[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.

                          ____________________