[Congressional Record Volume 143, Number 126 (Friday, September 19, 1997)]
[Senate]
[Pages S9721-S9722]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 
                                  1997

  Mr. KENNEDY. Mr. President, the underlying piece of legislation that 
we have before the Senate is S. 830, which is the drug reform 
legislation. Earlier in the course of the debate and discussion, I 
pointed out one of the most serious proposals in that particular piece 
of legislation that puts the future health care of all at serious. I 
also pointed out the bewilderment the President of the United States 
and I share, which every consumer group shares: Why in the world are we 
providing the kind of change in protections for the American consumer 
that are included in this legislation?
  I am reminded, Mr. President, that 30 years ago this Nation was faced 
with a thalidomide tragedy, and all the implications that that terrible 
situation had for hundreds of mothers and children. Twenty years ago, 
we had the Dalkon Shield tragedy, where 18 women died from perforated 
uteruses, 2,700 women had miscarrages, and millions of women were 
adversely affected with great illness and sickness and, in many 
instances, were unable to have children in the future. Why? Because we 
had a medical device that wasn't safe for American women.
  Ten years ago, we had the Shiley heart valve. A certain part of that 
heart valve that was found to be unsafe here in the United States, but 
it was advertised and used overseas and resulted in hundreds of deaths.
  We know that some medical devices can be dangerous. We have to ask 
ourselves, as we are coming into the final consideration of this 
legislation, why in the world we are retreating from protecting the 
American public in this area? That is what we are doing. We are putting 
the interests of the medical device industry ahead of the public health 
of the American people. For what reason? For the profits of those 
medical device industries.
  The provisions of the legislation are clear and simple. S. 830 says:

       . . . prohibits FDA from reviewing the safety of a device 
     for uses not listed by the manufacturer.

  If the manufacturer labels a device as substantially the same as 
another device that has already been approved, the Food and Drug 
Administration cannot look at that medical device, beyond the use 
listed on the lablel, in terms of its safety and effectiveness in 
protecting the American consumer.
  We are effectively handcuffing the Food and Drug Administration with 
this language. The amendment, which will be offered by Senator Reed--on 
which I will join him, says:

       . . . prohibits FDA from reviewing the safety of a device 
     for uses not listed by the manufacturer unless the label is 
     false and misleading.

  Who could defend a medical device manufacturer that knowingly submits 
false and misleading information? Anybody who is listening to this 
would say, we can't believe that, Senator. We can't believe that is 
really happening. Well they should believe it because that is what is 
happening.
  The clearest illustration of this development is the use of a certain 
biopsy needle that has been manufacture by U.S. Surgical Co. A biopsy 
needle used to excise tumor tissue to see whether it is cancerous or 
not. The biopsy needle is maybe the size of the lead in a pencil. It is 
used to remove sufficient amount of material to be analyzed. Now, along 
comes U.S. Surgical Corp., which develops medical devices, with a new 
medical device that can take 50 times more material than the earlier 
biopsy needle. U.S. Surgical says: Look, this new device is the same 
purpose as the other medical device. It is substantially the same. It 
is for taking material that can be a biopsied. We have been approved 
previously in terms of safety and effectiveness. According to our 
label, this new device is a biopsy needle and, according to the law, 
under S. 830, FDA cannot look beyond that use and into the real purpose 
of this new device to determine whether or not the device is safe and 
effective for that new use.

  Well, Mr. President, unfortunately for U.S. Surgical Corp., a number 
of us have seen their ads and promotions for this particular medical 
device. What is U.S. Surgical Corp. promoting? It is promoting this new 
device as a device that is going to remove the tumor, not just take the 
biopsy, but remove the tumor from a woman's breast. Now, it may be very 
good in removing that tumor. It may be able to get all the cancerous 
material. It may do the job better than any other medical device we 
have had before. But we don't know that. The patient won't know it. The 
doctor won't know it. The family of the patient won't know it. Why? 
Because U.S. Surgical Corp. would not have to provide one paragraph of 
information demonstrating that this medical device is safe and 
effective for removing tumors. The doctors will see it and say, well, 
this has been approved by the FDA, it must be safe. I think I will use 
it, especially after reading about, hearing, or watching the promotion 
film used in Canada to promote this device.
  The FDA would be prohibited from looking behind the labeling of the 
device to determine whether it is safe and effective. The FDA can say, 
look, we know the manufacturer is out there day in and day out 
promoting this device for tumor removal. They can hardly wait to get 
approval to go out and sell that medical device for the purposes of 
removing the tumor. According to the proposal under S. 830, if the 
label says that it is substantially equivalent to the biopsy needle, 
the Food and Drug Administration cannot require U.S. Surgical Corp. to 
provide information demonstrating that the device is safe and effective 
for its marketed purpose. That is wrong.
  We are taking an important step backward in protecting the American 
people. And it is not just this particular medical device. The real 
concern is all the other medical devices that are out there now being 
considered. It is the mammography screening machines that are being 
used for breast cancer screening. The mammography screening machines 
may be very good in terms of the diagnostic evaluation of tumors, once 
the tumor is detected. They may be even better as screening tools to 
look for such a tumor. But we don't know because the FDA wouldn't be 
able to ask for safety and effectiveness data for its use in breast 
cancer screening. So we have examples of mammography machines coming 
into the FDA that will be approved because they are effective in terms 
of evaluating and diagnosing tumors, but have not been studied in terms 
of their effectiveness in screening. Yet we find the machine is being 
used for screening purposes. American women will say that they have 
been screened with

[[Page S9722]]

mammography machines, and they have been found to be free of any kind 
of cancer. They will be very happy about that. Since we have no data on 
how effective this device is for screening, they may find later, maybe 
too late, that they have some kind of a tumor. They may find out that 
this machine didn't do what it was represented to do because it had not 
been tested in terms of effectiveness. That should not be the case.

  That is true with regard to the surgical lasers that haven't been 
tested for safety and effectiveness in cutting cancerous prostate 
tissue. It has been demonstrated that the lasers are safe and effective 
in cutting general tissue. But, the manufacturer changes the design and 
puts another laser in that also cuts tissue. But the purpose of that 
new laser is to cut through tissue in the prostate area, whether it is 
a cancerous tissue or noncancerous tissue. The laser has not been 
approved for that purpose. We do not have safety information to know 
that it is effective in dealing with this particular kind of operation. 
The manufacturer doesn't have to provide it. All they have to do is say 
it is a laser that cuts tissue and they get approved. The FDA can be 
fully aware that they are going to promote it for prostate cutting, but 
they will not be able to ask the manufacturer to provide safety 
information for that use.
  The same is true with contact lenses that get approved though this 
loophole channel--saying that the lenses are substantially equivalent 
to equipment that has already been approved. But those lens 
manufacturers are intend to promote these new lenses for long-term use 
rather than short-term use like the ones that have been approved. The 
FDA can know about the advertising--and can even tell from the change 
in materials used to make the new lenses that they are designed for 
long-term use. But they cannot evaluate the new lenses for safety and 
long-term use. We can see the dangers that could result--maybe even 
blindness.
  Mr. President, we shouldn't be taking a risk with the health of the 
American people in this way. It is fundamentally wrong. The only reason 
to do so is to give a competitive advantage to unethical medical 
manufacturing companies. Those are the ones that will use this 
loophole. And when they do, they will gain a competitive advantage over 
the ethical manufacturers that take the time and spend the money to 
conduct the safety and effectiveness studies to show that thier devices 
are safe. They will be at a financial and competitive disadvantage 
because less ethical companies will use this loophole for approval.
  That is why each and every one of these consumer groups are opposed 
to this provision--why we have recommended five different alternatives 
to address this issue over the past weeks. The medical device industry 
has turned those down because they say they have the votes. They can 
roll over the public health concerns of the American people. That has 
happened in the past. But I hope it will not happen next Tuesday. This 
issue is too important. It is important for our wives, our daughters, 
our sons, our fathers, our grandparents--to be sure that when they have 
to use medical devices, those devices are going to be safe and 
effective. We have the ability to ensure safety in so many new ways--
ways that were unimaginable years ago.
  But with this provision, we are effectively tying the hands of the 
FDA. If there is an appropriate title for the provision, it is the 
false-claims provision of the medical device and pharmacy legislation, 
S. 830. And it is the wrong way to go.
  We look forward to debating this issue next week. I am hopeful that 
we can address it in a way that will provide the real protection the 
American people deserve.
  Mr. President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. LEAHY. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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