[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.
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