Congressional Record, Volume 142 Issue 76 (Wednesday, May 29, 1996)

[Congressional Record Volume 142, Number 76 (Wednesday, May 29, 1996)]
[House]
[Pages H5631-H5639]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

REFORM OF THE FOOD AND DRUG ADMINISTRATION

The SPEAKER pro tempore. Under the Speaker's announced policy of May

[[Page H5632]]

12, 1995, the gentleman from Pennsylvania [Mr. Greenwood] is recognized
for 60 minutes as the designee of the majority leader.
Mr. GREENWOOD. Mr. Speaker, a number of my colleagues and I this
evening have taken it upon ourselves to engage in a 1-hour special
order on a very special package of bills we intend to move from the
Committee on Commerce, on which we all serve, through the House of
Representatives. We expect that the Senate will move its package and
that we will put this package on the President's desk and that he will
sign it.
The issue is reform of the Federal Food and Drug Administration.

general leave

Mr. GREENWOOD. Mr. Speaker, before we proceed, I would like to ask
unanimous consent that all Members may have 5 legislative days within
which to revise and extend their remarks on this special order.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Pennsylvania?
There was no objection.
Mr. GREENWOOD. Mr. Speaker, the Food and Drug Administration was
created by this Congress at the turn of the century, about 90 years
ago, and the Food and Drug Administration has a very important task.
Americans from all walks of life, as parents, as sons and daughters, as
spouses, rely on the Food and Drug Administration to make sure that the
drugs that are prescribed to us, that the food that we consume, that
the medical devices that are utilized in our care and hospitals are
safe and are effective.
And we are blessed because in this country we have the greatest
pharmaceutical industry in the world, we have the greatest medical
device industry in the world, and our people enjoy safety and the best
health care in the world as a result of the work of the Food and Drug
Administration. It does a very good job of making sure that the
products that reach us in the marketplace, that our doctors prescribe
to us, that we encounter in our hospitals are, in fact, safe and, in
fact, are effective; that they do what the makers say they will do for
us.
That is the good news. But there is another side of the FDA, and the
problem with the FDA is the time it has taken to move these products
from the research laboratory through the Federal bureaucracy of the
FDA, some 10,000 employees, to those Americans who are waiting for
miracle cures, for new drugs, for the latest heart transplant devices,
mechanical hearts. That time is too long. It is taking 12 years, on
average, to move a product, a pharmaceutical product, through the Food
and Drug Administration. It costs about $350 million for a company to
do it.
And I think that probably most Americans watching tonight would be
surprised to learn that two-thirds of all of the drugs that are
actually developed in the Untied States by our pharmaceutical companies
are first available to patients overseas, not in our country at all.
So our task has been with this legislation to see if we cannot
reengineer the FDA, the Food and Drug Administration; to redesign it,
reform it, update it, modernize it, make it better so that as we move
into the next century, the FDA can still be the gold standard for
safety and efficacy but also will begin to be able to bring these
miracle products and miracle cures to our people much more quickly,
because patients die in America today waiting for the bureaucracy
within the FDA to act.
We appreciate the FDA needs to act with caution, but we think that we
can reform the FDA so that it will act much more efficiently and much
more in the patient's interest.
Now, as many Americans have noticed, getting things done in this
Congress is not easy. It is a partisan place. It is a place of 535
individual Members of Congress. And in a Presidential election year, an
election year for most of the Congress, it is difficult to come to an
accord, and particularly on an issue as important and critical as
reform of the FDA.
So my colleagues who we will hear from tonight, Mr. Barton from
Texas, Mr. Klug from Wisconsin, Mr. Burr from North Carolina, and Mr.
Fox from my own State of Pennsylvania, have done something that is a
little unusual lately in the Congress, and that is we have reached out
from the beginning in a bipartisan fashion. We have said to our
colleagues on the other side of the aisle, this issue is about life and
death. This issue is about saving the lives of our children and our
parents and our husbands and our wives, and we need to put partisan
politics aside.

2045

We need to get the job done. We need to cooperate. We need to work
together. And our success to date has been, I think, miraculous. We
have gathered 159 cosponsors onto our bills, Republicans and Democrats
across the political spectrum.
We have reached out to the patient groups. We have talked to our
fellow Americans who suffer from AIDS or who are HIV-positive. We have
talked to cancer patients. We have talked to the practitioners treating
those patients and talked to patients who suffer from multiple
sclerosis and Lou Gehrig's disease, kids who suffer from diabetes, and
Americans who suffer from coronary artery diseases and a long, long
list of diseases that is extensive.
We asked them what they think we need to do to make sure that these
miraculous products being developed in our universities and our
laboratories are brought to those who are literally dying, to receive
them more quickly; and the result has been legislation that we think is
exciting, we think is innovative, and we think actually will be signed
into law in 1996.
We would like to share the details of this information with America
this evening. To that end, I would first like to recognize my good
friend and colleague from Texas, Mr. BARTON, who is the primary sponsor
and the lead on the medical devices bill. He will tell us about medical
devices and what we hope to do there.
Mr. BARTON of Texas. Mr. Speaker, I thank my friend from
Pennsylvania, Mr. Greenwood, for organizing this special order. I am
pleased to be on the House floor this evening with the gentleman from
Pennsylvania [Mr. Greenwood], the gentleman from North Carolina [Mr.
Burr], the gentleman from Wisconsin [Mr. Klug], the gentleman from
Florida [Mr. Bilirakis], and the gentleman from Pennsylvania [Mr. Fox],
as we talk about a very important issue.
Mr. Speaker, if you went out to the American people and asked them,
what does FDA stand for, I doubt very seriously that very many people
could say that it stand for Food and Drug Administration. I joked
earlier in the year in a television interview that it stands for ``foot
dragging and alibis,'' because it takes about 12 years and $350 million
to get a drug and medical device through the entire gauntlet of
approval steps at the FDA that are currently in place.
The people that are participating in this special order this evening,
colleagues that have cosponsored the bills in a bipartisan effort, we
want FDA to stand for fair decisions for all.
We have the best medical devices in the world; we have the best
pharmacological drugs in the world; we have the safest food supply in
the world. But more and more, our medical device companies, our
pharmaceutical, innovative, companies are going overseas because the
approvals do not take as long and the regulatory jungle is not as
complex as it is here in this country.
To put a personal face on it, Mr. Speaker, my father is in his early
70's. He is a veteran and served his country in World War II. He was a
navigator for the B-24 Liberator. Is now a diabetic and has been
diagnosed within the last several months to have a slow-growing form of
prostate cancer.
There are drugs in the marketplace today and procedures in the
marketplace today in other countries that, were he a citizen of Great
Britain or France or Germany, he would have access to those drugs and
devices. Because he is a citizen of the United States, he does not.
It is very difficult for me to go to Waco, Texas, where my father
lives, and say, Dad, I would like to help you, but under the current
law we cannot let you use that noninvasive glucose sensor, so you do
not have to prick your finger two or three times a day. Or, Dad, there
is a new drug that has been approved for prostate cancer overseas, but
it has not yet been approved by the FDA. If you live another 10 years,
maybe it will be approved.

[[Page H5633]]

I cannot say that.
But I can say, Dad, in the next 3 months, I hope to be a part of a
coalition of Republicans and Democrats in both the House and the Senate
that passes an FDA reform package that makes those drugs and makes
those devices accessible to you, not 10 years from now but next year,
and maybe even in the next 5 or 6 months.
In the medical device bill that I am the chief sponsor of we have
four basic principles. We do want a responsible method for third-party
review where a medical device applicant can either go outside the
system to an accredited third-party reviewer or can go within the
system within the FDA currently to have their application reviewed.
We want a dispute resolution which is obvious in any complex
situation. There are going to be disagreements. We think there needs to
be some mechanism where if the applicant and the FDA have a
disagreement about the application, you can get a fair resolution of
that disagreement. We do not want it to be a trivial disagreement; we
want it to be a substantive policy disagreement or a time disagreement.
But let there be a internal dispute resolution that is actually
workable.

Most Americans do not realize, but there is a cutoff date for medical
device qualifications in this country. If your device was in existence
before 1976, it is reviewed under a certain set of circumstances and if
it came into existence after 1976, it has to go through a much more
complex set of regulatory findings. We want to do away with this
artificial 1976 bright line and we want all devices to be reapproved
and, as they are, given an original classification and not
automatically put into the most complex classification of Class III.
I think you would be surprised, Mr. Speaker, to realize that a simple
piece of plastic called a breast sensor paid, which is two pieces of
plastic with a silicone gel between it, about 6 inches in diameter, it
took the FDA 10 years to approve the breast sensor device and then only
with the use of prescription under the care of a physician, because
under current law the breast sensor pad has to be classified as Class
III, which would be like a heart implant.
Under our legislation, if approved and put into law, the breast
sensor pad would be given a reclassification and almost certainly be
put into Class I or Class II, where it would be available over the
counter so that millions of American women could obtain it at a nominal
fee and would be able to self-examine their breast in the privacy of
their home.
The last thing that we want to insist on in the medical device bill
is that all new devices be given a fair evaluation within a time
certain of when they are presented. And that may again be third-party
or may be within the FDA.
Mr. Speaker, I am pleased to participate in this special order. I
commend Mr. Greenwood and, again, all the other chief sponsors that are
here this evening: Mr. Klug, Mr. Burr, the chairman of our
subcommittee, Mr. Bilirakis of Florida, and of course Mr. Fox of
Pennsylvania.
This is a bipartisan effort. It has got overwhelming support among
the American people, 70 to 80 percent approval in the various polls,
and we hope that before we adjourn to go home that we can have a bill
on the President's desk and we think President Clinton will sign it.
I yield back to the distinguished gentleman from Pennsylvania.
Mr. GREENWOOD. Before the gentleman leaves, I want to recall the
gentleman who came to our first press conference who suffered from a
coronary problem where he had an artery that was closing down, and he
needed a stint. Is that the right term? A stint that could be implanted
in this artery to keep it open and keep the blood flowing.
He was told that his time was limited, he did not have long to live.
There was a device that had been invented; I have it in my hand. I do
not know that the camera can pick it up. It looks like a spring you
might take out of a ball point pen. This is implanted in the artery and
holds it open.
Mr. BARTON of Texas. I believe that device is available in Italy, but
not in the United States.
Mr. GREENWOOD. Finish the story. He did go to Italy.
Mr. BARTON of Texas. It wasn't on the approved list in the United
States it was approved in Europe. And so the gentleman went to Italy
and his surgeons, I believe, flew to Italy with him, and they had the
operation, and it was a success and he went mountain climbing within 6
months after the operation.
Had he stayed in the United States and waited for the FDA for
approval, it is arguable that the gentleman would be dead today. He
would not only not be mountain climbing, but he would not be breathing
today. But because he did go overseas and was fortunate enough to have
the money to go overseas, he is alive to tell the story today.
Mr. GREENWOOD. That story tells what needs to be told and what we are
trying to accomplish here, and that is save lives. He was fortunate. He
could afford to go to Italy and have the surgery and pay for it, but
most Americans do not have that luxury.
Let me share one final point with the gentleman. We have something
else in common. My dad is a B-24 liberator pilot as well.
Mr. Speaker, I would like to now yield to my colleague, the gentleman
from Wisconsin [Mr. Klug], who is the prime sponsor of the second of
our three-bill package and that is the bill that would reform FDA with
regard to its responsibilities for approving food products.

Mr. KLUG. Mr. Speaker, I thank the gentleman from Pennsylvania, Mr.
Greenwood, for the time and also thank him and Chairman Bliley and
Chairman Bilirakis for their leadership on this proposal, as well as my
colleagues from Texas and North Carolina.
Mr. Speaker, I want to go back, because I do not think we can stress
this often enough, to what is at stake in FDA reform, period. Because
you managed, Mr. Greenwood, at the end of your conversation with Mr.
Barton, I think, to put a very human face on what happens with FDA
reform.
I can remember standing about 6 weeks ago in a press conference in
Madison with the family of a young boy, Cody Young, who lives in
Baraboo about an hour from Madison, the place where the Ringling
Brothers Circus was founded. And he has a severe case of epilepsy. And
the tragedy of this story, as you will hear over and over tonight, is
that the original medication developed for Cody Young's severe case of
epilepsy was first conceived at a United States research facility. It
was tested in the United States, and it now sits essentially at the
FDA's desk, ready to be approved, while the drug is already available
in Switzerland. And here is Cody Young's family saying, I do not get
it. Developed in the United States, first tested in the United States,
ready to be marketed in the United States; and the FDA has it tangled
up in bureaucratic redtape while it is available to citizens in Europe.
That is unfortunately not only the story of what happens to
individual families, but also the story of individual companies.
Frightening statistics say that a majority of United States medical
device manufacturing companies, such as Lunar, which makes devices to
check bone density, important in diagnosing osteoporosis in elderly
women or, for example, a large anesthesia equipment manufacturing
operation based in Madison, have considered in their recent past moving
some of their operations offshore. Not only is it easier to get
pharmaceutical products approved quicker overseas, but also approval of
medical devices overseas, in addition, because of the liability
problems we have in the United States. And we tried in this Chamber
this year to fix the whole tort system and its attendant problems and
dramatic costs.
The bottom line is, those companies' items, conceived in the United
States, increasingly are being manufactured overseas and United States
citizens will not be given access to them.
It is easy to understand why you need to care about pharmaceutical
products, when they are available, and medical devices that cannot get
approved, such as a child with juvenile diabetes who does not have
access to noninvasive glucose testing. I talked to a little girl in
Madison, 7 years old, whose fingertips are covered with scars because
she has to prick them several times a day to do blood testing, where
the testing machinery in Canada measures it in the sweat and you never
have to prick your fingers.

[[Page H5634]]

Mr. Speaker, I have the middle part which is food. The Food and Drug
Administration has grown so dramatically in recent years, it now covers
a quarter of the Nation's economy and the first part is food. The
second part is drugs, but the first part is food.
Over the years, the FDA has grown so cumbersome it has made it
extraordinarily difficult for normal manufacturing operations to go on
and normal farming practicing to evolve. What does that mean to you
sitting in the Chamber or what does it mean if you are watching this at
home? It means that it is more expensive to get food products to your
shelves.
And the situation in the droughts affecting the Southwest in
particular and the threat we see with wheat crops in Nebraska, it may
be more difficult, for example, to help those crops spring back up. If
they are hurt in the drought, they are more susceptible to disease and
more susceptible to problems with insects and other calamities; and we
want to make it more available, make it easier for the American farmer
to grow crops and make it easier to get the products to grocery stores
at a price that still is reasonable for you as a consumer.
Mr. Speaker, let me tell you a couple of issues. There are four major
companies in the United States which sell food gift packages, catalogs
that you get at Christmas. Three are based in Wisconsin with two in my
districts. No jokes about cheeses tonight.

2100

Wisconsin Cheese is located in Sun Prairie, and another one of them
is located in Monroe, WI. Swiss Colony is in fact the largest gift
package company in the United States. Now, when you buy something from
Swiss Colony, you will notice you get those kinds of little packages of
cheese or sausage or crackers, whatever the case may be. Under the
Nutritional Labeling and Education Act that was passed several years
ago, we have to describe in some detail the ingredients in that
packaging.
They were scared to death because imagine if you have a company that
manufactures millions of pounds of cheese and sausage and you have got
to come up with individual labels that fit on this little 1-by-1-inch
square. We worked out an agreement with the FDA at that point that says
when you buy a gift box, we will have a loose-leaf sheet in it. We
worked that deal out. But now the problem is all across the country.
Suddenly, municipalities and States are developing their own labeling
requirements. So now for somebody like Swiss Colony, you look down the
road and see that not only do you have to have federal labeling, you
now have to have 50 different labels for every State that wants its own
set of nutritional information. It may be that municipalities and
communities and cities pass their own labeling standards as well, so
you have got 50 States and thousands of communities and cities and
towns. You cannot do business that way.
Folks say, wait a minute, are not Republicans for shifting power back
to States? You want welfare back there, Medicaid back there. Why
suddenly are you arguing about nutritional labeling? Because one of the
things we are supposed to do in the Committee on Commerce is to take
care of interstate commerce. We want to make sure it is easy for things
to get shipped across State lines. That is why you do not have toll
booths when goods move from Illinois to Wisconsin or from Pennsylvania
to New York. It is one of the founding principles in our Constitution.
So, Mr. Speaker, one of the things we are trying to do in this bill
is develop national nutritional labeling standards, one size fits all.
You can do one label that works in California and in Florida, and one
label that works in New York and Wisconsin and Washington State.
Now, a very parallel case several years ago was something called the
Town of Casey decision, also involving pesticides. The question in the
Town of Casey decision is that the Town of Casey decided they were
going to do their own standards for putting pesticide applications on
farm fields around the Town of Casey. That was the community's right to
do that, until you step back for a minute and try to think of that.
What if every community in the United States developed its own
standards for pesticide application and pesticide labeling? And some
communities said you had to call 24 hours in advance, and some said 48
hours in advance, and some said you had written notice 7 days in
advance and 14 days in advance, and 7 days afterwards, and 3 days
afterwards with a phone call. It would be crazy. It would make it
impossible to farm in the United States.

Mr. Speaker, that was actually a Supreme Court decision, and the Town
of Casey went against the town. They said we are going to have one
national standard for pesticide application and for labeling and for
warning. That is what we are really trying to get at. I think it is a
terrific idea that today consumers can pick up any product, whether it
is a chunk of cheese or whether it is a piece of chicken or a candy bar
and cereal, and look at the back and understand exactly what it is you
are eating: what the ingredients are, what the fat content is, what the
nutritional value is.
I think we all agree. This Chamber passed that several years ago. The
President signed it into law. That is terrific. But one national
nutritional labeling standard only is necessary. If you do not like
what is listed, then you come here to Congress and you come to the FDA
to change it.
Mr. Speaker, the second point I want to make for my colleague in
Pennsylvania and other people in the Chamber and folks watching at home
tonight is something called the Delaney clause. Now, this is real
inside baseball, so stick with me for a minute. But the Delaney clause
was passed in the late 1950's to guarantee we would not have cancer in
our food chain, or I should say not have products that cause cancer in
our food chain.
Now, what has happened over the last 45 years is that our testing
equipment has gotten extraordinarily better, and the food chain is
safer than it ever was before. But Delaney says you cannot have
anything in food products which might even marginally be tied to
cancer, one in a billion case. In fact, the testing equipment has now
gotten so good. And a story that everybody in my home State of
Wisconsin strangely seems to understand is that, if you throw a glass
of beer into the Great Lakes, you can detect it with today's testing
equipment.

That is the kind of standard you are looking at with an individual
piece of food. The food is safer than it ever was before, but the
testing equipment is so much better.
Now, what happens from a practical standpoint? The honest answer is
nobody enforces Delaney. We make no differentiation whatsoever between
a product that causes serious cancer risk or a product that has
negligible cancer risk. We simply want to bring this into today's
scientific standards.
Now wait a minute; this is not some kind of crazy radical idea. You
know who wanted to do this back in 1982? Al Gore. Al Gore, when he was
in the U.S. Senate, decided to try to change the Delaney clause to
bring it up to today's standards.
In fact, what we do in this piece of legislation is say: Wait a
minute, we are not even sure we are smart enough to know how to do it.
We are going to ask the Food and Drug Administration to do it. We say
to them you bring it up to today's standards. We do not want to do it
because it will then be seen as political or be seen as not being tough
enough.
The bottom line is everybody knows Delaney does not work, and the
Food and Drug Administration has got to fix it. Again, keep in mind the
two fundamental points. The idea is to make farming more practicable
and safer.
Second, the easier it is to farm, the easier it is to get things to
the supermarket, the better selection you will have as a consumer, and
the cheaper prices that you will have in front of you.
So the bottom line again in all this FDA reform, what we are really
trying to accomplish tonight is to make the Food and Drug
Administration more responsible to changes in science and to make the
Food and Drug Administration more responsible to changes in the
marketplace. It is to tell the Food and Drug Administration your first
priority should be to make sure that pharmaceutical products and
medical

[[Page H5635]]

devices and food manufacturing in the United States is extraordinarily
safe. But when it takes 12 years, as my colleague, the gentleman from
Pennsylvania [Mr. Greenwood] said and $390 million and 400,000 pages of
documents in order to get a new prescription drug approved, it has
gotten out of control.
Mr. Speaker, that is what this special order is about tonight, which
is to take the Food and Drug Administration, which has done a terrific
job over the years, and give it the tools and strip away some of the
undergrowth and cut back some of the bureaucracy so it can do its job
even better and simpler and less costly and less bureaucratic in 1996.
Mr. GREENWOOD. Mr. Speaker, I thank the gentleman. I think it is fair
to say that, in both of the central issues of the food bill, what we
are really trying to do is leave the authority in the FDA in terms of
the uniformity. I represent the State of Pennsylvania, and we have
Hershey Foods. As you talked, I tried to imagine a Hershey bar that
might have to have one label in Minnesota and a different label in
Houston, TX, and yet a third label in some community in New York, et
cetera. It would be virtually impossible for the company to comply with
all of that crazy patchwork quilt of labels.
All we are saying is the FDA does a good job at this. Let them be the
experts. Let them determine what should be on the label, and leave it
there because of the interstate commerce.
Mr. KLUG. Mr. Speaker, the gentleman is exactly right. If we think
this through rationally, essentially what will happen is, if we end up
with this crazy local, State, national patchwork of requirements for
labeling standards, eventually companies will say well, we will do that
for California, because California has got so many people in it, it is
worth the investment. But it might not be in North Dakota, or it might
not be in Delaware.
So essentially you will see a situation where companies and consumers
will be deprived of the opportunity to buy things off the shelves
simply because of labeling standards that add very little value to the
amount of information that a consumer already has in front of him or in
front of her. Again, we all agree on the committee that you want
nutritional labeling standards in place, but one set of labels
nationally. And if you are unhappy with an individual provision, get it
changed once for California and Delaware and Wisconsin and Pennsylvania
and not for every single community.
Mr. GREENWOOD. Mr. Speaker, then on the Delaney clause, all we are
saying, again, is we want the FDA to decide what the standard should be
for products that might be remotely tested in animals to have some
carcinogenic quality.
It is the old story, you hear these stories, well, if you ate 500,000
pounds of grapes every day for the next 500,000 years, you might have a
one-in-a-million chance of having cancer. That is sort of an absurd
level of micromanagement. What we really want the FDA to do is tell us
what is safe for our kids to eat, what is safe for us to eat, what will
not increase our chances of cancer. And you tell us, you have got the
experts, and we will make it apply nationwide.
Mr. KLUG. Mr. Speaker, it gets back to what I was talking about
earlier with medical devices. It is part of that culture of fear. It is
a fear within the FDA itself that they cannot say yes. If they say yes,
it is that on-in-a-million chance that something will go wrong. But
when you look at pharmaceutical products, what you forget is that
999,000 cases where something goes right; and that has really been the
problem.
Again on the Delaney clause, what you have to remember is this is a
very centrist idea. Al Gore suggested it. Dr. Kessler at the head of
the Food and Drug Administration, when he was a staffer in the U.S.
Senate, spent years trying to fix the Delaney clause. So this is not
any radical idea. If you can get Al Gore and David Kessler and Joe
Barton and Scott Klug and Jim Greenwood to all agree on the same
issues, I would suggest everybody, including everybody at the FDA,
understands Delaney does not work and that it has to get fixed.
Mr. GREENWOOD. Mr. Speaker, I thank the gentleman for his very good
work on this legislation and look forward to its passage.
We are very privileged to have with us the gentleman from Florida
[Mr. Bilirakis], the chairman of the Subcommittee on Health and
Environment of the Committee on Commerce, who has provided the
leadership for this effort, who has given us the green light to move
this important package of legislation through his committee and who
will now share his thoughts as our leader on this issue.
I yield such time as the gentleman from Florida may consume.
Mr. BILIRAKIS. Mr. Speaker, I thank the gentleman from Pennsylvania
[Mr. Greenwood].
Mr. Speaker, tough acts to follow, certainly as we are all here this
evening to talk about improving and saving people's lives. That is
really what it is all about. We all want to ensure the health and
safety of our citizens, and streamlining the approval process at the
FDA will help to do just that.

Simply stated, the FDA must be reformed. Simply stated, it has to be
reformed. Consumers must have quicker access to safe and effective new
drugs, medical devices, and foods. Countless numbers of individuals and
groups have contacted Congress to ask for help, and many of us have
received this message loud and clear. The message is that FDA
approvals, as so many of us have already said, of drugs, medical
devices, and foods take too long.
Mr. Speaker, I would like everyone here today to know that this
message has not fallen on deaf ears. I will not say that the message
which we all have received time and again over these many past years
has fallen on deaf ears prior to this Congress, but the fact of the
matter is nothing was done by the Congress. Since this effort was
started this year, some approvals all of a sudden, I might add, have
been expedited. I am sure that is just a coincidence. Anyhow, Mr.
Speaker, as chairman of the Health and Environment Subcommittee, I am
really proud to be part of the FDA reform team created by the gentleman
from Virginia, Chairman Bliley, and spearheaded by the gentleman from
Pennsylvania, Mr. Greenwood.
The team has come forward with several bipartisan proposals for
reform that will speed up the approval process for drugs, medical
devices, and foods so that consumers will have increased access to
these products while still being assured of their health and safety. I
want to underline that, as others have, while still being assured of
their health and safety. This goal has guided our team in this effort.
As we have heard, the approval process takes much too long. Today, it
takes something like 12 years and $350 million to get the average new
drug from the laboratory to American patients who need it. To make
things even worse, as others have said, the majority of the new drugs
approved by the FDA in the last 5 years were already approved and in
use in other countries.
The FDA approval process actually interferes with the essential need
to approve vital research in products that fight serious illness. This
legislation changes that. In the medical device area, I know it has
been very thoroughly discussed. The average time it takes for the FDA
to approve a medical device has increased from 415 days in 1990 to 773
days in 1995, all while the FDA is required by law to take no longer
than 180 days to approve new medical devices. The legislation
introduced in the House addresses these concerns.

Mr. Speaker, let me stress that streamlining and improving the FDA
does not weaken our resolve for the safety or effectiveness of
products. Once again, I would like to thank Chairman Bliley for his
leadership on this issue and especially Jim Greenwood, who has directed
our FDA reform effort. Together with Joe Barton, Richard Burr, and
Scott Klug, we have developed a balanced, bipartisan approach to
approving the FDA's approval process. I am proud of you guys. You have
done good, as we say in the South.
As I have said before, in closing, Mr. Speaker, the safety and health
of our Nation's citizens is my and our concern. This FDA reform
legislation is a balanced, bipartisan approach that will streamline the
approval process to allow safe and effective drugs, devices and foods
to reach patients, consumers

[[Page H5636]]

more quickly and efficiently without sacrificing safety. So I urge my
colleagues to carefully consider this legislation which would
streamline and improve the approval process to allow our Nation's
citizens better access to safe and effective drugs, medical devices,
and foods.
Mr. Speaker, I thank the gentleman from Pennsylvania for his
wonderful work.
Mr. GREENWOOD. Mr. Speaker, I thank the chairman very much. Let me
say that the gentleman from Florida [Mr. Bilirakis] has served long and
with great distinction on the Health and Environment Subcommittee, and
this is his first term as the chairman of that committee. I think that
working together in bipartisan fashion, we will be able to accomplish
something that we will be able to say that on your watch, we passed
legislation, the President signed it, and we talked about life and
death issues. This will save lives. Children will survive rare
diseases. Cures for horrible plagues, like AIDS and cancer will come to
patients, relieve their suffering much more quickly for years and years
to come. That will be just a part of your legacy as chairman of this
subcommittee, and we are very pleased for your leadership.
Mr. Speaker, I would now like to yield time to my colleague, the
gentleman from North Carolina [Mr. Burr]. Mr. Burr is the prime sponsor
of the pharmaceutical bill, deals with pharmaceutical products and
biologic products, all that new science that deals with fighting
disease at the molecular level. It is where we are, I think, on the
dawn of a new age in medicine where we will have cures for diseases
that we cannot even image right now.
Mr. Speaker, Mr. Burr is a new Member. He is a freshman, but he has
done just an extraordinary job on this project. He has, I would say,
far more than anyone else in the House been responsible for the large
number of cosponsors on this bill. He has been working with Members
from around the country, from both sides of the aisle, preaching the
good word of FDA reform and has converted a lot of folks to this cause.
With that, I would like to yield such time as he may consume to the
gentleman from North Carolina [Mr. Burr].

2115

Mr. BURR. Mr. Speaker, I thank the gentleman from Pennsylvania [Mr.
Greenwood] and thank him for his leadership, as I do the gentleman from
Florida [Mr. Bilirakis] and the gentleman from Virginia [Mr. Bliley],
and I think the gentleman raises a good question.
It is 9:15 at night. Why are we here? We are here tonight, and we
have put months of work into hearings and into meetings with patient
coalitions and with hospitals and with doctors about the horror stories
at FDA, and I am here tonight to say that we also heard some successes
with FDA.
We have an agency in the Food and Drug Administration that needs to
be here. It has a purpose. But we have also seen the instances where
the Food and Drug Administration has no human face, and what we have
seen is, in fact, the human faces.
I never will forget, Jim, when I got to Washington just a year and a
half ago; it seems like eternity now. In one of the first hearings I
ran into a product called the censor pad, and I am sorry Joe Barton is
not here because Joe usually talks about it; I am the one that carries
it around. And the reason I carry it around with me:
It probably was the best example since I have been here about the
failure of bureaucracy, the fact that bureaucracy cannot make decisions
that apply common sense to something. This product was designed to aid
women with the examination of a breast for possible cancer. It
increases the sensitivity over soap and water because it is plastic
with some silicon in the middle, and it allows a woman at any time of
the day to apply this pad and to begin an exam.
If this pad were to find breast cancer in 1 woman, then I feel that
it is our responsibility to have it on the market because it is
nonintrusive, it cannot hurt a person, it is not there to replace a
mammogram or any other exam that is done in a medical office. It is
there to encourage a woman any time of the day or night to check
herself. This is the type of common sense thing that I think we ought
to make sure is approved by the FDA.
Now this was classified as a medical device under the same category
as a pacemaker because there was no prior product like it, and the
reality is that this has been at the Food and Drug Administration now
for 11 years. The person who invented this product won the inventor of
the year award in medical devices, and the year after that the FDA sued
him. It is an incredible story about the abuses that happen in
bureaucracy.
But we are here to talk about positives tonight, we are here to talk
about what we can do by this Congress taking a responsible look at the
problems that we have at the Food and Drug Administration using the
talents and creativity of people there that are the best in the
country, and then, looking at the private sector in America where we
have more talented people and saying how can we plug them into this
process. How can we do it while assuring safety and efficacy to all the
American people for the drugs and pharmaceuticals and medical devices
that they have become so accustomed to that safety?
The gentleman from Texas [Mr. Barton] talked about tonight third
party review. Think of the teaching hospitals that we have in this
country who do clinical trials today, who do drug research, who come up
with new compounds that might be the breakthrough for cancer or for
diabetes; they are at our disposal to try to use them not only in the
clinical process, but in the overall overseeing of the clinical trial
and maybe with the applications. There is an option that we look at. It
is not that we have to do it. It is that we have a responsibility to
explore any option that exists that might make it better because in
fact what we hope is that we can reach new efficiencies while
maintaining safety and efficacy.
As a matter of fact, the first thing, Jim, we changed, I think, was
the mission statement. The mission statement was changed to say that
the FDA should promote and protect, to promote, to move forward, to
advance and to protect the integrity of the safety system that
Americans had come to know. In fact, what we want to do is we want to
open up the communication of what has been a very closed agency, one
that communicates freely with the applicants of pharmaceuticals and
devices, one that shares with the companies where they are in the
process, one that solicits information from companies that companies
are willing to supply because it is their intent to speed up the
process.
I think we alluded to the fact earlier tonight that right now it
takes 14.8 years to approve a new pharmaceutical in this country. In
fact, in the 1960's, in 1963, it was 8.1 years. Today it is $350
million. Then it was about $70 million. If Americans wonder why drugs
that hit the marketplace that are new are so expensive, all they have
to do is look at the investment that pharmaceutical companies have to
make in research and development and the approval time to realize why a
new prescription is a hundred dollars. Well, nobody wants to make it
$30 worse than we do, and if we can reach that through new
efficiencies, we have a responsibility, as Members of Congress, to try
to explore how in fact we can do that with the help of the FDA.
In fact, one of the single most important things of the FDA reform
legislation is that we require the Food and Drug Administration to do
an annual report to Congress, tell us how many drugs have we had
applications for, how many have we approved. Is it unreasonable to
believe that the American people deserve some type of accountability
for the approval process? I think it is very much within the
responsibility of Congress, as we represent people all across this
country, to say to every agency in the Federal Government you have
accountability to the people through us.
In fact, one of the most contentious parts of the bill deals with the
dissemination of information. 70 percent of all the cancer treatment
today is the off-label use of an approved drug. Doctors find that there
is a drug that is already on the marketplace that works well for a
certain disease, and they choose to use that drug to treat that
particular problem. But in fact pharmaceutical companies cannot take
their experience, their successes where they might

[[Page H5637]]

write about them in professional medical journals and duplicate those
and send them to other doctors. They can only make a copy and send it
to a doctor when a doctor requests that information.

Well, 70 percent of my district is rural. My doctors are doing
everything they can to provide primary care to their population. They
do not have time to read medical journals. This would be such a
tremendous aid to them, to have the ability for peer review articles to
be replicated and sent to them. Think of the valuable information that
one can find in peer review articles.
Mr. GREENWOOD. Mr. Speaker, if the gentleman will yield on that
point, just to make this crystal clear to everyone because I think
Americans will be surprised to understand this.
In your district, rural North Carolina; in my district in Bucks and
Montgomery Counties of Pennsylvania, we can have a physician treating a
child for a disease and frustrated because he cannot cure that disease,
and somewhere in another part of the country a physician may have
treated a thousand children with this disease with a pharmaceutical
product that was not originally designed for that purpose, but it
works, and it is saving these children. And today under the law, if the
maker of that drug wanted to send an article that the doctor who
treated the thousand kids wrote in a medical journal, wanted to mail it
to the doctor, your physician in your district or my district, and say,
``You might want to see what this doctor over here has done; he's
curing these kids,'' it is against the law.
Mr. BURR. It is not only against the law, but to do it he would have
to rely, we would have to rely, on our doctor who might not have read
it to request it. What an insane way to go through the process.
And I think the thing that is scary and should be scary for the
American people is that as this off-label use is tried more frequently,
a doctor might determine that the dosage is very crucial, and if other
doctors are going to use that off-label use or that pharmaceutical for
an off-label use, should they not have the latest information about the
dosage to use and the frequency of usage, where today again that is
information that pharmaceutical companies can only disseminate when a
physician requests it, not when there is a peer review article that
states this new information that might have been found.
So in fact there are many areas, many parts of this legislation, that
are crucial to the health of the American people. America has the best
health care system in the world. It is unconscionable for Americans to
have anything less than superior access to lifesaving drugs. I believe
that by safely streamlining the drug approval process it will not only
help families by lowering drug prices and keeping high paying jobs here
in America, but give terminally ill patients access to lifesaving
treatments.
FDA reform is not radical, it is responsible. It is not senseless, it
is safe. America's health industry and patients are chained to an FDA
process that provides no flexibility, has no common sense and has no
human face. The FDA reform legislation will remove these chains and
ensure safety in a process structured to more effectively and
efficiently approve drugs.
In fact, as people have told stories tonight, Jim, about patients in
their own districts, I have got several, too, several patients who are
now being treated by alternative methods. Why are they doing that?
Because it is their choice. They have determined that that choice that
exists is the best choice for them, and right now we are slowly moving
to a situation, if we are not there already, where the Government will
tell us no, you cannot do that.
Well, when these people have a choice between nothing and nothing, do
we not have a moral responsibility as Members of Congress to present
them with an option? I think we do, and that is why I am proud to be
here tonight. I am proud to be a sponsor of 3199, I am proud to say
that this is a bill Jon Fox started legislation long before I did, and
this has incorporated much of Jon's it has incorporated the thoughts of
hundreds of people around this country and in this town, but more
importantly, it is a bill that we can all stand here tonight and say
that we are proud that it has bipartisan support, that Democrats and
Republicans believe very strongly in the changes that we propose to
make.
Why? Because we have put politics aside and we tried to put human
health in the forefront. Well, we will succeed to do that. We will
succeed by marking up this legislation in a bipartisan way, coming to
this very House floor and debating with our critics the importance of
it, and we will win because we are right.

2130

Mr. GREENWOOD. Mr. Speaker, I thank the gentleman for his remarks,
and also for his stellar work throughout this process. Just to follow
up, on a bipartisan note, I spend 2\1/2\ to 3 hours today in my office,
and I am a Republican, with a Republican staff member, an attorney, a
Democratic staff member, and we worked through the bills line by line,
Republicans and Democrats, just using our common sense, just using the
knowledge that each of us brings to the subject.
It has been a joy for me, in contrast to so much of what the House of
Representatives has done since I have been in Congress that has been so
partisan and had such a biting edge to it, to do it together, Democrats
and Republicans, because we know that lives hand in the balance.
Mr. Speaker, I yield to my colleague, the gentleman from Pennsylvania
[Mr. Fox], who represents the district immediately to the west of mine.
Mr. Fox and I served in the Pennsylvania legislature, and he has been a
leader in FDA reform and introduced his own legislation. I would like
him to share his thoughts with us.
Mr. FOX of Pennsylvania. Mr. Speaker, I thank the gentleman from
Pennsylvania and the gentleman from North Carolina [Mr. Burr] for his
leadership in this movement. I know that he in the Pennsylvania
legislature and the Pennsylvania Senate was particularly a leader into
his own right when it came to health care reform and to making sure
medical devices and pharmaceuticals were covered in the legislature, to
the extent they could get them to those patients.
So I am very happy that the gentleman from Virginia, Mr. Bliley,
chairman of the Committee on Commerce, appointed you as the point
person, the task force chairman for FDA reform, to bring together
people like the gentleman from North Carolina, Mr. Burr, who has
fashioned legislation which, I appreciate the acknowledgement of our
initial efforts, but your bill, working with Mr. Greenwood and the
gentleman from Virginia, Mr. Bliley, and the gentleman from Florida,
Mr. Bilirakis, the gentleman from Texas, Mr. Barton, and the gentleman
from Wisconsin, Mr. Klug, together you have the package here that I
think is the most important legislation in the second session of the
104th Congress.
We may have set the tone on reforming Congress in the first session
and getting our fiscal house in order, but what could be more important
for our constituents than making sure that health care opportunities to
live longer and better can in fact be a reality?
What you two gentlemen, the gentleman from Pennsylvania [Mr.
Greenwood] and the gentleman from North Carolina [Mr. Burr] have done
here tonight I think is to bring out to our colleagues and to others
exactly what can be done by the passage of this reform legislation. So
I am very appreciative of your leadership and looking forward to having
the bill passed.
I did want to mention that from my perspective and that of the
American public, this legislation will speed up the lifesaving life-
extending drugs and medical devices while people are awaiting a cure or
a vaccine. Very important. What is amazing to me is that American
patients have been denied, even though they have already been approved
overseas, many important drugs. If the FDA had approved the drug
Interleukin 2 in the United States as soon as it was approved in
Europe, the lives of 3,500 kidney cancer patients might have been
saved. On Alzheimer's disease, the drug THA was delayed for 7 years
after it was available in Europe. I had a hearing in my country seat of
Montgomery County in Norristown just last year with patients who had
cancer, ALS, AIDS, epilepsy. One

[[Page H5638]]

individual with epilepsy explained that they had to go to England to
get a drug which really was not as good as the American drug, but the
American drug was not approved by FDA yet.

So the fact is this legislation that Mr. Greenwood Mr. Burr are here
tonight talking about will streamline product approval, allow for third
party review, establish a fast track standard for filings and
applications, have a collaborative approach to clinical research,
promote harmonization; and by that we mean the discoveries overseas and
in other countries which are clinically correct, we will allow their
studies to be used and implemented here in the United States without
the delay of further time.
Those annual reports by the FDA to Congress will certainly let us
know how we are doing on speeding up the process. If we do not pass
this legislation, but I am sure we will, the discoveries and jobs that
they bring will go overseas. We just have to look to a 1995 study by
the American Electronics Association that found 40 percent of medical
device firms reduced their number of U.S. employees because of FDA
delays. Twenty-nine percent boosted investment in foreign operations.
Twenty-two percent moved U.S. jobs out of the country.
With the legislation that the gentleman from Pennsylvania [Mr.
Greenwood] and the gentleman from North Carolina [Mr. Burr] are
discussing tonight with their colleagues from the Committee on
Commerce, we will stop that. The jobs will return, the discoveries will
be made earlier, and our patients will be the beneficiaries.
So by working together with Commissioner Kessler, Republicans and
Democrats together, House and Senate Members together, working with the
White House, we will have FDA reform this year in the 104th Congress,
and then we will be able to go back to our districts and say that we
really passed important, bipartisan legislation that will improve the
health care of every American.
I thank the gentlemen for their leadership, and for allowing me to
join them in this important special order.
Mr. GREENWOOD. Mr. Speaker, I thank the gentleman. What I would like
those Americans who are listening to us and watching us on C-Span
tonight to think about is to imagine that their mother or father, their
elderly parent, lies in a bed in a hospital, with a condition that is
fatal, and the doctor takes you outside the room and says, ``It does
not look good for your mom or your dad. It does not look like he or she
is going to make it,'' and why.
And you say, ``Isn't there anything that you can do?'' And the doctor
says, ``Well, there is a device that has been developed in our country,
it has been tested in Europe, and it seems to be working in cases just
like this, in France and in England and in Italy. And if I had that, if
it was legal for me to use that, I would take your mom or your dad to
surgery right away, we would implant that device, and I think the
prognosis would be excellent. But it has not been approved by the Food
and Drug Administration, it has been sitting there for years, and until
I can get it, there is nothing I can do.''
Or imagine your little child, boy or girl, the same situation, in a
hospital, suffering, and as a parent you want to relieve that
suffering. And the doctor tells you that there is a drug, there is a
medicine, it is a wonderful medicine that has fixed these kids up
elsewhere in the world, but we cannot get it through the FDA. It is
still bogged down there. ``If I could only get that, I could relieve
your child's suffering or save his life.''

I think if Americans picture themselves in that situation as sons and
daughters of their elderly parents, or thinking about their husband or
their wife in that situation, or in the worst case of all, a small
child, they would say, somebody has to take care of this.
That is what we are doing. That is what we are trying to do. We are
trying to say that the U.S. Congress needs to take an agency that has
been around for 90 years, doing some very good work, and bring it into
the next century, so that the spectacular and wonderful drugs that are
being developed by the brightest and most dedicated people in our
country, who want nothing other than to save those lives, to relieve
that suffering, to get that product through the Food and Drug
Administration, make sure that it is safe, make sure that it works, and
get it to those patients as quickly as possible.
If we do that, and we do that because we put politics aside and say
that Republicans and Democrats will work together, we will hold hands
on this, we will get it done and we will all go over to the White
House, Republicans and Democrats, for the bill signing ceremony, that
will have made my stay in this Congress worthwhile.
Mr. BURR. Mr. Speaker, if the gentleman will continue to yield, I
think the interesting thing here is that we are convicted to make sure
that this legislation passes and gets a Presidential signature. Why? It
is because we have seen the human face that we need to apply to the
problem. Bureaucracy never tends to see the human face. I think for
many people who listen tonight, they may wonder, you are Members of
Congress. What do you know about reforming the FDA?
The number of hearings in oversight and investigation, and I would
say to my colleague, Jim you were there, the number of hours that we
spent once we had the first draft of this legislation, I believe 17
hours in 2 days, where we brought people in from all over the country
who could lend their expertise to the language and to the intent, and
to assure the efficacy and the safety, it all exists in this one
package. For once, we have seen the process work exactly like it is
supposed to.
But to an agency that I continue to hear the same remarks that I hear
from other agencies, ``We are making changes. Let it work. Let it
happen. It will fix itself,'' it only reminds me of a statement that a
gentleman made several years ago, that a fool is one that believes you
can continue to do the same thing and expect a different result. In
fact, we have to change culturally and fundamentally what we do if we
want to expect a different result.
I carry in my voting card wallet a statement that I think is very
appropriate, that is printed at the Jefferson Memorial. I will read it
just very briefly. It is Jefferson's words: ``I am not an advocate of
frequent change in laws and constitutions, but laws and institutions
must go hand in hand with the progress of the human mind. As that
becomes more developed, more enlightened, as new discoveries are made,
new truths discovered and manners and opinions change, with the change
of circumstances, institutions must advance also to keep pace with the
times.''
Mr. Speaker, tonight we are keeping pace with the times.
Mr. GREENWOOD. Mr. Speaker, I thank the gentlemen who have
participated in the special order. I think we are going to make this a
textbook example of how the Congress of the United States can put
politics aside completely and utterly, work with Democrats and
Republicans evenhandedly, put a bill into law that will save thousands
of lives, and I look forward to the bill signing ceremony.
Mr. TOWNS. Mr. Speaker, I am pleased to participate in this evening's
special order on FDA reform. On March 29, three ``FDA reform'' bills
were introduced to amend the Food, Drug and Cosmetics Act with respect
to the regulation of drugs and biological products, foods and animal
drugs and medical devices.
I believe that three bills offer an earnest and responsible approach
to the reform of FDA regulations and procedures which govern a variety
of very different and distinct products and industries. These
legislative reforms recognize the need to streamline the operations of
the Food and Drug Administration while giving the agency ultimate
authority to protect the public's health.
Under the reform approach now before the Commerce Committee, the FDA
would also be responsible for getting new products on the market
through a prompt, efficient review and approval process. This effort
responds to the agency's critics who argue that the current product
approval process slows down the availability of safe and effective
products. It is an approach which I believe will still protect the
public health but it will also enhance American companies' ability to
be more competitive in the internatonal marketplace.
That is why I am supporting these legislative reforms and also why I
am the principal cosponsor of H.R. 3200, introduced by the gentleman
from Wisconsin [Mr.Klug], to address needed changes in the food and
animal drug areas.
H.R. 3200 proposed changes to the labeling of Foods and the approval
process for animal

[[Page H5639]]

drugs. The current standard which subjects health claims to the same
scrutiny that is applied to drugs is simply not warranted. In addition,
the food additive petition process, which has allowed 200 petitions to
languish, is in dire need of revision. Last year, an investigative
report by the Subcommittee on Human Resources and Intergovernmental
Relations found that reviewers requested too much data that was not
even used to determine the safety of a food additive. Irrelevant data
only adds unnecessary cost and depresses investments in new food
ingredients and technologies. This ``zero risk'' management approach
could be directly attributed to the influence of the Delaney clause
which almost everyone agrees is no longer reflective to today's best
scientific measurements. The findings, in this report, support the
proposed change in H.R. 3200 from zero risk to a ``negligible risk''
standard.

H.R. 3200 also incorporates the provisions of H.R. 2508, to modernize
the requirements for the regulation of animal drugs. The time frame for
approval is shortened from 180 days to 90 days. In addition to these
provisions, the bill provides for the regulation of certain drugs
through a ``veterinary feed directive'' regulation for medicated feeds
to be issued by a veterinarian.
Mr. Speaker, it is my hope that the three reform bills currently
under consideration will retain FDA as a strong and viable agency that
has the necessary resources to ensure product quality. It is also my
expectation, however, that these reforms will make FDA a strong
partner, rather than an impediment, in making useful technology and
products to market.

____________________