[Congressional Record Volume 143, Number 125 (Thursday, September 18, 1997)]
[Senate]
[Pages S9694-S9697]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 
                                  1977

  The Senate continued with the consideration of the bill.
  Mr. KENNEDY. Mr. President, as I understand the agreement, we have an 
hour for the discussion of S. 830, which is the FDA reauthorization 
bill. Is that correct?
  The PRESIDING OFFICER. That is correct, Senator.
  Mr. KENNEDY. I thank the Chair. I will say this evening what I have 
said before, and that is to commend the chairman of our committee, 
Senator Jeffords, and the other members of our committee for working 
out, by and large, a commendable piece of legislation to bring 
pharmaceuticals onto the market safely and rapidly, and to assure that 
Americans would be able to have the benefits of advances in the areas 
of medical devices.
  There is a very important provision which has been included in the 
bill and which I think poses a very significant threat to the health 
and safety of the American people. I want to take some time this 
evening to discuss the reasons why this particular provision should be 
eliminated from the bill or modified to retain existing protections 
available under the Food and Drug Act.
  I will use the time that I have this evening to try to spell out for 
the Senate and for those who are watching these proceedings the dangers 
of this provision so that, hopefully, when the Senate has the 
opportunity to change this particular provision on Tuesday next it will 
do so. It is time to make the changes that will protect the American 
people, and it is important that we do so.
  Mr. President, this is not just a provision that I have reservations 
about. We have put in the Record, and I will mention at this time once 
again, that the President of the United States has indicated that this 
is one of four major concerns that he has in this legislation because 
of its potential to adversely effect the public health.
  It isn't only the President of the United States who has identified 
this particular provision as being a danger to the health of the 
American people, but it is the Patients' Coalition, which is made up of 
patients from all over this country, who review various pieces of 
legislation to ensure that the patients of this country are adequately 
protected: the Consumer Federation of America, the National Women's 
Health Network, the National Organization of Rare Disorders, the 
American Public Health Association, Consumers Union, Center for Women's 
Policy Studies, the National Parent Network on Disabilities, the 
National Association of Social Workers, and the list goes on and on and 
on.

[[Page S9695]]

  That is why, Mr. President, this particular provision should be 
revised to protect the health of the American people. It does not do so 
now, and it has not since it has been reported out of the committee.
  If this provision becomes law, it would force the Food and Drug 
Administration to approve unsafe or ineffective medical devices in 
cases where a manufacturer submits false or misleading information 
about the product. This issue goes to the heart of the role of the FDA, 
and it is an unconscionable provision. The result is that patients who 
rely on medical devices may well be exposed to dangerous products that 
could maim or kill.
  Ninety-five percent of all devices approved by the FDA involve 
upgrades of existing devices. The upgrades are reviewed in what is 
called the 510(k) procedure under the statute. Under this procedure, 
the manufacturer of the device asks for an FDA approval based on the 
fact that the new device is substantially equivalent to an existing 
device that is already on the market and that has already been approved 
as safe and effective.
  On this basis, the FDA usually quickly approves the new device. If 
the new device has significant technological changes, the manufacturer 
must submit the data to the FDA to show that the new device is as safe 
and as effective as the older device to which it is being compared. 
That is the current law.
  In making these determinations under the current law, the FDA looks 
at the use of the earlier device and the claims that the manufacturer 
of the new device makes on the label for the new product. Sometimes, 
however, the new device has technological characteristics that make it 
clear that the device is intended to be used for a new purpose, a 
different purpose than the one the manufacturer claims on the proposed 
label.
  All we are asking is that the FDA be able to act in these 
circumstances to assure that the device is safe. We want to prohibit 
false and misleading labels.
  Mr. President, this is not a hypothetical case. A recent case 
demonstrates the basic problem.
  A new biopsy needle for diagnosing breast cancer in women was 
submitted for approval to the FDA by the U.S. Surgical Corporation, a 
well-known manufacturer of medical devices. Compared to the existing 
biopsy needle, the new needle was huge, far larger than would normally 
be used in a biopsy. In fact, the tissue removed by the device was 50 
times as large as the standard instrument would remove.
  It was obvious to the FDA that the new needle would be used to remove 
small tumors, not just to perform a biopsy. In fact, the company 
marketed the device for that purpose in Canada. Yet, the corporation 
proposed to market the device with the old biopsy label, which gave no 
hint of the obvious new use of removing cancer cells. Under current 
law, the FDA has the authority in such cases to require the 
manufacturer to submit data on the safety and effectiveness of the 
needle for the new use, to be sure that it is capable of removing 
tumors without leaving some cancer cells in place.
  Under this legislation, if the FDA said, ``Well, let us examine 
whether this particular medical device provides safety and protection 
for American women when that device is used to remove tumors,'' the FDA 
would not be permitted to do so. Under the old law, it would. Under the 
new law, it would not.
  In this particular case the tissue removed by the device was 50 times 
as large as the standard instrument would remove. It was obvious to the 
FDA the new needle would be used to remove small tumors, not just to 
perform biopsies. In fact, videos were distributed in Canada 
demonstrating how to use the device to remove breast tumors. Yet, the 
corporation proposed to market the device with the old biopsy label 
which gave no hint of the obvious new use for removing tumors.
  Under the current law, the FDA has the authority in such cases to 
require the manufacturer to submit the data on safety and effectiveness 
of the needle for the new use to be sure that it is capable of removing 
tumors without leaving some cancer cells in place. But not under the 
law that is before the U.S. Senate.
  No woman would want to have a breast cancer removed by a medical 
device that cannot do the job safely and effectively. No Member of the 
Senate would want their wife or mother or sister or daughter put at 
risk by such a device. That is precisely what this bill does in 
changing the existing law that would permit the FDA to look behind the 
label to examine the safety and efficacy of a use clearly intended by 
the technological characteristics of the device.
  The proponents of this legislation say no to an amendment when we 
have tried to ask that the FDA be able to look at the primary use of 
medical devices to make sure that when a company, such as the U.S. 
Surgical Corporation, is going to say that this is really just the old 
small needle, to permit the FDA to look behind it. They say, ``No. 
We've got the votes. Public be dammed.''
  Unless the American people are going to pay attention to this issue, 
they will have the votes when we vote on this next Tuesday. But they 
should not have the votes on it. They should not have the votes on it 
if we are interested in protecting the American consumer, not only on 
this particular measure, this particular device, but on others as well.
  The justification offered by the proponents of this provision is that 
the FDA, in its zeal to protect the public, has sometimes required 
manufacturers to offer data on safety and effectiveness on purely 
hypothetical, possible uses of the new device, uses never intended by 
the manufacturer.
  If that is the goal of the provision, it goes too far because it puts 
public health at risk. No American should die or suffer serious injury 
because the FDA is forced to ignore false or misleading claims. That is 
what Senator Reed's amendment next week will be, just prohibiting false 
and misleading claims. People will have a chance to vote on that up or 
down.
  No American should die or suffer serious injury because the FDA is 
forced to ignore false or misleading claims. That is what this is 
about.
  As I mentioned, the administration has singled out this proposal as 
one of the four in this legislation that merit a veto. It is 
strenuously opposed by a broad coalition of health and consumer groups. 
An obvious compromise can correct this defect so it achieves what the 
sponsors say is its legitimate purpose, without undermining health and 
safety. Under the compromise, the FDA will have the authority to look 
behind the label only in cases where the label is false or misleading.
  This is a bare minimum requirement to protect public health. What 
possible justification can there be for the FDA to approve a device 
based on false or misleading labels? No ethical manufacturer would 
submit a device with a false or misleading label. No unethical 
manufacturer should get away with submitting one. And no Senator should 
vote to protect a false and misleading label.
  The protection is already in the bill for the 5 percent of the 
devices that go through the traditional approval process. But for the 
95 percent of the devices that go through the 510(k) procedures, the 
bill gives a license to lie to the FDA and harm the public.
  Mr. President, a few days ago the public was made aware of 
the tragedy that resulted from the use of diet drugs in ways that had 
not been approved by the FDA as safe and effective. This so-called 
``off-label'' use of fen/phen may well have caused serious and 
irreversible heart damage in tens of thousands of women who thought the 
drugs were safe. The legislation before us would actually encourage the 
use of off-label, unapproved uses of medical devices. We have seen in 
every newspaper in the country, we have heard on every radio station, 
every television, the dangers that the off-label use of fen/phen has 
posed for the American people. Now, just at the time that the country 
is looking at that, we are inviting the same kind of disaster for off-
label use of medical devices.

  It is shocking that this shameful provision has been so cavalierly 
included in the bill. It is incomprehensible that reputable device 
manufacturers are not prepared to support a compromise that allows the 
FDA to look behind the labels that are false and misleading.
  Medical devices can heal, but they can also maim and kill. The 
history of medical devices is full of medical stories of unnecessary 
death and suffering.

[[Page S9696]]

 But thanks to the authority the FDA now has, there are also many 
stories of lives saved by the vigilance of the FDA. What is 
incomprehensible about the bill before us is that it would take us 
backward in the direction of less protection of public health rather 
than more.
  That isn't just Senator Kennedy saying that, Mr. President. Those are 
the findings of our Secretary of HHS, the Patients' Coalition, Consumer 
Federation of America, National Women's Health Network, National 
Organization for Rare Disorders, the American Public Health 
Association, Consumers Union--the list goes on and on. They have 
reached the same kind of conclusion, Mr. President, that we are going 
backwards instead of advancing the interests of the public health.
  The whole story of device regulation has been to provide the public 
greater protections since the mid-1970s.
  Mr. President, let me just take a few moments and talk about what has 
happened previously in terms of medical devices that posed very 
important health threats, injury and death to American people when we 
were not attentive to the public health interests of the people of this 
country.
  Two decades ago, the Dalkon Shield disaster led to the passage of a 
law giving the FDA greater authority over medical devices. At the time, 
this birth control device went on the market, the FDA had no authority 
to require manufacturers to show that devices are safe and effective 
before they are sold. In 1974, an FDA advisory committee recommended 
that the Dalkon Shield be taken off the market--after almost 3 million 
women had used it. The device was found to cause septic abortions and 
pelvic inflammatory disease. Hundreds of women had become sterile, and 
many required hysterectomies. According to the manufacturer's own 
estimates, 90,000 women in the United States alone were injured. The 
manufacturer, A.H. Robins, refused to halt distribution of the device, 
even though the FDA requested it, while the issue was reviewed by the 
advisory committee.
  The Shiley heart valve disaster was so serious that it led to the 
enactment of further legislation. This mechanical heart valve was 
approved in 1979. It was developed by the Shiley Company. The Shiley 
Company was subsequently sold to Pfizer, which continued marketing the 
valve. It was taken off the market in 1986 because of its high breakage 
rate. By that time, as many as 30,000 of these devices had been 
implanted in heart patients in the United States. One hundred and 
ninety-five valves broke and 130 patients died. Thousands of other 
patients who had the defective valves in their hearts had to make an 
impossible choice--between undergoing a new operation to remove the 
device, or living with the knowledge that they had a dangerous device 
in their heart that could rupture and kill them at any moment. 
Depositions taken from company employees indicated that cracks in 
defective valves may have been concealed from customers.
  Before the defective valve was withdrawn, the manufacturer had tried 
to introduce a new version with a 70 degree tilt instead of the 60 
degree tilt approved by the FDA. The increased tilt was intended to 
improve blood flow and reduce the risk of clotting. The FDA's review 
found that the greater tilt increased the likelihood of metal fatigue 
and valve breakage, and the new version was not approved for use in the 
United States. Four thousand of the new devices were implanted in 
Europe. The failure rate was six times higher than for the earlier 
valve--causing at least 150 deaths.
  In another example of a human and public health tragedy involving a 
medical device, the firm Telectronics marketed a pacemaker wire for use 
in the heart. Twenty-five thousand of these pacemakers were marketed, 
beginning in 1994, before it was discovered that the wire could break, 
cause damage to the wall of the heart, or even destroy the aorta.
  The case of artificial jaw joints--referred to as TMJ devices--are 
another tragedy that devastated tens of thousands of patients, mostly 
women. These devices were implanted to assist patients with arthritic 
degeneration of the jaw joint, most with relatively mild discomfort. 
But the impact of the new joints, sold by a company called Vitek, was 
catastrophic. The new joints often disintegrated, leaving the victims 
disfigured and in constant, severe pain. To make matters worse, Vitek 
refused to notify surgeons of the problems with the joints, and FDA had 
to get a court order to stop distribution of the product. Similar 
problems were experienced with Dow Corning silicone jaw implants.
  You see with this chart these dramatic, tragic, human disasters 
caused by unsafe, inadequately tested medical devices. Do we want less 
safety? Do we want less protection when we have seen these kinds of 
human tragedies take place, when there have been these instances?
  Mr. President, another device disaster is the toxic shock syndrome 
from super absorbent materials in tampons. Most women would not think 
that a tampon could kill them, but they would be wrong. About 5 percent 
of toxic shock syndrome cases are fatal. What seemed like minor design 
changes, the absorbency of the material, resulted in enormous human 
tragedy. Women and their families deserve protections from unsafe 
medical devices. FDA should be strengthened, not crippled.
  In yet another example, the FDA was able to block a device that 
involved a plastic lens implanted in the eye to treat near-sightedness. 
The device was widely marketed in France, but the FDA refused to 
approve it for use in the United States. Long-term use of the device 
was later shown to cause damage to the cornea, with possible blindness.
  The angioplasty catheter marketed by the Bard Corporation turned out 
to be a dangerous device that the company sold with a reckless 
disregard for both the law and public health. The device was modified 
several times by the corporation without telling the FDA in advance, as 
required by the law. The company was prosecuted and pleaded guilty to 
391 counts in the indictment, including mail fraud and lying to the 
government. Thirty-three cases of breakage occurred in a two-month 
period, leading to serious cardiac damage, emergency coronary bypass 
surgery, and even death.
  Now, Mr. President, these tragedies resulted in expanded powers for 
the FDA to protect the public against dangerous devices and greater 
vigilance on the part of the agency. But this bill steps back by 
forcing the FDA to protect the public with one hand tied behind its 
back. This bill actually forces FDA to approve devices based on false 
and misleading labels.
  I have already discussed the dangers of a breast cancer biopsy needle 
that would have been used to treat breast cancer without adequate 
evidence that it was effective. There are many other examples of the 
kind of dangerous devices that could be foisted on the American public, 
if the provision of the bill allowing false and misleading labels is 
allowed to stand. Under the provision, the FDA cannot look behind the 
manufacturer's proposed use to demand appropriate safety and 
effectiveness data, even if it is obvious that the device has been 
designed for an altogether different use than the manufacturer claims.
  Surgical lasers are increasingly used for general cutting, in place 
of traditional instruments such as scalpels. In a recent case, a 
manufacturer called Trimedyne adapted the laser in a way that indicated 
it was clearly intended for prostate surgery. But it submitted an 
application to the FDA saying that the laser was only intended for 
general cutting. The label was clearly false, and the FDA was able to 
require adequate safety data before the product was allowed on the 
market. But under this bill, the FDA would be forced to approve the 
product, without requiring evidence that the device is safe and 
effective for prostate surgery.
  Prostate surgery is a very common procedure affecting tens of 
thousands, if not hundreds of thousands of older men. Failed surgery 
can result in permanent incontinence and other devastating side 
effects. Do we really want surgical tools to be used to treat this 
common illness that may not be safe and effective? If this legislation 
passes unchanged, that is exactly the risk that large numbers of 
patients needing prostate surgery could face.
  A further example involves digital mammography, an imaging technology 
that is becoming an alternative to conventional film mammography. The 
new

[[Page S9697]]

device is being tested for better diagnostic imaging of a potentially 
cancerous lump in the breast that has already been detected and shows 
great promise. But it is not known whether the new machine can be used 
effectively in screening for breast cancer when there are no symptoms. 
Under this bill, if a manufacturer seeks approval for a digital 
mammography machine that is clearly designed for breast cancer 
screening, not just for diagnosis, the FDA would be prohibited from 
requiring data to show that the machine is effective for screening. 
Does the Senate really want to support legislation that could result in 
women dying needlessly from undetected breast cancer? That is what this 
device provision could cause.
  We know that there is more money that is going to be made by those 
particular companies that can get on the market faster than their 
competitor through this loophole. Is that what we are about in terms of 
trying to protect the public? The FDA is the principal agency of the 
government to protect the health and safety.
  The various professionals in consumer organizations and patient 
organizations that spend every day trying to protect the public health 
understand the dangers that are involved in this provision. They are 
all saying why doesn't the Senate build in these protections?
  But no. There is that majority in the United States Senate that would 
go ahead and accept this, and pass this legislation as it is without 
the adequate protections. And, unless the public is going to understand 
that this is something which is important and let their representatives 
understand that by Tuesday next, that is what will happen.
  The President of the United States has had the courage to say no to 
this particular provision, because he understands, as the Secretary of 
Health and Education understands, and as the public health community 
understands the dangers to the American consumer if we let this 
provision continue.
  Mr. President, I want to review as clearly as I can exactly what the 
bill that is before us, S. 830, does. It prohibits the FDA from 
reviewing the safety of a device for uses not listed by the 
manufacturer.
  Senator Reed's amendment will prohibit the FDA from reviewing the 
safety of a device for uses not listed by the manufacturer unless the 
label is ``false or misleading.'' You would think we would get 100 
votes on that. Is the Senate going to say, ``OK, it is going to be all 
right for device manufacturers to have false and misleading labels?''
  Other examples in the way that this provision could allow unsafe and 
ineffective devices abound. A stent designed to open the bile duct for 
gallstones could be modified in a way that clearly was designed to make 
it a treatment for blockages of the carotid artery. Without adequate 
testing, it could put patients at risk of stroke or death. But under 
this bill, the FDA would be prohibited from looking behind the label to 
the actual intended use of the device.
  Mr. President, the vast majority of medical device manufacturers meet 
high ethical standards. Most devices are fully tested and evaluated by 
the FDA before they are marketed. But as many examples make clear, if 
the FDA does not have adequate authority to protect innocent patients, 
the result can be unnecessary death and injury to patients across the 
country. There is no justification--none whatever--for Congress to 
force the FDA to approve devices with false or misleading labels.
  Each and every time amendments to medical device and pharmaceutical 
provisions have been approved by the Congress, Republican and Democrat, 
the public health and safety of the American people has been enhanced. 
There are provisions in this legislation that will do so. But not this 
provision. This provision, if left to stand, poses significant health 
risks to American consumers.
  We ought to be making sure that when the FDA gives their stamp of 
approval, that devices are going to be safe and efficacious, and that 
every doctor in this country and every patient knows they are going to 
meet the highest safety standards. That ought to be our commitment to 
the American people.
  But this particular provision does not do it. Rather than being a 
step forward, it is a significant and dangerous step backward. 
Unscrupulous manufacturers do not deserve a free ride at the expense of 
public health.
  We have good legislation that is going to extend the PDUFA which is 
going to mean that we will have many excellent additional professional 
people to help to move various pharmaceutical products onto the market 
sooner.
  The public health organizations know what is happening out there, and 
they have pleaded with all of us in the Senate and said, My God, for 
once put the profits of this handful of industries that is trying to 
circumvent the health and safety protections of the American people, 
put that aside and make sure, when you act next week, the roll will be 
called, act to protect the public here in the United States.
  That is what this debate is about. That is what we will have a chance 
to vote on next week.
  Mr. President, I believe my time is just about up. I thank the Chair. 
We will have an opportunity to go back to this tomorrow morning at 9:30 
to add additional information. We hope we will hear from the American 
people if they care about assuring that their children are going to 
have safe medical devices, that their parents are going to have safe 
medical devices, that their daughters and their husbands, their 
grandparents are going to have safe medical devices. There is only one 
way to do it, and that is on next Tuesday when the rollcall comes, 
Senators will support the Reed amendment, which I welcome the 
opportunity to cosponsor, which will be the most important action we 
can take in the Senate on this legislation to protect the health and 
safety of the American people.
  Mr. President, I yield the floor.

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