section 204 provides full discretion to the agency to develop 
appropriate standards. The agency will not be limited in any way in 
developing these guidelines. In fact, the agency has already developed 
extensive conflict-of-interest guidelines as part of its existing 
third-party program, including protections from situations such as if 
the third party or any of its personnel involved in 510(k) reviews has 
any ownership or other financial interest in any medical device, device 
manufacturer, or distributor.
  The Senator's concerns have caused us to reexamine the important 
issue of preventing conflicts of interest. We commend him for doing so, 
but I urge a no vote.
  Mr. FEINGOLD. Mr. President, I am pleased to join my friends and 
colleagues, Mr. Durbin of Illinois and Mr. Johnson of South Dakota, in 
cosponsoring amendment No. 1140. This amendment will ensure that 
private, third-party reviewers of class I and II medical devices will 
be subject to the same conflict-of-interest restrictions that federally 
employed reviewers are.
  Under current law, employees of the Food and Drug Administration who 
review drugs and medical devices are subject to strict regulations 
governing their interaction with the companies whose products they are 
reviewing. They are not allowed to accept gifts from such companies. In 
addition, they cannot designate other persons to accept gifts on their 
behalf. Another important restriction prohibits reviewers from having a 
financial interest in any company whose products they are reviewing.
  Mr. President, these are commonsense measures which help to maintain 
the public's confidence in the safety of our Nation's drugs and 
devices. The pharmaceutical and medical device industries command 
billions of dollars every year. We live in a world in which FDA 
approval can mean immediate and enormous profits for investors. In such 
an environment, it is absolutely critical that the Government be 
vigilant in its responsibility to ensure that applications are reviewed 
thoroughly and in an unbiased manner.
  We all know people--family members and friends--whose health, and 
even lives, rely on important medication and devices. There are few 
jobs more significant than assuring the safety and efficacy of these 
items. In my mind, Mr. President, this is a role--protecting health and 
safety--that is best served by Government, rather than by the private 
sector. However, the bill before us takes a different view, and 
establishes a large-scale pilot project to allow private sector review 
of medical devices. If we are to take this step, it is absolutely 
critical that we subject those private sector reviewers to the same 
conflict-of-interest restrictions that Government reviewers are subject 
to.
  The amendment sponsored by the Senator from Illinois would do just 
that. It would say to private sector reviewers, ``You cannot own stock 
in any company whose product you review. You cannot accept any gifts 
from a company whose product you review, and you cannot designate any 
other person to receive such a gift.'' That's it. Pretty simple and 
straightforward. But very important.
  As one of the lead sponsors of the Senate gift ban several years ago, 
I feel strongly that the public has a right to know that elected 
officials are working in the best interests of their constituency, and 
cannot be bought or sold over lunch provided by high-paid lobbyists. 
Just as politicians should not be trading on their influence, neither 
should private sector medical device reviewers be swayed in their 
decision process by gifts from industry representatives or the promise 
of huge profits derived from a recommendation for FDA approval.
  I hope my colleagues will do the right thing, and limit the potential 
for corruption in this bill by voting for this important amendment.
  The PRESIDING OFFICER. The yeas and nays have not been ordered.
  Mr. JEFFORDS. I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.
  The PRESIDING OFFICER. The question is on agreeing to the Durbin 
amendment No. 1140.
  The yeas and nays have been ordered.
  The clerk will call the roll.
  The assistant legislative clerk called the roll.
  Mr. NICKLES. I announce that the Senator from North Carolina [Mr. 
Helms] is necessarily absent.
  The PRESIDING OFFICER (Mr. Roberts). Are there any other Senators in 
the Chamber desiring to vote?
  The result was announced--yeas 40, nays 59, as follows:

                      [Rollcall Vote No. 252 Leg.]

                                YEAS--40

     Akaka
     Baucus
     Biden
     Bingaman
     Boxer
     Breaux
     Bryan
     Bumpers
     Byrd
     Cleland
     Conrad
     Daschle
     Dorgan
     Durbin
     Feingold
     Feinstein
     Ford
     Glenn
     Graham
     Harkin
     Hollings
     Inouye
     Johnson
     Kerry
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Moseley-Braun
     Moynihan
     Murray
     Reed
     Reid
     Robb
     Rockefeller
     Sarbanes
     Torricelli
     Wellstone
     Wyden

                                NAYS--59

     Abraham
     Allard
     Ashcroft
     Bennett
     Bond
     Brownback
     Burns
     Campbell
     Chafee
     Coats
     Cochran
     Collins
     Coverdell
     Craig
     D'Amato
     DeWine
     Dodd
     Domenici
     Enzi
     Faircloth
     Frist
     Gorton
     Gramm
     Grams
     Grassley
     Gregg
     Hagel
     Hatch
     Hutchinson
     Hutchison
     Inhofe
     Jeffords
     Kempthorne
     Kennedy
     Kerrey
     Kohl
     Kyl
     Lott
     Lugar
     Mack
     McCain
     McConnell
     Mikulski
     Murkowski
     Nickles
     Roberts
     Roth
     Santorum
     Sessions
     Shelby
     Smith (NH)
     Smith (OR)
     Snowe
     Specter
     Stevens
     Thomas
     Thompson
     Thurmond
     Warner

                             NOT VOTING--1

       
     Helms
       
  The amendment (No. 1140) was rejected.


                           Amendment No. 1139

  The PRESIDING OFFICER. Under the previous order, we will resume 
consideration of amendment 1139 by the Senator from Illinois with 2 
minutes of debate equally divided.
  Mr. JEFFORDS. Mr. President, the Senate is not in order.
  The PRESIDING OFFICER. The Senator from Vermont is correct. The House 
is seldom in order and the Senate is not in order. The Senate will come 
to order.
  We will not resume consideration of the amendment until the Senate 
comes to order.
  Will the Senators to my left please cease audible conversation?
  The Senator from Vermont.
  Mr. JEFFORDS. Mr. President, I would defer to the Senator from 
Illinois, and I reserve my time.
  The PRESIDING OFFICER. The Senator from Illinois is recognized for 1 
minute in behalf of his amendment.
  Mr. DURBIN. Mr. President, if you buy a car in America the 
manufacturer keeps a record of your name and address, or if there is a 
defect they can recall the car. This bill removes the requirement for 
medical device manufacturers to keep a record of those people who 
receive pacemakers and heart valves. Why is that important? Because, if 
there is a defect in that lifesaving medical device, they can't find 
the patients. What results?
  Just a few years ago 300 Americans died. They had the Bjork-Shiley 
heart valve that was defective and they couldn't be found. Does it make 
sense for us to remove this responsibility of medical device 
manufacturers?
  Take a look on your desk at a letter from 27 different organizations 
representing patients across America who say it is only sensible to 
make certain that we track and keep track of those who are receiving 
these medical devices.
  I urge my colleagues to vote for this amendment. It is not too great 
a burden on a medical device manufacturer to keep a record of those 
receiving pacemakers and heart valves.
  The PRESIDING OFFICER. The time of the Senator from Illinois has 
expired.
  Mr. JEFFORDS addressed the Chair.

[[Page S9739]]

  The PRESIDING OFFICER. The Senator from Vermont is recognized to 
speak for 1 minute.
  Mr. JEFFORDS. Mr. President, I disagree entirely with the statement 
made by the Senator from Illinois. The Senator's amendment strikes the 
agreement reached on these provisions among the bill's sponsors, the 
FDA, and Senator Kennedy. The FDA should have the discretion to decide 
when it makes sense to require device tracking or surveillance for a 
product.
  Current law requires tracking for certain product types and gives the 
FDA discretion to require tracking for other products. It is simply not 
necessary for every current and future device in the mandatory category 
to be subject to the tracking requirement. This provision allows FDA 
affirmatively to indicate which products in the mandatory category 
should be subject to tracking. FDA may use its discretion to add new 
products to the list of products which must be tracked, or put a 
product back on the list for tracking if evidence indicates the need.
  The FDA is overburdened. We want to free them up to do the things 
that need to be done.
  The FDA has publicly stated that it is unnecessary for all devices in 
the mandatory category--postmark and surveillance category--to be 
subject to its postapproval evaluation.
  I urge defeat of the amendment.
  The PRESIDING OFFICER. The time of the Senator has expired.
  The question is on agreeing to the amendment of the Senator from 
Illinois. The yeas and nays have not been ordered.
  Mr. JEFFORDS. I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.
  The PRESIDING OFFICER. The question is on agreeing to the amendment 
of the Senator from Illinois. On this question, the yeas and nays have 
been ordered and the clerk will call the roll.
  The bill clerk called the roll.
  The result was announced--yeas 39, nays 61, as follows:

                      [Rollcall Vote No. 253 Leg.]

                                YEAS--39

     Akaka
     Baucus
     Bingaman
     Boxer
     Breaux
     Bryan
     Byrd
     Cleland
     Conrad
     Daschle
     Dorgan
     Durbin
     Feingold
     Feinstein
     Ford
     Glenn
     Graham
     Harkin
     Hollings
     Hutchison
     Inouye
     Johnson
     Kerrey
     Kerry
     Kohl
     Leahy
     Levin
     Mikulski
     Moseley-Braun
     Murray
     Reed
     Reid
     Robb
     Rockefeller
     Sarbanes
     Shelby
     Specter
     Torricelli
     Wellstone

                                NAYS--61

     Abraham
     Allard
     Ashcroft
     Bennett
     Biden
     Bond
     Brownback
     Bumpers
     Burns
     Campbell
     Chafee
     Coats
     Cochran
     Collins
     Coverdell
     Craig
     D'Amato
     DeWine
     Dodd
     Domenici
     Enzi
     Faircloth
     Frist
     Gorton
     Gramm
     Grams
     Grassley
     Gregg
     Hagel
     Hatch
     Helms
     Hutchinson
     Inhofe
     Jeffords
     Kempthorne
     Kennedy
     Kyl
     Landrieu
     Lautenberg
     Lieberman
     Lott
     Lugar
     Mack
     McCain
     McConnell
     Moynihan
     Murkowski
     Nickles
     Roberts
     Roth
     Santorum
     Sessions
     Smith (NH)
     Smith (OR)
     Snowe
     Stevens
     Thomas
     Thompson
     Thurmond
     Warner
     Wyden
  The amendment (No. 1139) was rejected.
  The PRESIDING OFFICER. Under the previous order, the Senator from 
Rhode Island is recognized to offer an amendment.


                           Amendment No. 1177

 (Purpose: To ensure that determinations of the Secretary with respect 
  to the intended uses of a device are based on the proposed labeling 
           only if such labeling is not false or misleading)

  Mr. REED. Mr. President, I have an amendment at the desk, amendment 
No. 1177. I would like to call up my amendment at this time.
  The PRESIDING OFFICER. The clerk will report.
  The bill clerk read as follows:

       The Senator from Rhode Island [Mr. Reed] proposes an 
     amendment numbered 1177.

  Mr. REED. Mr. President, I ask unanimous consent that reading of the 
amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is as follows:

       On page 30, line 16, insert before the first period the 
     following: ``if the proposed labeling is neither false nor 
     misleading''.

  The PRESIDING OFFICER. The Senator is recognized.
  Mr. REED. I ask unanimous consent Senators Kennedy and Bingaman be 
added as cosponsors of this amendment.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. REED. Mr. President, today we are debating very important 
legislation, important for the country in the reformation and 
reauthorization programs at the Food and Drug Administration. 
Particularly important in this legislation is the prescription drug 
user fee program, which has proven to be a remarkable achievement that 
has speeded the approval of drugs, getting these necessary medicines to 
the American public.
  S. 830 includes a number of provisions that will include and 
streamline the regulation of prescription drugs, biological products 
and medical devices, and we have made great progress over the last 
several weeks and months in reaching this position today. This bill is 
a result of ongoing renegotiations, both prior to and subsequent to the 
markup of the legislation. Through this process, a number of provisions 
that could have threatened the public health and safety have been 
dropped or otherwise reformed in such a way that we have made, as I 
said, remarkable and very effective progress.
  However, this legislation still contains provisions which could 
jeopardize the public health. I rise today to address one of these 
areas and that is the elimination of an important consumer protection 
against unsafe or ineffective medical devices. The bill, as it is 
proposed today, as we deal with it today, would limit the FDA's 
authority to ask device manufacturers for safety data. It prohibits the 
FDA from considering how a new device could be used, if the 
manufacturer has not included that use in the proposed labeling.
  As a general matter, the FDA does not typically consider uses that 
the manufacturer has not included in its proposed labeling. However, 
there are instances where the label does not tell the whole story. In 
these instances, when the label may be false or misleading--it is in 
these instances that my amendment would give the FDA the authority to 
look behind the label. In fact, this is such a critical issue that the 
administration has made it clear that this provision could put the 
whole bill at risk, including, I might add, the reauthorization of the 
PDUFA, the prescription drug user fee amendment, because they have 
threatened, if this provision does survive, to veto the legislation. 
And that would, I think, derail a great deal of very positive work that 
we have done today.
  A great deal of discussion has taken place on the medical device 
provisions of this bill. I certainly want to compliment Senator 
Jeffords and Senator Kennedy and all my other colleagues on the 
committee for resolving most of these issues and doing so in a very 
reasonable, very thoughtful, and very responsible manner. However, the 
provision regarding device labeling still raises substantial concerns, 
as I have alluded to, and it could be corrected very simply by my 
amendment without, I believe, undermining the attempt of this bill 
which is to provide for a streamlined, effective process so that new 
medical devices, new pharmaceuticals can reach the market and be used 
by the American public for their health and well-being.
  Let me preface discussion of my amendment by briefly describing the 
process of how the FDA regulates and clears medical devices for market. 
Under current law, manufacturers of new class I and class II devices 
can get their products onto the market quickly by showing that they are 
substantially equivalent to devices already on the market. For example, 
the manufacturer of a new laser can get that laser onto the market if 
it can show the FDA that the laser is, again, ``substantially 
equivalent'' to a laser that is already on the market. Similarly, the 
manufacturer of a new biopsy needle can get the biopsy needle onto the 
market by showing it is substantially equivalent to a biopsy needle 
already on the market. And the manufacturer of new patient examination 
gloves can get the same expedited market clearance by claiming 
substantial equivalency.

[[Page S9740]]

  Under current law, manufacturers are required to demonstrate this 
substantial equivalency to the FDA by showing that the new product has 
the same intended use as the already-marketed product; and that the new 
product has the same technological characteristics of that already-
existing product in the marketplace. If the new product has certain 
different technological characteristics, these characteristics must not 
raise new types of safety and effectiveness questions in order for the 
product to still be substantially equivalent to the older product. The 
logic of this process for moving medical devices onto the market is 
quite simple. If a product is very much like an existing product, it 
can go to market quicker. But if it raises new safety or effectiveness 
questions, those questions should be thoroughly answered before the 
product is made available to the public.
  The process for getting new medical devices on the market is commonly 
known as the section 510(k) process or the 510(k) process. It's 
considered to be the easiest route for FDA approval. In fact, 95 
percent of all medical devices that come onto the market come through 
this 510(k) process. In a sense, because of this, because of this ease, 
this is the process that is most used by manufacturers. There is, in 
many cases, an incentive to bring your new product through this 510(k) 
procedure. It has the lowest thresholds for approval, if you will, and 
this incentive requires, essentially, the manufacturers at times to 
look about in the marketplace and say this is going to do just what 
this item does currently, even though the new technology or the new 
innovation or new design might be adaptable to other purposes. But 
there is, I believe, a regulatory incentive to try to speed things 
through the FDA by saying: No, no, this is substantially equivalent, 
that's all we are going to do, this is it. As a result, I think the FDA 
has to seriously look at, not just the labeled use, but in certain 
circumstances--not common circumstances but in certain circumstances--
look behind the label.
  The bill as it is currently proposed would compromise the FDA's 
existing ability to do that and this change could raise substantial 
risks to the public health. My amendment addresses this bill that would 
prohibit the FDA from considering how a device would be used if the 
manufacturer has not included the use in its proposed label. My 
amendment would add 9 simple words to the bill. Let me first show you 
the existing language that is under discussion, and that is:

       The determination of the Secretary under this subsection 
     and section 513(F)(1) with respect to the intended use of a 
     device shall be based on the intended use included in the 
     proposed labeling of the device submitted in a report under 
     section 510(k).

  Essentially, what this says is if a manufacturer says, ``This is what 
we are going to do,'' on a label, this is all we can consider in our 
application process, even if the FDA considers the possibility of other 
uses or even, some would argue--even if the FDA felt that the label was 
misleading or, indeed, false.
  My language would be added at the very end, and it would simply say, 
``if the proposed labeling is neither false nor misleading.'' In a 
sense, it would give the FDA the opportunity to look at a proposed use 
on a proposed label and say, ``This is consistent with the device, 
consistent with use, let's get this onto the market through the 510(k) 
process expeditiously.'' But if they thought there was another possible 
use, another likely use, or that the intended use was really perhaps a 
subterfuge for other uses, they could challenge the application at that 
juncture.

  I believe this is something that the FDA should have the authority to 
do. In fact, I would assume the American public believes that the FDA 
has this authority, that they can look very closely, very carefully; 
that they don't have to take as the final authority the 
characterization of the device by the manufacturer. And they can, by 
simply examining the device, using their experience, conclude that 
there might be other uses which should be evaluated before this device 
gets on the market.
  As I indicated, my amendment would allow them to effectively look 
behind the label, look behind the characterization that was proposed by 
the company.
  It is also important to note that this is not a particularly novel or 
startling approach to legislation. Because if you turn to the other 
major approval process, that is for a class II product, a new product 
that has to do extensive premarket review, in this case they do have 
the explicit authority, under present law, to look beyond the label. 
Because even if the manufacturer indicates one use on the label, they 
do not have to accept that use if they determine that it is false or 
misleading. So this is not a novel concept. In fact, I think it 
represents what should be the normal practice for the FDA, to be able 
to look behind the label.
  My amendment would give the Food and Drug Administration this 
authority. It would give them the authority, and does so for new 
information, additional information, additional data. This is not an 
attempt to frustrate progress, to slow up the process, to impede the 
rapid deployment of new technologies into the marketplace. This is, I 
hope, an attempt to protect the public health and safety, protect the 
consumers of these devices; and, hopefully, to delineate the authority 
of the FDA which typically they would use only in rare circumstances so 
we don't have a battle at the FDA about whether this device is 
technologically different. So I hope, by using this approach, this 
language, we could conform the 510(k) process in this respect to the 
existing process and we could move forward with good, sound public 
policy regarding the Food and Drug Administration and medical devices.
  Let me give just a few examples, because this is not just a legal, 
academic issue. This is a very real issue. There has been one example 
that has been discussed on the floor by my colleagues and that is the 
use of biopsy needles. Biopsy needles are approved for one use, 
principally. That is, as the name implies, to take a biopsy to remove 
tissue from a breast lesion, for example. Typically, these needles will 
remove a very small bit of tissue, about the size of the tip of a 
pencil. But a manufacturer could present a device that could remove 50 
times that--not a typical pencil, but the width of a hot dog. And that 
would obviously raise questions about how this new device is going to 
be used.

  But under the language in the legislation, there is a very strong 
argument that the FDA could not look to possible other uses because the 
manufacturer said simply, ``We're going to use this for the traditional 
biopsy of tissue, a small biopsy of tissue. That's all. We're not going 
to use it or suggest it be used for the removal of tumors, the removal 
of tissue, just the biopsy.'' Then they would be essentially prevented 
from looking at this other use which may in fact be the actual use of 
the device in the marketplace.
  So we have to be very careful about that. The FDA should be able in 
this case to say, ``Well, this could be used for something beyond a 
simple biopsy. If that's the case, show us some data about its success 
rate, show us some data about the effects if it's used in this way and 
not the precise label use.''
  This is something that I believe we should have. There are proponents 
of the existing language which say that the FDA can get at that simply 
by saying this is a new technology, it is not equivalent to the old 
one. But the manufacturer could argue that there are no questions of 
safety or effectiveness even if it was a new technology. Essentially 
this new language designed to streamline the process could lead us 
right back to the contentious issues about whether or not this new 
technology endangers health and safety. It could lead us back, I think, 
in a way in which the FDA has the weaker hand in the argument.
  I believe that the American public would like to see the FDA with the 
authority and the ability to ensure that these devices are thoroughly 
reviewed before they get to the marketplace.
  As we go forth, there are other examples. In fact, my colleague from 
Massachusetts, I think, will talk specifically about one example of a 
biopsy needle which went on the market. Before this device went on the 
market, it was tested only on two cows and, I am told, 13 roast beef. 
Now we hear that the device marketed as a biopsy needle has in practice 
been used for other surgical procedures. Now, this is an example of

[[Page S9741]]

how something, even if it was not deliberately designed by the 
manufacturer, can be changed in its use in practice. And, again, I 
think the FDA should be able to anticipate those rare circumstances 
where it might happen and take effective action to protect the public 
health.
  There are other examples. Another good example is a surgical laser. 
Lasers have been used for decades for the removal of tissue. Several 
years ago a manufacturer added a side-firing mechanism to their laser 
to improve its use for prostate cancer. While the manufacturer did put 
that specific use in the proposed label, it was very, very clear that 
this new side-firing design was intended solely for this purpose of 
treating prostate patients. As a result the FDA, using its current 
authority, its ability to look beyond the actual labeling use, was able 
to require the manufacturer to submit data demonstrating the laser's 
safety and effectiveness in treating prostate patients.
  This is precisely how the approval process should work. In rare 
circumstances, when the device obviously looks different than the label 
use, the FDA should be able to say, this could be used in ways that you 
are not labeling. We have to look at all the likely, obvious ways 
beyond the label. Let us do that. Let us get beyond the label. Under 
the present language, without the Reed-Kennedy-Bingaman amendment, the 
FDA would have a difficult time looking behind the label, looking at 
actual uses and requiring the data and the analysis which should be 
done beforehand, before the goods get on the market.
  I do not think you have to do this simply because there are people 
out there who would have a maligned motive. This is a situation where, 
if we create through our legal structures opportunities to get products 
quicker to the marketplace, then companies, with their expert legal 
counsel, will exploit those ways. It is our responsibility to ensure 
that we have a process that protects the public health.
  Whatever process we develop here today will be used by the companies 
in a way which, if we were executives of companies, we would use in the 
same way. But we have to take into consideration not the benefits or 
the position of the manufacturer, but the position, I think, of the 
general public that would use the devices.
  So, I believe we have to have standards that are sufficient to give 
the Food and Drug Administration the authority they need to do the job. 
I believe that my amendment does this. I believe we have to have these 
procedures in place before a device gets into the marketplace. There 
are those who would argue that the FDA has the power to recall an item, 
has the power to intervene, but then of course it is too late because 
obviously the public has already suffered in some way.
  Indeed, it is not as easy as it may appear for the FDA to step into 
the marketplace and get goods off or an item off the market that has 
already been approved. So I think the idea that this can be corrected 
after the fact is not sufficient weight to preclude us from taking 
effective steps before a device gets in the marketplace.

  What I would like to do in my amendment is simply give the FDA the 
authority to look at a proposed use, a labeled use, make a 
determination that this device and this label is consistent and get it 
through the 510(k) process quicker. But in those rare circumstances 
where the device itself and the label do not appear to be consistent, 
coherent, where there is the possibility of a false label or a 
misleading label, or the possibility that the company may indeed in 
most cases in very good faith be insisting this is how they want to 
market it, this is how they propose it be used, but the medical 
profession itself would adapt this very quickly for other uses, in 
those circumstances I believe the FDA should have the authority.
  I hope that my colleagues will recognize this, will support this 
amendment, support giving what the FDA has today: the authority to look 
behind the label and to require that companies provide data for the 
likely uses of the product they intend to market.
  Before concluding, I ask, Mr. President, unanimous consent that 
Senator Durbin be added as a cosponsor to this amendment.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. REED. I thank the Chair.
  The PRESIDING OFFICER. Who seeks time?
  Mr. JEFFORDS addressed the Chair.
  The PRESIDING OFFICER. The Senator from Vermont.
  Mr. JEFFORDS. My colleague from Rhode Island is a welcome addition to 
the Labor Committee. He has been active and has made some good 
suggestions for improving this legislation, but this is not one of 
them.
  This amendment sounds like simple good Government but in fact would 
gut the provision and 20 years of effective medical device regulation.
  Mr. President, I yield 15 minutes to the Senator from Connecticut.
  The PRESIDING OFFICER. The Senator from Connecticut is recognized.
  Mr. DODD. Thank you, Mr. President.
  Let me begin by commending the chairman of the committee, Mr. 
President, for the work he has done on this bill and for others who 
have been involved in it.
  We are arriving at the point here where we have a 211-page bill put 
together in the past 2\1/2\ years, where we are, hopefully, down to its 
last provision, which has been the subject of some discussion over the 
last number of days.
  I want to just at the outset commend those who have been involved in 
it, explaining what the purpose of the intent here is. We have passed 
this bill out of our committee 14 to 4. There was some disagreement 
over a number of provisions, but I believe we produced a very fine 
product which is going to assist tremendously in making this even more 
secure in the quality of products we are getting but also the 
efficiency with which those products become available to patients and 
people in this country. I thank my colleague from Rhode Island for the 
explanation.
  This has become an arcane subject matter when we talk about 
paragraphs and titles and how the FDA process works. That is the reason 
the committee has spent so much time going back over this material, to 
try to sort out exactly what would work best and how it would apply.
  Contrary to how it has been portrayed thus far, the provision in the 
bill which is the subject of this amendment--what it does, Mr. 
President, is it shrinks back to current law an authority that the FDA 
has been stretching, in our view, past the bounds of fair practices.
  So the effort here is to try to get back exactly to what the intent 
has been. All we, the authors of the bill, are asking is that the FDA 
not force manufacturers to supply information on other than the imputed 
uses for which the manufacturer is not seeking approval and could not 
market the product even if they wanted to.
  You can see how the FDA in the current practice of second-guessing 
manufacturers can certainly create uncertainty not only in terms of the 
manufacturer but also in terms of consumers. A manufacturer, Mr. 
President, can spend years designing a product for a specific purpose 
only to be told by the FDA that it should go back to the drawing board 
and test the product for uses other than those for which the product 
was created in the first place. That creates tremendous uncertainty.
  Let me, if I can, Mr. President, try to describe this process and 
what we are talking about. That is where it gets a bit arcane. The 
Senator from Rhode Island, I think properly, characterized some of the 
differentiations here, but I think he gets lost on some people. What we 
are talking about here are not high-risk devices but lower risk 
devices.
  Ninety-five percent of the products that come out of the FDA for 
approval in this area are lower risk devices. What is a lower risk 
device and what is the process that exists today that allows for the 
approval of these products to be marketed?
  Well, the lower risk device goes through, as the Senator from Rhode 
Island has described, a 510(k) process. That is the applicable 
provisions at the FDA. Under that provision, if a manufacturer wants to 
bring out a lower risk medical device, they must prove that the new 
device is ``substantially equivalent''--I am quoting here--``to a 
device already on the market,'' the so-called predicate device. That is 
why it is called a lower risk device. There already then has been the 
approval of a

[[Page S9742]]

product that is substantially equivalent to a product that the 
manufacturer wants to bring out.
  So the decision was made, instead of having a manufacturer go through 
a de novo process, which can take years, as it should, that we are 
going to expedite that process as long as there is a predicate out 
there--there is a predicate out there--there has already been a product 
that is ``substantially equivalent,'' to quote the FDA. If that exists, 
then you can go, for the lower risk device, to the 510(k) process.
  There are two tests--two tests--that you must meet if you are going 
to get FDA approval under that provision--the lower risk device, not 
the higher risk device. No one is debating that. We are talking about 
the lower risk device. The two tests are the following.
  The first is that the device has the same intended use as the 
predicate device. That is a subjective test. Does it have the same 
intended use? Does the label say that? Does the marketing, does the 
information the company is putting out have the same intended use? That 
is a subjective test. And if a manufacturer puts on the label some 
other use, then they would fail that test--the intended use.
  To say that a manufacturer must also now have some imputed use that 
you could not imagine, that you did not design, that you did not think 
about, that some doctor may decide they want to use it for, is not what 
that paragraph is all about. That is the first test.
  But the second test is far more important. This bill does nothing to 
the second test at all. The second test is that the new device's 
technological differences do not raise new questions of safety and 
efficacy. That is an objective test, Mr. President. That is an 
objective test. Nothing in this bill changes anything in that second 
test.
  What we are trying to do is to get back to that first test and say it 
is the intended use of that predicate device, the intended use of the 
predicate device. If the manufacturer does not meet both of these 
tests, then the FDA does not have to clear the device.
  This provision does not change that in any way whatsoever. You have 
to meet both tests. All that we are asking in this bill, among other 
things that we have tried to reform here, is that we be able to draw 
some lines around the first and very subjective test of the intended 
use while retaining FDA's full discretion on the much more objective 
tests of the technological differences. Now, in our view, with all due 
respect, the FDA has been stretching its authority by trying to impute 
uses that the manufacturer has no intention of doing.
  We have been given some examples over the past week of how the act 
would only test the intended use on the label. In fact, as I said, 
there are two tests under 510(k). In each of the examples that have 
been given, the FDA had the ability to stop the devices from going on 
the market because they failed the second test. No reference has been 
made to that. They failed the second test, not the intended purpose, 
but the technological differences.
  All the examples that have been given, of course, are tragic ones, 
deaths and injuries resulting from the Dalkon shield, a woman who 
contracted toxic-shock syndrome from superabsorbent tampons, 
disfigurement caused by artificial jaw joints, and faulty plastic 
eyelashes that led to blindness.
  These are all tragic examples without question. But in every single 
case it was not because they failed the first test, the intended use; 
it was because they failed the second test. They were technologically 
flawed. It was not somehow that the manufacturer produced a product 
that was used for some different purpose than the intended use on the 
label, but that the product was faulty, technologically it was faulty.
  So we cite these examples and then say the reason that people lost 
their lives or were disfigured was because the manufacturer used it for 
some purpose or someone used for it for a purpose other than was 
labeled. That is not the case. It just is not the case. So I urge my 
colleagues when looking at this, as technical and as arcane as it may 
be--and most Members do not follow FDA regulations, do not get involved 
in the details of it--but with lower risk devices there are two tests, 
all within this bill. This amendment we are dealing with is the first 
test, the intended use.
  In every example cited, the horror stories cited, the tragic losses 
cited, in every single case it was the failure of the second test, 
which is not the subject of the amendment offered by the Senator from 
Rhode Island.
  I urge my colleagues to pay attention to those of us who worked on 
this and understand what we are talking about. We are trying to see if 
we cannot narrow down the problem on the intended use sections.
  Mr. President, let me talk here a bit about what our purposes are 
here. If we allow the FDA to have free rein in the sense of having to 
guess at what a lower risk product could conceivably be used for once 
it is in the hands of physicians, then there is no end, in my view, to 
the studies that could be required of manufacturers to produce.
  Some suggest perhaps we need a threshold to that guessing; maybe the 
FDA is ``kind of'' sure that the doctors would not use the device for 
another purpose. That would be the right threshold. Maybe ``really'' 
being sure would be sufficient in some cases. Can you see how 
unworkable a concept like this would be? Anytime the FDA is told they 
can look into their crystal ball and guess how a doctor might use a 
product, the result is going to be uncertainty.
  Mr. President, let me step back a second. There is not a single 
Member of this body that in any way wants to be associated with or part 
of an effort that is going to endanger anyone's life at all. In fact, 
quite the contrary. We want to do everything we can to see to it that 
people are getting safe products, efficient products, effective 
products that will serve their interests and protect their lives. That 
is our purpose and intent. We also want to see patients able to get 
products and have them reach the market. Certainly there are going to 
be those who will be fraudulent, bad actors. No one is suggesting they 
do not exist. Nothing we will do here will stop that, I suppose.
  But to suggest somehow that because we are trying to in some way 
tighten up the intended use or purpose on the lower risk devices, that 
those who support this idea are guilty of somehow jeopardizing people 
all across this country, I think is an unfair characterization. It is 
quite the contrary.
  In fact, a major company in my State of Connecticut, U.S. Surgical, 
with 9,000 employees, has come up with some of the most creative, 
imaginative, and effective devices to reduce the risks of injury and to 
preserve lives. It is a very reputable company. The company has brought 
to the American people revolutionary technology.
  They were leaders in creating minimally invasive surgery using 
laparoscopes. Patients used to be laid up for months, or weeks anyway, 
after a gall bladder operation. As a result of laparoscopic surgery, 
now a person can be back at work within days because of the technology 
developed by U.S. Surgical.
  The breast biopsy, which has been discussed here, was developed 2 
years ago by U.S. Surgical and has been received by surgeons with 
overwhelming support in this country. Women have benefited from its use 
in over 7,000 cases worldwide. It is a safe and reputable company. I 
think it has been unfairly labeled as otherwise. In fact, regarding the 
biopsy, in trying to approve technology that would improve the 
technology, they should have received plaudits for that. The FDA 
approved it. There were questions raised about whether or not this was 
actually being used as a surgery to remove tumors. Never did the 
manufacturer ever suggest that was the case. Having listened to some of 
the debate, that was the implication.
  Mr. President, I think it is unfortunate that that becomes the manner 
in which we debate a question here about one provision we are trying to 
narrow a bit in lower risk products.
  Mr. President, there are a few examples of instances where the FDA 
has attempted to second-guess the manufacturers of a device about the 
device's intended use. One was an endoscope, an example where a 
manufacturer was asked to submit data on how the materials of a device 
would hold up after multiple uses. The company, in fact, insisted the 
label clearly state the product should only be used once and then 
discarded. That is what the label said. That is what the company and 
the

[[Page S9743]]

manufacturer intended--one usage of this endoscope. In the second case, 
a manufacturer designed a hearing aid to reduce background noise. The 
FDA decided that the real intended use was better hearing, and required 
the manufacturer to submit clinical data to prove that the device 
helped hearing overall. In a third case, Mr. President, a manufacturer 
developed a catheter that was coated with a substance that enhances the 
integrity of the device materials when the device is implanted in the 
body. The FDA decided the coating was really intended to reduce 
infection, and required clinical data to prove it.
  Mr. President, in each of these cases the manufacturer was not 
seeking to promote or market the device for the imputed use at all and 
would have been prohibited from doing so, and the FDA's authority in no 
way is eroded. If the FDA believes that the company is off on some 
imputed use they have the authority to deal with that problem. We don't 
change that in this law at all.

  I also point out, Mr. President, in each case a useful device was 
delayed from reaching consumers in this country. That is what we are 
talking about here.
  I talked earlier about the biopsy, the testing device developed by 
U.S. Surgical. U.S. Surgical received approval from the FDA for a 
breast biopsy needle to be used for diagnostic purposes only, 
diagnostic purposes only. After the product was approved and on the 
market, the FDA asked for more information about the efficacy and the 
safety of the device for taking adequate biopsy samples--an appropriate 
request. U.S. Surgical supplied the information, and the second 
approval for the product was given by the FDA. At no time was the 
device marketed for another purpose. At no time was the device marketed 
for any other purpose than for diagnostic purposes.
  I come back to the section, the 510(k), the lower risk medical 
devices. Two tests--the subjective test of intended use based on the 
label; and the second test on the technological questions, which is an 
objective test. Had the manufacturer said on its label or in its 
information or its marketing packages, ``By the way, this will be a 
good diagnostic device and it may just work in terms of dealing with 
the tumor,'' you have immediately violated the first test because your 
intended purpose is other than what you are seeking approval. But that 
is a subjective case. That is the way this works.
  If you want to scrap 510(k) and put everything on the same footing, 
why don't we have an amendment that does that? I don't hear anyone 
suggesting that. We are trying to get these devices out where there is 
a predicate; that is, there has been a product already approved, which 
is substantially equivalent, substantially equivalent, to the device 
seeking approval. I urge my colleagues to remember that when you are 
considering how to vote on this. This is not high risk. This is low 
risk. Two tests--subjective test, intended purpose; second test, is it 
technologically faulty, is it safe?
  In the case of U.S. Surgical's diagnostic test for breast cancer, 
which has been overwhelmingly received, by the way--in fact, I think we 
will hear later from a colleague of ours who is a beneficiary of this--
overwhelmingly accepted. Had they thought to do something else with 
that biopsy, then they would be in violation of this test. That was not 
the case and to suggest otherwise is just not true.
  If it had been, the FDA would have had full authority to request data 
on the safety and efficacy of the device for the unapproved purpose. It 
would still have that authority under this provision. At no time did 
the FDA request any data for U.S. Surgical regarding the use of the 
breast biopsy device for tumor removal. So when this case is cited now, 
twice I heard it cited, I hope my colleagues would understand what the 
facts are. This is a fine company and the suggestion somehow they are 
producing devices out there for purposes other than what was intended, 
risking consumers in this country, is unfair to that company and unfair 
to the people who work there.
  Mr. President, I urge our colleagues when considering this 
amendment--and again I respect entirely the motivations behind it; 
certainly all of us want to see the safest possible devices on the 
market, but we also want to see a process that will allow the products 
to get to that marketplace and serve the people they are designed to 
serve. If we are talking about something new, the tests are different, 
and they should be. If it is substantially equivalent to a device 
already out there, we have made the collective determination 20 years 
ago that the test ought to be different. When you go beyond that, in 
effect, if you are trying to take a lower risk device and apply it to a 
standard that exists to a higher risk device you are defeating the very 
purpose for which 510(k) exists.

  With all due respect to my colleague from Rhode Island, I urge this 
amendment be defeated. In my view, the responses here are not arguing 
this provision on its merits. Instead, we are hearing language that I 
don't think reflects exactly what the situation is, what the facts are. 
While appealing on the surface, because some horrible cases have been 
cited as I pointed out, in every single instance in those cases it was 
not a debate about whether or not the manufacturer was producing a 
product for one purpose and used for another. In every single case 
those devices failed the second test of 510(k), not the first test of 
the intended purpose.
  By definition, the process of determining substantial equivalence, a 
label is neither true nor false. It is the same as the predicate. If it 
is not the same as the predicate, then it does not pass the first test. 
In effect, trying to squeeze false and misleading language into a place 
it doesn't fit means all devices would be undergoing the PMA process, a 
process that can take up to six times longer, six times longer. When 
there are patients out there and families out there that want to see 
this material get to them, we don't need to be complicating a process 
on low risk devices, delaying that event occurring, causing more pain 
and suffering. There are people who suffer as a result of a regulatory 
process that is so overburdened and so complicated that people cannot 
get these materials when they need them.
  Mr. President, again, with all due respect, I urge my colleagues 
reject this amendment.
  I yield the floor.
  Mr. JEFFORDS. I yield to the Senator from Indiana 10 minutes.
  The PRESIDING OFFICER (Mr. Santorum). The Senator is recognized for 
10 minutes.
  Mr. COATS. I thank the Senator for yielding.
  I want to commend the Senator from Connecticut, Senator Dodd, for his 
statement. Much of what I was going to say he has articulated probably 
better than I could articulate, in terms of the purpose of the 510(k) 
approval process, the nature of the tests that are involved in 
approving the devices that are substantially equivalent, and the 
technicalities that are involved in this that I know not a lot of 
Members have had the opportunity to focus on or really even the 
necessity of focusing on.
  The point the Senator makes about the fact that the work of the 
committee over 2\1/2\ years has been careful and thoroughly undertaken 
in a way that is designed to provide the very best of protection for 
the consumer, the very best of safety and effectiveness so that the 
drugs and devices that are approved by FDA are devices and drugs that 
we can have confidence in.
  No one on the committee is attempting to undermine the essential 
function and the essential purpose of the Food and Drug Administration. 
We want a dynamic, vibrant, effective agency in this country that tests 
the safety and effectiveness of devices and drugs before they are 
brought to the market.
  Now, no process is ever going to be perfect. There will be 
mistakes. But we want to ensure that this agency has the very best of 
what it needs to accomplish that essential purpose. What we don't want, 
and what we are attempting to do with this reform bill is to have a 
situation continue where the approval process cannot even begin to meet 
the requirements that the agency thinks are appropriate and that we 
have dictated by law, by statute.

  Numerous examples have been cited here on the floor, whether it is 
for drugs, or devices, or even other products that the FDA reviews, of 
unconscionable delays, of unnecessary delays, of letters being lost, of 
material that has been misplaced, of the inability of FDA to have the 
personnel, the

[[Page S9744]]

manpower, the computer power, the administrative procedures in place 
that provides for effective, efficient approval. It is all of this that 
has led to a number of suggested reforms of FDA. And one, which has 
been working very successfully is the PDUFA, Prescription Drug User Fee 
Act, where the drug companies themselves put money into a fund that 
allows the FDA to hire individuals and to purchase equipment and speed 
up the approval of life-saving and health-improving drugs to the 
market. That has worked. We want that to continue. We are up against a 
deadline on that. Funding for that runs out on September 30, the end of 
the fiscal year. We have been pressing hard now for several months--in 
fact, all year--to try to move this process forward so we don't run up 
against this deadline. Yet, we have encountered delay after delay after 
delay because of disputes about very small portions of a 200-plus page 
bill, carefully undertaken by the committee over a 2\1/2\ year period.
  This is not a partisan issue, as Members who have been engaged in 
this understand. The Senator from Connecticut; the Senator from 
Minnesota, Senator Wellstone; the Senator from Iowa, Senator Harkin; 
the Senator from Maryland, Senator Mikulski, have joined with the 
majority, Senator Jeffords and others on the committee, to produce a 
very, very substantial majority in support of the original bill, a 14 
to 4 margin. Since then, some of the concerns of those four have been 
addressed in ways that the vote margin and support for the bill has 
even increased. There were 30-some concessions, which I held up a list 
of on the floor last week--more than 30 such negotiations and 
concessions with those who had continuing concerns about the bill.
  So it is not a matter of saying: we won, 14 to 4, and this is the 
bill, take it or leave it. We are open to producing the very best bill 
that we can, and we think we have. We have been open to negotiation. 
But every time we have met an objection, something new pops up. It is 
ironic that in the committee the amendment we have been talking about 
here, the amendment that Senator Kennedy has been debating at length, 
the reason for the filibuster that has gone on, is over language that 
wasn't even brought up in committee. If this was such an important, 
egregious omission on the part of the committee, how come an amendment 
wasn't offered in the committee to debate it or to discuss it or to 
change it?
  The language that we are talking about here was proposed by Senator 
Wellstone--hardly someone who is viewed as being anticonsumer or 
someone viewed as trying to open a loophole so that the health and 
safety of Americans is jeopardized. In the negotiations and 
discussions, postcommittee markup, this wasn't on the list. I have in 
my hand the memo from the Labor Committee, from David Nexon, suggesting 
items that need to be covered and need to be discussed. This isn't even 
on the list. We went over these amendments. All of a sudden, when at 
one point, the only thing left, to our knowledge, was a resolution of 
the cosmetic portion of the bill, which was resolved, all of a sudden 
this then pops up. So you have to question what is going on here.
  We have a bipartisan coalition, people from liberal, conservative, 
and in-between perspectives, politically--Democrats, Republicans, 
people who worked on the committee, delved into the issues and worked 
to ensure that we have the very best bill possible. Yet, we meet delay 
after delay after delay and obstruction after obstruction after 
obstruction. So I think it is important not just to look at the 
specifics of the amendment, but to ask the question: What else is going 
on? What is the true intent here? Is it to undo FDA reform? Is it to 
block any reform? Here we are up against this deadline for PDUFA, and I 
think it is important that Members keep all that in mind.
  I was going to go through the technicalities of the 510(k) process, 
but Senator Dodd did a marvelous job explaining it. As he said, it's 
the lower risk devices. We are attempting to find a way in which we can 
efficiently expedite the approval of devices that are designed for the 
same purpose, which, in the FDA language, are substantially equivalent, 
and give those devices the opportunity to come to market without having 
to go through the same lengthy, costly approval process that the 
original device--the device called the predicate device--is subject to. 
Sometimes that takes months; often it takes years for that original 
device to accomplish a specific purpose to be approved. Once that is 
approved, there are others that can market and make devices that are 
roughly equivalent--not roughly, substantially equivalent to that. If 
the FDA determines that it is substantially equivalent under their 
review procedures, then that device can be approved.

  As Senator Dodd has said, however, that is only one part of the test. 
The other part of the test is that if there is a technological 
difference that raises safety and effectiveness concerns, FDA can say, 
``not substantially equivalent.'' You have to go through the process. 
FDA retains that authority. Nothing in this bill changes that 
authority. Nothing in this bill alters one iota of that authority. 
Every example raised by the Senator from Massachusetts ignored totally 
and failed to acknowledge that the second part of the test gives FDA 
the authority that they said FDA doesn't have.
  So that's what is at issue here. It is an issue that doesn't have to 
be here. It is an issue that we don't need to be talking about. No one 
raised it in committee. No one raised it in negotiations postcommittee. 
No one indicated that this was a bill stopper. The last indication of a 
bill stopper was the cosmetic concern, which was negotiated and an 
acceptable compromise was reached. Then, all of a sudden, this 
provision, 404(b), the language offered by the Senator from Minnesota, 
Senator Wellstone, and accepted by the committee as part of the bill, 
without objection, all of a sudden this now becomes the bill stopper, 
the killer language, the language that is going to destroy the FDA and 
place 260 million Americans in jeopardy of their life and their health.
  I think Senator Dodd very effectively outlined why the examples used 
were not relevant examples. They are tragic examples. We all regret 
that they happened. But they have nothing to do with the language that 
we are talking about. They have nothing to do with the amendment 
offered by the Senator from Rhode Island. And so let's keep that in 
mind as we move forward here in this torturous process of getting a 
bill passed through the Senate that has been substantially delayed 
because of procedural practices, which enjoy no support from this body. 
We have had two votes. I think the opponents of the legislation got 
five votes on the first try and four votes on the second try. The other 
95 of us, or 96, depending on how you count it, are still here 
attempting to move forward.
  Now, we have the good fortune of having Dr. Frist--Dr./Senator 
Frist--on our committee. For those of us who don't have the medical 
training and expertise to fully understand all of this, we frequently--
in fact, every opportunity we have on medical questions--turn to Dr. 
Frist for the expert's view. I think it is a phenomenal addition to the 
Senate that we have this capability available to us. He will be 
commenting on this and, frankly, I put a great deal of reliance on his 
judgment. Some of us could be reading this the wrong way, could be not 
understanding certain aspects of the process. We represent companies 
that make these devices. We hear their side of the story and it 
certainly sounds reasonable, and we try to make sure there is a proper 
balance between the need to bring products to market quickly and a need 
to make sure they are safe and effective. So we turn to people like Dr. 
Frist to give us the expert view in terms of what we are doing.
  I know I have used my time here. I will have more to say about that, 
as I think we have considerable time left under the cloture procedures 
here.
  At this point, I yield the floor.
  Mr. LIEBERMAN. Mr. President, I rise to address Senator Reed's 
amendment to S. 830, the FDA reform bill. The proponents of the 
amendment have failed to distinguish between devices that are 
substantially equivalent to devices the FDA has approved and devices 
for which no predicate exists. That distinction is central to the 
regulatory scheme for device approval.
  Most medical devices brought to the market represent a small 
incremental change. Around 95% of medical device approvals granted by 
the FDA involve

[[Page S9745]]

devices that are substantially equivalent to a device already approved 
by the agency.
  Most devices are not breakthroughs. They are not devices with bold 
new uses. They do not represent a sharp departure in medical science. 
They are devices with a foundation of testing, experience in the field, 
and most important, devices with a foundation in previous FDA approval.
  Policies and regulations that are appropriate for devices without a 
predicate are not appropriate where devices are substantially 
equivalent to a device that has already received the FDA stamp of 
approval. If each new device represented such a break with the past, it 
would be sensible to fully reexamine safety and efficacy every time FDA 
was asked to grant approval.
  But in a world of small changes, this unwarranted bureaucratic 
impediment would strangle progress, limit the benefits available to the 
public from technological advances, and yield little if any public 
health benefit.
  To capture the public health benefits of small incremental change, 
such devices are approved by the FDA under special procedures called 
the 510(K) approval process. The critical test applied by the FDA in 
approving the device is demonstrating that the device is substantially 
equivalent to a device that has already been approved by the agency. 
The test of substantial equivalence is a flexible definition that 
includes both products that are identical to previously approved 
devices, and those with a certain degree of technological change.
  In contrast, where the new device represents a major advance and is 
used in supporting life or avoiding substantial impairment of health, 
the FDA uses entirely different tests before approving the device. 
These breakthrough devices undergo extensive safety and effectiveness 
trials before marketing. They require extensive premarket review 
because the FDA has no assurance the new device is safe and effective 
based on studies of a previous device, field experience, or FDA 
approval.
  Approving substantially equivalent products expeditiously allows the 
FDA to concentrate its resources on those devices that involve new 
technologies or uses rather than waste time and staff conducting full-
blown reviews of the equivalent device again and again and again.
  In the example we have heard so much about over the last few days, 
U.S. Surgical Corp.--which is headquartered in my State--submitted an 
application for approval of an advanced breast biopsy instrumentation 
device in October 5, 1995. The application was granted by the FDA on 
February 1, 1996. The FDA based their approval on substantial 
equivalence in design, materials, methods of use, and intended use to 
biopsy needles the FDA had previously approved. Since that date the 
ABBI device has been used in over 7,000 cases worldwide.
  In granting approval to U.S. Surgical, the FDA applied the two 
statutory tests of substantial equivalence. First, the device was shown 
to have ``the same intended use as the predicate device'' and second, 
``the same technological characteristics as the predicate device''.
  Some Members have mistakenly stated that U.S. Surgical has marketed 
the device to remove breast cancer tumors, but the Members are in 
error.
  A degree of technological variation is permissible and specifically 
envisioned in the statute. Where the device has different technological 
characteristics, it can still be approved under 510(K) if the 
manufacturer submits

       * * * information, including clinical data if deemed 
     necessary by the Secretary, that demonstrates that the device 
     is as safe and effective as a legally marketed device, and 
     does not raise different questions of safety and efficacy 
     than the predicate device.

  ABBI uses a larger cannula than previously approved biopsy needles. 
The wide cannula allows the physician to extract a broader sample of 
breast tissue. The wide cross section allows more accurate diagnosis of 
breast lesions that appear in the x-ray as clusters of tiny particles 
rather than discrete nodes.
  U.S. Surgical's product insert states in boxed, large type ``The 
ABBI* system is to be used ONLY for diagnostic breast biopsy; it is NOT 
a therapeutic device.'' Its patient pamphlet on the device discusses 
biopsy uses to the exclusion of any other potential use.
  In the ABBI example, the FDA requested clinical data from U.S. 
Surgical about impact of the new technology, broader cannula. U.S. 
Surgical submitted the data on September 23, 1996 and the FDA updated 
the 510(K).
  The sponsors of the amendment state that manufacturers have an 
incentive to seek approval based on false and misleading statements of 
intended uses. Under the 510 (K) approval process, the device must have 
the ``same intended use as the predicate device'' but the amendment 
sponsors state that manufacturers are able to undercut this test. The 
amendment sponsors suggest that the FDA be allowed to establish a new 
intent test for 510(K) approvals that allows the FDA to impute new 
uses, demand new safety and efficacy tests, and ignore the 
manufacturers intended uses.
  First, I would point out that U.S. Surgical specifically responded to 
the FDA's concerns by adding new labeling to its device clearly stating 
that the device was to be used ``only for diagnostic breast biopsy''.
  Second, the FDA already has ample power to confront potential 
problems in labeling. For example, they sent a warning letter to the 
U.S. Surgical Corp., on June 3, 1996, regarding labeling and 
advertising claims made for the ABBI. The warning letter lead to the 
modifications in labeling and resubmission of the 510(K) application.
  Finally, the FDA has a host of criminal and civil penalties to 
prevent the marketing of mislabeled products including administrative 
detention and seizure, criminal and civil penalties, injunction, 
mandatory consumer and physician mandatory notifications, mandatory 
recall, and adverse agency publicity.
  For example, FDA can administratively detain devices that are 
misbranded based on FDA's unilateral determination that a detention is 
appropriated, and can last up to 30 days to permit the agency an 
opportunity to either perfect a civil seizure through the courts or 
obtain injunctive relief.
  Into the middle of this, the Reed amendment would throw a major 
change. The amendment does not state grounds or procedures by which the 
FDA would determine that the proposed labeling was ``false'' or 
``misleading''. The evidentiary basis by which the FDA will impute the 
manufacturers intent is unknown, as is the frequency of off-label uses 
that spurs additional FDA requirements or the adequacy of additional 
clinical trials necessary to satisfy their concerns. If the amendment 
passes, manufacturers have to be prepared to conduct trials of safety 
and efficacy for uses they are not seeking. Furthermore, the additional 
requirements only apply to the unapproved device--not to the predicate 
device previously approved by the FDA.
  The 510(K) process is intended to provide an expedited basis for 
bringing new versions of previously approved products to the market. It 
employs relatively simple and easy to apply tests of substantial 
equivalence. The tests are straight forward and predictable in their 
application. We should continue to protect this path of technological 
innovation. The FDA has ample power to prevent mislabeled products from 
endangering the public health. If the amendment passes, many innovative 
devices will not be available to consumers and the public health will 
suffer.
  Mr. KENNEDY addressed the Chair.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, I would like to just respond briefly to 
some of the points that have been made and then to get into the 
substance of the argument. I want to reiterate the importance of this 
particular provision. There are those who are trying to dismiss it as a 
relatively unimportant part of this legislation, and saying that we 
really didn't bring this issue to the attention of the committee until 
the final hours, therefore, we could not have been serious about it. Of 
course, this is completely untrue.
  I won't take the time to put in the Record the agenda for June 17 
where this was listed in ``items under discussion'' on section 4 of the 
labeling claims. This was exactly the matter that was brought up in the 
markup in June. It was identified by the Secretary of HHS in the June 
11 letter to the committee. It was repeated on September 5. Secretary 
Shalala identified

[[Page S9746]]

the very few items that she would recommend that the President veto 
this legislation about. She listed the environmental issue, the 
elimination of the environmental impact statement. Another one was a 
technical amendment dealing with PDUFA. A third item was the cosmetic 
provisions. But this is the provision that was identified by the 
principal protector of the American people's health as the most 
important provision in terms of adverse effects to public health, this 
provision. Let's understand that right from the beginning.
  I know that my colleagues say, well, there are only a couple of 
Members of this body that are really concerned about this particular 
provision. Well, it is interesting that, time in and time out, the No. 
1 person in the administration that has the principal responsibilities 
for protecting the American health has said this is it, this is the 
provision. With all due respect to those who say this is a low-risk 
issue that doesn't matter, that this is a technical question and we 
should just get through this business and get on with the vote, these 
arguments should be disregarded, because this is an enormously 
important issue. It was raised during the course of the markup back in 
June, and identified by the Secretary of HHS during the course of the 
summer. Many people were briefed by the Secretary indicating her 
priorities and this was right out there. It is in the papers submitted 
by her in September as being the primary technical concern in regard to 
safety for the American people. That might not make a difference to 
some Senators but it ought to make a difference to the American people. 
And it is not just the Secretary who is concerned about this provision. 
We have virtually every single group of health professionals charged 
with protecting the consumers' interests have expressed concern about 
this issue--the President of the United States, the Secretary of HHS, 
the Consumer Federation, the National Women's Health Network, the 
National Order for Rare Disorders. Who are these groups and 
individuals? They are the very people that benefit from innovations in 
medical devices. They are the people whose lives are enhanced. They are 
ones who are saying, ``No, don't do this. Support the Reed amendment.''

  I am glad to listen to my colleagues. I am interested in the number 
of people employed by these companies. I am interested in what a great 
job a company does. I am interested in the opinion of some of our 
colleagues who say, ``Well, this really isn't such an important measure 
because there are only a few people out there who oppose it.''
  Go down the list of the organizations that are out there protecting 
the people that will benefit most from progress in these areas, and 
they say, ``Don't do this. Support the Reed amendment.'' Do they make 
the judgment that this is not important just because it deals only with 
class II devices--the relatively low risk devices. There has been the 
suggestion here on the floor of the Senate that these are virtually 
low-risk devices.
  These are some of the devices: Ventilators. Low-risk? Who has not 
been in the hospital with a member of their family and hasn't 
understood the importance of making sure that ventilators are going to 
perform as they are labeled?
  You have digital mammography with possibilities of missing tumors in 
women with breast cancer. We want to make sure that these devices are 
going to be safe and do what they are represented and designed to do--
not just what is listed on the label.
  You have the fetal cardiac monitors that monitor infants.
  I saw them working yesterday in Springfield at the Bay State Fetal 
Center in one of the greatest neonatal centers in this country.
  Do you want to take a chance on fetal cardiac monitors? Or on 
surgical lasers?
  The list goes on--these are class II devices, low risk. We are not 
talking about tongue depressors. We are not talking about bedpans. We 
are talking about the kinds of items where we need to make sure they 
are going to be safe and effective. That is why these organizations 
whose job it is to protect the public are concerned.
  With all respect to my colleague and friend from Connecticut, who I 
heard state three times that these products, which have not been 
approved for safety and effectiveness for the uses for which they are 
being advertised, are not being mislabeled. And that we shouldn't 
dispute or cast aspersions on the good, legitimate name of the U.S. 
Surgical Corp.
  Mr. President, I have right here the letter from Dr. Monica Morrow, 
professor of surgery at Northwestern University School of Law, dated 
September 22.

       Dear Senator Kennedy:
       I am writing you to express my feelings regarding the 
     importance of the FDA's mandate to evaluate behind the scene 
     use of devices and drugs. The need for such evaluation is 
     clearly exemplified by the marketing strategy of U.S. 
     Surgical's breast biopsy device. This device was approved as 
     a diagnostic instrument. However, the company video clearly 
     depicts the use of the device for definitive breast cancer 
     therapy with no clinical trial using the accepted 
     technology for comparing cancer treatments that have been 
     conducted to evaluate this claim, and without such trials 
     the device could potentially pose a significant risk to 
     patients.
       In addition, other claims regarding approved cosmetic 
     outcome and patient acceptance are similarly unsubstantiated. 
     The indication for use of the devices and drugs should be 
     determined by appropriate clinical and scientific data, and 
     not by their appeal as a marketing gimmick. This video was 
     dropped off at my office by a company representative as part 
     of an effort to interest me in purchasing the company 
     equipment.

  I have it right here. For people who doubt it, take a minute and 
watch the video. Read the letter. Call Dr. Morrow.
  It is being marketed out there today. This is what we are talking 
about. That is the issue. When colleagues get up and say, ``Well, it 
has not been, and it won't be, and that is wrong if it is?'' I say, 
``It is being done.'' And that is exactly the problem that we are 
attempting to address.
  Mr. President, this is an enormously significant and important health 
issue. This body has taken many actions on medical devices since the 
mid-1970's to enhance public health the protections since the mid-
1970's that enhanced protections for public health. This provision 
which will create a loophole through which unscrupulous manufacturers 
of a medical device will be able to drive a truck is the exception to 
that commendable history. This provision will make a mockery of the 
substantial equivalence requirement, and will allow irresponsible 
companies to go out, as this company has, and advertise and represent a 
particular product for a purpose and use that differs from the one they 
put on the label.
  Mr. President, it was interesting that some of our colleagues 
addressing the Reed amendment pointed out that there are two ways of 
approving the medical device. Only about 5 percent medical devices use 
this particular provision, the premarket approval. That provision says, 
``In making the determination whether to approve or deny * * * the 
Secretary shall rely on the conditions of use included in the proposed 
labeling as the basis for determining whether or not there is a 
reasonable assurance of safety and effectiveness, if the proposed 
labeling is neither false nor misleading. In determining whether or not 
such labeling is false or misleading, the Secretary shall fairly 
evaluate all the material facts pertinent to the proposed labeling.''
  Mr. President, I daresay that there is probably a less compelling 
reason to use the proposed labeling as ``neither false nor misleading'' 
in this provision because you are going to have such a survey in an 
oversight for new materials as it is in the other provision.
  What the proposal that is before us now, the one that is for 95 
percent of all devices, says is, ``* * * the determination of the 
Secretary under this subsection * * * with respect to the intended use 
shall be based on the intended use included in the proposed labeling.''
  I would like to point out to those that have suggested here on the 
floor that the intended use is a subjective decision to be made by the 
FDA, that isn't what the legislation says. It says, ``* * * the 
determination of the Secretary under this * * * section with respect to 
the'' * * * device ``* * * shall be based on the intended use included 
in the * * * labeling.''
  Who makes up the labeling? The manufacturer has the labeling 
``submitted a report under this section.''
  The only thing the amendment of Senator Reed is proposing is that the

[[Page S9747]]

FDA be restricted to looking solely at the labeled use only in 
instances where ``* * * the proposed labeling is neither false nor 
misleading.''
  How can anyone be opposed to that?
  We have just seen the example of the approval of a biopsy needle for 
one particular purpose--taking the biopsy. Then we find that this 
similar machine is represented as being for the purpose of biopsies, 
here it is in their advertisement--the latest technique in minimally 
evasive breast biopsy. This device takes 50 times the amount of 
material as the other one. Here it is being advertised in Canada. Here 
it is being advertised in the United States--not for use in biopsies 
but to remove the tumor itself. And there is no information available 
to the Food and Drug Administration about how good or safe the device 
is for that use. Maybe it does work. We are not here to say it doesn't 
work. We just want the company to have to provide the information that 
says it does work. If that is what you are going to use it for, why 
should the Food and Drug Administration, which has the responsibility 
of protecting Americans, be limited by the language of this particular 
legislation that says you can only look at what is on the label? When, 
at the same time, they have letters from doctors and they have 
videotapes that show it is being used for an entirely different 
purpose.

  That is the issue. The Reed amendment says, OK, we are willing to 
only look at the use on the label, but let's just make sure that we are 
not going to encourage false and misleading labeling.
  Is the Senate of the United States going to say to the FDA that if 
even if they know that the labeling is false and misleading that they 
should be prevented from protecting the American public?
  That is what you are going to do if you do not accept the Reed 
amendment. That is what this debate is about. It is as simple as that.
  Here we have this extraordinary example, where you have a biopsy 
machine that is supposed to take a biopsy about the size of the lead in 
that pencil versus something that takes 50 times the amount and the 
purposes for it is intended to be used are quite different, as 
mentioned here in the letter which says, ``I am expressing my feelings 
* * * the importance of the FDA mandate.''
  ``The video was dropped off at my office'' with the interest of 
purchasing the equipment.
  When the FDA became aware that the company was promoting the device 
for this unauthorized purpose, it also became aware that it had made a 
mistake in clearing a device that was clearly designed for a purpose 
not stated on the labeling--tumor removal for clinical testing. The FDA 
then acted to require the company to include a strong label that the 
device was only to be used for tissue sampling; not tumor excision.
  I cannot imagine why the company failed to give the full information 
on that. But, nonetheless, that is what is happening.
  Mr. President, I listened with interest to many of our colleagues 
talking about how there really are no dangers in terms of medical 
devices, that my examples are not really what this issue is all about. 
They are mistaken.
  We are committed to ensuring that these kinds of circumstances will 
not occur in the future. That is why we are out here. We don't have to 
go through another incidence similar to the Dalkon shield where 18 
women died from a perforated uterus and 2,700 women suffered 
miscarriages. We don't want to go through another episode like the 
Shiley heart valve one where a change in the angle of the valve would 
have changed the way the device interacted with the heart raised 
questions as to its safety. The FDA discovered this and refused to let 
it go to market in the United States. But the modified device was 
marketed in Europe and 15 times the number of people died using the new 
device over the earlier one. With all respect to those who say how much 
better the system is in other countries--15 times the deaths. And the 
whole toxic shock issue that we raised and its impact on American 
women.
  What we are pointing out is that there are dangers that can take 
place in our country, that affect our people, when you start fiddling 
around with safety and effectiveness and medical devices.
  That is the issue.
  There are those who say, ``Look. We have a little loophole. But it 
really isn't quite the same as it is with some of these other terrible 
kinds of situations.''
  We have given the illustration of the kinds of challenges that are 
out there today.
  There are the laser technologies, cutting tissue laser technologies, 
where you have submitted to the FDA a laser that, everyone who has 
really looked at it agrees, is going to be used for prostate surgery. 
But there is virtually no information as to the safety and 
effectiveness of that particular medical device for that use--none. 
That is what happens.

  There are the various digital mammography devices that may be very 
good for obtaining diagnostic information and evaluating a particular 
tumor but may be questionable for screening purposes. Questionable as 
to there effectiveness in allowing women to know whether they are going 
to have the first indications of a small tumor. Don't we want to be 
sure that this isn't what it is going to be used for? Don't we know 
what they are out there marketing this for and how well it performs?
  We have just seen in the period of the last 5 days, the example of 
the terrible events concerning the off-label use of the drug fen/phen--
and the health hazards and challenges faced by the people who have used 
it.
  Are we here today saying we don't want to include language in this 
bill that will allow the FDA to be able to look at safety of medical 
devices if they find the labeling is false and misleading? We have 
offered five different compromises to work this out. It is the No. 1 
concern of the Secretary of Health and Human Services, the No. 1 
concern by the FDA. I have listened here in the Chamber, to those who 
oppose this amendment who say the FDA has all the authority in the 
world to protect the public. I have quotes here from Senators who have 
said, in effect, that we should not be bothered by this because the FDA 
has all the power it needs and that this is really not a problem.
  I was tempted to take the language of their quotes and offer it as an 
amendment because their description of the FDA is not what the law is 
and will be if this legislation is passed. We would have taken the 
kinds of protections that were implied by their quotes. Where they say, 
look, they have the real right to go behind if they think there is some 
kind of question in terms of safety.
  The FDA would not have that authority under this bill as written. But 
if it is your understanding and that is what you want, let's take an 
amendment and ensure that they do.
  But we do not have that opportunity. We are faced with the real 
possibility for a situation where the FDA does not believe it has the 
power and the authority to protect the American consumer. The FDA does 
not believe it has authority. If they know that the predominant use is 
going to be other than that which is listed on the label and which 
could provide a substantial threat to the American people, the FDA will 
not have the power or the authority to protect the American public.
  Members of Congress can come out here and say, ``Oh, yes, they do.'' 
I have listened to that argument. ``Oh, I don't know why everyone is 
getting so worked up about it. You know, they really do have the 
authority.''
  They do not have it. The FDA itself states they do not. They have 
testified they do not. The President does not believe it. The Secretary 
of HHS does not believe it. The consumer groups do not believe it. 
National Women's Health Network does not believe it, the Consumer 
Federation, the Patients Coalition.
  We have had this discussion and debate for a number of days. We 
believe we are finally getting through. But where are all the consumer 
calls saying, ``Look, let's go with what is proposed in the 
legislation. We have read the record. We have looked at the law. We 
believe the FDA is out there and can protect the American public. I 
don't know what everybody is getting worked up about.''
  But we aren't getting those calls because virtually every consumer 
group

[[Page S9748]]

that has looked at this issue, has discovered that the language in the 
bill will not provide adequate protection for consumers.
  National Women's Health Network: ``Women need the FDA to act as a 
safety sieve screening out drugs and devices that are hazardous and 
defective. If 404 is enacted, a device manufacturer could label its 
product for a very simple use. The FDA would be limited to ask for 
safety and effectiveness for that use only.''

  The groups understand this issue, and they are concerned. ``Even if 
it were clear from the device's technical characteristics that it might 
be used for other more riskier purposes.''
  That is the biopsy needle. You have a needle that is 50 times larger 
than is necessary for a biopsy and you have the clear evidence from 
doctors, both in this country and abroad, who have seen the videotape 
that the company is out there marketing it for a different use. We have 
it right here--a slick promotion for this particular issue. All we are 
saying is if the FDA is able to show that the labeling is false and 
misleading, they can look at safety.
  Mr. DODD. Will my colleague yield on that point?
  Mr. KENNEDY. I yield, sure.
  Mr. DODD. I would respectfully suggest to my colleague that U.S. 
Surgical is not marketing a video that promotes an unapproved use for 
this device. Now, there are clinicians out there who have put out 
videos and other educational materials on medical practice issues. U.S. 
Surgical is aware of that. It can happen. But the implication that U.S. 
Surgical is now actively promoting unapproved uses is not true.
  Mr. KENNEDY. Has the Senator seen this video?
  Mr. DODD. No, I have not, but I am told categorically that U.S. 
Surgical is not promoting or marketing this device other than for 
breast biopsies.
  Mr. KENNEDY. I suggest the Senator take the time to see it because 
when you turn it on, the first thing that you are going to see is the 
U.S. Surgical logo on it. I don't see how you can say that it is not 
being promoted or advanced or whatever if that is exactly what you will 
see. I would suggest to the Senator, if you are saying that those of us 
who have represented that it is being promoted for other uses--and we 
have the doctors' letters and we have this video, which you haven't 
seen--I would think that perhaps you ought to check again with U.S. 
Surgical and find out what they are doing. We have just seen it.
  Mr. DODD. Will my colleague yield?
  Mr. KENNEDY. I will yield in a second. We have just seen what the 
medical companies were doing with fen/phen. They weren't promoting it. 
All they were doing was paying the doctors thousands and thousands of 
dollars to go out and promote it. When we look at this promotion, it 
has ``U.S. Surgical'' on it, and it is a U.S. Surgical medical device--
and we have the doctors' letters on this that say, ``The indications 
for the use of devices. . . it should be determined by appropriate--

       This video was dropped off in my office by a company 
     representative--

  Company representative--

     as part of an effort to interest me in purchasing this 
     equipment.

  Now, there may be other information. I am glad to have it included in 
the Record but I find this convincing.
  Mr. DODD. If my colleague will yield. This company is not engaged in 
promoting unapproved uses for this biopsy needle. And U.S. Surgical 
categorically denies any association with any materials produced by 
others where this might have occurred. The FDA has approved the breast 
biopsy needle. The FDA has approved it twice, in fact, only for breast 
biopsies. Accordingly, U.S. Surgical does not promote the device or 
market the device for tumor removal. It is aware now that articles and 
videos do exist which discuss other uses of the devices. It is very 
common, and completely legal, for physicians to explore other possible 
uses of both drugs and devices as part of the practice of medicine. But 
the suggestion somehow that the company is now actively promoting this 
device for something other than diagnostic purposes, with all due 
respect, is just not true.
  And the question that we should be asking here--a very important 
question--is, if this obviously illegal practice is occurring, if U.S. 
Surgical is actively promoting this product for an off-label use, why 
hasn't the FDA gone after the company? Now, clearly, if it were true, 
the FDA, with all the force of law would go out and pursue them 
vehemently. Promotion of a device for unapproved uses is one of the 
most egregious violations a company can commit. Surely if this were the 
case, and evidence of it were so readily available, FDA would have 
acted. But there has been no FDA action, because there has been no 
violation. And to suggest otherwise is irresponsible.

  I mentioned earlier, if my colleague will continue to yield, that 
U.S. Surgical has promoted this device for the purpose for which it was 
approved--to give women and their surgeons a useful option in 
conducting breast biopsies. There are good medical reasons that a 
larger size biopsy might need to be taken. In conducting biopsies you 
do can not always get a reliable tissue sample just with a small 
needle--some tumors are just too diffuse. Evidence shows that, with 
some types of tumors, taking a larger biopsy gives the surgeon a far 
better chance of determining the quality of the tumor accurately 
without the need to take multiple, painful biopsies.
  That is why this device was developed. And as women who have been 
through this will tell you, it is important to have this device as an 
option for taking an accurate and safe breast biopsy.
  Mr. KENNEDY. Mr. President, I would like to regain my time.
  I say that that is a promotional document. I would suggest the 
Senator watch it before he represents that it is not. It has the U.S. 
Surgical logo on it. We have the doctors who claim this is the case. 
The FDA has been going after U.S. Surgical.
  That is another issue. It is an important issue. FDA ought to be 
concerned about it, and they are. But that doesn't get away from what 
the FDA may not be able to do sometime in the future. They won't be 
able to do it in the future, because all the FDA will have the power to 
do is look at what is on the label.
  Mr. COATS. Will the Senator yield?
  Mr. KENNEDY. No. I would like to just finish my presentation on this 
part here, and then I will be glad to yield.
  Mr. COATS. If the Senator will yield----
  Mr. KENNEDY. That is just the part I am going to mention.
  Let me quote some extracts because that is the issue that is before 
us--the extracts of the promotion. This is the promotion that some do 
not think is being promoted by U.S. Surgical, even though its logo is 
on it, even though doctors have said it is being distributed by company 
representatives.
  This is the quote:

       U.S. Surgical is entering a new millennium in breast 
     surgery by combining advanced stereotactic technology with 
     minimal invasive surgery.

  Not biopsy, surgery.

       Unlike needle biopsies where small samples of the lesion 
     are removed for pathological analysis, U.S. Surgical removes 
     the entire specimen.

  That sounds like an operation to me.

       If the specimen proves to be cancerous but pathology 
     reports the entire margin is clear, its up to the clinical 
     judgment of the surgeon to decide to remove the additional 
     tissue, or if the procedure can be considered complete.

  Translated, if you use this device and you take out the tumor, then 
it is the doctor who removes the tumor who makes the judgment whether 
he has to do any other surgery. That is not a biopsy needle. It 
continues.

       The U.S. Surgical system allows the surgeon to provide the 
     benefits of the minimally invasive technique to breast 
     surgery. Benefits to the patients include reduced physical 
     and emotional trauma as a woman undergoes only one versus two 
     procedures. Minimal invasive breast surgery, a new standard 
     of patient care offered only by United States Surgical 
     Corporation.

  I rest my case on that, Mr. President, about advertising and 
promotion. I rest my case on exactly the words of that 
promotion. ``Minimal invasive breast surgery, a new standard of patient 
care offered only by United States Surgical Corporation.''

  If there are Members in this body who want to say U.S. Surgical is 
not promoting it, that they are not associated with it, that they don't 
know anything about it, I suggest that they watch this videotape.
  Now, Mr. President, I want to just come back to--how much time 
remains

[[Page S9749]]

because I know there are others who wish to speak.
  The PRESIDING OFFICER. The Senator has used 33 minutes and 30 
seconds.
  Mr. KENNEDY. I yield at this point now. I would like to go on to just 
some other remarks.
  Mr. COATS. Just briefly. Senator Dodd asked the question, if this is 
such an egregious violation of FDA policy, why hasn't FDA acted on it? 
Why has it not acted?
  Mr. KENNEDY. They have. As I understand, they have requested the 
additional information on safety and efficacy. They are demanding that 
kind of information now. I will be glad to provide that.
  But that has as much relevancy as yesterday's score of the Green Bay 
Packers. They are out there now promoting this for unintended uses. I 
do not think they should be. FDA says they are looking into this. I 
will find out and give the Senator a more detailed description.
  Mr. COATS. I have a copy of a letter. The Senator was handed a 
letter. I was handed a letter.
  The letter was addressed to Senator Kennedy thanking him personally 
for the assistance that he provided, for the ``assistance provided by 
your staff'' to U.S. Surgical ``in our efforts to deal with the Food 
and Drug Administration on the matter of the certification of the 
Advanced Breast Biopsy Instrumentation.''
  That is what we are talking about.
  Mr. KENNEDY. Sure.
  Mr. COATS. It says here the Senator assisted in making sure the FDA 
did not withdraw it. It specifically cites, ``Please convey my 
gratitude to Dr. David Nexon and Gerry Kavanaugh,'' who I believe are 
on the Senator's staff, ``for their willing assistance.'' Maybe they 
are on the market because the Senator intervened to keep it on the 
market.
  Mr. KENNEDY. Well, Senator, I will be glad, first of all, to have it 
included in the Record so the record is clear. But I will say to you 
that, if U.S. Surgical was distorting and misrepresenting to the 
American public, then I think they ought to be pursued to every extent 
of the law. That is my response on it.
  I had no idea of that unfair kind of consideration at that time, but 
clearly they have misrepresented themselves in this instance. They 
practiced that kind of misrepresentation on me as they are doing it 
with the American public.
  Mr. COATS. Will my colleague yield?
  Mr. KENNEDY. Here is their--I will yield briefly on this point. But I 
want to get back to my theme.
  Mr. COATS. Apparently they convinced your staff, Dr. Nexon, that this 
was a safe procedure and it should not be withdrawn.
  Mr. KENNEDY. I will be glad to take a look at the letter.
  Mr. COATS. I ask unanimous consent the letter be printed in the 
Record.
  There being no objection, the letter was ordered to be printed in the 
Record, as follows:

                                              Thermo Electron,

                                     Waltham, MA, October 8, 1996.
     Hon. Edward M. Kennedy,
     U.S. Senate, Russell Senate Office Building,
     Washington, DC.
       Dear Ted: I want to thank you personally for the guidance 
     and assistance provided by your staff to our representatives, 
     and those of U.S. Surgical Corporation, in our efforts to 
     deal with the Food and Drug Administration on the matter of 
     the certification of the Advanced Breast Biopsy 
     Instrumentation (ABBI) system technology. Our concern, simply 
     stated, is that the FDA will call for the withdrawal of this 
     product from the market without appropriate cause.
       The ABBI technology, jointly developed and marketed by both 
     companies, is today in the marketplace, and as a result of 
     its success, represents a fast-growing opportunity for Thermo 
     Electron's Trex Medical Corporation subsidiary and our 
     Connecticut partners, U.S. Surgical. The technology is a non-
     invasive, cost-effective alternative to surgery. In over 500 
     cases in which it has been utilized, there has not been a 
     single complaint. Indeed, because it does represent a 
     significant advance in women's health care, it is fast 
     becoming the treatment of choice.
       Thermo Electron has made a significant investment in this 
     technology, and with the recent acquisition of XRE 
     Corporation of Littleton, Massachusetts, plans to expand 
     production of the product. Along with one hundred new jobs, 
     we are projecting revenue production in excess of $50 
     million. Thermo Electron is proud of its responsiveness to 
     societal needs. The ABBI technology is a step forward in the 
     field of women's health care.
       Thank you for your interest, and please convey my gratitude 
     to Dr. David Nexon and Gerry Kavanaugh for their willing 
     assistance.
           Best regards,
                                            George N. Harsopoulos,
                                            Chairman of the Board.

  (Mr. SESSIONS assumed the chair.)
  Mr. KENNEDY. The Senator from Indiana introduced a copy of a letter 
from a Massachusetts constituent of mine dated October 8, 1996, which 
purports to thank me for the guidance and assistance my staff provided 
to U.S. Surgical Corp. in connection with the FDA certification of the 
advanced breast biopsy instrumentation [ABBI]. The Senator suggested 
that this letter was proof that I had intervened with the FDA to urge 
them to approve an off-label use for this device. The letter does not 
substantiate any such allegation, and it is untrue. I ask that the full 
text of the letter be printed in the Record.
  There being no objection, the letter was ordered to be printed in the 
Record, as follows:

                                              Thermo Electron,

                                     Waltham, MA, October 8, 1996.
     Hon. Edward M. Kennedy,
     U.S. Senate, Russell Senate Office Building,
     Washington, DC.
       Dear Ted: I want to thank you personally for the guidance 
     and assistance provided by your staff to our representatives, 
     and those of U.S. Surgical Corporation, in our efforts to 
     deal with the Food and Drug Administration on the matter of 
     the certification of the Advanced Breast Biopsy 
     Instrumentation (ABBI) system technology. Our concern, simply 
     stated, is that the FDA will call for the withdrawal of this 
     product from the market without appropriate cause.
       The ABBI technology, jointly developed and marketed by both 
     companies, is today in the marketplace, and as a result of 
     its success, represents a fast-growing opportunity for Thermo 
     Electron's Trex Medical Corporation subsidiary and our 
     Connecticut partners, U.S. Surgical. The technology is a non-
     invasive, cost-effective alternative to surgery. In over 500 
     cases in which it has been utilized, there has not been a 
     single complaint. Indeed, because it does represent a 
     significant advance in women's health care, it is fast 
     becoming the treatment of choice.
       Thermo Electron has made a significant investment in this 
     technology, and with the recent acquisition of XRE 
     Corporation of Littleton, Massachusetts, plans to expand 
     production of the product. Along with one hundred new jobs, 
     we are projecting revenue production in excess of $50 
     million. Thermo Electron is proud of its responsiveness to 
     societal needs. The ABBI technology is a step forward in the 
     field of women's health care.
       Thank you for your interest, and please convey my gratitude 
     to Dr. David Nexon and Gerry Kavanaugh for their willing 
     assistance.
           Best regards,
                                            George N. Harsopoulos,
                                            Chairman of the Board.

  Mr. KENNEDY. Obviously, if it is a biopsy needle and it was intended 
to do that, I had no idea they were out there promoting, as they have 
been, and representing it for an entirely different purpose. That is 
the issue we are talking about here, and that is what we want to do. We 
want to make certain that the FDA is going to be able to look beyond 
false and misleading information on devices labels.
  Mr. DODD. Will my colleague yield?
  Mr. KENNEDY. I will yield in just a moment now.
  Mr. DODD. Just on this point, if I could, on the point of the needle.
  Mr. KENNEDY. On the needle? All right.
  Mr. DODD. I'd like to clear up for everyone why we are discussing the 
size of the needle for the biopsy. Let's put aside for a moment your 
question of what the company has or hasn't said since we have been told 
that the FDA has not found that they are promoting the needle for tumor 
removal.
  Mr. KENNEDY. If I can reclaim my time, I cannot let that go by, that 
the FDA has said they are not promoting it. That is not the information 
on it. I cannot let the statement go by. It is your opinion that it is 
not promoting. I don't see how you can have that opinion in the face of 
the fact that this videotape has stated what it has, with this U.S. 
Surgical's logo right on it.
  Mr. DODD. If my colleague will yield, as I said earlier, if U.S. 
Surgical were promoting for uses beyond those on the label, I think the 
FDA would be acting on it. But let me again get to the point of why a 
larger needle is useful in some biopsies situations. I am not a surgeon 
or a doctor, but I am just sharing with my colleagues here, and my 
colleague from Massachusetts, why this larger needle may be needed. 
This Advanced Breast Biopsy device, as it is called, does remove a 
larger amount of tissue

[[Page S9750]]

than a conventional biopsy needle. Why? Why does it need to do that? 
This difference in needle size is not related to tumor removal. Rather, 
it addresses clinicians' requirements for sampling different types of 
lesions. Why do they do that?
  Mr. KENNEDY. If my colleague----
  Mr. DODD. I will just finish the paragraph. Breast lesions exist not 
only as discrete nodules but oftentimes as clusters of tiny particles 
known as microcalcifications. These microcalcifications appear diffuse 
on an X-ray; similar to the Milky Way. That's how surgeons describe it.
  Due to this fact, obtaining adequate amounts of tissue for biopsy is 
important in order to optimize accurate diagnosis, so that women don't 
have to go through surgery unnecessarily. This needle allows clinicians 
to take a larger single sampling, rather than many, painful, smaller 
samples that could perhaps miss the tumor tissue. That is why this 
product was developed. That is why it has been so supported by women 
and by surgeons.
  My colleague from Massachusetts can talk about videos that promote 
purposes other than this one. However, if that is the case, the FDA 
ought to be in there this very minute. But, they have not acted because 
no violation has occurred.
  Mr. KENNEDY. The Senator is not correct. The FDA is out there looking 
into this, and it doesn't do much good to try to cloud up the issue as 
to what the purported purpose of this particular medical device is.
  Here is what is in the ad. I say again, I wish the Senator would look 
at the ad, rather than just reading the U.S. Surgical statements on it. 
This is what their ad says:

       Minimal invasive breast surgery. A new standard of patient 
     care offered only by United States Surgical Corporation.

  That is what the ad says. It doesn't say minimal invasive biopsy; it 
says breast surgery.
  Maybe that is a new way of doing it. Maybe that is the best way that 
has ever been devised for protecting American women in terms of breast 
tumors. But the FDA does not have one sentence of proof or evidence 
from U.S. Surgical that provides data on the safety and effectiveness 
on this method of removing a tumor that other medical devices should 
provide. They have the biopsy needle. It is effectively the size of 
this pencil. They want one that is 50 times larger. You don't have to 
have a lot of sense to know what this is all about.

  Maybe U.S. Surgical convinced the Senator from Connecticut. But the 
documents and their promotional materials indicate what they are about, 
and that is to provide for removal of tumors from American women, one 
out of seven, who have breast cancer. And doctors who see, ``Approved 
by the FDA,'' then tell their patient this has been approved by the 
FDA, that it must be safe, and so they undergo tumor removal with this 
device. These women are entitled to adequate protection, to know 
whether that device was safe in removing that tumor. They do not know 
that today.
  And that is just the tip of the iceberg. You know about all the other 
kinds of medical devices that can fall within this category. We have 
mentioned some, like the mammography screening machines that may 
misdiagnose breast cancer. All this amendment says is, you cannot, if 
you are a medical device company, submit false and misleading 
information. I can say it another way, ``Do you want false and 
misleading information on the labeling?'' If you vote against our 
amendment, that is what you are going to be pegged with. We are going 
to be characterized as not caring if labels are false and misleading.
  Why can't we say we will support the labeling as long as it is not 
false and misleading? That doesn't sound like an extraordinary or 
revolutionary concept. This is basically what we are arguing about. 
Those who are opposed to us say, ``All right, let them provide false 
and misleading information.'' That is the other side of this argument. 
If they are not going to go through this kind of loophole, to promote 
it for some other reason, what do they have to fear?
  Mr. President, there are all kinds of technologies out there that are 
just on the cusp, ready to go on ahead through this particular kind of 
loophole. You have the mammography screening machines that have not 
been certified for use in screening. The manufacturers have not been 
provided information on that use. We know the difficulty we have faced 
in terms of mammography machinery and false negatives and false 
positives.
  Are we going to come out on the side of protecting American women on 
breast cancer, or are we going to say we are going support whatever any 
medical device company wants to do, no matter how false and misleading 
that information may be? The vast majority of manufacturers won't use 
this loophole. But you don't hear the arguments here about what the 
financial benefit will be to those companies that will not have to 
conduct the exhaustive tests for safety and efficacy. They will be at a 
competitive advantage over the other medical device companies that are 
trying to do it right.
  Mr. DODD. Will my colleague yield?
  Mr. KENNEDY. In a second. Because there will be those in those 
corporate boardrooms who will say, look, our competitor is getting in 
through this particular labeling device loophole. All you have to do is 
change the label a little bit. We will be able to do it as well. We can 
avoid the time it will take to do it right, we will save a good deal of 
our resources. We will get on the market sooner, we will beat the 
competitor, we will be on the shelves sooner.
  We can use what U.S. Surgical did, where they denied--denied--that 
they were promoting it, and yet they had some other group that was 
putting promoting it with their logo, talking about using it for an 
entirely different purpose.
  That is the issue. This is not a very complex issue. We heard earlier 
about sifting out the chaff and moving to the substance on this. This 
is it.
  What woman in this country who is facing having a tumor removed from 
her breast by a medical device believes that device is a low risk 
device? What mother that looks over a sick child in the hospital and 
sees a ventilator, thinks that ventilator is low risk? That is the 
reason that the Secretary of HHS, the President of the United States, 
virtually every consumer group, every patients' group, every group that 
will benefit the most by this kind of innovative progress in terms of 
medical devices, are saying don't do this. Don't play with our future 
health, don't pass that provision without this language. That is what 
they are telling us here on the floor of the U.S. Senate.

  We have been out here with five different sets of language ready to 
compromise. But, they won't compromise, they have the votes. They say, 
``We have the votes. We have the profits that are going to come from 
it.'' They will profit over their competition. Other hard-working, 
decent, ethical medical device companies that are trying to play by the 
rules, trying to get their product in--are going to think, ``Why not? 
Why not go ahead and do it the other way? Our competitors are doing it 
and beating the pants off of us.''
  I have just a few moments and I will be glad to yield the floor.
  The question is, will the Senate vote in favor of approving medical 
devices based on false or misleading labels? Will the Senate allow 
dangerous medical devices that have not been tested for safety and 
effectiveness to be foisted on the American people? Will companies like 
U.S. Surgical Corp. be rewarded for deceiving the FDA? Will the Senate 
put a higher value on the profits of the powerful than the health of 
the American people?
  Section 404 of the FDA bill requires the FDA to approve a medical 
device based on the user claim on the label submitted by the 
manufacturer, even if that label is false or misleading. It prevents 
the FDA from requiring the manufacturers to show their product is safe 
and effective for the purposes for which it will really be used--as 
opposed to the purpose falsely claimed on the label. It stands 20 years 
of progress toward safer and more effective medical devices on its 
head.

  Nothing better shows the need for the Reed-Kennedy amendment than the 
recent history of the advanced breast biopsy instrumentation system, a 
device developed and marketed by the U.S. Surgical Corp. This attempt 
to mislead the FDA and foist an untested machine on women with breast 
cancer

[[Page S9751]]

shows why it is critical that section 404 not be passed in its current 
form.
  The U.S. Surgical Corp. submitted their new machine to the FDA for 
approval based on a labeled claim that it was to be used for biopsying 
breast tissue suspected of being malignant. This is a common procedure 
used when mammograms or other diagnostic techniques identify suspicious 
looking areas of the breast that may indicate malignant tumors. If the 
biopsy of a small piece of the suspicious material indicates a 
malignancy, surgery would normally follow to remove the cancerous 
tissue.
  But U.S. Surgical's labeled claim was false. One of the models of the 
machine was designed to excise a piece of tissue 50 times as large as 
previous biopsy instruments--the size of a piece of a hot dog as 
compared to the size of the tip of a lead pencil. It was clearly 
designed to be used to excise small tumors--not just to perform a 
biopsy. But the machine was not tested to see whether it was safe and 
effective for this purpose. The company was, in effect, proposing to 
subject women with breast cancer to surgery with a machine that might 
have been less effective in curing their illness than existing 
therapies.
  Women ought to have a choice on existing therapies whether they want 
to take a chance on this.
  It placed the company's profits first--and the patient's needs last.
  In fact, the only clinical testing the company submitted to the FDA 
in support of their application had been performed on seven cow's 
udders and two pieces of beef.
  Because FDA initially relied on U.S. Surgical's false and misleading 
label, the device was subjected only to an engineering review and was 
cleared for use on February 1, 1996. Had the product been honestly 
labeled, FDA would have reviewed it using a multidisciplinary team and 
required the company to present genuine clinical data in support of the 
application.
  On March 29, 1996, the FDA obtained a copy of a promotional videotape 
that U.S. Surgical was distributing to physicians to try to sell their 
product. The videotape clearly describes the device as appropriate for 
surgically removing small lumps of cancerous tissue. Let me quote some 
extracts from this slick production:

       U.S. Surgical is entering a new millennium in breast 
     surgery by combining advanced stereotactic technology with 
     minimally invasive surgery * * *.
       Unlike needle biopsies where small samples of the lesion 
     are removed for pathological analysis, the ABBI system 
     removes the entire specimen * * *.
       If the specimen proves to be cancerous but pathology 
     reports the entire margin is clear, it is up to the clinical 
     judgment of the surgeon to decide to remove additional tissue 
     or if the procedure can be considered complete.
       The ABBI system allows surgeons to provide the benefits of 
     a minimally invasive technique to breast surgery. * * *
       Benefits to the patient include: reduced physical and 
     emotional trauma as a woman undergoes only 1 versus 2 
     procedures. * * *
       Minimally invasive breast surgery. A new standard of 
     patient care offered only by United States Surgical 
     Corporation.

  They have the audacity to suggest they are not promoting it.
  It is clear that this company has designed this machine for breast 
surgery, not just biopsy. And it is promoting it for this purpose--
despite the false and misleading label submitted to the FDA.
  Here is what a distinguished physician, Dr. Monica Morrow, professor 
of surgery at Northwestern University, had to say about the company's 
machine--I referenced that--

       I am writing to express my feelings regarding the 
     importance of the FDA's mandate to evaluate ``behind the 
     label'' uses of devices and drugs.
       The need for such evaluation is clearly exemplified by the 
     marketing strategy for the U.S. Surgical breast biopsy device 
     (ABBI). This device was approved for use as a diagnostic 
     instrument. However, the company video clearly depicts the 
     use of the device for definitive breast cancer therapy.
       No clinical trials using the accepted techniques for 
     comparing cancer treatments have been conducted to validate 
     this claim, and without such trials, the device could 
     potentially pose a significant risk to patients. In addition, 
     other claims regarding improved cosmetic outcome and patient 
     acceptance are similarly unsubstantiated. The indications for 
     the uses of devices and drugs should be determined by 
     appropriate clinical and scientific data, and not by their 
     appeal as marketing gimmicks.
       This video was dropped off in my office by a company 
     representative as part of an effort to interest me in 
     purchasing this equipment.

  When the FDA became aware that the company was promoting the device 
for this unauthorized purpose, it also became aware that it had made a 
mistake in clearing a device that was clearly designed for a purpose 
not stated on the label--tumor removal--without adequate clinical 
testing. The FDA then acted to require the company to include a strong 
cautionary label that the device was only to be used for tissue 
sampling, not tumor excision. And it required it to submit clinical 
data on its use for the original claimed purpose of biopsy. Based on 
this revised label and the new clinical data, the FDA re-cleared the 
machine for breast biopsy on September 24, 1996.
  That is what the FDA has been doing, effectively denying them the 
opportunity to use it for these other purposes, and permitting them to 
use it only for biopsy.
  And it further required the company to conduct studies on the safety 
and effectiveness of the machine for tumor removal, studies which are 
ongoing.
  Evidently, the company, when asked to provide the additional studies, 
they agreed. That is interesting, isn't it? Now, once they have gotten 
caught they say, ``OK, we'll supply the data.''
  If section 404 is passed in its current form, the FDA will be 
handcuffed in its efforts to protect the public against untested and 
potentially harmful--even fatal--devices. Under current law, the FDA is 
able to require that the company develop data to show that the new 
device was safe and effective for removing tumors--the real use 
intended by the company, not the false and misleading use submitted on 
their proposed label. When the FDA made a mistake and inappropriately 
cleared the device, it had the authority to go back to the company and 
warn that it would revoke their approval unless adequate warnings were 
placed on the label and necessary clinical testing was performed.
  I hope our colleagues will listen to this.
  But under section 404 of the FDA reform bill, the FDA would be forced 
to approve the new device without such evidence. Unscrupulous companies 
will not only be allowed but encouraged to submit misleading labels, 
because they will gain a competitive advantage over companies that play 
by the rules.
  American women do not want to die from breast cancer because 
companies are allowed to sell devices that may be unsafe and 
ineffective. No Senator would want their own wife or mother or daughter 
to be subjected to such an untested device, solely because a greedy 
company wanted higher profits.
  The issue goes far beyond products to excise breast cancer. If 
applies to lasers to treat prostate disease, stents to be placed in 
carotid arteries, imaging systems to detect breast cancer, and a host 
of other treatments for dread diseases.
  The FDA believes those numbers will increase dramatically as the new 
technologies come into play.
  If allowed to stand, this provision will give unscrupulous companies 
a license to lie to the FDA. It will penalize ethical companies who are 
truthful and do the necessary testing to prove that their products are 
safe and effective. Most of all, it will put the health of American 
people at risk so that a greedy few may profit.
  Companies that hope to benefit by weakening the FDA are powerful and 
profitable. They believe they have the votes to push this disgraceful 
provision through the U.S. Senate. Later today, we will see if they are 
correct. But if the American people truly understand what is at stake, 
I do not believe they will permit this dangerous provision to become 
law. When the vote comes, we will see how many Senators are willing to 
stand with the American people--and how many are willing to vote in 
favor of false and misleading labeling. And let me make very clear that 
this vote will not be the end of the story, whichever way it ends up. 
We will continue to fight to keep this provision from becoming law, and 
I believe we will ultimately succeed.
  The FDA reform bill has many constructive elements. But this 
disgraceful provision should be eliminated. False or misleading labels 
should have no place in approval of medical devices. Unscrupulous 
manufacturers do not deserve a free ride at the expense of public 
health.
  The Reed-Kennedy amendment will protect Americans against dangerous

[[Page S9752]]

machines and unethical practices. It is a simple amendment. It says 
that the FDA should not be bound by the company's label if the label is 
false or misleading. Every Member of the Senate should support this 
simple, common-sense change. I know that the American public supports 
it.
  And I know that every patient and every physician deserve to know 
that the FDA has had a fair opportunity to assure that the devices on 
which lives and health depend are safe and effective.
  I yield the floor.
  Mr. JEFFORDS addressed the Chair.
  The PRESIDING OFFICER. The Senator from Vermont.
  Mr. JEFFORDS. Let me try to remove some of the confusion that I think 
must exist. Certainly the Senator from Massachusetts most eloquently 
has expressed his feelings, but his feelings and the law are not 
necessarily the same.
  I point out, first of all, that false statements, all these kinds of 
problems, are certainly reachable. Let us get back to where we are. Let 
us remove first a couple of the things that have been invoked here in 
the discussion. Fen/phen, for instance. Fen/phen deals with drugs, not 
with devices. So do not get that confused with this particular 
situation here.
  In addition to that, I point out that because of the off-label use of 
drugs, this committee appropriately put in place a system which would 
have probably even prevented fen/phen but at least would have made it 
possible for the FDA to intervene through the knowledge that they might 
not have had. So I want to take that completely out. That just raises 
insecurities in people which is inappropriate under this legislation.
  Second, with respect to the debate on devices, I think it is 
important that we take a look at what we are talking about here. 
Devices are different from drugs. Devices have to do with things which 
are implanted in you or are used like the neck collar, whatever else, 
which do require approval.
  There are two ways to approve these matters. One is the PMA, the 
premarketing approval.
  The amendment that they are asking for would require not only the 
premarketing analysis but would move the same kinds of standards which 
are in the premarketing approval process over to the 510(k) process.
  Why is that? First of all, the premarket approval is the one which 
requires all the clinical trials and tests and which makes it very 
clear as to whether a device is going to create a threat.
  Let us put that into dimension here. Just in the 510(k) process, 
there were over 5,000 a year. Over the last 6 years that has been about 
30,000 devices. There have only been five or six that have created any 
problem which required mandatory recall.
  So that evidence is with respect to two points: First, these are rare 
things and, second, there is the present ability to handle those 
situations.
  So by putting in these words ``false and misleading,'' you take this 
device basically and move it back in under the premarketing approval 
process because, if you have to approve everything, if you have the 
duty of going out and inquiring among doctors, ``Are you using this 
device which has already been approved?'' and you say, ``I have 
something which is substantially equivalent to be used for that 
purpose,'' they would have the burden of going out among the doctors 
and finding out what the practice of medicine is and whether their 
device was being used for something other than what it was approved for 
under the premarketing approval process.
  That means a huge increase in costs to each of these companies that 
are trying to get something on the market to compete with the one that 
is already on the market. This creates huge delays. And for what 
reason? For no real purpose because it is only going to be used for 
that use intended unless somebody decides to use it otherwise.

  So I think we have to remember here there is authority under the law 
for those people who abuse the process. But one of the purposes of the 
510(k) was to reduce the time so that competition can get out there 
with a better device and bring the costs down because there would be no 
longer a monopoly in that situation.
  The second purpose is to relieve the FDA from having to recheck and 
reexamine a device which is substantially or equivalent to the one that 
has already been studied and require the FDA to go out and examine all 
the doctors, all those kinds of things and create a huge burden on the 
FDA.
  So our purpose here in the bill is to make sure that we have an 
efficient, effective FDA with adequate resources to do their job. So I 
want to make it clear as to what the discussion is supposed to be 
about. I also remind you that the 510(k) process only applies to those 
devices which are not life threatening, so they are not the devices 
that would do the kind of horrendous things that the Senator from 
Massachusetts has alluded to.
  I yield to the Senator from Connecticut.
  Mr. DODD. I thank my colleague for yielding.
  Mr. President, may I ask--the hour of 12:30 is going to arrive here. 
I think there has been an earlier order that would have us recess.
  Mr. JEFFORDS. I ask unanimous consent that we be allowed to proceed 
until 12:40.
  Mr. DODD. I thank my colleague for yielding.
  Mr. President, I sat here and listened to this debate this morning. A 
good part of it has been focused, not on the merits of the provision, 
but on one individual company in the State of Connecticut, U.S. 
Surgical Corp., and a device which they developed for diagnostic 
purposes related to breast cancer.
  I think it is unfortunate that there have been so many misleading 
statements made about this company, who not once, but twice, received 
full FDA approval for this diagnostic device.
  I would like to make the fact extremely clear--just for the purposes 
of the Record. The company's original application was submitted to the 
FDA on October 5, 1995 and was cleared by the FDA 119 days later, on 
February 1, 1996.

  The company resubmitted their medical device under the 510(k) on 
September 23, 1996, with additional clinical data requested by the FDA. 
This resubmitted 510(k) was cleared by the FDA on December 20, 1996, 88 
days later. The process works.
  I cite for the Record here, Mr. President, what is on the label.

       Indication: For diagnostic sampling of breast tissue where 
     large diameter incisional breast biopsies are desired.
       Contraindication: The device is used for diagnostic breast 
     tissue biopsies; it is not [in bold letters] intended for 
     therapeutic excision of tissues.

  Now, I don't know what could be more clear than that. I ask unanimous 
consent this be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                      ABBI biopsy device chronology
            Original 510(K)                Indication: Transection of
                                         tissue during a surgical biopsy
                                                    procedure
October 5, 1995                         Original 510(K) Premarket
  through                                Notification submitted to FDA.
February 1, 1996                           Minor questions answered.
                                        FDA clears 510(K) and issues
                                         Substantial Equivalence letter.
                                         (119 days)
 
May 8, 1996                             FDA raises questions regarding
  through                                the ABBI device.
June 6, 1996                               FDA states they made a
                                            mistake in clearing the
                                            original 510(K) without
                                            asking for clinical data.
                                           FDA states USSC has done
                                            nothing wrong; it was FDA
                                            who neglected to request
                                            data.
 
                                           FDA issues Warning Letter to
                                            USSC, 6/3/96, regarding
                                            labeling and advertising
                                            claims made for the ABBI.
                                           FDA meeting held, 6/6/97,
                                            with USSC, Dr. Barbara
                                            Schwartzberg and Dr. Bill
                                            Kelly to review data
                                            demonstrating the safe and
                                            efficacious use of the ABBI
                                            as a diagnostic biopsy
                                            device. USSC agreed to work
                                            with FDA to gather
                                            retrospective clinical data
                                            from ABBI users to address
                                            FDA safety and efficacy
                                            issues stemming from larger
                                            core needle design.
          510(K) Resubmission              Indication: For diagnostic
                                         sampling of breast tissue where
                                            large diameter incisional
                                           breast biopsies are desired
                                         Contraindication: The device is
                                            used for diagnostic breast
                                            tissue biopsies; it is NOT
                                             intended for therapeutic
                                               excision of tissues
 

  


[[Page S9753]]

  


                ABBI biopsy device chronology--Continued
September 23, 1996                      USSC resubmits 510(K) for ABBI
                                         including modified labeling, 39
                                         clinical case reports and
                                         commitment to submit additional
                                         clinical case reports over the
                                         next several days.
                                           USSC submits additional
                                            clinical case reports to
                                            supplement the original 9/23/
                                            96 submission for a total of
                                            312 ABBI clinical case
                                            reports. On 10/16/96 FDA
                                            requested that no more data
                                            be sent while they analyze
                                            what has been submitted.
                                           USSC responded to numerous
                                            FDA questions regarding
                                            clinical data and labeling.
December 20, 1996                       FDA clears 510(K) resubmission
                                         and issues Substantial
                                         Equivalence letter. (88 days)
December 23, 1996                       FDA rescinds original 510(K),
                                         dated October 5, 1995, so no
                                         other substantially equivalent
                                         device will have a basis for
                                         submission without
                                         corresponding clinical data.
 

  Mr. DODD. This is the chronology of the events. This device is being 
used to try and improve biopsy and diagnostic purposes and reduce, 
hopefully, the need for unnecessary surgery--something most people 
applaud. And the label clearly limits the product to that purpose.
  The Senator from Massachusetts suggests that this is somehow a 
rationale for us to reduce or change the language of this bill that 
deals with the approval process for less riskier medical devices. He 
cites a lot of examples that has nothing to do with this issue. Fen/
phen has nothing to do with this amendment. The Dalkon shield has 
nothing to do with this amendment; that was a failure of technology 
that had nothing to do with the intended purpose of the device.
  The examples cited, one after another, do not address the issue at 
hand. The issue at hand is how the FDA interprets intended use in 
making a substantial equivalence determination --the first test a lower 
risk device undergoes. That is what we are dealing with here.
  If you have to say to a company that it must try and imagine what a 
device conceivably could be used for by some surgeon out there, and on 
that basis FDA can hold up its 510(k), you might as well scrap 510(k) 
and make every new device, even low-risk ones, go through the PMA 
process. You can make a case for that, I suppose. But I don't hear 
anyone advocating that. But if you really believe that we ought to so 
change this process, then get rid of 510(k) altogether--that is the 
safest way to go. But again, I don't hear anyone suggesting that.
  All we are saying here is, the FDA ought to look at the intended 
purpose listed, and ought not try and go beyond that, particularly when 
they have full authority to apply the second test of reviewing 
technological differences. All we are trying to do here is to expedite 
the process a bit so we do not delay further the ability of very 
worthwhile devices to get approved by the FDA and get to the 
marketplace.
  I regret deeply that a very fine company with a tremendous track 
record that has produced some wonderful devices has been the subject of 
an attack here on the floor. It is not deserved. It is not deserved. 
They produce a very worthwhile product, the breast biopsy needle, that 
has been approved by the FDA and is making a difference in women's 
lives. There are thousands of examples of where this device and other 
products made by this company have made a difference in people's lives. 
This company, U.S. Surgical, has been manufacturing medical devices in 
Connecticut for over 30 years now and has an excellent track record for 
producing safe, effective, and innovative products. In addition to 
setting the gold standard for the laproscopic surgery devices, as I 
mentioned earlier, I should also note that U.S. Surgical pioneered the 
technique of closing wounds with staples, rather than sutures--a 
revolution in everyday medical practice. The thousands of Connecticut 
workers who help create these products, ought to be applauded by our 
colleagues rather than used as an irrelevant example, somehow, of some 
attempt to limit the protections that the FDA offers.
  For those reasons, Mr. President, I urge our colleagues, with all due 
respect, to reject the Reed-Kennedy amendment and to support the 
provision we have included in this legislation which we feel not only 
adequately protects people, but does even more than that. It allows 
them to get the materials they need to see they have a healthier and 
safe life.
  Mr. JEFFORDS. I yield 5 minutes to the Senator from Indiana.
  The PRESIDING OFFICER. The Senator from Indiana.
  Mr. COATS. Mr. President, again I want to tell Members I think it is 
important to keep their eye on the goal here and on the facts. Senator 
Dodd went through part of the chronology of the approval of the device 
that Senator Kennedy was talking about.
  I say to my colleagues, the system is working the way it is supposed 
to work. FDA has the authority. The company submitted the application, 
FDA cleared the device, then questions came up about it, and the FDA 
responded and asked for some additional material, and then they 
acknowledge that, yes, we had the material, you sent it to us, but we 
didn't get a chance to review it. We have now reviewed it.

  Mr. KENNEDY. Will the Senator yield?
  Mr. COATS. I will be happy to in a moment.
  They made a change in the ``indication'' and ``contraindication'' in 
accordance with what FDA asked them to do. They resubmitted for a new 
510(k). FDA, with the help, apparently of Senator Kennedy and his 
staff, approved the 510(k) and then the new 510(k) was applicable.
  So that is exactly how FDA is supposed to work and it did work under 
the existing procedures.
  Again, over and over and over, what has not been described and 
discussed is the authority that the FDA has regarding changes in 
technology that raised questions of safety and efficacy, effectiveness 
of the predicate device.
  Mr. KENNEDY. Will the Senator yield?
  Mr. COATS. Happy to yield for a question.
  Mr. KENNEDY. If you would be willing just to maintain the current 
law, we could move very quickly toward final passage.
  The Senator has just given an excellent explanation about how the FDA 
works at the present time. That procedure is being halted dramatically 
in this law. So if the Senator would support----
  Mr. COATS. Reclaiming my time.
  Mr. KENNEDY. I had yielded----
  The PRESIDING OFFICER. The Senator from Indiana has the floor.
  Mr. COATS. I think the Senator from Massachusetts knows exactly what 
it is we are attempting to do and why we are doing it. It is part of 
the two-part test. The second part, which the Senator admits on every 
example he uses and every example he uses does not apply to the 
situation as it exists. Dalkon shield has nothing to do with this; fen/
phen, as the Senator knows, has nothing to do with this language. This 
whole thing was supposedly prompted by the fen/phen scare, and the 
Senator failed to admit that fen/phen is a drug and not a device.
  Most of us are trying to keep some level of patience and some level 
of perspective on this whole process and procedure. I don't know of 
anybody at U.S. Surgical--they may have visited my staff. I have never 
talked to anybody that I know of from U.S. Surgical. I didn't even know 
they made that device. All I know is when they got in trouble they went 
to Senator Kennedy, and the very device he is talking about that is so 
dangerous to women's health, he intervened, or at least participated in 
the process of clearing U.S. Surgical.
  I had printed in the Record the letter citing specifically Senator 
Kennedy's help and the help of Dr. David Nexon, Senator Kennedy's 
staffer and Gerry Kavanaugh. There was no explanation of that minor 
omission in the Senator's presentation. I would be interested to hear 
what that might be.
  So, the Senator criticizes the Senator from Connecticut for 
supporting this company and not being objective with the facts, when 
the Senator, who is raising the issue in the first place, has been the 
person to provide that support.
  What we are attempting to do is to return to past law which sets in 
place a reasonable procedure whereby devices that are substantially 
equivalent under FDA's determination to devices

[[Page S9754]]

that have already gone through lengthy premarket approval processes, 
where those devices can be expedited into the system because there is 
no difference and the question is on the label what the intended use 
is, not on what somebody tries to make the intended use to be. It would 
be impossible for anybody, any company, anybody to possibly speculate 
and list all the ways in which people might think up of using devices. 
The company produces it for a specific purpose, it provides an 
indicator for a specific purpose, and a contraindicator for how it is 
not to be used, and if there is in any way a technological change in 
that device, then FDA has full and complete authority to deny the 
substantial equivalency label.
  Let's keep our eyes focused on what we are attempting to do here and 
not be confused by egregious examples that don't even fit the issue, 
that don't even go to the core of what we are debating. It makes for 
good theater. It makes for lousy legislation.
  Mr. JEFFORDS. I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll. The bill clerk 
proceeded to call the roll.
  Mr. JEFFORDS. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                      Unanimous-Consent Agreement

  Mr. JEFFORDS. Mr. President, I ask unanimous consent that the Senate 
stand in recess until 2:15 p.m., and when the Senate reconvenes, there 
be only the following time remaining, limited in the following fashion: 
20 minutes under the control of Senator Kennedy, 20 minutes under the 
control of Senator Jeffords, 10 minutes under the control of Senator 
Harkin, and 10 minutes under the control of Senator Frist.
  The PRESIDING OFFICER. Is there objection?
  Mr. HARKIN. Mr. President, reserving the right to object. I ask the 
manager of the bill, would the 10 minutes under my control occur prior 
to the vote on the Reed-Kennedy amendment or after the vote?
  Mr. JEFFORDS. After the vote.
  Mr. HARKIN. I appreciate that. I have no objection.
  The PRESIDING OFFICER. Without objection, it is so ordered.

                          ____________________