[Congressional Record Volume 143, Number 123 (Tuesday, September 16, 1997)]
[Senate]
[Pages S9378-S9385]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 
                                  1997

  The Senate continued with consideration of the bill.
  The PRESIDING OFFICER. The Senator from Vermont is recognized.
  Mr. JEFFORDS. I yield 10 minutes to the Senator from Connecticut.
  Mr. DODD. Mr. President, I thank the Chair and I thank my colleague 
from Vermont, the chairman of the committee.
  Let me begin these brief remarks by commending all of our colleagues 
on the Labor and Human Resources Committee. This has been a long 
process, 2\1/2\ to 3 years. The Presiding Officer is a member of this 
committee as well and all have worked very hard, I think, to bring a 
bill which I think most would agree is a very good bill.
  There obviously still are some issues that will have to be resolved, 
but this has been a very fine product that has been assembled by both 
Democrats and Republicans for the first time in several decades of 
reforming the Food and Drug Administration and the processes by which 
we bring important pharmaceutical products and medical devices to 
patient groups and individuals across this country in an efficient, 
safe, and expeditious fashion.
  Let me begin as well by thanking our colleagues for their 
overwhelming support earlier today of the cloture motion to proceed 
with this bill. Mr. President, 94 Senators, of both parties, loudly and 
clearly told us they are ready to move forward to reauthorize PDUFA and 
begin debating the other critical reforms this bill contains.
  There is no Federal agency with a more direct or significant impact 
on the lives of the American people than the Food and Drug 
Administration. The foods that we serve our family, the medicines we 
take when we are sick, even the drugs we give our pets are all approved 
and monitored by the Food and Drug Administration. We must not lose the 
opportunity that we have before the Senate today to enact legislation 
that ensures that the FDA has the authority it needs to bring safe and 
effective products to the American people quickly, efficiently and 
safely.
  I again thank both Senator Jeffords and Senator Kennedy for their 
perseverance on this issue. Time after time they have been willing to 
return to the bargaining table after many others would have just walked 
away. With open minds and good faith they have extensively negotiated 
this bill line by line.
  Mr. President, we have now come to a point where issues on which 
Members were previously completely polarized--third-party review of 
medical devices, off-label dissemination of information, health claims 
for food products, the number of clinical trials needed for drug 
approval, and just today, national uniformity of cosmetics--we have now 
reached agreement.
  I don't know that any of us would have thought unanimity possible on 
these provisions even a month or two ago. Yet here we are, this 
afternoon on this day, with full agreement on all but a handful of 
issues, or less.
  I know we have a better bill for all the arduous negotiations that 
have occurred. As an example of how far we have come, let me just 
briefly describe third-party review of medical devices. The bill would 
expand the pilot program currently administered by the FDA. This is a 
program, I should note, that is supported by the FDA as a way to make 
more efficient use of its resources.
  In last year's debate on this issue, which many may recall as being 
one of the more acrimonious, we were told that this provision was a 
nonstarter, no room for compromise, subject closed.
  This year, I am pleased to say a spirit of bipartisanship and 
compromise has prevailed. Senator Harkin, Senator Kennedy, and Senator 
Coats, the Presiding Officer, worked diligently to draft language that 
ensures that higher risk devices are not inappropriately included in 
this pilot program and that strong conflict of interest protections are 
in place.
  Late last week, again on an issue that appeared unresolved, national 
uniformity for cosmetics, we have reached agreement. Senator Gregg of 
New Hampshire has offered what I think is a very reasonable compromise. 
In the area of packaging and labeling, States can continue to regulate 
where the FDA has not acted. Conflicting State requirements that could 
confuse consumers will be removed. But where the FDA has not chosen to 
act, where it does not have either the manpower nor the authority to 
protect the public, States can still play their historic role in 
regulating cosmetics.
  This is the kind of effort, Mr. President, made over and over again 
on this bill--some 30 times just since the markup 2 months ago that we 
have made improvements in this legislation. A great many of us take 
pride in the product that we have created --a bill that would speed 
lifesaving drugs and devices to patients and that clearly retains the 
FDA as the undisputed arbiter of the safety and effectiveness of the 
products.
  I will speak about some of the positive reforms contained in this 
bill, as well.

  At the heart of this bill is the 5-year reauthorization of PDUFA, the 
Prescription Drug User Fee Act, a piece of legislation remarkable for 
the fact

[[Page S9379]]

that there is unanimous agreement that it really works. PDUFA has set 
up a system of user fees which drug companies pay to the FDA. These 
fees have enabled the agency to hire more staff. As a result, drug 
approval times have been cut almost in half, getting new and lifesaving 
therapies to patients more quickly.
  In addition, by improving the certainty and clarity of the product 
review process, S. 830 encourages U.S. companies to continue to develop 
and manufacture their products in the United States, not an 
insignificant matter. The legislation emphasizes collaboration early on 
between the FDA and industry during the product development and product 
approval phases. This will prevent misunderstandings about agency 
expectations and we think should result in quicker development of 
approval times.
  Mr. President, in addition, S. 830 establishes or expands upon 
several mechanisms to provide patients and other consumers with greater 
access to information and lifesaving products. For example, the 
legislation will give individuals with life-threatening illnesses 
greater access to information about the location of ongoing clinical 
trials of drugs.
  Based on a bill originally championed by Senators Snowe of Maine and 
Dianne Feinstein of California, I offered an amendment in committee, 
which I was pleased to see adopted, to expand the existing AIDS 
database to include trials for all serious or life-threatening 
diseases.
  Experimental trials offer hope for patients who have not benefited 
from treatments currently on the market. Currently, patients' ability 
to access experimental treatments is dependent on their spending large 
amounts of time and energy contacting individual drug manufacturers 
just to discover the existence of trials.
  Mr. President, this is not a burden that we should place on 
individuals already struggling with chronic and debilitating diseases. 
This database will provide one-stop shopping for patients seeking 
information on the location and the eligibility criteria for studies of 
promising treatments.
  Mr. President, I am particularly pleased that this legislation 
incorporates the Better Pharmaceuticals for Children Act, legislation 
originally introduced by our former colleague from Kansas, Senator 
Kassebaum, and now cosponsored by myself and Senator DeWine of Ohio, 
along with Senator Kennedy, Senator Mikulski, Senator Hutchinson, 
Senator Collins, and Senator Cochran.
  This provision, Mr. President, addresses the problem of the lack of 
information about how drugs work on children, a problem that just last 
month President Clinton recognized publicly as a national crisis.
  According to the American Academy of Pediatrics, only one-fifth of 
all drugs on the market have been tested for their safety and 
effectiveness on children. This legislation provides a fair and 
reasonable market incentive for drug companies to make the extra effort 
needed to test their products for use by children.
  It gives the Secretary of Health and Human Services the authority to 
request pediatric clinical trials for new drug applications and for 
drugs currently on the market. If the manufacturer successfully 
conducts the additional research, 6 extra months of market exclusivity 
would be given.
  I recognize that there are a few matters unresolved in this bill 
despite the best efforts of all involved, and we will need to hold 
votes on those issues. One issue, which I plan to discuss further when 
we debate the bill this week, involves section 404 of the bill, which 
relates to the FDA's medical devices. This provision, the so-called 
labeling claims provision, clarifies current law by stating that while 
reviewing a device for approval, FDA should look at safety and efficacy 
issues raised by the use for which the product was developed and for 
which it was marketed.
  Again, this is current law. Unfortunately, in a few instances the FDA 
has inappropriately expanded the scope of its review by requiring 
manufacturers to submit data on potential uses of the product. Some 
have raised concerns that under this provision a manufacturer could 
propose a very narrowly worded label for a device and that the FDA 
would be barred from asking for information on other obvious uses.
  I don't believe this is the case. The FDA retains its current 
authority to not approve a device if features of the device raise new 
questions of safety and efficacy. Clearly, if a bad actor device 
manufacturer attempted to get a misleading label past the FDA, the 
agency would have full authority to disapprove the product.
  Again, I urge, on this matter, that some common ground be sought to 
see if we cannot resolve this, but I do believe the present legislation 
is more than adequate to protect the concerns that have been raised 
about a use for a device beyond what its intended purpose would be.
  I was pleased to join Senator Jeffords, the chairman of 
the committee, as the first Democratic cosponsor of this bill. I thank 
him again for the hard work and long hours that he and his staff, as 
well as Senator Kennedy, Senator Mikulski, Senator Wellstone, Senator 
Coats, Senator Gregg and others, have contributed.

  Mr. President, this has been a long process, and while there are 
still some outstanding issues, I think this committee deserves a great 
deal of credit for having been open to the suggestions of others. There 
are about 50-some-odd amendments that are kicking around that may be 
offered. I don't know how many will actually survive the germaneness 
test when they are raised, but I hope, for those who are bringing up 
new matters here that we have not had a chance to look at, that they 
would reserve those unless there is an overwhelming need for them. In 
many cases, if the matters had been brought before the committee 
earlier, we might have been able to handle them.
  We have a few days left to get the bill done. PDUFA goes out of 
existence on September 30. We have been 2\1/2\ years at this now. My 
hope is we will not delay this to such a degree that we lose a historic 
opportunity to make a difference. When it takes 14 to 17 years to get 
some cancer treatments approved, there is something fundamentally wrong 
with that kind of a process. We ought to be able to make it far more 
efficient than that and also be able to provide people with the safety 
that they demand. It is a wonderfully encouraging thing in this 
country, when we think how many places we go and how many products we 
ingest and how many products we apply to our bodies and to our children 
and families, that we have a high sense of confidence that when we do 
that, it is safe and, by and large, efficient and effective. We don't 
want to lose that.
  We also believe in this day and age with all the technology available 
to us that we ought to be able to not give up on safety or efficacy and 
be able to move that process forward.
  I thank my colleague from Vermont for yielding.
  Mr. KENNEDY. Mr. President, I yield 7 minutes to the Senator from 
Illinois.
  Mr. DURBIN. I thank the Senator from Massachusetts for yielding.
  We can all remember 2 years ago when there was a debate on Capitol 
Hill about closing down the Federal Government. Rush Limbaugh and 
people like him went on the radio and said, ``Go ahead and do it, no 
one will notice. No one will notice if you close down these Federal 
agencies. They are just a drain on the Treasury and our tax dollars.''
  But the agency that we are talking about today is an agency you would 
notice immediately--immediately--because the Food and Drug 
Administration, as small as it is by Federal standards, is one of the 
most important. There is not a single thing you buy in the drugstore or 
look at in your medicine chest at home that the Food and Drug 
Administration has not taken a look at to make sure it is safe for you, 
your kids, and your family.
  That is why this FDA reform bill is so critically important to this 
Nation to make sure we make this agency more efficient. I want to 
salute the Senator from Vermont and the Senator from Massachusetts. 
They have had their differences on issues, but I think most Senators, 
Democrats and Republicans, agree reform is needed. This bill is a step 
in the right direction.
  It is in that spirit that I will offer several amendments. Let me 
tell you about two that I think people should take notice of. If you 
went out today and decided to buy a car for your family--a few years 
ago I went out and

[[Page S9380]]

bought a Ford--you will have your name and address entered into a 
computer. If at some later date something is found wrong with that car, 
the brakes are faulty or there is some mechanism on the door that is 
not safe, they will notify you, they will track you down, and they will 
send you a notice. A lot of Americans have received them, ``Come on in 
to our shop, and we will fix your car.'' That is reasonable. None of us 
want to drive an unsafe vehicle.
  My amendment says is it not now reasonable, when it comes to heart 
valves and pacemakers and items like that, that we do the same thing? 
If you or your loved one is told by the doctor you need a pacemaker, 
you think long and hard about it but say, ``Doctor, if you think that 
is what I need to live, so be it.'' You go through the surgery, and 
everything works out just fine. Wouldn't you like to be on a list 
somewhere so that if a defect is found in that pacemaker 6 months, a 
year, or 2 years later, that you can be notified? That is what my 
amendment says. Track and surveillance, find the customers that use the 
products. If there is a change, let the customers know, let the people 
know, so they can go back to their doctor, back to the hospital. I 
don't think that is unreasonable.
  The second thing is we want to move some of the drug surveillance, 
for example, and drug approval off the Food and Drug Administration 
campus and take it to third-party reviewers. Now, this is being done in 
Europe and other places. It is not unreasonable that we would go to a 
laboratory and say, ``You do the testing, you read the results; you 
tell us whether this drug is ready for the market.'' I think that is a 
reasonable thing for us to try to do, under supervised 
circumstances. But my amendment says let us make certain, absolutely 
certain, that this third-party reviewer does not have an economic 
interest in the drug company seeking approval. Would you trust a 
reviewer who just happened to have a thousand shares of stock of the 
company making the product that he is deciding whether it will go to 
market or not? Would you have second thoughts if that person was being 
offered a job by the same company whose drug he is reviewing just 
happened to get a vacation in the Caribbean last summer at the expense 
of the same company?

  Conflict of interest statutes are important here. If we are going 
beyond the Federal Government and we are going to have private 
laboratories doing this, for goodness sakes, let's be certain that 
their judgment and decisions are based on sound science and not on 
financial gain. That is what my second amendment will do.
  I think these will move us along toward making the FDA an even better 
agency. There are a lot of critics of the Food and Drug Administration. 
I have worked closely with this administration for over 12 years. Some 
of the finest people in Government are working out there. Sometimes 
they are frustrated that we wish they would bring things to market more 
quickly. Did you read the newspaper this morning? Occasionally, things 
are moved to the market that aren't safe. Thank goodness, the FDA can 
say it is time to take the item off the market, or decide the benefits 
are not outweighed by the problems this drug creates. We have to keep 
this agency strong and independent and above political criticism. The 
two amendments which I will be offering on the floor are an attempt to 
do that.
  I thank the Senator from Massachusetts for yielding.
  The PRESIDING OFFICER. Who yields time?
  Mr. KENNEDY. Mr. President, how much time do I have?
  The PRESIDING OFFICER. The Senator from Massachusetts has 25 minutes, 
20 seconds under his control.
  Mr. KENNEDY. I yield myself 20 minutes, Mr. President.
  The PRESIDING OFFICER. The Senator is recognized for 20 minutes.
  Mr. KENNEDY. Mr. President, I thank my colleague and friend from 
Illinois for reminding us how important this debate is here on the 
floor of the U.S. Senate. We are talking about the agency of Government 
that has the prime responsibility for protecting the health of the 
American consumer. We all have an interest in making sure that medical 
products are available earlier. Every one of our families have 
benefited from the innovation and resourcefulness of the medical device 
industry and from the advances of pharmaceuticals. I doubt there is any 
Member of the body that has not. So all of us want to be able to make 
sure that medical advances will be available to the American public.
  We are in a situation today where the United States through the FDA 
is leading the world, in terms of approving new drugs as well as 
medical devices. That has changed from recent years. I think all of us 
have seen some very dramatic and important progress made in recent 
years. As I have said many times before, I want to give a tribute to 
the chairman of our committee who has worked tirelessly on this issue. 
He has brought together those individuals on our committee and outside 
that have differing views, all struggling to try and advance the 
interest of the public health. I think he has made remarkable progress 
in moving us forward to where we are today. But there are important 
remaining items that I hope we can dispose of in the Senate within a 
reasonable time period so that the process could move forward. I take 
exception from the understanding of the language that has been included 
in this bill with regard to ensuring that the consumers of medical 
devices and users of medical devices have the kind of protection that 
has been referred to here by my friend and colleague, the Senator from 
Connecticut, and others.
  I have here, Mr. President, a letter from the Secretary of Health and 
Human Services, which indicates that they have four major concerns with 
this particular legislation. One of them was the area of cosmetics. 
Another area is environmental considerations, and another area is 
device manufacturing procedures. But the other important area is the 
one that I am going to address here today, and that is what I call the 
safety issue, the fen/phen issue as it applies to medical devices.

  The Secretary, speaking for the President of the United States, has 
identified this as being a major issue. So when others gather around 
and say, ``Look, we have debated this and discussed it, why are we 
bringing these matters up in this debate at this time?'' The reason 
that we are bringing it up is, as the Secretary of Health and Human 
Services has recognized, there are very powerful health consequences we 
ought to take note of and deal with and that we ought to alter and 
change.
  It isn't only the Secretary of HEW. Here is the National Women's 
Health Network, who points out:

       The network is extremely concerned with the section 404, 
     which prevents FDA from requiring medical device companies to 
     perform complete reviews on the safety and effectiveness of a 
     medical device. This must be amended to give FDA the 
     authority to verify that the label is not false or 
     misleading. Section 404 is a serious danger to women's 
     health, which must be fixed before S. 830 is acted upon by 
     the Senate.

  Then the Patients' Coalition indicates a similar concern. It outlines 
probably eight or nine major issues and section 404 is one of them.
  The Consumer Federation of America wrote:

       We are writing in support of your amendment to change 
     section 404 to prevent serious injuries to patients and 
     consumers from medical devices with false or misleading 
     labels.

  This isn't just the Senator from Massachusetts that is saying this. 
Here is the Secretary of HEW saying it. Here are the primary groups 
defending women's health and consumers' health, all who have joined in 
recognizing the dangers that this particular provision provides, and 
why it is so important that we are going to change it and alter it.
  The Consumer Federation says:

       Section 404 has been crafted to permit medical device 
     manufacturers of class II devices to limit FDA's review of 
     the safety and effectiveness of a device based upon 
     conditions of use listed on the label. Even if it were clear 
     from the device's technical characteristics that its real use 
     would be for risky purposes, FDA would be prevented from 
     looking beyond the conditions of use on the label.

  There it is. That is what the issue is. The Consumer Federation 
understands it. They are pointing out that 404 was crafted to permit 
the device manufacturers of class 2 devices to limit FDA's review of 
the safety and effectiveness of a device based upon conditions of use 
listed on the label. Even if it were clear from the device's technical 
characteristics that its real use would be for

[[Page S9381]]

risky purposes, FDA would be prevented from looking beyond the 
conditions of use of the labels.
  That is what we are addressing, Mr. President, and why this is 
important. Mr. President, all we have to do is look at today's 
newspapers. Look at this morning's newspapers, the Washington Post, 
Wall Street Journal, all across the Nation, talking about the off-label 
use of pharmaceuticals, those pharmaceuticals that were used on an off-
label basis. That is similar to the issue we are talking about here 
today with regard to medical devices, the off-label use of medical 
devices.
  But the issue that we have before the Senate this afternoon is more 
insidious. Why? Because it says that if a medical device company is 
submitting an application for a certain use, FDA can't look at any 
other uses even if there is a clear intention--and we are glad to spell 
out what that criteria would be--for example predominant use--to use 
the device or market the device for another use. That is what we are 
interested in--having FDA look at the safety and efficacy of a use 
clearly intended by the design of the medical device.
  I am going to illustrate this in just a few moments. The issue is 
whether the FDA has the authority to look at whether that medical 
device has been tested for the off-label use, which is the clear 
intention of the medical device company. And the answer is, no, they 
cannot. This isn't off-label use of two products that are being put 
together and then prescribed by various medical professions. This is 
the guardian of the American public, the FDA, that is being denied the 
ability to look beyond the label at the technological differences of a 
device in terms of safety and effectiveness. That is the issue.
  Now, there are those that say--and we heard the argument by my friend 
from Connecticut--that FDA inherently retains that power. If they do, 
let's spell it out. If we spell it out, we haven't got a problem. But 
the Secretary of HEW does not believe they have the inherent power. The 
Consumer Federation doesn't believe they have the inherent power. The 
various patient groups don't believe they have the inherent power. The 
various groups that are out there protecting the public, virtually none 
of them believe they have the inherent power. If they have it, let's 
spell it out. We can work that language out. We have been attempting to 
do that for a considerable period of time, but we have not been able to 
do so.
  The answer on the other side is, well, we can't anticipate every 
possible use that a medical device might have and we are not going to 
submit safety data for every possible use and that FDA shouldn't get in 
the minds of various doctors using that medical device, for whatever 
purpose. That is not the argument. That will be the argument you will 
hear out here on the floor of the Senate. That isn't what we are 
talking about.
  We are talking about a limited number of medical device companies 
that will go to FDA and abuse this process because they are able to get 
through the process with a label that in so many respects matches a 
previously approved one, but the medical device has an entirely 
different technology that clearly indicates a different intended use. 
That is what we are talking about.
  For example, the new lasers that are being approved by the FDA 
labeled as general lasers that are for cutting various tissue, but 
clearly designed to treat prostate cancer. We want the FDA to be able 
to say, if you are going to use that for prostate cancer, we want to 
make sure that it is safe and efficacious. We don't want to permit the 
medical device industry to submit false and misleading statements.
  That is a powerful statement. But I daresay if they are going to 
submit a statement that says they are going to use a particular medical 
device for one purpose and FDA can demonstrate that the company has 
intended the device for another purpose, and they are already involved 
in, advertising and promoting that particular medical device in 
countries all over Europe for an entirely different purpose, I say that 
is false and misleading. The Members of the U.S. Senate are going to 
have a chance to decide whether or not they are going to stand and say 
we will not permit the medical device industry to submit false and 
misleading information on labeling. We will see how that vote will go.
  We include false and misleading under what they call the PMA's, which 
means the various medical devices that have to go through a more 
elaborate procedure. We have protections against false and misleading 
advertising on that. But we are going to say that the American public 
shouldn't be assured that when the medical device industry submits a 
particular product, that they do not submit information that is false 
and misleading. And what we mean by that is that they have an intention 
to use that various medical device for an entirely different purpose 
for which there have not been adequate safety standards established or 
safety records advanced. That is the issue, Mr. President.
  That is a very, very important health issue. It is a very important 
one. You can say it is only one section out of a whole piece of 
legislation, but it is very important. First of all, let me review very 
quickly about how medical devices are approved in the FDA, so that we 
understand and put this into some criteria.
  I want to go through examples of some of the problems that we are 
facing today. I'd like to let the American people make judgments and 
decisions about whether they think adequate safety information should 
be available for digital mammography and digital diagnostic x rays. Let 
the American people judge whether these devices should be used in 
surveying women who may have cancer when they haven't been approved for 
that.
  Mr. President, let's get back to where we are today. In the light of 
today's revelations about fen/phen should we be thinking about a 
provision in this bill that would allow device manufacturers to get 
their products approved for off-label use on the basis of a false and 
misleading label.
  There are two stories in the Wall Street Journal--one yesterday and 
one today--as well as one in the Post today, which tell us why the 
Senate should give a resounding ``no'' to this fen/phen device 
division.
  The first article explains in detail how an unscrupulous drug company 
engaged in a broad conspiracy to illegally promote the use of a product 
for treatments that have not been shown to be safe and effective. This 
conspiracy involved the laundering of money, deceptive deals, and 
hospital physicians' coercion of honest employees who objected to these 
corrupt practices. Fortunately, companies which engage in these kind of 
fraudulent practices are the exception rather than the rule. But it is 
precisely the exceptions that make a strong FDA so critical.
  The second story outlines the tragic results of off-label use of two 
approved drugs, dexfenfluramine and fenfluramine. These two drugs, used 
in unapproved combination for weight reduction, were found to have 
caused irreversible heart damage in thousands of women. In addition, 
there are early revelations that fenfluramine phentermine, known as 
fen/phen, had also caused severe heart damage.
  This is truly appalling--women receiving medical assistance for 
weight reduction, assistance they have been led to believe was entirely 
safe but which has not been tested adequately for that use--ended up 
suffering severe heart damage.
  The provision that is before us, rather than increasing protection 
for American consumers against products that have not been safe and 
effective, would actually reduce those protections. It would permit a 
device manufacturer to design a product for one use and falsely claim 
on the label submitted to the FDA that the device was for a different 
use. The FDA would be barred from protecting consumers. It would 
require the FDA to accept the manufacturer's label at face value. The 
FDA under this legislation has to accept the labeling that the 
manufacturer has put forward, even if it were false or misleading. Fen/
phen should teach us that the American consumers deserve to be 
protected against unsafe product uses. But the provision before us goes 
in exactly the opposite direction. That is why the President has 
threatened to veto it. That is why a broad coalition of consumer health 
groups oppose it. And that is why the Senate should reject it.
  Mr. President, as we know, there are two categories of medical 
devices. Let me give a brief explanation of how the

[[Page S9382]]

FDA regulates and clears medical devices for marketing. It will help 
clarify the need for this amendment.
  Under the current law, the manufacturers of new class I and class II 
devices get their products onto the market 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 substantially equivalent to a 
laser that is already on the market.
  Similarly, the manufacturer of a new biopsy needle can get that 
biopsy needle onto the market by showing that it is substantially 
equivalent to a needle already on the market. These manufacturers are 
obligated to demonstrate substantial equivalence to the FDA by showing 
that the new product has the same intended use as the old product, and 
that the new product has the same technological characteristics as the 
old product. If the new product has 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.

  So, if the product is substantially equivalent and doesn't raise new 
safety effectiveness questions, it moves on through. The logic of the 
process for bringing medical devices onto the market is simple. If the 
product is very much like an existing product, it can get to market 
quickly, but if it raises new safety or effectiveness questions, those 
questions should be answered before it gets on the market.
  This process for getting new medical devices on the market, commonly 
known as the 510(k) process, is considered by most to be the easier 
route to the market. That process accounts for how 95 percent of all 
devices get to the market. Devices that are not substantially 
equivalent class I or class II devices already on market must go 
through a full premarket review. Thus, device manufacturers have an 
incentive to get new products on the market through the 510(k) process. 
In fact, well over 90 percent of the new devices get on the market 
through the submission of a 510(k) application. Section 404 of the bill 
prohibits the FDA from requiring safety and effectiveness data on any 
device following the 510(k) route except for uses the manufacturer 
chooses to put on the label, even if the label is false and 
misleading--even if the manufacturer says, ``We are just going to use 
it for cutting tissue, we are not going to use it for prostate 
cancer,'' knowing full well that they intend to use it for prostate 
cancer. All the world knows that they are going to use that device for 
prostate cancer. The FDA is prohibited from saying, ``Let us see where 
the safety is.'' Where is the safety information on that? That, Mr. 
President, is the issue.
  Let me give you a few more examples.
  On the biopsy needle for breast tumors, the needle is labeled for 
performing a biopsy. But the design clearly indicates that it is 
designed to remove tumors. Here you have a case where you have a small 
needle with a very narrow opening at the one end which is used for 
testing a biopsy of a particular tumor. Now the manufacturer comes in 
with a much broader needle, a much wider needle, and says, ``Look, our 
needle is for the same thing, just to biopsy the tumor.'' The design 
clearly indicates that it is built to remove tumors. Under the bill 
language, FDA could not ask for safety and efficacy data for the 
needle's use for tumor removal, even though that is clearly indicated 
by the designer of the device. The company comes in, and says, ``Look, 
we have a biopsy needle right here. Sure, ours is a little larger. But 
this biopsy needle is really absolutely intended to do the same thing 
as the others out there and, therefore, we are substantially 
equivalent,'' even though they are out there advertising that this 
needle can be used for removing a tumor. They don't have to provide any 
safety information about how safe or effective that device is for the 
removal procedure.
  There is also the ``laser for cutting'' issue. The labeled use is for 
general cutting. But the laser has been adapted specifically and 
clearly to cut prostate tissue. Under the bill language, FDA could not 
ask for safety and efficacy data for cutting prostate tissue.
  Digital mammography is currently approved and labeled for diagnostic 
x rays--which are used to confirm the suspicion of a breast tumor. If 
digital mammography is clearly going to be used for screening, based on 
the design of the instrument, which requires a higher degree of 
accuracy, FDA should be able to look at the effectiveness of that 
technology for that use. Without this assurance, too many women may 
undergo biopsies or be misdiagnosed. But this bill would prevent FDA 
from asking for the data needed to protect women.
  Orthopedic implants--plates and screws for long bones--some implants 
are made to be removed after the bone has healed and, therefore, 
labeled for short-term use. But if the FDA determines from the design 
of the device, or from the particular materials that the implant will 
clearly be left in the patient on a long-term basis, FDA should be able 
to ask for safety and efficacy data. For example, how does the bone 
react to having the implant there over a long period of time? Is the 
bone weaker? But this bill would prevent the FDA from asking these 
questions.

  Mr. President, I can go on, and will go on when we have the more 
general debate. But these stories exemplify the issue. The issue is 
safety. The issue is protecting the safety of the American consumer in 
regards to the use of medical devices which clearly demonstrate that 
the dominant use of those medical devices differs from what is put on 
the label.
  It would surely seem to me that men and women of reason would be able 
to work this out in a spirit of order to provide those protections. But 
we have been unable to do so. Being unable to do so we should 
understand the real implications. As when you have the off-label use of 
fen/phen, and the concern of the American people and all of the 
newspapers all over the country. You would think that here in the U.S. 
Senate we would be thinking about how we are going to provide further 
protections for the American people instead of fewer protections. Here 
in this particular medical device provision, we are hamstringing the 
FDA and its ability to gather data on safety and efficacy when it is so 
clear that the devices are going to be used for in a manner that 
differs from the one claimed.
  That is why many of us--not only the administration, but many public 
health groups and organizations that represent women--have been so 
concerned about this issue.
  I withhold the remainder of my time.
  The PRESIDING OFFICER. Who yields time?
  Mr. JEFFORDS. Mr. President, I yield myself 10 minutes.
  The PRESIDING OFFICER. The Senator is recognized to speak for 10 
minutes.
  Mr. JEFFORDS. Mr. President, I think I would like to talk a little 
bit about where we are right now in the process.
  We had an agreement this last weekend which would have allowed us to 
dispose of this bill without the necessity of going through the cloture 
process. But then fen/phen happened. All of a sudden the Nation is 
alarmed and concerned, and reasonably so. But to bring the 
pharmaceutical fen/phen issue into the device issue is disingenuous. 
The situation with fen/phen is that two different, approved drugs were 
used in combination on the basis that doctors found out that when used 
in combination they were more effective in achieving their purpose of 
reducing weight. It was determined by some astute doctors who noted 
that there were some problems being caused with respect to heart valves 
that there was a relationship between those problems and the drug 
combination. This was brought by the doctors to the attention of FDA, 
and the FDA immediately alerted the marketplace and called for a prompt 
in-depth evaluation. On the basis of further data the companies 
voluntarily removed them from the market.
  Now we are talking about a very, very different issue when it comes 
to the device issue discussed by the Senator. For instance, let's go 
back to fen/phen. If a drug company had to test its drug in combination 
with every other drug that is on the market with which it might 
reasonably be expected to be used in combination, it would take decades 
before anything would be approved. Right now I have had a whiplash. I 
am taking two different drugs to

[[Page S9383]]

manage the injury. But I don't think anybody has done a study to figure 
out whether Ibuprofen and the other drug I am taking is going to create 
some problem for me. I hope they don't spend all of that time 
researching that question because we would never get anything approved. 
That is certainly the case with the devices, we must not allow the FDA 
to endlessly question device manufacturers about how physicians might 
or might not use their product in the future, especially if the 
manufacturer does not seek permission to market or promote for that 
use.
  Again, we had an agreement going into this week that we would argue 
this device thing out, and then we would vote on it. Now that is off 
because of fen/phen. So we are now in the a post-fen/phen situation.
  But let us remember that we just had a vote. It was 94 to 4 that we 
ought to go forward. Why? Last week we were delaying consideration over 
6 pages of a 152-page bill, we are now talking about 2 pages of a 152-
page bill. I agree that section 404 is an important issue. We need 
section 404 to correct problems at FDA.
  Also, I am concerned that my good friend from Massachusetts is 
getting into an emotional argument about the security of people in this 
Nation, and that somehow we are threatening their security by this 
particular provision--I have been chastised in my own State, and 
perhaps the country, saying I am threatening the lives of all Americans 
with this bill. That is life in politics. You have to take that.
  Let me talk about the issue that we have with respect to the devices.
  While the past has been marked by advances for both patients and the 
economy, the present is increasingly troublesome, and the future is by 
no means assured. For both premarket-approved products and the 510(k) 
product--that is, nearly identical products--the FDA's review 
requirements have become more burdensome and are taking more time. This 
has resulted in the delay of approving new devices. That is the issue 
here. Should we have to wait years to get something which will help us, 
help our health, help save our life, because FDA wants to explore 
hypothetical uses of the product by physicians, acting on their own 
initiative?
  This has resulted in the delay of approving new devices. Furthermore, 
the current regulatory system is not keeping pace with medical 
innovation. U.S. patients face delayed access to the newer, more 
advanced generations of devices. In some cases, Americans are going 
abroad to take advantage of these technologies. U.S. device firms are 
themselves moving production and research facilities to other 
countries.
  A study conducted by Medical Technology Consultants, MTCE Ltd., found 
that patients in the United States wait up to three times as long as 
their European counterparts for Government approval of new medical 
devices. The study also found that higher risk, breakthrough medical 
devices were approved in Europe within 80 to 120 days, provided the 
manufacturer has passed an EU facility inspection, which is completed 
within 120 days. Similar devices take an average of 773 days to be 
approved in the United States. New lower risk devices entered the 
European market with no delay once a manufacturer has passed the 
initial facility inspection. Similar devices take an average of 178 
days to be approved in the United States.
  The FDA already takes four times as long to approve breakthrough 
medical devices as is allowed by U.S. statute--it has to do them 
faster--according to the Health Industry Manufacturers Association, 
HIMA. The approval times for these devices have nearly doubled since 
1990. The FDA's record on approving incremental improvements to 
existing devices is similar, with approval times also nearly doubling 
since 1990. Manufacturers will not continue to research and develop 
devices in the United States--they will all be overseas--if they face 
such egragious delays. Patients presently have to wait for devices 
stuck in the FDA's pipeline, and manufacturers have little incentive to 
bring new devices into that pipeline in the first place.
  According to another study conducted by the Wilkerson Group, a New 
York-based independent consulting firm, FDA delays in approving devices 
will lead to the loss of U.S. jobs to nations where approval processes 
are more streamlined--an estimated 50,000 jobs over the next 5 years. 
Governments in Ireland, the Netherlands and elsewhere have already 
begun to highlight the impediment of FDA regulatory delay in their 
marketing materials to attract United States businesses overseas. Such 
actions will erode our Nation's medical research infrastructure over 
time.
  So we are going to be getting them all from Europe. That is not going 
to help us obtain better health care for our citizens.
  I would say one of the problems we have had, and the reason we have 
PDUFA and everything else, is to try to help the FDA be more efficient 
and effective in getting through their duties. It is important that we 
become more effective and efficient in reviewing these devices. I point 
out we here in this country have a wonderful record, but it can be a 
better record.
  Certainly another thing I would like to point out--why are the 
patients' representatives in favor of amendments that we have and 
consumers opposing them at times? Because consumers, obviously, are 
looking at it from a different perspective. They are not ill. They 
don't need it. So they say, ``Don't do anything that might hurt us. It 
is better to be safe and take a long time and delay it, than it is to 
put it on the market.'' That's fine. But if you are a patient, you say, 
``Hey, wait a minute. I am willing to take a little risk. I am willing 
to take a little risk. I'm in bad shape.'' So you have to keep those 
things in mind when you listen to the arguments. In most all the cases, 
the patients certainly are on one side, in a sense, and the consumer is 
on the other.
  With that, I reserve the remainder of my time.
  Mr. KENNEDY. Mr. President, how much time remains?
  The PRESIDING OFFICER. The Senator has 2 minutes.
  Mr. KENNEDY. I yield 1 minute to the Senator from Rhode Island.
  Mr. REED. I thank the Senator from Massachusetts for yielding time. 
Very briefly, what we have done in the overall FDA law is create an 
incentive for companies, under section 510(k) to get approval of class 
I and II devices, to go out and pick out existing devices and say the 
new device is substantially equivalent. This, I think, provides 
pressure for companies to go out and simply say we are going to do 
exactly what these other devices do, even though their new design might 
have many more capabilities. This is not an academic problem.
  Take, for example, the issue of a biopsy needle. Typically these 
needles are very small. They remove a very small amount of tissue, 
about the size of a pencil tip. If the FDA was presented with a new 
biopsy needle that was claimed to be simply for biopsy of tissue but in 
fact removed 50 times that amount of tissue, a much, much larger bit of 
tissue, the suspicion would be that this is not just for biopsies, it's 
actually to remove the lesion. Yet under this law, today, as we speak, 
they could not look behind that claim on the label. They could not look 
behind it and say, give us some data about the removal of lesions. This 
is a serious public health problem. That is what we are addressing 
today. I hope, with Senator Kennedy's direction and leadership, we can 
resolve this along with Senator Jeffords and his colleagues. I yield 
the remainder of my time.
  Mr. JEFFORDS. I yield to the Senator from Indiana 2 minutes.
  Mr. COATS. Mr. President, I don't intend at this particular point to 
get in a specific discussion over section 404. I just urge--clearly, 
there is a differing point of view. We heard from Senator Dodd from 
Connecticut, who was involved in the drafting of the bill; and Senator 
Jeffords from Vermont, the committee chairman, explained this. This was 
someone who was directly involved in the 404 question and has been 
drafting the language and negotiating the language. This is clearly an 
issue we are going to have to address. The committee debated it. There 
has been negotiation subsequent to that. We are now in a position where 
we are going to have to agree to disagree. I just urge the Senator from 
Massachusetts, at the earliest possible time--I know it can't be done 
today given the problems we

[[Page S9384]]

have with scheduling the Interior appropriations bill--to bring the 
amendment to the floor and then let us have the debate and then let the 
Senate work its will by vote and then go forward. Hopefully, this is 
not something that is going to further delay passage and then 
implementation of FDA reform.
  Every day we delay, many things happen, most of them bad. No. 1, we 
move ever closer to September 30, at which time the PDUFA, the drug 
prescription user fee which is used to provide the individuals with the 
resources necessary to expedite drug approval, expires. That expires on 
September 30. The House has yet to act on this. They are waiting for 
the Senate to act. We are trying to wrap up appropriations bills. The 
clock is ticking and we need to move forward with this so we can allow 
the House to go forward, get into conference, get the bills back here.
  I wonder if I can ask additional time from the Senator from Vermont? 
Maybe an additional minute or two. I don't know how much time is left.
  Mr. JEFFORDS. The Senator can have whatever time he wants.
  Mr. COATS. I thank the Senator from Vermont.
  Mr. President, it is going to be extraordinarily difficult for us to 
finish our business on this bill, unify the different positions between 
the House and the Senate, and get the legislation to the President of 
the United States before September 30 so we do not have to lay off 
people at FDA, so we do not have to further delay review of devices and 
drugs and health-saving and health-improving and lifesaving products 
for the American people. That is what all this is about, is expediting 
the process; not to short-circuit the process but just to bring some 
efficiencies to the process.

  The United States lags dramatically behind our foreign competitors. 
But more important than that, we have American citizens who are being 
denied access to health-improving and lifesaving drugs and devices 
because of this huge backlog at FDA. So, we can continue to go through 
these debates, as the Senator from Vermont said, 2 pages out of 150 
pages--an important part but a small part of the entire, overall reform 
bill.
  I hope we can come to some reasonable agreement in terms of bringing 
forward amendments; where there are disagreements, agreeing to a time 
limit on debate of those amendments, let each side present their case 
and then let the Senate vote on the matter and then move forward. 
Delay, delay, delay simply postpones what is, or at least what I 
believe is, inevitably going to happen and what should happen. That is 
that a majority of the Members of the U.S. Senate, on a bipartisan 
basis, and a majority of the Members of the U.S. House of 
Representatives, on a bipartisan basis, and the vast majority of the 
American people, want to see changes in the current FDA so they can 
bring lifesaving devices and drugs and health-improving devices and 
drugs safely but efficiently to the marketplace so that people can 
utilize those without having to get on a plane and go to Mexico or a 
foreign country, so we do not have to keep shifting manufacturing 
facilities and jobs out of the United States into areas which have a 
more reasonable and effective review process.
  Many of us thought the device section was resolved and closed and 
that--at least last week it was presented that the only remaining item 
left on the agenda was the cosmetics. We went through great drama here 
over the problem with cosmetics. Now cosmetics has been agreed to. All 
of a sudden we are back onto devices. Many of us are concerned that 
even if this issue is resolved, we will suddenly have a new issue 
appear that will further delay the steps that we need to take here in 
the Senate to move this legislation forward.
  So, I ask our colleague from Massachusetts if we could at least set 
some schedule here to ensure that we do not go another week, that at 
least this week we complete debate on the amendments, move to final 
passage, and then allow the House of Representatives to begin their 
process. I am not asking him to respond. It's just a plea here that we 
have spent 2\1/2\ years, and each day we delay we run into problems 
with reauthorization of PDUFA and we run into serious, considerable 
delay in terms of bringing in the processes which will allow us to more 
efficiently do the work, the legitimate work, of the Food and Drug 
Administration.
  How much time is left? I will be happy to yield whatever time is 
remaining back to the Senator from Vermont.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, I just say to my good friend from 
Indiana, as well as the Senator from Vermont, I think if we could work 
this particular provision out we would probably be able to end this 
legislation today--tonight. I think this is really the last remaining 
major issue.
  I know the Senator mentions the cosmetic issue and then this new 
issue was raised. This was one of the four items that were identified 
in the President's letter. I have identified this issue previously. We 
had a brief discussion on section 404 during the cosmetic debate.
  But this, I believe, is really the last issue. There are other issues 
that other colleagues have spoken about, but I urge early time 
considerations if we are able to resolve this legislation. I shall try 
to do the best I can to continue to work on these issues.
  If I can ask consent to have 1 more minute and then 1 more minute on 
his side, too? I ask unanimous consent to have 1 more minute on either 
side.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. KENNEDY. We will try to work with the Senator hoping that we 
might now be able to work something out that will meet both the 
legitimate objectives that the Senator has and the concerns that I have 
discussed and share with the administration. I am not suggesting that 
FDA read the minds of all the device companies and determine every 
conceivable way that a device might be used. Instead that they be 
limited to the very narrow case where there is a predominant or 
dominant use or clearly defined use that would be intended that was not 
on the label. Perhaps an advisory group could make these decisions. I 
am not interested in trying to anticipate every possible use, just in 
those very narrow areas which I think pose a threat.
  I will try to explore a compromise with both the Chair and the 
Senator. We are going to the Interior bill and then come back to the 
FDA reform bill, but as I indicated to Senator Jeffords earlier I 
thought there could be a very timely disposition of all of the 
remaining amendments.
  The PRESIDING OFFICER. The time of the Senator has expired.
  Mr. KENNEDY. I thank the Chair.
  Mr. JEFFORDS. Mr. President, I ask unanimous consent for 1 minute.
  The PRESIDING OFFICER. Without objection, it is so ordered. The 
Senator from Vermont.
  Mr. JEFFORDS. Mr. President, I will say, we will continue to 
cooperate to bring this to an expeditious ending. I thought we had that 
agreement. I am ready to enter another one. I hope by the time the 
Interior bill is over, we will have one. I urge us to work together. I 
yield back whatever time I have.
  Mr. COATS addressed the Chair.
  The PRESIDING OFFICER. The Senator from Indiana.
  Mr. COATS. Mr. President, I am not sure what unanimous consent is 
required.
  The PRESIDING OFFICER. One minute, I believe.
  Mr. COATS. Mr. President, I ask unanimous consent for 1 additional 
minute to respond to the remarks of the Senator from Massachusetts.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. COATS. Mr. President, the Senator from Massachusetts offers 
expediting of this process. No one wants to keep delaying it. We have 
been in negotiation for months, if not years. This particular item has 
been discussed, debated, turned upside down, dissected. I think we are 
at the point where the best way we can expedite this is simply to have 
the amendment offered, have the debate, let the Senate work its will. 
There are Members on both sides who are willing and able to present the 
case, and then let the Senate work its will.
  Having said that, this Senator has on two occasions now responded to 
the Secretary of Health and Human Services, who personally called and 
asked

[[Page S9385]]

that I look at new language. I said I will be happy to look at new 
language, but it just seems every time we look at new language and make 
a concession, there is another issue that pops up. We made 30 some 
concessions. We don't want to have 31 and then 32.
  I appreciate the offer of the Senator from Massachusetts, and we will 
continue to operate in that spirit.
  The PRESIDING OFFICER. The time of the Senator has expired.

                          ____________________