[Congressional Record Volume 143, Number 128 (Tuesday, September 23, 1997)]
[Senate]
[Pages S9755-S9769]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 
                                  1997

  The Senate continued with the consideration of the bill.


                           Amendment No. 1177

  The PRESIDING OFFICER. Who yields time?
  Mr. KENNEDY. Mr. President, I understand we have 20 minutes to each 
side.
  The PRESIDING OFFICER. The Senator from Massachusetts has 19 minutes 
remaining.
  Mr. KENNEDY. I yield 10 minutes to Senator Reed. I will take 9 
minutes.
  Mr. REED. I thank the Senator. Thank you, Mr. President.
  Mr. President, we debated this morning the Reed amendment, which 
would give the Food and Drug Administration the authority to look 
behind the labeled use in evaluating a class 1 or class 2 medical 
device before that device would be sold on the marketplace. My 
amendment is very simple. It would allow the FDA, if they felt the 
label was misleading or false, to ask for additional information with 
respect to possible uses other than the labeled use. This is consistent 
with their current practice. And it would protect the public health 
dramatically.
  I urge all of my colleagues to support this amendment.
  I heard opposition on the floor this morning to the amendment--first, 
not so much opposition but an attempt to diminish the importance of 
this amendment by saying, ``Well, class 1 and 2 devices are just simple 
little medical devices. They are low-risk medical devices.'' I don't 
know about you. But, like many Americans, I think the definition of a 
low-risk medical device is a device that is being put into someone 
else's body, not my own. Because, if there is any type of device that 
is coming into a person's body, they expect and anticipate that the FDA 
would thoroughly review it, ask all the questions, and look at all the 
possible uses that are reasonably discernible from the device itself.
  The other objection which has been made to the amendment is that it 
is unnecessary because the FDA can step in and ask for this type of 
information. But, in fact, that is not the case.
  As some have explained here today, there is a two-prong test to get 
501(k) approval under current. First, the device must be substantially 
equivalent to another device already on the market, and this device 
performs essentially the same task that the other device does. If there 
are technological differences in the device, then the FDA can make an 
evaluation of this technology to determine its effectiveness.
  But all of these different tests collapse into one point. The 
question is, what is the device being used for?
  That is where the current language in the bill is so restrictive of 
FDA responsibility and the obligation we expect them to discharge. 
Because, according to the language in the bill, the FDA and the 
Secretary of HHS reviewing any of these proposals could only do so with 
respect to the intended use of the device based on the intended use 
included in the proposed labeling of the device.
  You have to evaluate these devices for safety and health, and 
efficacy based upon some use. And if the FDA is restricted solely to 
the use indicated on the label, then they will not be able to look 
behind the label to other possible uses--look beyond the label to other 
possible ways--in which the device could be used and ask for supporting 
data to justify those uses.
  We have seen and heard examples today on the floor with respect to 
biopsy needles, with respect to lasers, with respect to a host of very 
important medical devices. The American public I hope would demand that 
these devices be evaluated thoroughly for all reasonable uses--not only 
the use that a manufacturer would suggest as a way to take advantage of 
this expedited procedure for review and entry into the marketplace.
  One does not have to repute ill will or bad motives to the 
manufacturers of these devices. Simply stated, they have a tremendous 
incentive to get these items into the marketplace. Once they are in the 
marketplace, there are different uses that could be promoted.
  Also, in terms of marketing, there are scores of salesmen and women 
who are zealous in trying to promote these goods. They might not be as 
scrupulous with respect to these uses as intended by the manufacturer.
  All of these factored together suggest strongly that if we do not 
initially have a good approval process which allows the Food and Drug 
Administration to look behind the label, to look at likely uses other 
than the ones presented by the company, we could run the risk of 
introducing medical devices into the marketplace that would be harmful 
to the American public.

[[Page S9756]]

  We have made great progress on this legislation. We have done so 
because we all feel sincerely that our chief responsibility is to 
protect the public health. My amendment would do so.
  My amendment would give the FDA the authority to request additional 
safety information in the rare circumstances in which they have 
suspicions that the labeled use is either false or misleading. The FDA 
could look behind that label and require additional data before they 
would release a device onto the marketplace.
  I hope that we all support this concept. I hope we can all rally 
around the principle that when in doubt, and when confused about the 
different interpretations of various sections, that we will ultimately 
allow the FDA to use its judgment and its discretion to protect the 
public health of the American people.
  I yield our time.
  The PRESIDING OFFICER. Who yields time?
  Mr. JEFFORDS. Mr. President, I yield to the Senator from Tennessee 10 
minutes.
  The PRESIDING OFFICER. The Senator from Tennessee is recognized for 
10 minutes.
  Mr. FRIST. Mr. President, thank you.
  Mr. President, the issue that we are facing in the next several 
minutes on which my colleagues will be voting appears very simple on 
the surface. Why would anybody oppose an amendment that really strikes 
at the heart of what so much of the FDA is about--that is, a medical 
label that is maybe false or misleading?
  So, on the surface it seems simple. But it really is not. The larger 
bill, the underlying bill, is about strengthening the FDA, and making 
sure that we fulfill that mission to the American people of having 
products, drugs, and devices that improve health and not huge barriers 
that push over the great new technological advancements that we see--
push them off into the future so that we cannot benefit from the 
technology that is out there today.
  The amendment is unnecessary. The amendment we are going to be voting 
on right now is unnecessary, and a little bit worrisome because if it 
were to pass, there is a possibility that we hurt the system. In other 
words, we disallow improved devices which can benefit heart disease or 
lung disease, we put up barriers and push them off into the future. So 
if the amendment passes, it may be harmful. It clearly is unnecessary 
today.
  The bottom line is this. The Food and Drug Administration is required 
to deny premarket approval for a device if the proposed label is false 
or misleading--current law--and that is why it is unnecessary.
  To really understand the overall process, we talk about 510(k) and 
PMA, premarket approval. It is really pretty simple. You have a device 
today that goes through the FDA system that has all sorts of standards 
that have to be met in terms of safety, efficacy, and false and 
misleading labels. That device goes through that process, what is 
called the PMA, premarket approval of the device. Then with technology 
and science new devices, better devices are developed; for example, a 
stint in the heart after a heart attack. Over time you improve the 
stint. That is the great thing about science today. That improved 
device may be almost exactly like the earlier version of that device. 
The FDA has to make a decision. Does it go through a process which says 
they are so similar that there is no reason to make it go through all 
the other standards or is it different enough it has to go through all 
the initial requirements and jump through the hoops and standards, and 
the FDA has to make that decision. Premarket approval initially, an 
improvement on that device or a new device, is it similar enough. Now, 
the words are used, is it substantially equivalent to the initial 
device itself. FDA has to make that decision.
  What we really have not talked very much about is how they make that 
decision. It is written in the current law. We do not do anything about 
current law today, whether or not this new version is ``substantially 
equivalent.'' Those are the words.
  What is the requirement? What is the current law? They are 
substantially equivalent if, No. 1, the new device has the same 
intended use as the earlier device and--and--it has the same 
technological characteristics as the predicate device.
  Now, that is a pretty good standard because the idea is, if you get a 
little stint that you put in the heart and it is improved, it works 
better, same principles, technologically equivalent, same intended use, 
then you go through this process of the 510(k).
  Now, the amendment we are going to be voting on says we have to put 
it back again through the false or misleading label requirement. 
Remember, this improved device going through this process has already 
met the criteria of false and misleading labeling when it was in the 
PMA, the initial approval. That is very important to understand because 
we all are against anything in terms of labeling that is false or 
misleading. It is very important to understand the process.
  So what we are debating right now is not whether a label is false or 
misleading but whether the FDA will have the ability to compel a 
manufacturer to produce clinical data to prove safety and efficacy for 
uses that are not included on the label. This brings me to the 
worrisome part of this amendment. Again, I am very comfortable that the 
FDA has standards today to make sure that the labeling is honest, is 
truthful. The worrisome thing is about just what if the FDA came in and 
said that this device, which is medically equivalent to an earlier 
device, technologically improved but the equivalent device, what if the 
FDA says, ``No, let's make people go back and jump through all the 
initial hoops once again.''
  We already know for a device that we are not meeting device approval 
or disapproval over the time required in statutes. Already it takes 
months and years to go through the approval process. So with every 
improvement, when it is substantially equivalent to the earlier device, 
if we take all those improvements, make them meet all these new 
criteria again, what are we going to do? We are going to push off the 
great advancements today to save lives, to improve the quality of life 
to some time in the future where we and maybe even our children cannot 
benefit from that device.

  Now, a key question that I think we all have is, if a device is 
determined by the FDA to be safe and effective for the labeled use, 
should the FDA--for the labeled use that has been approved --should the 
FDA be able to force a manufacturer to produce a clinical device that 
is safe and effective for other uses, other uses. Remember, it is 
approved for what is on the label. I would answer no. We do not do that 
for pharmaceuticals today. We do not do it for drugs today. Should we 
do it for devices? I say no.
  My real fear is that when the FDA reaches outside of the proposed 
labeling, it is going to require a very subjective decision in 
determining what goes through those initial PMA, premarket criteria.
  Finally, let me also step back and look at the enforcement procedures 
that the FDA already has. My colleagues make it sound as if the FDA is 
unable to protect the public health by keeping unsafe products off the 
market. In fact, the FDA today has the enforcement authority which 
allows the agency to remove devices that endanger public health from 
use and availability immediately, even if the device is on the market 
and the manufacturer's intended use for a device changes over time.
  Any device which the FDA has, and I quote, ``a reason to believe is 
misbranded or adulterated in any way'' can be detained today under law. 
FDA has a long list of remedies to protect consumers against persons 
who violate device laws including criminal prosecution, injunctions, 
civil seizures, and civil penalties.
  Claims were made earlier by some of my colleagues that manufacturers 
will market and advertise for uses other than those approved by the 
FDA. That is illegal today.
  Under the proposed bill--not the amendment, the underlying proposed 
bill--it is illegal. Again, let me say claims have been made over the 
course of the morning by some of my colleagues that manufacturers will 
market and advertise for uses other than those approved by the FDA. 
That is illegal. The Reed amendment does not change the fact that 
manufacturers cannot do this today, and it does not

[[Page S9757]]

change the fact that the FDA has enforcement authority today.
  With that, I urge my colleagues to oppose the amendment. Again, I 
think it is unnecessary and worrisome in the sense that it would raise 
the barriers sufficiently in an unnecessary way for approval of devices 
that are substantially equivalent to devices that already have jumped 
through the hoops.
  I yield the floor.
  The PRESIDING OFFICER. Who yields time? The Chair informs the Senator 
from Vermont there are 8 minutes 32 seconds remaining under his control 
and the Senator from Massachusetts has 12 minutes remaining under his 
control.
  Mr. JEFFORDS. Mr. President, I yield 2 minutes to the Senator from 
Indiana.
  The PRESIDING OFFICER (Mr. Frist). The Senator from Indiana.
  Mr. COATS. Mr. President, I am going to repeat points that have 
already been made, because I think it is essential to the understanding 
of what we are about here just before we are ready to vote.
  Section 404, the section under debate, preserves a very key premarket 
statutory authority to the agency. It is important for Members to 
understand that the agency can call, still call for a premarket action 
requiring full data on the safety and effectiveness whenever there is a 
technological difference arising, and I quote from the statute, ``that 
raises different questions of safety and effectiveness in the earlier 
approved device.''

  This authority is premarket. In other words, the product is never 
cleared for marketing. It is never distributed before the agency has an 
opportunity to act.
  The authority is extremely broad. As soon as a product raises a 
question about safety and effectiveness, the agency can require the 
filing of a premarket authority, PMA. The agency retains full 
discretion to control the showing of safety and effectiveness. There 
are no words of limitation on that statutory authority. I point out 
that that authority has never been challenged successfully by a company 
in court.
  It was Senator Kennedy's own committee, as chairman of the committee, 
his own committee report on safe medical devices in the 1990 Device Act 
that confirmed the breadth of this authority, and I quote from that 
report.

       However, notwithstanding data that may demonstrate 
     comparable performance, the agency will not find the device 
     substantially equivalent to a predicate device where the 
     newer device raises different safety and effectiveness 
     considerations than the predicate device. Under these 
     circumstances, a finding of not substantially equivalent is 
     made, necessitating a class 3 designation and the requirement 
     of an approved PMA before the new device is marketed.

  This is the language that was--
  Mr. REED. Will the Senator yield?
  Mr. COATS. Incorporated in the 1990 Medical Device Act, demonstrating 
in the Senator's own committee report the breadth and scope of this 
particular authority.
  The PRESIDING OFFICER. The Senator's 2 minutes have expired.
  Mr. REED. Will the Senator yield?
  Mr. COATS. My time has expired.
  Mr. REED. Will the Senator yield?
  Mr. KENNEDY. Two minutes.
  Mr. REED. I concur with the Senator's notion that the FDA could look 
at safety and effectiveness but the critical question is safety and 
effectiveness to do what? To do what the labeled use is or to do 
something else. And the language of the bill restricts the answer to 
that question, to do what, statutorily to simply say whatever the 
company puts into the label. And that seems to be the crux of this 
debate. Yes, they can look at safety and effectiveness; yes, they can 
look at technological change, but only in the context of what the 
company purports in the label to say is the intended use. They can't 
look beyond it.
  I yield back to the Senator from Massachusetts.
  The PRESIDING OFFICER (Mr. COATS). Who yields time?
  The Senator from Massachusetts.
  Mr. KENNEDY. How much time, Mr. President?
  The PRESIDING OFFICER. The Senator has 11 minutes 15 seconds.
  Mr. KENNEDY. I yield myself 8 minutes.
  Mr. President, my good friend from Rhode Island has put his finger on 
exactly the problem and the issue. Now, I listened to our friend, 
Senator Frist, who believes that the FDA doesn't really have a problem 
if the information is going to be false and misleading, that the FDA 
has the authority to look behind the label itself and find out if that 
information is false and misleading.
  If that is the case, we do not have a problem. We can accept an 
amendment that would restate what he has just said, or we can drop this 
whole provision.
  It is interesting to listen to those who are opposed to the Reed 
amendment say, well, look, the FDA can do this and that and protect the 
public, while at the same time they are emasculating the very safety 
valve with this new provision--restricting the FDA in its ability to 
judge on the issues of substantial equivalence.
  Now, Mr. President, before we move to the vote, I want to reiterate 
where we are so that those who have been listening to the debate for 
these last few minutes understand where we are.

  We are talking about the preeminent issue identified by the 
administration's principal spokesperson charged with protecting 
American health. This has been identified as the one provision in the 
whole legislation that is of central concern to the public health of 
the American people. They mentioned the issues of cosmetics; they 
mentioned the fact that this eliminates environmental impact 
statements; they mentioned technical issues dealing with PDUFA; but 
there was only one public health issue that the Secretary of HHS has 
recognized, and it is this particular provision which Senator Reed has 
tried to address.
  It is of such importance that the Secretary of HHS indicated that if 
that provision remains unchanged, she would recommend that the 
President not sign the legislation. And it is not just the Senators 
from Rhode Island and Massachusetts who are concerned about this 
provision. Every single consumer group is concerned about it as well. 
All of the groups that speak for patient rights, all of the groups that 
are concerned about women's health issues, all of the various consumer 
groups--I have listed them before--all of them say that we ought to 
support the Reed amendment, if we are truly interested in protecting 
the American consumer. We have, over the last few days, talked about 
why this is so important.
  Those who are opposed to this amendment keep repeating their 
assertions that the FDA has the authority to protect the public. That 
is hogwash. They may believe it. I have yet to see a Member of the 
Senate who is opposed to our amendment take out this legislation and 
thumb through it and point to the specific language that states the FDA 
will have authority to protect the public if this amendment is not 
carried by the Senate of the United States. They have not done it 
because they cannot do it. They cannot point to a provision in here 
that says, ``OK, if we defeat the Reed amendment, FDA will still have 
the authority.'' They have these assertions on the floor of the U.S. 
Senate. But they have not pointed to specific language in this 
legislation, and that is what counts. They cannot point to it because 
it is not there.

  We are talking, as the Senator from Rhode Island has pointed out, 
about medical devices submitted to the FDA for approval, which a 
company would say is ``substantially equivalent'' to an existing 
device. But which, in reality, is a device which has significant 
technological changes in its design and in fact, is designed for 
another use. However, when the new device is submitted for approval, 
the label will still maintain that the device will be used for the same 
purposes as the original device. That is what is happening. That is the 
danger and that is what the Reed amendment is attempting to prevent.
  We have discussed the example of this that is currently unfolding. 
The biopsy needle that was supposed to be substantially equivalent to a 
biopsy needle the size of your pencil lead but which actually removes 
an amount of material the size of a hot dog. This device is used to 
take the place of surgery for women, but it is untested and untried for 
that purpose. We don't know if it's safe. The company hasn't submitted 
evidence as to whether it is

[[Page S9758]]

safe. But we know that this device developed by U.S. Surgical was not 
designed for the narrow biopsy; it was designed for another purpose. It 
takes out 50 times the amount of material necessary for a biopsy.
  We know what it was designed for, we have the promotion tape. We have 
the statements from doctors saying they were being solicited to use it 
for surgery, not biopsy.
  You can claim that these are low-risk devices. You can claim that is 
really just a technical issue, that its not important. But we know that 
is not the case. We are talking about anesthesia machines which are 
used for major surgeries. We want those to be able to perform the way 
they should and to meet safety and efficacy standards. We are talking 
about fetal cardiac monitors. We want to make sure that children who 
need that kind of monitoring have a device that will be safe and do the 
job. What mother wants to discover that her child is using a fetal 
cardiac monitoring system that has been approved for some other use and 
here the hospital or clinic is using it for a different purpose without 
knowing that it is safe and effective for that use?
  The list goes on. We have had the situation where surgical lasers are 
being submitted as general cutting tools when it is clear that the 
intention is to use them for surgeries for prostate cancer and no 
information about how safe or effective they are for that purpose has 
been submitted to the FDA. Why are we risking the health of the 
American people over this issue? What is the benefit?
  I have cited examples where we have been called on in this body to 
make decisions about whether we are going to use a limited amount of 
money to feed the elderly people--how much will we use in congregate 
sites? How much will we use for home delivery? If you use more in home 
delivery, you will be able to feed fewer people. It's a painful issue, 
and whatever we do some are going to benefit, some are going to lose. 
We can understand men and women of good judgment differing on that 
issue.
  But not on this issue. What is the balance? The balance is that the 
protections of American consumers are weakened in the area of medical 
devices--significantly weakened for the first time in 25 years. And the 
profits of the medical device industry go up. And they have a 
competitive advantage over the other companies who do the right thing 
and conduct the tests to provide health and safety information on their 
devices.
  Why are we doing that? What is the rush? Why aren't we hearing from 
the other side that, ``We have 10 consumers' groups that believe we can 
get the information much more rapidly and their health needs will be 
advanced and we don't need the Reed amendment.'' Where are those 
statements, why haven't we heard them. Because they are not there.

  We have to decide whether we are going to retain, for the Food and 
Drug Administration, the ability to deal with labeling. The ability to 
look beyond the label when they find it to be false and misleading. 
That is a pretty high standard. FDA has to find it false and 
misleading. Only then can they look to safety. Some of us wish it was a 
lower standard, but that is the standard we have here, false and 
misleading.
  We have given examples, ads have been used to promote medical devices 
for other purposes. That is happening now. We have also spelled out the 
human tragedies that occurred when medical devices malfunctioned, when 
we did not have all the necessary information to assess safety.
  Are we going to deny the principal health agency charged with 
protecting the American public, the authority to ask for more data if 
they find that the label on a medical device is false and misleading. 
Are we going to say your hands are cuffed?
  The PRESIDING OFFICER. The additional 2 minutes of the Senator have 
expired.
  Mr. KENNEDY. How much time do we have?
  The PRESIDING OFFICER. The Senator has 1 minute remaining.
  Mr. KENNEDY. I yield that to myself.
  Are we going to tie their hands, tell them that they cannot do a 
thing? Are we going to tell them that we understand that they have done 
the scientific review? We understand that the label is false and 
misleading, but you are not allowed to protect the consumers or the 
American public from it.''
  I think that is the wrong position for this body to take, and I hope 
the amendment is accepted for the reasons I have outlined and for the 
splendid reasons outlined by the Senator from Rhode Island. I withhold 
the remainder of my time.
  Mr. JEFFORDS. I yield to the Senator from Connecticut 2 minutes.
  Mr. DODD. Mr. President, let me say briefly to my colleagues that 
what I believe is false and misleading is to suggest what we are trying 
to do in any way is something injurious to the American consumer. What 
we are doing is saying that we shouldn't create roadblocks in a process 
that has been in place for more than 20 years and that has worked well 
for lower risk devices. To prove a device is substantially equivalent 
to a product that has already been in the marketplace there are tests 
which must be complied with, but you don't force the product to prove 
itself all over again. That negates the process that was set up to be 
quicker and more efficient and makes patients wait too long to get 
access to devices which can change their lives, even save their lives.
  If you want to scrap the process altogether and require that every 
new variation of the predicate product begin this process all over, 
then let's do that. I don't hear anyone calling for that.
  What the law says is that if it's substantially the same product and 
if the intended purpose as stated is the same, you don't ask the 
company to try to guess how someone may use that product for some 
purpose that the company has not supported. To suggest that a company 
is going to have to guess as to what other ideas someone may have for 
the use of that product, and develop data to support those uses--that 
would make this process null and void. We might as well scrap the 
entire section and 25 years of effort here.
  The purpose of this bill is to take advantage of new technologies, to 
see to it we have safe and effective products that are going to reach 
consumers. To allow an agency to cause a company to have to guess and 
guess again as to what some other intended purpose would be, I think 
would be a mistake.
  So I urge, with all due respect, this amendment be rejected and the 
committee bill be supported.

  The PRESIDING OFFICER (Mr. Kempthorne). The time of the Senator has 
expired. Who yields time? The Senator from Vermont.
  Mr. JEFFORDS. Mr. President, as we close debate on this issue, I want 
to say if I listened to this and didn't understand the law and the 
protections in it, I would go home and be depressed that I was backing 
such legislation. However, knowing the law and knowing the process, I 
still come away totally opposed to this amendment.
  First of all, let's take a look. We have had about 36,000 devices 
approved over the past 6 years. Out of that, there would have been six 
recalls. So this is not an issue that is something which has proved to 
be a failure in the law.
  Second, what we are dealing with here is the definition of false and 
misleading. Actually, the regulations cover the important aspects of 
it. But false and misleading means if you knew or should have known. 
They want to get into the practice of medicine. They want to say if 
this person has this device, and it is the same as the device with the 
premarket approval, they should be looking around and deciding and 
finding out all the possible and conceivable uses out there, and then 
they could be required to run clinical trials on all these.
  The purpose of the 510(k) process is to allow something that is 
identically the same, having gone through all this, not to have to go 
through it again. This would send fear through the device industry 
because it may know it is impossible to get anything improved again 
without expending thousands and thousands of dollars and waiting 2 or 3 
years. That is totally unnecessary. The law fully protects the consumer 
now. This is totally unnecessary and will increase the cost to 
consumers and decrease the availability of devices to them in a timely 
manner. That is why I am opposed to it.
  It has been greatly overexaggerated as to what kind of problem is 
created here.

[[Page S9759]]

  Mr. President, I move to table the amendment.
  The PRESIDING OFFICER. The time of the Senator from Massachusetts has 
not yet expired. If the Senator will withhold his motion? I recognize 
the Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, as I understand I have 30 seconds?
  The PRESIDING OFFICER. That is correct.
  Mr. KENNEDY. Mr. President, I list those who support the Reed 
amendment: The administration, the President, Patients' Coalition, 
Consumer Federation of America, National Women's Health Network, 
American Public Health Association, National Organization for Rare 
Disorders, the Consumers Union, and the Center for Women's Policy 
Studies. I believe my time is expired. I ask for the yeas and nays.
  Mr. JEFFORDS. Mr. President, I move to table the amendment. Mr. 
President, I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.
  The PRESIDING OFFICER. The question is on agreeing to the motion to 
table the amendment of the Senator from Rhode Island.
  The yeas and nays have been ordered.
  The clerk will call the roll.
  The bill clerk called the roll.
  The result was announced, yeas 65, nays 35, as follows:

                      [Rollcall Vote No. 254 Leg.]

                                YEAS--65

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

                                NAYS--35

     Akaka
     Baucus
     Biden
     Bingaman
     Boxer
     Bryan
     Bumpers
     Byrd
     Cleland
     Conrad
     Daschle
     Dorgan
     Durbin
     Feingold
     Feinstein
     Glenn
     Graham
     Harkin
     Inouye
     Johnson
     Kennedy
     Kerrey
     Kerry
     Kohl
     Lautenberg
     Leahy
     Levin
     Moseley-Braun
     Moynihan
     Reed
     Reid
     Robb
     Rockefeller
     Sarbanes
     Torricelli
  The motion to lay on the table the amendment (No. 1177) was agreed 
to.


                      Unanimous-Consent Agreement

  Mr. JEFFORDS. Mr. President, I have a unanimous-consent request which 
I will offer.
  I ask unanimous consent that immediately following the cloture vote 
with respect to S. 830, if invoked, there be only the following time 
remaining in the following fashion: 4 hours equally divided between the 
chairman and the ranking minority member or their designee for use 
during today's session only; 4 hours equally divided between the 
chairman and the ranking minority member or their designee for use 
during the session of the Senate on Wednesday, September 24, beginning 
at noon.
  I further ask, notwithstanding rule XXII, that following the 
conclusion or yielding back of time, the Senate proceed to vote on S. 
830, as amended, without further action or debate.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                           Amendment No. 1137

  The PRESIDING OFFICER. Under the previous agreement, we now have 20 
minutes equally divided on the Harkin amendment numbered 1137, 10 
minutes under the control of the Senator from Iowa and 10 minutes under 
the control of the Senator from Tennessee.
  The Senator from Iowa is recognized.
  Mr. HARKIN. I yield myself 5 minutes.
  Mr. President, there are many positive provisions in this bill that I 
am pleased to support. However, I am disappointed that an essential 
element has not been included in this bill. A major goal of FDA reform 
is to ensure that the public has access to medical innovations without 
compromising public safety. But the multimillion-dollar cost of 
obtaining FDA approval often excludes from the review process all 
medical therapies not promoted by major corporations, those that are 
nonpatentable or low cost.
  Very few sponsors of alternative medicines and treatments have the 
resources to go through this process. Unfortunately, this means that 
millions of Americans are denied access to important alternative 
medicines and treatments every day. In committee, I proposed and 
withdraw an amendment that would improve the access to medical care. It 
was called the Access to Medical Treatment Act. It was introduced this 
spring by Senator Daschle, cosponsored by the majority leader, Senator 
Lott, Senators Hatch, Inouye, myself, and many others. It would allow 
greater freedom of choice and increased access in the realm of 
alternative medical treatments, while preventing abuses of unscrupulous 
practitioners.
  However, it appears that we may not be ready to move on this 
important consumer reform. Mr. President, while we may not be ready for 
this, we cannot delay in moving to assure and improve and expand 
rigorous scientific review of alternative and complementary therapies. 
That is the purpose of my amendment.
  Mr. President, increasingly Americans are turning to alternative 
medicine. A study done by Harvard University showed, in 1990, American 
consumers spent over $14 billion on these practices. In that year, 
there were over 425 million visits to alternative practitioners, more 
than visits to conventional practitioners.
  In light of that, in 1992, the Congress passed a bill setting up the 
Office of Alternative Medicine at the National Institutes of Health. We 
now have 4\1/2\ years' experience with that office operating. It has 
done some good things, but it has been severely hampered by the fact 
that it must go through the entire process at NIH, through the 
institutes at NIH, for its peer review and for its grant-making 
authority.
  The amendment I have before the Senate now would simply change the 
status of the Office of Alternative Medicine from an office under the 
Director to a center for complementary and alternative medicine. It 
would not be an institute but a center. As such, that center could set 
up a peer review process and make its own grants.
  Now, why is that important? Mr. President, every year since we 
established the office, we put in the legislation that the office's 
responsibility was to investigate and validate treatments, practices 
and medicines. That has been in there every year--to investigate and 
validate--because what we want is scientific analysis done of these 
treatments. Now, I have always heard, ``There are a lot of quacks out 
there practicing alternative medicine.'' While that may be true, there 
are a lot of good people out there doing good things with alternative 
medicine. We need the review and the science to let us know what is 
good and what is working.
  I asked the Director of NIH a few months ago, who was in my office, 
how many treatments, or practices, or medicines they had investigated 
and validated since 1992. I was met with a deafening silence. The 
answer is, none. Yet, next year we are putting $13 million into the 
Office of Alternative Medicine. One might rightly ask, where is it 
going? What is happening?
  So the purpose of my amendment was to set up a center to elevate its 
status so that that center could do its own peer review and have its 
own grant-making authority. That way, we can cut through and save a lot 
of money and save a lot of time, without in any way compromising 
rigorous scientific review. That is what this amendment does. It also 
incorporates within that center the Office of Dietary Supplements, 
which was also set up at NIH, to bring the two of them together in a 
new center which would provide more independence, assure economies of 
scale and efficiencies without in any way denigrating good scientific 
research. That is the purpose of the amendment.
  Now, I understand that the Senator from Tennessee is going to raise a 
point of order that this amendment is not germane. Under the rules of 
cloture, I admit that it is not germane. That doesn't mean it is not 
important. It is very important. It is critically important. It should 
be passed.

[[Page S9760]]

  Mr. President, I understand my 5 minutes are up. I yield 2 minutes to 
one of my chief cosponsors, the Senator from Maryland.
  The PRESIDING OFFICER. The Senator from Maryland is recognized.
  Ms. MIKULSKI. Mr. President, I rise to cosponsor Senator Harkin's 
amendment to establish the Center of Alternative Medicine. I helped him 
establish the Office of Alternative Medicine in 1993 at NIH. Why did I 
do that? One, because I want everyone who is sick in the United States 
of America to have access to all possible means of treatment that are 
safe and have efficacy. At the same time, I wanted to prevent quackery. 
I also was aware of the Harvard study by a Dr. Eisenberg that said one 
out of three Americans was using alternative or complementary medicine, 
but we were not aware of scientific investigation to establish its 
efficacy or its safety. Yet, many of us have enjoyed those practices.
  Some years ago, I had some very severe illnesses. Western medicine 
was of limited utility for me and I turned to acupuncture. Acupuncture 
helped me get well and has helped me stay well. I am pleased about 
that. But there are many other modalities out there being utilized by 
the American consumer. I want to make sure they are safe. I want to 
make sure they have efficacy. I want NIH to investigate it, and then I 
want them to validate it. I believe there is merit in this.
  I am puzzled why NIH wants to continually try to submerge this Office 
of Alternative or Complementary Medicine. The hallmark of NIH is to 
have an open mind and to pursue scientific investigation. I believe 
Senator Harkin is on the right track. Though this amendment might not 
be germane, it is certainly relevant to the American people. If we 
don't find a way to move it on this bill, let's explore other ways.

  I yield back such time as I might have.
  The PRESIDING OFFICER. Who yields time?
  Mr. JEFFORDS. I have a unanimous-consent request, Mr. President.
  The PRESIDING OFFICER. The Senator from Vermont is recognized.


                      Unanimous-Consent Agreement

  Mr. JEFFORDS. Mr. President, I ask unanimous consent that following 
debate and disposition of the Harkin amendment, Senator Murray be 
recognized for 5 minutes to offer her amendment No. 1161, and that 
following her remarks, her amendment be agreed to.
  I further ask unanimous consent that the following amendments be 
called up, considered en bloc and agreed to: A Jeffords amendment No. 
1174; a Jeffords amendment No. 1175; a Kennedy amendment No. 1152; a 
Wellstone amendment No. 1156, and Senator DeWine's amendment No. 1136, 
as modified in the amendment I send to the desk.
  The PRESIDING OFFICER. Is there objection?
  Mr. HARKIN. Reserving the right to object, Mr. President. I was hard-
pressed to hear the numbers. Was amendment No. 1131 included in that?
  Mr. JEFFORDS. There are no nongermane amendments in the unanimous-
consent request.
  Mr. HARKIN. I appreciate that.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Who yields time?
  Mr. FRIST. Mr. President, I yield myself 9 minutes.
  Mr. President, I rise today to respond to my colleague from Iowa with 
regard to an amendment to the Food and Drug Administration [FDA] reform 
bill, to establish a new national center for complementary and 
alternative medicine at the National Institutes of Health [NIH].
  Again, remember the debate today and the past several days, and maybe 
through tomorrow, is on the FDA. Yet, we have introduced an amendment 
on another agency--the NIH. I oppose the offering of this proposal as 
an amendment to the FDA bill for that very reason.
  Comments have been made earlier about the importance of complementary 
and alternative medicine to the public and to this country, the 
importance of science, and the importance of peer review--all of which 
I support. I have been in the field of medicine, in a broad sense, for 
the last 20 years. I have been involved in many medical fields, 
including a great part of which has been designated as alternative 
therapies--at least initially, because when I first started doing lung 
transplants, very few had been done in the history of this country 
before. Therefore, I, as a scientist, a medical professional, and a 
U.S. Senator, do feel that alternative medicine and complementary 
medicine is vitally important to the health and the well-being of 
Americans and people throughout the world.
  What I do oppose, however, is dealing with this issue of elevating an 
office to the level of a center when most of our colleagues do not even 
know what a center in the NIH really means. What are the 
responsibilities of a center? What are the authorities? What is the 
difference between an office and a center and an institute? As I talk 
to my colleagues, they do not know. Why? Because we have not addressed 
the issue in the appropriate environment--that is, through the 
committee structure.
  I am the chairman of the Subcommittee on Public Health and Safety, 
which oversees the reauthorization of the NIH. We are, right now, 
looking at the reauthorization of the NIH. We have held two hearings in 
the past examining how you set biomedical and medical research 
priorities. It is a process where we have people come in and testify, 
and we discuss and debate back and forth. This amendment, as proposed 
by the Senator from Iowa, has not been taken through that process. It 
is being brought to the floor on a bill that does not have anything to 
do with the NIH, but rather the FDA bill. Therefore, I do believe it is 
not germane.

  I believe we should not be placing NIH authorizing legislation on an 
FDA bill. Rather, the more appropriate process would be to take it 
through the committee structure. I should also add, for the benefit of 
my colleagues, most of whom have not addressed this issue at all 
because it has not been through the committee process, that no 
legislative bill to establish a center of alternative medicine has been 
introduced into the Senate. Therefore, a bill has not been referred to 
the appropriate committee, it has not been vetted, it has not had 
hearings. There has been no formal debate. This would create a huge 
center within the NIH without that debate. Therefore, I object to 
bypassing this process, again, with a tremendous amount of respect for 
alternative medicine.
  My colleague from Iowa is a senior member of the subcommittee, and he 
and I have had the discussion that we do need to look at the 
appropriate role for alternative medicine at the NIH. We have scheduled 
a hearing in early October. It has been mentioned on the floor of the 
Senate that one of the panels should address the issue of alternative 
medicine.
  We have a 4-year history with the Office of Alternative Medicine. 
Let's debate and look at the results of that history. Let's see the 
results of peer review and see what advances have been made.
  The issue of whether to elevate an office to a center--again, as I 
talked to my colleagues over the last few weeks about taking an office 
at the NIH and elevating it to a center--is one that I think we need to 
discuss, but not today on the FDA bill, not over the course of a few 
minutes, but look at it through the appropriate hearing process. What 
does it mean to elevate an office to center status? What is a center at 
the NIH? I hope my colleagues ask themselves right now, do I really 
know what a center at the NIH is? Most will say no. The role of the 
current Office of Alternative Medicine, the office--as outlined by the 
Senator from Iowa, my colleague, who basically defined what the office 
is --is to coordinate and foster the conduct and support of alternative 
medicine research at the NIH. Right now, the office provides a central 
focus for a research area that is germane to all NIH components. In 
other words, the office can work with all the various institutes.
  I understand that the majority of complementary and alternative 
research is performed and supported by those 24 centers and institutes 
and divisions within the NIH, and it is integrated within the 
scientific research portfolio of each of those institutes. My colleague 
is arguing--and he may be right, and that is why we need to discuss 
it--that we must consider alternative medicine being a center in and of 
itself. But that would mean that the scientists and researchers who are 
responsible for broad areas of science may not have the opportunity to 
integrate alternative medicine into their

[[Page S9761]]

respective research portfolios as they do today. It needs to be 
discussed. It needs to be debated in the appropriate forum.
  I recognize that the Senator from Iowa has concerns about whether the 
current approach is working or not. Again, I look forward, through our 
reauthorizing committee, to the Subcommittee on Public Health and 
Safety, on which he serves, to address this very issue.
  I do know that when you elevate an entity like an office to an 
institute or to center status, the scientific potential of the field 
should be sufficiently demonstrated so that the new institute or center 
can support a thriving intramural and extramural program. Are we at 
that point today? I do not know. I daresay that most of my colleagues 
have not studied this specific issue yet.
  I will have to say that as I have reached out to people, many others 
in the scientific community have raised concerns about establishing a 
new center at the NIH. Let me read to you a portion of a letter sent to 
me from the Association of the American Medical Colleges expressing 
their concerns:
  This is the AAMC, Association of the American Medical Colleges:

       Any change in the organizational structure of the NIH of 
     this magnitude raises significant scientific and 
     administrative questions. . . .
       Further, the AAMC believes all members of the research 
     community should have the opportunity to address these issues 
     in a full and public manner during a hearing conducted by the 
     subcommittee.

  Mr. President, I ask unanimous consent that the letter by the AAMC be 
printed in the Record.
  There being no objection, the letter was ordered to be printed in the 
Record, as follows:

                                                    Association of


                                    American Medical Colleges,

                               Washington, DC, September 16, 1997.
     Hon. Bill Frist,
     Chairman, Subcommittee on Public Health and Safety, Committee 
         on Labor and Human Resources, U.S. Senate, Washington, 
         DC.
       Dear Chairman Frist: The Association of American Medical 
     Colleges (AAMC) opposes efforts to attach to the pending FDA 
     reform bill, S. 830, a proposal creating a National Center 
     for Complementary and Alternative Medicine at the National 
     Institutes of Health (NIH).
       Any change in the organizational structure of the NIH of 
     this magnitude raises significant scientific and 
     administrative questions. The AAMC believes that research 
     into complementary and alternative medical practices is best 
     conducted by the individual disease-based institutes, and 
     that creating a separate office will isolate and impede 
     rather than promote and coordinate ongoing research 
     activities in these areas. Moreover, it appears that the 
     additional administrative costs associated with the creation 
     of a new organizational entity at the NIH are not justified 
     at the present time.
       Further, the AAMC believes all members of the research 
     community should have the opportunity to address these issues 
     in a full and public manner during a hearing conducted by 
     your subcommittee. The necessarily limited floor debate that 
     would occur if this proposal is considered as an amendment to 
     S. 830 would not afford sufficient time or opportunity for 
     such deliberations.
       The AAMC urges the Senate to reject the effort to attach 
     this proposal to the FDA bill and instead consider it during 
     the upcoming NIH reauthorization legislation.
           Sincerely,
                                             Jordan J. Cohen, M.D.

  Mr. FRIST. Mr. President, raising the Office of Alternative Medicine 
to a center at NIH greatly increases its statutory authority. Has the 
field of alternative medicine demonstrated that track record to date? 
Again, let's review these issues in the committee process. The Office 
of Alternative Medicine today clearly does not have the organizational 
structure or the necessary budget to support this proposal--creating a 
national center for complementary and alternative medicine would 
require setting up a whole new administrative structure and a whole new 
research infrastructure to support this activity.
  Are we ready for that today? Possibly.
  Let's ask the scientists around the country. Let's have alternative 
medicine researchers come forward and testify. Let's ask the National 
Institutes of Health. Before we go out and create another center, which 
again is a new entity, we need to look at the proposal about its 
administration, and about how it will be paid for.
  Again, the watchwords today are ``consolidation and coordination,'' 
not proliferation.
  Mr. President, I would like to reserve the remaining minute of my 
time.
  The PRESIDING OFFICER. Who yields time?
  Mr. HARKIN. Mr. President, I have a couple of minutes.
  The PRESIDING OFFICER. The Senator from Iowa has 2 minutes and 45 
seconds.
  Mr. HARKIN. Mr. President, I will respond to my friend from Tennessee 
who made the argument. He said it would create a huge center at NIH. I 
am sorry. The Office of Alternative Medicine has 14 employees, the last 
count I had, and its budget next year is $13 million out of $13 billion 
at NIH. That is one-tenth of 1 percent. Huge? I beg to differ.
  There are only two changes under this amendment. It provides that it 
could make grants, that it could do its own grants, and could have peer 
review. That is the only difference. We are not creating anything new 
and huge. It is up to the Congress to decide later on if they want to 
expand it or not. I am just changing its status.
  Also, Mr. President, I want to say that if it were not for this point 
of order this amendment would pass. The cosponsors are Senators Hatch, 
Daschle, Craig, Mikulski, Lugar, Specter, Grassley, Durbin, Wellstone, 
Moseley-Braun, and a number of others. I am not going to read them all.
  This amendment would pass, if the point of order were not raised.
  The Senator says it should go through the committee structure, that 
we have not had hearings, and stuff. I say in all friendship--and he is 
a great friend of mine, the Senator from Tennessee--that just a couple 
of weeks ago the Senator voted on the Gorton amendment that cut out 
title I--vocational education, safe and drug-free schools, education 
technology, bilingual education--knocked it all out. And, yet, we never 
had one hearing on it. It never went through our committee, of which 
the Senator and I both sit. We never had any hearings on that. Yet the 
Senator from Tennessee says fine. He stepped up and voted to abolish 
all of those without going through the hearing process.
  But I would say to my friend from Tennessee, you want more testimony. 
Look at the Record. Our subcommittee on both the appropriations side 
and on the authorizing side have had hearing after hearing after 
hearing on this. We have had all kinds of testimony come in.
  But the most compelling testimony, Mr. President, for this amendment 
is that more and more Americans are using alternative practices in 
medicines than they are using with mainstream doctors. They are 
spending billions of dollars a year. At last count it was over $13 
billion in 1 year.
  It is up to us to make sure that we do the adequate scientific 
research to find out what alternative medicines are working and what 
are not.
  That is why this center is needed. It may not be germane to this 
bill. But I will tell you. It is needed. It is drastically needed 
today--not next year or 2 years or 3 years from now. We have had enough 
testimony basically from the American people.
  Mr. President, I ask unanimous consent to have printed in the Record 
a letter from a number of organizations supporting the amendment.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

     To the Honorable Tom Harkin, United States Senate:
       We write in support of the proposed amendment to Bill S. 
     830, the purpose of which is to increase the authority of the 
     Office of Alternative Medicine by creating in its place a 
     national Center for Complementary and Alternative Medicine at 
     NIH.
       It is our understanding that this amendment would assure 
     that relevant projects are reviewed by scientists with 
     expertise in the particular area of complementary and 
     alternative medicine proposed to be studied, and the Center 
     would have the ability to directly fund projects without 
     oversight from other NIH Institutes. In addition, the Office 
     of Dietary Supplements would be included within the proposed 
     Center, thereby ensuring improved coordination of research 
     and resource allocation.
       These reforms will, in our view, facilitate and expedite 
     the implementation of rigorous and scientifically based 
     evaluation of complementary and alternative medical 
     therapies. Patients and their families need and deserve 
     responsible and authoritative advice concerning the use or 
     avoidance of these therapies. We must therefore do more to 
     distinguish useful from useless complementary and alternative 
     medical interventions.

[[Page S9762]]

       We thank you for your efforts in this area.
           Sincerely,
     David M. Eisenberg, M.D.,
       Beth Israel Deaconess Medical Center, Harvard Medical 
     School.
     Brian M. Berman, M.D.,
       Complementary Medicine Program, University of Maryland.
     William L. Haskell, Ph.D.,
       School of Medicine, Stanford University.
     Fredi Kronenberg, Ph.D.,
       Center for Complementary and Alternative Medicine Research 
     in Women's Health, Columbia University.
     M. Eric Gershwin, M.D.,
       Division of Rheumatology, Allergy, and Clinical Immunology, 
     University of California, Davis.
     Guy S. Parcel, Ph.D.,
       Center for Health Promotion Research and Development, The 
     University of Texas, Houston.
     Samuel C. Shiflett, Ph.D.,
       Research Department, Kessler Institute for Rehabilitation, 
     Inc.
     Ann Gill Taylor, R.N., Ec.D., FAAN,
       Center for the Study of Complementary and Alternative 
     Therapies, University of Virginia School of Nursing.
     Leanna J. Standish, N.D., Ph.D.,
       AIDS Research Center, Bastyr University.
     Thomas J. Kiresuk, Ph.D.,
       Center for Addiction and Alternative Medicine Research, 
     University of Minnesota Medical School.

  Mr. DASCHLE. Mr. President, I am pleased to cosponsor this amendment 
with my friend from Iowa. The amendment promotes the same fundamental 
goals that have fueled FDA reform--that is, to improve access to safe 
and effective medical treatments, and respond to the growing popularity 
of alternative health care options.
  I commend Senator Harkin for his dedication to breaking down barriers 
that are too often a function of ignorance, inertia or territorialism 
in order to increase the health care options available to all 
Americans. Senator Harkin has advocated long and hard for openminded 
exploration of treatments outside the box of western medicine, and we 
owe him a debt of gratitude both for his common sense and his vision in 
promoting the safe and effective use of promising alternative 
treatments.
  I would also like to thank Senator Jeffords and Senator Kennedy for 
their commitment and leadership throughout this process. I appreciate 
their willingness to work with us on reforms aimed at creating a more 
level playing field for alternative medical treatments.
  And I would be remiss if I did not acknowledge my good friend Berkley 
Bedell, who represented Iowa's sixth congressional district so ably for 
12 years. Berk has worked tirelessly, against strong odds, to give 
consumers more health care options, and the fact that we are here 
today, talking about the potential of alternative medicine, is largely 
due to his vision, conviction and persistence.
  For those of us whose health and well-being may ultimately depend on 
these options, Berkley Bedell's contribution is an invaluable one. 
Thank you, Berk, for your time, energy and unyielding commitment to 
expanding consumers' choices.
  The strategy outlined in this amendment--increasing the autonomy and 
authority of the NIH Office of Alternative Medicine --is a sorely 
needed and long overdue response to the obstacles hindering access to 
alternative medical treatments. Under this amendment, the role of the 
NIH Office of Alternative Medicine would be enhanced through the 
authority to conduct and support intramural and extramural research.
  The Office would no longer be relegated to the second tier, placed in 
the untenable position of convincing other institutes within NIH to 
take on as part of their own resource-constrained agendas, projects the 
Office deems important. As a full research institute, the Office of 
Alternative Medicine could respond to the growing interest in 
alternative treatments by identifying research gaps and fulfilling 
those gaps on a timely basis.
  Mr. President, as you may recall, in February Senator Harkin and I 
reintroduced the Access to Medical Treatment Act, a bill intended to 
give consumers greater freedom to use alternative and complementary 
medical treatments. The bill provoked some controversy, as was 
expected.
  There is no stronger opponent to change than the status quo, no 
matter how valuable. It has become abundantly clear that unless we 
shake things up a little, we will continue to tread water in our 
efforts to tap the full potential of alternative medical treatments. 
Like S. 578, this amendment definitely shakes things up, but it does so 
from a different angle.
  S. 578 promotes the idea that consumers should be free to use 
nontraditional medicines. This amendment confronts the resource 
barriers that prevent essential research into the benefits and risks of 
alternative treatments.
  Too often an alternative treatment is written off because, the 
traditional medical establishment claims, there is no proof of its 
effectiveness. In fact, untested does not necessarily translate as 
ineffective. It may mean that insufficient resources are available to 
definitively prove what has been demonstrated again and again on an 
anecdotal basis. A small firm or single practitioner may not have 
access to the resources necessary to conduct large-scale clinical 
trials in the U.S. to document the safety and effectiveness of a drug 
or device. If the treatment isn't patentable or profitable, it may be 
difficult to attract the interest of drug or device companies.
  This doesn't mean the drug doesn't work or isn't safe. It means we 
don't know. How many beneficial alternative treatments gather dust 
because they are not ``brand name'' material?
  Even more important is the issue of safety. Regardless of the 
obstacles hindering alternative medical treatments, they are 
increasingly popular. A 1993 article in the New England Journal of 
Medicine reported that more than one-third of Americans use 
alternative, nonconventional medical treatments.
  In 1990 alone, Americans spent over $14 billion on these treatments. 
Consumers are using these medical treatments, yet research on the 
safety and effectiveness of alternative treatments remains scarce, and 
the current regulatory system remains focused on large-scale, 
mainstream medicines.
  This amendment is intended to open doors to alternative treatments so 
that they can be assessed for safety and effectiveness and, when they 
are found to be safe and effective, made widely available.
  It's the right thing to do, and the longer we wait to do it, the more 
opportunities we forsake to make use of beneficial medical treatments. 
This amendment promotes the best interests of every health care 
consumer in the Nation, and I am proud to support it.
  The PRESIDING OFFICER. Who yields time?
  Mr. FRIST. Mr. President, how much time is remaining?
  The PRESIDING OFFICER. The Senator from Tennessee has 1 minute.
  Mr. FRIST. Mr. President, in closing, to go right to the heart of the 
matter, to increase and elevate the alternative medicine from an office 
to a center needs to be addressed, but not in this forum. To establish 
a center means you give it grantmaking authority, establish an advisory 
council, and you instruct the center to study the integration of 
alternative medicine, establish a new data system, establish research 
centers, all of which is something that is not just moving toward peer 
review.
  We will address it in the future--hopefully actually in a panel 2 or 
3 weeks from now, in early October.


                             point of order

  Mr. President, I make a point of order that the pending amendment No. 
1137 is not germane.
  The PRESIDING OFFICER. The point of order is sustained.

[[Page S9763]]

  The amendment falls.
  Mr. COATS addressed the Chair.
  The PRESIDING OFFICER. The Senator from Indiana is recognized.
  Mr. COATS. Mr. President, I ask unanimous consent to speak for 2 
minutes prior to the scheduled vote on the committee substitute.
  The PRESIDING OFFICER. Is there objection?
  Without objection, it is so ordered.
  Mr. COATS. Mr. President, in 2 minutes we will be voting on the FDA 
reform bill.
  This committee substitute has been legislated for a 2\1/2\ year 
period thoroughly and carefully and responsibly. It is a piece of work 
that has received a 14-to-4 vote in committee by Democrats and 
Republicans. People of different philosophical backgrounds have 
supported it. It is legislation that has survived two filibusters, and 
the cloture votes have been overwhelming to move forward. It is 
legislation that has been changed and modified 34 times to meet the 
objections of the Senator from Massachusetts and some others about its 
deficiencies; 34 modifications since that 14-to-4 committee vote.
  There are 8 days left in this month before PDUFA--the tax on the drug 
companies that funds up to 600 employees at FDA to review and to 
expedite the review of drugs--8 days left before that authorization 
expires. The clock is ticking. FDA will be laying off more than 600 
people in just 8 days unless we can move this legislation forward. We 
don't need more filibusters. We don't need more debate. It is time to 
move forward. If we do not, drug and device reviews will be delayed 
substantially, and reform will be stopped. Responsible people have 
legislated responsibly, and I urge my colleagues to support us on this 
vote coming up.
  The PRESIDING OFFICER. Under the previous agreement, the Senator from 
Washington is recognized for up to 5 minutes on amendment No. 1161.


                           Amendment No. 1161

  (Purpose: To modify the exemption requirements relating to national 
  uniformity for nonprescription drugs to provide an exemption for a 
State or political subdivision requirement that protects the health and 
                          safety of children)

  Mrs. MURRAY. I send an amendment to the desk
  The PRESIDING OFFICER. The clerk will report.
  The assistant legislative clerk read as follows:

       The Senator from Washington (Mrs. Murray) proposes an 
     amendment numbered 1161.

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

       Beginning on page 117, strike line 24 and all that follows 
     through page 118, line 10, and insert the following:
       ``(b) Exemption.--
       ``(1) In general.--Upon application of a State or political 
     subdivision thereof, the Secretary may by regulation, after 
     notice and opportunity for written and oral presentation of 
     views, exempt from subsection (a), under such conditions as 
     may be prescribed in such regulation, a State or political 
     subdivision requirement that--
       ``(A) protects an important public interest that would 
     otherwise be unprotected, including the health and safety of 
     children;
       ``(B) would not cause any drug to be in violation of any 
     applicable requirement or prohibition under Federal law; and
       ``(C) would not unduly burden interstate commerce.
       ``(2) Timely action.--The Secretary shall make a decision 
     on the exemption of a State or political subdivision 
     requirement under paragraph (1) not later than 120 days after 
     receiving the application of the State or political 
     subdivision under paragraph (1).

  Mrs. MURRAY. Thank you, Mr. President.
  Mr. President, I filed two amendments to this bill, the intent of 
which were aimed at what I believe is a serious problem with national 
uniformity. And that is the issue of poison control labeling to prevent 
unintentional exposure to dangerous over-the-counter drugs and 
cosmetics by children.
  During markup of this bill, national uniformity for labeling of over-
the-counter drugs and cosmetics was adopted as an amendment. At the 
time, I raised concerns that I have about the State of Washington's 
successful Mr. Yuk campaign which simply teaches children and parents 
about the dangers of many common household products. I was concerned at 
the time that this program, which I have personal experience with and 
know how successful it is, would be in jeopardy.
  This is a Mr. Yuk sticker. It is a small green sticker that parents 
and teachers can put onto products--toxic household products. And kids 
across my State are taught if they see a Mr. Yuk sticker they don't 
swallow what is inside of it.
  I was concerned that national uniformity would harm my State's 
ability to continue this very important program. I raised this point 
during markup, and I was assured that the objective of the amendment on 
national uniformity was not to impede a State's ability to protect 
their children.
  Since the markup, I have become even more concerned about poison 
control labeling. I am well aware of the fact that Mr. Yuk is 
voluntary, and there is no State mandate involved. However, this is 
where I became concerned. Under the uniformity language that is 
contained in this bill, a State can petition the Secretary for a 
mandated labeling requirement on OTC's and cosmetics if they meet 
certain public health and safety standards, and if--and only if--the 
labeling requirement does not unduly burden interstate commerce. This 
standard is extremely high and the only way for a State to meet the 
threshold is for the Secretary to make the requirement a national 
requirement.
  What does this mean for Mr. Yuk? If New York, based on a local health 
concern files a petition with the Secretary for a symbol, like a skull 
and cross bones to be placed on mouthwash or hair coloring, and they 
make a strong and sound case, the Secretary can be convinced. However, 
in order to comply with the act and not unduly burden interstate 
commerce, she must make this a national labeling requirement. Now 
Washington State faces a situation where they have a Mr. Yuk Program 
and must also teach about the skull and cross bones warning. This would 
be extremely confusing to young children in my State. I can say that as 
a former teacher.

  Both of my amendments that I put forward attempted to address this 
issue. My first amendment would add poison control efforts using 
symbols in the criteria a State can use to petition the Secretary and 
change the ``and'' to an ``or'' unduly burdening interstate commerce; 
giving the Secretary the opportunity to continue to allow States to 
have their own poison control programs if they decide that a voluntary 
effort has not worked. Only through a mandate requirement will they be 
able to protect young children. Simply changing the ``and'' to an 
``or'' would give the Secretary the needed flexibility, and would at 
least guarantee that one State requirement would not become a national 
requirement if it was not applicable to all 50 States.
  Mr. President, my amendments have strong opposition by the industry. 
They simply don't want to have 50 different State legislatures coming 
forward with 50 different proposals. And I certainly believe there is 
an argument for preemption in many situations. But I don't believe 
there is one in this case.
  I am really at a loss as to why supporters of the uniformity language 
in one breath talk about the need to reform and revitalize the FDA to 
prevent unnecessary delays in approving drugs and devices and then in 
the next breath talk about how States must petition an already 
overburdened agency for the approval to do what they have been doing 
for years without any public threat of consumer confusion problems.
  It is interesting to note that the managers' amendment does exempt 
one State from uniformity. Our State is going to be treated 
differently. One State, the State of California, will be allowed to 
bypass the petition process and have different health and safety 
labeling cosmetics.
  Because of the strong opposition to my original amendment and the 
well-financed national campaign to defeat my amendment, I have revised 
my language. The new amendment which I am offering today will at least 
acknowledge the importance of protecting health and safety of children, 
and will require the FDA to act on a State's petition within 120 days. 
The new amendment does not address all of my concerns. But because 
there has been a strong lobby and I am only one Senator that seems to 
be concerned about poison control, I recognize that my original 
amendment does not have the

[[Page S9764]]

votes. But I cannot allow these uniformity provisions to go to 
conference without some recognition of the health and safety of 
children.
  So I thank the chairman for working with me. I am pleased that he has 
recognized my efforts and has supported the pending underlying 
amendment which has already been agreed to.
  I thank the Chair. I yield my time.
  The PRESIDING OFFICER. Is there further debate on the amendment 
offered by the Senator from Washington? If not, the question is on 
agreeing to the amendment of the Senator from Washington.
  The amendment (No. 1161) was agreed to.
  The PRESIDING OFFICER. Is there further debate?
  Mr. JEFFORDS addressed the Chair.
  The PRESIDING OFFICER. The Senator from Vermont.


              Amendments Nos. 1182, As Modified, and 1183

  Mr. JEFFORDS. Mr. President, I ask unanimous consent to call up and 
adopt Senator Hatch's amendment No. 1183, and 1182, as modified by the 
amendment, which I send to the desk.
  The PRESIDING OFFICER. Is there objection?
  Without objection, it is so ordered.


                           Amendment No. 1182

  Mr. HATCH. Mr. President, the Hatch-Wyden amendment, number 1182, 
modifies FDA's mission statement contained in S. 830.
  For the first time, this legislation puts into statute a mission 
statement for the Food and Drug Administration. Because of its 
important public health role, Congress needs to give FDA the proper 
mission.
  In short, the Hatch-Wyden amendment charges FDA to act in partnership 
with the public, scientific experts, and regulated entities as the 
agency performs its critical public health mission. The language of our 
amendment simply makes explicit what is already implicit, proper, and, 
in fact, necessary: that FDA should work, ``in consultation with 
experts in science, medicine, and public health and in cooperation with 
consumers, users, manufacturers, importers, packers, distributors, and 
retailers of regulated products.''
  As longtime advocates of modernizing and reforming the FDA, Senator 
Wyden and I are convinced that this amendment will help FDA improve and 
protect the public health. Regulators can increase their effectiveness 
if they act more closely in concert with the public that they serve.
  As Vice President Gore, the leader of the administration's 
Reinventing Government initiative, has said:

       We can put the days of almighty holier-than-thou, mister-
     know-it-all Washington behind us. We can become partners.''
       Business owners and local governments are noticing the 
     changes, too, as the federal government becomes more of a 
     partner and less of an adversary.
       Regulatory agencies are on orders to make partnership with 
     business their standard way of operating. We have tested it 
     long enough to know it increases compliance * * * Now we can 
     move beyond pilot programs for partnership into the 
     mainstream.

  The purpose of the Hatch-Wyden amendment is to inject this spirit of 
partnership right into the FDA mission statement. Giving such 
prominence and visibility to the idea of partnership can help the 
agency better fulfill its public health mission.
  In no way does the Hatch-Wyden amendment limit, or is intended to 
limit, FDA from carrying out its enforcement obligations. The Hatch-
Wyden amendment does not concern itself with particular regulatory 
decisions, that is, product approvals, enforcement sanctions, etc., 
rather it simply clarifies that as part of the general manner in which 
the agency conducts itself, FDA should work closely with those affected 
by its regulatory actions.
  We are informed that the FDA is supportive of this amendment so long 
as language is added to make clear that the Secretary has discretion to 
see that only appropriate interactions between FDA and outsiders take 
place. We have incorporated this change.
  In order to fulfill its current statutory responsibilities FDA 
routinely solicits advice from dozens of standing advisory committees 
of outside experts and consults with its colleagues at the National 
Academy of Sciences, the National Institutes of Health, the Centers for 
Disease Control and Prevention and many others. Similarly, FDA works 
closely with consumer groups such as patient advocacy groups and 
various regulated entities such as manufacturers of foods, drugs, 
cosmetics and medical devices.
  In fact, S. 830 contains many particular provisions that detail 
partnerships between FDA and others such as the reauthorization of the 
user fee provisions for new drug review, and the rules that grant 
access to experimental drugs for patients suffering from serious or 
life-threatening conditions.
  In March 1997 testimony to the Senate Labor Committee, Dr. Michael 
Friedman, the highest ranking FDA official, observed:

       One of the themes that runs throughout the Agency's efforts 
     to improve its performance of involving all stakeholders both 
     in defining the problems that exist and in developing 
     appropriate solutions.

  While this amendment is philosophical and exhortatory in nature, we 
believe this philosophy, if adopted, can achieve tangible benefits for 
the FDA and pubic alike. As Lead Deputy Commissioner Friedman 
testified:

       This model of public participation . . . is most clearly 
     delineated in the procedures the Agency has promulgated for 
     the issuance and use of Agency guidance documents. Concerns 
     about the absence of public input on guidance documents and 
     the inappropriate application of such guidance raised in a 
     Citizen's Petition . . . and were the subject of a [House] 
     hearing. . . In response to these concerns, the Agency 
     undertook a thorough review . . . We found inconsistencies 
     and lack of clarity, and we set about to fix it.

  As the FDA's testimony indicates, there is reason to believe that 
encouraging the agency to interact appropriately with the public can 
have practical benefits.
  We firmly believe that if the Congress formally embraces the 
principle of partnership in the FDA mission statement we will help 
create an atmosphere conducive to improving the public health. 
Accordingly, I hope my colleagues will support giving the FDA a 21st 
century mission statement.
  Mr. WYDEN. Mr. President, I am happy to join my colleague Senator 
Hatch in offering an amendment which will add strength, substance, and 
a new level of appropriate public accountability and involvement in the 
missions of the Food and Drug Administration.
  Quite simply, our amendment provides for real access and 
participation by patients and consumer groups, science and health 
experts, and the regulated manufacturers in appropriate policy making 
functions within the scope of the agency's missions.
  As my colleague Senator Hatch has pointed out, our amendment 
underscores the real partnership FDA must forge with all Americans as 
it conducts its work certifying the safety and effectiveness of so many 
products important to our everyday lives.
  I certainly want to acknowledge and applaud the assistance and 
encouragement of our colleagues Senators Jeffords and Kennedy with 
regard to the development of the FDA reform bill generally, and their 
work with us in perfecting the agency's mission statement in 
particular.
  I believe this legislation will help create the dialog necessary 
between the agency and all interested parties in order to effectively 
exercise all of the other far-reaching elements of this reform bill. I 
was very pleased to have played some part in the development of that 
legislation and the broader reform effort, and I know that American 
citizens dependent on pure food, life-saving new drugs and medical 
devices, and safe electronic equipment will benefit for many years to 
come from the work we do here, today.


                    Amendment No. 1183, as modified

  Mr. HATCH. Mr. President, the second amendment we are considering, 
No. 1183, will encourage the prompt and complete reporting of 
potentially vital public health information to the FDA.
  Essentially, my proposal codifies a rule that already applies to 
drugs and medical devices and makes it applicable to all FDA-regulated 
products.
  Specifically, my amendment would codify the liability disclaimer 
provisions that appear at 21 CFR section 803.16, for devices; 21 CFR 
section 314.80(l), for new drugs; and, 21 CFR 312.32(e), for 
investigational new drugs.
  My amendment is closely patterned after these three provisions of 
existing regulation.
  The public health benefit and rationale for my amendment are simple: 
A rule that encourages reporting to the

[[Page S9765]]

FDA of any alleged adverse incident now and resolving liability issues 
later, helps the FDA achieve its public health mission.
  The FDA is a public health agency, not an arbiter of tort liability. 
That is the job of the courts.
  But what is important for the public health is that FDA be able to 
receive quickly and completely raw data pertaining to adverse 
experiences with products under its regulatory purview.
  Please understand that my amendment, like the existing regulations, 
is tort neutral.
  Nothing in my amendment, or in the existing regulations, increases or 
decreases an ultimate finding of liability.
  The Hatch amendment simply says that the mere filing of an adverse 
reaction report or submission of other information to FDA does not 
necessarily reflect an admission of fault or a finding of liability on 
the part of a manufacturer or the Federal Government.
  Of course, the actual information contained in the report may, or may 
not, justify a finding of liability but that is an entirely other 
matter.
  What this amendment says is that the mere filing of a report does not 
automatically mean anything with respect to the issue of liability.
  This is a public health amendment that encourages timely reporting 
and complete reporting to the FDA.
  Let me give a little background into the amendment and the existing 
FDA rules that it builds upon.
  Back in mid-1980's when FDA issued proposed and final rules governing 
mandatory reporting for adverse incidents with respect to medical 
devices, a concern arose among those subject to these new reporting 
requirements.
  In particular, there arose concern about the tight reporting 
timeframe for reporting deaths and serious injuries.
  The argument was that medical device firms should have an opportunity 
to conduct fully its own investigation into alleged malfunctions of its 
products before turning over these reports to FDA.
  After all, went the argument, this information which may have come 
from interested third parties--such as doctors and patients--could 
place the manufacturing firm in a precarious position vis-a-vis 
liability.
  Inevitably, some reports will contain inaccurate information but 
regardless of this it is clear that the FDA had an overriding public 
health interest in getting this information as quickly as possible to 
see whether a national trend was developing.
  The way this matter was resolved in the final medical device 
reporting rule was with the inclusion of language that permitted 
manufacturers to disclaim liability based solely on the filing of the 
report with the FDA.
  To be sure, the information contained in the report might be used to 
establish, or help establish, liability on the part of the 
manufacturer. That depends on what is in the report and the veracity of 
that information.

  What the rule says simply is that the mere filing of the legally 
required report in and of itself does not establish liability.
  One can easily imagine a case where a device malfunctioned and the 
MDR report does, and should properly be used to, establish liability. 
An example would be a case in which a heart pacemaker short circuited 
and failed.
  On the other hand, there will be occasions when required reports do 
not necessarily establish any fault on the part of the manufacturer. An 
example of this might include a case in which a medical scalpel is used 
as a murder weapon; an unfortunate, legally reportable event no doubt, 
but not one likely to establish fault on the part of the manufacturer.
  Building on the success of the disclaimer statement in the medical 
device rule, the FDA later included similar language both for approved 
and investigational drugs.
  Once again, the rule advances the FDA's public health mission by 
helping to get information to the FDA in a timely and complete fashion.
  The Hatch amendment codifies the basic regulation that now applies to 
mandatory reports that device and drug manufacturers now must make and 
establishes this basic principle of ``report now, resolve liability 
issues later'' for all products under the FDA's regulatory domain.
  This would include products like foods, cosmetics, and dietary 
supplements, as well as drugs and devices.
  So, I have drafted the amendment to cover situations where there are 
no rigorous mandatory reporting requirements, such as those which now 
govern drugs and devices.
  For example, we have heard a lot in the press recently about the 
Chesapeake Bay outbreak of Pfiesteria. Obviously, it would be in the 
public interest for the Government to have reports about the incidence 
of this toxic microbe. That is something we would want to encourage.
  I believe that it is more likely this information, even sketchy 
third-party, unverified reports, would be transmitted to FDA if this 
disclaimer clearly applied in this situation.
  What is good policy for drugs and devices, is also good policy for 
foods, cosmetics, dietary supplements, and other products under FDA's 
jurisdiction.
  The Hatch amendment embraces the ``report now/resolve liability 
later'' rule that is already in place by regulation for drugs and 
medical devices and applies this principle for all FDA-regulated 
products, and further applies the provision both to mandatory and 
voluntary reports.
  This is a consumer-friendly, FDA-friendly, tort-neutral provision and 
I urge its adoption.
  Mr. President, I ask unanimous consent that letters in support of 
these two amendments from Brian H. Moss, president of the Utah Life 
Science Industries Association, and Alan F. Holmer, president of the 
Pharmaceutical Research and Manufacturers of America, be printed in the 
Record.
  There being no objection, the letters were ordered to be printed in 
the Record, as follows:

                                       Pharmaceutical Research and


                                     Manufacturers of America,

                               Washington, DC, September 17, 1997.
     Hon. Orrin Hatch,
     U.S. Senate, Russell Senate Office Building, Washington, DC.
       Dear Mr. Chairman: You have asked for comment on two 
     proposed amendments to S. 830. We are pleased to offer our 
     support for these amendments.
       We particularly endorse Section 908, Safety Report 
     Disclaimers, which would place into law a disclaimer that is 
     currently found in FDA regulations. It should be noted that 
     on page 2, line 3, the word ``necessarily'' is no longer 
     found in the Medwatch disclaimer which was drafted more 
     recently than the FDA regulation and pertains to the same 
     circumstances which give rise to the need for the disclaimer. 
     It would be an improvement if the word necessarily were 
     deleted from the amendment, but in any case PhRMA companies 
     support the need for the disclaimer in legislation.
       We would also support the suggested amendment to the 
     mission statement which sets forth a more collaborative and 
     cooperative mission for the agency. PhRMA believes that the 
     agency has responsibility to both protect and promote the 
     public health. There are times when the pendulum has swung 
     too far toward enforcement at the expense of the agency's 
     mission to help bring safe drugs to patients sooner.
           Sincerely,
     Alan F. Holmer.
                                  ____

                                                 Utah Life Science


                                       Industries Association,

                           Salt Lake City, UT, September 18, 1997.
     Hon. James M. Jeffords,
     U.S. Senate, Hart Senate Office Building, Washington, DC.
       Dear Mr. Chairman: I am writing as President of the Utah 
     Life Science Industries Association, concerning the two 
     proposed amendments by Senator Hatch to S. 830. We are happy 
     to extend our support for the two amendments.
       We are pleased to support the amendment to the missions 
     statement. We support the idea of a partnership between the 
     FDA and the private sector, in such that the FDA will consult 
     with experts in science, medicine, public health, and in 
     cooperation with consumers and users. We believe that this 
     will ``help ensure'' the public health.
       We are supportive of the amendment to the Safety Report 
     Disclaimer, and can see a need for this amendment. The 
     amendment will encourage manufacturers to send safety data to 
     the FDA, therefore, helping the FDA to protect the public 
     good.
       Utah Life Science Industries Association was formed three 
     years ago by the Biotechnical, Biomedical and Medical Device 
     industries in Utah. We represent the interest of these Utah 
     companies on local and national issues. We are pleased that 
     you and Senator Hatch have shown such great interest and 
     concern for our industry.
           Sincerely,
                                                    Brian H. Moss,
                                                        President.

  Mr. JEFFORDS. Mr. President, I ask for the yeas and nays on the 
adoption of the committee amendment.
  The PRESIDING OFFICER. Is there a sufficient second?

[[Page S9766]]

  At the moment there is not a sufficient second.
  Mr. JEFFORDS. Mr. President, I make a point of order that a quorum is 
not present.
  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 (Mr. Gorton). Without objection, it is so 
ordered.
  Mr. JEFFORDS. Mr. President, I ask for the yeas and nays on adoption 
of the committee amendment, as modified.
  The PRESIDING OFFICER. Is there a sufficient second? There is a 
sufficient second.
  The yeas and nays were ordered.
  The PRESIDING OFFICER. Without objection, the two preceding 
amendments sent up by the Senator from Vermont are agreed to.
  The amendments (Nos. 1182, as modified, and 1183) were agreed to, as 
follows:


                           amendment no. 1182

              (Purpose: To improve the mission statement.)

       Beginning on page 4, strike line 11 and all that follows 
     through page 5, line 6, and insert the following:
       ``(1) In general.--The Secretary, acting through the 
     Commissioner, and in consultation, as determined appropriate 
     by the Secretary, with experts in science, medicine, and 
     public health, and in cooperation with consumers, users, 
     manufacturers, importers, packers, distributors, and 
     retailers of regulated products, shall protect the public 
     health by taking actions that help ensure that--
       ``(A) foods are safe, wholesome, sanitary, and properly 
     labeled;
       ``(B) human and veterinary drugs, including biologics, are 
     safe and effective;
       ``(C) there is reasonable assurance of safety and 
     effectiveness of devices intended for human use;
       ``(D) cosmetics are safe; and
       ``(E) public health and safety are protected from 
     electronic product radiation.
       ``(2) Special rules.--The Secretary, acting through the 
     Commissioner, shall promptly and efficiently review clinical 
     research and take appropriate action on the marketing of 
     regulated products in a manner that does not unduly impede 
     innovation or product availability. The Secretary, acting 
     through the Commissioner, shall participate with other 
     countries to reduce the burden of regulation, to harmonize 
     regulatory requirements, and to achieve appropriate 
     reciprocal arrangements with other countries.''.
                                  ____



                           AMENDMENT NO. 1183

 (Purpose: To provide for a disclaimer with respect to safety reports)

       At the appropriate place, insert the following:

     SEC.    . SAFETY REPORT DISCLAIMERS.

       Chapter IX (21 U.S.C. 391 et seq.), as amended by section 
     804, is further amended by adding at the end the following:

     ``SEC.    . 908. SAFETY REPORT DISCLAIMERS.

       ``With respect to any entity that submits or is required to 
     submit a safety report or other information in connection 
     with the safety of a product (including a product which is a 
     food, drug, new drug, device, dietary supplement, or 
     cosmetic) under this Act (and any release by the Secretary of 
     that report or information), such report or information shall 
     not be construed to necessarily reflect a conclusion by the 
     entity or the Secretary that the report or information 
     constitutes an admission that the product involved caused or 
     contributed to an adverse experience, or otherwise caused or 
     contributed to a death, serious injury, serious illness, or 
     malfunction. Such an entity need not admit, and may deny, 
     that the report or information submitted by the entity 
     constitutes an admission that the product involved caused or 
     contributed to an adverse experience or caused or contributed 
     to a death, serious injury, serious illness, or 
     malfunction.''.


     Amendments Nos. 1174, 1175, 1152, 1156, and 1136, as modified

  The PRESIDING OFFICER. Under the preceding order, the Senate will 
consider the following amendments, numbered 1174, 1175, 1152, 1156, 
1136, as modified. The question is on agreeing to the amendments en 
bloc.
  Without objection, the amendments en bloc are adopted.
  The amendments (Nos. 1174, 1175, 1152, 1156, and 1136, as modified) 
were agreed to, as follows:


                           amendment no. 1174

(Purpose: To maintain authority of the Food and Drug Administration to 
                           regulate tobacco)

       On page 30, strike lines 17 and through 20, and insert the 
     following:
       (c) Rule of Construction.--Nothing in the amendments made 
     by subsections (a) and (b) shall be construed to alter any 
     authority of the Secretary of Health and Human Services to 
     regulate any tobacco product, or any additive or ingredient 
     of a tobacco product.

  Mr. NICKLES. Mr. President, Members of this Chamber are well aware of 
the national debate on the question of the Food and Drug 
Administration's jurisdiction to regulate tobacco and tobacco products. 
To highlight the scope of this debate, I want to point out that this 
question is currently under review by the U.S. Court of Appeals. It is 
also a significant issue of debate between Members of Congress as well 
as Congress and the administration. I am concerned that the inclusion 
of this provision may be interpreted by some as an attempt by Congress 
to indirectly affirm FDA's authority to regulate tobacco.
  It is my understanding that a recent report from the American Law 
Division of the Congressional Research Service stated that section 404 
or any other provision in the FDA reform bill ``would not interfere 
with or lessen the agency's authority to regulate tobacco products.'' I 
notice that a rule-of-construction amendment has been included in the 
FDA reform bill that is intended to clarify further that section 404 of 
the bill will not affect any authority which the FDA may have to 
regulate tobacco. Is this the understanding of the Chairman?
  Mr. JEFFORDS. Yes. This amendment I believe will address the concerns 
of several Senators who have a concern regarding the effect of this 
legislation on FDA's authority to regulate tobacco. I believe we all 
have the same intent.
  In drafting S. 830, my intent was and is to improve the efficiency 
and accountability of the product review process at FDA. In drafting 
section 404, we modified a provision in the FDA reform bill from the 
104th Congress in an effort to more accurately capture our policy 
intent--my point is that the subject matter is section 404 has been 
under consideration in the Senate Labor Committee, as well as in 
legislation introduced in the House, for several years. The concern 
over FDA's tobacco authority came to our attention only after the 
markup of this bill in committee, in June of this year.
  Section 404 introduces needed elements of due process to certain, 
very limited aspects of medical device reviews. None of the language in 
S. 830 is intended to address FDA's tobacco authority. Late in the 
course of negotiations on this bill, FDA raised the possibility that 
section 404(b) might be interpreted to limit the agency's future 
tobacco regulation authority. At the time we told the agency we did not 
agree with their interpretation but eventually offered to insert the 
rule of construction now before us in the substitute to make absolutely 
clear our neutrality on the tobacco issue. Subsequently, FDA and others 
have raised the possibility that section 404(a) of S. 830 could also 
affect FDA's authority in this area. As you mentioned, the 
Congressional Research Service, American Law Division, has evaluated S. 
830 and determined that it, in fact, does not interfere with any 
tobacco authority FDA may have. This analysis was made part of the 
Congressional Record on September 5.
  None of the provisions of S. 830 or the substitute should be 
interpreted as taking a position, one way or the other, on whether FDA 
has any authority under current law to regulate tobacco products, which 
as you know, is the subject of ongoing litigation in the Federal 
courts. The intention of the rule of construction in the substitute is 
to make clear that the Federal courts can continue to determine FDA's 
authority over tobacco without any interference from this act. Thus, 
the language in section 404 has no effect on whether or not FDA has 
authority over tobacco products, it only relates to a procedural aspect 
of reviewing 510(k) medical device submissions.

  To sum up, I am pleased to offer an amendment extending the rule of 
construction to all of section 404 on the basis outlined in my 
preceding remarks--to keep the bill strictly neutral on the question of 
FDA tobacco authority, that is that we are not prejudging the outcome 
of any pending litigation on any tobacco authority the FDA may have. 
Further, it is my view that if this provision is included in the final 
FDA reform bill as reported by the conference committee, the conference 
report should include language which reinforces this point.

[[Page S9767]]

  Mr. NICKLES. I thank the chairman for his explanation of this 
provision and his efforts to bring this important legislation to the 
floor. At some point in the 105th Congress, we may be considering the 
national tobacco settlement entered into by the State's attorney's 
general and the tobacco companies. At the appropriate time Congress 
will have the opportunity to fully examine what FDA's role should be in 
the regulation of tobacco products.


                           amendment no. 1175

(Purpose: To provide that an environmental impact statement prepared in 
accordance with certain regulations of the Food and Drug Administration 
 shall be considered to meet the requirements of section 102(2)(C) of 
             the National Environmental Policy Act of 1969)

       Strike section 602 and insert the following:

     SEC. 602. ENVIRONMENTAL IMPACT REVIEW.

       Chapter VII (21 U.S.C. 371 et seq.), as amended by section 
     402, is further amended by adding at the end the following:

     ``SEC. 742. ENVIRONMENTAL IMPACT REVIEW.

       ``Notwithstanding any other provision of law, an 
     environmental impact statement prepared in accordance with 
     the regulations published in part 25 of title 21, Code of 
     Federal Regulations (as in effect on August 31, 1997) in 
     connection with an action carried out under (or a 
     recommendation or report relating to) this Act, shall be 
     considered to meet the requirements for a detailed statement 
     under section 102(2)(C) of the National Environmental Policy 
     Act of 1969 (42 U.S.C. 4332(2)(C)).''.
                                  ____



                           amendment no. 1152

   (Purpose: To improve the standard for binding determinations with 
respect to the specification of valid scientific evidence with respect 
                    to the effectiveness of devices)

       On page 24, line 19, strike ``is'' and insert ``could be''.
                                  ____



                           AMENDMENT NO. 1156

(Purpose: To provide for a study and report concerning the treatment of 
                   health care economic information)

       Strike section 612 and insert the following:

     SEC. 612. HEALTH CARE ECONOMIC INFORMATION.

       (a) In General.--Section 502(a) (21 U.S.C. 352(a)) is 
     amended by adding at the end the following: ``Health care 
     economic information provided to a formulary committee, or 
     other similar entity, in the course of the committee or the 
     entity carrying out its responsibilities for the selection of 
     drugs for managed care or other similar organizations, shall 
     not be considered to be false or misleading if the health 
     care economic information directly relates to an indication 
     approved under section 505 or 507 or section 351(a) of the 
     Public Health Service Act (42 U.S.C. 262(a)) for such drug 
     and is based on competent and reliable scientific evidence. 
     The requirements set forth in section 505(a), 507, or section 
     351(a) of the Public Health Service Act (42 U.S.C. 262(a)) 
     shall not apply to health care economic information provided 
     to such a committee or entity in accordance with this 
     paragraph. Information that is relevant to the substantiation 
     of the health care economic information presented pursuant to 
     this paragraph shall be made available to the Secretary upon 
     request. In this paragraph, the term `health care economic 
     information' means any analysis that identifies, measures, or 
     compares the economic consequences, including the costs of 
     the represented health outcomes, of the use of a drug to the 
     use of another drug, to another health care intervention, or 
     to no intervention.''.
       (b) Study and Report.--The Comptroller General of the 
     United States shall conduct a study of the implementation of 
     the provisions added by the amendment made by subsection (a). 
     Not later than 4 years and 6 months after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall prepare and submit to Congress a report 
     containing the findings of the study.
                                  ____



                    AMENDMENT NO. 1136, AS MODIFIED

   (Purpose: To improve the provisions relating to pediatric studies)

       Strike section 618 and insert the following:

     SEC. 618. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.

       (a) General Authority.--Chapter V of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 
     inserting after section 505 the following:

     ``SEC. 505A. PEDIATRIC STUDIES OF DRUGS.

       ``(a) Market Exclusivity for New Drugs.--If, prior to 
     approval of an application that is submitted under section 
     505(b)(1), the Secretary determines that information relating 
     to the use of a drug in the pediatric population may produce 
     health benefits in that population, the Secretary makes a 
     written request for pediatric studies (which may include a 
     timeframe for completing such studies), and such studies are 
     completed within any such timeframe and the reports thereof 
     submitted in accordance with subsection (d)(2) or completed 
     within any such timeframe and the reports thereof are 
     accepted in accordance with subsection (d)(3)--
       ``(1)(A) the period during which an application may not be 
     submitted under subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) 
     of section 505 shall be five years and six months rather than 
     five years, and the references in subsections (c)(3)(D)(ii) 
     and (j)(4)(D)(ii) of section 505 to four years, to forty-
     eight months, and to seven and one-half years shall be deemed 
     to be four and one-half years, fifty-four months, and eight 
     years, respectively; or
       ``(B) the period of market exclusivity under subsections 
     (c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii) and (iv) of 
     section 505 shall be three years and six months rather than 
     three years; and
       ``(2)(A) if the drug is the subject of--
       ``(i) a listed patent for which a certification has been 
     submitted under subsection (b)(2)(A)(ii) or 
     (j)(2)(A)(vii)(II) of section 505 and for which pediatric 
     studies were submitted prior to the expiration of the patent 
     (including any patent extensions); or
       ``(ii) a listed patent for which a certification has been 
     submitted under subsection (b)(2)(A)(iii) or 
     (j)(2)(A)(vii)(III) of section 505,

     the period during which an application may not be approved 
     under subsection (c)(3) or (j)(4)(B) of section 505 shall be 
     extended by a period of six months after the date the patent 
     expires (including any patent extensions); or
       ``(B)  if  the  drug  is  the  subject  of  a  listed   
     patent   for   which   a   certification has been submitted 
     under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of 
     section 505, and in the patent infringement litigation 
     resulting from the certification the court determines that 
     the patent is valid and would be infringed, the period during 
     which an application may not be approved under subsection 
     (c)(3) or (j)(4)(B) of section 505 shall be extended by a 
     period of six months after the date the patent expires 
     (including any patent extensions).
       ``(b) Secretary To Develop List of Drugs for Which 
     Additional Pediatric Information May Be Beneficial.--Not 
     later than 180 days after the date of enactment of this 
     section, the Secretary, after consultation with experts in 
     pediatric research (such as the American Academy of 
     Pediatrics, the Pediatric Pharmacology Research Unit Network, 
     and the United States Pharmacopoeia) shall develop, 
     prioritize, and publish an initial list of approved drugs for 
     which additional pediatric information may produce health 
     benefits in the pediatric population. The Secretary shall 
     annually update the list.
       ``(c) Market Exclusivity for Already-Marketed Drugs.--If 
     the Secretary makes a written request for pediatric studies 
     (which may include a timeframe for completing such studies) 
     concerning a drug identified in the list described in 
     subsection (b) to the holder of an approved application under 
     section 505(b)(1) for the drug, the holder agrees to the 
     request, and the studies are completed within any such 
     timeframe and the reports thereof submitted in accordance 
     with subsection (d)(2) or completed within any such timeframe 
     and the reports thereof accepted in accordance with 
     subsection (d)(3)--
       ``(1)(A) the period during which an application may not be 
     submitted under subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) 
     of section 505 shall be five years and six months rather than 
     five years, and the references in subsections (c)(3)(D)(ii) 
     and (j)(4)(D)(ii) of section 505 to four years, to forty-
     eight months, and to seven and one-half years shall be deemed 
     to be four and one-half years, fifty-four months, and eight 
     years, respectively; or
       ``(B) the period of market exclusivity under subsections 
     (c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii) and (iv) of 
     section 505 shall be three years and six months rather than 
     three years; and
       ``(2)(A) if the drug is the subject of--
       ``(i) a listed patent for which a certification has been 
     submitted under subsection (b)(2)(A)(ii) or 
     (j)(2)(A)(vii)(II) of section 505 and for which pediatric 
     studies were submitted prior to the expiration of the patent 
     (including any patent extensions); or
       ``(ii) a listed patent for which a certification  has  been 
      submitted  under subsection (b)(2)(A)(iii) or 
     (j)(2)(A)(vii)(III) of section 505,

     the period during which an application may not be approved 
     under subsection (c)(3) or (j)(4)(B) of section 505 shall be 
     extended by a period of six months after the date the patent 
     expires (including any patent extensions); or
       ``(B)  if  the  drug  is  the  subject  of  a  listed 
     patent   for   which   a   certification   has   been 
     submitted under subsection (b)(2)(A)(iv) or 
     (j)(2)(A)(vii)(IV) of section 505, and in the patent 
     infringement litigation resulting from the certification the 
     court determines that the patent is valid and would be 
     infringed, the period during which an application may not be 
     approved under subsection (c)(3) or (j)(4)(B) of section 505 
     shall be extended by a period of six months after the date 
     the patent expires (including any patent extensions).
       ``(d) Conduct of Pediatric Studies.--
       ``(1) Agreement for studies.--The Secretary may, pursuant 
     to a written request for studies, after consultation with--
       ``(A) the sponsor of an application for an investigational 
     new drug under section 505(i);
       ``(B) the sponsor of an application for a drug under 
     section 505(b)(1); or
       ``(C) the holder of an approved application for a drug 
     under section 505(b)(1),
     agree with the sponsor or holder for the conduct of pediatric 
     studies for such drug.
       ``(2) Written protocols to meet the studies requirement.--
     If the sponsor or holder

[[Page S9768]]

     and the Secretary agree upon written protocols for the 
     studies, the studies requirement of subsection (a) or (c) is 
     satisfied upon the completion of the studies and submission 
     of the reports thereof in accordance with the original 
     written request and the written agreement referred to in 
     paragraph (1). Not later than 60 days after the submission of 
     the report of the studies, the Secretary shall determine if 
     such studies were or were not conducted in accordance with 
     the original written request and the written agreement and 
     reported in accordance with the requirements of the Secretary 
     for filing and so notify the sponsor or holder.
       ``(3) Other methods to meet the studies requirement.--If 
     the sponsor or holder and the Secretary have not agreed in 
     writing on the protocols for the studies, the studies 
     requirement of subsection (a) or (c) is satisfied when such 
     studies have been completed and the reports accepted by the 
     Secretary. Not later than 90 days after the submission of the 
     reports of the studies, the Secretary shall accept or reject 
     such reports and so notify the sponsor or holder. The 
     Secretary's only responsibility in accepting or rejecting the 
     reports shall be to determine, within the 90 days, whether 
     the studies fairly respond to the written request, whether 
     such studies have been conducted in accordance with commonly 
     accepted scientific principles and protocols, and whether 
     such studies have been reported in accordance with the 
     requirements of the Secretary for filing.
       ``(e) Delay of Effective Date for Certain Applications; 
     Period of Market Exclusivity.--If the Secretary determines 
     that the acceptance or approval of an application under 
     subsection (b)(2) or (j) of section 505 for a drug may occur 
     after submission of reports of pediatric studies under this 
     section, which were submitted prior to the expiration of the 
     patent (including any patent extension) or market exclusivity 
     protection, but before the Secretary has determined whether 
     the requirements of subsection (d) have been satisfied, the 
     Secretary shall delay the acceptance or approval under 
     subsection (b)(2) or (j), respectively, of section 505 until 
     the determination under subsection (d) is made, but such 
     delay shall not exceed 90 days. In the event that 
     requirements of this section are satisfied, the applicable 
     period of market exclusivity referred to in subsection (a) or 
     (c) shall be deemed to have been running during the period of 
     delay.
       ``(f) Notice of Determinations on Studies Requirement.--The 
     Secretary shall publish a notice of any determination that 
     the requirements of subsection (d) have been met and that 
     submissions and approvals under subsection (b)(2) or (j) of 
     section 505 for a drug will be subject to the provisions of 
     this section.
       ``(g) Limitation.--The holder of an approved application 
     for a new drug that has already received six months of market 
     exclusivity under subsection (a) or (c) may, if otherwise 
     eligible, obtain six months of market exclusivity under 
     subsection (c)(1)(B) for a supplemental application, except 
     that the holder is not eligible for exclusivity under 
     subsection (c)(2).
       ``(h) Study and Report.--The Secretary shall conduct a 
     study and report to Congress not later than January 1, 2003 
     based on the experience under the program. The study and 
     report shall examine all relevant issues, including--
       ``(1) the effectiveness of the program in improving 
     information about important pediatric uses for approved 
     drugs;
       ``(2) the adequacy of the incentive provided under this 
     section;
       ``(3) the economic impact of the program; and
       ``(4) any suggestions for modification that the Secretary 
     deems appropriate.
       ``(i) Termination of Market Exclusivity Extension Authority 
     for New Drugs.--Except as provided in section 618(b) of the 
     Food and Drug Administration Modernization and Accountability 
     Act of 1997, no period of market exclusivity shall be 
     extended under subsection (a) for a drug if--
       ``(1) the extension would be based on studies commenced 
     after January 1, 2004; and
       ``(2) the application submitted for the drug under section 
     505(b)(1) was not approved by January 1, 2004.
       ``(j) Definitions.--In this section, the term `pediatric 
     studies' or `studies' means at least 1 clinical investigation 
     (that, at the Secretary's discretion, may include 
     pharmacokinetic studies) in pediatric age-groups in which a 
     drug is anticipated to be used.''.
       (b) Market Exclusivity Under Other Authority.--
       (1) Through calendar year 2003.--
       (A) Determination.--If the Secretary requests or requires 
     pediatric studies, prior to January 1, 2004, under Federal 
     law other than section 505A of the Federal Food, Drug, and 
     Cosmetic Act (as added by subsection (a)), from the sponsor 
     of an application, or the holder of an approved application, 
     for a drug under section 505(b) of such Act (21 U.S.C. 
     355(b)), the Secretary shall determine whether the studies 
     meet the completeness, timeliness, and other submission 
     requirements of the Federal law involved.
       (B) Market exclusivity.--If the Secretary determines that 
     the studies meet the requirements involved, the Secretary 
     shall ensure that the period of market exclusivity for the 
     drug involved is extended for 6 months in accordance with the 
     requirements of subsection (a), (c), (e), and (g) (as 
     appropriate) of section 505A of such Act (as in effect on the 
     date of enactment of this Act.).
       (2) Calendar year 2004 and subsequent years.--
       (A) New drugs.--Effective January 1, 2004, if the Secretary 
     requests or requires pediatric studies, under Federal law 
     other than section 505A of the Federal Food, Drug, and 
     Cosmetic Act, from the sponsor of an application for a drug 
     under section 505(b) of such Act, nothing in such law shall 
     be construed to permit or require the Secretary to ensure 
     that the period of market exclusivity for the drug is 
     extended.
       (B) Already marketed drugs.--
       (i) Determination.--Effective January 1, 2004, if the 
     Secretary requests or requires pediatric studies, under 
     Federal law other than section 505A of the Federal Food, 
     Drug, and Cosmetic Act (as added by subsection (a)), from the 
     holder of an approved application for a drug under section 
     505(b) of such Act, the Secretary shall determine whether the 
     studies meet the completeness, timeliness, and other 
     submission requirements of the Federal law involved.
       (ii) Market exclusivity.--If the Secretary determines that 
     the studies meet the requirements involved, the Secretary 
     shall ensure that the period of market exclusivity for the 
     drug involved is extended for 6 months in accordance with the 
     requirements of subsection (a), (c), (e), and (g) (as 
     appropriate) of section 505A of such Act (as in effect on the 
     date of enactment of this Act.).
       (3) Definitions.--In this subsection:
       (A) Drug.--The term ``drug'' has the meaning given the term 
     in section 201 of such Act.
       (B) Pediatric studies.--The term ``pediatric studies'' has 
     the meaning given the term in section 505A of such Act.
       (C) Secretary.--The term ``Secretary'' means the Secretary 
     of Health and Human Services.

                              section 807

  Mrs. FEINSTEIN. Section 807 of the committee substitute for S. 830 
prohibits State and local governments from establishing or continuing--
for nonprescription drugs, any requirement that is different from, in 
addition to or otherwise not identical to a Federal requirement; for 
cosmetics, any requirements for packaging and labeling that are 
different from, in addition to or otherwise not identical to a Federal 
requirement. This includes any requirement relating to public 
information or any other form of public communication relating to a 
warning of any kind for a nonprescription drug.
  My State, California, has a long history of regulating 
nonprescription drugs and cosmetics and I would like to ask the bill 
manager's to engage in a colloquy with me to clarify his intent and the 
language of the bill.
  The California Department of Health Services in a September 12 letter 
expressed their concern that they would have to request interpretations 
from FDA. They wrote: ``For interpretation of Federal requirements, and 
in order to determine if a State conflict exists, it will be necessary 
for States to continually request from the Federal Government an 
interpretation of their requirements and both Federal and State legal 
review of those interpretations.''
  Could you explain the bill's intent?
  Mr. JEFFORDS. In most cases, it will be abundantly clear and States 
will not have to continually request written interpretations of Federal 
law. There should be no need to delay enforcement.
  Mrs. FEINSTEIN. According to California officials, a number of 
requirements now in force in California could be considered to be in 
addition to Federal law under this bill and therefore could be 
preempted.
  The first area relates to public warning requirements. The California 
Department of Health Services maintains that the bill would likely 
prohibit State-initiated public health warnings.
  California DHS asked, for example, if point-of-purchase placards 
could be required.
  Could my colleague comment on the intent of the bill with regard to 
State public warning requirements?
  Mr. JEFFORDS. The public information and communication provisions of 
S. 830 would not prevent a State from issuing its own public statements 
to warn the public. But although the State is free to utilize the media 
and other such avenues, the State could not require point-of-purchase 
placards to be posted.
  Mrs. FEINSTEIN. For both drugs and cosmetics, currently under 
California law, if DHS has probable cause to believe that a drug or 
cosmetic is adulterated, misbranded, or falsely advertised, DHS can 
embargo the product, remove it from commerce. In their letter, DHS 
says, ``This power may be considered in addition to a Federal 
requirement.''

[[Page S9769]]

  Could you clarify your intent in this area?
  Mr. JEFFORDS. Enforcement authority is not covered by the preemption 
provision of the bill, so a State's embargo and other enforcement 
authority would not be affected.
  Mrs. FEINSTEIN. For nonprescription drugs, California law requires 
comprehensive and annual inspections of manufacturers. Federal law 
requires limited inspections on no timetable. DHS maintains that the 
``State's requirements for drug manufacturer licensing and the annual 
inspections may be considered a requirement in addition to the Federal 
requirement.''
  What is the chairman's intent in this bill, as it addresses licensing 
and inspections by States?
  Mr. JEFFORDS. As I said previously enforcement authority is not 
covered by the national uniformity provisions. Thus, drug manufacturer 
licensing and inspection in the States would not be affected.
  Mrs. FEINSTEIN. My State has expressed concerns about advertising, 
saying that State law has advertising restrictions, that is prohibition 
on false and misleading advertisment, advertising of unproven remedies, 
that may be preempted. Could you elaborate on the bill's intent in the 
drug advertising area?
  Mr. JEFFORDS. The national uniformity provisions would not affect 
traditional drug advertising laws because this bill does not address 
the authority of the Federal Trade Commission Act. State laws that 
prohibit false and misleading advertising or to prohibit 
unsubstantiated claims for nonprescription drugs, for example, would 
not be affected. Traditional advertising issues relating to claims 
substantiation, fair balanced and truth are outside the scope of 
national uniformity.
  Mrs. FEINSTEIN. I thank my colleague. I hope that this discussion 
will clarify the true intent of the authors of this bill and provide 
some clarification of the State's authority to protect the public 
health under this bill.


                Vote on Amendment No. 1130, as modified

  The PRESIDING OFFICER. The question is on agreeing to the committee 
substitute, No. 1130, as modified. The yeas and nays are ordered. The 
clerk will call the roll.
  The assistant legislative clerk called the roll.
  The result was announced--yeas 98, nays 2, as follows:

                      [Rollcall Vote No. 255 Leg.]

                                YEAS--98

     Abraham
     Akaka
     Allard
     Ashcroft
     Baucus
     Bennett
     Biden
     Bingaman
     Bond
     Boxer
     Breaux
     Brownback
     Bryan
     Bumpers
     Burns
     Byrd
     Campbell
     Chafee
     Cleland
     Coats
     Cochran
     Collins
     Conrad
     Coverdell
     Craig
     D'Amato
     Daschle
     DeWine
     Dodd
     Domenici
     Dorgan
     Durbin
     Enzi
     Faircloth
     Feingold
     Feinstein
     Ford
     Frist
     Glenn
     Gorton
     Graham
     Gramm
     Grams
     Grassley
     Gregg
     Hagel
     Harkin
     Hatch
     Helms
     Hollings
     Hutchinson
     Hutchison
     Inhofe
     Inouye
     Jeffords
     Johnson
     Kempthorne
     Kerrey
     Kerry
     Kohl
     Kyl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lott
     Lugar
     Mack
     McCain
     McConnell
     Mikulski
     Moseley-Braun
     Moynihan
     Murkowski
     Murray
     Nickles
     Reid
     Robb
     Roberts
     Rockefeller
     Roth
     Santorum
     Sarbanes
     Sessions
     Shelby
     Smith (NH)
     Smith (OR)
     Snowe
     Specter
     Stevens
     Thomas
     Thompson
     Thurmond
     Torricelli
     Warner
     Wellstone
     Wyden

                                NAYS--2

     Kennedy
     Reed
       
  The amendment (No. 1130), as modified, was agreed to.
  Mr. LOTT. Mr. President, I move to reconsider the vote.
  The PRESIDING OFFICER. Without objection, the motion to lay on the 
table the motion to reconsider is agreed to.
  The motion to lay on the table was agreed to.
  The PRESIDING OFFICER. The majority leader.

                          ____________________