[Congressional Record Volume 143, Number 129 (Wednesday, September 24, 1997)]
[Senate]
[Pages S9811-S9847]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 
                                  1997

  The PRESIDING OFFICER (Mr. Smith of Oregon). Under the previous 
order, the Senate will now resume consideration of S. 830, which the 
clerk will report.
  The legislative clerk read as follows:

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

  The Senate resumed consideration of the bill.
  The PRESIDING OFFICER. Under the previous order, there will now be 4 
hours of debate to be equally divided between the chairman and the 
ranking member.
  Mr. JEFFORDS. Mr. President, this is, hopefully, the final moments of 
debate on the FDA reform bill. There is no Senator who has been of more 
help and assistance, not only to the committee but to her constituents, 
than the Senator from Maryland. Thus, I am pleased that the one who 
will be opening the debate today is that Senator. So I yield her such 
time as she may consume; and may she consume a lot of time.
  The PRESIDING OFFICER. The Senator from Maryland is recognized.
  Ms. MIKULSKI. Mr. President, thank you.
  Mr. President, in a few hours we will be voting on the final passage 
of the FDA Modernization and Accountability Act.
  I am so pleased that this day has finally arrived. I thank the 
chairman of the Labor Committee, Mr. Jeffords, for all of his 
incredible patience, persistence, dedication, and attention to really 
lead the mission to move FDA into the 21st century. I thank him for his 
heartfelt devotion to accomplishing this mission and for never giving 
up. I also want to thank his staff for their hard work and for the 
bipartisan, nonpartisan way in which they worked.
  Let me also acknowledge the tremendous contribution of the ranking 
member, Senator Kennedy. There is no doubt that this is a better bill 
and FDA will be in better shape because of his efforts.
  Mr. President, I have worked on FDA reform for a number of years. 
When I was a Member of the House of Representatives, we embarked, on a 
bipartisan basis, to ensure consumer protection, to prevent dumping of 
drugs that did not meet our standards into Third World countries.
  Then coming to the Senate, I joined with my colleague from 
Massachusetts, Senator Kennedy, and with the Senator from Utah, Mr. 
Hatch, in fashioning something called the Prescription Drug User Fee 
Act, otherwise nicknamed PDUFA. What PDUFA did is provide, through a 
user fee mechanism, the ability to hire 600 more people at FDA to 
analyze the safety and efficacy of pharmaceuticals to move them to the 
marketplace.
  Because of PDUFA and the great legislative idea of Kennedy-Hatch, FDA 
was able to hire more people to examine products that were being 
presented for evaluation and get them to clinical practice more 
quickly.

  The leadership of Kennedy-Hatch on PDUFA has not only stood the test 
of time, but it has shown that we can expedite the drug approval 
process while maintaining safety and efficacy.

[[Page S9812]]

  But while PDUFA made a huge difference, it became clear that PDUFA 
was not enough. More staff operating in an outdated regulatory 
framework without a clear legislative framework was deficient.
  That is when we began to consult with experts in the field of public 
health, particularly those involved in drugs and biologics on where we 
needed to go. While we were considering this, the world of science was 
changing. We were experiencing a tremendous revolution in biology. We 
went from basic discoveries in science, particularly in the field of 
chemistry and physics, to a whole new explosion in biology and genetics 
and biologic materials. We also went from a smokestack economy to a 
cyberspace economy in which the very tools of information technology 
could enable us to improve our productivity.
  It became clear that we needed an FDA with a new legislative 
framework and a new culture and a continued commitment to the 
traditional values of safety and efficacy. This is when we began to put 
together what we called the sensible center on FDA reform. One often 
hears about partisan bickering. One often hears about prickly 
relationships between the two parties. But I tell you, thanks to the 
leadership of Senator Kassebaum, who initially chaired this initiative, 
we, Republicans and Democrats, worked together because we never wanted 
to play politics with the lives of the American people. What we wanted 
to do is to make sure the American medical community and the world 
medical community had the best clinical tools at their disposal to help 
save lives.
  We saw the reform of FDA accomplishing two important policy goals--
saving lives and at the same time generating jobs in our own American 
economy in the fields of pharmaceuticals, biologics, and medical 
devices.
  Senator Kassebaum took important steps forward. Senator Jeffords 
assumed that mantle and brought us to this point today.
  What will this bill do? Why is it so important? It gives, first of 
all, a clear statement on what is the mission and purpose of FDA--to 
save lives with pharmaceutical and biologic products and to maintain 
the safety of our food supply. This bill does not deal with the food 
safety issue, but it sure does focus on those things that normally 
would take place in clinical practice.
  Why is it so important? It streamlines the regulatory process, it 
reauthorizes that very highly successful PDUFA, to make sure we have 
adequate staff, and it creates an FDA that rewards significant science 
while protecting public health.
  It means that new lifesaving drugs and devices will get into clinical 
practice more quickly. It will enable us to produce products that we 
can sell around the world saving lives and generating jobs.
  What is so great about pharmaceuticals, biologics, and medical 
devices is that they are translingual, they are transcultural. When you 
need a new drug and it is approved by FDA, whether you live in 
Baltimore or whether you live in London or whether you live in 
Bangladesh, you need it. If you then use a medical device, you know if 
it is safe in Maryland, it will be safe in Moscow or Malaysia. This is 
why this will offer us a whole new opportunity in exports.
  I am really proud of FDA. I am proud of all the people who work at 
FDA, and under very Spartan resources. Why? Because it is known as the 
gold standard around the world for product approval. We want to 
maintain that high standard, and at the same time we want to make sure 
that the FDA is ready to enter the 21st century.
  This legislation will be the bridge to the future, maintaining the 
evaluation of safety and efficacy with the new tools to be able to 
participate in a 21st century science environment and a 21st century 
economy. This bill sets up a new legislative and regulatory framework 
which reflects the latest scientific advancements. That framework 
continues the FDA's strong mission to public health and safety, but it 
sets a new goal for FDA--enhancing public health by not impeding 
innovation or product liability through unnecessary red tape that only 
delays approval.

  There is an urgency about reauthorizing PDUFA. Its authority expires 
at the end of this month. PDUFA has enabled FDA to hire 600 new 
reviewers, and to cut review times from 29 to 17 months over the last 5 
years. If we fail to act now, it means the people who have been working 
on behalf of the American people and the world will get RIF notices. We 
cannot let them down, because we do not want them to let the American 
people or the world down. We risk losing talented employees and slowing 
down the approval process.
  Delay will hurt dedicated employees, but more importantly it will 
hurt patients. Patients benefit the most from this legislation. Safe 
and effective new medical tools will be helping patients live longer 
lives or get better quicker.
  We are not just extending PDUFA. We are improving it. Currently, 
PDUFA only addresses something called the review phase of the approval 
process. Our bill extends PDUFA to streamline the early drug 
development phase as well.
  What does this mean? New innovations. We are going to be able to 
allow for electronic submissions. We want to improve productivity. 
Instead of carloads of paper, stacks and stacks of material not being 
able to be utilized in an efficient way being deposited at FDA, 
companies will be able to make those electronic submissions. This 
reduces not only paperwork but actually provides a more agile way for 
scientific reviewers to get through the data in a way that improves 
efficiency while they are analyzing efficacy.
  Updating the approval process for biotechnology is another critical 
component of this bill. Biotechnology is one of the fastest growing 
industries in our country. In my own State of Maryland, there are 143 
of these companies. They are working on everything from AIDS to 
Alzheimer's to Parkinson's disease, to breast and ovarian cancer, as 
well as new immunizations for children.
  These are absolutely vital areas of endeavor. We want to be able to 
help them develop these new areas, go through a submission at FDA to 
make sure they are safe, and get new products out there doing their job 
of improving people's health.
  The job of FDA is to make sure that safe and effective products get 
to our patients. Our job, as Members of Congress, is to fund scientific 
research through NIH and other Federal laboratories and extramural 
research at great institutions like the University of Maryland and 
Johns Hopkins and at the same time to provide FDA the regulatory and 
legislative framework to evaluate new products to make them available 
to doctors and to patients.
  That is why I am fighting for this. There have been many issues 
raised in this debate. Some have been very robust. Some have even been 
prickly. But I tell you, I want to absolutely say that I am on the side 
of FDA. I am absolutely on the side of safety. I am absolutely on the 
side of efficacy. I believe this is what this bill does.
  This legislation should not be a battle of wills, it should not be a 
battle over this line item or that line item. It should be really a 
battle over what is the best way to make sure the American people have 
from their physicians and other clinical practitioners the best devices 
and products to be able to save their lives.
  Mr. President, my dear father died of Alzheimer's. He was in the 
final stages when I became a U.S. Senator. He was so ill that he could 
not come to that marvelous night in my life when I won the general 
election and knew I would be the first Democratic woman ever elected in 
her own right. I spoke to my father that election night, via TV because 
he could not be there, to thank him for what he did for me and my 
sisters. With Alzheimer's, I watched my father die one brain cell at a 
time. It did not matter that I was a U.S. Senator, it did not matter 
that I was helping fund research at NIH, my father was dying.
  My father was a modest man. He didn't want a fancy tombstone or a lot 
of other things, but I vowed, I promised, in my heart of hearts I would 
do all I could to find a cure for Alzheimer's. I would do all I could 
for those people who have Alzheimer's or other forms of dementia or 
other mind diseases. While I did that, I promised also that I would do 
all I could to make sure those tools moved to the clinical practice as 
fast as they could.
  Every one of us has faced some type of tragedy in our lives where we 
look

[[Page S9813]]

to the American medical, pharmaceutical, biological, and device 
communities to help us. I have done that so many times. I am grateful 
to the medical communities in the United States of America.
  When my own mother had one of her last horrible heart attacks that 
was rapidly leading to a stroke there was a new drug that was so 
sophisticated that if it was administered quickly could help her avoid 
having a stroke. It required informed consent, because even though it 
was approved it was so dramatic in the way it thins the blood, almost 
to a hemophilia level, that you needed consent on the scene.
  I heard all of the medical pros and cons of that. I was advised by a 
great clinician at Mercy Hospital and I gave that approval because my 
mother was not conscious and not able to do that. And guess what? That 
new drug approved by FDA, developed in San Francisco, got my mother 
through her critical medical crisis with the hands-on care of the 
Sisters of Mercy at Mercy Hospital. My mother did not have a stroke 
because we avoided the clotting with the help of this new dramatic 
drug.
  I give praise and thanksgiving to God for that and the ingenuity of 
the American medical community that enabled my mother to stay with us 
100 more days so she could be back at home, have conversations with us, 
her grandchildren, and so she could, even in her final days, continue a 
telephone ministry that she had. She was a member of a parish group 
called the Cheer Up Club where other shut-ins called each other. Let me 
tell you, the best ``Cheer Up Club'' I can belong to is right here in 
the U.S. Senate when we pass FDA reform to make sure that when a 
physician works with a patient or a family they are cheered because 
they have these new tools.
  Mr. President, I thank you for the time given to me to speak today. 
If I seem a little emotional, you bet. I love my family, as so many of 
us do, and this is why I so rely upon the American medical community 
and FDA to make sure that the best pharmaceutical, biological, and 
medical devices are available to the American people and also to the 
people of the world.
  I look forward to voting for final passage and having a conference 
report to bring back.
  Mr. JEFFORDS. I thank the Senator from Maryland for a most eloquent 
and moving personalized statement, as well as her efforts that have 
gone on to improve the FDA for all of us.
  Mr. KENNEDY. Mr. President, I also join in expressing great 
appreciation to the Senator from Maryland in terms of the FDA reform.
  She speaks very eloquently, passionately, and emotionally about the 
family's personal experience with the breakthroughs of modern medicine 
and what it can mean to those afflicted by the scourge of so many of 
these diseases.
  I must say I join with Senator Jeffords in saying that no one on the 
committee has been as tireless in pursuit of FDA reform as the Senator 
from Maryland. As a tireless advocate for FDA, she has brought great 
knowledge and understanding to achieve the goals that she has outlined 
here and I think all of us pay tribute to her.

  I want to thank her, as well, for commenting positively on the work 
of the people at the agency. There are many individuals at FDA who 
could, at the drop of a hat, go to the private sector and other areas 
and be better off financially. But who, because of their commitment to 
the public, are trying to do a job they believe in and are willing to 
serve the public.
  Ms. MIKULSKI. I thank the Senators from Massachusetts and Vermont for 
their very kind comments.
  I also thank you for the cooperation of your staff, and wish to 
acknowledge the role of Lynne Lawrence and Roberta Haeberle.
  But let's get FDA the right staff that they need.
  Mr. JEFFORDS. Mr. President, before yielding to the Senator from New 
Hampshire I would like to say he has spent as much or more time than 
anyone on this legislation and has had the very difficult chore of 
working in this very controversial area of uniformity. It is so 
essential that this Nation have uniformity so that when they buy a 
product they can know with the assurance of the FDA that the product 
they are getting is one that will be safe and helpful. Many, many hours 
the Senator has spent working on this issue, as well as the bill 
generally. I praise and thank him.
  Mr. GREGG. I thank the chairman of the committee.
  Mr. JEFFORDS. I yield such time as the Senator from New Hampshire 
desires.
  The PRESIDING OFFICER (Mr. Roberts). The Senator from New Hampshire.
  Mr. GREGG. I wish to join with others in stating my admiration for 
the chairman's efforts here in getting this bill forward. He 
understates his role if he thinks somebody has worked harder than he. 
He is clearly the person who has put the most time in this and 
developed an excellent bill.
  That is the point. The bill reported out of the committee came out of 
the committee with a huge vote, 14-4, a very definitive statement by 
the committee which has a fair number of experts, one of whom you just 
heard, Senator Mikulski from Maryland, on various parts of this bill, a 
fair number of experts who understand the importance of bringing the 
FDA into the 21st century.
  Why is it important? I think the statement has been made over and 
over again here in the last few days, but I think it needs to be made 
again. The fact is this involves people's lives. We have spent a lot of 
time on this bill and we have had a lot of votes on this bill. We had 
an 89-5 cloture vote on September 5; a 94-4 cloture vote on September 
17; and yesterday, a 98-2 vote in favor of the bill. At some point, 
people should be willing to say enough is enough. It was inappropriate 
to delay this bill as much as it has been delayed.
  This is about people's lives. The capacity to get these drugs out, to 
get these devices out, to give people the ability to use these various 
pharmaceutical treatments and various device treatments which are in 
many instances going to save lives and in almost all instances going to 
improve lives, is critical.
  I have a situation in New Hampshire. An attorney named John Hanson 
wrote to me about a friend of his who, regrettably, has ALS, or Lou 
Gehrig's disease. This is a horrible disease. It is a disease that eats 
away at your capacity as an individual to function. Although your mind 
stays sharp, the rest of your body fails. Every day that goes by is a 
critical day to this individual, every day that goes by.
  Now, the FDA had a product before it called myotropin which is 
waiting for approval. The people who have ALS are very interested in 
getting this drug, but they can't get it because the FDA has taken the 
position that it is not yet available on the market.
  Why is that? It is because of this long lead time of bureaucratic 
activity that is the wrap-up period for the approval of drugs. 
Regrettably, as a result of that long lead time, which can be years and 
years and years, many people are unable to get these drugs which are so 
important to them. In a case like ALS, of course, it really is the 
individual who should have some option in being able to choose whether 
or not to use a drug. That individual has a pretty stark choice before 
them--die as a result of the disease you have; or maybe have a chance 
of surviving as a result of taking a drug which maybe has not had years 
of review but has only had a few years of review.

  So the issue is how do we get the FDA to approve these drugs, approve 
these devices in a prompter manner, in a manner which doesn't give up 
any of the need for making sure that the drugs are safe and that they 
work, making sure that the devices are safe and that they work, but 
does give up the bureaucracy which has for so long and so often stifled 
a prompt review process.
  So this bill which the Senator from Vermont has brought forward today 
really does attempt to overcome what you might call the culture of 
overcautiousness which has become, regrettably, the culture of the FDA. 
It is an attempt to say to the FDA in a very definitive way, listen, we 
understand the importance of what you do, we understand that you are 
sincere and committed individuals. But we also understand there is 
another part of this formula that is called getting the drugs to the 
patients, getting the devices to the patients.

[[Page S9814]]

  So, let's start working as a team to get these things out quickly. To 
accomplish that, a number of proposals were put forward to make the FDA 
work more effectively and make the drugs and devices which are 
distributed across this country more understandable in their usage and 
also more readily available when they work.
  We have heard a lot of discussion, of course, about section 404. I 
note that the Senator from Massachusetts has another group of lists up 
there on section 404 of people involved in this issue. One thing that 
has been mentioned is that this new section 404 may in some way be tied 
into the fen/phen issue. Well, it is not. Section 404 is a device 
section. It is not a drug section and does not apply to drugs or drug 
manufacturers. Using that as an example, which just recently occurred, 
is truly a red herring. The purpose of section 404 obviously is to try 
and get these devices out in a more prompt and efficient manner.
  Now this language was put together after a lot of work and a lot of 
negotiation, a lot of discussion, with all the different parties 
involved. I know the Senator from Vermont was actively involved, the 
Senator from Indiana was aggressively involved. My sense is that 
everybody who had a legitimate concern about section 404 had a fair 
hearing before the committee, and the committee decided that the 
compromise language which was put in the bill--and believe me, it was 
compromise language--on section 404 was the most effective and 
appropriate way to go. The committee decided it by a 14-4 vote.
  I hope this Congress and this Senate specifically would give 
considerable respect to the efforts that were made at the committee 
level on this specific issue. I do think in this instance the Senator 
from Massachusetts is just plain wrong. His position is not consistent, 
in my opinion, because he has brought in debate over drugs with the 
medical device issue, but more importantly, it is not the position 
which was adopted by a vast majority of the members of the committee, 
because we understood the importance as a majority in the committee, 14 
people who voted for this, of getting out some major reform in the FDA 
laws which would allow for a prompter approval process without giving 
up any of the issues of safety or effectiveness of the drugs or the 
devices that are being involved here.
  I congratulate the Senator from Vermont again for moving forward. It 
appears we may actually be getting to the end of the day on this bill 
relative to passage. I hope we would not see any more of this delay 
tactic as we move down the road because every day that gets delayed 
potentially costs a life, and certainly causes people who need these 
drugs, need these devices, a tremendous amount of anxiety on top of a 
situation which in almost every instance is already filled with 
extraordinary anxiety because of the type of disease or problem they 
have. So let's get on with doing the business of the Senate and pass 
this bill.

  Mr. JEFFORDS. Mr. President, I want to take a moment to thank the 
Senator from New Hampshire again for the incredible amount of work he 
has done, and I hope we heed his advice.
  I yield the floor.
  Mr. KENNEDY. Mr. President, I yield as much time as he needs to the 
Senator from New Mexico.
  The PRESIDING OFFICER. The Senator from New Mexico is recognized.
  Mr. BINGAMAN. Mr. President, I thank the Senator from Massachusetts 
and I wish to speak as in morning business for up to 10 minutes.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (The remarks of Mr. Bingaman pertaining to the introduction of S. 
1210 are located in today's Record under ``Statements on Introduced 
Bills and Joint Resolutions.'')
  Mr. KENNEDY. Mr. President, we are moving on in the consideration of 
FDA reform. I would like to review where we are, where we have come 
from, and where I believe we ought to go on this important issue that 
is intimately tied to the public health and safety of the American 
people.
  I would just like to remind our colleagues and others about the 
importance of this agency. We will be debating about section 404 of the 
FDA legislation that is before us. It might sound like a small, narrow 
provision in a complicated piece of legislation, but its implications 
are profound in terms of potential impacts on the health and safety of 
millions of American people.
  Senator Reed, myself, and others have attempted to make the case that 
we are unnecessarily risking the health of the American people. We are 
doing this because we are effectively permitting false and misleading 
information to be placed on the labels of medical devices that are 
submitted to the FDA for review. We are doing this and at the same 
time, tying the hands of the FDA to look behind those labels and into 
the real purpose of the medical device. We are creating a loophole that 
will allow companies to submit their products under a protocol they 
know will allow for quick approval, but whose clear intention is to 
market the device for uses that are different from those they listed 
when they went through the approval process.
  Over the last few days, we have reviewed the most prominent example 
of this issue when we talked about the biopsy needle of U.S. Surgical 
Co. We discussed how they were able to get approval for the device by 
telling FDA that it was substantially equivalent to a device they 
already had on the market. But, in reality, the biopsy needle that was 
on the market excised an amount of tissue that was less than the size 
of the lead in a pencil, and the new device they submitted to FDA 
removes a piece of tumor that is 50 times larger than would be removed 
with the existing needle biopsy device.
  It is quite clear from the evidence that we are able to advance on 
the floor of the Senate, both the correspondence we received from 
doctors about marketing practices and a promotional videotape, that 
this device was being promoted for an entirely different purpose than 
the one U.S. Surgical listed on the label it submitted to FDA. Due to 
this maneuvering, we did not have the proper kind of safety information 
available to the principal agency of Government that is charged with 
protecting the safety and health of the American people.
  I cannot understand why we, by way of this legislation, are denying 
that Federal agency the opportunity to adequately protect the American 
people. And it isn't just me, 35 other Members of the Senate, more than 
a third of the Senate, indicated a similar position with their votes 
yesterday. Virtually all of the consumer groups are with us as well.
  I have illustrated on this chart some of the organizations that are 
working to protect patients, that listen to patients, and that 
understand the need of patients, and that stand with us on this issue. 
They are virtually unanimous in their concern about this particular 
provision.
  I have in my hand articles about the FDA which have been published 
over the period of the last 2 days. This is an agency that is on the 
cutting edge of many health-related issues. It is charged with many 
different responsibilities that have enormous impacts on the lives and 
well-being of American people.
  Here we have on September 22 a major article: ``Doctors want approval 
to inject themselves with live virus''--HIV. This will be a decision 
the group will seek approval. From whom? From the FDA.
  Here is another--``FDA sets rules on supplemental labels.'' The FDA 
published final rules yesterday aimed at making * * * manufacturers put 
more information on labels.
  Why are they doing that? To protect the American public. They have 
responsibilities for that.

       FDA acts to get more women in drug studies. That is very 
     appropriate and very important to do.
       FDA moved [yesterday] to force drug companies to stop 
     excluding young women from studies of promising new medicines 
     out of fear they will get pregnant, curbing the research.

  And, again:

       FDA told the drug companies to include women in all stages 
     of drug tests.

  Then it goes on about the importance of having women represented in 
drug trials so we can understand how they will affect women. That can't 
be learned from studying the effects on men because of the metabolic 
and other differences between men and women.
  Here is another example of FDA looking out after public health 
issues, and the impact of pharmaceuticals on our population.

[[Page S9815]]

  On September 23 here is the long story in the New York Times.

       Thirty-seven years later, a second chance for thalidomide. 
     Officials at the agency announced today they intend to 
     approve thalidomide for use in leprosy patients, as long as 
     the New Jersey . . . company seeking market approval adheres 
     to conditions, including elaborate restrictions intended to 
     keep the drugs away from women who might be pregnant.

  Here is the FDA looking after what? Looking after a possible cure for 
leprosy and making sure that women who are expecting are protected from 
thalidomide.
  What is the role of the agency? Looking after the women and 
children--looking at trying to find some cure for leprosy.
  What is another role of the FDA? Trying to make sure that all members 
of our population are included in the review of various 
pharmaceuticals.
  Here is a story on E. coli bacteria. We remember the stories across 
the country a little over a year ago and the dangers that were posed in 
terms of the health of the American people. This has no direct 
connection with the issue surrounding FDA reform except that it, too, 
comes against a background of years of determination, --the ``meat 
industry and anti-regulatory forces to block long overdue improvements 
in the way the Government monitors the meat safety.''

  Here is an example of an editorial advising us to be cautious in our 
rush to regulatory reform. Let's not override safety.
  That is what this editorial is about--the same message we are 
delivering today--in our rush to reach these thoughtful and important 
reforms, let's not override safety.
  This editorial involved a different issue--E. coli and meat products. 
It may be E. coli today, but it may be an unsafe medical device 
tomorrow.
  Again, on the 23d, FDA. The approval of thalidomide, lawsuits filed 
against the fen/phen, and many other articles. The FDA published a rule 
on the 23d--from the Washington Post:

       Final rules aimed at making supplemental manufacturers put 
     more information on the labels. The rules restrict the use of 
     the term ``high potency,'' requiring products such as 
     vitamins, minerals, herbs, and amino acids to be labeled as 
     dietary supplements and labeled also to provide information 
     about serving size.

  What is the agency doing in each of these cases that made the 
newspapers over the past few days? Protecting the American public. In 
each and every example that we have cited FDA is trying to protect the 
American public on a wide variety of issues.
  We are talking today about doing the same thing with regard to 
medical devices, protecting the public from false and misleading 
labels. That is the issue. It is not the only issue, but the Senator 
from Massachusetts, the Senator from Rhode Island, for the patient 
advocacy and consumer groups, it's the primary issue. There hasn't been 
a single patient advocacy group that has been advanced by those that 
are opposed to our position here during the course of this debate. Not 
one. Why? Because they cannot find any. Why? Because this provision is 
a direct threat to the health and safety of the American consumers. And 
virtually every group that has studied it, that has reviewed it, 
understands that.
  That is where we are. We want to let the American people know the 
importance of the FDA. Let them know how it is out there trying to 
provide protection for the American people. That is what we believe 
should be the case on the provisions that we have been discussing here, 
with section 404.
  Because of the Senate vote yesterday tabling the Reed amendment, the 
FDA reform bill still includes the provision that seriously threatens 
the public health--the provision that must be removed before this 
legislation becomes law. This provision encourages device manufacturers 
to lie to the FDA and forces FDA to approve medical devices that have 
not been adequately tested to assure that they are safe and effective. 
Weeks ago, the Secretary of HHS identified this provision as one that 
would lead her to recommend a veto if it were not removed. Despite what 
some of my colleagues say, this is not a new issue. The Secretary 
identified it last June, identified it again in July, and identified it 
again in September as one of the administration's principal concerns.
  It is virtually the only technological issue that remains to be 
resolved on this bill. Every major public health and consumer 
organization that has taken a position on this provision strongly 
opposes it.
  While the Reed amendment was defeated yesterday, I anticipate the 
bill itself will be adopted by the Senate today. This is not the end of 
the story. There are many procedural steps that must be taken before 
the bill becomes law, including action by the House, reconciliation of 
the bills passed by the House and Senate, and the signature of the 
President. There will be many more opportunities for debate before this 
bill can even go to conference. I believe that in the end the public 
interest will prevail.
  I intend to discuss this provision during the course of today's 
debate on the bill. I would like to begin by reviewing the reasons we 
embarked on an FDA reform bill in the first place and how much we have 
been able to improve the original bill.

  As I mentioned earlier, there are few more important agencies of the 
Federal Government than the Food and Drug Administration. The FDA is 
responsible for assuring that the Nation's food supply is pure and 
healthy. The FDA provides a guarantee that the drugs and devices we 
rely on to cure or treat diseases are safe and effective. It wasn't 
always that way. Medical device legislation was adopted in the mid-
1970's.
  If it does its job well, the FDA can speed medical miracles from the 
lab bench to the patient's bedside. And if the agency does its job 
poorly, it can expose millions of Americans to unsafe or ineffective 
medical products and jeopardize the safety of our food.
  The record of the FDA in moving these various medical devices through 
the process and moving them from the manufacturer onto the market is 
improving. We have seen significant and dramatic improvement over the 
period of the last 3 years. In the premarket notification process known 
as 510(k), which about 95 percent of all the medical devices come 
through, the median review times have dropped from 199 days to 93 to 85 
days, meeting the standard of 95 percent of all of those submitted. 
That is extraordinary progress. And for the more complicated, newer 
devices, the breakthrough kinds of devices, which account for only 5 
percent of submissions, review times have been reduced to about 40 
percent of the time between 1993 and 1996.
  This is the record. That is why there is within the medical device 
industry, general support for the steps taken by the agency.
  Here is the Medical Device and Diagnostic Industry magazine of this 
year.

       With improvements in FDA product review performance, 
     despite a more challenging domestic market, device companies 
     are more optimistic than ever. Company executives report a 
     substantial improvement in FDA performance, particularly in 
     510(k) product approval times.

  This is the Medical Device and Diagnostic Industry magazine 
commenting on the performance of the FDA in terms of its approval 
ratings.

       This year's survey of medical device manufacturers marks 
     the highest business climate ratings ever.

  Here we have the industry magazine talking about how effective the 
FDA is in moving these devices through the process expeditiously. And 
now, even with this information, we are undermining the ability of that 
agency to provide adequate protections for public health and safety.
  (Mr. COATS assumed the chair.)
  Mr. KENNEDY. If the agency was not doing a good job, if we were 
seeing these bureaucratic delays denying patients products, at least 
there would be an arguable position. But what we are talking about here 
is the industry's own assessment about the effectiveness of the agency. 
They are pointing out how hopeful and optimistic they are about the 
recent performance of the agency in quickly approving devices.
  Not only have they made progress in moving them expeditiously, but 
now a number of the medical manufacturers want to diminish the existing 
power of the FDA to assure proper safety. The American people must ask 
why. We do not have the kind of problems that we had years ago with the 
Dalkon shield and the Shiley heart valve. We do not have the kinds of 
problems that we had

[[Page S9816]]

with earlier medical device tragedies. What we have now is an excellent 
record of safety and effectiveness with devices, and it is against that 
background we find some in the medical device industry want to make it 
even more profitable for themselves, and to do so at the risk of the 
public.
  Continuing along with the survey:

       The overall results of the survey indicate widespread 
     satisfaction with the medical device business climate. A 
     substantial majority of the survey respondents characterized 
     business conditions for the device industry as good to 
     excellent. One important cause of this year's improved 
     outlook is perceived improvement in relationships with the 
     FDA. The declining complaints about the agency mirror the 
     increase in positive business outlooks. Much of this 
     improvement is no doubt due to the dramatic decrease in the 
     last 2 years of 510(k) product approval times which the FDA 
     has made a lead focus of its internal reforms.
       Ray Larkin, President and CEO, Nelcor, Purett & Bennett, 
     Pleasanton, CA, underlines the extent of the improvement of 
     the FDA: ``As critical as I may have been a year ago, I think 
     they have made significant improvements in the product 
     approval and the compliance side. The whole regulatory 
     environment is improving.''

  This is what industry itself is saying about the FDA. This is not 
just those of us who are opposed to this particular provision. This is 
the industry itself. How many times have we heard, ``If it is not 
broke, why fix it.'' And here we have the wide approval by the 
regulated industry itself. And yet some here in this body want to 
deride this progress and put the American public at risk by denying the 
agency the ability to review important information about safety and 
effectiveness when the information on the label is false and 
misleading.
  And here is Medical Economics of this year.

       The demand for devices has created a worldwide market of 
     $120 billion including $50 billion in the U.S.

  That's growing by 8 percent annually.
  A healthy industry, thank goodness, because I think all of us know 
the importance of these medical devices when they are safe and 
effective. But we have to make sure they are safe and effective. We do 
not want to compromise the current superb safety record.
  An extensive study was conducted by the Medical Device Diagnostic 
Industry magazine this year that showed that the executive rating of 
device industry business is at an all-time high--58 percent favorable, 
11 percent unfavorable. ``Expectations of the medical device business 
conditions.'' The best that it has been in any time in recent years. 
All the measures indicating that the medical device industry is doing 
well, that the public is being served, safety is being addressed.
  Even with regulatory protections for safety, the speed with which 
these devices are being approved has been improved, nonetheless we are 
being asked to alter those conditions. We are being asked to handcuff 
the FDA from being able to look at that medical device that may meet 
the safety standard substantial equivalence but it clearly intended to 
be used and marketed for another purpose. A purpose for which safety 
and effectiveness data have not been gathered or evaluated.
  Let's get back to the fundamentals. The main purpose of the FDA 
reform bill was to reauthorize the Prescription Drug User Fee Act of 
1992 known as PDUFA. PDUFA is one of the most effective regulatory 
reform programs ever enacted. Under PDUFA, the pharmaceutical industry 
pays the user fees that cover part of the cost of FDA's drug approval 
and regulatory functions. And with these additional resources the FDA 
has been able to hire additional personnel so that drugs can be 
reviewed more promptly. As important as these additional resources 
were, equally important were the specific performance targets for 
speedier drug review negotiated between the industry and the FDA as 
part of the PDUFA agreement.
  This is where the industry, working with the agency, said, well, if 
we give support for this and it becomes law and they get the additional 
resources to hire the personnel, can we reach these target timeframes 
for approval, and the agency agreed to that. And we had extraordinary 
accountability. We found a 90 to 95 percent compliance with those 
goals. The industry establishing the support for the PDUFA fee resulted 
in important and dramatic progress made. The combination of performance 
targets, additional resources, and the leadership of Dr. Kessler, the 
former FDA Commissioner, has created a regulatory revolution at the 
FDA.
  Listening to some of the speeches we have heard during the course of 
this debate, you would think the FDA was a regulatory dinosaur mired in 
the past, cumbersome and bureaucratic, imposing unnecessary and costly 
regulatory burdens on industry and denying patients speedy access to 
lifesaving drugs.
  That is a myth that those who want to destroy the FDA in the interest 
of an extreme ideological agenda or in the interest of higher profits 
and at the expense of the patients, would love you to believe. It is 
not true. The FDA's regulatory record is the envy of the world, and it 
sets the gold standard for protection of patient health and safety.
  Over the last few years, in partnership with Congress and the 
administration, the FDA has responded to growing criticisms of delays 
in approving new products by taking impressive steps to improve its 
performance. The Prescription Drug User Fee Act of 1992 was one of the 
most effective regulatory reform programs ever enacted. The bill 
established a new partnership between the industry and the agency. The 
industry agreed to provide the additional resources. The agency agreed 
to a measurable performance standard to speed the review of products, 
and every goal set by the legislation has not only been met but been 
exceeded.
  So today the FDA is unequaled in the world for its record in getting 
new drugs to market quickly, without sacrificing patient protection. In 
fact, last year average review times in the United States were twice as 
fast as in Europe. Fifteen new drugs were approved in both the European 
Union and the United States. In 80 percent of the cases, the United 
States approved the new drugs either first or at the same time as the 
European Union. More companies chose the United States for the 
introduction of breakthrough drugs than any other country.
  That is the current record. In addition to speeding the review times, 
the FDA has taken far-reaching steps to reduce unnecessary burdens on 
industry and modernize its regulatory processes. More needs to be done, 
but these steps have added up to a quiet revolution in the way FDA 
fulfills its critical mission. When the prescription drug user fee was 
originally passed, the device industry refused to agree to the user 
fees that would give the FDA additional resources and performance 
standards that have contributed so much to the agency's outstanding 
record on drugs and biologics. But even in the device area, the recent 
FDA achievements have been impressive.
  I think it is fair to say that following passage of PDUFA, the 
primary priority of the FDA was to implement that commitment and 
contract with the pharmaceutical industry. And I do think that the 
agency gave that a higher priority than it did moving ahead in terms of 
the medical devices.

  I think that is probably a fair criticism. But once PDUFA had been 
effectuated, the priorities shifted to the medical device industry.
  I remember the debate on PDUFA quite clearly. I welcomed the 
opportunity to join with my colleague, Senator Hatch, and others in the 
adoption of PDUFA, and I remember the efforts we made in the area of 
the medical device industry to do exactly the same thing. But we were 
unable to get the device industry to agree to that. I think it is 
unfortunate. Any fair evaluation in terms of the FDA in looking over 
the period of the time since the passage of the PDUFA, the changes in 
the way that the agency worked in advancing and accelerating the 
consideration of pharmaceuticals and biologics would understand that 
they get the priority. It has been only in recent years that the device 
industry has received attention, with the results which I mentioned 
just a few moments ago.
  The so-called 510(k) application devices, which are approved on the 
basis of substantial equivalence to a device already on the market, 
account for 95 percent of the device submissions. The FDA has virtually 
eliminated its backlog. Last year it reviewed 94 percent of these 
devices within the statutory timeframe compared to 40 percent just 4 
years ago--dramatic improvement. And we haven't compromised safety in 
the process. Why are we now attempting to undermine the health and the

[[Page S9817]]

safety of the American public? Why are we risking it?
  Mr. President, even in the area of class III devices, which is where 
most problems remain, the FDA has improved its performance 
substantially. According to a study by the GAO, median review times 
dropped 60 percent between 1991 and 1996. A recent survey of device 
industry executives reported that the business climate for the industry 
is the best in a 5-year history of the survey. The sponsor of the 
survey attributes the favorable response in large measure to the 
improvements at FDA and concludes:

       The agency has not only reduced the product approval delays 
     that slowed new product introductions, but, perhaps more 
     importantly, has also greatly reduced both executives' and 
     investors' uncertainty about the timeliness of future product 
     introductions.

  That is the conclusion of the General Accounting Office. That is not 
the conclusion of those of us who are trying to say look, the system is 
working, the devices that are getting into the FDA are being approved 
in record time, they are getting out to benefit the people and we have 
a solid safety record.
  We are being asked here to walk away from that safety record. We are 
being asked here, for the first time since we passed serious medical 
device legislation 25 years ago, to take steps backward in the area of 
protecting the American public.
  In a recent FDA report, the agency sets new targets for even quicker 
review of the class III devices while still giving assurances that we 
are going to continue to protect the public. The agency is doing a good 
job now. It will be doing an even better job in the future. There is no 
justification for weakening the FDA power to protect the public--not 
based on the myth that it is denying patients prompt access to needed 
new products.
  If you listened to this debate for the past days, the other side's 
description of the FDA may have been accurate 5 years ago or 10 years 
ago, but does not reflect where the FDA is today. And that is not just 
my opinion, but it is what we hear from the General Accounting Office, 
and what we have the industry itself saying.
  The most important aspect of this bill is the reauthorization of 
PDUFA. The new PDUFA program was negotiated between the FDA and the 
industry. It expands existing programs by setting additional 
performance standards and puts special emphasis on expanding early 
cooperation between the FDA and industry so the drug development 
process, not just the regulatory process, can be stepped up. The agency 
has been creative in anticipating the possibility of major new drug 
breakthroughs. They have been working with the industry in new ways to 
help shape and formulate the way the industry effects its application 
so it can be approved in more expeditious manner. This is because we 
are not just interested in drug approvals but also development times.
  We had a long debate about how we were going to reduce the number of 
days: 180, 360, 120, or 90 days--for the approval on these various 
issues. That was taking our eye off the ball. What is important is 
development time. In our own review of FDA, what makes the most 
difference reducing total approval time is reducing development time. 
The agency has been doing really excellent work. In addition to PDUFA, 
there are a number of other provisions changing the way the agency does 
business, particularly in the area of medical devices. As originally 
introduced, the bill included many extreme provisions that posed 
significant threats to public health. It was important that these 
provisions be modified before the legislation could be allowed to move 
forward. I compliment Senator Jeffords and the other members of the 
committee, Republicans and Democrats alike, on their willingness to 
compromise on these unacceptable proposals over the months we worked on 
the bill. I would like to review a number of these provisions for the 
Members of the Senate so they understand the changes this legislation 
makes and the pitfalls that have been avoided. These compromises must 
not be undone as the bill moves further through the legislative 
process. I am proud the progress that has been made. We have reached 
constructive compromises on more than 20 items.
  I have here the letter that was sent to the chairman by the Secretary 
of Health and Human Services in June, June 11, as the committee was 
considering the FDA reform. In this, the Secretary mentions, 
``Unfortunately, the Chairman's substitute to S. 830, also includes a 
number of provisions which as drafted do not reflect consensus and 
about which I have very significant concerns.''
  I will not take the time of the Senate now to review those. But 
basically they include some 20 different provisions. I ask unanimous 
consent to have those printed in the Record.
  There being no objection, the letter was ordered to be printed in the 
Record, as follows:

                       Secretary of Health and Human Services,

                                    Washington, DC, June 11, 1997.
     Hon. James M. Jeffords,
     Chairman, Committee on Labor and Human Resources,
     U.S. Senate, Washington, DC.
       Dear Senator Jeffords: For the past several months the 
     Administration has been working with the Senate Labor and 
     Human Resources Committee on legislation to improve the 
     performance and accountability of the Food and Drug 
     Administration (FDA or the Agency), while preserving and 
     enhancing the Agency's ability to protect and promote the 
     public health. I appreciate the efforts that you, Senator 
     Kennedy, and the other members of the Committee have made in 
     this regard and believe that considerable progress has been 
     made toward these goals.
       The Food and Drug Administration Modernization and 
     Accountability Act of 1997, S. 830, includes approximately 20 
     provisions that represent significant consensus reforms. 
     Among the provisions that we all agree on are those that set 
     forth the Agency's mission, codify reforms to the regulations 
     of biotechnology products, provide expedited authority for 
     the adoption of third party performance standards for device 
     review and for the classification of devices, and streamline 
     submission requirements for manufacturing changes and 
     marketing applications for drugs and biologics.
       I must emphasize that these provisions represent very 
     significant reform, on which all parties have worked hard to 
     reach consensus, and which I hope will not be jeopardized by 
     insistence on other provisions on which we have not reached 
     agreement.
       Unfortunately, the Chairman's substitute to S. 830, also 
     includes a number of provisions which as drafted do not 
     reflect consensus and about which I have very significant 
     concerns. Also, the current version is not ``balanced'' in 
     that it does not take advantage of significant opportunities 
     to strengthen current law so FDA can more effectively protect 
     the public health. The most significant of the non-consensus 
     provisions, summarized on the enclosed list, would undermine 
     the public health protections that the American people now 
     enjoy, by: (1) lowering the review standard for marketing 
     approval; (2) allowing distribution of experimental therapies 
     without adequate safeguards to assure patient safety or 
     completion of research on efficacy; (3) allowing health 
     claims for foods and economic claims for drugs and biologic 
     products without adequate scientific proof; (4) requiring 
     third party review even for devices that require clinical 
     data; and (5) burdening the Agency with extensive new 
     regulatory requirements that will detract resources from 
     critical Agency functions without commensurate enhancement of 
     the public health. Another significant nonconsensus item is 
     the set of adjustment provisions in sections 703 and 704, 
     which together require significant increases in FDA's 
     appropriations levels over FY 1998 through 2002 (almost $100 
     million above the FY 1998 Budget with levels rising 
     thereafter). We recognize that the ability of the FDA to 
     commit to specific performance goals under PDUFA depends on 
     the resources it will have available. We would support a user 
     fee proposal that is consistent with our FY 1998 Budget 
     proposal, but we are concerned that the proposal to collect 
     user fees in this legislation imposes additional pressure on 
     the fixed level of the discretionary resources agreed to 
     under the Bipartisan Budget Agreement.
       We note the inclusion of the provision on pediatric 
     labeling in the most recent version of the Committee mark. We 
     believe it should be revised to assure a more appropriate 
     system for testing drugs for pediatric use before they are 
     prescribed for children.
       I want to commend you and members of the Committee on both 
     sides of the aisle on the progress we have made together to 
     develop a package of sensible, consensus reform provisions 
     that are ready for consideration with reauthorization of the 
     Prescription Drug User Fee Act (PDUFA). We are interested and 
     prepared to continue working with the Committee to reach 
     consensus on additional issues--and have proposed acceptable 
     alternative approaches to many of the objectionable 
     provisions. My concern is the time for reauthorization of 
     PDUFA is running perilously short. As I indicated in my 
     recent letter to you, I am concerned that the inclusion of 
     non-consensus issues in the Committee's bill will result in a 
     protracted and contentious debate. This would not serve our 
     mutual goal of timely reauthorization of PDUFA and passage of 
     constructive, consensus bipartisan FDA reform.

[[Page S9818]]

       A copy of this letter is also being sent to the ranking 
     Minority member, Senator Kennedy, and the other members of 
     the Senate Labor and Human Resources Committee.
           Sincerely,
                                                 Donna E. Shalala.
       Enclosure.


                     s. 830 (Chairman's Substitute)

     A. Major Concerns:
       1. Cumulative Regulatory Burdens/No Provisions to Promote 
     Public Health.--Many new regulatory burdens are being imposed 
     on FDA (list enclosed) and little that can be advanced as 
     promoting public health.
       2. Third Party Review of Devices (Sec. 204).--Expansion of 
     FDA's existing pilot project for review of medical devices 
     (includes devices that require clinical data) by 
     organizations accredited by FDA.
       3. Approval Standard for Drugs/Biologics/Devices (Secs. 
     404/409/609/610/611/619).--Effectiveness standard for drugs 
     and biologics needs further clarification; for supplements 
     (applications for new uses) lowers standard such that they 
     might not ever require a single investigation; limits FDA 
     authority to evaluate clinical outcomes for devices; and 
     lowers approval standard for radiopharmaceuticals, including 
     PET drugs.
       4. Health Claims For Foods (Sec. 617).--Health claims not 
     approved by the FDA but consisting of information published 
     by authoritative government scientific bodies (e.g., NAS or 
     NCI) would be permitted for use by companies in the labeling 
     of food products, even if it is very preliminary.
       5. Expanded Access to Investigational Therapies (Sec. 
     102).--Would allow drug and device companies to sell an 
     investigational product for any serious disease or condition 
     without FDA approval and without appropriate protections for 
     clinical investigations.
       6. Device Modifications (Sec. 601).--Would allow companies 
     to make manufacturing changes that affect a device's safety 
     and effectiveness without FDA agreement.
       7. Health Economic Claims (Sec. 612).--Would allow industry 
     to discuss health economic claims given to managed care 
     organizations under a lower evidentiary standard and without 
     FDA review, even if the claim compared the safety or efficacy 
     of two drugs.
       8. Pediatric Labeling.--Would provide an incentive of six 
     months of market exclusivity to encourage pharmaceutical 
     companies to conduct necessary clinical trials for FDA 
     approval of their products for children; doesn't assure that 
     necessary labeling for children will be included; and might 
     undercut FDA's ability to use other means such as 
     regulations.
     B. Other Significant Concerns:
       1. Expanded Humanitarian Use of Devices (Sec. 103).
       2. Device Collaborative Determinations/Review (Secs. 301/
     302).
       3. Limitations on Initial Classification Determinations 
     (Sec. 407).
       4. Evaluation of Automatic Class III Designation (Sec. 
     604).
       5. PMS (Sec. 606).
     C. Currently In The Bill--No Language Provided Yet:
       1. Off-Label Use of Drugs (floor amendment expected).
       2. Drug Compounding (amendment expected).

  Mr. KENNEDY. They are listed here. There are 20 items, major concerns 
about the cumulative aspect of the regulatory burdens, the various 
kinds of advisory committees, the advisory committees and the 
regulatory burdens that would have added to the complexity, and even 
the process of considering new drugs. The basic concerns the 
administration had on features of the third-party review, the approval 
standard for some of the drug and biologic devices, limits that were 
put on the FDA to evaluate some of the clinical outcomes for devices, 
and the lower approval standards that were included in some radio-
pharmaceuticals.
  They had some concerns about the health claims for foods and expanded 
access to investigational therapies, which allow drug or devices 
companies to sell investigational products for any serious disease 
without FDA approval and without appropriate protections for clinical 
investigators. The device modification allowed the companies to make 
manufacturing changes that affected devices' safety and effectiveness 
without ever notifying the FDA; the health economic claims that would 
allow industry to discuss health economic claims given to managed care 
organizations under a low evidentiary standard and without FDA review.
  There was pediatric labeling, and the whole question on the 
humanitarian use of devices and collaborative determinations. There 
were also some concerns about off-label use of drugs, drug compounding.
  If you look at the improvements in the bill and the compromises 
worked out here, 19 of the 20 have been worked out to the satisfaction 
of HHS and the FDA. There may be some groups that do not feel that 
certain provisions are worked out adequately. But I am prepared to 
defend those compromises. There is only one that remains. That is the 
provision that we are addressing here. Whether we are going to permit 
false and misleading labeling on a particular product and deny the FDA 
the right to look behind that label in order to protect the safety of 
the families of America. There were 19 accepted, only one remains--but 
it is an important one.
  Why is it, if we are able to work out 19 of the 20, can't work out 
this one? The Senator from Rhode Island offered an excellent amendment 
yesterday saying, ``OK, we will go along with the existing language 
that is in the bill. But we will also add the language that nothing in 
the label will be false and misleading.'' False and misleading; that 
was defeated. Those Member who voted against it, I expect, will have to 
explain to their constituents why they would resist an amendment that 
said we should not permit the medical manufacturer to submit something 
false and misleading.
  Members are saying that this has been a long process that has taken a 
good deal of time. This measure was considered in the last Congress and 
now again in this Congress. We could have acted on these measures. We 
could have acted before June 11 and not dealt with any of the 
outstanding health and safety issues. But the fact of the matter is, we 
took the time, we listened to the arguments of the FDA and the 
Department of Health and Human Services, the people who are charged 
with protecting the American people. We worked out the 19 of the 20. 
Everyone gave a little, took a little, but 19 of those 20 have been 
worked out. Not this particular provision. It took time to work out 
those compromises. I think the time spent was well worth it. This is a 
much better bill than would have come out of that committee or on the 
floor in June or July or August, or even the early part of September.
  What were those steps that we took? First of all, we preserved the 
States' oversight of the safety of cosmetics. This compromise assures 
that the States will be able to continue to regulate the safety of 
cosmetics. The Gregg proposal in the underlying bill would have barred 
the States from any regulation whatsoever of cosmetics, even though the 
FDA has neither the authority nor the staff to regulate these products. 
The compromise allowed the States to continue their regulation unless a 
specific inconsistent regulation has been issued by the FDA in a 
particular area. We went through that debate. We found the examples, 
particularly with regard to the State of California, how they were able 
to protect their consumers. In some cases there were carcinogens in the 
products and the manufacturing company changed the formula and were 
able to get right back out there and produce the product and have 
record sales.

  The toluene that was in lipstick, which is related to another 
carcinogen that was related to some birth defects with children was 
altered and changed.
  We have had important studies that have been done up in Seattle, WA, 
at the University of Washington and other medical centers, about some 
of the potential dangers of use of talcum powder on small infants and 
its relationship to ovarian cancer.
  These were studies, scientific studies that were done by the States, 
that are directly related to protecting health and safety. The FDA does 
not provide for that kind of protection. Nonetheless, there was an 
effort to preempt States from protecting health and safety. We were 
able to defeat that. I think that was important. I believe the 
consumers in those States think so.
  Second, the safeguard for off-label use of drugs. This important 
compromise will allow companies to circulate reputable journal articles 
about off-label use of drugs but will ultimately enhance the public's 
health and safety because the FDA will be given the opportunity to 
review, comment on, and approve articles which the companies circulate. 
The compromise also requires the companies to undertake studies on the 
safety of their drugs for the specific off-label use and submit 
applications to the FDA for approval for their drugs for these uses 
within 3 years. That was not in the legislation prior to this 
compromise. We saw the steps that were taken to meet the safety 
standards.

[[Page S9819]]

  Currently, companies are circulating articles without reviewing them 
for off-label use, without seeking review or approval by the FDA, and 
without conducting the studies which would lead to an ultimate FDA 
approval or disapproval of the drug.
  We wanted to make sure that the companies were going to conduct the 
safety standards for the use of those particular drugs. We were able to 
work that out. Again, to protect the American public.
  Expanding access to drugs for patients and fast track approval. The 
fast track approval--this is one of the most important new initiatives 
in the legislation--will provide the same streamlined availability for 
drug treatments for patients with any life-threatening disease now 
available to patients with cancer or AIDS. It is a major breakthrough 
for patients who have life-threatening diseases.
  We were moving through the measures in the bill and pointing out in 
June of last year that the Secretary of HHS identified 20 major areas 
that we ought to review and work through in trying to accommodate some 
of the health and safety concerns.
  Effectively, we have resolved 19 of those. The only unresolved 
matter, according to the letter from the HHS, is the provision on 
section 404.
  What I was trying to do is to point out a number of these areas where 
we have made important progress and to mention the safety provisions 
that had been worked out and included in a bipartisan way.
  I was mentioning the expanded access to drugs for patients on the 
fast-track approval. We have had more than 17 different pharmaceuticals 
or drugs that have been identified for fast-track procedure. We are 
taking what has been the practice of the FDA and actually demonstrating 
by legislation, the importance of this particular procedure. We are 
trying to make the progress available to all those that have life-
threatening diseases by giving authority to those researchers who 
believe the opportunities for fast-tracking these various 
pharmaceuticals will benefit the American public.
  That has been successful for AIDS and cancer, and now we are 
encouraging its use for other life-threatenting conditions.
  We have also expanded access for drugs under investigation for 
patients who have no other alternative. So an individual who might not 
otherwise qualify for various clinical trial protocols can get access 
to a drug if they have no other alternative. If this is the last gasp, 
the last hope that they will be able to have access to some of the 
modalities that might not have been particularly identified for this 
particular illness or sickness but their medical professionals believe 
they should have access, and we are moving in that direction. I think 
that gives a degree of hope to many of those who really wonder if they 
have any hope at all in trying to get some of the modern kinds of 
breakthrough drugs
  We have accepted the Snowe-Feinstein piece of legislation that will 
give individuals who have a particular life-threatening illness or 
sickness the opportunity to tap into the NIH database to find out what 
clinical trials are taking place. This is a very, very important 
additional provision, and I commend our Senators who are not on the 
committee but who have been interested and involved in this. That is 
very, very important.

  Mr. President, another area that we reviewed is the streamlining of 
the FDA procedures. The concern initially was in the areas of 
contracting out of various functions of the FDA. We talk about not only 
timeliness but also about the importance of preserving quality. We have 
to make sure that we are not only interested in timeliness, but we are 
also concerned about the quality.
  We have also, in this streamlining of the FDA procedures, worked out 
how we were going to try to review third-party review. That was worked 
out in a way which I think has virtual broad support. It permits 70 
percent of all the devices that would be eligible to be reviewed. But 
in the areas that are the very significant higher level of class II--a 
limited number of class II and class III will remain outside of that 
particular protocol so that we will have a chance to review the results 
of the research that will be done. We have accelerated the time for 
that review, so the information will come back in quicker and we will 
be able to evaluate the results of that particular process.
  Mr. FRIST addressed the Chair.
  The PRESIDING OFFICER (Mr. Thomas). The Senator from Tennessee.
  Mr. FRIST. It is a real pleasure for me to take a few moments and 
reflect on my interpretation of where we are today and the significance 
of the bill that is before us.
  It was 1938, not that long ago, that Congress passed the Food, Drug 
and Cosmetic Act. And at that time the primary mission was defined 
fairly clearly to be to protect the public health by safeguarding 
Americans from unsafe and ineffective products.
  Over the past 60 years, the FDA has truly done an excellent job on 
the whole in fulfilling this mission to make sure that food is safe and 
wholesome and that drugs and medical devices are safe and effective for 
treating disabilities and the diseases that have plagued us over the 
years.
  You can look back and cite numerous, numerous examples that recall 
the FDA's important role, their vigilance in protecting the American 
public from unsafe drugs. Think back to Thalidomide. We think back to 
the FDA's quick response to the Tylenol tampering case as evidence of 
the effectiveness that that very important Government entity plays that 
affects each of our lives in ways that many of us do not realize.
  But during this same period of time, the United States has been the 
most innovative nation in the world, particularly in the arena of 
medical research. I think back to my dad, who is 86 years of age, who 
practiced medicine for 55 years. I remember when I was a very young boy 
traveling with him as he would make house calls, and now to think how 
much things have changed over that period of time in terms of 
antibiotics, antiviral agents, vaccines, treatments for diseases that 
when I was a child were devastating to large populations. You look at 
hepatitis B, chicken pox, polio, many forms of cancer, the list goes on 
of what we can treat today.
  We have developed important new surgical procedures. As a surgeon who 
has been in the medical field for the past 20 years, I have had the 
real privilege to watch fields unfold that were nonexistent even when I 
was in medical school. I think of certain types of tissue transplants, 
lung transplants, which I was doing routinely before coming to the 
Senate, that 15 years ago were not done at all.
  I think of the new medical device implants like little stents we can 
now place in the coronary arteries which feed the heart, which were 
nonexistent 10 years ago; the artificial joints, the hips, the knees.
  Thanks to the new biomedical drugs and products, we have new 
protocols for treating everything from AIDS, where we demonstrated 
tremendous success in the last year, to the treatment of other diseases 
like cystic fibrosis.
  However, in recent decades the FDA, which has never had in writing a 
clear mission statement to guide its hand, has become too bureaucratic, 
too top heavy, with excessive regulation. I say this again out of 
tremendous respect for the FDA, having seen firsthand the tremendous 
successes of that agency.
  To address this problem the FDA, to its credit, has been very 
aggressive in undertaking a number of reforms internally that have 
reduced the regulatory burden on industry and have improved patient 
access to new therapies.
  However, it is clear that much, much more needs to be done. In the 
past, medical discoveries typically reached the patient in a relatively 
short period of time. Again, when my father first started the practice 
of medicine, it took an average of anywhere from 7 to 8 years for a new 
drug, a new pharmaceutical agent to pass through the entire discovery 
and approval process. Now, although in certain areas there has been 
tremendous improvement, it takes anywhere from 10 to 15 years to go 
through that discovery process and through that approval or disapproval 
process. Everybody agrees that is too long. Everybody agrees that you 
can have the same or improved standards if we streamline, if we 
coordinate, if we modernize the Food and Drug Administration.

[[Page S9820]]

  That is what this bill is about, not a lowering of standards, not 
putting devices or pharmaceutical agents out on the market that have 
not gone through that eye of the needle of disciplined, very high 
standards that we all expect of the Food and Drug Administration.
  Unfortunately, up-to-the-minute advances in medical science, advances 
that are occurring at increasing speed, are not making it to our 
marketplace as quickly as they should. Many times these advances are 
going overseas.
  Too often you see that a drug that is in this long pipeline, and we 
know it is a potential benefit, all of a sudden moves overseas. It 
moves overseas for trials, for ultimate approval too often. Many times 
the manufacturing of that drug or of that device also follows it 
overseas.
  I think the FDA regulatory structure simply has not kept pace with 
the rapid rate at which scientific discovery is being made. In too many 
cases, which I personally hear among investigators in the academic 
community and the private sector, the FDA has become a barrier, a 
barrier instead of a partner, to innovation and to access to medical 
therapies. It is that concept of dropping down the barrier and 
facilitating that partnership with very high standards that this bill 
achieves.
  I mentioned U.S. biomedical research moving overseas. The 
implications are significant. It is very hard to put a price tag on 
this in the short term. But if we drive our very best biomedical 
science, our very best biomedical research off our shores to other 
countries, over the long term it is to the detriment of our health 
care, to our quality of life, and to our economy. Our once almost 
impenetrable edge in a U.S. dominated market can be lost forever if we 
do not act responsibly now.
  I find my fellow doctors often travel to Europe to train, to study, 
to see, not the general foundation of medical knowledge of which we 
have the best in the world, evident by people from all over the world 
coming here to study medicine, but for innovative, breakthrough 
therapies. Too often today the therapies, the technologies, the 
research is moving overseas, and, therefore, even my colleagues go 
overseas to learn something that they should be learning right here in 
this country.
  In the future, as medical science moves away from the contemporary 
practice of just treating overt symptoms when somebody comes in with a 
complaint, an organ failure, to a medical field where we begin to 
fabricate organs, where we do transplants, where we diagnose and treat 
disease at the molecular level, at the genetic level, playing off the 
tremendous success we have seen in the human genome project, a project 
that I might add as an aside is coming in under budget and much quicker 
than we would have ever anticipated even 6 years ago, the possibilities 
for new drugs, new devices, new methods of patient treatment are 
virtually limitless.
  Thus, we need a structure to address these great breakthroughs, this 
great innovation, that is up to date, that is modernized, that is well 
organized, that is disciplined, that is coordinated. That is what this 
bill achieves. With the explosive growth in technology, the FDA needs 
to better use the considerable genius and talent of non-Government 
scientists and researchers.
  There is always a great fear when we approach this issue of so-called 
contracting out because people can paint the picture that only 
Government people, only Government scientists have the ethics, have the 
honesty, have the integrity to be able to make decisions, to be able to 
look at clinical data and say what is best, what is dangerous, what is 
a benefit to the patient.
  That is just not right. We have many good people in the private 
sector. In truth, because science is moving so fast and is so 
complicated, so intricate, it is almost absurd for us to expect that we 
can hire in the Federal Government all of the research scientists 
necessary to be able to conduct studies, look at studies, interpret 
data from the studies. Almost by necessity, because of the speed with 
which science is developing, we need to reach out and access many very, 
very good experts that are in the private sector.

  One of the greatest complaints against the FDA that I hear is a 
feeling that the FDA has not been willing to collaborate and partner 
with others in the private sector, it might be industry, might by 
academia, it might be the academies, it might be individual scientists. 
People come in and say, ``You know, I sat down with the FDA,'' but 
there is a real feeling of an adversarial relationship rather than a 
collegial relationship.
  We need to make fundamental changes in this regard at the FDA. We 
need to build upon the successes in protecting the American public by 
reenergizing the process. We need to revitalize the process of product 
approval, speeding approval where appropriate, meeting high standards, 
improving and enhancing communication between the FDA and the public it 
serves, nurturing, not stifling, research and innovation. And, yes, we 
need to draw upon the untapped scientific excellence outside the FDA, 
at all times remembering that the FDA has the final say as to whether 
or not to accept the conclusions from that partnering with outside 
individuals and agencies.
  The bill before us today, S. 830, the Food and Drug Administration 
Modernization and Accountability Act of 1997, does represent a 
bipartisan effort, including significant input from the Food and Drug 
Administration aimed at making the FDA more efficient. The bill was 
passed out of the Labor Committee on June 18 with a bipartisan vote, 
again, 14-4. On September 23, the Senate overwhelmingly approved the 
substitute amendment by Senator Jeffords.
  I want to take this opportunity to commend Senators Jeffords, Coats, 
Dodd, and Mikulski and my other colleagues on the Labor Committee, 
Senator Kennedy, all for their tireless efforts and commitment to 
modernizing the FDA.
  But to the American people I hope we have sent a signal that we can 
accomplish a very good bill, yes, a first step, but a very good bill in 
updating an organization, in updating a Federal agency which will 
affect the lives of every American in a positive way.
  I do urge my colleagues later today to support this bill. But I also 
ask that we all view this legislation and discussion as an ongoing 
commitment to improve the agency, not just a one-shot change in the 
agency, which we will put aside and come look at again in 10 years, but 
realize this needs to be an ongoing process with continued oversight.
  The Prescription Drug User Fee Act, commonly known as PDUFA, has been 
commented upon today. It has been one of the great successes in the 
relationship between the FDA, industry, and the American people. This 
bill is much more than just a reauthorization of PDUFA. It is also 
about improving the FDA and fostering, better communication and 
partnering with the private sector.
  I am a cosponsor of this bill because I believe it is a needed step 
in the right direction. We need to continue the debate, to look at both 
short and long-term investment of resources in order to move the agency 
forward in areas of regulatory research, professional development, 
collaboration between Government, academia and the private sector. I 
hope to continue working with my colleagues in a bipartisan manner to 
further improve FDA in the following years.
  The Senator from Massachusetts was going through a number of the 
items in the bill and talking about the work on both sides of the aisle 
in pulling together areas that were contentious initially. I want to 
thank him formally, and his staff, for working together on what I 
consider a very important aspect of this bill that has to do with 
dissemination of scientifically, peer-reviewed medical literature to my 
colleagues, to people in the health care profession, about the uses of 
drugs, both on-label and off-label.
  As a physician, I understand the need for this up-to-date sharing of 
more information than is currently allowed today. Off-label uses have 
been in the news recently, both in terms of pharmaceuticals, and we 
have talked a lot about it in terms of devices recently.
  I think it is very confusing to the American people what off-label 
use of medicines is. In truth, about 90-percent of all cancer therapies 
are off-label today. So if you have cancer, there is a 90 percent 
chance you will be receiving off-label medicine. When we say off-label, 
it doesn't mean the medicines are bad. Sometimes it means those are the 
most effective, and in cancer therapy, it does mean they are the most 
effective, up-to-date modern therapy to

[[Page S9821]]

have if you want your cancer treated. The American Medical Association 
has estimated between 40 and 60 percent of all prescriptions are for 
off-label uses, and up around 50 to 60 percent for the pediatric 
population, which means if your child is sick today medical therapy is 
likely to be off-label.
  Why? It only makes sense. The FDA can't study every use for every 
drug in every combination of drug available. It is impossible to do 
today.
  I want to acknowledge the tremendous work by Senator Mack on this 
particular provision during the last few years. I have had the 
opportunity to work with him over the last 2\1/2\ years on this 
specific provision of dissemination of information. I want to thank 
Senators Dodd, Wyden, and Boxer, and Senator Kennedy for his work in 
negotiating with us in order to allow the inclusion of this important 
provision which will be to the benefit of all Americans in S. 830.
  The bill before the Senate today will help meet the need for 
increased access to scientific and technical expertise that is 
currently lacking at the FDA. I touched upon this. It is that whole 
concept of interagency collaboration with Federal agencies and with the 
private sector. We will see more collaboration with the National 
Institutes of Health, more collaboration with the Centers for Disease 
Control, the National Academy of Sciences.
  The bill allows the FDA to contract with outside reviewers and expand 
its current third-party medical device review pilot program which has 
been very successful to date. Everyone agrees that it has been 
successful, which in turn will help conserve FDA resources, so that 
those resources can be used in other areas. Because the FDA always 
retains the final authority to approve or disapprove new drugs or 
medical devices reviewed by outside experts, the FDA always has the 
final authority, and it will not impede nor weaken the FDA's ability to 
safeguard the public health. To help alleviate the confusion and 
frustration that many feel today in working with the FDA, the bill 
codifies evidence requirements for new drug and medical device 
application submissions, it improves communication between the agency 
and industry. After almost 60 years, the FDA will be held and made 
accountable by giving it a specific mission statement and requiring the 
FDA to develop a plan of action to meet its requirements under law.

  Again, we talk a lot about the specific provisions of the bill. The 
bill as a whole, once it is passed, will be of benefit to every 
American, to every consumer, to every patient. Thanks to the bipartisan 
efforts of Senators Snowe, Feinstein, and Dodd, individuals with 
serious life-threatening disease will be able to access new clinical 
trial databases providing expedited access to investigational 
therapies.
  Imagine yourself being in a situation of having a disease which 
somebody says is not treatable, it is incurable. Where do you turn 
today? Nobody knows. There is no central repository, no database for 
sharing information of where the most up-to-date clinical trials exist. 
There will be after this bill is passed.
  This bill will also expand the fast-track drug approval process for 
new drugs intended for the treatment of serious or life-threatening 
conditions. It puts a focus right on those conditions that we know 
people are dying from every day. Let's focus in that particular area, 
make sure we get potential drugs to market if they are safe, sooner 
than the 15 years that we are averaging over the last decade from 
beginning to the initial discovery to final placement on the market. 
The bill itself will provide access to investigational therapies for 
patients who have no other alternative but to try an unapproved 
investigational product.
  Consumers will also benefit from this bill. The Senator from New 
Hampshire talked earlier this morning about national uniformity. It is 
critically important. We have not talked much about that in terms of 
food and drugs over the last several days. The uniformity aspect of 
over-the-counter drugs, the uniformity there will have a huge impact. 
Again, touching people in all sorts of ways. It will keep prices down, 
it will provide the consumer with a unified and consistent information 
for self-medication.
  Another benefit to consumers, if the health claim information for 
food, published by the NIH or the CDC, Centers for Disease Control, or 
other Government, well-respected scientific bodies, will be allowed to 
appear on food labeling, giving the consumer accurate information, 
educating the consumer, empowering the consumer when they make their 
dietary choices.
  In closing, Mr. President, this bill is a good bill that will benefit 
all Americans now and into the future. Medical science, moving at 
skyrocketing speed, offers promise of not just longer, but healthier 
lives, a higher quality of life. In the not-too-distant future, medical 
science and medical technology will not just thwart the assaults of 
infectious agents, but will eliminate many of the ailments of modern 
life.
  The FDA must facilitate, not complicate, that endeavor. We need a new 
model for a new century. It is time to update the FDA. This bill 
accomplishes that reform, that modernization. It will give a starting 
point for a model that will facilitate, not stifle, the medical 
progress of mankind.
  I yield the floor.
  Mr. JEFFORDS. Mr. President, I would like to express my sincere 
appreciation to Senator Frist, especially for his most recent 
discussion.
  We have been concentrating on one small part of this bill--small in 
the sense of the number of pages or words relative to the rest of the 
bill, and by outlining and expressing the tremendous advancements we 
made in many of these areas in this bill, which has kind of gotten lost 
in the dialog, especially in the off-label use which has been a very 
contentious issue. But I think the resolution which you and Senator 
Mack, working with Senator Kennedy, myself and others have come up with 
is a tremendous step forward in preventing such things that have 
occurred in fen/phen and things like that, and making sure we exchange 
knowledge and that we work together to improve what can be improved.
  I deeply appreciate the comments of the Senator and all the work the 
Senator has put into this bill. Your expertise and your knowledge has 
been a reward to us and has given us confidence that we have done the 
right thing. You have done a fantastic job and it is deeply 
appreciated. I yield the floor.
  I see the Senator from Delaware on the floor. I would be glad to 
yield to him for the time that he might take.
  The PRESIDING OFFICER (Mr. Gregg). The Senator from Delaware is 
recognized.
  Mr. BIDEN. I thank my colleague. With the permission of the Chair and 
my colleagues, I will take about 12 minutes, if I may.
  Mr. President, the purpose of this FDA reform bill we are considering 
today is obviously to streamline the process for approving drugs so 
that they are available to people who need them more quickly. I support 
the bill and I look forward to its becoming law.
  But, Mr. President, I rise today to speak to several amendments and 
several points that were, quite frankly, made nongermane as a 
consequence of the cloture vote, so I will pursue this at another date. 
I rise today to discuss the problem of drugs that do not get to the 
market, even though we need them desperately, because there are 
insufficient financial incentives for pharmaceutical companies to 
develop these drugs that we need to get to the market. In particular, I 
am speaking about medicines to treat addiction to illegal drugs like 
cocaine and heroin, so-called pharmacotherapies--that is, drugs that 
would be able to be developed and used to combat addiction to cocaine 
and heroin and other scheduled drugs.
  Since 1989, when I first offered a comprehensive report, which--I 
don't know whether I am going to burden the Record with it, but I will 
point it out to my colleagues. It was a report entitled 
``Pharmacotherapy: A Strategy for the 1990s.'' Since that time, I have 
argued that a key component of our national drug strategy should be the 
development of these pharmacotherapies that would act as antigens or 
antagonists to the effects of the illegal drugs being purchased on the 
streets.
  These medicines are critical for turning around addicts, particularly 
addicts who are difficult to treat with traditional methods. Getting 
these addicts off of drugs is one of the most important efforts we can 
undertake to reduce the harm done to our Nation by the drug epidemic--
because these

[[Page S9822]]

treatment-resistant addicts commit such a large percentage of the drug-
related crime, we would, if we could find some of the answers, 
significantly impact on and increase the safety of all Americans.
  In my 1989 report, I posed the question: ``If drug use is an 
epidemic, are we doing enough to find a medical `cure' for this 
disease?'' The obvious answer, as the report concludes, is, no, we are 
not. If, for example, everyone who was victimized by a drug addict who 
has knocked them on the head or hurt them or robbed them or burglarized 
their home, and everyone who is addicted to drugs had a rare disease 
instead of the victims of drug addiction, or of being addicted to 
drugs, we would have a multibillion dollar national campaign to find a 
medical cure for it, as we rightfully are attempting to do with AIDS, 
breast cancer, or cancer generally. But there is precious little going 
on, although there is a lot of potential in the area of developing 
medicines, drugs, to combat drug addiction.
  Based on my report, I offered legislation with Senators Kennedy, 
Moynihan, and others, enacted into law in 1992, which created the 
Medications Development Program of the National Institute of Drug Abuse 
and commissioned a major study by the National Academy of Science on 
pharmacotherapies.
  This study highlighted the promise of the medical research that I 
referred to. In fact, in recent years, there have been a number of 
promising advances that give hope that effective medicines could be 
developed if we dedicated a sufficient amount of energy and resources.
  One example of this promising research is the recent development of a 
compound that appears to immunize laboratory animals against the 
effects of cocaine. Let me say that again. There is a compound that has 
been developed in a laboratory that appears--it hasn't gone through 
clinical trials--to be able to immunize laboratory animals against the 
effects of cocaine. The compound works like a vaccine by stimulating 
the immune system to develop an antibody that blocks cocaine from 
entering the brain.

  Now, this is pure conjecture on my part. Let's assume that that was 
able to be developed and it worked for human beings. What an incredible 
impact it would have on the United States of America. What an 
incredible impact it would have not only on the addicts, but on those 
of us who are victims of the addicts. I want to remind everybody that 
over 60 percent of all the violent crime committed in America is 
committed by people who are addicted. At the moment they are committing 
the crime, they are high, they are on a drug or a substance. Just think 
what a difference that would make.
  Now, there are at least eight new medicines with promising potential, 
beyond the one that I mentioned, to treat drug addictions which are at 
various stages of research and development. By the way, I commend to my 
colleagues the report put out by the Institute of Medicine called the 
``Development of Medications for the Treatment of Opiate and Cocaine 
Addiction.''
  Now, of the eight promising medicines that are out there, one is 
LAAM, a treatment for heroin addiction, the first new medicine since 
methadone was approved in the early 1970's. Others are Naloxone, 
Naltrexone, Imipramine, Desipramine, Carbamazepine, Burprenorphine, and 
Diltiazem. These are all medicines identified by the various studies--
in this case, by the Institute of Medicine--that in fact have promising 
capacity to deal with either blocking the effect of the drug when it is 
ingested by an addict or someone attempting to use it for the first 
time, or it has the effect of causing that person to be sick and not 
wanting to take the drug again. Not a silver bullet that cures 
everything, but every single drug expert I have spoken with indicates 
that if these could be developed, they would be significant tools in 
aiding in the recovery of addiction and preventing addiction.
  The National Academy of Sciences study also outlined the key steps we 
have to take to fully realize the promise of pharmacotherapeutic 
research. Yet, almost a decade after my original report, almost a 
decade after Senators Kennedy, Moynihan, myself and others moved to 
change the law in 1992, despite promising research, despite the 
tremendously important gains that such medicines would mean for our 
national effort against a drug epidemic, despite the fact that it's 
clear what steps we have to take to speed and encourage the research in 
this area, despite all this, we are still not doing enough to encourage 
the development of medicines to treat drug addiction.
  That is why I have come to the floor today, Mr. President--to discuss 
three amendments I had offered to the FDA reform bill. These amendments 
sought to take three different approaches to addressing our critical 
need to develop pharmacotherapies to deal with our drug epidemic.
  First, I believe we should reauthorize the Medications Development 
Program of the National Institute of Drug Abuse and increase its 
funding to $100 million by the year 2002. I might add, every time we 
identify serious and pernicious diseases like breast cancer, prostate 
cancer, or AIDS, what do we do? We all immediately know that if we 
spend more money on research, we will attract more brilliant women and 
men into the field to find the answer because they have funding to do 
their research, and we increase exponentially the prospects that we 
will find a cure or find something to mitigate against the ravages of 
the disease. But not all people instinctively reach that conclusion. 
Why don't we reach that conclusion about drug addiction when the 
medical community says there are so many promising avenues we could go 
down? It would be different if the National Academy of Sciences and 
researchers and experts said, ``You know, there isn't any promise here, 
there is nothing we should bother to do, there is nothing we can do. 
This is like trying to be able to go warp speed in our Challenger.'' 
Well, that would be one thing. But that is not the case. That is not 
the case.

  Currently, the program I have referred to at the National Institute 
of Drug Abuse receives about $67 million. Increasing that level by 50 
percent over the next 5 years is the very least we should be doing in 
light of the savings in crime reduction, reduction in health care 
costs, and other expenses that would be eliminated or diminished if we 
could effectively treat drug addiction with medicine.
  Yet, despite the progress being made by Government and university 
researchers, the Federal Government cannot solve this problem by 
itself, even if the amendment I proposed were not out of order or were 
accepted.
  Private industry has not aggressively developed pharmacotherapies for 
a variety of reasons, including a small customer base, difficulties in 
distributing medicines to the targeted population, and fear of being 
associated with the notion of substance abuse.
  There are two major, major drug companies in my State--Zeneca and Du 
Pont Merck. They have a number of brilliant researchers. I have visited 
their laboratories.
  They say to me what every other drug company says. ``OK. Biden, how 
many addicted drug people are there in all America?'' I believe the 
number is estimated at 5.6 million people. Let's say we spend $200 
million, $300 million, $500 million, or $700 million developing it. 
They say, ``Say we go out and spend all this money. And let's say we 
come up with a cure or a silver bullet. How do we get that to the 5.6 
million people who need it? They don't have the money to buy it. Are 
you going to guarantee us that you will buy it? Are you going to 
guarantee us they will take it? What are you going to do? Our return on 
investment is de minimis. We will lose money in all probability, even 
if we come up with a silver bullet,'' which they are not suggesting 
they will.
  Conversely, if they come up with a silver bullet for prostate cancer, 
or a silver bullet for breast cancer, the world would beat a path to 
their door to buy it. That is one of the reasons they don't want to get 
into the game, even though they acknowledge that these are promising 
opportunities.
  Second, none of these companies, or anyone I named--Lilly, Squibb, 
any of them--wants to be known as the company that deals with drug 
addiction. It is bad public relations.
  So for these and many other reasons, private industry has not really 
gotten

[[Page S9823]]

into the fray. We need to create financial incentives to encourage 
pharmaceutical companies to develop and market these treatments. And we 
need to develop a new partnership between private industry and the 
public sector in order to encourage the active marketing and 
distribution of new medicines so they are accessible to all addicts who 
need treatment.
  My amendments sought to create these incentives in two ways.
  First, I believe we must provide additional patent protections for 
companies that develop drugs to treat substances abuse. Under my bill, 
pharmacotherapies could be designated ``Orphan Drugs'' and qualify for 
an exclusive 7-year patent.
  These extraordinary patent rights would increase the market value or 
pharmacotherapies--providing a financial reward for companies that 
invest in the search to cure drug addiction.
  This provision was contained in a bill introduced by Senator Kennedy 
and me which passed the Senate in 1990, but the provision was dropped 
in conference. It was also contained in the pharmacotherapy bill I 
introduced last year and the youth violence bill I introduced this 
year.
  In addition, I proposed an amendment which would provide a 
substantial monetary reward for companies that develop medicines to 
treat drug addition and shift responsibility for marketing and 
distributing such drugs to the Government--a ``Biden Bounty'' as some 
have called it.
  This approach would create a financial incentive for drug companies 
to invest in research and development but enable them to avoid any 
stigma associated with distributing medicine to substance abusers.
  To qualify for the award, a pharmaceutical company would have to 
demonstrate that the new medicine meets strict guidelines--developed by 
the National Academy of Sciences--that the medicine effectively treats 
cocaine or heroin addition.
  At a minimum, the guidelines will require the producer of the drug to 
conduct a controlled, long-term performance test which demonstrates 
that: Patients--addicts--will actually take the medicine; addicts will 
continue taking the medicine for as long as it takes to cure the 
addition; a significant percentage of those who receive treatment 
refrained from using cocaine or heroin for at least 3 years; and the 
medicine has a reasonable cost.
  So, it is real simple--if a medicine meets the National Academy of 
Science test and it is approved by the Food and Drug Administration, 
then the Government will purchase the patent rights for the drug from 
the company that developed it.
  So this bounty that would be made available to them is literally a 
reward. A reward, not unlike if I were a billionaire and say, ``I will 
give any company $100 million if they found the cure for cancer, or for 
any cancer.'' It is the same notion.
  The key reason the Government must not only reward companies with a 
bounty for developing medicines, but also purchase the patent rights is 
due to the stigma problem identified by the National Academy of 
Sciences report. This stigma problem is the legitimate concern of 
companies that they not be identified as the drug addicts company.
  I would also note, that if a company does want to market and 
distribute the medicine, they do not have to sell the patent to the 
Government. But if they don't want to they can sell the patent to 
Government, and we market it.
  The purchase price for the patent rights is established by law: $100 
million for a drug to treat cocaine addiction and $50 million for a 
drug to treat heroin addiction, figures recommended by the Tufts 
University Center on Drug Development.
  So the way it works. You develop a patent. You don't want to be 
distributing it because you don't want to be known as that company. The 
Federal Government would pay you $100 million for the patent after it 
has demonstrated that it works, and it was effectively done, and we 
would be the one engaged in the business of doing it. We can pay all of 
this money to buy cops, we can pay all of this money for prisons, and 
pay all of these other moneys for other things. It is a reasonable 
expenditure for taxpayer dollars, in my view, to deal with the problem 
and scourge of drug addiction.
  Once the Government has purchased the patent rights, then the 
Government would contract out the production of the drug and distribute 
it to the existing clinics, hospitals, State and local governments, and 
other entities qualified to operate drug treatment programs.
  This is not a radically different process from how our military 
procurement works: The Pentagon specifies what they want a fighter 
plane to be capable of--how fast, its stealth capabilities, what kind 
of weapons, et cetera; then the powers of the private sector are 
unleased because the Government will buy the best plane which meets the 
specifications.
  If my colleagues doubt that any such medicine could ever be 
developed, fine.
  If you are right, the Government will never spend the money.
  But, if I am right--just imagine the promise--in terms of reduced 
drug abuse; reduced crime; and reduced health care costs.
  The bottom line is that--this joint public/private endeavor I seek 
will harness the most important engine of innovation the world knows--
the private sector.
  The three pharmacotherapy amendments I offered were directly related 
to the purpose of the FDA reform bill and I hoped they would be 
accepted. Nonetheless, I understand that for procedural reasons, my 
amendments were out of order and could not be offered for a vote.
  Still, I urge the Labor Committee to hold hearings on the topic and 
consider this legislation as soon as possible. And, I put my colleagues 
on notice that I will be back to offer these amendments on the next 
appropriate legislation.
  In closing, I would observe that America's drug epidemic is reduced 
each and every time a drug abuser quits his or her habit. Fewer drug 
addicts mean fewer crimes, fewer hospital admissions, fewer drug-
addicted babies and fewer neglected children. The benefits to our 
country of developing new treatment options such as pharmacotherapies 
are manifold.
  Each dollar we spend on advancing options in this area can save us 10 
or 20 times as much in years to come. The question should not be--``can 
we afford to pursue a pharmacotherapy strategy?'' But rather, ``can we 
afford not to?''
  I urge my colleagues to join me in promoting an important, and 
potentially ground breaking, approach to addressing one of our Nation's 
most serious domestic challenges.
  A lot of the scientific community says that there are great promising 
medicines out there but which the companies will not move on for the 
reasons I have stated. We should be doing all that we can for our own 
safety's sake.
  I thank my colleagues. I yield the floor.
  Mr. JEFFORDS addressed the Chair.
  The PRESIDING OFFICER. The Senator from Vermont.
  Mr. JEFFORDS. Mr. President, I yield to the distinguished Senator 
from Ohio who has worked tirelessly on this bill as well as the bill we 
reported out of committee by unanimous agreement relative to the work 
force improvement. So I yield to him 6 minutes.
  The PRESIDING OFFICER. The Senator from Ohio.


                         Privilege of the Floor

  Mr. DeWINE. Mr. President, let me first make a unanimous-consent 
request that my congressional fellow, Jan Burrus, be granted floor 
privileges during the duration of this debate.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. DeWINE. Mr. President, I wish to make some comments about one 
particular element of this year's FDA reform bill--one that I believe 
is especially important and valuable.
  I want to thank Chairman Jeffords and my colleagues for including in 
this bill a revised version of the Better Pharmaceutical for Children 
Act (S. 713). Senator Dodd and I introduced this bill earlier this year 
because an overwhelming majority of pharmaceuticals currently on the 
market have not been tested for safety or effectiveness in children.
  In fact, Mr. President, a shocking 80 percent of the drugs that are 
on the market today have never been tested for children.
  We need to provide our young people with prescription drugs that have 
been studied for their effects on children's

[[Page S9824]]

bodies and appropriately labeled with doses suitable for young ages. 
Too many children today are taking adult-size drugs because we don't 
have a comprehensive strategy to test drugs to determine appropriate 
dosages for children.
  Children deserve better than this. Children deserve he same assurance 
adults have--that the drugs they take are safe and effective.
  Section 618 of the FDA reform bill includes a modified version of the 
bill Senator Dodd and I have worked so hard on. It provides an 
additional 6 months of market exclusivity to drug manufacturers who 
complete requested or required pediatric studies on drugs that are 
useful for children. This exclusivity will act as financial incentive 
for manufacturers to do research on their products for young patients.
  As our legislation with incentives came close to final passage, the 
FDA proposed a rule to mandate pediatric studies. The rule was proposed 
last month and would require pediatric studies for most new drugs and 
for many drugs that are already on the market.
  When the administration released its new regulation, I applauded 
their decision to join Senator Dodd and myself in trying to fix this 
problem. I offered to work with them in a bipartisan way to combine the 
proposals for the benefit of the Nation's children. The legislation 
before us today does just that, and in essence combines our bill along 
with the administration's proposal.
  We have adapted the legislation that Senator Dodd and I originally 
introduced so that it will work with the FDA's regulation. To ensure 
that we do the best that we can for children, we have combined the two 
approaches to this problem: the financial incentives from the better 
pharmaceuticals for children bill and the mandates from the proposed 
FDA rule.
  We're now moving in the right direction. This combined approach may 
not yet be perfect, but we can still work on it. I have extended an 
invitation to all interested parties to continue to work toward a 
better compromise between now and conference. The most important thing 
is to get it right. I think this compromise between a market-based 
approach and mandates goes a long way toward that.
  Time is of the essence in ensuring that children and their doctors 
have the information they need to safely and effectively use 
pharmaceuticals. Providing market incentives to manufacturers will help 
speed this process along.
  In closing, Mr. President, I would like to again congratulate 
Chairman Jeffords for the tremendous job that he has done over a long 
period of time in bringing this bill to the floor. This is a good FDA 
reform bill. The ``Better Pharmaceuticals for Children'' section is 
only one of many creative, practical steps this bill makes and takes in 
the right direction.
  The reform bill makes commonsense changes that will help patients get 
access to new medical technologies. At the same time, Mr. President, it 
maintains assurances that products are safe and that they are 
effective.
  Again, I applaud Chairman Jeffords for this bill. I look forward to 
its speedy passage.
  Mr. JEFFORDS. Mr. President, I thank the Senator for his excellent 
comments and praise him again for his work.
  Mr. President, the goal of this legislation is to ensure a strong and 
efficient FDA.
  The modernization and revitalization provision included in S. 830 
makes for a better FDA--not a weaker one, as some have suggested.
  Like many of my colleagues, I have had the opportunity to meet with 
industry groups here in Washington, and with consumers, patients, and 
physicians--both here and at my home in Vermont. All of these 
interested parties have made important points about how to modernize 
the agency while ensuring that its stellar standards for public safety 
remain as strong as ever. Though the large industries regulated by FDA 
are by and large not present in Vermont, all of us use their products. 
The people and the patient advocates in Vermont have told me that more 
needs to be done to ensure their timely access to the best therapies 
available.
  I believe we have accomplished that with this bill.
  Mr. President, I yield the floor.


                         FOOD LABELING REFORMS

  Mr. McCONNELL. Mr. President, I want to thank Senator Jeffords and 
Senator Kennedy for the inclusion of my two amendments in S. 830. My 
amendments address specific food labeling reforms that benefit both 
consumers and the food and agriculture industry.
  First, the Nutrition Labeling and Education Act of 1990 [NLEA] 
requires that any nutrient content claim on a food label be accompanied 
by a referral statement--``See Back Panel for Nutrition Information.'' 
The original intent of this provision was to help educate consumers 
about the presence and location of nutrition information on food 
products. Based on the NLEA's success, today few consumers even notice 
this generic referral statement because most individuals immediately 
look to the mandatory Nutrition Facts panel to obtain nutrition 
information.
  My proposal seeks to improve the effectiveness of this consumer 
notice by requiring a referral statement only in those instances where 
the FDA identifies that a food contains a nutrient at a level that 
could increase the risk of a health condition for vulnerable persons.
  For example, if a food label states that the product is low in fat, 
but the FDA finds that the sodium content could prove harmful to 
persons with high blood pressure, the referral statement would state--
``See Nutrition Information Panel for Sodium Content.''
  Through the continued use of a specific referral statement, persons 
who may find themselves at risk from potentially harmful levels of some 
nutrients would be reminded where to find detailed nutrition 
information. My proposal simply removes the requirement for a generic 
referral statement whose purpose is now fulfilled by active consumer 
use of the Nutrition Facts panel.
  My second proposal addresses a keen concern for American consumers 
today--food safety. The much publicized outbreaks of E. Coli 0157:H7, 
cyclospora, and salmonella have captured the attention and apprehension 
of Americans, particularly parents, who are concerned about the 
inadvertent exposure to food pathogens.
  Since the 1960's, food irradiation has presented a safe, simple, and 
inexpensive process to kill harmful pathogens in many foods. Today, 
this approved food safety technology promises to reduce the incidence 
of many food borne illnesses which threaten the health of millions of 
Americans, especially the very young and the very old.
  The food irradiation process is quite straightforward. Food is 
exposed to a carefully measured amount of intense radiant energy which 
kills parasites and micro-organisms. Food irradiation is not a cure-
all, but it can be an important food safety tool. Broader use of FDA-
approved irradiation promises a significant step forward in improving 
our Nation's food safety. Dr. Michael T. Osterholm of the Minnesota 
Department of Health eloquently sets forth the argument in favor of 
food irradiation's use in his May 1997 editorial in the New England 
Journal of Medicine. I ask that the text of his editorial be printed in 
the Record after my statement
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (See exhibit 1.)
  Mr. McCONNELL. In addition to the FDA, the World Health Organization, 
the American Medical Association, and the U.S. Department of 
Agriculture agree that food irradiation presents no health risk, and 
have endorsed irradiation as a method to prevent food borne diseases. 
Today, more than 35 countries have approved irradiation as a safe food 
treatment technology.
  Despite their well-documented food safety benefits, few irradiated 
foods are marketed in the United States. Why? Because the current 
labeling requirements render the foods virtually unmarketable. FDA 
regulations require that irradiated foods prominently and conspicuously 
bear the international radura symbol and the phrase ``treated with 
irradiation'' or ``treated by irradiation.'' Clearly, public notice of 
irradiation is necessary for informed consumer choice. However, the 
degree of prominence for the current irradiation labeling creates a 
false impression among many consumers that the irradiation statement is 
a warning. This

[[Page S9825]]

unintended labeling result must be corrected. Targeted improvements in 
the labeling will provide consumers with clearer information on 
irradiation's approved use and provide a simple means to further food 
safety in our Nation.

  My amendment simply requires irradiated foods to bear an appropriate 
disclosure requirement and specifies that the FDA-approved disclosure 
need not be more prominent than the ingredient statement. The intent of 
my amendment is for the FDA to revise its irradiation disclosure 
requirement to assure that consumers do not misinterpret this 
disclosure as a warning.
  Clearly, the FDA should have the authority to require appropriate 
disclosure of food irradiation. However, the use of a disclosure design 
that discourages the utilization of this government-approved technology 
compromises efforts by the FDA and food processors to improve food 
safety in our Nation.
  Mr. President, two dozen well-known and well-respected food and 
agriculture groups--such as the American Farm Bureau Federation, the 
National Cattlemen's Beef Association, and the Institute of Food 
Technologists--have endorsed this targeted change as a means of 
promoting greater use of irradiation as a food safety tool. I ask that 
the text of their letter of support be printed in the Record at the 
conclusion of my remarks.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (See exhibit 2.)
  Mr. McCONNELL. I want to emphasize that even with this amendment FDA 
would retain full authority to regulate all aspects of irradiation on 
food, including products on which it can be used, what dose can be 
used, and the content and placement of irradiation labeling. Under my 
amendment, the FDA can still use the current radura symbol and the 
disclosure statement. No information would be hidden from consumers. In 
the same manner that the FDA alerts purchasers to the presence of 
allergens, the FDA has the ability to inform consumers of the use of 
food irradiation. I also want to emphasize that this modest labeling 
improvement does not diminish the need for the FDA, USDA, the food 
industry, and consumer groups to work together to improve the public's 
understanding of how food irradiation works and its potential benefits 
to public health.
  Mr. President, I believe that the inclusion of these amendments in S. 
830 demonstrates the U.S. Senate's interest in food safety and 
effective labeling. Again, I greatly appreciate the consideration that 
the chairman and ranking member of the Senate Committee on Labor and 
Human Resources have given to these targeted food labeling reforms.

                               Exhibit 1

        [From the New England Journal of Medicine, May 29, 1997]

         Cyclosporiasis and Raspberries--Lessons for the Future

                       (By Michael T. Osterholm)

       One hundred years ago, Osler observed that to know syphilis 
     was to know clinical medicine. Today, to know and appreciate 
     the many clinical, microbiologic, and public health aspects 
     of the outbreak of cyclosporiasis associated with raspberries 
     that Herwaldt and colleagues describe in this issue of the 
     Journal \1\ is to know foodborne disease in the modern world. 
     The investigation conducted by Herwaldt et al. illustrates 
     the changing epidemiologic characteristics of foodborne 
     disease in this country.
---------------------------------------------------------------------------
     Footnotes at end of article.
---------------------------------------------------------------------------
       Two of the key factors that have contributed to these 
     changes are the substantial alterations in the American diet 
     over the past two decades and the globalization of the food 
     supply.\2\ Although the promotion of a ``heart-healthy'' diet 
     (high consumption of fruits and vegetables and low 
     consumption of fat) may be improving cardiovascular health, 
     it has led to a new range of problems for the 
     gastrointestinal tract. Infectious-disease specialists 
     frequently remind persons traveling to developing countries 
     to reduce the risk of traveler's diarrhea by eating only 
     foods that can be boiled or peeled. Yet seasonally, up to 70 
     percent of selected fruits and vegetables consumed in this 
     country come from developing countries. One does not need to 
     leave home to contract traveler's diarrhea caused by an 
     exotic agent. Although produce from U.S. growers is also a 
     source of pathogens, fruits and vegetables from developing 
     countries are cause for additional concern. Many developing 
     countries are just entering the global produce market. The 
     first raspberry vine was planted in Guatemala in 1987, yet 
     approximately 20 percent of all fresh raspberries sold in May 
     1996 in the United States came from Guatemala.
       Emerging or reemerging infectious agents are another factor 
     associated with the changing epidemiologic characteristics of 
     foodborne disease. Cyclospora cavetanensis is such an agent. 
     When an emerging foodborne agent is first recognized, there 
     are typically many unanswered questions about the 
     epidemiologic characteristics of the infection and its 
     prevention. Furthermore, clinicians need to be aware of the 
     clinical presentations associated with new agents. For 
     example, a patient presenting with a diarrheal illness of 
     five or more days' duration, severe fatigue, and loss of 
     appetite should be evaluated for cyclosporiasis regardless of 
     whether the patient has traveled to a foreign country or 
     consumed contaminated water. Clinical laboratories now need 
     to be proficient at performing routine examinations for a 
     wide variety of emerging agents. Moreover, public health 
     officials need to be aware of the importance of initiating 
     and maintaining population-based surveillance for these types 
     of agents. Today, the resources for conducting surveillance 
     are severely limited at the state and local levels.
       A serious problem posed by new agents such as C. 
     cayetanensis is our lack of understanding of their biology. 
     Herwaldt et al. emphasize the potential role of contaminated 
     water. However, there appears to have been only limited 
     consideration of the role that birds or other animals may 
     have had in contaminating the berries. Recent evidence 
     suggests that eimeria, a recognized coccidial parasite in 
     birds, may be very similar to C. cayetanensis, if not the 
     same agent.3,}}4 Eimeria has long been recognized 
     as an important cause of diarrheal disease in birds. 
     Consumption of berries by birds is a major cause of crop loss 
     and results in frequent contamination of the berries. The use 
     of high-quality water for irrigation and pesticide spraying 
     and other good management practices will not solve the 
     problem of C. cayetanensis contamination if birds play a 
     major part in that contamination. A similar outbreak of 
     cyclosporiasis in Florida during the spring of 1995 was only 
     later recognized as likely to be associated with Guatemalan 
     raspberries. Yet no outbreaks were documented in association 
     with the fall harvest and shipment of Guatemalan raspberries 
     in 1995 or 1996. The season migration of wild birds in 
     Guatemala needs to be evaluated as a possible explanation for 
     the patterns seen with berry shipments and outbreaks of 
     disease in the United States. One test of this hypothesis 
     will be whether there is another outbreak of cyclosporiasis 
     associated with this year's spring shipment of raspberries 
     from Guatemala.
       I believe that one of the unfortunate lessons of the 
     outbreak in the spring of 1996 came from public announcement 
     of the apparent association between a product and an illness 
     without sufficient epidemiologic evidence. The implications 
     of this lesson reach far into the future. When an outbreak 
     occurs, public health agencies are often under pressure to 
     act quickly. The public has come not only to expect a quick 
     response but also to demand it. The Texas Department of 
     Health and the Houston Department of Health and Human 
     Services investigated a cluster of cases of cyclosporiasis 
     among 20 participants at a May 9, 1996, conference in 
     Houston. On June 8, these agencies issued a press release 
     summarizing the results of their epidemiologic investigation. 
     In that announcement, they concluded that the consumption of 
     fresh California strawberries was associated with the 
     illness. The need to warn the public is legitimate, but it 
     must be weighted carefully against the possibility of being 
     wrong, which will result in economic loss for the falsely 
     accused industry, as well as weaken the confidence of both 
     industry and the public in future public health warnings. 
     Confusion about the actual cause of this outbreak persisted 
     for more than six weeks, until additional epidemilogic 
     studies conducted by state and local public health agencies, 
     the Centers for Disease Control and Prevention, and health 
     officials in Canada concluded that raspberries from 
     Guatemala were the source of the outbreak.\5\
       We need to establish well-defined criteria for evaluating 
     the quality of epidemiologic data from investigations of 
     outbreaks, particularly when the etiologic agent is not 
     readily isolated from the implicated food product. 
     Furthermore, when a widely distributed product is implicated 
     in an outbreak, we must ensure that before public 
     announcements are made, all available epidemiologic and 
     microbiologic evidence and information on product 
     distribution are reviewed quickly and that the conclusion is 
     supported by federal, state, and local experts in foodborne 
     disease.
       On January 25, 1997, President Bill Clinton announced an 
     important new initiative to improve the safety of the 
     nation's food supply, including improvements in our ability 
     to detect foodborne outbreaks and coordination of the local, 
     state, and federal responses. However, we already have the 
     means of virtually eliminating the problem of cyclosporiasis 
     associated with fruit and vegetable consumption--namely, 
     irradiation. The use of ionizing radiation for food 
     pasteurization has been extensively evaluated and is 
     supported by the World Health Organization, the Food and 
     Agriculture Organization, the International Atomic Energy 
     Agency, and various other international agencies,

[[Page S9826]]

     scientists, and government officials.\6\ Irradiation provides 
     the greatest likelihood of substantially reducing bacterial 
     and parasitic causes of foodborne disease associated with 
     numerous foods, including fresh fruits and vegetables. 
     However, the food industry remains reluctant to use this 
     technique out of fear of incurring the wrath of activist 
     groups that wrongly proclaim that irradiation is unsafe or 
     seriously compromises the quality of the food product. The 
     time has come to use irradiation; we must not let any group 
     use arguments without a scientific basis to keep such an 
     important technique from the marketplace. This may be the 
     most crucial lesson to be learned from the story of 
     cyclosporiasis and imported raspberries.


                          footnote references

       \1\ Herwaldt BL, Ackers M-L, Cyclospora Working Group. An 
     outbreak in 1996 of cyclosporiasis associated with imported 
     raspberries. N Engl J Med 1997; 336:1548-56.
       \2\ Hedberg CW, MacDonald KL, Osterholm MT. Changing 
     epidemiology of food-borne disease: a Minnesota perspective. 
     Clin Intect Dis 1994;13: 671-82.
       \3\ Relman DA, Schmidt TM, Gajadhar A, et al. Molecular 
     phviogenetic analysis of Cylospora, the human intestinal 
     pathogen, suggests that it is closely related to Eimeria 
     species. J Infect Dis 1996;173:440-5.
       \4\ Garcia-Lopez HL, Rodriguez-Tovar LE, Medina-De la Garza 
     CE, Identification of Cyclospora in poultry. Emerg Intect Dis 
     1996;2:356-7.
       \5\ Update: outbreaks of Cyclospora cayetanensis 
     infection--United States and Canada, 1996. MMWR Morb Mortal 
     Wkly Rep 1996;45:611-2.
       \6\ Monk JD, Beuchat LR, Doyle MP. Irradiation inactivation 
     of foodborne microorganisms. J Food Prot 1995;58:197-208.
                                  ____


                               Exhibit 2

                                                    June 10, 1997.
     Hon. Mitch McConnell,
     Committee on Labor and Human Resources, U.S. Senate, Russell 
         Senate Office Building, Washington, DC.
       Dear Senator McConnell: We are writing to advise you of our 
     enthusiastic support for an amendment you may offer to FDA 
     Reform legislation regarding labeling of food products under 
     the Federal Food, Drug, and Cosmetic Act. We understand that 
     your amendment is intended to remove labeling impediments 
     that discourage consumer acceptance of irradiation as a 
     technology designed to strengthen food safety and expand the 
     availability of safe and affordable food products.
       Irradiation is a simple and inexpensive process used since 
     the 1950s to kill harmful pathogens in many foods, but is 
     rarely used today because of FDA's label disclosure 
     requirements. Irradiated food products must prominently bear 
     the international ``radura'' symbol and the phrase ``treated 
     with radiation'' or ``treated by irradiation.'' These bold 
     labeling requirements more prominent than required warning 
     statements, render the foods virtually unmarketable. Again, 
     we understand that your amendment would require irradiated 
     foods to bear an appropriate disclosure requirement, but 
     specifies that the disclosure need not be more prominent than 
     the ingredient statement. In this way, concerned Americans 
     may be assured that food that has been irradiated will be 
     marked as such but the prominence of disclosure will not be 
     so bold as to create the false impression that the 
     irradiation statement is a warning. Broader use of 
     irradiation and other pathogen-reducing technologies promises 
     a significant step forward in further improving food safety.
       We enthusiastically support your irradiation prominence-of-
     disclosure amendment. It would provide for labeling policies 
     that encourage the use of FDA-approved food safety and 
     agricultural production technologies.
           Sincerely,
         American Farm Bureau Federation, American Feed Industry 
           Association, American Meat Institute, Animal Health 
           Institute, Apple Processors Association, Chocolate 
           Manufacturers Association, Florida Fruit And Vegetable 
           Association, Food Distributors International, Institute 
           of Food Technologists, Millers' National Federation, 
           National Cattlemen's Beef Association, National 
           Confectioners' Association, National Fisheries 
           Institute, National Food Processors Association, 
           National Meat Association, National Pork Producers 
           Council, National Turkey Federation, Northwest 
           Horticulture Association, Produce Marketing 
           Association, U.S. Chamber of Commerce, United Egg 
           Producers, United Egg Association, United Fresh Fruit & 
           Vegetable Association, and Western Growers Association.

  Mr. KENNEDY addressed the Chair.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, how much time remains?
  The PRESIDING OFFICER. The Senator from Massachusetts has 30 minutes.
  Mr. KENNEDY. Mr. President, I yield myself 20 minutes.
  Mr. President, I will just review quickly the work that was done by 
the committee.
  As I outlined earlier, there were 20 major proposals that were made 
by the Secretary in June. We have addressed 19 of those. The one 
remaining proposal we have not addressed is the one that brought about 
the Reed-Kennedy amendment which was defeated yesterday, and the one 
which virtually all of the consumer groups feel ought to be altered and 
changed before we get to final resolution and passage of this 
legislation.
  I reviewed some of the other provisions and the changes that were 
made as a result of bipartisan efforts, which I think are important and 
significant improvements, and also provide additional kinds of 
protection.
  I mentioned the fast tracking of the various products, and the 
ability of individuals who do not have expanded access to drugs still 
under investigation for patients who have no alternatives, the 
inclusions of the Snowe-Feinstein bill that will help to expand 
opportunities by using the NIH database, and some of the streamlining 
of the FDA procedures.
  I will mention just a final few.
  One concerned the improved consultation between manufacturers and the 
FDA. Prior to this provision, if there were any changes being 
implemented by manufacturers with these medical devices, they had to be 
cleared.
  We have changed that so that manufacturers can make adjustments and 
changes that are not going to affect issues of safety in order to make 
their production more efficient. But we also have some protections for 
safety included in there.
  The environmental issues. The original bill would have eliminated all 
the environmental impact statements from FDA applications. I didn't 
think that was what we were doing when we were extending PDUFA. We made 
adjustments and changes on that to ensure that those environmental 
impact statements will be preserved.
  The strengthening of the safety protections of the various medical 
devices. FDA will still require device manufacturers to file 
supplemental applications when they are making changes that affect 
safety and effectiveness of the devices, but we have made efforts to 
streamline that provision.
  The tracking of various devices after approval. Under the initial 
bill, there was a termination of tracking of medical devices. We had a 
good debate on this. I thought the Senator from Illinois [Mr. Durbin] 
made a strong case for continuing postmarketing surveillance of medical 
devices. We have now compromised and said that we permit the FDA to 
make the judgment. We have found that a principal reason for 
postmarketing surveillance was a safety factor, a belief that if you 
track the various medical devices and are able to get information that 
shows that those medical devices may pose a danger to the people, you 
should be able to notify others who might have used a similar kind of 
device to give those individuals protections as well.
  Initially it was thought that by having that kind of review, you 
could advance these medical devices because you are going to have a 
pretty good evaluation of those medical devices as they affect people 
by having tracking mechanisms rather than just attempting to evaluate 
safety and effectiveness prior to the time that the medical devices are 
actually utilized. So it was an attempt to speed up the process that 
the tracking provisions were put into effect initially. Now they are 
enormously important because if we find out that people do have adverse 
impacts from these medical devices--and we have tracking mechanisms--we 
can protect not only those individuals but also others who might have 
the same kind of device implanted in them.
  We worked out a compromise, and I think the public interest is 
protected. It would not have been if we had not worked it out.
  The tightening of the process for FDA approval of medical devices. We 
have 180 days for these devices. What we are saying is at the end of 
100 days the FDA indicates the deficiencies in those devices but still 
has 180 days to be able to make a final judgment. But it does give an 
earlier indication to the medical device manufacturer about the 
potential problems that they are going to face.
  Recordkeeping by distributors of devices. In the initial bill, they 
wiped out all of that information. So if there was an adverse impact 
from the medical device, the distributors would not have collected the 
information and the FDA

[[Page S9827]]

would not know about it. What we have done is maintained that the 
distributors have to keep the information which they have with regard 
to adverse impacts from devices. They do not have to report it to the 
FDA, but they have to keep it. And then if there is some kind of 
indication about adverse impact, the FDA will be able to pursue it. It 
saves a good deal of paperwork. And, it still adequately protects the 
public.
  We have made many changes in a bipartisan effort to improve and 
strengthen the bill. We have safety standards for drugs to ensure that 
the alternative use of a drug is going to meet high safety standards. 
That is an improvement.
  Health care economic information. When pharmaceuticals are given or 
sold to health care organizations, there is going to be complete 
information given in terms of alternative treatments for individuals, 
and this is a very important element.
  Health claims for food products. In the initial proposal, this 
legislation which was to extend the PDUFA to ensure 
faster consideration of pharmaceutical drugs, was effectively going to 
eliminate any FDA rule on health claims for food products. There was an 
example where the industry was leaning on us again in order to 
undermine the kind of information that would be given to consumers on 
these various food products, the health claims.

  I was around here in the late 1980's when we passed the legislation 
with regard to food labeling to make sure that the consumer was going 
to have the right information as to the health assets a particular food 
might provide, and our committee wanted to effectively eliminate those 
advances. We were able to maintain them. I think that was important. 
Those are some of the items. And in each and every instance, the public 
health was enhanced, with the exception of one--404. There is the 
record. I could have taken more time and gone into greater detail. And 
there can be no review of any of those 19 that would bring one to a 
different conclusion except for the one that we are talking about here. 
That is the only one that was brought out in the June 11 letter by the 
Secretary of HHS that said you have to address it because of the 
compelling need to protect the public.
  That is the one that every consumer group has said, why don't you 
address that the way you did the other 19? You worked out bipartisan 
agreements on all of the other 19 proposals and enhanced the public 
protection. Why can't you do it on this one?
  Well, we have been unable to. But we still hear from some of our 
colleagues about what a long process this has been, that we could have 
passed this in June, you would not have passed it without those health 
protections. I think that we protected the public with the one 
exception--and that stands out.
  We have gone over the FDA's impact on the lives of the consumers of 
this country. How in so many different ways it impacts and affects our 
lives and how they have taken action in each and every one of those 
circumstances to protect the public health. I have gone through in 
detail about how the medical device industry is prospering. They have a 
more positive attitude than they have ever had.
  Now what they are going to do is restrict the protection of the 
public health with this particular provision, and it is wrong. The 
issue is clear. Will medical devices be approved on the basis of false 
and misleading labels? All we needed was to add the words ``false and 
misleading`' to the bill. This bill would have gone through 
unanimously. But we were defeated on the amendment that would have 
prohibited false or misleading labels. When our colleagues go back home 
and they are asked in their town halls, why were you for permitting 
medical device companies to submit false information? I hope they have 
a good answer, because I cannot think of one, not when the industry is 
making the progress it is making and is having record sales, and safety 
is still being protected.
  Will dangerous medical devices that have not been tested for safety 
and effectiveness be foisted on the American people?
  Will unscrupulous companies like U.S. Surgical Corp. be rewarded for 
deceiving the FDA?
  Will there be a higher value placed on the profits of the powerful 
than the health of the American people?
  Section 404 of the FDA bill requires the FDA to approve a medical 
device based on the use identified on the label submitted by the 
manufacturer, even if that label is false or misleading. It prevents 
the FDA from requiring the manufacturers show that their product is 
safe and effective for the purpose for which it will be really used as 
opposed to the purpose falsely claimed on the label. It stands 20 years 
of progress toward safer and more effective medical devices on its 
head.
  Nothing better shows the need for the Reed-Kennedy amendment than the 
recent history on the Advanced Breast Biopsy Instrumentation system 
device developed and marketed by the U.S. Surgical Corp. This attempt 
to mislead the FDA and foist an untested machine on women with breast 
cancer shows why it is critical that section 404 not be passed in its 
current form.
  The U.S. Surgical Corp. submitted their new machine to FDA for 
approval based on a label claim that it was to be used for biopsy of 
breast tissue suspected of being malignant. This is a common procedure 
used in mammograms or other diagnostic techniques to identify 
suspicious looking areas of the breast that may indicate malignant 
tumors. If the biopsy of a small piece of the suspicious material 
indicates a malignancy, surgery would normally follow to remove the 
cancerous tissue.
  But U.S. Surgical's label claim was false. One of the models of the 
machine was designed to excise a piece of tissue 50 times as large as 
previous biopsy instruments--the size of a piece of hot dog as compared 
to the size of the tip of a lead pencil. It was clearly designed to be 
used to excise small tumors, not just to perform a biopsy. But the 
machine was not tested to see whether it was safe and effective for 
this purpose. The company was, in effect, proposing to subject women 
with breast cancer to surgery with a machine that might have been less 
effective in treating their illness than existing therapies. It placed 
the company's profits first and the patient's needs last.
  Because FDA initially relied on U.S. Surgical's false and misleading 
label, the device was subjected only to an engineering review and was 
cleared for use on February 1, 1996. Had the product been honestly 
labeled, FDA would have reviewed it using a multidisciplinary team and 
required the company to present genuine clinical data in support of the 
application.
  On March 29, 1996, the FDA obtained a copy of a promotional videotape 
that U.S. Surgical was distributing to physicians to try to sell their 
product.
  We have a copy of it right here, Mr. President, and the videotape 
clearly describes the device as appropriate for surgically removing 
small lumps of cancerous tissues. Let me quote some extracts from this 
slick production.

       U.S. Surgical is entering a new millennium in breast 
     surgery by combining advanced stereotactic technology with 
     minimally invasive surgery.
       Unlike needle biopsies where small samples of the lesion 
     are removed for pathological analysis, the ABBI system 
     removes the entire specimen.
       If the specimen proves to be cancerous but pathology 
     reports the entire margin is clear, it is up to the clinical 
     judgment of the surgeon to decide to remove additional tissue 
     or if the procedure can be considered complete.
       The ABBI system--

  Which is the needle I referred to--

     allows surgeons to provide the benefits of a minimally 
     invasive technique to breast surgery. . .. Benefits to the 
     patient include: Reduced physical and emotional trauma as a 
     woman undergoes only one versus two procedures.
       Minimally invasive breast surgery. A new standard of 
     patient care offered only by United States Surgical Corp.

  Here is their advertisement: ``The latest technique is minimally 
invasive breast biopsy.''
  And here is the language included in the videotape that says minimal 
invasive breast surgery. And we heard out on the floor, well, U.S. 
Surgical Corp. did not have anything to do with promoting this. ``A new 
standard of patient care offered by the United States Surgical Corp.''
  It is clear that this company has designed this machine for breast 
surgery, not just biopsy, and is promoting it for this use despite the 
false and misleading label submitted to the FDA.
  Here is what a distinguished physician, Dr. Monica Morrow, professor 
of surgery at Northwestern University, had to say about the company's 
machine:


[[Page S9828]]


       I am writing to express my feelings regarding the 
     importance of the FDA's mandate to evaluate ``behind the 
     label'' uses of devices and drugs.
       The need for such evaluation is clearly exemplified by the 
     marketing strategy for the U.S. Surgical breast biopsy device 
     (ABBI). This device was approved for use as a diagnostic 
     instrument. However, the company video clearly depicts the 
     use of the device for definitive breast cancer therapy.
       No clinical trials using the accepted techniques for 
     comparing cancer treatments have been conducted to validate 
     this claim, and without such trials, the device could 
     potentially pose a significant risk to patients. In addition, 
     other claims regarding improved cosmetic outcome and patient 
     acceptance are similarly unsubstantiated. The indications for 
     the uses of devices and drugs should be determined by 
     appropriate clinical and scientific data, and not by their 
     appeal as marketing gimmicks.
       This video was dropped off in my office by a company 
     representative as part of an effort to interest me in 
     purchasing this equipment.

  When the FDA became aware that the company was promoting the device 
for this unauthorized purpose, it also became aware that it had made a 
mistake in clearing a device that was clearly designed for a purpose 
not stated on the label--tumor removal--without adequate clinical 
testing. The FDA then acted to require the company to include a strong 
cautionary label that the device was only to be used for tissue 
sampling, not tumor excision. And it required it to submit clinical 
data on its use for the original claimed purpose of biopsy. Based on 
this revised label and the new clinical data, the FDA recleared the 
machine for breast biopsy on September 24, 1996.
  And it further required the company to conduct studies on the safety 
and effectiveness of the machine for tumor removal, studies which are 
ongoing.
  Evidently the company sees its potential now, and now is doing the 
studies which it didn't do before on the removal of the breast. Now 
they are doing it, after the FDA caught them promoting this device for 
that purpose.
  We have listened out here, ``This is just another machine. This is 
just another biopsy machine.'' And we find the clearest example of a 
case where it gets approved for one purpose, it is promoted and used 
for another purpose. When it is caught by the FDA, they did submit 
additional clinical information for the removal of breast--and they are 
doing it now. They didn't say, Tumor removal? We never thought we were 
going to use it for tumor removal. Why is the FDA suggesting that we 
had ever intended to use it for that, but, OK, there is an idea, we 
will go out and conduct the clinical studies.
  Let's be realistic here, they had intended to use it for an 
alternative use. They promoted it for an alternative use. And they 
never supplied the FDA with the safety information on that alternative 
use.
  How much time do I have remaining?
  The PRESIDING OFFICER. The Senator has 10 minutes.
  Mr. KENNEDY. Mr. President, U.S. Surgical's public response to this 
sorry record of profiteering at public expense is a disgraceful attempt 
to avoid responsibility for its unacceptable behavior. It claimed it 
had not produced the video--even though the video carries the company 
log and it is impossible to watch it without it being clear that the 
company paid for it, produced it, and wrote the script.
  It claimed that it had not distributed the video, even though there 
is no reason to produce a promotional video except to distribute it, 
and even though Dr. Morrow has written that the video was delivered to 
her office by a company representative trying to convince her to buy 
the U.S. Surgical machine. And, according to the Associated press, a 
company spokesman said that ``the label * * * makes clear that the 
biopsy divice is `to be used only for diagnostic breast biopsy and is 
not a therapeutic device.' '' But as the history of this machine makes 
clear, that clear disclaimer is only on the label because the FDA 
stepped in and stopped the company from its illegal promotional 
efforts.
  If section 404 is passed in its current form, the FDA will be 
handcuffed in its efforts to protect the public against untested and 
potentially harmful--even fatal--devices. Under current law, the FDA is 
able to require that the company develop data to show that the new 
device was safe and effective for removing tumors--the real use 
intended by the company, not the false and misleading use submitted on 
their proposed label. When the FDA made a mistake and inappropriately 
cleared the device, it had the authority to go back to the company and 
warn that it would revoke their approval unless adequate warnings were 
placed on the label and necessary clinical testing was performed.
  But under section 404 of the FDA reform bill, the FDA would be forced 
to approve the new device without such evidence. Unscrupulous companies 
will not only be allowed but encouraged to submit misleading labels, 
because they will gain a competitive advantage over companies that play 
by the rules.
  American women do not want to die from breast cancer because 
companies are allowed to sell devices that may be unsafe and 
ineffective. No Senator would want their own wife or mother or daughter 
to be subjected to such an untested device, solely because a greedy 
company wanted higher profits.
  Supporters of this measure claim that FDA will still have the power 
to require that dangerous devices be shown to be safe and effective 
before they are sold. They point to the language of the statute that 
says a device approved as substantially equivalent must meet two tests. 
First, it must have the same intended use as the predecessor device. 
Second, ``the information submitted that the device is substantially 
equivalent to the predicate device contains information, including 
clinical information if deemed necessary by the Secretary, that 
demonstrates that the device is safe and effective as a legally 
marketed device, and does not raise different questions of safety and 
efficacy that the predicate product.''
  What their argument ignores is the first part of the test--the 
intended use test. Today, the FDA can look at the device and say, from 
the technical characteristics of the product, that it is obvious that 
it has been redesigned so that it is primarily for a different use than 
the older device. But under the amendment, they would be barred from 
doing this. They would be forced to accept the manufacturer's word as 
to the intended use of the device--even if that label were false and 
misleading, even if the manufacturer was lying. That is what happened 
with U.S. Surgical and the biopsy machine that was really designed to 
treat breast cancer. Under the current law, FDA could require that U.S. 
Surgical show their device was safe and effective for treating breast 
cancer. Under the amendment, they could not.
  This is not just my opinion. It is the reason that the administration 
has singled out this provision as possible grounds for a veto. It is 
the reason it is opposed by a broad coalition of consumer and public 
health groups. It is obvious that the only reason that the proponents 
of this provision are not willing to compromise is that they want to 
hamstring the FDA for the benefit of the industry. How else can they 
possible justify requiring FDA to evaluate a device based on a false 
and misleading label.
  If allowed to stand, this provision will give unscrupulous companies 
a license to lie to the FDA. It will penalize ethical companies who are 
truthful and do the necessary testing to prove that their products are 
safe and effective.
  Most of all, it will put the health of America people at risk so that 
a greedy few may profit.
  The issue goes far beyond products to excise breast cancer. If 
applies to lasers to treat prostate disease, stents to place in carotid 
arteries, imaging systems to detect breast cancer, and a host of other 
treatment for dread diseases.
  A few days ago, the public was made aware of the tragedy that 
resulted from the use of diet drugs in ways that had not been approved 
by the FDA as safe and effective. This so-called off-label use of 
fenphen may well have caused serious and irreversible heart damage in 
tens of thousands of women who thought the drugs were safe.
  The legislation before us would actually encourage the use of off-
label, unapproved uses of medical devices. It can fairly be called the 
fen-phen device provision.
  It is shocking that this shameful provision has been so cavalierly 
included in this bill. It is incomprehensible that reputable device 
manufactures are not prepared to support a compromise that allows the 
FDA to look behind labels that are false or misleading.

[[Page S9829]]

  Medical devices can heal, but they can also main and kill. The 
history of medical devices is full of stories of unnecessary death and 
suffering.
  But thanks to the authority the FDA now has, there are also many 
stories of lives saved by the vigilance of the FDA. What is 
incomprehensive about the bill before us is that it would take 
backward--in the direction of less protection of public health rather 
than more. The whole history of device regulation has been to provide 
the public greater protections.
  Two decades ago, the Dalkon shield disaster led to the passage of a 
law giving the FDA greater authority over medical devices. At the time, 
this birth control device went on the market, the FDA has no authority 
to require manufacturers to show that devices are safe and effective 
before they are sold. In 1974, an FDA advisory committee recommended 
that the Dalkon shield be taken off the market--after almost 3 million 
women had used it.
  The device was found to cause septic abortions and pelvic 
inflammatory disease. Hundreds of women had become sterile, and many 
required hysterectomies. According to the manufacturer's own estimates, 
90,000 women in the United States alone were injured. The manufacturer, 
A.H. Robbins, refused to halt distribution of the device, even though 
the FDA requested it, while the issue was reviewed by the advisory 
committee.
  The Shiley heart valve disaster was so serious that it led to the 
enactment of further legislation. This mechanical heart valve was 
approved in 1979. It was developed by the Shiley Co. the Shiley Co. was 
subsequently sold to Pfizer, which continued marketing the value. It 
was taken off the market in 1986 because of its high-breakage rate.
  By that time, as many as 30,000 of these devices had been implanted 
in heart patients in the United States. One hundred and ninety-five 
valves broke and 130 patients died. Thousands of other patients who had 
the defective valves in their hearts had to make an impossible choice--
between undergoing a new operation to remove the device, or living with 
the knowledge that they had a dangerous device in their heart that 
could rupture and kill them at any moment. Depositions taken from 
company employees indicated that cracks in defective valves may have 
been concealed from customers.
  Before the defective valve was withdrawn, the manufacturer had tried 
to introduce a new version with a 70 degree tilt instead of the 60 
degree tilt approved by the FDA.
  The increased tilt was intended to improve blood flow and reduce the 
risk of clotting. The FDA's review found that the greater tilt 
increased the likelihood of metal fatigue and valve breakage, and the 
new version was not approved for use in the United States. Four 
thousand of the new devices were implanted in Europe. The failure rate 
was six times higher than for the earlier valve--causing at least 150 
deaths.
  In another example of a human and public health tragedy involving a 
medical device, the firm Telectronics marketed a pacemaker wire for use 
in the heart.
  Twenty-five thousand of these pacemakers were marketed, beginning in 
1994, before it was discovered that the wire could break, cause damage 
to the wall of the heart, or even destroy the aorta.
  Another device disaster is toxic shock syndrome from superabsorbent 
tampons. Most women would not think that a tampon could kill them or a 
change as minor as increasing the absorbency of the material used could 
have life-threatening consequences. About 5 percent of toxic shock 
syndrome cases are fatal. As a result of this problem FDA began 
requiring testing of the absorbency of all types of tampons. Women 
deserve protection. FDA should be strengthened, not crippled.
  The case of artificial jaw joints--referred to as TMJ devices--are 
another tragedy that devastated tens of thousands of patients, mostly 
women. These devices were implanted to assist patients with arthritic 
degeneration of the jaw joint, most with relatively mild discomfort. 
But the impact of the new joints, sold by a company called Vitek, was 
catastrophic. The new joints often disintegrated, leaving the victims 
disfigured and in constant, severe pain. To make matters worse, Vitek 
refused to notify surgeons of the problems with the joints, and FDA had 
to get a court order to stop distribution of the product. Similar 
problems were experienced with Dow Corning silicone jaw implants.
  In yet another example, the FDA was able to block a device that 
involved a plastic lens implanted in the eye to treat nearsightedness. 
The device was widely marketed in France, but the FDA refused to 
approve it for use in the United States. Long-term use of the device 
was later shown to cause damage to the cornea, with possible blindness.
  The angioplasty catheter marketed by the Bard Corp. turned out to be 
a dangerous device that the company sold with a reckless disregard for 
both the law and public health. The device was modified several times 
by the corporation without telling the FDA in advance, as required by 
the law. The company was prosecuted and pleaded guilty to 391 counts in 
the indictment, including mail fraud and lying to the Government.
  Thirty-three cases of breakage occurred in a 2-month period, leading 
to serious cardiac damage, emergency coronary bypass surgery, and even 
death.
  Devices as simple as patient restraints used in nursing homes and 
hospitals have been implicated in 231 injuries, including 128 deaths.
  The list goes on and on.
  These tragedies resulted in expanded powers for the FDA to protect 
the public against dangerous devices and greater vigilance on the part 
of the agency. But this bill steps backward by forcing the FDA to try 
to protect the public with one hand tied behind its back.
  This bill actually forces the FDA to approve devices based on false 
and misleading labels.
  Under the provision, the FDA cannot look behind the manufacturer's 
proposed use to demand appropriate safety and effectiveness data, even 
if it is obvious that the device has been designed for an altogether 
different use than the manufacturer claims. I have already discussed 
the dangers of a breast cancer biopsy needle that would have been used 
to treat breast cancer without adequate evidence that it was effective. 
There are many other examples of the kind of dangerous devices that 
could be foisted on the American public, if the provision of the bill 
allowing false and misleading labels is allowed to stand.
  Surgical lasers are increasingly used for general cutting, in place 
of traditional instruments such as scalpels. In a recent case, a 
manufacturer called Trimedyne adapted the laser in a way that indicated 
it was clearly intended for prostate surgery. But it submitted an 
application to the FDA saying that the laser was only intended for 
general cutting. The label was clearly false, and the FDA was able to 
require adequate safety data before the product was allowed on the 
market. But under this bill, the FDA would be forced to approve the 
product, without requiring evidence that the device is safe and 
effective for prostate surgery.
  Prostate surgery is a very common procedure affecting tens of 
thousands, if not hundreds of thousands of older men.
  Failed surgery can result in permanent incontinence and other 
devastating side effects. Do we really want surgical tools to be used 
to treat this common illness that may not be safe and effective? If 
this legislation passes unchanged, that is exactly the risk that large 
numbers of patients needing prostate surgery could face.
  A further example involves digital mammography, an imaging technology 
that is becoming an alternative to conventional film mammography. The 
new device is approved for better diagnostic imaging of a potentially 
cancerous lump in the breast that has already been detected. But it is 
not known whether the new machine can be used effectively in screening 
for breast cancer when there are no symptoms.
  Under this bill, if a manufacturer seeks approval for a digital 
mammography machine that is clearly designed for breast cancer 
screening, not just for diagnosis, the FDA would be prohibited from 
requiring data to show that the machine is effective for screening. 
Does the Senate really want to support legislation that could result in 
women dying needlessly from undetected breast cancer? That is what this 
device provision could cause.

[[Page S9830]]

  Another example involves the large number of patients who have 
suffered serious fractures and who benefit from orthopedic implants 
that help the broken bones to heal. In some cases, these implants are 
designed to be removed after the healing is complete. In other cases, 
to avoid further surgery or to strengthen the bone, the implants are 
left in place.
  Under this legislation, a manufacturer of plates and screws approved 
for short-term use could modify them in a way that clearly shows they 
are intended for long-term use. The FDA would be prohibited by this 
bill from looking behind the false and deceptive label and requiring 
the manufacturer to show that the device will not degenerate or weaken 
the bone during long-term use.
  Pedicle screws are a clear example of just such behavior by 
manufacturers. Originally designed to hold long bones in place after a 
fracture, they were modified by the manufacturer so that they could be 
used to make the spine more rigid, with the goal of reducing painful 
back problems. But the many manufacturers of these screws did not 
present safety and effectiveness data to the FDA for this new use.
  The result: the screws sometimes broke and sometimes caused spinal 
fractures. Reoperation rates ranged from 14 to 52 percent--and patients 
suffered permanent pain and disability. This is exactly the kind of 
unethical behavior by manufacturers that this bill encourages.
  Other examples in the way that this provision could allow unsafe and 
ineffective devices abound. A stent designed to open the bile duct for 
gallstones could be modified in a way that clearly was designed to make 
it a treatment for blockages of the carotid artery. Without adequate 
testing, it could put patients at risk of stroke or death. But under 
this bill, the FDA would be prohibited from looking behind the label to 
the actual intended use of the device.
  Still another example involves contact lenses, which can be approved 
for either short- or long-term wear. Extended wear contact lenses can 
be left in the eye overnight, and sometimes are worn for weeks. Under 
this bill, a manufacturer could take contact lenses approved for short-
term wear, and modify them in a way clearly intended for long-term 
wear. The FDA would have to approve the modified lenses based on the 
false and misleading label for short-term use. Unsuspecting patients 
could suffer corneal ulcers and even blindness.
  The vast majority of medical device manufacturers meet high-ethical 
standards. Most devices are fully tested and evaluated by the FDA 
before they are marketed.
  But as many examples make clear, if the FDA does not have adequate 
authority to protect innocent patients, the result can be unnecessary 
death and injury to patients across the country. There is no 
justification--none whatever--for Congress to force the FDA to approve 
devices with false or misleading labels. And there is certainly no 
justification for giving a competitive advantage to unscrupulous 
companies who will exploit this gaping loophole in the law.
  Companies that hope to benefit by weakening the FDA are powerful and 
profitable. They believe they have the votes to push this disgraceful 
provision through the U.S. Senate. Today, they probably do have the 
votes.
  But if the American people truly understand what is at stake, I do 
not believe they will permit this dangerous provision to become law. 
When the vote comes on Tuesday, we will see how many Senators are 
willing to stand with the American people--and how many are willing to 
vote in favor of false and misleading labeling.
  The legislation we are considering has many constructive elements. 
But it does not deserve to go forward unless this disgraceful provision 
is removed. False or misleading labels should have no place in approval 
of medical devices. Unscrupulous manufacturers do not deserve a free 
ride at the expense of public health.
  I intend to continue to fight to modify this provision so that public 
health can be protected, and I believe that we will ultimately be able 
to reach a compromise that will not sacrifice the public interest to 
the profits of greedy manufacturers. We have been successful in 
assuring that every other objectionable provision of this bill has been 
modified so that the public health is protected. This provision must be 
changed as well.
  Here are some significant advances in the FDA bill and compromises 
worked out on S. 830 since the committee markup on June 18.
  First, preserving State oversight of safety of cosmetics. This 
compromise assured that the States will be able to continue to regulate 
the safety of cosmetic products. The Gregg proposal in the underlying 
bill would have barred States from any regulation whatsoever of 
cosmetics, even though the FDA has neither the authority nor the staff 
to regulate these products. The compromise allows States to continue 
their regulation unless a specific inconsistent regulation has been 
issued by the FDA in a particular area.
  Second, safeguards for off-label use of drugs. This important 
compromise will allow companies to circulate reputable journal articles 
about off-label use of drugs but will ultimately enhance the public 
health and safety because the FDA will be given the opportunity to 
review, comment on, and approve articles which the companies will 
circulate. The compromise also requires companies to undertake studies 
on the safety of their drugs for the specific off-label use and submit 
applications to the FDA for approval of their drugs for these uses 
within 3 years. Currently, companies are circulating articles without 
reviewing them for off-label use without seeking review or approval by 
the FDA and are also never conducting the studies which would lead to 
ultimate FDA approval or disapproval of the drug.
  Third, expanding access to drugs for patients and fast track 
approval:
  Fast track approval. This is one of the most important new 
initiatives in the legislation. Fast track approval will provide the 
same streamlined availability for drug treatments for patients with any 
life-threatening disease now available only to patients with cancer or 
AIDS.
  Expanded access to drugs still under investigation for patients who 
have no other alternatives. The compromise combines protections for 
patients with expanded access to new investigational therapies, without 
exposing patients to unreasonable risks.
  Providing access for patients to information about clinical trials 
for serious or life-threatening diseases. This compromise will assure 
that patients suffering from serious or life-threatening diseases will 
have available to them information about ongoing clinical trials 
relating to these diseases.
  Fourth, streamlining FDA procedures. In order to expedite some 
product reviews, the compromise authorizes the Secretary to contract 
out to third-party reviewers when it will improve timeliness, but not 
when it will reduce quality. For medical devices, the compromise 
establishes in law an already existing pilot program for reviewing 
devices by outside third parties. The compromise limits the review only 
to low-risk class I devices and specifically excludes higher risk 
devices that are life-sustaining or if the device was not shown to be 
appropriate could cause substantial impairment to human health. The FDA 
will not have to expend resources on unnecessary reports which may be 
duplicative of other reports already required to be filed by the 
agency.
  Fifth, improved consultation between manufacturers and FDA. The 
compromise increases the requirements on the FDA to consult with device 
manufacturers and specifically to work toward achieving agreement on 
what set of data needs to be provided by the device manufacturer before 
approval can be granted. In addition, the device manufacturers are 
required to supply progress reports to the FDA, and in particular, 
report significant deficiencies in the device which have developed 
during the review period.
  Sixth, environmental issues. The original bill would have eliminated 
environmental impact statements from FDA applications. The compromise 
ensures that the bill does not undermine environmental protections 
provided by the Environmental Protection Act.
  Seventh, strengthening safety protections of medical devices:
  Safety and effectiveness of devices. The FDA will still require 
device manufacturers to file supplemental applications when they are 
making changes to

[[Page S9831]]

their manufacturing procedures which may affect the safety and 
effectiveness of the devices.
  Tracking of devices after approval. The compromise ensures that FDA 
can require surveillance of products after they have been approved for 
as long as needed to protect the public health.
  Tightening up the process for FDA approval of medical devices. The 
FDA will now be required to accept the classification made by the 
manufacturer unless questions are raised within a specific period of 
time. The compromise also tightens up timeframes within which the FDA 
must make a final decision on a device application.
  Recordkeeping by distributors of devices. The compromise requires 
limited recordkeeping by device distributors so that patients using 
devices will be readily identifiable if there is a health problem.
  Eighth, other issues:
  Safety standards for drugs. Supplemental applications for drug 
approvals need to meet the same safety standards as the original 
application.
  Health care economic information. Only valid and supportable health 
economic claims may be made by drug manufacturers.
  Health claims for food products. This compromise assures that the 
Nutrition Labeling Act is not undercut or weakened, and that any health 
claims by food manufacturers have to be substantiated.
  Mr. President, we want to be able to give the FDA the authority, when 
it is clearly indicated as a result of the technological changes in 
that medical device that an alternative use is intended, to look in 
behind the proposal and examine the safety data that would indicate 
that device is going to be safe, for the American public to be 
protected.
  That is the issue. We have had too many medical device tragedies in 
this country. It has not been that long ago, whether it is the Dalkon 
shield or the Shiley heart valve, or even the adjustments in absorption 
level in tampons that produced toxic shock and resulted in the deaths 
of women--there have been too many medical device tragedies. We have 
been able to avoid them in recent times. The industry is doing well. We 
are having new breakthrough technologies.
  We have reviewed 19 of the 20 key elements that have been raised by 
those who have been most concerned about the safety and security of the 
American people. We have addressed them and advanced the public's 
interest in protecting the health of the American people with the 
exception of this provision.
  It would be wrong and a major mistake to permit this legislation to 
be passed without making that change.
  I reserve the remainder of my time.
  The PRESIDING OFFICER. Who yields time?
  Mr. JEFFORDS. Mr. President, I yield such time as he may consume to 
the Senator from Indiana, who has been somewhat involved in this issue. 
I am sure he may have a few things to say.
  Take as long as you like.
  Mr. COATS. Mr. President, I thank the Senator from Vermont. I have 
been listening carefully to the words of the Senator from 
Massachusetts. I have clearly come to the conclusion the only remaining 
problem with the entire 215-page bill is section 404. We have had 
considerable debate about that yesterday and today. The Senator said 
this is the last remaining piece. The Senator correctly pointed out, of 
the 20 items that he was interested in, 19 have been resolved. That is 
an awfully good batting average, 19 out of 20. Yet the Senator says the 
bill cannot go forward until the last one is resolved.
  We had a debate on this. The Senator passionately presented his case, 
but it was not persuasive. Mr. President, 65 Members of the Senate did 
not agree with the Senator from Massachusetts. We had the vote. That 
issue has been dispensed with. I know the Senator is upset that his 
view did not prevail, but it did not prevail, despite lengthy and 
passionate argument to the contrary.
  But, putting that aside, I hope we can take the Senator at his word, 
that this is the only part of the bill that remains of concern to him. 
I have word the FDA lobbyists are currently trying to work the House to 
undo the negotiations, some of the negotiations on some of those 19 
items. I trust the Senator, having acknowledged that those have been 
negotiated fairly and addressed, would support us in maintaining the 
language that is in the Senate bill when this bill goes to conference, 
and not encourage any kind of modification of that or weakening down of 
that agreed-upon compromise.
  I assume that means section 406 is satisfactory and there is nothing 
more we need to do with it, based on the Senator's remarks. I am 
pleased we can go forward on that basis.
  I also heard the Senator say that basically everything is fine at 
FDA, that this revolution that has taken place under Dr. Kessler solved 
the problem, admitting there were problems before but we really don't 
need to do anything more. To quote him, he said, ``If it ain't broke, 
don't fix it.'' FDA is improving as we speak. Everything is going fine 
at FDA.
  The reason why we are here is that everything is not going fine at 
FDA. It has not for 20 years. We have been attempting to reform the 
process at FDA for the past 20 years and there are some reasons for 
that. It is not fine because there clearly have been delays that have 
resulted in impaired health and safety of Americans.

  You know, there are two edges to this sword. There are two sides to 
this issue. One side is making sure that we have a Food and Drug 
Administration that follows careful procedures before approving drugs 
and devices, because clearly that is in the best interests of the 
health and safety of Americans. There is no one on this floor, as 
Senator Dodd said yesterday, who does not want to maintain a vital FDA, 
with the authority to review drugs and to review devices and to make 
sure, to the best of their ability, that those drugs and devices 
promote the health and promote the safety of Americans.
  They will not always be perfect, as we have learned in this 
discussion. They make mistakes. Sometimes politicians lean on them to 
approve things that should not be approved and they approve them only 
to find out later that they should not have approved them. Maybe they 
should not be subject to that political pressure. They should not. None 
of us, whether we are for or against a particular drug or device, 
should be involved in the scientific process of approving or not 
approving a drug. But we can involve ourselves in requiring that the 
FDA do what is necessary to avoid the bureaucratic delays, avoid the 
inefficiencies, and make itself a more efficient administration. I will 
talk about that in just a moment.
  But let me talk about the other side of this issue. Let me talk about 
the patients and the consumers, the Americans whose health and safety 
and whose lives have been jeopardized or lost because of inefficient 
FDA bureaucratic delays. We talk about those who have been impacted by 
drugs that have been approved, in some people's view, too quickly. What 
about those whose health and safety has been impaired and who have died 
because the drugs have not been approved quickly enough? A very 
prestigious institution, the Hudson Institution, has done a seminal 
study on that issue and put out a report in November of 1995 titled, 
``The Human Cost of Regulation. The Case of Medical Devices and the 
FDA.''
  I hope my colleagues will read this to understand the other side of 
the issue, the rest of the story. I will just quote briefly from it.

       When policymakers weigh the costs and benefits of our 
     current policies governing the production of new medical 
     technologies, persons who die from the absence of a device 
     that should have been available should count as much as the 
     victims of a defective device.

  We have heard a lot here about victims of defective devices, but we 
have not heard very much about victims of devices that have been 
unnecessarily delayed that could have saved patients' lives, that could 
have improved their safety.
  Mr. KENNEDY. Will the Senator yield just for a question?
  Mr. COATS. I will be happy to yield to the Senator for a question.
  Mr. KENNEDY. What is the date of that particular study? I did refer 
to recent studies. I was just interested in the date.
  Mr. COATS. November 1995. I will quote further:

       Although these improvements are certainly laudable, they 
     are not worth the human costs of the FDA's approval system.

[[Page S9832]]

      Rather than protecting public safety, in some cases the 
     FDA's system for approving medical devices actually endangers 
     lives.

  Let me cite some examples: Coronary stents. Coronary stents are 
simply a wire mesh tube that holds the artery open to facilitate the 
flow of blood to the heart muscle. During angioplasty, which nearly 
400,000 Americans a year undergo, before the coronary stent was 
developed 15 percent of patients undergoing that operation had a blood 
vessel collapse and had to go into emergency bypass surgery, which 
placed them at greater risk, and a lot of lives were lost. The coronary 
stent, however, became an alternative method of treatment for most of 
these patients and reduced dramatically the amount of collapsed blood 
vessels and dramatically the lives that were lost.
  You would think that, given the importance of this technological 
breakthrough, the FDA would have given expeditious handling to the 
application for approval of the stent. Sadly, for thousands of 
Americans who died when they could have benefited from this stent, this 
was not the case. It took 9 months for the device's developers to 
obtain permission from the FDA to even begin preliminary phase I 
clinical trials. These trials took another year. Then the manufacturer 
conducted phase II trials for 9 months, and based on those results 
requested immediate permission to begin the final phase III trials.
  The FDA rejected this request. The manufacturer appealed and then 
again requested permission to begin phase III trials. Three more months 
and the FDA came back and said no, you can't start. In the meantime, 
the manufacturer had repeated a whole series of phase II trials again. 
Finally, 7 months later, the manufacturer completed the first segment 
of phase III after the FDA finally granted permission, and on and on it 
went for another 15 months.
  Four months later the FDA's advisory panel of medical experts said 
OK, we will issue the order granting approval--excuse me. They 
recommended the order to grant approval. It then took the FDA 12 months 
to comply with their medical experts' request to order the approval of 
the stent.
  The Hudson Institute estimated the number of lives lost, and it is an 
estimate. But, based on a very thorough study, and it is all documented 
here in this report, they estimated that the lag time attributable to 
the FDA cost Americans 2,888 lives. That is the other side of the 
story.
  We hear about mistakes, and, yes, mistakes are made. We are all 
humans after all. We hear about mistakes, and the Senator from 
Massachusetts has detailed and had his charts up about individual 
patients who have been injured, or had their health jeopardized through 
FDA approval of a product and then the fact that product was not 
everything that it was billed to be. But we have not heard anything 
said about the 2,888 patients who died because of FDA bureaucracy and 
inefficiency in approving a lifesaving medical device.
  Let's assume that only 25 percent of that delay was due to FDA. We 
are still talking about 1,570 lives. That is the other side of the 
story.
  I could go on and on. The omnicarbon heart valve, the left 
ventricular assist device, the heart transplant procedures, all of 
these, just dealing with the heart--delays because of FDA inefficiency.
  That is why the committee has been so insistent on moving forward 
with reform. That is why the committee has said, no, everything is not 
fine at FDA. Yes, we appreciate the fact that they are doing a little 
bit better since they taxed the pharmaceutical industry to provide the 
funds to hire the researchers to expedite the approval of drugs. But 
they have not done better with devices.
  The statements that the Senator has made were wrong. We have not had 
improvement in the way that devices are handled. High-risk and novel 
device review times in 1995 increased from 348 days to 773 days; if you 
count the days in FDA hands, 247 to 606. That is on average.
  I could go over example after example. In fact, in the budget this 
year, in responding to that, FDA said we are actually going to slow 
down, we are actually going to have to slow down review times with 
respect to device submissions. The agency itself predicted that they 
would complete 6 percent fewer reviews but review them 20 percent 
slower. Part of that is our fault. We are not giving them the resources 
that they need to speed up the process.
  But there is another part of this story that we have not heard from 
the Senator from Massachusetts. That is the testimony of the then-
Commissioner of FDA, Dr. David Kessler. The Senator this morning said 
that under the revolution that is taking place under the leadership of 
Dr. Kessler, everything now is just hunky-dory.
  Well, we had Dr. Kessler before our committee. Dr. Kessler did not 
say everything was hunky-dory. Dr. Kessler did not say everything was 
fine. In fact, Dr. Kessler pretty much threw up his hands and said, ``I 
can't control the agency. I can't administer this agency.'' In an 
astounding statement to Members of Congress, he said, ``It's only under 
pressure from the Congress that we have been able to expedite and move 
things here.'' He said, ``I'm at a loss to do this, but you keep the 
pressure on.''
  Well, if we listen to the Senator from Massachusetts, we would take 
the pressure off. Then they probably would revert to the same old ways. 
It is a bureaucracy that has not been administered well under the 
previous Commissioner. Let us hope the current acting Commissioner or 
the new Commissioner can do a lot better job than the previous 
Commissioner. The previous Commissioner seemed more intent on pursuing 
a political agenda than he did in approving drugs and approving devices 
that save the lives and improve the health of Americans.
  To respond to a question from a Member of Congress, to make the 
statement that, ``The only way we can improve is if you put pressure on 
us,'' probably explains the sudden rash of approvals that have come out 
of FDA. Why? Because we have a reform bill in the process. They have 
gotten the message. They have gotten the message that Congress will no 
longer tolerate this delay.
  They heard it not just from Republicans, not just from people who so-
called represent the device industry or the pharmaceutical industry or 
the business side, they have heard it from Republicans and Democrats, 
liberals and conservatives, people on both sides of the aisle.
  How did we possibly get out of that Committee on Labor and Human 
Resources, probably as divided philosophically as any committee in the 
U.S. Senate, how did we possibly get 14 out of 18 votes? We got it 
because liberals, Democrats, Republicans, conservatives, all came to 
the same conclusion. The conclusion was: FDA needs reform, and it needs 
it now.

  We have delayed several weeks here, and even months here, simply 
trying to get this thing through the Congress. We have had two 
filibusters. We have had untold procedural tricks and gimmicks, all 
perfectly within the rules but designed to delay the process. We have 
had one objection after another.
  It was not that long ago when the Senator from Massachusetts was down 
on the floor saying, ``If we can just fix this cosmetic''--he had his 
pictures up with problems with the cosmetic and food industry. ``That 
doesn't go to the heart of the problem; the FDA's drugs and devices, 
that part is fine. That part is settled. We just have to fix the 
cosmetic part.'' And so we said, ``OK. We'll fix it.'' And Senator 
Gregg negotiated a compromise with the Senator from Massachusetts and 
the Senators from California, and others, and we eliminated that 
concern.
  All of a sudden, when we were told that that is all we needed to do 
to move this forward, all of a sudden a new issue comes popping up, not 
one that was offered by amendment in the committee. If it was the 
primary, the No. 1 priority of the President and the Secretary of 
Health and Human Services, you would have thought the Senator from 
Massachusetts or someone would have offered an amendment in committee. 
But no, it was then the next thing to delay the bill, the next cause 
celeb, the next throw down the gauntlet, the next draw down the line in 
the sand, the next ``we can't move forward,'' the next ``this bill is 
totally worthless without a fix here.'' Fix 19 out of 20. Actually it 
was 34. The Senator miscounted. Since markup--14-4--since markup, 30 
sections of this 60-section bill have been altered. And 34 provisions--
as I hold this here in my

[[Page S9833]]

hand--of negotiations trying to get the Senator to allow us to move 
forward with this bill.
  The Wall Street Journal today in an op-ed piece calls this a timid 
bill. It has been watered down. It has been watered down substantially. 
A lot of us would have liked to have gone a lot farther than we have 
been able to go with this bill. We had provisions which would allow 
outside help for the agency, third-party accreditation. Only over the 
strenuous objections and resistance of the Senator from Massachusetts 
were we able to move forward with that.
  Yet, the FDA had its own pilot program going on that. This is the 
medical device equivalent of the PDUFA, of the user fee. Let us get 
some outside help from accredited agencies that FDA certifies, not that 
Dan Coats selects, not that some device company selects, but that FDA 
selects. We gave FDA the authority to go out and find scientific 
laboratories and testing laboratories that met their standards and, 
under their standards, would be able to assist them in the process of 
speeding up the review time of devices. Then we built in all kinds of--
all kinds of--FDA authority to select the companies, to make sure that 
there was no conflict of interest, to oversee the process, to withdraw 
it at any time, to have a final veto over the approved product. Those 
are just some of them. I have five pages in this bill here of 
accredited party participation, restrictions that go to FDA to make 
sure that process is valid, to make sure it has integrity, to make sure 
it is not a loophole.
  Here we are trying to do something that helps FDA, that helps speed 
the approval of devices that can save lives and improve health. We give 
FDA all kinds of authority, and we still have to negotiate as if this 
was going to destroy FDA. Every latest thing we saw, and then something 
else comes up. ``This is going to destroy FDA.'' FDA retains plenty of 
authority here, but it gets some help in the reform business and gets a 
strong message from Congress to ``get your act together, get a 
Commissioner that knows how to administer as well as how to politic.''

  I am more exercised than I usually get on this legislation. We have 
all tried to be patient as we have worked through this process. But 
more than one person on this Senate floor can get indignant and upset 
when people's safety and health and lives are in jeopardy. And there is 
more than one way that people's safety, health and lives are in 
jeopardy. Delay of this bill, obfuscation, resistance also jeopardize 
people's health and safety and lives. To suggest that those of us who 
do not agree that the Senator's 20th item that he wants compliance with 
is something that is going to destroy FDA, undermine the entire device 
section of FDA, put Americans at risk of their health and safety and 
maybe even their lives, I do not think that is a responsible charge.
  I think the obvious answer to that is, delay puts just as many, if 
not more, people at risk. The Hudson study certainly points that out. 
What does that mean? It does not mean that we should have no FDA 
reform. It does not mean we should necessarily have the FDA reform I 
think we should have. But it means we should have FDA reform. It means 
we ought to move forward without an ill-conceived attempt to destroy 
the whole bill.
  I do not think the opposition here has been designed to make this a 
better bill. I think the opposition--and I think it has been made clear 
with the Senator's statement this morning that everything is fine at 
FDA, hunky-dory, it is not broke, it does not need to be fixed, it is 
improving as we speak, with revolutionary changes under Dr. Kessler. I 
do not think anybody believes that. Well, maybe two people. We had a 
vote yesterday 98 to 2. Sixty-five people voted for the so-called 
provision that the Senator said would absolutely kill the bill. And 
then 33 more joined with those 65 in voting for the bill, even though 
the Senator's point did not prevail.
  So 98 to 2 is a pretty good indication that there is a solid belief 
here for reform and the solid need for reform. I just hope now we do 
not have to go through this same tortuous delay process in the House of 
Representatives where the hard work that has been accomplished here is 
undermined by those foes of any change in FDA, the status quo people. 
``Everything's fine. Let us just keep it as it is. Let's just keep 
denying Americans the health and safety improvements. Let's keep 
denying them an efficient FDA.''
  Anybody who can stand up and defend efficiency and the effectiveness 
of this Government-run monopoly has not had very much experience with 
the private sector. All we are trying to do here is--not strip FDA's 
authority; there is a public function for that. We are trying to give 
them some help in accomplishing what I think, what 98 of us at least 
believes needs to be accomplished.
  I am glad I do not have to vent my spleen any more than I already 
have on this because we are nearing final disposition of this in the 
Senate. It goes to the House. We will have a contentious conference. I 
think those who do not want FDA reform will continue to resist this. As 
I said yesterday, the clock is ticking. If we want funds to provide for 
the expedited review of drugs, we have to complete this very shortly. 
September 30 is the date on which it runs out.
  We are not going to go forward with PDUFA funds, appropriations or 
reauthorization unless it includes the reforms that are in this bill. I 
think that has been made clear. And I think 98 people made that clear 
yesterday.
  I will tell you what. I am reluctant to put this whole Hudson study 
in. It is several pages. It would be at considerable cost to the 
taxpayers. I ask unanimous consent that excerpts, some portions, of the 
Hudson briefing paper be printed in the Record so it is not so 
voluminous. But it is available in my office for anybody to review it.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

          [Excerpts from the Hudson Briefing Paper, Nov. 1995]

 The Human Costs of Regulation: The Case of Medical Devices and the FDA

(By David C. Murray)

                           *   *   *   *   *



                    Gianturco-Roubin Coronary Stents

       The development of coronary stents has revolutionized the 
     treatment of certain heart conditions related to a severe 
     blockage in or collapse of a coronary artery, the vessel that 
     carries blood to the heart muscle. A sent is basically a wire 
     mesh tube. The surgeon places the stent over an uninflated 
     balloon on the tip of a long guide wire, inserts it into the 
     body through a major blood vessel, and snakes it through the 
     blood vessels into a coronary artery. Next, he anchors the 
     stent inside the artery by inflating the balloon. Then he 
     deflates the balloon, leaving the stent in place to hold the 
     artery open and facilitate the flow of blood to the heart 
     muscle. During the next few weeks, the lining of the artery 
     grows over the stent, anchoring it permanently in place.
       Several other interventional techniques, including 
     angioplasty, can treat blockages of a coronary artery. During 
     angioplasty, the surgeon inserts an angioplasty balloon into 
     the coronary artery and expands the balloon next to the 
     blockage, thereby compressing the blockage into the artery 
     wall and allowing blood to flow freely through the artery.
       During angioplasty, the coronary artery may collapse, 
     preventing the flow of blood to the heart muscle. This occurs 
     in 2 to 4 percent of the 400,000 such operations performed in 
     the U.S. each year. Unless the flow of blood is restored, the 
     patient suffers a heart attack. Before the development of 
     stents, the surgeon could restore the flow of blood to the 
     heart in about half of all patients by performing an 
     emergency coronary artery bypass graft (CABG) surgery. This 
     operation was quite risky, resulting in the death of 
     approximately 15 percent of patients undergoing the bypass 
     operation.
       The coronary stent, however, became an alternative method 
     of treatment for most of these patients. In fact, at 
     hospitals that evaluated the stent during clinical trials, 
     only 8 percent of the patients suffering from abrupt closure 
     of the artery needed to have the bypass surgery. Of those 
     that did require the bypass surgery, only 5 percent died. At 
     the time the clinical studies were done, the late 1980s and 
     early 1990s, there were approximately 350,000 angioplasties 
     done per year in the U.S. Based on these numbers, it is 
     estimated that roughly 1,300 Americans died each year from 
     abrupt closure before the stent was available. Had the stent 
     been approved for use at that time, it is estimated that only 
     70 Americans would have died per year from abrupt closure, 
     resulting in roughly 1230 lives being saved per year.
       Given the importance of this technological breakthrough, 
     one would assume that the FDA would have given expeditious 
     handling to the application for approval of the stent. Sadly 
     for the thousands of Americans who died when they could have 
     benefited from the stent, this was not the case. It took nine 
     months for the device's developers to obtain permission from 
     the FDA to begin preliminary, or Phase I, clinical trials. 
     These trials took another year. The manufacturer then 
     conducted Phase II trials for nine months and, based upon the 
     results of these trials,

[[Page S9834]]

     requested immediate permission to begin the final Phase III 
     trials.
       The FDA rejected this request. The manufacturer appealed 
     and again requested permission to begin Phase III trials. 
     After three more months, the FDA said no. In the meantime, 
     the manufacturer had begun a second set of Phase II trials. 
     The manufacturer appealed again, and after another three 
     months, the FDA finally granted permission for the Phase III 
     trials to begin. Seven months later, the manufacturer had 
     completed the first segment of the Phase III trial and 
     requested permission to expand it. After another seven 
     months, the FDA granted this request; this trial was 
     completed in another 15 months. Four months later, the FDA's 
     advisory panel of medical experts recommended approval of the 
     device, but the FDA did not issue the actual order granting 
     approval until another 12 months had passed. At last, on May 
     28, 1993, more than six and a half years after the initial 
     application to begin the clinical trials, the FDA approved 
     the device for use in the U.S.
       Obtaining approval in Europe was quite another matter. 
     Belgium first approved the device in June 1992, after only a 
     few months of review. Several other European countries 
     quickly followed suit. On the face of it, there appears to be 
     only an eleven-month lag between the European and FDA 
     approval dates, but the whole approval process in Belgium 
     took only a few months, compared with two years for the 
     formal review of the data by the FDA and four and a half 
     years for the clinical trials.
       One could argue that the European approval process was a 
     ``free rider'' on the clinical trials the FDA mandated, thus 
     making this comparison unfair. The Europeans did use much of 
     the clinical data generated for the FDA approval process, but 
     the Europeans have a streamlined process for facilitating 
     clinical trials, with the go-ahead generally granted in fewer 
     than 60 days. It is unlikely that it would have taken nine 
     months just to get the clinical trials under way in Europe, 
     as it did in the U.S., just as it is unlikely that the 
     manufacturer would have encountered so many delays in 
     expanding the clinical trials. Indeed, manufacturers who move 
     their clinical trials to Europe cite regulatory flexibility 
     in designing and conducting clinical trials as their primary 
     reason.
       Given the complexity of the situation, it is worthwhile to 
     create a range of estimates for the human costs of the FDA's 
     regulatory delays in approving the coronary stent. At an 
     absolute minimum, the delay in approval time between Belgium 
     and the U.S. was 11 months. Using the estimated loss of 1,230 
     lives per year, the minimum human cost of the 11-month delay 
     is approximately 1,128 lives (11/12 times 1,230). This 
     estimate, however, does not include the delays associated 
     with the FDA's design and oversight of the clinical trials.

   TABLE 1.--ESTIMATED NUMBER OF LIVES LOST DUE TO REGULATORY DELAY IN
                      APPROVING THE CORONARY STENT
------------------------------------------------------------------------
                                          Percent of Lag Attributable to
                                Time lag              the FDA
       Regulatory Phase         (months) -------------------------------
                                            25%     50%     75%    100%
------------------------------------------------------------------------
Investigational Device                 7     182     365     547     718
 Application..................
Begin Phase III trials........         5     130     260     391     521
Expand Phase III trials.......         5     130     260     391     521
Clinical Subtotal.............        17     442     885   1,329   1,760
Approval Lag..................        11   1,128   1,128   1,128   1,128
                               -----------------------------------------
    Total.....................        27   1,570   2,013   2,457   2,888
------------------------------------------------------------------------

       Taking these delays into account substantially increases 
     the human costs attributable to the U.S. system. Table 1 
     provides varying estimates of the number of lives lost due to 
     FDA regulatory delay. The estimates vary according to whether 
     the FDA is assumed to be 25 percent, 50 percent, 75 percent, 
     or 100 percent responsible for the delay at each phase of the 
     approval process. The lags in clinical trials in the table 
     are the time in excess of 60 days that it took a manufacturer 
     to obtain FDA permission to proceed to the phase in question. 
     The table estimates FDA responsibility for the 11-month lag 
     between European and FDA approval at 100 percent for all 
     scenarios.
       It seems reasonable to estimate that between 1570 and 2888 
     lives were lost in the U.S. due to the regulatory lags 
     imposed by the FDA for this device. It is readily evident 
     that delay does have a heavy price.


                IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS

       As mentioned earlier, implantable-defibrillators have saved 
     the lives of tens of thousands of Americans, many of whom 
     would have survived only a short time had they not received 
     the implant. The U.S. first approved implantiable 
     defibrillators for use in 1986; CPI, then a subsidiary of Eli 
     Lilly and Company, first brought them to market. The original 
     defibrillators were so large that they could not be implanted 
     in the chest; instead the surgeon placed them inside the 
     patient's abdomen. To connect the defibrillator to the 
     patient's heart, the patient needed a thoracotomy, which 
     involves cracking the sternum and opening the chest. The 
     surgeon then embedded a wire or lead from the defibrillator 
     into the chest and grafted it onto the heart. Needless to 
     say, this was quite a traumatic procedure for the patient and 
     resulted in substantial operative mortality. The early 
     defibrillators certainly saved many, many more lives than 
     they claimed; however, they were only able to deliver one 
     type of energy shock to the patient's heart. The high-energy 
     shock that these devices delivered was effective in some 
     patients, but not all.
       A second generation of implantable-defibrillators was 
     approved for use in Europe in 1988 and in the U.S. in 1991. 
     These devices could deliver both high- and low-energy shocks 
     to the patient's heart and the physician could program them 
     to maximize effectiveness.
       The third generation of implantable defibrillators was 
     approved for use in Europe in 1991 and in the U.S. in 1993. 
     These were multiprogrammable. The physician could tailor the 
     type of shock the defibrillator would deliver, according to 
     the patient's needs, even after the device was implanted, 
     through the use of an electronic wand. The defibrillator also 
     had an internal memory that kept a record of the number times 
     it had discharged, as well as several key statistics 
     concerning the nature of the shock it had delivered. The 
     physician could access this information with the wand. The 
     defibrillator could also pace the patient's heartbeat; it 
     incorporated recent advancements in pacing technology that 
     allowed the device to correct for both slow- and rapid-
     beating problems.
       The physician used either epicardial or endocardial leads 
     to attach third-generation defibrillators to the heart. He 
     grafted epicardial leads onto the heart muscle by means of 
     screw-in or stab-tab electrodes. This type of lead required a 
     thoractomy, or open chest procedure. Endocardial leads, on 
     the other had, could be threaded through the patient's blood 
     vessels to the heart. Because these leads stay inside the 
     blood vessels, there is no reason to open the chest. 
     Endocardial leads were not originally approved for use with 
     third-generation defibrillators in the U.S., but became 
     available in December 1993. Endocardial leads were first 
     widely available in Europe in late 1991, two years before 
     they were widely available in the U.S.
       The clinical evidence in favor of endocardial leads over 
     epicardial leads is extremely strong. A clinical study 
     carried out at 125 participating hospital centers 
     demonstrated that 4.2 percent of patients receiving the 
     epicardial leads died within 30 days following surgery, and 
     only 0.8 percent of patients receiving the endocardial leads 
     died during the same period. Two years after surgery, 87.6 
     percent of the patients receiving endocardial leads were 
     alive, but only 81.9 percent of patients with epicardial 
     leads were still alive. The medical characteristics of 
     patients in both groups were similar. Other studies have also 
     demonstrated the superiority of endocardial leads, exhibiting 
     a differential in survival rates of about 4 percent.
       The fourth generation of implantable defibrillators is much 
     smaller than the previous three. These can be implanted in 
     the chest, under the pectoral muscle, much like a 
     conventional pacemaker. This greatly reduces the length of 
     the leads required and results in a smaller incision. The 
     devices can send out a more efficient type of energy wave 
     that allows the use of endocardial leads in nearly all 
     patients. This new wave, which is biphasic, achieves the same 
     results as the formerly used monophasic waves, but at 
     substantially lower energy levels and with fewer electrodes. 
     The gains in efficiency allow near-universal use of 
     endocardial leads. Another result of the enhancement in 
     efficiency is that the device needs far less testing while 
     the patient is on the operating table. This leads to a 
     reduction in the time the patient is in surgery and should 
     decrease several other complications.
       Operative mortality with this fourth-generation device 
     again fell, this time to less than 0.5 percent. The smaller 
     device is also said to be much more comfortable for the 
     patient than the bulkier devices previously implanted in the 
     abdomen. Fourth-generation defibrillators were first approved 
     for use in Europe in October 1993 and in the U.S. in March 
     1995.
       It is evident that during the last several years European 
     consumers have had earlier access to the latest model of 
     implantable defibrillators than American consumers. In fact, 
     American consumers were one full product cycle behind their 
     European counterparts for most of the past five years. Given 
     the improvements in patient survival for each generation of 
     the device, this is hardly a trivial issue. It is estimated 
     that in the early 1990s roughly 13,200 Americans received 
     defibrillators each year, and that the figure reached 20,000 
     by the mid-1990s.
       Because of the regulatory lags outlined earlier, it can be 
     estimated that 1,206 Americans died who, statistics indicate, 
     would not have died if the same device that was available in 
     Europe had been available in the U.S. The two-year regulatory 
     lags in approving endocardial leads led to 1,056 of these 
     deaths, and the 18-month regulatory lag in the approval of 
     fourth-generation defibrillators was responsible for the 
     remaining 150 deaths. Once again, the price of inefficient 
     regulation carried a heavy human cost for American heart 
     patients.

  Mr. COATS. Let me yield the floor, because I do not think I will 
speak again, but not before commending the chairman of the committee, 
who has persisted with the patience here that is remarkable. He has 
persisted because he believes that this is an important thing to move 
forward on, that this issue is important to the health and safety and 
lives of Americans. I appreciate his effort and work and his 
cooperation and his standing tall with us even though it has not been 
easy.

[[Page S9835]]

  So I thank the chairman, The Senator from Vermont, and, in view of 
that, yield the floor.
  Mr. JEFFORDS addressed the Chair.
  The PRESIDING OFFICER (Ms. Collins). The Senator from Vermont.
  Mr. JEFFORDS. Madam President, I want to thank the Senator from 
Indiana for bringing to the awareness of my colleagues what the other 
side of the story is with respect to the famous 404 provision relative 
to devices.
  I only add, as I would point out, there are some 6,000 devices 
approved each year, and during the period of the last 5 years around 
30,000, of which there were only 5 or 6 that were found to have had 
problems after approval. So I want to try to get the dimensions of this 
problem which has really dominated our time.
  I thank the Senator from Indiana.
  Madam President, I ask unanimous consent that the statement of the 
managers be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                       Statement of the Managers

       After the mark-up of S. 830, supporters of the bill, the 
     minority, and the FDA were able to come to agreement on 
     several provisions, previously the subject of disagreement, 
     on the basis of new legislative history. Other new provisions 
     were agreed to which require accompanying legislative 
     history. The following substitutes for the language in the 
     committee report for S. 830, which shall not be considered 
     part of the legislative history of this bill on the topics 
     discussed below.


                    section 601--minor modifications

       The Committee changed section 601 only as that section 
     relates to manufacturing changes, and this statement only 
     supplants prior legislative history to the extent such 
     history describes and explains manufacturing changes to 
     approved PMA devices covered by the markup version of 601(c). 
     Section 601 now better reflects the Committee's desire to 
     ensure a workable means of expediting the clearance of 
     significant manufacturing changes. The provision permits 
     manufacturers to submit a notice to FDA describing 
     manufacturing changes, summarizing data and information 
     supporting the changes, and asserting that the changes were 
     made in accordance with current good manufacturing practices. 
     Before commercially distributing a device subject to such 
     manufacturing changes, the manufacturer must wait 30 days 
     from the date of the Secretary's receipt of the notice. If 
     within the 30 day period the manufacturer receives from the 
     Secretary a written statement that the notice is inadequate, 
     the device may not be distributed until sufficient 
     information is added to the notice to make it adequate within 
     the meaning of the notice requirements of this subsection.
       The Secretary will also have the option of requesting PMA 
     supplements for the manufacturing changes identified in 
     notices. If such a request is made, the Secretary will have 
     135 days from the date of receipt of the manufacturing 
     supplement to approve or deny it. However, to the extent that 
     a notice satisfies the content requirements for a 
     manufacturing supplement, the time used by the Secretary for 
     reviewing the notice will be deducted from the 135 day review 
     period. For example, if the Secretary used 30 days to review 
     a notice and requested a PMA manufacturing supplement, then 
     the Secretary would have 105 days to review the supplement 
     from the day of its receipt by the Secretary. The Committee 
     expects that the Secretary commonly will permit manufacturing 
     changes through the 30 day notice procedure after gaining 
     experience with the procedures outlined by this subsection 
     and with the performance of regulated persons. Important to 
     the Committee's consideration in advancing this approach to 
     manufacturing changes was the Secretary's recent 
     implementation of pre-production design controls which 
     require consideration of manufacturing specifications in the 
     overall design evaluation of a device.


              section 604--automatic class iii designation

       Section 604 includes a process that permits the Secretary 
     to classify devices based on the Act's risk-based 
     classification criteria when a device is found to be not 
     substantially equivalent to a predicate devise. Specifically, 
     thirty days after receipt of a not substantially equivalent 
     determination, the person receiving the Secretary's 
     classification order may request that the Secretary make a 
     risk based classification determination for the person's 
     device, if the type of device had not been previously 
     classified. The manufacturer should provide information to 
     assist the Secretary in making the risk-based classification. 
     The Secretary will then determine the device's classification 
     based on the classification definitions in section 513(a)(1) 
     and any material provided for the Secretary's review. These 
     classification definitions have been used by the Secretary to 
     classify or reclassify over a thousand types of devices.
       Within 60 days of the above request, the Secretary must 
     make a classification determination, placing the device into 
     one of three statutory device classes. If the device is 
     placed into classes I or II, it may be commercially 
     distributed immediately. Of course, like any device, devices 
     classified into class I or II under section 604 will be 
     subject to all provisions of the Act. However, if the device 
     is placed in class III, its status will remain unchanged from 
     its not substantially equivalent designation; that is, the 
     device will be classified into class III and will require an 
     approved premarket application under section 515 before 
     marketing.
       Once a device is classified into class I or II under 
     section 604, it becomes a predicate for future premarket 
     notification submissions. Persons who file reports under 
     section 510(k) may demonstrate the substantial equivalence of 
     newer devices to these predicates in the same manner as under 
     current law.
       The Committee realizes that ``special controls'' can be 
     controls or a variety of controls that will assist in 
     providing a reasonable assurance of device safety and 
     effectiveness. When conducting a classification review under 
     this section, the Secretary may classify a device into class 
     II even when special controls do not yet exist.
       Importantly, the fact that a device is subject to a special 
     control under this section does not mean that enforcement 
     authority over such controls in other parts of the Act become 
     ineffective. For example, postmarket surveillance and 
     labeling can be special controls. Nonetheless, postmarket 
     surveillance is still enforceable as a misbranding under 
     section 502(t) and specified labeling instructions remain 
     enforceable under either section 502(a) or 502(f)(1) as 
     misbrandings, depending on the labeling control at issue.
       The Committee included section 604 to avoid the needless 
     expenditure of the Secretary's resources that would occur if 
     lower risk devices were subjected to premarket approval 
     reviews under section 515 because such devices were unique 
     and found to be not substantially equivalent to a predicate 
     device. The Committee also believes that section 604 may 
     permit the Secretary to avoid time and resource consuming 
     substantial equivalence determinations that rely on remote 
     predicates. The committee does not intend that this provision 
     will alter the Act's substantial equivalence provisions or 
     the Secretary's longstanding approach to the 510(k) 
     classification process.
       In sum, insofar as special controls are referenced in 
     section 604, the committee intends to clearly communicate 
     that any special control is enforceable to the extent 
     enforcement authority specifically addressing such controls 
     exists in the Act. Special controls that are voluntary, for 
     example standards recognized by FDA under section 205 or 
     agency guidance documents, may not be required to demonstrate 
     substantial equivalence or, more generally, compliance with 
     any requirements under the Act; however, alternate means of 
     achieving compliance must be demonstrated by regulated 
     persons.


             Section 612--health care economic information

       The purpose of section 612 is to make it possible for drug 
     companies to provide information about the economic 
     consequences of the use of their products to parties that are 
     charged with making medical product selection decisions for 
     managed care or similar organizations. Such parties include 
     formulary committees, drug information centers, and other 
     multidisciplinary committees within health care organizations 
     that review scientific studies and technology assessments and 
     recommend drug acquisition and treatment guidelines. The 
     provision is limited to analyses provided to such entities 
     because such entities are constituted to consider this type 
     of information through a deliberative process and are 
     expected to have the appropriate range of expertise to 
     interpret health care economic information presented to them 
     to inform their decision-making process, and to distinguish 
     facts from assumptions. This limitation is important because 
     it will ensure that the information is presented only to 
     parties who have established procedures and skills to 
     interpret the methods and limitations of economic studies. 
     The provision is NOT intended to permit manufacturers to 
     provide such health care economic information to medical 
     practitioners who are making individual patient prescribing 
     decisions nor is it intended to permit the provision of such 
     information in the context of medical education.
       Health care economic information is defined as an analysis 
     that identifies, measures, or compares the economic 
     consequences of the use of the drug to the use of another 
     drug or another health care intervention or no intervention. 
     Incorporated into economic consequences are the costs of 
     health outcomes. Data about health outcomes associated with 
     the use of drug, other treatments, or no treatment are 
     therefore incorporated into the economic analysis. This 
     provision limits such incorporation to health outcomes that 
     are directly related to the approved use of the drug and are 
     based on competent and reliable scientific evidence. The 
     provision presumes that the current standard practice of 
     including full disclosure of all assumptions and health 
     outcomes used in the economic analysis will continue.
       The type of health care economic information that can be 
     provided pursuant to this section is that which is directly 
     related to an approved labeled indication. To illustrate this 
     point, economic claims based on preventing disease 
     progression would ordinarily not be considered to be directly 
     related to an approved indication for the treatment of

[[Page S9836]]

     symptoms of a disease, for a drug for which the use in 
     prevention of disease progression has not been approved. 
     For example, rheumatoid arthritis drugs are approved for 
     the treatment of symptoms and not for the prevention of 
     deformity. Therefore, economic claims based in part on an 
     assumption of prevention of deformity would not be 
     considered directly related to the approved indications 
     for these drugs.
       Similarly, economic claims based on prolonging patient 
     survival would not be considered directly related and would 
     not, therefore, be permitted under this subsection, for 
     agents approved for the symptomatic treatment of heart 
     failure, but not approved for prolonging survival in heart 
     failure patients. This provision also is NOT intended to 
     provide manufacturers a path for promoting off label 
     indications or claiming clinical advantages of one drug over 
     another when such claims do not satisfy FDA's evidentiary 
     standards for such claims.
       However, the provision would permit health care economic 
     information that includes reasonable assumptions about health 
     care economic consequences derived from, but not explicitly 
     cited in, the approved indication that is supported by 
     competent and reliable scientific evidence. The nature of the 
     evidence needed will depend on how closely related the 
     assumptions are to the approved indication and to the health 
     significance of the assumptions. For example, modeling the 
     resource savings from tight control of blood sugar in Type 1 
     diabetes with insulin therapy could include costs savings 
     associated with the prevention of retinopathy (an eye 
     disease) and nephropathy (kidney disease) based on well-
     controlled study(ies) that demonstrate that control of blood 
     sugar levels with insulin leads to a reduction of such 
     consequences. Because prevention of retinopathy and 
     nephropathy could not simply be assumed to be a result of 
     blood sugar control, these prevention claims would have to be 
     shown by well-controlled study(ies) before inclusion as 
     health care outcome assumptions.
       In contrast, economic claims that model, based on 
     observational studies in a population of women, the economic 
     consequences of prevention of fractures due to osteoporosis 
     would be permitted for drugs already approved for prevention 
     of fractures due to osteoporosis. This is possible because 
     observational data may be considered competent and reliable 
     for making an assumption about the secondary consequences of 
     an osteoporotic fracture once the primary prevention has been 
     established. Similarly, the long-term economic consequences 
     of the prevention of meningitis by haemophilus be influenza 
     vaccine could be modeled using population-based data once the 
     primary prevention claim is established.
       The standard of competent and reliable scientific evidence 
     (49 Fed. Reg. 30999--August 2, 1984) supporting health care 
     economic information provided under this subsection takes 
     into account the current scientific standards for assessing 
     the various types of data and analyses that underlie such 
     information. Thus, the nature of the evidence required to 
     support various components of health care economic analyses 
     depends on which component of the analysis is involved. For 
     example, the methods for establishing the economic costs and 
     consequences used to construct the health care economic 
     information would be assessed using standards widely accepted 
     by economics experts. The methods used in establishing the 
     clinical outcome assumptions used to construct the health 
     care economic analysis would be evaluated using standards 
     widely accepted by experts familiar with evaluating the 
     merits of clinical assessments. In addition, the evidence 
     needed could be affected by other pertinent factors.
       Under FDA's current postmarketing reporting regulations, 
     health care economic information as defined in this section 
     must be submitted to FDA at the time it is initially provided 
     to a formulary committee or other similar entity. In 
     addition, pursuant to this provision, FDA will have access, 
     upon request, to any data or other information related to the 
     substantiation of the health care economic information. Such 
     information is evaluated by the Secretary to determine if the 
     health care economic information meets the requirements of 
     this section. This consists of, for example, health outcome 
     data, health resource utilization data and other information 
     related to the economic consequences of the use of the drug. 
     It would not include, for example, confidential corporate 
     financial data, including confidential pricing data.


                       Section 617--Health Claims

       Section 617 of the bill amends section 403(r)(3) of the Act 
     to authorize a health claim based upon a published 
     authoritative statement of an authoritative body of the 
     United States. Such a claim would be lawful if it meets the 
     requirements of clause (C), including the requirement that 
     the Secretary be notified 120 days prior to a claim appearing 
     on a food in interstate commerce. It is expected that the 
     Secretary will ensure that all relevant offices of the 
     Department give sufficient priority to evaluating the 
     information in the notice submitted under clause (C) so that 
     only accurate and appropriate claims appear on food labels. 
     Specifically, the Committee expects that where the Secretary 
     determines that a claim should be modified or prohibited 
     under clause (D), a regulation can be drafted by the Food and 
     Drug Administration within 100 days, and that the remaining 
     20 days will be adequate for other necessary reviews, 
     including review within FDA and within the Department. The 
     Committee also expects that the Office of Management and 
     Budget will either waive its review of a regulation 
     promulgated under clause (D) or complete that review 
     expeditiously. In the event that FDA must consult with the 
     authoritative body whose statement forms the basis of the 
     claim, the Committee expects that the authoritative body will 
     give the highest priority to that consultation to facilitate, 
     within the 120 day notification period, the resolution of any 
     outstanding differences.


               Section 619--Positron emission tomography

       The Committee intends in section 619 to require FDA to 
     develop a framework for the regulation of radiotracers used 
     in positron emission tomography (PET) scans based on the 
     unique characteristics of PET and taking into account, where 
     appropriate, the differences between the limited quantities 
     of PET radiotracers compounded by not for profit 
     institutions, such as academic medical centers, and the 
     larger quantities that may be produced by commercial PET 
     centers.
       The Committee has established a period of four years as a 
     reasonable time period in which appropriate new regulatory 
     procedures will be developed by FDA and any necessary 
     applications submitted by PET centers. Until the expiration 
     of that four year period, the Committee intends to require 
     that PET radiotracers meet the standards set by the United 
     States Pharmacopoeia (USP) for safety, efficacy and 
     compounding, and that the FDA or state agencies will enforce 
     the standards set by the USP. In addition, makers and users 
     of PET radiotracers will continue to be subject to the 
     requirements of the various state boards of medicine and 
     pharmacy which they are currently required to meet.
       USP standards are recognized in the Food, Drug, and 
     Cosmetic Act (FDCA) in the adulteration and misbranding 
     sections of the Act (Secs. 501(b) and 502 respectively). USP 
     establishes standards for marketed drugs in the U.S. It first 
     provided standards for PET pharmaceuticals in 1988. During 
     these years, USP standards have served to standardize and 
     help assure the quality of these items and protect the public 
     health. USP establishes standards or drugs through a rigorous 
     peer reviewed process, and the FDA provides input and comment 
     to USP as part of this process.
       Section 619(a)(1) amends the FDCA to add a definition of a 
     ``compounded positron emission tomography drug'' to mean a 
     PET drug and associated software and hardware which has been 
     compounded in accordance with state law by or on the order of 
     a practitioner licensed in that State or in a federal 
     facility in accordance with the law of the State in which it 
     is located.
       Section 619(b)(1) amends the FDCA to provide that a 
     compounded PET drug is adulterated, and thus subject to 
     regulatory and/or legal action by FDA, if it is compounded, 
     processed, packed, or held other than in accordance with the 
     PET compounding standards and the official monographs of the 
     USP.
       Section 619(b)(2) provides that the amendment effected by 
     section 619(b)(1) shall cease to be effective four years 
     after the date of enactment of this act, or two years after 
     the adoption by FDA of the requirements specified in section 
     619(c), which occurs later.
       Section 619(c)(1) requires that, no later than two years 
     after the enactment of this act, FDA shall establish 
     appropriate procedures for the approval of PET drugs pursuant 
     to section 505 of the FDCA and appropriate current good 
     manufacturing practice standards for such drugs. In both 
     instances, the Committee intends that FDA shall take due 
     account of any relevant differences between non-profit 
     institutions that compound PET drugs for their own patients 
     and commercial manufacturers of such drugs. FDA is directed 
     to consult with patient advocacy groups, professional 
     associations, manufacturers and physicians and scientists 
     licensed to make and/or use PET drugs prior to establishing 
     the procedures and requirements contemplated by this 
     provision.
       Section 619(c)(2) provides that FDA shall not require the 
     submission of a new drug application for an abbreviated new 
     drug application pursuant to section 505 of the FDCA for PET 
     drugs which meet the appropriate USP standards referenced by 
     section 619(b)(1) for a period of four years after the 
     enactment of this act, or for two years after the 
     establishment of the procedures and requirements under 
     section 619(c)(1), whichever occurs later. The Committee 
     intends that FDA shall use up to two years of the four 
     year period to consult with the groups mentioned above and 
     to formulate its procedures and requirements. Thereafter, 
     the Committee intends that a period of one year be allowed 
     to prepare and submit any necessary applications. Finally, 
     FDA is given one year to review and act upon the 
     applications. The Committee would expect that FDA would 
     take no action against an applicant if, at the end of the 
     four year period, the agency has neither approved nor 
     issued a not approvable letter in response to an 
     application filed within one year after the agency's 
     procedures for PET drugs have been promulgated.
       Section 619(d) requires the revocation of certain Federal 
     Register notices which announced a rule inconsistent with 
     this legislation.
       PET is an imaging technique that produces a computerized 
     image (scan) using small quantities of a radioactive tracer 
     to measure biochemical activity in the body. It has been 
     demonstrated to be an effective method of separating benign 
     from malignant lesions,

[[Page S9837]]

     staging the degree of metastasis, determining therapeutic 
     effectiveness and identifying early recurrence of disease in 
     several types of cancer, including lung, breast, colorectal, 
     head and neck. In addition, PET has a high degree of accuracy 
     in identifying early signs of coronary artery disease and in 
     assessing whether cardiac tissue is alive following a heart 
     attack. In more than one million uses of PET tracers in 
     Europe and one million in the United States, the Committee is 
     unaware of any reported instance of an adverse reaction to 
     PET radiotracers. PET radiopharmaceuticals have been used in 
     patients in the United States for over 30 years. Recent 
     research and advances in imaging technology have enhanced the 
     clinical importance of PET.
       PET radiotracers are unique among radiopharmaceuticals 
     because of their short half-lives, ranging from 30 seconds to 
     110 minutes. Therefore, most PET radiotracers are made using 
     a cyclotron which is at or near the PET site, and most are 
     made up on an individual dose basis upon the prescription of 
     a licensed physician. At present, there are 70 PET centers in 
     the United States, almost all of which are part of academic 
     medical centers. PET technology and its applications were 
     developed in large part with almost $2 billion in federal 
     research funds. Yet, while PET is widely used in Europe, its 
     benefits have not been widely available to American patients, 
     mainly because of lack of reimbursement and inappropriate and 
     costly regulations promulgated by FDA.
       Under current FDA requirements, PET centers which compound 
     PET radiopharmaceuticals on an individual dose basis would be 
     required to meet FDA's Current Good Manufacturing Practices 
     (CGMP) and to file NDA's and ANDA's for each type of PET 
     tracer and for each indication for which the tracer might be 
     used. This is the same type of regulation which the FDA 
     applies to large pharmaceutical manufacturers.
       Academic medical centers are facing unprecedented cost 
     pressures. Without regulatory relief and expanded 
     reimbursement, particularly from the Medicare program, many 
     PET centers are likely to close, and the benefits of PET will 
     be unavailable to the taxpayers who funded their development. 
     For example, the University of California at Los Angeles 
     estimated that FDA's new PET regulations would cost the 
     University at least $300,000 for a single application for 
     a single use of a PET radiotracer.
       The Committee intends that adoption of this section will 
     permit FDA to establish a regulatory framework for PET drugs 
     that will enable PET centers to continue to make this 
     valuable technology available to patients at reasonable cost 
     and assure that the public health will be protected. The 
     Committee also expects that the Health Care Financing 
     Administration will, until four years after the enactment 
     date, consider PET drugs which meet USP standards under the 
     provisions of this section to be approved by FDA for purposes 
     of Medicare reimbursement.


                    section 807--national uniformity

                                Warnings

       New Section 761 provides for national uniformity for OTC 
     drugs for human use. Under this section state and local 
     governments may not in general have requirements for OTC 
     drugs that are different from or in addition, or otherwise 
     not identical with, a requirement under this Act, the Poison 
     Prevention Packaging Act of 1970 or the Fair Packaging and 
     Labeling Act.
       Section 761(c)(2) makes it clear that the scope of national 
     uniformity extends to any state requirement upon a 
     manufacturer or distributor to mandate, by any method of 
     communication, a warning of any kind. Such a requirement 
     might relate to a warning on the label, in labeling, through 
     posters or advertising, in letters or other mailing, or in 
     any other form of public notification. Similarly, the 
     provision applies to all forms of required warnings, not just 
     those formally designated as a ``warning.'' It includes any 
     statement, vignette, or other representation which indicates, 
     directly or by implication, that the drug presents or may 
     present a hazard to health or safety. For public health 
     reasons, any warning of any kind, in any type of public 
     communication, should be uniform throughout the country.
       The reference to ``a warning of any kind'' is intended to 
     make clear that a state requirement is preempted if it 
     relates to a warning, regardless of whether the state 
     requirement is described as a ``warning.'' For example, if 
     the substance of a state requirement is to mandate a warning, 
     it would be subject to preemption even if it were called a 
     ``notification'' or ``information'' requirement.
       It should be noted that the provision would not prevent the 
     states from undertaking unilateral action to issue their own 
     public statements in the form of health department releases, 
     public service announcements, or public education campaigns 
     to alert state consumers about its concerns about an OTC 
     drug.

                               Exceptions

       Subsection (d) deals with the situation where a drug is 
     neither subject to a new drug application (NDA) or a final 
     OTC drug monograph, and therefore has not been the subject of 
     a full review by FDA of all applicable regulatory 
     requirements. Until that FDA review occurs, national 
     uniformity only applies where a state requirement relates to 
     the same subject as a federal regulation or the same subject 
     as a federal statutory amendment made on or after the date of 
     enactment, but is different from, or in addition to that 
     specific federal requirement. Where there is no such specific 
     federal requirement and the drug is not subject to an NDA or 
     a final monograph, the state remains free to impose its own 
     requirement.
       Thus, a state generally can impose a requirement on the 
     content or labeling of a product not the subject of a final 
     monograph. But a state cannot establish a different 
     requirement (warning or otherwise) for a drug not subject to 
     a final monograph where a final federal regulation on the 
     subject is in place. For example, alcohol containing OTC drug 
     products intended for ingestion (whether or not the subject 
     of a final monograph) must meet the requirements of a final 
     federal regulation which specifies maximum permissible 
     concentrations of alcohol. A state could not issue a 
     different regulation on that subject even if the state 
     regulation applied only to products not subject to a final 
     monograph. A similar situation is presented by FDA's proposed 
     regulation requiring massive and in-depth changes in labeling 
     format for OTC drugs. That proposal applies to all OTC drugs 
     whether or not they are subject to a final monograph and 
     therefore when final would preempt any different or 
     additional state requirements.
       Once FDA has conducted its full review in the form of an 
     NDA or final OTC drug monograph, the FDA regulatory program 
     will have a general preemptive effect for drugs subject to an 
     NDA or final monograph, no state may enact any additional or 
     different requirement that is of the type imposed by the 
     three designated federal statutes. States may enforce 
     identical provisions, but not requirements that are in 
     addition to, different from, or otherwise not identical with 
     the federal requirements. The full FDA review involved in an 
     NDA or final monograph, along with the requirements of other 
     applicable FDA regulations assures that all appropriate 
     regulatory requirements including those involving safety, 
     effectiveness, manufacturing, packaging, and labeling, are 
     all in place for OTC drug products. For that reason, no other 
     state requirements will be permitted.
       Thus, generally (unless another final federal regulation 
     applies) a state can require a warning for a drug that is not 
     subject to an NDA or a final monograph, because FDA has not 
     yet had an opportunity to conduct a full review of all 
     potential warnings applicable to the drug. Once FDA approves 
     an NDA or promulgates a final OTC drug monograph for the 
     drug, however, no state may thereafter require any form of 
     warning on any subject, through any form of public 
     communication, unless it is identical with whatever warning 
     is required by FDA. Additional or different warnings would 
     thereafter be precluded.


                   section 811--information exchange

                        Incentives for Research

       It is the Committee's belief that section 771 will provide 
     health care practitioners important scientific information 
     about uses that are not included in the approved labeling of 
     drugs, biologics, and devices. We recognize, however, that 
     our goal should also be to ensure that these new uses get 
     onto the product label. That is why we have incorporated 
     strong incentives to conduct the research needed to get those 
     uses on the label. Pursuant to subsection (a)(3)(A), a 
     manufacturer who seeks to disseminate information about a new 
     use must either certify that it will file a supplemental 
     application for the new use (if the studies have already been 
     completed) or must submit a proposed protocol and schedule 
     for conducting the necessary studies and a certification that 
     a supplemental application will be filed. If the studies are 
     completed at the time dissemination begins, a supplemental 
     application must be filed within 6 months from the date of 
     the initial dissemination. If the manufacturer commits to 
     conduct the studies, a supplemental application must be filed 
     within 3 years, unless the Secretary determines that more 
     time is needed to complete the studies and submit a 
     supplemental application. The Secretary may grant an 
     extension of the three year period if the manufacturer has 
     acted with due diligence to conduct the studies in a timely 
     manner, but such extension may not exceed two years.
       Although our goal is to ensure that the research is done to 
     get new uses on the product label, we also recognize that 
     there may be limited circumstances when it is appropriate to 
     exempt a manufacturer from the requirement to file a 
     supplemental application. Subsection (a)(3)(C) provides that 
     a manufacturer may file a request for an exemption from the 
     requirement if such manufacturer can demonstrate (I) that due 
     to the size of the patient population or lack of potential 
     benefit to the sponsor, the cost of obtaining clinical 
     information and submitting a supplemental application is 
     economically prohibitive, or (ii) it would be unethical to 
     conduct the studies necessary to obtain adequate evidence for 
     approval of a supplemental application.
       In making the determination of whether to grant an 
     exemption pursuant to subsection (a)(3)(C), the Secretary may 
     consider, among other things, the following factors, if 
     relevant, whether:
       (1) the new use meets the requirements of section 
     186(t)(2)(B) of the Social Security Act;
       (2) a medical specialty society that is represented in or 
     recognized by the Council of Medical Specialty Societies (or 
     is a subspecialty of such society) or is recognized by

[[Page S9838]]

     the American Osteopathic Association, has found that the new 
     use is consistent with sound medical practice;
       (3) the new use is described in a recommendation or medical 
     practice guidelines of a Federal health agency, including the 
     National Institutes of Health, the Agency for Health Care 
     Policy and Research, and the Centers for Disease Control and 
     Prevention of the Department of Health and Human Services;
       (4) the new use is described in one of three compendia: The 
     U.S. Pharmacopeia--Drug Information; the American Medical 
     Association Drug Evaluations; or the American Hospital 
     Association Formulary Service Drug Information;
       (5) the new use involves a combination of products of more 
     than one sponsor of a new drug application, a biological 
     license application, a device premarket notification, or a 
     device premarket approval application; and
       (6) the patent status of the product.
       Subsection (a)(3)(D) requires manufacturers who commit to 
     conduct studies to obtain evidence on new uses to provide the 
     Secretary with periodic reports that describe the status of 
     the studies. The reports required by this provision are not 
     intended to be burdensome. In many cases it would be 
     sufficient for manufacturers to provide brief updates on the 
     status of the studies. In general, the purpose of this 
     provision is to keep the Secretary apprised of how patient 
     enrollment is proceeding, any significant problems that could 
     affect the manufacturers' ability to complete the studies, 
     and expected completion dates.

                         Additional Information

       The principal policy considerations that underlie this 
     provision are the facilitation of greater access to timely 
     and accurate information to health care providers. Coupled 
     with this goal is a recognition that the FDA has a 
     responsibility to protect the public health. Thus, the 
     discretionary authority of the Secretary to offer objective 
     statements on the proposed dissemination and to require the 
     manufacturer to disseminate additional information to achieve 
     objectivity and balance is preserved.
       It is important to recognize that it has been the long held 
     view of Congress that the FDA cannot, and should not, 
     regulate the practice of medicine. Thus, the FDA has no 
     authority or jurisdiction to regulate how physicians 
     prescribe approved drugs. This means that physician 
     prescribing of off label uses of approved products is not 
     within the jurisdiction of the FDA. In this case, because the 
     physician is receiving information from a drug sponsor (whose 
     conduct is within the jurisdiction of the FDA) the FDA has a 
     role to play with respect to assuring balanced and 
     objectivity necessary to fulfill its statutory mission. 
     Because health care providers retain responsibility of making 
     treatment decisions with respect to individual patients, the 
     FDA's role with respect to individual treatment decisions 
     based on peer reviewed articles and textbooks is advisory. In 
     that advisory capacity the FDA will take steps to make sure 
     that the amount of information given to the provider is 
     useful, useable, and in compliance with this section. This 
     requirement should not be read as requiring the FDA to 
     comment on each and every proposed dissemination, rather 
     this authority will likely be used in the limited 
     circumstances in which balance can not be fully met by the 
     options listed above of appending other journal articles 
     or data or analyses. The intent is that the statement be 
     limited to objective and scientific information and not 
     present an opportunity to editorialize independently-
     derived scientific information. The statement is intended 
     to provide significant scientific information to the 
     health care providers.

                            New Information

       This section offers a safeguard to assure the health care 
     provider community that a disseminated journal article or 
     textbook which discusses an off label use will trigger an 
     update requirement in the event that the Secretary determines 
     that there is a risk that the drug may not be effective or 
     may present a significant risk to public health. The new 
     information submitted by the manufacturer will be in a form 
     prescribed by the Secretary in regulations. The Committee 
     notes that manufacturers are already legally required by 
     section 314.81 of volume 21 of the Code of Federal 
     Regulations to submit annual reports to the Secretary. As 
     opposed to the comprehensive data required under section 
     314.81, this requirement is limited to data on safety and 
     efficacy. The Committee assumes that this requirement will 
     not be burdensome, rather tailored to meet the public health 
     responsibilities to be exercised by the Secretary. In 
     addition, after the Secretary makes a finding under this 
     provision the Secretary is required to consult with the 
     manufacturer before determining what corrective actions are 
     commensurate with the public health need of the affected 
     health care provider community and what is in the best 
     interests of potentially affected patients.

                          Rule of Construction

       Subsection (d) provides that nothing in section 771 shall 
     be construed as prohibiting a manufacturer from disseminating 
     information in response to an unsolicited request from a 
     health care practitioner. The Committee has an interest in 
     ensuring that current agency policies that encourage 
     scientific exchange are not being modified by section 771. At 
     the same time, insofar as the Secretary may currently have 
     authority in other sections of the statute to restrict a 
     manufacturer's dissemination of information in response to an 
     unsolicited request from a health care practitioner, nothing 
     in section 771 is intended to change or limit that authority.

 Establishment of List of Articles and Textbooks Disseminated and List 
      of Providers That Received Articles and Reference Textbooks

       In order to effectively implement the authority of the 
     Secretary to require corrective actions be taken by the 
     manufacturer, the regulations promulgated by the Secretary 
     may include record keeping requirements to make sure that 
     such corrective actions are effective. These record keeping 
     provisions should be tailored to meet the underlying purpose 
     of the provision requiring corrective action. For example, in 
     the case of new information under Section 771 that requires 
     an update of a disseminated article, it may be appropriate to 
     require the publication of an advertisement in the journal of 
     a specific medical specialty society; or, in other cases, a 
     ``Dear Doctor'' letter may be appropriate. It should not be 
     necessary for manufacturers to keep a list of all providers 
     who receive information disseminated under this section, if 
     the company is willing to notify by letter or advertisement a 
     larger group of health care providers in order to implement a 
     corrective action.


                            pdufa sideletter

  Ms. MIKULSKI. Madam President, I would like to have the chairman's 
understanding of the letter to be submitted by the Secretary of Health 
and Human Services concerning the performance goals of the FDA in 
connection with the reauthorization of the Prescription Drug User Fee 
Act of 1997, PDUFA.
  Mr. JEFFORDS. I thank the Senator from Maryland for raising this very 
important point. As with the 1992 law, I intend that the FDA's 
performance goals that have been worked out between FDA and industry in 
the PDUFA reauthorization be covered in a separate letter. The letter 
will be sent by Secretary Shalala to Chairman Bliley and me, as well as 
the distinguished ranking members of the House Commerce Committee, Mr. 
Dingell, and our committee, Mr. Kennedy.
  This letter is referenced in the findings section of the user fees 
provisions of the bill. It will spell out in detail the performance 
goals that FDA has agreed to meet for each of the 5 years of the 
reauthorized user fee law.
  I consider the provisions that will be in the Secretary's letter and 
attachment to be as mandatory as if they were in the statute itself. I 
expect the FDA will treat them as such just as it has with the 
provisions in the 1992 letter.
  Ms. MIKULSKI. Mr. Chairman, I agree completely with what you just 
stated. The provisions that have been negotiated between FDA and 
industry and set forth in the sideletter from the Secretary are a key 
part of PDUFA. These provisions cover electronic submissions, meeting 
management goals, clinical holds, major dispute resolution, special 
protocol question assessment and agreement, and additional procedures, 
such as action letters.
  Not only should these performance goals be considered fully binding 
on the agency, they should be considered as minimum, not maximum 
commitments. If the agency can do better, it should. I know that FDA 
will do its best to exceed the performance goals and other matters 
spelled out in the letter, just as it has exceeded its commitments in 
the 1992 PDUFA letter.


             Effective and aggressive oversight of the fda

  Mr. JEFFORDS. I yield to the Senator from Washington, a member of the 
Senate Labor and Human Resources Committee for purposes of engaging in 
a colloquy.
  Mrs. MURRAY. As a new member of the Senate Labor and Human Resources 
Committee I have spent the last 8 months coming up to speed on the FDA, 
reform proposals and the impact of these proposals. I have met with 
groups representing all sides on these issues--from the biotech 
industry to groups representing patients. I have tried to keep an open 
mind and work to find acceptable solutions to the many problems pointed 
out by industry and the patient groups. There appears to be a general 
mistrust among all interested parties. As a result each side is 
concerned about going too far--industry is concerned about burdensome 
and unnecessary regulation by FDA and the patients are concerned about 
effective regulation of the industry. It appears that this general 
mistrust is based on past experiences and each side can give numerous 
examples.

[[Page S9839]]

  My objective was to revitalize the FDA to give it the regulatory 
flexibility to effectively regulate the pharmaceutical and medical 
device industry without jeopardizing timely approval of safe and 
effective lifesaving drugs and devices. At the same time, I am well 
aware of the prominent public health role played by the FDA--it is 
after all, a public health agency, not a drug or device manufacturer. 
My support for real reforms by no means says that I did not support an 
aggressive public health agency role for the FDA.
  Several weeks ago, I met directly with several biotech companies in 
the State of Washington. As I sat at the table listening to their 
concerns I was struck by the amount of experience at the table and 
level of integrity that many of the companies are known for. I am proud 
to represent these companies that are on the cutting edge of medical 
technology and have contributed significantly to improving health care 
for all Americans. I knew that those companies would not market a 
dangerous, life threatening drug or device; that none of these 
companies deliberately act to falsify clinical data or would refuse to 
complete clinical trials. I knew that these companies were more 
concerned with getting their lifesaving technologies to patients than 
simply making a profit. They know the value of one's reputation and are 
truly proud of the lifesaving work they have done. Sadly, however, not 
all companies have the same commitment to the patient's health and are 
allowing stockholders, not scientists, to make decisions. Because of 
this, I am asking for the Chairman's commitment that the Senate Labor 
and Human Resources Committee will retain a strong and aggressive 
oversight role.
  We are making some sweeping and some may argue dramatic changes in 
the way the FDA operates. We need to be sure that these changes are 
positive and that FDA has the resources and ability to remain an 
effective public health agency. If we detect future problems or 
conflicts, I need your commitment and support for swift and thorough 
hearings. I need to know that we will continue to monitor the FDA, and 
if legislative revisions are necessary to protect the public health, we 
will act with great speed. There is probably no other Member more 
hopeful that some of these reforms will means that patients get access 
to safe and effective drugs and devices sooner, but I also know that we 
cannot forget the past. There are certainly many examples of situations 
where the public health was put into jeopardy by unscrupulous 
pharmaceutical and medical device manufacturers. I need your assurances 
that if problems arise we will act to address any potential threat to 
the public health.
  Mr. JEFFORDS. I share the Senator's goal of ensuring a strong FDA and 
believe the modernization and revitalization provisions included in S. 
830 make for a better FDA, not a weaker one. Like you I have had the 
opportunity to meet with industry groups here in Washington and with 
consumers, patients, and physicians both here and at home in Vermont. 
All of these interested parties have made important points about how to 
modernize the agency while ensuring that its stellar standard for 
public safety remain as strong as ever. Though Vermont doesn't have any 
of these large industries regulated by the FDA, all of us use their 
products. The people and the patient advocates of Vermont have told me 
that more needs to be done to ensure their timely access to the best 
therapies available. I believe we have accomplished that with this 
bill.
  I think that the Senator from Washington would agree that it's 
important to put aside once and for all that consumers, patients, and 
physicians universally oppose this measure. Vermont patient groups and 
their members--and I'm sure you have heard from your constituents--have 
told me that they support this effort to modernize the FDA. The Vermont 
Epilepsy Association, the Vermont Medical Society, the Vermont 
Association for the Deaf, the Vermont Board of Pharmacy, the Vermont 
Alliance for the Mentally Ill, and the Epilepsy Foundation of Vermont 
have all urged passage of the measure. At the national level we have 
heard from innumerable groups that support S. 830 and urge its passage. 
For example, the National Health Council--which includes the Arthritis 
Foundation, the National Multiple Sclerosis Society, and the Leukemia 
Society among its over 100 member organizations--took out a full-page 
advertisement in the Roll Call newspaper urging that the Senate move 
forward with this legislation.
  I agree with my colleague from Washington and you can be assured that 
if problems do arise, I would act quickly to address any threat to the 
public health. Simply because we are authorizing PDUFA for 5 years does 
not mean that we cannot change other sections of the Food, Drug and 
Cosmetic Act. It could also turn out that some of these reforms, like 
expanded third party review for medical devices, will become such a 
success that the FDA will want to extend the program beyond the pilot 
phase.
  Effective and aggressive oversight is one of the most important tools 
of the Labor and Human Resources Committee for making sure that the FDA 
can keep pace with the rapid changes in medical technology and still be 
a public health agency that is the envy of the world. I thank the 
Senator for her commitment to working toward real reforms that 
strengthen the FDA and the contributions she has made in crafting this 
bipartisan measure.
  Mrs. MURRAY. I thank the Chairman for his support and commitment to a 
strong FDA and am grateful for his leadership on this legislation.


                          pharmacy compounding

  Mr. KENNEDY. Madam President, I would like to engage my colleagues, 
Senator Jeffords, the distinguished chairman of the Labor and Resources 
Committee, and Senator Hutchinson, the distinguished Senator from 
Arkansas, regarding a provision in S. 830 pertaining to the practice of 
pharmacy compounding.
  Mr. JEFFORDS. I would be pleased to enter into such a colloquy with 
the distinguished Senators from Massachusetts and Arkansas.
  Mr. KENNEDY. First, I want to commend my colleagues and their staffs 
for their efforts in the difficult task of drawing the line between 
drug manufacturing and pharmacy compounding. Ordinary pharmacy 
compounding has been traditionally regulated by the States, but drug 
manufacturing, even when conducted by State-licensed pharmacists, is 
regulated under Federal law. Under current law, the Federal Food, Drug, 
and Cosmetic Act specifically exempts from the inspection and 
registration provisions of the act pharmacies that compound drugs for 
sale in the regular course of dispensing or selling drugs at retail. 
However, FDA and the courts that have addressed the matter interpret 
the act as not providing any general exemption from the new drug, 
adulteration, and misbranding provisions for drugs compounded by 
pharmacists. It is my understanding that section 809 of S. 830 would 
bring the legal status of compounding in line with FDA's longstanding 
enforcement policy of regulating only drug manufacturing, not ordinary 
pharmacy compounding. This legislation would, as I understand it, 
exempt drugs compounded in pharmacies from the new drug, and certain 
other, provisions of the act, but the exemption would not create a 
loophole that would allow unregulated drug manufacturing to occur under 
the guise of pharmacy compounding.
  Mr. HUTCHINSON. As the sponsor of the amendment that became section 
809 of S. 830, I concur with the distinguished ranking minority member 
of the Labor and Human Resources Committee that this legislation would 
ensure patient access to individualized drug therapy, and prevent 
unnecessary FDA regulation of health professional practice. This 
legislation would exempt pharmacy compounding from several regulatory 
requirements but would not exempt drug manufacturing from the act's 
requirements. The legislation also sets forth a number of conditions 
that would have to be met in order to qualify for the exemption from 
the act's requirements. I would note that the conditions established by 
section 809 should be used by the State boards of pharmacy and medicine 
for proper regulation of pharmacy compounding in addition to State-
specific regulations. When a State board determines that certain 
compounding activities are outside the parameters established in 
section 809, that State board should refer the practitioners in 
question to the FDA for review.

[[Page S9840]]

  Mr. KENNEDY. I thank the distinguished Senator from Arkansas for 
describing the reasons why this section is so important to patients and 
to the health professions. I want to especially commend his staff for 
working with mine to develop this legislation that exempts from Federal 
law the activities that are appropriately regulated by the States.
  It is my understanding that some of the conditions are intended to 
ensure that the volume of compounding does not approach that ordinarily 
associated with drug manufacturing. Other conditions appear to be 
intended to ensure that the compounded drugs that qualify for the 
exemption have appropriate assurances of quality and safety since these 
compounded drugs would not be subject to the more comprehensive 
regulatory requirements that apply to manufactured drug products.
  Mr. JEFFORDS. I believe the Senator is correct in his understanding.
  Mr. DOMENICI. Madam President, I rise in support of S. 830, the FDA 
Modernization Act. This bill provides comprehensive--and long overdue 
reform to the FDA.
  The primary focus of S. 830 is to streamline and strengthen the FDA's 
review and approval of lifesaving drugs and medical devices. One 
important mechanism for doing this is the Prescription Drug User Fee 
Act [PDUFA]. PDUFA authorizes the FDA to use fees collected from 
prescription drug manufacturers to expedite the FDA's review of drugs. 
The fees collected go to hiring new employees to increase the FDA's 
resources for reviewing new drugs.
  With all of the advances in science and medicine, we must ensure the 
swift review of new drugs for life-threatening diseases. When there are 
backlogs and delays in drug approval, American lives can be lost. For 
example:
  The 7-year delay in the FDA's eventual approval of beta blocker heart 
medicines cost the lives of 119,000 Americans; and
  The FDA's 3\1/2\-year delay in approving the new drug Interleukin-2 
(IL-2) cost 25,000 Americans to die of kidney cancer, even though the 
drug already had been approved for use in nine other countries.
  This bill is good because it will give Americans access to lifesaving 
medication, without needless delay.
  I would like to share with you the story of one man from my home 
State of New Mexico who would benefit from this bill.
  Leonard Alderete is 39 years old and has lived in Albuquerque, NM all 
of his life. In 1987, Leonard was diagnosed HIV positive. Five years 
later, Leonard sought medical intervention because his condition 
worsened and he feared his life would end. Leonard began taking the 
standard AZT. In 1996, Leonard's health again took a downturn. Blood 
tests revealed that the virus had spread at an alarming rate through 
his system. In order to slow the spread of the virus, Leonard needed an 
aggressive treatment.
  Leonard's doctor prescribed the drug regiment of 3TC, AZT, and 
Crixivan, which is also known as a triple cocktail. A key drug in this 
mixture is the protease inhibitor, Crixivan. Through PDUFA, Crixivan 
was made available to consumers within 3 months of its submission to 
the FDA. Shortly thereafter, Leonard began taking Crixivan.
  Thanks to the ``triple cocktail,'' the virus is now below detectable 
levels. Although this is not a cure, it does provide Leonard hope--a 
more long-term hope for the future.
  Leonard is a member of the Governor's task force on HIV/AIDS. He is 
the only member who has HIV. As a member of the Task Force, he 
advocates for the rights of those who are HIV infected--as well as 
those in the community who are affected.
  Leonard has written, called, and even traveled to my office in 
Washington, DC two times this year to urge my support for this bill. 
Leonard provides testimonial for the importance of FDA reform, and 
especially PDUFA.
  Fortunately, patients afflicted with AIDS as well as other life 
threatening diseases have a ``Leonard'' advocating for them. There are 
many other Leonards both silent and vocal all across the country who 
will benefit from this bill. It is on their behalf that I urge my 
colleagues to support S. 830.
  Ms. MOSELEY-BRAUN. Madam President, I support S. 830, the Food and 
Drug Administration Modernization and Accountability Act of 1997. I 
also want to commend Senators Jeffords and Kennedy for their hard work 
on this legislation, and the compromises that will ultimately improve 
the FDA and improve the public's access to cutting edge medical 
technology.
  Despite recent improvements, I am concerned that the length of time 
and amount of paperwork required for FDA approval of new products may 
still be excessive. For many companies desiring to market new products, 
application to the FDA is a formidable obstacle. In some cases, the 
length and complexity of the process can deter companies from even 
applying. This is a particularly troubling prospect given the 
increasing globalization of markets for health care products and food.
  The FDA cannot continue to protect the public health through its 
traditional methods. Most industrialized and emerging nations 
participate in multilateral trade agreements that aim to reduce trade 
barriers. These agreements will continue to bring pressure on the FDA 
to harmonize its regulatory policies with other international safety 
and performance standards. The policies that have made the United 
States the ``gold standard'' in public health protection must be 
reformed to function properly in this global economy. This does not 
mean that we cannot continue to be the gold standard. It simply means 
that market forces will bring pressure on the FDA to implement policies 
that encourage the launching of new products in this country, as 
opposed to Europe, and ensures that the United States maintains its 
technical and scientific leadership in health disciplines.
  As stewards of this generation, we must move to strike the balance 
between protecting the public health, fostering global trade under 
multilateral agreements, ensuring swift access to new health technology 
for Americans, and strengthening the U.S. technical and scientific 
leadership. S. 830 is a very good effort to balance those sometimes 
competing goals.
  First, the bill reauthorizes the Prescription Drug User Fee Act 
[PDUFA] for an additional 5 years. PDUFA has been one the most 
successful pieces of governmental reform legislation. During the 5 
years since we first passed PDUFA, the average approval time for 
pharmaceutical products has dropped over 40 percent. There is still 
more room for improvement. Many product reviews remain cumbersome, and 
applicants at times do not have a clear indication of the type of 
information necessary for FDA review.
  S. 830 also makes considerable progress in expediting patients access 
to important new therapies and potentially life-saving experimental 
treatments. Just a few months ago, one of my constituents encountered 
considerable bureaucratic red-tape in her effort to access a 
potentially life-saving treatment for Hodgkin's disease. Only after 
countless appeals by my office and hundreds of my constituents did the 
FDA acquiesce. The troubling part of this incident was that the FDA had 
approved the same treatment for other patients several years prior. 
This is not to say that the people who work at the FDA were not 
following their current guidelines. They were probably following the 
guidelines to the letter. But the spirit of the FDA's mission was 
utterly lost in the process. S. 830 makes the much needed reforms.

  Along the same lines, the bill also establishes a national registry 
of clinical trials. The primary impediment to patients access to 
potentially life-saving treatment is not the FDA but actually a lack of 
knowledge about ongoing research. A national database, which patients 
can access, will greatly assist people across the Nation who are 
searching for hope for their illnesses. This important reform is long 
overdue and absolutely necessary to continue providing Americans the 
best in medical treatment and technology.
  Finally, the bill strikes an appropriate balance between protecting 
the public interests and allowing manufacturers to share important off-
label use information with providers. It would have been a grave 
mistake to either prevent the distribution of off-label use information 
or not allow the FDA to play a vital role in ensuring the adequacy of 
information being distributed by manufacturers. I know that a lot of 
work went into the compromise

[[Page S9841]]

reached regarding off-label usage information and the agreement greatly 
benefits the American public.
  I would like to congratulate the architects of legislation including 
patient and industry groups who worked so hard to achieve balance. 
Patients groups are to be especially congratulated for their steadfast 
pursuit of this reform. Just 2 weeks ago, I met with some of my 
constituents who have multiple sclerosis and amyotrophic lateral 
sclerosis--also known as Lou Gehrig's disease. Their message was loud 
and clear--pass FDA reform now. This is a resounding message that I 
cannot ignore.
  Madam President, it is equally important to say that this legislation 
is not meant as an attack on the efforts of the women and men who work 
at FDA. I have great respect for the role that the agency and its 
employees play in protecting consumers from unsafe and ineffective 
healthcare, food, and cosmetic products. The FDA has taken a number of 
steps over the last several years to streamline administrative 
functions and work better with industry and consumers to facilitate the 
availability of cutting edge medical technology. The success that FDA 
has achieved in reducing the time to review new drugs and get 
potentially life-saving therapies on the market is laudable. The 
reviewers at FDA should take pride in these accomplishments. This 
legislation simply builds on those reforms.
  My support for S. 830 should not be construed as a complete 
endorsement of the bill. This is not a perfect piece of legislation. 
There are features that patient advocates, industry, and regulators 
simply do not support. Senator Kennedy has done a good job of 
highlighting some of the issues and there have been a number of 
amendments accepted that further improve the bill.
  I am particularly concerned that the bill does not adequately address 
food safety, which will certainly emerge as a major public health 
issue. Most of the recent criticism of the FDA has focused on the 
biologics and medical technology areas. Regulation of imported food 
products will probably be the pressing issue of the next millennium. As 
more imported agricultural products find their way to American tables, 
there will be more pressure upon FDA to act to prevent tainted products 
from getting to the market.
  Nonetheless, reform is absolutely necessary and S. 830 is a good 
start in that direction. This bill represents a full year of work by 
stakeholders aimed at reaching compromise legislation. The bill does 
not contain the draconian hammer provisions that made many of us 
reluctant to support FDA reform last year. I am happy to have a bill 
that I can support and that I truly believe moves the country in the 
right direction. S. 830 is good for patients, good for the industry, 
and good for the Nation's global competitiveness. I hope that my 
colleagues will join me in supporting this important legislation.
  Mr. McCONNELL. Madam President, in 1906, Congress approved the first 
national statute to prevent the sale of adulterated and misbranded food 
and drugs. Since then, the FDA's responsibility to protect the health 
and safety of American consumers from unsafe products has expanded to 
cover over one-third of the products sold in our Nation.
  While medical research and technological developments have 
revolutionized our Nation's capacity to advance the public health, the 
FDA's adherence to bureaucratic and inefficient practices threatens to 
undermine the potential benefit of these hard-earned innovations. In 
the 1950's, it took a new drug or medical device approximately 8 years 
or less to achieve FDA approval. Today, the average time for approval 
runs between 12 to 15 years. Over the course of 20 years, the FDA's 
product approval system has undergone careful study by Congress, 
investigational committees, and the FDA itself, and each has identified 
key areas of reform that would enhance FDA performance.
  This week, the U.S. Senate considers vital legislation to ensure that 
the FDA can successfully fulfill its core mission to protect public 
health and safety through priority management, timely review of product 
applications, and effective use of expert resources. S. 830, the Food 
and Drug Administration Modernization and Accountability Act, reflects 
the fundamental recommendation of the Advisory Committee on the Food 
and Drug Administration that the FDA ``should be guided by the 
principle that expeditious approval of useful and safe new products 
enhances the health of the American people.'' The Advisory Committee 
noted that product approval ``can be as important as preventing the 
marketing of harmful or ineffective products, . . . especially . . . 
for people with life-threatening illnesses and for diseases for which 
alternative therapies have not been approved.'' In other words, 
antiquated procedures that promote unnecessary delays in the review of 
new products and therapies fail to promote the public health.
  In recent weeks, misinformation regarding the purpose and application 
of S. 830 reforms has been disseminated. As a supporter of S. 830 and a 
member of the Senate Committee on Labor and Human Resources, I want to 
clarify the objectives of this important legislative initiative.
  First, this bill clearly sets forth the FDA's mission to protect the 
public health by ensuring products meet appropriate regulatory 
standards, and to act promptly and efficiently in its review of 
clinical research and other information relevant to the marketing of 
approved products.
  Second, S. 830 responds to increasing public concern on the lack of 
access to investigational products for patients suffering from serious 
or life-threatening diseases. The FDA has established programs for the 
compassionate use of investigational products, however, only a limited 
number of patients have benefited from these opportunities. This bill 
will enable any patient with a seriously debilitating or immediately 
life-threatening condition to gain access to an investigational drug or 
device if the request is made by a licensed physician and the product's 
use meets the FDA's standards for expanded access. S. 830 also improves 
patient access to new therapies through a new fast-track drug approval 
process.
  Third, the bill addresses key deficiencies in the assessment of 
pharmaceutical effects on children. Currently, there is no systematic 
means for testing drug safety and efficacy for pediatric use. S. 830 
will allow the Secretary to request pediatric clinical trials for new 
drug applications and provide an extra 6 months of market exclusivity 
to manufacturers who voluntarily meet conditions under the trial 
program.
  Fourth, this measure will improve the availability of health care 
economics information for medical providers, and create data bases 
about on-going research and clinical trials for new lifesaving 
therapies for patients. Access to clear, concise information will help 
both health care professionals and patients identify the best course of 
medical treatment available.
  Fifth, S. 830 contains a series of reforms to assure that the FDA 
utilizes the scientific expertise of qualified Federal agencies, like 
the National Institutes of Health, and accredited outside organizations 
in order to improve the timeliness and quality of product reviews. The 
bill also contains reforms to ensure that the application process for 
new products is governed by consistent and equitable regulatory 
requirements in the areas of product classification, review, and 
approval.
  Sixth, this measure reaffirms the FDA's accountability for the 
performance of its Federal obligations. As a member of the Senate 
Appropriations Subcommittee for Agriculture, I have repeatedly 
questioned the FDA regarding its failure to prioritize resources for 
the fulfillment of its statutory requirements. In response to these 
concerns, S. 830 requires the FDA to develop a clear plan outlining how 
it will comply with its obligations under Federal statute, and report 
to Congress annually on the plan's implementation. In addition, the FDA 
must streamline and update procedures for product review and inspection 
so its resources are applied cost effectively.
  Seventh, S. 830 contains targeted reforms for food regulation. The 
bill simplifies the approval process for indirect food contact 
substances. It provides a more reasonable standard for the use of bona 
fide health claims based on the authoritative recommendations of 
qualified scientific bodies, such as the National Institutes of Health 
and the Centers for Disease Control and Prevention. While food reforms 
take on a minor role in this bill, I look forward

[[Page S9842]]

to working with my fellow members on legislation that will more 
thoroughly address the regulatory concerns of the food industry.
  Finally, S. 830 reauthorizes the Prescription Drug User Fee Act. In 
1992, the FDA and pharmaceutical industry agreed to the collection of 
additive user fees to pay for the additional staff needed to rectify 
delays in the review of new drug applications. This reauthorization 
proposal seeks to build upon those successes through new performance 
goals and equipment modernization plans. PDUFA serves as a clear 
example that the FDA can work with regulated industry and consumers to 
advance the public health through priority management and efficient use 
of resources.
  Madam President, S. 830 has been formed brick by brick from 
inclusive, bipartisan negotiations by representatives of the FDA, the 
Clinton administration, the U.S. Senate, industry, and consumer groups. 
The purpose of this bill is not to weaken the FDA's ability to defend 
the public health, but rather to enhance its capacity to fulfill this 
statutory obligation. Whether the issue is food safety or a 
breakthrough medical treatment, our Nation's researchers will only be 
successful if the FDA is prepared to effectively respond to the 
quickening pace of scientific discovery. S. 830 lays this essential 
foundation for the FDA's future, and I urge my colleagues to join in 
its approval.
  Mr. REED. Madam President, I rise today to address S. 830, the Food 
and Drug Administration Modernization and Accountability Act of 1997. 
This is an important bill with serious implications for the health of 
the American people.
  The FDA is responsible for assuring that the Nation's food supply is 
pure and healthy as well as providing a guarantee that drugs and 
medical devices are safe and effective. The FDA has an immense impact 
on the lives of all Americans. Few government agencies provide this 
kind of important protection for the American people. Indeed, the FDA's 
mandate requires it to regulate over one-third of our Nation's 
products. Daily, the FDA faces the delicate balance between ensuring 
that patients have swift access to new drugs and devices, while 
guaranteeing that those new products are safe and effective.
  S. 830 contains many positive elements. It reauthorizes the important 
Prescription Drug User Fee Act, one of the most effective regulatory 
reforms ever enacted. S. 830 also includes a number of provisions that 
will improve and sensibly streamline the regulation of prescription 
drugs, biologic products, and medical devices. I believe that these 
important reforms to the operation of the Food and Drug Administration 
will increase its efficiency and speed the delivery of important new 
medical treatments to patients.
  One of the most important elements of this legislation is the 
reauthorization of the Prescription Drug User Fee Act, often referred 
to as PDUFA. PDUFA established an important partnership between the 
agency and the industry, and has successfully streamlined the drug 
approval process.
  I am pleased that S. 830 will provide expedited access to 
investigational therapies. This provision builds on current FDA 
programs related to AIDS and cancer drugs. Another important element 
will allow designation of some drugs as fast track drugs, thus 
facilitating development and expediting approval of new drugs for the 
treatment of serious or life-threatening conditions. The bill will also 
require the Secretary of the Department of Health and Human Services to 
establish a database on the status of clinical trials relating to the 
treatment, detection, and prevention of serious or life-threatening 
diseases and conditions. Patients have long deserved access to such 
information, and I am pleased that this bill provides it.
  S. 830 is the result of ongoing negotiations both prior to and 
subsequent to the markup of the legislation. Through this process, a 
number of provisions that seriously threatened public health and safety 
were dropped or otherwise resolved. I am particularly pleased that 
improvements made since the markup include important protections to the 
third party review process. Important changes have also been made to 
provisions regarding health claims for food products, health care 
economic claims and a number of other provisions in the original 
legislation.
  Yet, there was one important change that was not made to S. 830. 
Yesterday, along with Senators Kennedy, Bingaman, and Durbin, I offered 
an amendment that would make a change on device labeling claims--an 
issue that has been identified by the Secretary of HHS as worthy of a 
recommendation to the President to veto this bill. Although our 
amendment did not prevail, I am still hopeful that this issue can be 
resolved as the bill continues through the legislative process.
  In effect, the bill limits the FDA's current authority to ask device 
manufacturers for safety data. It prohibits the FDA from considering 
how a new device could be used if the manufacturer has not included 
that use in the proposed labeling application. As a general matter, the 
FDA does not consider uses that the manufacturer has not included in 
its proposed labeling materials. However, there are instances when the 
label does not tell the whole story. It is these instances--when the 
label is false or misleading--that our amendment addressed.
  I am disappointed that we were not able to resolve this one issue, 
because the rest of the bill is worthy of support. However, I am unable 
to support this bill today because the device labeling issue remains 
unresolved. This matter is too important to the health and safety of 
Americans to vote for S. 830 at this time.
  I look forward to working with my colleagues to resolve the issue of 
the FDA's authority in the device approval process. And when this issue 
is resolved, I am prepared to vote in favor of this bill.
  Mrs. BOXER. Madam President, I want to begin my remarks by 
acknowledging the tremendous amount of work both Senator Jeffords and 
Senator Kennedy have put into this bill. I know there are a few issues 
where there is still disagreement. I also realize that some of my 
colleagues may be offering amendments which they believe will 
strengthen the bill.
  On balance, however, I believe this is a good bill that will have a 
very positive impact on helping to streamline and expedite some of the 
FDA review processes; and thus, help patients get access to new and 
promising treatments and devices in a safe, efficient, and expeditious 
manner. There is no agency within the Federal Government which has as 
direct or significant an impact on the American people as the Food and 
Drug Administration.
  The FDA is responsible for ensuring the foods that we eat are safe, 
wholesome, sanitary, and properly labeled, that the drugs that we take, 
and that we give our pets, are safe and effective and that there is a 
reasonable assurance that the medical devices which we use are safe and 
effective. I believe the FDA has done, and continues to do, a 
tremendous job in carrying out this mission--it is internationally 
recognized as the gold standard for the approval of medical products.
  The most important aspect of any FDA reform bill must be public 
safety. We have the safest food, drugs, and medical devices of any 
country in the world; and nothing we do should ever undermine this--
period.
  I also believe, however, that rapid technological advancements being 
made by biotechnology companies, and others, necessitate, and allow 
for, an expeditious product review and approval process. Obviously, 
this product review and approval process must simultaneously assure 
safety and efficacy. Again, safety and efficacy should not be 
compromised.
  Let me share with my colleagues an example of the technological 
advances being made by the biotechnology industry. Affymax, a 
biotechnology company located in my home State of California, has 
developed a technology to speed-up the analysis of drug and biological 
compounds.
  Affymax is a leader in the emerging field of combinatorial chemistry. 
Combinatorial chemistry functions by creating large numbers of diverse 
compounds to test against different disease targets. Affymax combines 
chemistries, sophisticated software and innovative molecular biology 
techniques to rapidly analyze and synthesize these potentially useful 
drug and biological compounds.
  I know about this process because I had the pleasure of seeing it 
when I

[[Page S9843]]

toured Affymax's laboratories last year. Affymax has greatly 
accelerated the pace of drug discoveries by developing high technology 
automated machines which can synthesize and screen 10,000 compounds in 
just one week. The same testing, previously done in test tubes and 
petri dishes, used to take about 5 years.
  These are the kinds of advancements which I believe make it necessary 
for the FDA to streamline its process, in those areas which can be 
streamlined, so that patients may get safe and effective products as 
expeditiously as possible. There are literally hundreds of thousands of 
patients around the country waiting for the next new and promising drug 
therapy and/or device to be approved.
  There are, of course, other very important aspects of this bill. Not 
the least of which is the reauthorization of the Prescription Drug User 
Fee Act--commonly referred to as PDUFA.
  PDUFA is generally considered the most successful piece of FDA reform 
legislation in recent history. It enables the FDA to collect user fees 
from pharmaceutical and biotechnology companies. Those fees are used to 
pay the salaries of hundreds of additional product reviewers and to 
fund product review. As a result, the FDA is able to speed-up its drug 
approval process and to more expeditiously get new and promising drug 
therapies, and medical devices, to those that need them.
  By all measures, PDUFA has been enormously successful. One measure of 
that success is the assertion by all parties involved--the FDA, 
patients, prescription drug manufacturers, consumer groups, and 
policymakers--that the program has worked. Certainly any program that 
receives the unanimous support of industry, consumer groups, the FDA, 
and policymakers must be extremely beneficial and should continue to be 
supported.
  This bill has other constructive elements as well. For example, the 
bill allows for expedited access to investigational drug therapies and 
for the expanded humanitarian use of devices. The bill also provides an 
incentive for drug manufacturers to conduct studies which support the 
safety and effectiveness of pediatric drugs and it provides for 
expanded collaboration and communication between the FDA and device 
manufacturers.
  The pediatric drug provision in this bill is especially important 
inasmuch as the overwhelming number of drugs on the market today are 
not tested for safety and effectiveness on children. It is important, 
therefore, that we provide drug manufacturers an incentive to test 
their products on children.
  I believe this provision, which gives drug manufacturers an 
additional 6 months of market exclusivity, is a reasonable and 
appropriate incentive, and will be a first step toward getting more 
drugs labeled for pediatric use. A very important and significant goal.
  I am also excited about the provision in this bill which allows for 
expanded communication and collaboration between the FDA and device 
manufacturers. It is important that device manufacturers and FDA 
examiners, early on in the review process, clearly establish the type 
of scientific evidence that will be necessary to demonstrate device 
effectiveness. Not only will this provision help bring about increased 
clarity and certainty in the review process, it will also help speed 
safe and effective devices to market. I believe this is especially 
important given the rapid technological advancements being made in this 
area.
  Finally, I want to thank Senators Gregg and Jeffords for working with 
me to ensure that California's proposition 65 will not be preempted by 
the uniformity provisions of this bill. California's proposition 65 was 
passed by California voters in 1986 and requires that persons who 
expose others to certain levels of carcinogens or reproductive toxins 
give a clear and reasonable warning.
  Proposition 65 has successfully reduced toxic contaminants in a 
number of consumer products sold in California and it has even led the 
FDA to adopt more stringent standards for some consumer products. For 
example, proposition 65 has been used successfully to reduce toxic 
contaminants in ceramic dishware and in lead-foil wine bottle caps. 
Notably, the FDA followed the lead of California in both those 
instances. In fact, the FDA has adopted a standard completely barring 
the use of lead-foil wine bottle caps pursuant to California's 
agreement with the wine industry to convert to tin or plastic bottle 
caps. So I am very pleased that the FDA reform bill now being debated 
will exempt California's proposition 65.
  As I stated at the outset, I believe, on balance, this is a good bill 
and will be beneficial in helping to get safe and effective drugs and 
devices to the American people in a more expeditious manner.
  Mrs. FEINSTEIN. Madam President, S. 830, the bill before us today, 
will improve the tools used by the Federal Food and Drug Administration 
to bring more, safe and effective drugs, biologics and medical devices 
to the American people more quickly.
  FDA is one of our Government's most important agencies because FDA 
approves life-saving medicines and devices and FDA protects us from 
unsafe and ineffective medicines and devices. Thanks to FDA, products 
like defective heart pacemakers, dangerous intrauterine devices, and 
overheating infant incubators are not sold.
  FDA's 2,100 scientists and 7,000 other employees monitor about $1 
trillion worth of products each year, inspect over 15,000 facilities a 
year, and examine about 80,000 product samples. FDA finds about 3,000 
products a year unfit for consumers and detains 30,000 imports a year 
at ports of entry.


                      Hope for Cures for Diseases

  Millions of Americans have serious, debilitating illnesses for which 
there is no treatment or cure. There are 3,000 to 4,000 genetic 
diseases alone. Cancer kills half a million Americans per year. 
Diabetes afflicts 15 million Americans a year, half of whom do not even 
know they have it. Fifteen thousand American children die every year. 
And, for children, the rates of asthma, bronchitis, sinusitis, heart 
murmurs, epilepsy, and anemia are on the rise. We put our faith in the 
medical industry and Government to find cures and therapies. Americans 
want an FDA that brings safe and effective drugs to market as quickly 
as possible to alleviate suffering, pain, and disease and to prevent 
death.
  The bulk of the bill before us today, a bill to accelerate the 
approval of prescription drugs, biologics, and devices, is an important 
bill to the Nation and especially to my State. It is a good bill, 
except for section 807, ``National Uniformity'', provisions that could 
interfere with California's efforts to protect the public health laws.


                           California's Role

  California is the Nation's premier medical technology base, public 
and private. Many of the Nation's leading drug, biotech, and device 
companies collaborate with the State's nine academic medical centers 
and conduct some of the world's leading health research. The UC system 
has spawned 30 Nobel laureates. Forty percent of California's biotech 
companies were started by UC scientists.
  The Nation's largest concentration of health care technology 
companies is in California who employ 165,000 people. California's 900 
health care technology companies are producing leading edge products, 
for example, the first new therapy for cystic fibrosis in 30 years, 
Genentech; technology that enables doctors to do heart surgery without 
opening the chest cavity, Heartport; a cancer drug that is genetically 
engineered and stimulates the bone marrow to produce important white 
blood cells, Amgen; and linear accelerators for treating cancer, 
Varian, and intraocular eye lenses, Allergan.
  California produces 19 percent of all U.S. medical instruments, 20 
percent of all diagnostic materials, and 13 percent of all biologics. 
There are 915 drugs, biologics, and devices under development in my 
State.
  So the bill before us is important to both the human health and the 
economic health of the Nation and of California.


                             Key Provisions

  The bill includes several improvements over current law that will 
bring more drugs, medical devices, and biotech products to people more 
quickly:
  1. Extends User Fees: Extends for 5 years the Prescription Drug User 
Fee Act to accelerate drug and biologics approvals. The prescription 
drug user fees, enacted in 1992, have enabled FDA to hire 600 
additional drug reviewers and FDA has cut drug approval times almost in 
half, from 29.2 months in 1992

[[Page S9844]]

to 15.5 months in 1996, according to the drug industry. This means that 
patients have had access to drugs almost a year sooner. These include a 
new class of drugs for asthma; a new treatment for multiple sclerosis; 
five new cancer drugs; the first new insulin product in 14 years; and 
three new antiviral medicines for AIDS, including two protease 
inhibitors.
  This bill reflects the agreement of the drug and biotech industries 
to pay over $500 million in new user fees over the next 5 years, which 
could bring to the public 1,000 medicines now in the pipeline. These 
renewed user fees could help FDA cut drug approval times even more, an 
additional 10 to 16 months.
  2. Clinical Trials Database (the Feinstein-Snowe bill): Requires NIH 
to establish a database, including a 1-800 number, for patients and 
medical providers to obtain information on clinical trials on serious 
and life-threatening diseases. This provision incorporates S. 87, a 
bill I introduced with Senator Snowe, last August, was suggested by one 
of my constituents in a hearing of the Senate Cancer Coalition, which I 
co-chair. Facilitating access to information can help patients and 
their doctors learn about research underway and can expand the pool of 
research participants.
  4. Pediatric Drugs: Provides 6 months of additional market 
exclusivity of a drug when the manufacturer, at the request of the FDA, 
conducts pediatric studies to support pediatric labeling for a drug.
  According to the American Academy of Pediatrics, only 20 percent of 
drugs have been tested and proven to be safe and effective for use in 
infants and children. This creates serious problems for pediatricians 
who must prescribe with inadequate information or deny children 
important therapies. In a July 24 letter to me, they give the example 
of asthma and say that in most children it manifests itself by age 
five, but there is only one asthma drug labeled for children under age 
five.
  5. Accelerating Approvals: The bill includes a number of provisions 
designed to modernize, streamline, and accelerate the drug and device 
approval process. For example, it allows products manufactured at a 
small or pilot facility to demonstrate safety and efficacy prior to 
scaling up to full manufacturing, unless FDA determines that a full-
scale facility is necessary to ensure safety and effectiveness.
  For biotech products, it establishes one license, rather than the 
current two, covering both the biologics or product license and the 
plant's manufacturing processes license . For medical devices it 
requires FDA to meet with manufacturers to establish the type of 
scientific data needed to demonstrate efficacy of the device and it 
requires FDA and the applicant to meet to evaluate the status of an 
application 100 days after submitting applications.


               PreEmpting California's Public Health Laws

  California has a long history of regulating nonprescription drugs and 
cosmetics and has led the Nation in many instances in protecting the 
public in these areas. For example, in 1981, California adopted a 
requirement that nonprescription drugs carry a label warning pregnant 
or nursing women to consult with their physician or pharmacist prior to 
using a drug. In the following year, FDA adopted the California 
requirement.
  But section 807 of the bill, titled ``National Uniformity,'' 
restricts States' actions by prohibiting States from establishing or 
continuing, for nonprescription drugs, any requirement that is 
``different from or in addition to or that is otherwise not identical 
with'' a Federal requirement. For cosmetics, Section 807 prohibits 
states from establishing or continuing requirements for packaging and 
labeling that are ``different from or in addition to or that is 
otherwise not identical with'' a Federal requirement.
  California Attorney General Lungren, in a July 14 letter, cites the 
Sherman Food, Drug, and Cosmetic Law as an example. He argues, ``* * * 
we are concerned that this provision may be construed to preempt States 
from imposing any requirements on cosmetics or over-the-counter drugs, 
and could therefore prevent the State of California from enforcing 
significant laws dealing with the health and safety of its citizens in 
the absence of a specific FDA exemption.''
  The California Department of Health Services has also raised concerns 
about the preemption language, concern about the bill's impact on their 
ability to protect the public health. I believe in allowing States to 
enact stronger laws to protect the health of citizens and introduced an 
amendment on September 15 to allow California's laws to stand.
  I appreciate the colloquy of my colleague and the bill manager, 
Senator Jeffords, that clarifies the extent of preemption intended by 
the authors of the bill. Senator Jeffords clarified that it is not the 
intent of this bill to prohibit the state from issuing public 
statements to warn the public about public health dangers. He said that 
it is not the intent of the bill to preempt State enforcement authority 
such as California's power to embargo products and to license and 
annually inspect facilities. On advertising, he stated that it is not 
the intent of the bill to affect State laws that prohibit false and 
misleading advertising or to prohibit unsubstantiated claims for 
nonprescription drugs. My office will remain in communication with the 
State to determine if problems develop and work with Senators Jeffords 
and Kennedy in this regard.
  The bill does include, at my request, an explicit protection--an 
exemption from preemption--for California's ``Proposition 65,'' a 
ballot initiative enacted in 1986 on a 63 to 37 percent vote which 
requires anyone exposing someone to chemicals known to cause cancer or 
birth defects to give a warning. Attorney General Lungren wrote on July 
14 to Senator Jeffords, ``S. 830 [as reported from the Labor Committee] 
would, in the absence of specific FDA exemption, appear to prevent the 
State of California from enforcing both the Sherman Food, Drug and 
Cosmetic Law as well as Proposition 65, a state `Right to Know' 
statute, passed by the voters of California in 1986. * * * We therefore 
respectfully urge you to seek modification of your bill to address this 
issue.''
  Proposition 65 has provided important protections to the public and 
has prompted manufacturers to reformulate products. Because of this 
law, for example, manufacturers removed toluene from nail polish, lead 
from antacids, and calcium supplements and leadfoil from wine bottles. 
I am pleased that the Senate agreed with my request to explicitly 
exempt proposition 65, preserving this important California law, and I 
thank my colleagues for their support.
  I believe it is wrong to preempt California's progressive drug and 
cosmetic laws. The citizens of my State have chosen to safeguard the 
public health through a strong State law and I have worked to protect 
our State's laws in this bill.


                               Conclusion

  By extending prescription drug user fees, we can give FDA some of the 
resources it needs to bring products to the public and alleviate human 
suffering. I hope that this bill can move quickly to enactment so that 
the public will have a strong FDA.
  Mr. WELLSTONE. Madam President, I take this opportunity to thank my 
colleagues for all of the hard work that they have done on S. 830, the 
FDA Modernization and Improvement Act of 1997. Senator Jeffords has 
provided his leadership in bringing this legislation forward, and my 
other colleagues have worked to negotiate agreement on provisions where 
there was concern. I would like to thank Senator Coats, who was true to 
his word that he would work with us to come to an agreement on third 
party issues, and Senator Gregg, who worked to reach a compromise on 
the national uniformity provision.
  It is my belief that we can provide medical products to consumers in 
a more timely manner through many of the provisions in this bill, while 
retaining significant consumer protections. Many of the provisions in 
S. 830 will take a significant step toward addressing Americans' 
concerns with the FDA. The legislation would improve the 
predictability, timeliness and focus of the regulatory process for 
medical products. The legislation would also improve communication and 
collaboration between the FDA and the regulated industries. I strongly 
endorse the view that these objectives can be met

[[Page S9845]]

and unnecessary regulatory burdens can be minimized without 
compromising the quality of the reviews.
  My colleagues and I have worked very hard on bringing forward needed 
reform proposals with respect to the review and approval of medical 
devices. We have negotiated many of the original provisions in the bill 
to the point that we have reached agreement on them, and can join 
together in supporting them. We have taken into consideration the 
comments and concerns of consumers and industry in order to present a 
bill that will improve the review and approval processes.
  As you know, I have always been and will continue to be a strong 
consumer advocate. I think that S. 830 provides many things for 
consumers and will help to bring them medical therapies that are safe 
and effective in a more timely fashion. This is especially true with 
respect to devices. This is the part of the bill on which I have 
focused the bulk of my attention, and I do think that a large number of 
concerns that I and some of my colleagues, in particular Senator 
Kennedy, had have been addressed.
  There has been a great deal of discussion and debate about section 
404 of the bill, which deals with labeling for intended use of devices. 
This issue is highly technical, but it is clear that all of us have the 
same goals in mind: First, to provide a degree of consistency in the 
way devices are reviewed by individual reviewers, so that reviewers do 
not try to second guess an honest manufacturer with respect to the 
intended use of a device, and second, to prevent the very few companies 
who might try to avoid presenting the FDA with adequate data about 
safety and effectiveness from having their devices classified and 
brought to market under the 510(k) process. I do not believe that the 
provision in this bill prohibits the FDA from exercising its authority 
to not find a device substantially equivalent to its predicate device 
when there are technological differences that raise new issues of 
safety and effectiveness. But obviously, there are differences of 
opinion with respect to this provision. Since we all agree on the goals 
that we are trying to achieve, I think that there must be a way of 
clarifying the authority of the FDA in a way that is satisfactory to 
everyone.
  The Reed-Kennedy amendment offered one option, but this option is not 
the appropriate one. Several other suggestions for language to clarify 
this have been offered, but none capture what we are all trying to do. 
Rather than reiterate all of the arguments that were stated in the 
debate over the past several days, I will ask that my colleagues who 
are appointed as conferees work together to ensure that this provision 
is worded to make clear that it will penalize anyone who tries to get 
around the law, but will not penalize those who are complying with the 
intent of Congress and the law.
  Madam President, as I have said before, I think this is an important 
piece of legislation. It is clearly important that we reauthorize and 
improve PDUFA, and that we work to bring safe and effective medical 
therapies to the public in a timely manner. Again, I would like to 
thank my colleagues, especially Senator Jeffords and Senator Kennedy 
and their staff members for all of their efforts on this bill. I would 
also like to thank the consumer groups for their input, and the 
administration for its assistance in the negotiations process. I trust 
that the conferees will keep the importance of this bill in mind as 
they negotiate to bring the final legislation to the floor for passage.
  Mr. JEFFORDS. I ask unanimous consent that a letter from the 
Nonprescription Drug Manufacturers Association to Senator Lott be 
printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

               Nonprescription Drug Manufacturers Association,

                               Washington, DC, September 15, 1997.
     Hon. Trent Lott
     U.S. Senate, Washington, DC.
       Dear Senator Lott: In a letter to you dated September 4, 
     the National Governors' Association (NGA), National 
     Conference of State Legislatures (NCSL) and Association of 
     State and Territorial Health Officials (ASTHO) stated their 
     opposition to the national uniformity provision (Sec. 761) in 
     S. 830, the Prescription Drug User Fee Act (PDUFA) and FDA 
     modernization legislation. Unfortunately, their letter 
     contained several incorrect and misleading statements 
     concerning nonprescription, over-the-counter (OTC) medicines 
     and the application of the national uniformity provision. In 
     order to set the record straight on this important issue, I 
     offer the following comments.


1. national uniformity for otc drugs will protect the public health and 
                                 safety

       One national, uniform system of regulation for OTC drugs 
     protects the interests of all American consumers. There is 
     simply no difference in the safety, effectiveness, and proper 
     labeling of OTC drugs from one state to another. An OTC drug 
     that is safe, effective, and properly labeled for a consumer 
     in Louisiana is safe, effective, and properly labeled for a 
     consumer in Massachusetts, and vice versa.
       Allowing states to establish a patchwork of different 
     requirements for OTC drugs makes no sense. It would even be 
     detrimental, resulting, for example, in confusion as 
     consumers are confronted with different labels for the very 
     same OTC drug obtained in different states. Moreover, non-
     uniform laws for OTCs would drive up consumer expense through 
     the costs of different and inconsistent state requirements 
     for testing, labeling, and packaging, and through disruption 
     of the distribution for products required to meet as many as 
     50 disparate state systems.
       The authors assert that there is no evidence that shows a 
     need to preempt state laws regulating OTC drugs. Attachment A 
     lists several examples of state proposals, which, if enacted, 
     would have disrupted national uniformity.


   2. Important state interests would be fully protected under S. 830

       The authors mistakenly say that states would be prevented 
     from effectively addressing compelling OTC drug problems 
     unique to their states under S. 830. They particularly 
     criticize the exemption procedure in S. 830. The exemption 
     provision enables a state to petition FDA to depart from the 
     single uniform national standard for an OTC drug. The 
     preparation and submission of an exemption petition will not 
     be a very burdensome or expensive process, and FDA can be 
     expected to rule on such petitions promptly. Moreover, the 
     three requirements for exemption from uniformity for a state 
     are logical. If the public interest represented by the state 
     proposal is already protected, there is no need for a state 
     exemption to protect it. As interstate products, OTC drugs 
     could not and should not violate other applicable federal 
     laws. The prohibition against unduly burdening interstate 
     commerce simply requires a sensible balancing of competing 
     interests.
       The authors also claim that states would be prohibited from 
     taking action on their own even where there are compelling 
     local conditions. They argue that states are expected to 
     address compelling local conditions and that the Constitution 
     already prohibits state laws that unduly burden state 
     commerce. Therefore, they argue that the preemption provision 
     of S. 830 is unneeded, and that states should not be required 
     to petition FDA for exemptions from preemption.
       The authors' premises are flawed. States are not limited to 
     laws that address ``compelling'' local conditions. They have 
     broad police powers to enact laws that deal with any 
     legitimate issue. Moreover, they can pass laws that affect 
     not just local conditions but regional and national ones as 
     well. When analyzed under the ``dormant'' Commerce Clause, 
     state laws enjoy a presumption of validity, and they will not 
     be invalidated unless they impose burdens on interstate 
     commerce that are clearly excessive in comparison to their 
     benefits. This is a very different test from the one embodied 
     in the national uniformity provision of S. 830 for OTC drugs.
       A state law that does address a compelling local condition 
     and does not unduly burden interstate commerce would be 
     eligible for FDA consideration of an exemption petition. Many 
     state laws, however, will not meet such a test and therefore 
     should not be permitted to stand. The only way to distinguish 
     one type of law from the other is to establish an exemption 
     petition procedure. The petition process would not be 
     expected to be burdensome, as described above.
       Apart from the exemption procedure from preemption in S. 
     830, states would retain full authority to take action in 
     emergency and (non-emergency) situations involving OTC drugs 
     as follows: First, the bill would not affect the right of a 
     state to take action immediately, without consultation with 
     FDA, to deal with an authentic local emergency involving a 
     nonprescription drug, such as outbreak of an abuse problem. 
     If there is a true local emergency, as the authors 
     acknowledge, the state could take immediate action to place a 
     nonprescription drug on prescription status until the problem 
     abates: And as noted below, some states have done that in the 
     case of ephedrine-containing OTC drug products.
       Second, the bill would prevent the states from undertaking 
     unilateral action, again without consultation with the FDA, 
     to issue their own public statements in the form of health 
     department releases, public service announcements, or other 
     public education campaigns to alert state consumers about its 
     concerns about an OTC drug. The bill would simply prevent the 
     states from imposing 50 different notification requirements 
     on the OTC maker, whether in labeling, packaging or other 
     form of public communication, which would disrupt the 
     longstanding national system of review and marketing for 
     nonprescription drugs.

[[Page S9846]]

       Third, the bill would not prevent the states from utilizing 
     their enforcement authority to take immediate action against 
     an OTC drug that was adulterated, misbranded, or otherwise 
     out of compliance with laws that are the same as federal 
     laws.
       Fourth, as recognized by the authors, the states can also 
     require an OTC drug to be dispensed only by prescription.


  3. states can petition for adoption of their ideas as the national 
                            uniform standard

       The authors comment that FDA lacks adequate resources to 
     act and states must be permitted to provide ``important 
     protections'' FDA is unable to provide. This is specious. FDA 
     has not failed to act in any case in the OTC area where 
     action was otherwise warranted, on the basis of resources. 
     FDA regulation of OTC drugs under the OTC Review, for 
     example, is unrivaled in the world as the most comprehensive 
     system of safety, effectiveness, and labeling review of its 
     kind ever undertaken. Similarly, FDA is currently embarked 
     upon a mammoth program to completely overhaul and standardize 
     the format and content of all OTC drug labels.
       The authors' argument also ignores the fundamental policy 
     embodied in the national uniformity provision--that FDA is a 
     national expert agency that should set national standards. 
     The states remain laboratories of good ideas, which FDA can 
     adopt as national standards or allow to take effect locally 
     if they qualify for an exemption. But there is no 
     constitutional or policy reason to prefer 50 mini-FDAs over a 
     singly national one.
       The bill would preserve the states right to petition the 
     FDA to adopt a state proposal as the uniform national 
     standard for OTC drugs. If a state believes it has an 
     innovative idea for protection of the nation's OTC drug 
     consumers as a whole that is superior to protection provided 
     by FDA, it can petition FDA to adopt the idea as the national 
     standard. That way, potential improvements in the OTC 
     regulatory system can be evaluated by all interested parties 
     against the background of the overall FDA regulatory program 
     for OTC drugs. If FDA concludes that the state's proposal is 
     the right one, then it can adopt it as the national standard.


 4. states would not be preempted in regulation of dietary supplements 
                        or other kinds of foods

       The authors mistakenly assume that dietary supplement state 
     regulation and other health food regulation would be affected 
     by preemption. Neither dietary supplements nor foods of any 
     kind, including dietary supplements or health foods 
     containing ephedrine, would be covered by the OTC drug 
     preemption provision of S. 830. Thus, none of the state laws 
     cited by the authors in Louisiana, New York, Michigan, 
     Maryland, Vermont, Washington, or Minnesota, would be 
     preempted by S. 830 because there is no preemption of food 
     laws.


 5. states would not be preempted from regulating OTC drugs other than 
 with respect to the federal laws governing OTCs that are specifically 
                          enumerated in S. 830

       With respect to ephedrine-containing OTC drug products, 
     contrary to the authors' statements, no state has imposed any 
     labeling or packing restrictions on these products different 
     from or beyond those imposed by the FDA. Some states have 
     taken action on some OTC ephedrine products to place certain 
     products on a controlled substance schedule, to place 
     ephedrine on prescription status, to limit access to adults, 
     and to prohibit possession of large quantities of the drug 
     with intent to make methamphetamine. None of these state laws 
     or actions would be preempted by the national provision of S. 
     830, because they are not laws enumerated in the section 807 
     of the bill (Sec. 761(a)(1)(B)).


     6. all otc drugs are subject to the same exacting fda safety, 
                effectiveness and labeling requirements

       The authors make an unfounded and alarmist assertion that 
     as more medications are switched from prescription to OTC 
     status, consumers, especially the elderly and youth, are 
     placed at greater risk. All nonprescription drugs, whether 
     brought to market by being switched from prescription status, 
     or marketed as OTC drugs from the outset, are subject to the 
     same high and exacting standards for safety, effectiveness, 
     and labeling. Indeed, nonprescription drugs are required to 
     have an especially wide margin of safety precisely because 
     they are intended to be purchased and used by consumers 
     without the intervention of a doctor.


    7. national uniformity is supported by many state and national 
           organizations and several former FDA commissioners

       Support for national uniformity of OTC medicines is 
     widespread and continues to grow. Over 90 organizations 
     including the American Medical Association, National 
     Consumers League, United Seniors Health Cooperative, as well 
     as several state pharmacy, medical and retail organizations 
     are in favor of one, uniform system of regulation for these 
     important products. In addition, four former FDA 
     Commissioners support this provision. (See Attachment B.)
       Thank you for considering our views on this important 
     subject. We urge you to continue your support for national 
     uniformity for OTC medicines.
           Sincerely,
                                                    James D. Cope.
                                                        President.
       Attachments: (A) Examples of State Proposals That Would 
     Disrupt National Uniformity; (B) Organizations Supporting 
     National Uniformity.

                              Attachment A


   examples of state proposals that would disrupt national uniformity

       The authors state that there is no evidence that there is a 
     need for pre-exemption of state laws that seek to regulate 
     OTC drug packaging and labeling. That quite simply is not 
     true!. Here are just a few examples of state proposals that 
     would, if enacted, disrupt national uniformity.
       First, in 1993 alone, three states proposed to require 
     bittering agents in certain OTC medicines sold in those 
     states to deter childhood poisonings and overdoses. These 
     state bills received consideration despite the federal CPSC's 
     rejection of bittering agents under the Poison Prevention 
     Packaging Act in favor of child resistant packaging and 
     consumer education to address the problem.
       Second, in the 1990s, at least fifteen state legislatures 
     have considered legislation to require ``environmentally-
     friendly packaging'' of OTC drugs, that would mandate certain 
     recycled content levels and plastic resins. These proposals 
     would have conflicted with FDA's safety requirements that 
     certain drugs be packaged only in ``virgin'' materials to 
     prevent adulteration of the drugs. In some cases, these 
     various proposals would conflict with each other as well.
       Third, numerous states have proposed to require certain 
     language and label warnings on OTC drugs that add additional, 
     inconsistent and confusing precautions to these labels, in 
     addition to the lengthy and comprehensive labeling 
     requirements imposed by the FDA. Where would this extra room 
     on OTC labels come from to accommodate all the suggestions 
     that would be imposed by 50 states? Most OTC drugs are 
     relatively small products, and thus have very limited label 
     space.
       OTC drug labels contain much FDA required information 
     essential to their safe and proper use; therefore state-by-
     state proposals requiring additional label information 
     obscure FDA-mandated warnings. Such proposals must be viewed 
     in the context of the available label space. FDA makes these 
     judgments recognizing the need for judicious use of scarce 
     label space. Examples of these state-by-state proposed 
     requirements include:
       Conflicting proposed legislation in various states that 
     would require--(1) the word ``poison'' along with antidote, 
     (2) a ``Mr. Yuk'' symbol affixed to the label, (3) a special 
     poison warning including a dark green background, and (4) a 
     black ``X''--each of these different state proposals seek to 
     address the same problem of childhood poisonings; label 
     disclaimers that the elderly should disregard label dosages 
     and consult a physician before taking any OTC drug, despite 
     an absence of any scientific evidence that drug absorption or 
     metabolism is connected to turning 65 years old; label 
     disclosure that a certain product was tested on animals in 
     its development, even though the FDA may require animal 
     testing of the drug prior to its use in humans; label 
     warnings that a product is unsuitable for disposal on land or 
     in water; one state's attempt to require extensive label 
     cautions on fluoride-containing toothpastes that fluoride is 
     an enzymatic and protoplasmic poison 15 times more poisonous 
     than arsenic; and initiatives or legislation in ten states 
     that would have required special label warnings that certain 
     ingredients may be carcinogens, even where the FDA has 
     reviewed the drug and determined that it is safe and 
     effective at the levels that the ingredient is used in that 
     product. These states would reject the FDA's careful risk/
     benefit analysis of medications in favor of scaring consumers 
     even where only trace quantities of the substance are 
     present.
       One can easily understand the confusion to consumers that 
     would result if these warnings showed up on products in one 
     state but not on the same identical product destined for 
     another state. If any of the above ideas are good ones, they 
     should be considered by FDA; receive comments from the 
     public, the states, and the industry; and if they are 
     determined to be sound public policy, they should be made 
     national requirements.
       There is absolutely a need for national uniformity to 
     prevent such state proposals from disrupting commerce and 
     confusing consumers.

                              Attachment B


              organizations supporting national uniformity

       American Association of Colleges of Pharmacy; American 
     Beauty Association; American Medical Association; American 
     Society of Health-System Pharmacists; Area Agencies on Aging 
     Association of Michigan; Arizona Retailers Association; 
     Associated Food Dealers of Michigan; Association of Commerce 
     and Industry of New Mexico; California Arthritis Foundation 
     Council; California Chapters of the National Association of 
     Pediatric Nurse Associates & Practitioners; California 
     Coalition of Hispanic Organizations; Central Ohio Retail 
     Grocers Association; Chain Drug Marketing Association, Inc.; 
     Citizens for the ``Right to Know''; and Congress of 
     California Seniors.
       Congress of California Seniors--Los Angeles; Connecticut 
     State Medical Society; Florida Medical Association; Food 
     Marketing Institute; Generic Pharmaceutical Industry 
     Association; Giant Food, Inc.; Gulf Coast

[[Page S9847]]

     Grocers Association (Texas); Health Advocacy Services 
     (California); Independent Cosmetic Manufacturers & 
     Distributors, Inc.; Indiana Manufacturers Association; 
     Indiana Retail Council; Industry and Commerce Association of 
     South Dakota; Interamerican College of Physicians and 
     Surgeons; Iowa Retail Federal, Inc.; and Maryland Association 
     of Chain Drug Stores.
       Maryland Retailers Association; Medical Society of the 
     State of New York; Medical Society of Virginia; Michigan 
     Chamber of Commerce; Michigan Distributors and Venders 
     Association, Inc.; Michigan State Medical Society; Minnesota 
     Chamber of Commerce; Minnesota Grocers Association; Minnesota 
     Retail Merchants Association; Mississippi Wholesale 
     Distributors Association; Missouri Grocers Association; 
     Missouri Retailers Association; Missouri State Medical 
     Association; National Association of Chain Drug Stores; and 
     National Association of Manufacturers.
       National Coalition of Hispanic Health and Human Services; 
     National Community Pharmacists Association; National 
     Consumers League; National Council on the Aging; National 
     Hispanic Council on Aging; National Retail Federation; 
     National Wholesale Druggists' Association; New Hampshire 
     Medical Society; New Mexico Pharmaceutical Association; 
     Nonprescription Drug Manufacturers Association; North 
     Carolina Retail Merchants Association; Ohio Council of Retail 
     Merchants; Ohio Grocers Association; Ohio Wholesale Druggists 
     Association; and Pennsylvania Association of Chain Drug 
     Stores, Inc.
       Philadelphia Association of Retail Druggists; Philadelphia 
     College of Pharmacy; Retail Merchants Association of New 
     Hampshire; Retailers Association of Massachusetts; Robbie 
     Vierra-Lambert Spinal Cord Organization for Regaining 
     Excellence; Safety & Health Council of New Hampshire; 
     Safeway, Inc.; Senior Medication Awareness & Training 
     Coalition, Sickle Cell Disease Association of America, Inc.; 
     South Dakota Pharmacists Association; Tennessee Association 
     of Business; Tennessee Grocers Association; Texas Association 
     of Business & Chambers of Commerce; Texas Food Industry 
     Association; and The 60 Plus Association.
       United Seniors Association; United Seniors Health 
     Cooperative; United States Hispanic Chamber of Commerce; 
     Ukrop's; Vermont Board of Pharmacy; Vermont Chamber of 
     Commerce; Vermont Grocers Association; Vermont Medical 
     Society; Virginia Chamber of Commerce; Virginia Manufacturers 
     Association; Virginia Pharmacists Association; Virginia 
     Retail Merchants Association; Washington Retailers 
     Association's Retail Pharmacy Council; Washington State 
     Medical Association; White House Conference on Small 
     Business, New Jersey Delegation; Wisconsin Grocers 
     Association, Inc.; and Wisconsin Manufacturers and Commerce.


        former fda commissioners supporting national uniformity

       Charles C. Edwards, M.D.; Arthur Hull Hayes, Jr., M.D.; 
     Donald Kennedy, Ph.D.; and Herbert Ley, Jr., M.D.

  Mr. JEFFORDS. Madam President, we are nearing the end of the debate. 
I have no more requests for time that I am aware of. So I will make 
some comments and then go into a quorum call. But I want to alert 
Senators that if I do not have a request within the next 10 minutes, it 
is my intention to yield back the remainder of my time, assuming the 
minority would do the same thing, so that we can expedite the process 
and the movement of legislation through the Senate.
  Madam President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  Mr. JEFFORDS. Madam President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. JEFFORDS. Madam President, I yield 6 minutes to the Senator from 
Arkansas.

                          ____________________