[Congressional Record Volume 143, Number 126 (Friday, September 19, 1997)]
[Senate]
[Pages S9701-S9713]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 
                                  1997

  The PRESIDING OFFICER (Mr. Sessions). The clerk will report S. 830.
  The assistant legislative clerk read as follows:

       A bill (S. 830) to amend the Federal Food, Drug and 
     Cosmetic Act and the Public Health Service Act to improve the 
     regulation of foods, drugs, devices and biological products, 
     and for other purposes.

  The Senate resumed the consideration of the bill.
  Pending:

       Modified committee amendment in the nature of a substitute. 
     (The modification incorporated the language of Jeffords 
     amendment No. 1130, in the nature of a substitute.)
       Harkin amendment No. 1137 (to amendment No. 1130), 
     authorizing funds for each of fiscal years 1998 through 2000 
     to establish within the National Institutes of Health an 
     agency to be known as the National Center for Complementary 
     and Alternative Medicine.

  The PRESIDING OFFICER. The Senator from Massachusetts is recognized 
for up to 1 hour.
  Mr. KENNEDY. Mr. President, I yield myself 50 minutes.
  Mr. President, this morning we continue the discussion of one of the 
most important and one of the most controversial and I believe one of 
the most dangerous provisions of S. 830. We are hopeful that we will be 
able to garner the attention of the Members of the Senate to support an 
amendment that will be offered and voted on Tuesday next that will 
address this dangerous provision that puts the American consumer at 
risk.
  At the outset, I want to mention that those of us who are concerned 
about this particular provision are many. The Department of Health and 
Human Services, which is the principal agency of our National 
Government responsible for the health and safety of the American 
people, is strongly opposed to section 404, and supports the position 
that I have taken here today.
  Other groups opposed to section 404. Those groups that are opposed to 
the provision also include the Patients' Coalition, which represents 
patients from all over this country, a real grassroots organization 
that understands, at the grassroots level, or the Main Street level, 
the dangers that this particular provision will mean unless we address

[[Page S9702]]

it; the Consumer Federation of America; the National Women's Health 
Network; the National Organization for Rare Disorders; the American 
Public Health Association, which is charged with protecting the public 
health of Americans; the Consumers Union, another grassroots 
organization that looks after the interests of the consumer for a range 
of different issues and has targeted this particular provision; the 
Center for Women's Policy Studies; the National Parent Network on 
Disabilities; the National Association of Social Workers; the Policy 
Center for Children, Youth and Families; the American Council on 
Consumer Awareness; and the TMJ Association, they are the victims of 
the artificial jaw joint group. All of these organizations, and there 
are many more, are reflecting the anxiety and very deep concern and 
legitimate concern that consumers have about a particular provision 
that is included in this legislation, which will effectively handcuff 
the FDA from looking beyond just the manufacturer's label to get to the 
bottom line, whether a particular device which has a manufacturer's 
label is really going to be both marketed and utilized in such a way as 
to pose a serious and grievous health hazard to the American consumer.
  I think the National Women's Health Network states the situation very 
well. I will just take a moment, before getting into the principal 
reasons for hoping that we will be able to alter and change this 
provision on Tuesday next, to read it, because it really summarizes the 
concerns of, in this case, the National Women's Health Network 
representing the millions of women across this country.

       On behalf of the 13,000 individual and 300 organized 
     members of the National Women's Health Network, I am writing 
     to express our continued opposition to S. 830 because of the 
     serious implications this legislation has for our Nation's 
     women. The network is extremely concerned that section 404 
     prevents the FDA from requiring medical device companies to 
     perform complete reviews of the safety and effectiveness of a 
     medical device. This provision must be amended to give the 
     FDA the authority to verify that the label used is not false 
     or misleading.

  That is what we are talking about this morning, labeling, by the 
manufacturing company, of a medical device, that is false and 
misleading. The amendment which we will offer next Tuesday will say 
that when FDA finds that the medical device company is filing a false 
and misleading label, that the FDA will be able to look at the safety 
considerations of that device in order to protect the American 
consumer.

  The Food and Drug Administration has a staff of scientists and 
researchers, individuals who have expert knowledge of different medical 
devices, whose only purpose is to protect the public. It is that group 
of individuals that we entrust--we recognize that they are human and 
are capable of making mistakes, nonetheless, they are the principal 
agent to trust to protect the American public's health and safety. When 
we have false and misleading labels by medical device industries, we 
need to make sure that the FDA scientists and researchers, who are 
charged with protecting the American public, are going to be able to 
make a thorough determination as to the safety and the efficacy of the 
devices. This is the issue. That is what the National Women's Health 
Network illustrates. The letter continues:

       Women need the FDA to act as a safety sieve, screening out 
     drugs and devices which are hazardous or ineffective. If 
     section 404 were enacted, a device manufacturer could label 
     its product for a very simple use and the FDA would be 
     limited to asking for proof in safety and effectiveness about 
     that use only. Even if it were clear from the device's 
     technical characteristics that it might be used for other, 
     riskier purposes, the FDA would be prevented from looking 
     beyond the conditions of use on the label.

  If we are concerned about protecting the American consumer, this 
makes no sense. We should not be tying the hands of the FDA when we 
should be protecting the health of the American consumer. Look at 
recent history and the medical device disasters that this country has 
faced. This bill opens the potential for those diasters to be 
replicated. We all hope they will not be. But one of the principal 
safeguards for preventing this is the FDA being able to examine the 
safety of devices. The letter goes on:

       Section 404 is a serious danger to women's health.

  I repeat, this particular section, section 404--

     is a serious danger to women's health, which must be fixed 
     before S. 830 is acted upon by the Senate. In light of 
     today's front page coverage of the fen/phen catastrophe, in 
     which women were the victims of off-label drug use, we find 
     it inconceivable that the Senate would pass a bill with this 
     provision.

  There it is. They have it right. We just had the fen/phen disaster, 
in which scores of individuals have suffered--have perhaps lost their 
lives--as a result of off-label use. And here we have on the U.S. 
Senate floor a particular provision that will invite unscrupulous 
medical device companies not to clearly and accurately state what their 
medical device is going to be used for. This is the issue. We have 
scores of other letters, similar to the one I just read, expressing 
concern about section 404.
  The issues are clear. Will the Senate vote in favor of approving a 
medical device based on false and misleading labels? Will the Senate 
allow dangerous medical devices that have not been tested for safety 
and effectiveness to be foisted on the American people? Will companies 
like U.S. Surgical Corp. be rewarded for deceiving the FDA? Will the 
Senate put a higher value on the profits of the powerful than the 
health of the American people?
  Mr. President, let me point out, that if U.S. Surgical Corp. is able 
to have their way--if they are allowed to misleadingly label their 
medical device as being substantially equivalent--they will be 
virtually guaranteed approval under the language of this bill. Because 
this bill says that if the medical device is substantially equivalent 
to one that has been approved and meets those safety requirements, it 
must be approved. Despite the fact that this corporation, U.S. Surgical 
Corp., has a device that is being advertised and will be used for an 
entirely different purpose. A purpose for which it has not been tested 
for safety. What happens to the ethical companies? What happens to the 
other medical device companies that are trying to provide safe medical 
devices?
  They are going to be at a competitive disadvantage because they will 
come up and say to the FDA, ``Look, our device is for this purpose and 
we have conducted these expensive safety tests.'' That is going to cost 
that company, and it means that their medical device is going to be 
more expensive. What happens to these other companies when a company 
like the U.S. Surgical Corp. is able to get in the door without 
providing safety information, without doing that kind of testing? This 
is also an issue.
  It is not the most important argument. The most important one is 
health and safety. If this language is not altered or changed, it will 
be an invitation for medical device companies all over America to jump 
through this loophole in order to get their products on line. Will the 
Senate put a higher value on the profits of the powerful than the 
health of the American people?
  Section 404 of the bill requires FDA to approve a medical device 
based on the use claimed on the label submitted by the manufacturer--
even if that label is false and misleading.
  Think of it. The FDA will be required to give approval even though 
the label is false and misleading. Whose interests are we protecting? 
Are we protecting the American consumers' interests, or are we 
protecting the profits of the medical device company? The way this law 
is currently constructed, it will help protect the profits of companies 
like U.S. Surgical Corp. It prevents the FDA from requiring 
manufacturers to demonstrate that their product is safe and effective 
for the purposes for which it will be used as opposed to the purpose 
falsely claimed on the label.
  It stands 20 years of progress toward safer and more effective 
medical devices on its head. For 20 years, since 1974, we have tried, 
through the FDA, to make sure that medical devices are safe and 
efficacious. This is the first time in over 20 years that we are taking 
a step backward. We take modest steps forward on the basis of 
experience, at both the FDA and across the country, to provide 
additional protections for the American consumer. Now we are faced with 
the first significant and major step backward.

[[Page S9703]]

  Mr. President, to illustrate that, the U.S. Surgical Corp., a large 
and successful manufacturer of medical devices, submitted a new machine 
to the FDA for approval. This machine was called the Advanced Breast 
Biopsy Instrumentation System. The company claimed that the machine was 
to be used only for taking biopsies of breast tumors suspected of being 
cancerous. Cancer is a word that any family in America hates to hear. 
Many Members of this body, many Members of the House of Representatives 
and so many American families have been touched by cancer. There are 
few people listening today whose family has not been touched by cancer 
in some way. With the increasing number of breast cancers, this 
particular medical device is the most offensive, because the principal 
disaster is not only contracting cancer, but it is in the failure of 
being able to diagnose it and treat it effectively.
  What has the U.S. Surgical Corp. done? The company claimed that the 
machine was to be used only for taking biopsies of breast tumors 
suspected of being cancerous, but the machine was designed to excise a 
piece of tissue 50 times as large as other biopsy devices already on 
the market. It was obvious from the machine's design that it was 
intended to remove breast cancer tumors, not simply take samples for 
biopsy.
  Maybe it works. Maybe it is a major breakthrough. Maybe it can do all 
the things that the U.S. Surgical Corp. says can be done. Wouldn't that 
be wonderful? But we don't know. Maybe it doesn't. Maybe it doesn't 
work. Maybe when the doctor says we have excised the tumor, it doesn't 
do it completely. We don't know. Maybe when that woman walks out of the 
doctor's office or leaves the hospital, she is still in danger. She 
believes she has been treated effectively, but maybe this device isn't 
effective at removing tumors. Then there is the possiblity that in 4 
weeks, 5 weeks, 6 months, 1 year, 1\1/2\ years, the cancer is still 
present and life and health are still at risk.
  Why are we taking a chance, Mr. President? Because the medical device 
companies want this provision.
  It was obvious from the machine's design that it was intended to 
remove breast cancer tumors. In fact, we have obtained a videotape, 
made in Canada, that demonstrates that the company knew it would be 
used for that purpose, despite their false claims to the FDA.
  Here you have the U.S. Surgical Corp. saying to the FDA that we have 
a small biopsy needle the size of the lead in a pencil, that will be 
used to check a tumor, returning to the FDA for approval of what they 
label as a substantially equivalent medical device. Under this 
legislation--even though the company is out advertising that medical 
device for an entirely different purpose, for which they have not 
provided any health or safety information to the FDA and under this 
legislation--FDA would have to approve it. Despite the fact the FDA 
knows the device will be used for another purpose. Under this bill, the 
FDA could not say, ``Provide the information to show that this is safe 
and effective.''

  This is the example, Mr. President. We are talking about cancer--
breast cancer. We are talking about 1 out of 7 women who are going to 
be affected at some time in their lives. We know the enormous 
legitimate concerns that women have, that mothers have, that daughters 
have. And we are going to say we are prepared to allow them to have 
less than the best protections we can offer?
  Mr. President, under this section of the FDA bill, the FDA would be 
forced to approve the new device without any evidence on the safety and 
effectiveness for new uses. American women do not want to die from 
breast cancer because the companies are allowed to sell devices whose 
safety and effectiveness have not been demonstrated.
  No Senator would want their wife or mother or daughter to be 
subjected to such an untested device solely because a greedy company 
wants higher profits. The issue goes far beyond the products to excise 
breast cancer. It applies to lasers to treat prostate disease, stems to 
be placed in carotid arteries, imaging systems to detect breast cancer, 
and a host of other treatments for dreaded diseases.
  Public health professionals will tell you as we continue to develop 
new technological advances this problem will only grow along with the 
threats to public health and safety. We will be rolling the dice. How 
many people are willing to roll the dice for a member of their family 
and use a medical device that has not been adequately tested? The 
companies are out there, Mr. President, and they won't mind if we roll 
the dice. Are we going to permit that?
  This provision will give unscrupulous companies incentives to lie to 
the FDA. It will penalize ethical companies who are truthful and doing 
the necessary testing to demonstrate that their products are safe and 
effective. Most of all, it will put the health of the American people 
at risk so that a greedy few can increase profits. Companies that hope 
to benefit by weakening the FDA are already powerful and profitable. 
They believe they have the votes to push this disgraceful provision 
through the Senate--and this morning they probably would have. It is 
absolutely untenable and outrageous and unnecessary that we would, 
except to provide additional profits for a company that will use this 
loophole to get their devices on market earlier.
  If the American people truly understand what is at stake, I do not 
believe they will permit this dangerous provision to become law. When 
the vote comes on Tuesday, we will see how many Senators are willing to 
stand with the American people and how many are willing to vote in 
favor of false and misleading labels. Let me make it very clear that 
the Tuesday vote will not be the end of the story. We will continue to 
fight to keep this provision from becoming law, and I believe we will 
succeed in the end. The FDA bill has many constructive elements, but 
this disgraceful provision should be eliminated. The false or 
misleading label should have no place in the approval of medical 
devices. Unscrupulous manufacturers do not deserve a free ride at the 
expense of the public.
  Mr. President, what we are talking about is S. 830, and section 404, 
which prohibits the FDA from reviewing the safety of a device for uses 
not listed by the manufacturer.
  This provision handicaps the principal agency of Government that is 
charged with safety, and we are writing into the law language that will 
prohibit FDA--which is the agency charged with protecting the American 
people from unsafe pharmaceutical drugs and medical devices--from doing 
its job. The FDA would be prohibited from reviewing the safety of a 
device for uses not listed by the manufacturer.
  What our amendment says is, OK, we'll prohibit the FDA from reviewing 
the safety of a device for uses not listed by the manufacturer--unless 
the label is false or misleading. How can Members of this body say that 
they will refuse to stand with those of us who support the Reed 
amendment that says ``unless the label is false and misleading''?
  We have the example of U.S. Surgical Corp.'s biopsy needle. A needle 
designed to extract a small amount of cancerous tissue, maybe the size 
of a pen or the lead of a pencil. Now what has the company done? It has 
developed a much larger device that may be able to take a biopsy, but 
which, in fact, is primarily designed for tumor removal. But all they 
will have to be able to do is show that they are substantially 
equivalent.
  Under this proposal, the FDA will not be able to look at what the 
real purpose of this medical device is. We know what the U.S. Surgical 
Corp.'s real purpose for this medical device is. We know because we 
have seen the advertisement they have already prepared. This device 
which can take out 50 times more material than its predecessor--50 
times more material--is not intended to be used for a biopsy, but is 
designed to excise the tumor. Maybe it can do it well, Mr. President. 
Maybe it is an important and major step forward. But any woman who has 
a procedure done with this device, will not be able to judge from the 
safety information that is provided to the FDA because there has been 
none provided. They won't know the results of testing conducted on this 
device because there have been no tests submitted to the FDA. They 
won't know whether this is a successful device because there is no 
information to indicate its success.

[[Page S9704]]

  We are talking about women and breast cancer. We are talking about a 
medical device that is put forward with virtually no intention for use 
for biopsies. Where an earlier smaller, less intrusive device already 
exists for biopsies. A device that is going to be used to remove 
tumors, and is advertised to doctors as such.
  What are the American doctors supposed to believe? They say, ``Well, 
we have FDA approval.''
  ``Well, isn't that fine. Then it must be all right, it must be 
safe.''
  But no doctor is able to give that kind of assurance to a woman who 
is going to have this particular medical device utilized to excise a 
tumor, because it has not been done. How would our amendment change 
that? Our amendment would say that if the advertising is false or 
misleading, that anyone would be able to see that this particular 
device is going to be used to excise a tumor--U.S. Surgical, show us 
your studies, show us your information that would indicate that this is 
safe for American women. Show us where you have tested it to show that 
it does the job. Show us that it will do what you are advertising will 
be done. Let us examine that. And if that is the case, we approve it 
for that particular purpose.

  This provision is unconscionable, Mr. President, when you look at the 
tragedies that have resulted from device disasters. We are not talking 
about Band-Aids and tongue depressors. We have seen medical device 
disasters which have cost the lives of hundreds and thousands of 
American consumers.
  I was here and chaired the hearings on the Dalkon shield IUDs, which 
injured tens of thousands of women. Their injuries included pelvic 
inflammatory disease, sterility and perforated uteruses. That is 
because, Mr. President, with the Dalkon shield we found out that 
bacteria crept through the string of the device and caused infections 
in American women.
  As a result of this disaster in the mid-1970's we set up protections 
for the American consumer with regard to medical devices to ensure that 
they would be safe and efficacious. Prior to the mid-1970's we did not 
test for safety and efficacy. We want to be able to make sure that the 
FDA is going to be able to test for safety and efficacy on a product 
that is going to be the predominant use of a particular medical device.
  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.
  Why are we being asked in the U.S. Senate to deny the FDA adequate 
authority to protect the American people? Safe and effective medical 
devices is what the American public deserve and it is what Senator 
Reed's amendment to section 404 would ensure.
  Mr. President, another example is patients with defective Shiley 
heart valves who died, underwent painful and dangerous surgeries to 
remove the valves.
  The company increased the degree of a particular vent from 60 degrees 
to 70 degrees. But because FDA had the power to examine whether this 
presented any additional health hazards to the American people, the 
modified valve was not marketed in the U.S. The company sold them in 
Europe. And the modified valve had six times the amount of disasters in 
the hearts as a result of that 10-percent increase. Hundreds of deaths 
resulted in Europe and thousands and thousands of people put at risk.
  Then we have the angioplasty catheters that failed causing dozens to 
suffer emergency coronary bypass surgery, cardiac damage and death.
  Mr. President, this is what we are talking about. We are talking 
about S. 830 which allows false and misleading labels for medical 
devices. S. 830 could result in the surgical needles that do not safely 
remove the breast cancer tumors.
  FDA has been asked to clear surgical lasers for marketing despite the 
lack of safety data submitted to support the clear intent of the 
manufacturer--to cut prostate tissue. What we have are laser 
manufacturers that say, ``Well, all right, we want to use lasers in the 
operations on the prostate. And a certain amount of cutting is going to 
be necessary.'' They effectively say, ``Our laser is substantially 
equivalent to lasers that are already approved for general cutting,'' 
when the intention of the company is to use the newer designed laser 
not just in the ordinary cutting of tissues but for use in a prostate 
operation. Therefore, through this loophole, a device may be used for a 
purpose for which it was clearly designed but not adequately tested.
  We have also, Mr. President, the example of contact lenses that may 
cause blindness. FDA can tell by the materials and design of a contact 
lens that it will be used for extended wear. But a company could submit 
data only on a labeled use of daily wear and FDA would be prohibited 
from asking for additional information on extended wear. Extended wear 
lenses that are not adequately tested may cause ulcers on the cornea 
and can be sight-threatening.
  Mr. President, we may see in the future digital mammography screening 
machines that may misdiagnose breast cancer. We have seen enormous 
progress being made in terms of mammography with all the benefits of 
early detection of breast cancer which permits early treatment and 
saves lives.
  These advanced technologies, Mr. President, may be able to perform 
diagnostic mammography but not mammography screening. There is an 
important difference. The screening is used to find out whether there 
are tumors as compared to examining a tumor for diagnostic purposes to 
make a determination of the appropriate kinds of medical treatment. A 
mammography instrument labeled for use as a diagnostic machine could 
have features specific to mammography screening and the safety data 
should be submitted to support that use.
  Why do we have to take a chance on it? What is the compelling need to 
take a chance on women's health? Why shouldn't we say to FDA that if 
they have reason to believe that the primary purpose of this new 
machine is going to be for screening and the label is false and 
misleading that they can ask for safety data for the intended use.
  Why should we hamstring the FDA when we know that the purpose for 
these new kinds of medical devices are not consistent with what is 
being labeled by the manufacturing company?
  (Ms. COLLINS assumed the chair.)
  Mr. KENNEDY. Under this legislation, the FDA, even though they know 
this might provide an important safety question for the American 
people, are handcuffed from doing anything about it. Why are we doing 
this to the American people? For what purpose? Are we that far behind 
in terms of online medical devices? We are not.
  I can put in the Record the various publications of the medical 
device industry that show they have been making important progress over 
the past several years, and the profits have gone up, and a different 
atmosphere is out there to bring the various products on the market. A 
GAO report has shown that medical device review times are down.
  So if that is the case, why, now, are we going to rush these devices 
on through when their purposes are clearly different from the labeled 
use and for which we do not have adequate safety data? This is a major 
step back, and puts the public at risk.
  Madam President, we can go through what some of the dangers are when 
we find various devices are used for one purpose and then changed and 
altered for another purpose. In this diagram we have the long bone 
screws that are used effectively to mend bones. I have a member of my 
family that has had those implanted and they have been enormously 
effective. A member of the family had a broken shoulder, and I went 
back to see her 5 days later and she was able to move her arm, move her 
shoulder. It was unbelievable when you think of what most of us 
understood would be a recovery time of several months.
  We have seen how, when used properly, how they can help mend a bone, 
give stability to bone, and be effective in helping and assisting those 
people with that kind of a break to long bones. Then what happened? We 
found out the screws were being sold to back surgeons for another 
purpose. They were marketed for use in the spinal column to give 
stability to the spine.

[[Page S9705]]

  What happened? Madam President, the screws broke, and they were 
disasters for many Americans who had the operation. Those screws were 
not adequately tested for use in the back and should not have been used 
in that manner.
  These examples are what is happening every day. We have the biopsy 
needle, the contact lenses, we have the long bone screws, and the list 
goes on. We ought to be very careful about denying the Food and Drug 
Administration needed information in terms of their safety and 
effectiveness.
  Now, Madam President, we cannot prohibit off-label use of medical 
devices. We are not doing that in the proposed amendment. What we are 
saying is that when you have on the face of it a clear intention that 
the new proposal that is being submitted to the FDA is going to be used 
clearly as a dominant use for another purpose, such as the breast 
biopsy instrumentation, that the FDA ought to be able to look at the 
safety and efficacy of the device.
  Why are we going through this, Madam President? Why are we tying the 
hands of the agency that has the skill and the knowledgeable people to 
try to protect the public?
  All we are saying is when there is a clear record on the use of a 
device, make sure the American public's interest is going to be 
protected and not denied. All our amendment says is when the label is 
false and misleading, the FDA is going to be able to look behind it. 
That does not seem to me to be a very dramatic or radical kind of 
resolution to this particular issue.
  We have indicated four or five different types of compromises to this 
particular measure to try to protect the public's interest. We are 
ready to look at different language to protect the public's interest. 
But the guiding light is, when we know a medical device is being 
submitted with false or misleading information and that the device is 
clearly designed for another purpose, the FDA should be able to look at 
the safety and the efficacy of the device.
  We have seen in recent years the dangers of simple changes like the 
absorbency of tampon material. It looked like it was just a very modest 
kind of alteration or change. But women were injured, and subject to 
infections that caused toxic shock syndrome sometimes leading to death.
  Why are we doing less for the protection of our consumers? Why are we 
restricting the protections of the American consumers? We are going to 
have a difficult enough time trying to make sure that when medical 
devices go through vigorous requirements for safety and effectiveness 
that they are indeed safe and efficacious. Some mistakes may very well 
be made. At least we will know we have given it our best shot. At least 
we will know we have given to the American people the best we have, in 
terms of scientists and researchers, to try to make sure those products 
are safe.
  On this particular provision, for the first time in 23 years, we will 
be effectively rolling back public health protections at FDA. We will 
be effectively handcuffing the FDA on a major matter that affects the 
health and the safety of the American people. It is unwise. It is 
unjust. There is absolutely no rationale or justification for this 
provision other than the profits of the medical device industry.
  Madam President, I cannot help but believe as the American people 
understand this issue, understand the health implications, understand 
on the one hand we are risking the public health of the American people 
in favor of the profits of the medical device industry, that they will 
be heard on this issue. This provision puts at serious risk the health 
of the American people--that is what the HHS says, that is what the 
Women's Health Network says, that is what the principal consumers 
groups that are out there to protect the American people say.
  What is the benefit on the other side? The profits of unscrupulous 
medical device manufacturers. It is not only going to be the profit of 
those individual companies like U.S. Surgical, but it will be an 
invitation to other medical device companies to go through a loophole, 
because otherwise they will be put at a competitive disadvantage. It 
makes absolutely no sense.
  I hope very much, that when the Senate addresses this issue in the 
next week, we can have the support of our colleagues and we will have 
the support of the House of Representatives and we can move forward 
with an otherwise reasonable bill.
  I see my friend and colleague, Senator Durbin, here on the floor. I 
yield the floor.
  The PRESIDING OFFICER. The Senator from Illinois is recognized.
  Mr. DURBIN. It is my understanding under the unanimous consent I am 
allotted 30 minutes, 15 minutes on each side, on two separate 
amendments, amendments 1139 and 1140. Is that correct?
  The PRESIDING OFFICER. The Senator has the right under the agreement 
to call up either amendment 1139 or 1140. When he does so, he will have 
30 minutes on each amendment, equally divided.
  Mr. DURBIN. I thank you, Madam President.


                           Amendment No. 1140

   (Purpose: To require that entities and individuals accredited to 
 conduct reviews of device notifications be subject to the conflict of 
    interest standards that apply to employees of the Food and Drug 
                            Administration)

  Mr. DURBIN. I call up amendment 1140.
  The PRESIDING OFFICER. The clerk will report.
  The legislative clerk read as follows:

       The Senator from Illinois [Mr. Durbin], for himself, Mr. 
     Feingold, and Mr. Johnson, proposes an amendment numbered 
     1140.

  Mr. DURBIN. Madam President, I ask unanimous consent reading of the 
amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is as follows:
       In section 523 of the Federal Food, Drug, and Cosmetic Act, 
     as added by section 204, strike subsection (b) and insert the 
     following:
       ``(b) Accreditation.--
       ``(1) In general.--Within 180 days after the date of 
     enactment of this section, the Secretary shall adopt methods 
     of accreditation that ensure that entities or individuals who 
     conduct reviews and make recommendations under this section 
     are qualified, property trained, knowledgeable about handling 
     confidential documents and information, and free of conflicts 
     of interest.
       ``(2) Standards.--In adopting the methods of accreditation, 
     the Secretary shall ensure that the entities and 
     individuals--
       ``(A) are subject to--
       ``(i) the conflict of interest standards applicable to 
     employees of the Food and Drug Administration under subpart 
     E, H, and I of part 73 of title 45, Code of Federal 
     Regulations (as in effect on January 1, 1996); or
       ``(ii) if the standards described in clause (i) would be 
     inappropriate for the entities and individuals, conflict of 
     interest standards developed by the Secretary that are--
       ``(I) based on the standards described in clause (i); and
       ``(II) modified, as appropriate, to apply to the entities 
     and individuals; and
       ``(B) are not subject to the conflict of interest standards 
     under subpart J of such part.
       ``(3) Publication.--The Secretary shall publish the methods 
     of accreditation in the Federal Register on the adoption of 
     the methods.''.

  Mr. DURBIN. Before proceeding, I ask unanimous consent Senators 
Feingold and Johnson be added as cosponsors of amendment 1140.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. DURBIN. Madam President, the bill before the Senate is one of the 
most important we will consider during the course of this Congress. I 
don't believe that is an overstatement. This bill addresses the future 
of the Food and Drug Administration, an agency which we literally 
entrust with the safety and efficacy of thousands of drugs and 
prescriptions which we keep in our home and give to members of our 
family.
  This agency has to be above reproach, it has to be efficient and 
responsible. This amendment No. 1140 that I am offering is an attempt 
to make certain that the integrity of the Food and Drug Administration 
is not compromised by this bill. I think overall this is a good bill. 
There are some areas Senator Kennedy and I and others feel need to be 
addressed. But the one part of this bill that I address with this 
amendment is one of great concern.
  We are now going to say that we will take outside of this Federal 
agency, outside of the Food and Drug Administration, the review of 
medical devices. We will say to third parties, which are hired for the 
purpose of making these reviews, that they will decide whether or not a 
medical device is safe for the American people and whether it's 
effective; and having made that decision,

[[Page S9706]]

that company will then have an opportunity to sell that device across 
America. We as consumers will believe, as we should, that we can trust 
that judgment.
  The purpose of amendment No. 1140 is to address the question of 
whether or not the third-party reviewers are credible. This bill 
dramatically expands the ability of medical device companies to 
purchase their own third-party reviewers. Senators Feingold and Johnson 
and I are offering this amendment so that it's clear that it's only 
reviews and not approvals themselves that can be bought under this 
system.
  Up to 60 percent of medical devices going through the premarket 
notification process could utilize the outside reviewing system. A 
program of this magnitude will not permit the same level of close 
monitoring and oversight by the FDA as is currently undertaken. There 
are fewer than 10 firms that are credited for this purpose. That is why 
explicit anti-conflict-of-interest standards need to be laid out in the 
law. We should not cut corners when it comes to the question of 
conflict of interest. If we are going to give to these companies the 
authority to review and approve medical devices to be used across 
America, let us have no question that they are doing it in a 
professional way.
  The Project on Government Oversight, a nonpartisan, nonprofit 
Government watchdog group, described the bill's provisions in this area 
as grossly inadequate, and the Government Accountability Project, which 
is another watchdog group, described the current FDA regulations for 
their pilot program as ``inadequate to guard against conflict of 
interest.'' Both groups, along with a long list of consumer and patient 
groups, urge the Senate to adopt this Durbin amendment.
  Given the importance to the public of keeping the approval process 
untainted by monetary influence, we must ensure that there are strict 
anti-conflict-of-interest standards for product reviews.
  Only the vaguest language possible on the issue of preventing 
conflicts of interest is currently contained within the bill. Let me 
tell you what it says on page 16:

       The Secretary shall adopt methods of accreditation that 
     ensure that entities or individuals who conduct reviews and 
     make recommendations under this section are qualified, 
     properly trained, knowledgeable about handling confidential 
     documents and information and free of conflicts of interest.

  Nowhere does the bill mention what we mean by ``free of conflicts of 
interest.'' What are the standards that we will use? No reference point 
is given for a basic minimum that would satisfy and ensure unbiased 
review.
  Senator Harkin was successful in adding language that allows the FDA 
to look at contractual arrangements between an outside reviewing 
laboratory or entity and the company whose product is being reviewed. 
We would like to go a step further and add more protections against 
approval peddling.
  FDA employees themselves are subject to a wide range of anti-
conflict-of-interest regulations. This amendment seeks to establish 
basic requirements, and it is very simple. It merely asks that outside 
reviewers not be allowed to have a financial interest in the company 
they review.
  Think about what I just said. The outside reviewer, which will decide 
whether a medical device should go on the market, should not have a 
financial interest in the company that he is reviewing. That seems 
rather simple to me. Nor should they be allowed to receive gifts from a 
company that has products being reviewed, and they should not be 
actively looking for a job with that company while they are in the 
process of making their review. No gifts, no job offers, no stocks. It 
seems simple.

  It is amazing to me that we are arguing over this provision. I would 
have thought this would have been accepted long ago by the majority. 
But instead, there is a fight as to whether or not we are going to 
demand the highest level of integrity and honesty when it comes to 
these third-party reviewers.
  Let me tell you why this is critically important. The approval by the 
FDA of a device can have a dramatic positive or negative economic 
impact on a company. If the FDA rejects a device and doesn't approve 
it, a stock can languish for months, if not years. If the FDA approval 
goes through, it is the seal of approval, and that company knows that 
there is money to be made.
  Look at this chart indicating what happened in four different 
instances with medical device companies when there was an FDA approval. 
QLT Phototherapeutics, Inc. Look at how the stock shot right up with 
FDA approval. ATL Ultrasound. After FDA approval, it skyrockets. 
Thoratec Laboratories Corp., the same story; the stock is moving along 
slowly, and then, after FDA approval, it climbs dramatically, 50 or 60 
percent in 1 day. It was the same thing with Integra LifeSciences Corp.
  What we are trying to say is, the people making the decision on 
behalf of us, as consumers, should make that decision without any 
concern about the bottom line of that company. Would you think twice 
about giving to a reviewer the decision to approve a product if you 
knew that reviewer owned a thousand shares of the company that made the 
product? I think most of us would. What if that reviewer and his family 
had just come back from a Caribbean vacation, paid for by the company 
that submits the medical device for approval, or if that reviewer 
happens to have sent his resume to that company a week before, saying, 
``I would like to have a job with you and, incidentally, I am working 
on your FDA approval,'' with a wink and a nod? That doesn't make me 
feel any better about what we are dealing with here.
  The Durbin amendment basically says, let's get rid of the doubt as to 
whether or not people are going to use the highest professional 
standards. We should not cut corners here when it comes to conflicts of 
interest, when it comes to these outside laboratories. We have to 
demand the highest standards of professionalism.
  Time and again, companies have been shown to make dramatic profits 
with FDA approval. Dr. Kessler, a former head of the FDA, said, ``Make 
no mistake, they talk a lot about approvals in Europe and in other 
countries. They can be lucrative, they can be profitable. But if you 
can get the approval of the Food and Drug Administration of the United 
States of America, it is a seal of approval recognized worldwide. The 
product you are trying to sell becomes a winner overnight.'' Shouldn't 
the people making the decision as to whether or not this product is 
safe and efficacious be doing it on the basis of science, rather than 
on the question of their own financial interest?
  The medical device industry produces over $50 billion annually in 
sales. In fact, in a recent article in Medical Economics entitled ``Why 
Medical Stocks Belong in Your Portfolio,'' the medical device industry 
was described as ``a hot market that's only getting hotter.'' It 
doesn't take much imagination to see why we would not want to allow a 
reviewer to have stocks in the company they were reviewing. The 
connection between FDA approval and stock gain is just too clear. The 
money stakes are high for investors; however, the stakes are even 
higher for the patients who rely on these devices.
  The approval of an unsafe drug or device can have a devastating 
impact. Doctors, hospitals, nurses, and families rely on these 
decisions. If a corner is cut, if this reviewer has a financial 
interest and decides, well, I am just going to tip it a little bit 
toward my own stock portfolio here, the losers ultimately are the 
innocent people. Reviews must be of the most stringent nature and must 
be carried out without any outside corrupting influence.

  Surely, it is not too much to ask that a reviewer be prevented from 
accepting a gift or a loan from a company that he or she is reviewing. 
I can't imagine we are debating this. Should we allow the reviewer to 
take a gift from the company he is reviewing? That is an obvious 
conflict of interest and one that we can address explicitly. The 
language in the bill, unfortunately, is loaded with ``weasel'' words--
weasel words about what a conflict of interest might be. We should make 
it crystal clear. It would give this bill more stature. It is an 
important bill and it should have that.
  Furthermore, a reviewer or their spouse or minor child should not be 
allowed to have a financial interest in the company being reviewed. 
That means owning stock or a mutual fund that has more than 10 percent 
invested in the company. This is all laid out in subpart H of the 
regulations that we refer to in our amendment. A final restriction that 
we are asking for is that

[[Page S9707]]

the reviewer may not be actively soliciting future employment within 
the company they are reviewing.
  Our amendment, which sets out guidelines to prevent tainted reviews, 
allows the Secretary to modify such guidelines where it would be 
appropriate for outside reviewers.
  Therefore, if any provision included in these regulations would 
clearly not apply or not be appropriate, the Secretary can modify it. 
We have that flexibility built into our amendment.
  I have heard some of my colleagues argue for more flexibility. I 
believe our amendment gives enough. It sets out specific standards. I 
challenge any of my colleagues to suggest that a gift ban or a 
financial interest ban would be unreasonable. It would be a sad day in 
America if reviewers expect a gift, or a job offer, or some other 
financial gain in order to review a medical device and, worse, that we 
were not willing to categorically repudiate a potential for such 
``approval peddling.''
  This industry and their products are too important to the American 
people. These are literally life-and-death products. We should take a 
firm stand and specifically enumerate these basic standards within this 
legislation to prevent even the potential for the corruption of this 
process.
  Madam President, I yield the remainder of my time on this amendment.
  Mr. JEFFORDS addressed the Chair.
  The PRESIDING OFFICER. The Senator from Vermont is recognized.
  Mr. JEFFORDS. Madam President, first, let me very briefly review 
where we are. There has been considerable debate up to this point. I 
think it is important for me as the chairman of the committee to remind 
people as to where we are.
  We have before us a 152-page bill, which is the first real overhaul 
of the Federal Food, Drug and Cosmetic Act in the last 30 years. We 
have taken little tweaks here and there, but it has not been thoroughly 
reviewed and brought into the modern world.
  Out of that 152 pages, we are now spending most of the time debating 
on 2 or 3 pages. That is why the minority ranking member has praised 
the bill, but then picked on one--basically, we are here because of one 
provision, which is 404. On some standards, we cannot agree on the 
precise wording.
  So everybody agrees on almost all of this bill. The amendment that is 
being offered by the Senator from Illinois does get into a very, very 
important area, and we do not disagree with that. We praise him for 
having given us the opportunity to review, to restudy, and determine as 
to whether or not the provision he is striking with his amendment and 
replacing is necessary or appropriate. We have concluded--I say ``we'' 
because I am sure that Senator Kennedy joins me in this statement--that 
we adequately take care of the conflict of interest in this bill.
  Let me go through what his amendment attempts to do and what the bill 
provides. First of all, the Senator's amendment, at best, duplicates 
the third-party provision that we have in the bill now and, at worst, 
it unnecessarily constrains the agency.
  Section 204, conflict of interest protections, which is being 
stricken and replaced, provides a full statutory directive to the 
agency to prevent conflicts of interest that may be involved with both 
an individual reviewer and with the reviewing organization. As with 
Senator Durbin, this was a critical concern for members of the 
committee.
  Section 204(b) reads:

       Within 180 days after the date of enactment of this 
     section, the Secretary shall adopt methods of accreditation 
     that ensure that entities or individuals who conduct reviews 
     and make recommendations under this section are . . . free of 
     conflicts of interest.

  Section 204 provides full discretion to the agency to develop 
appropriate standards. The agency will not be limited in any way in 
developing these guidelines.
  We believe the FDA is the one that can best understand what will be 
effective in this regard. The agency has already developed extensive 
conflict of interest guidelines as a part of its existing third-party 
program. The notice of April 3rd, 1996, has almost a full page of 
Federal Register type laying out the standards, including restrictions 
if ``the third party, or any of its personnel, involved in 510(k) 
reviews has any ownership, or other financial interest, in medical 
device, device manufacturer, or distributor.''
  That is a quote from the wording.
  The agency has not identified any difficulties in the implementation 
of the conflict of interest guidelines, and it has expressed no concern 
about the conflict of interest provisions, as drafted. We have reviewed 
the FDA standards that appeared in the Federal 
Register on Wednesday, April 3, 1996, at page 14794, and believe that 
they adequately and appropriately address the problems which we are 
reviewing here. The agency's strict guidelines resulted in the 
elimination of 30 of the 37 applicants that originally sought 
accreditation. That means, obviously, that the FDA policy is effective, 
and it has outlined and again recognized--as the Senator from Illinois 
is aware--that there are problems that must be protected against. And 
we agree with him on that.
  The Durbin amendment attempts to set standards but in fact may 
constrain the agency. In fact, the standards cited are reportedly 
outdated and do not reflect recent revision. This may explain why in 
the second part of the amendment Senator Durbin effectively gives the 
agency discretion to craft appropriate guidelines. Section 204 provides 
a full statutory directive to the agency to prevent conflicts of 
interest that may be involved with both an individual reviewer and the 
reviewing organization. Therefore, it appears to us that the amendment, 
although well-intended, may even make it more complicated than 
necessary, and that we will end up perhaps with a less effective system 
than is already contained in the bill.
  Madam President, I ask, if we yield back time, what happens to that 
time? May we be advised on that?
  The PRESIDING OFFICER. The time would just lapse. I believe the 
Senator from Illinois has yielded his time on this amendment. If the 
Senator from Vermont yields the remainder of his time, then the Senator 
from Illinois could call up his second amendment.
  Mr. JEFFORDS. If at the end of the time we, for instance, end up 
instead of using an hour on the Durbin amendment using half an hour, 
does that time fall into the same category as the last half-hour of 
this unanimous consent? So we have an hour in that last part of the 
unanimous-consent request.
  The PRESIDING OFFICER. The Chair is not clear about the Senator's 
question. We would proceed to the next amendment, and there would be 30 
minutes equally divided on that amendment. Then we would stay on the 
bill, if that is the wish of the managers.
  Mr. JEFFORDS. Madam President, I believe I understand the ruling of 
the Chair. I appreciate that.
  The PRESIDING OFFICER. Regardless of the amount of time we use today, 
on Tuesday we will have 5 hours on the bill itself equally divided.
  Mr. JEFFORDS. I appreciate that clarification because this does get a 
little bit complicated as we move forward. This is an important issue.
  I think at this time I will just again restate that we believe that 
the bill as written adequately covers the problems of the conflict of 
interest situation.
  We commend the Senator from Illinois for really focusing attention on 
this and bringing it to our attention again so that all of my 
colleagues hopefully will understand that the bill--this is agreed to I 
believe also by Senator Kennedy--is effective in accomplishing the 
goals of the Senator from Illinois.
  So, again I commend him for what he has done.
  Madam President, I yield the remainder of my time.
  The PRESIDING OFFICER. All time on the amendment has been yielded.


 Amendment No. 1139 to Modified Committee Substitute Amendment No. 1130

  (Purpose: To eliminate provisions relating to the discretion of the 
 Secretary of Health and Human Services to track devices or to conduct 
                  post-market surveillance of devices)

  Mr. DURBIN. Madam President, under the unanimous-consent request, I 
would like to call up my amendment 1139.
  The legislative clerk read as follows:

       The Senator from Illinois [Mr. Durbin], for himself, Mr. 
     Harkin, and Mr. Johnson, proposes an amendment numbered 1139 
     to the modified committee substitute amendment numbered 1130.

  The amendment is as follows:


[[Page S9708]]


       On page 46, beginning on part 5, strike sections 605 and 
     606.
                                  ____

  Mr. DURBIN. Madam President, I ask unanimous consent that Senator 
Harkin be added as a cosponsor of amendment No. 1139.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. DURBIN. Madam President, the conflict of interest provision which 
we have just discussed is a very important one, but the one which I am 
addressing with this amendment may be even more important.
  Consider this possibility. On Monday of next week you go out to buy a 
Pontiac. On Tuesday when you go to the doctor, he says, ``You are going 
to have to go to the hospital, and you are going to need a pacemaker.'' 
In 1 week you have a Pontiac and a pacemaker. What is the difference? 
When you bought the Pontiac, General Motors took note of your name and 
address. If anything went wrong with the Pontiac, they would contact 
you in 6 months, 1 year, 2 years, or even later, and say, ``Bring it 
in. It needs to be fixed.'' It might not be safe, if you didn't. 
However, under this bill the pacemaker that you are going to have 
implanted by the surgeon perhaps a few days later doesn't have the same 
kind of following. Why? Because we let that exist.
  Why would we let people have lifesaving devices implanted in their 
bodies and not keep track of that fact? That is what this amendment is 
all about, because this bill, as good as it is, takes away the 
mandatory requirement that we have surveillance and tracking of these 
high-risk devices that can be implanted in people.
  I am glad to be joined by Senators Harkin and Senator Johnson in 
offering this amendment which strikes the sections of the bill that 
undermine many of the patient protections for medical devices put in 
place by the Safe Medical Device Act of 1990.
  This act of 1990 instituted a mandatory surveillance program to 
identify quickly any potential problems with approved high-risk 
devices. A mandatory tracking system to locate patients in the event a 
safety recall was also added.
  Sections 605 and 606 in this act are nothing more than a backdoor 
attempt to eliminate these programs that industry considers burdensome. 
Yes, they are burdensome. To keep track of the name and address of each 
person who is given a pacemaker is a big burden on industry. But what 
kind of burden is it on the patient when the pacemaker fails and the 
patient can't be found? I would suggest that it is a much greater 
burden. That is what this amendment addresses.
  Proponents of sections 605 and 606 say that the FDA has not been 
vigilant with respect to overseeing these vital programs. Does anyone 
imagine they are going to be more vigilant in enforcing these safety 
protections when they are relegated to an optional or discretionary 
status? Especially given CBO's high estimate of this bill's additional 
costs to the FDA without any corresponding increase in funding. 
Pressure can only increase on the agency to curtail its efforts in 
discretionary programs.
  Opponents of this amendment will point to the fact that the 
administration went along with this change. This point is in fact even 
more worrisome when you look at what types of devices we are talking 
about, and the tragedies that may occur.
  Many of us remember the tragedies that resulted from the Bjork-Shiley 
heart valve failures. Extensive congressional hearings were held in the 
late 1980's examining what had gone wrong and how we might prevent 
future repeats of these terrible tragedies.
  Over 300 people died in the United States from these heart valve 
failures, and over 1,000 worldwide.
  After it was concluded that these heart valves were defective--after 
they realized the product had failed--over 50 percent of the patients 
with these heart valves couldn't be located.
  One widow testified--and this is a tragic story--about how her 
husband, who had a Bjork-Shiley heart valve implant, suffered chest 
pains but had no idea that the heart valve was the cause of the 
problem. She was in a position to choose from two hospitals. She 
quickly raced to one hospital, and made the wrong choice. She went to 
the hospital that didn't specialize in heart surgery when her husband 
needed to live. She didn't know. Why didn't she know? She wasn't on the 
list. Her husband's name and address were not on the list to be 
notified that the heart valve he carried in his body was failing him.

  What does tracking actually involve? It involves a patient--this is I 
don't think a burden from that perspective--filling out a registration 
form with their address so they can be located if there is a recall of 
a pacemaker, or high-risk device. Most companies make this request 
already.
  What kind of devices are we talking about? Just about anything? No. 
There are 17 specific types of devices that require mandatory tracking. 
We are talking about heart valves; pacemakers and pacemaker leads; 
vascular stents; jaw, shoulder, and hip joint replacements; windpipe 
prosthesis; breathing monitors and ventilators.
  It is hard to imagine the tracking of these high-risk devices could 
ever been made optional, and yet that is exactly what this bill does.
  FDA has already complained that they find it extremely difficult to 
enforce this provision, and yet, instead of making it stronger and 
helping them with enforcement, this bill weakens it. It weakens the 
FDA's ability to make this kind of adequate tracking and surveillance 
available.
  Automobile manufacturers are required to have a tracking system to 
notify those who buy cars. It even happens with motorcycles. Look at 
this. What a coincidence. In the Phoenix Gazette of Friday, January 11, 
1991, there are two articles next to one another. Harley-Davison 
recalls its motorcycles. We have a problem here. It turns out that 
their brake calipers are defective and could cause their front wheels 
to lock while driving.
  Right next to it, on Consumer Watch, jaw implants. It is found that 
the implants of Vitek of Houston caused bone degeneration. If we cannot 
track the people who bought the jaw implants through their surgeon, we 
can certainly find the owners of the Harley-Davidsons. Does that make 
sense?
  I would like to submit for the Record a letter that I received from 
Victims Against Lethal Valves, a support group out of Pittsburgh for 
those who have suffered from defective heart valves. They urge the 
Senate to adopt my amendment. If you read this letter from the families 
of those who were caught unaware that they had a defective heart valve, 
you might think twice. I hope my colleagues will.
  I ask unanimous consent that this letter be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                Victims Against Lethal Valves,

                               Pittsburgh, PA, September 16, 1997.
     U.S. Senate,
     Washington, DC.
       Dear Senator: As a Bjork-Shiley heart valve survivor and 
     founder of VALV, a support group for people with the Bjork-
     Shiley heart valve, I strongly urge you to support Senator 
     Durbin's amendment to S. 830 to maintain mandatory tracking 
     and postmarket surveillance of high risk medical devices like 
     heart valves.
       The Bjork-Shiley heart valve experience was a major impetus 
     to enacting these two provisions in 1990. Almost 1,000 people 
     (world-wide, the device was marketed longer in Europe than in 
     the U.S.) have died as a result of the fracture of the Bjork-
     Shiley valve. S. 830 makes tracking and postmarket 
     surveillance of these very high risk devices discretionary 
     rather than mandatory.
       The Bjork-Shiley disaster highlighted the need to implement 
     a systematic method for tracking the device recipients. When 
     the FDA finally ``caught up'' with the significant numbers of 
     Bjork-Shiley heart valve fractures and ordered the company to 
     notify recipients of the valve's potential failure, what 
     symptoms to look for, and what to do if these symptoms 
     appeared, the manufacturer claimed that they had no record of 
     how to find as many as half of the recipients. Should a 
     defect in a device be identified, it is critical that device 
     recipients be notified so they can seek medical attention.
       The manufacturer knew that the Bjork-Shiley heart valve had 
     a tendency to fracture very soon after it went on the market. 
     But the firm conducted no systematic surveillance, and did 
     not accurately report the information about problems it 
     received to the FDA. Section 522 was designed to remedy this 
     gap in reliable, verifiable information--so that the 
     manufacturer would know, and the FDA could check--on problems 
     with new post-1991 devices.
       Most Market surveillance and tracking are consumer 
     safeguards that were won with the lives of people like me and 
     the members of

[[Page S9709]]

     VALV. We urge you to adopt Senator Durbin's amendment and 
     keep these consumer protections in place.
           Sincerely,
                                                  Elaine Levenson,
                                                          Founder.

  Mr. DURBIN. Madam President, another key aspect of the Safe Medical 
Device Act, which this bill undermines, is the mandatory surveillance 
program for high-risk medical devices.
  These surveillance programs are extremely important for early 
detection.
  In some cases, the initial breakage of a device may not cause 
instantaneous harm. For example, in the case of the Telectronics Heart 
Pacemaker ``J'' Leads which are found to be defective in 12 percent of 
the patients with them, breakage didn't result in any harm until the 
next bout of heart arythmia. Surveillance of these leads identified 
problems in some patients. And this led to the notification of patients 
with these leads of the need to have them checked.
  Likewise, in the case of the Bjork-Shiley heart valves, 300 Americans 
died when this tiny heart valve no bigger than a pen turned out to have 
a structural defect.
  This is a blowup of a photograph of a heart valve. And it shows a 
crack in one of these struts on this heart valve. This crack alone 
wouldn't be lethal. But when the strut next to it cracks, it is too 
late. You are going to die unless you have immediate surgical relief.
  We believe that once you know that the heart valve is in danger, you 
should know the people who have received it so that you can notify them 
so that they can go to a doctor and have the necessary test to see if 
they are in danger.
  Early detection and correction could have prevented many of the 300 
deaths that occurred when this Bjork-Shiley valve failed.
  Let me tell you about another case, teflon jaw implants. People with 
the temporal mandibular problems--TMJ--have turned to these implants as 
a way of dealing with a maddening situation, and a very painful one.
  In the case of the implants made by Vitek in the 1980's, early 
detection unfortunately wouldn't help. These implants splintered and 
caused massive corrosion of jaws and skull due to the triggering of 
inflammation and other immune responses. By the time the patients 
suffered pain, for many of them it was too late. Many of the patients 
required the removal of much of their jawbone structure because this 
implant had failed. Even some of their skulls were exposing their brain 
because of this subsequent surgery.
  If a surveillance program had been in place prior to the Vitek jaw 
implant defect, many of the patients would have been able to have their 
implants removed prior to the full deterioration of their jaws. In 
fact, many individuals would have been saved altogether from ever 
having the implants inserted in the first place.
  Vitek jaw implants were first marketed in 1983, but it wasn't until 
1990 that FDA sent out a safety alert, and in 1991 issued a recall.
  Think about that, 7 or 8 years later we finally realized that there 
was a problem with this implant.
  At that stage, between 25,000 and 26,000 patients had received these 
implants. The rate of failure was nearly 100 percent.
  Here on these charts you see some of the sad stories of the victims. 
These are troublesome to see, but think about these poor people and 
what they went through. Asking these companies to keep track of the 
people who received these implants is not unreasonable when you take 
this lovely young lady in this picture and look how she deteriorated 
after these implants started to fail. And the same thing, this lovely 
lady in this picture and what happened to her face as a result of the 
implant failure. On this one, look at this. After the implant failed, 
look what happened. It actually emerged from the skin.
  Is this something that we want to think twice about? I would think 
that as a matter of just decency we should include in this bill 
tracking and surveillance to try to avoid this from happening to 
anybody in the future.
  Some may try to argue we still have the medical device reporting 
system. That is no substitute for company surveillance. The medical 
device reporting system is basically a body count program. We hope that 
we could have a strong program to detect problems before death and 
injury. That is exactly what a surveillance program does. Many medical 
devices on the market are approved on the basis of data from trials of 
shorter than the lifespan of the device. Vascular stint, approved by 
the FDA this year, was approved on data after 6 months of use. FDA 
requires surveillance to check if the device will be safe for a longer 
period similar to the life expectancy of the device.
  I would like to also bring to the attention of my colleagues a recent 
GAO report on the inadequacies of the medical device reporting system 
before anyone starts arguing that it is a substitute for surveillance 
programs. This report from the GAO states that between March 1994 and 
April 1995, a backlog of about 48,000 malfunction reports from 
manufacturers accumulated at the FDA. Many of the malfunction reports, 
according to GAO, were not entered into the adverse event reporting 
system until 1996--almost 2 years in some instances. In fact, the House 
device bill suggests eliminating even this report because of its 
inefficiencies.
  In contrast to that system, the tracking and surveillance programs 
which I am pushing for are much more effective. This January a good 
example of this was seen in the case of a runaway pacing implantable 
cardioverter defibrillator manufactured by Ventritex. Due to their 
surveillance programs, Ventritex realized the clock in the 
defibrillator was running radically.
  For those who are not familiar, it is a situation where a person has 
a heart problem where the heart beats irregularly. The defibrillator 
feeds a shock to the heart to stop the defibrillation and save the 
person's life. The company realized it was not working right. That kind 
of problem could be fatal for individuals with these defective devices 
implanted. On January 15, the company met with FDA and proposed a 
temporary fix that could set these devices straight. Within less than a 
month, over 97 percent of the 5,600 patients were found and their 
devices were reprogrammed. Thousands of lives may have been saved by 
this effective tracking and surveillance.
  Shouldn't this be the case for every lifesaving device? Why does this 
bill water it down? Why does this bill take away the tracking and 
surveillance that would give us the necessary information to track this 
very sort of thing to save people's lives.
  In the pretracking days, before we started doing this, I have a 
letter from a lady named Charlotte Evans. She only discovered this year 
that her teflon jaw implant might be defective even though the product 
has been off the market for over 7 years, but no tracking program had 
been in effect when she bought it. For 11 years since she had this 
device implanted, her jaw had been undergoing deterioration due to this 
defect, but she had no notice of any problems with the device.
  I think the final chart says it all. Mandatory surveillance leads to 
early detection of problems, which results in fewer deaths and less 
serious injuries. Mandatory tracking gives us effective recall and 
saves lives. To rely only on the medical device reporting system is to 
treat American people as though they were lab rats while we wait for 
the body and injury count to mount.
  Let me tell you who supports my amendment: Victims Against Lethal 
Valves, the TMJ Association, the National Breast Implant Task Force, 
NORD, AARP, Consumers Union, Consumer Federation of America, Bazelon 
Center for Mental Health Law, the American College of Nurse-Midwives, 
AMFAR, the AIDS Action Council, DES Action, Center for Medical 
Consumers, Committee for Children, Human Rights Campaign, National 
Women's Health Network, Public Citizen, and the Treatment Action Group.
  I hope that it will also be supported by a majority of my colleagues. 
If any of us believed for a moment that someone we love, a member of 
our family, was about to undergo a surgery and have a device implanted 
in their body and then be lost so that if something is found wrong with 
that device later on and their lives are in danger, we would think 
twice about this provision in the bill.
  Let us keep tracking and surveillance in the bill. The medical device 
manufacturers must accept the burden

[[Page S9710]]

of keeping track of the people who receive these devices. If something 
goes wrong, it is literally our only way to avoid injury and save 
lives.
  Mr. President, at this point I yield back the remainder of my time.
  The PRESIDING OFFICER (Mr. Burns). The time of the Senator from 
Illinois has expired. The Senator from Vermont.
  Mr. JEFFORDS. Mr. President, I again commend the Senator from 
Illinois for focusing on some of the most critical problems that we 
have with respect to devices. However, I would only point out that the 
bill as is at this time is subject to a bipartisan agreement with full 
concurrence of FDA.
  At this time I ask unanimous consent that Senator Collins be 
recognized for up to 10 minutes as if in morning business and that upon 
completion of her remarks the Senate return to the consideration of S. 
830 and the Durbin amendment.
  The PRESIDING OFFICER. Without objection, it is so ordered. The 
Senator from Maine is recognized for 10 minutes.
  Ms. COLLINS. Mr. President, I thank the distinguished manager of the 
bill for yielding to me.
  (The remarks of Ms. Collins pertaining to the introduction of S. 1199 
are located in today's Record under ``Statements on Introduced Bills 
and Joint Resolutions.'')
  The PRESIDING OFFICER. Who seeks recognition? The Senator from 
Vermont.
  Mr. JEFFORDS. Mr. President, I now return to the Durbin amendment.
  Section 605, is also the subject of bipartisan agreement, with FDA's 
concurrence. By way of brief explanation, device tracking is intended 
to facilitate a product recall.
  Current law requires tracking for certain product types and also 
gives FDA discretion to require tracking for other products. It simply 
is not necessary for every device in the mandatory category to be 
subject to the tracking requirement. This provision allows FDA to 
affirmatively indicate which products in the mandatory category should 
be subject to tracking.
  FDA may use its discretion to add new products to the list of 
products which must be tracked or put a product back on the list for 
tracking if evidence indicates the need.
  This provision is needed because today, FDA will often indicate to a 
manufacturer that a product need not be tracked, even if it is in the 
mandatory category. While this many be good policy in the specific 
case, it puts both the FDA and the manufacturer in an undesirable legal 
situation. This provision allows FDA to exercise proper discretion and 
removes any potential cloud of legal liability which exists today.
  It is inconceivable that FDA would not require tracking in the tragic 
cases identified by the Senator. The provision in the bill is logical, 
safe, and necessary. Further, the GAO report cited by the Senator 
refers to areas of FDA control totally unrelated to device tracking and 
surveillance.


                  Section 606: Postmarket Surveillance

  Some have asked why we have made the FDA's postmarket surveillance 
authority discretionary. I am pleased to address that question and I 
think my colleagues will understand the good reasons for doing so. 
First, let me clearly state the FDA is in full concurrence with the 
appropriateness of this policy. I should add that FDA has actually 
required relatively few products to conduct postmarket surveillance. It 
is important to differentiate between this authority and the medical 
device reporting [MDR] and user reporting programs which are unaffected 
by this provision. The Medical Device Reporter Program is the keystone 
to the postapproval system for identifying hazardous or defective 
medical devices on the market place. The MDR Program, coupled with 
FDA's authority to force product recalls and the device tracking 
provisions are a strong web of protection for the consumer. User 
reports, submitted to FDA and manufacturers by hospitals and 
physicians, are an additional layer of information on the status of 
medical devices in the healthcare system.
  Postmarket surveillance has a different purpose--to gather additional 
data to provide the extra assurance in the relatively rare situation 
where FDA has approved a product, yet still believes that the product 
should be subject to a limited period of postmarket evaluation. This is 
because for certain types of devices, problems may arise years after 
approval--problems which may not be detected in even the most elaborate 
clinical trial but could be dangerous to the individual, or even life 
threatening.
  It is instructive to consider the history of this authority. The Safe 
Medical Devices Act of 1990 included a provision requiring a 
manufacturer to conduct postmarket surveillance for any device first 
marketed after January 1, 1991, that is a permanent implant the failure 
of which may cause serious adverse health consequences or death, is 
intended for use in supporting or sustaining human life, or potentially 
presents a serious risk to human health.
  In other words, if you have something which can prevent death or 
serious injury, you certainly want to try it and use it, but you want 
to keep track of it to make sure if it proves to be the reverse in 
certain situations, that you at least know that and then can take 
appropriate action.
  In addition to this mandatory surveillance, FDA was authorized to 
require postmarket surveillance for any device when the agency 
determined that surveillance is necessary to protect the public health 
or to provide safety or effectiveness data. All manufacturers subject 
to mandatory postmarket surveillance were required to submit protocols 
for FDA approval within 30 days of first marketing the device. The FDA 
was required to determine the adequacy of the principal investigator 
and the protocol and to approve the protocol after review by an 
appropriately qualified advisory committee.
  In practice, the provision for mandatory surveillance, like the one 
for mandatory tracking, is so broadly worded that it is causing a good 
deal of uncertainty about those devices which are subject to this 
requirement. In some cases, companies and the FDA are technically 
exposed to unfair liability when the FDA does not require surveillance 
for products where it is, in fact, not necessary. We simply give FDA 
the discretion to require postmarket surveillance on any product it 
deems appropriate. This provision in no way suggests that FDA should 
cease to require surveillance for the types of devices it is currently 
covering under the existing authority. Indeed, we expect that FDA will 
by and large continue to require surveillance for most if not all of 
the products currently covered in the mandatory category. The committee 
and FDA believe this will be an appropriate way to bring clarity and 
efficiency to this important agency function. Indeed, FDA Director of 
Surveillance, Larry Kessler, recently said that he hoped Congress would 
join FDA in moving toward doing more discretionary and less required 
postmarket surveillance. They want to ensure that they can use their 
time as is most appropriate and most effective and efficient for their 
work, and not be required to do things which their judgment has found 
not necessary to take their time.

  So, for that reason I must oppose this, and as I pointed out, Senator 
Kennedy, as well as the FDA, would concur in opposition to this 
amendment.
  I think now I will take some of the time to go back and discuss the 
404 situation here, why we are here. Senator Kennedy has taken 
extensive time last night and today. Certainly this is an important 
issue. It is an extremely important issue.
  The PRESIDING OFFICER. The Senator has 5 minutes.


            Section 404: Labeling claims for medical devices

  Mr. JEFFORDS. Mr. President, with the medical device amendments of 
1976, Congress intended that device classification and approval 
decisions be made based on the intended use of devices as described in 
labeling. In the 20th century, major strides in medical technology have 
revolutionized the practice of medicine. Thanks to achievements in such 
fields as fiber optics, imaging, biomaterials, electronics, and 
biotechnology, today's medical technology is faster, more efficient and 
more productive than ever. These achievements have provided benefits to 
individual patients and to society at large--benefits such as better 
health, more cost-effective medical treatments and the return of 
patients

[[Page S9711]]

to productive lives more quickly. Today more than ever, medical 
technology is advancing at an astounding rate. Around the world, 
medical providers and device innovators are working together to bring 
better, more cost effective therapies to patients.
  That is what we are involved with here. So we want to keep in mind, 
and this is why we sometimes have an interesting dilemma, where you 
have something which the patients' groups are plotting and which the 
consumer groups sometimes take an opposite position on, based upon 
their fears that this process may lead to something getting on the 
market which might cause a problem and they do not have the confidence 
that is built into the oversight part. I urge people to understand, the 
devices we are talking about are important to health. If we delay, as 
has been the case here, delay after delay after delay, unnecessarily 
so, then those who need it, those who are trying to improve their 
health, are denied it because some are so concerned that the delays 
which are deemed, really, unnecessary, lead to people having devices 
denied them.
  Over the years, FDA has made premarket regulatory decisions based on 
uses for devices that are unrelated to the intended uses set forth in 
labeling. S. 830 includes two provisions that express the committee's 
specific intention to limit FDA's review of premarket submissions to 
the proposed labeling before the agency. Considerations like cost-
effectiveness, relative effectiveness, or whether the product effects 
some improvement in a patient's quality of life, are irrelevant to a 
premarket review unless such claims are included in proposed labeling. 
Simply put, the FDA should not exceed its jurisdictional 
responsibilities by incorporating into the review process claims not 
before the agency for review consideration.
  For premarket notification submissions, the labeling proposed in the 
submission will be controlling of a device's intended use. If the 
intended use is the same or sufficiently similar to the intended use of 
a predicate device, then the device may be found to be substantially 
equivalent to the predicate. No considerations outside of the proposed 
labeling for the 510(k) device should bear on the question of whether 
or not the proposed labeling of the newer device is compatible with the 
labeling of the predicate device.
  For premarket approval applications, the determination of whether or 
not there is a reasonable assurance of device safety and effectiveness 
must be based on claims in proposed labeling if such labeling is 
neither false nor misleading. The FDA may fairly consider all facts 
which are pertinent to proposed labeling in PMA's in determining 
whether or not the labeling is false or misleading. Facts which are 
pertinent to proposed labeling are those which directly relate to 
claims in such labeling. For example, proposed labeling which states 
that a device is for use in treating atherosclerosis cannot be false or 
misleading because another device is more effective for that purpose. 
Nor can the proposed labeling be false or misleading because another 
device provides the same treatment benefits but is less expensive to 
purchase and operate. However, the failure to state a material fact 
about the device itself will make labeling in a pending PMA false or 
misleading.
  This provision, which has strong bipartisan support, provides a much 
needed element of due process to product reviews. We preserve all of 
FDA's enforcement authority and leave the agency wide discretion in 
making judgments about new products.
  What is at stake here? The ability of FDA to hold up a manufacturer's 
product on the basis of how a product might be used in the future--even 
if the company does not seek authority to market a product for those 
future uses.
  I think it will be helpful to delve a little deeper into the 
technical issues related to this amendment dealing with one part of 
section 404--it is worth a brief explanation of how FDA clears for 
marketing new products which are similar to older, legally marketed 
products, this is the 510(k) process. The agency considers whether the 
new product is substantially equivalent to the older one. In this 
process, FDA asks two questions. First, does the new product have the 
same intended use as the older product? Second, are there issues raised 
by technological differences in the new product compared to the older 
one?
  On the first question, FDA must not be allowed to second guess or 
impute new intended uses that the manufacturer does not claim--
essentially acting as judge and jury on that question. That is what our 
bill does. This is simply too subjective a question to allow FDA broad 
latitude. This bill would not allow that. If the product before FDA 
claims a legitimate intended use and the product can perform that 
intended use, this part of the test is met.
  But what if the new product has technological features not present in 
the older product which give rise to different safety and efficacy 
concerns? Under the bill, and it would certainly be my intent, FDA 
should and can demand data on those concerns or else not clear the 
product for marketing. That is what they do today, and that is what 
they would do under the bill. Further, if FDA determines that a 
manufacturer is promoting a product for a use that is not approved, all 
of its enforcement authority is available to correct that situation.
  Section 404 simply establishes a proper balance in the product review 
process and focuses FDA's authority on the more objective ground of 
technological considerations.
  Mr. MACK. Mr. President, I want to add my strong support for S. 830, 
which will reauthorize the Prescription Drug User Fee Act as well as 
provide much-needed reforms to the FDA, and the approval process for 
prescription drugs and medical devices.
  I want to specifically address one area of FDA reform which has 
become one of the most controversial, and most often misunderstood, 
provision of this legislation. I'm referring to the issue of off-label 
information dissemination.
  This is an issue I've worked on for more than 2 years. Joining me in 
this effort have been Senators Frist, Dodd, Wyden, and Boxer. We come 
from different political parties. We have different political 
philosophies. But, there is one principle upon which we strongly agree.
  Physicians, and other health care professionals, should have the 
ability to receive credible scientific information from reputable 
medical journals and medical textbooks in order to make informed 
treatment decisions with their patients.
  However, because of an FDA policy--not a law, not a regulation, but a 
policy--that is not happening today.
  Let me explain.
  When the FDA approves a prescription drug or medical device, it does 
so for specific uses. Frequently, scientists find the FDA-approved 
prescription drug or medical device is also effective for other uses. 
Doctors are legally able to prescribe drugs or use devices for these 
new uses, which are called off-label uses.
  According to the American Medical Association, between 40 and 60 
percent of all prescriptions written are for off-label uses. For cancer 
patients, up to 80 percent of prescriptions are for off-label uses. For 
example, the prescription drug Intron A has been approved by the FDA 
for the treatment of melanoma, hepatitis B, and other diseases. 
Additional studies, which were published in such prestigious 
publications as the New England Journal of Medicine and the Journal of 
Clinical Oncology, have shown the drug is also effective for such 
diseases as kidney cancer, myeloma--cancer of bone marrow--and bladder 
cancer.
  However, since 1991, the FDA has maintained a policy which prohibits 
manufacturers from giving doctors and other health care professionals 
scientific data about new uses of FDA-approved drugs and medical 
devices.
  That's simply bad public health policy--and the bipartisan agreement 
we have reached will correct this intolerable situation.
  The agreement will permit the dissemination to health care 
professionals of balanced, peer-reviewed articles from reputable 
medical journals and medical textbooks about new uses of FDA-approved 
prescription drugs and medical devices.
  It will also ensure that the important research on these important 
new uses of prescription drugs and medical devices moves forward.
  We ensure that only the highest quality of information can be 
disseminated

[[Page S9712]]

by defining the specific criteria for medical journals and medical 
textbooks. It is important to note this legislation does not permit the 
dissemination of marketing materials, brochures, promotional materials, 
newspaper or magazine articles, or other industry-generated materials.
  Our legislation ensures that a balance of material about the use must 
be disseminated. Sixty days prior to dissemination, manufacturers must 
submit the article it desires to disseminate to FDA along with a 
bibliography of other medical journal articles about that off-label 
use. The Secretary has the option of adding an objective statement 
which describes additional scientific findings about that off-label use 
of the prescription drug or medical device.
  The intent is that the statement be limited to objective and 
scientific information, and not present an opportunity to editorialize 
about independently derived scientific information. That statement, 
along with the required bibliography, must accompany the article or 
textbook. In addition, companies must also submit and disseminate a 
detailed statement which discloses that the article being disseminated 
describes a scientific study about an off-label use; any potential 
conflict of interest of the authors of the article; the source of 
funding for both the study and the dissemination of the article; and a 
statement which discloses if other products or treatments have been 
approved by the FDA for the use described in the article.
  In other words, in addition to the article the company wants to 
share, the doctor will also receive: the disclosure statement; a 
statement of additional scientific findings from the Secretary of HHS; 
any previous FDA notices about that off-label use; a bibliography of 
other articles about that off-label use; and a copy of the FDA-approved 
labeling for the drug or device described in the article.
  In order to disseminate the medical journal articles and textbooks, 
manufacturers must agree to conduct the required clinical trials in 
order to apply for a supplemental new drug application.
  Companies must either certify they will file an SNDA within 6 months, 
or they must submit a clinical trial protocol and time schedule for 
conducting the needed studies to apply for an SNDA within 3 years. The 
Secretary of HHS may grant a 2-year extension to comply with this 
requirement if the company is acting in due diligence to conduct the 
studies in a timely manner. Periodic progress reports are required to 
be filed with the Secretary. Companies may apply for an exemption under 
very limited circumstances.
  The manufacturer is also required to share with the Secretary new 
information about that same off-label use of the drug or device. If the 
Secretary determines the new information demonstrates that the drug or 
device may not be effective or may pose a significant risk to public 
health, then the Secretary shall, in consultation with the 
manufacturer, take corrective action to ensure public health and 
safety.
  The provision provides the Secretary of HHS with strong oversight 
authority, including the ability to stop dissemination of articles and 
the ability to require manufacturers who violate the provisions of this 
legislation to either take corrective action or return to compliance. 
The Secretary can order a manufacturer to cease dissemination if the 
SNDA application is denied.
  We also require that two future studies be performed. One study will 
examine the impact this legislation has had on FDA resources. The other 
study will assess the quality of the information disseminated and it 
will examine how useful the information has been to doctors and other 
health care providers.
  It is important to note that this legislation will expire in 2006, 
unless Congress acts to continue it.
  This legislation has earned the enthusiastic support of the American 
Medical Association. Let me quote from the AMA's Council on Scientific 
Affairs report:

       It is imperative that physicians have access to accurate 
     and unbiased information about unlabeled uses of prescription 
     drugs. Dissemination of independently derived scientific 
     information about unlabeled uses by manufacturers to 
     physicians can help physicians have access to the latest, 
     scientifically credible information.

  A Roper poll of oncologists released in July 1997 found that 70 
percent of doctors believe FDA rules about off-label information stand 
in the way of doctors' efforts to get the most credible information 
about cancer treatments. The poll also found that 99 percent found 
peer-reviewed medical journal articles is a source they use when making 
prescription decisions.
  In addition, numerous patient organizations also support the 
dissemination of scientific information regarding off-label uses of 
prescription drugs and medical devices. These organizations include the 
American Cancer Society, the Leukemia Society of America, the American 
Osteoporosis Foundation, the American Society of Clinical Oncology, the 
Cystic Fibrosis Foundation, the A-T Children's Project, the American 
Liver Foundation, and the National Alzheimer's Association.
  Mr. President, for the past 2 years, this bipartisan group of 
Senators--myself and Senators Frist, Dodd, Wyden, and Boxer--have 
worked together to craft legislation which will permit health care 
professionals to receive important scientific information while 
ensuring consumer safeguards.
  This bipartisan effort is based upon the belief that health care 
professionals should be able to receive scientific data while ensuring 
patient protections.
  Most importantly--and this is key--from a patient's point of view, 
this legislation will greatly increase one's odds of getting state-of-
the-art treatment which could cure a disease, slow the progression of a 
disease, or, at minimum, improve one's quality of life.
  It is simply wrong to continue this policy which denies the ability 
of a health care professional to receive an article from a medical 
journal or medical textbook.
  Doctors, nurses, and other caregivers help patients make life or 
death decisions every day. They need access to credible scientific 
information to discuss with patients. We must take this commonsense 
step to make sure they are able to receive accurate, unbiased 
information, including information about off-label uses, which will 
help them make informed treatment decisions with their patients.
  I am very pleased to report this agreement has received the support 
of our colleague, Senator Ted Kennedy, the ranking member of the Senate 
Committee on Labor and Human Resources. It also has the support of the 
Secretary of Health ad Human Services, Donna Shalala.
  I would like to thank them, along with Richard Tarplin, Assistant 
Secretary of HHS, and Bill Schultz and Dianne Thompson of the FDA, for 
their cooperation in reaching this historic agreement on what has been 
a very contentious issue.
  Finally, I want to thank my colleagues who worked with me on this 
agreement, Senators Frist, Dodd, Wyden, and Boxer. It's been a pleasure 
to work with each of you, and I look forward to working with you on 
other public health issues in the future.
  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. JEFFORDS. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. JEFFORDS. I understand the Senator from Georgia has time, and I 
ask if he would yield me 5 minutes.
  Mr. COVERDELL. I yield up to 5 minutes to the distinguished Senator 
from Vermont.
  The PRESIDING OFFICER (Mr. Hagel). Without objection, it is so 
ordered.
  Mr. JEFFORDS. I am sorry to have to report, we have been trying in 
this last 45 minutes to see if we could move some amendments that 
everybody has agreed to and to show that we are really trying to bring 
this bill before this body and to make progress so we can decrease the 
amount of time that will be needed at the end as we move through the 
cloture process.
  Unfortunately, we have not been able to get that agreement. So such 
amendments as those of Senator Murray, Senator DeWine, and others, that 
would have been approved by unanimous consent by will have to wait for

[[Page S9713]]

some future time in hopes that we can get agreement.
  I want to point out there are a large number of amendments pending on 
this bill, many of which are agreed to, others that probably will fall 
by the wayside, it should not be that difficult to finish work on this 
bill. However, if we continue to have this delay, without any 
cooperation to move the process forward, then it is going to foul up 
our very crowded calendar. That is unfortunate, as we all want to get 
the legislation done, get the conference reports on appropriations 
bills passed, and other pending legislation which is essential, so that 
we do not have to shut the Government down. If we fail to get the 
cooperation of the minority in even agreeing to things that everybody 
agrees to, it is unfortunate.
  Let me point out some of the Senators we would have helped today: 
Senator DeWine, for instance, and Senator Dodd; their amendments should 
have been agreed to. They have shown great leadership in advocating 
greater research into pediatric uses of new and existing drugs. Their 
amendment reflects Senator DeWine's successful effort to marry the 
mandated approach in the administration's regulations with the 
incentive-based approach underlying Senator DeWine and Senator Dodd's 
provision. Senator Murray has worked diligently to protect the health 
and safety of children. Her amendment, which everybody agrees should be 
approved, modifies the national uniformity provision clarifying that 
the exemption requirement is applicable to the health and safety of 
children.
  Other amendments by other Members that we could have adopted today 
will have to be done at some later time as long as the minority 
continues to block progress on the 152-page bill, of which 150 pages 
are agreed to. That does not make much sense. Why do we have this delay 
over a provision on which there is a disagreement, and general 
knowledge that the disagreement will have to be taken care of in the 
conference committee. The White House will insist that we come up with 
something different than is in the bill and the House has already taken 
a different position. Why should we delay the meeting of that 
conference committee?
  I urge the minority to let us vote--they are holding up an extremely 
important piece of legislation. The only advantage in doing this is to 
raise more public attention to one issue--that the minority is willing 
to tie up the Senate over one sentence in this bill in full knowledge 
that further work will be done on the issue in conference.
  So let's move this bill along, get it to conference. The House is 
moving expeditiously, so we can go to conference probably at the end of 
next week if we can get this bill done. I urge the minority to change 
the tactics of delaying any progress on this bill.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Georgia.

                          ____________________