# Special Order: Prescription Drug Reimportation

05/20/03

Congressman Burton and Congressman Gutknecht address the House floor on
reimporting prescription drugs. They discuss the reasons the FDA has
given against allowing drug reimportation, why these reasons are not
valid arguments and how this hurts Americans.

# Full Text

Mr. Burton: They have 600 lobbyists in the United States, 600 making
sure the prices stay high. They pay those lobbyists \$.5 million a year.
And in order they have congressmen who will look with favor upon what
they want, they paid \$20 million last year in contributions to our
colleagues. I\'m not saying any of our colleagues and their votes can be
purchased. I'm not saying that at all, but what I am saying is that the
money that\'s being spent by the pharmaceutical industry for our health
agencies, FDA, H.H.S., and C.D.C., the revolving door policy that
appears to be prevalent over there, because they make so much more money
when they go with these pharmaceutical companies, and they get these
benefits and everything, a lot of these people look with a jaundiced eye
at anything that might impede their money when they go to the
pharmaceutical and try to get a job, but many of our colleagues get jobs
from the pharmaceutical companies. Many people in the health agencies go
from the pharmaceutical industry to the health agency and back again.
And I think that does have an impact on what goes on around this place.
And as a result, who suffers? The American people. We should not pay any
more for our pharmaceutical products in this country than they do in
Europe, Canada, Mexico, or anyplace else, or South America. And yet as
you said so eloquently, and you\'ve been the lone voice in the
wilderness for so long, you\'ve said so many times that it\'s because
America is paying the freight for the rest of the world. And we\'ve got
to do something about that. And I applaud you for taking the lead on
this. I might tell you that we are going to have another hearing in
early June, and you will be invited to be a participant in that hearing.
And we anticipate that some of the companies that are trying to cut off
the pharmaceutical supplies coming from Canada into the United States we
anticipate will be testifying before that committee. And we would like
for you to participate, and hopefully, we\'ll get some answers from them
directly as to why they say that they don\'t want to have their
pharmaceutical products sold from a Canadian pharmacist to an American
citizen for any reason other than the American citizen is saving money.
We\'ve heard, as you and I have talked about before, we\'ve heard them
say well, it\'s a safety issue. We know that\'s not the case now because
the Canadian health agencies have said very clearly, publicly, they test
everything, they check everything out before it goes into or out of
their country. And so we want to find out from the pharmaceutical
executives themselves why they\'re discriminating against American
purchasers and that hearing will be taking place in June.

Mr. Gutknecht: Well, I want to thank the gentleman for joining this
discussion tonight, because as I say, there are a number of us here in
the house who have been willing to speak out, but you\'re among the few
chairmen of committees who has actually had some hearings, brought in
experts, let people really talk about this. One of the things we\'ve
learned, for example, is as you mentioned over a million Americans today
are actually buying their prescription drugs from other countries today.
And the FDA, the food and drug administration, keeps very accurate
records. And if a million people are buying their drugs from other
countries, you would think, especially along the Canadian border, but
more importantly, along the Mexican border, where again, we\'ve learned
from research done by a professor at the university of Texas, something
like two out of every three Americans who crosses the border and goes
into Mexico brings back with them prescription drugs, which they buy
there for a fraction of the price that they can buy them in the united
states for. But they bring back drugs. More importantly, they don\'t
just bring back a few drugs. Usually, when they go across the border,
they take a list with them. They come from a senior center. They come
from a retirement center. They come from a condominium project where
most of the people are seniors. And they take a list with them when they
go into Mexico. And they bring back thousands of dollars worth of
prescriptions. Now, with all of those people buying drugs illegally,
according to the FDA, you would think if this is so dangerous, you would
think all of these seniors would be dropping like cord wood in Minnesota
and in Texas and in California and the other states where this is very
common. But the fact of the matter is we know exactly how many people
have died from taking prescription drugs which they bought from other
countries. The FDA keeps perfect records. And accord together FDA, it's
an easy number to remember. It's a nice round number. It's zero. Now,
it\'s called the food and drug administration. They're also responsible
for protecting us from all of the imports of food that comes into the
United States. Every day, we import millions of tons of food. I think
last year we imported into the United States something like 317,000 tons
of plantains. I had to double check, what is a plantain? But we import
tons of food every day. Do you know what the FDA says about all that
imported food? Not much. They wave as it goes by. But they do keep
records as well. According to the FDA, eating imported strawberries,
something like 25,000 Americans have gotten ill and some have died from
eating imported strawberries. And yet we eat strawberries every day. The
FDA does almost nothing. But one area where we can absolutely guarantee
safety, the FDA has put a wall between American consumers and being able
to afford these drugs. Let me give you an example. I am holding in my
hand a package of Tamoxifen. This is probably one of the examples that
makes me angrier any other. Tamoxifen is an amazing drug. It's a miracle
drug. And particularly for women who are suffering from breast cancer,
this may save their lives. This is an amazing drug. The most amazing
thing is we help pay for it. We, the taxpayers. This drug was developed
almost exclusively with research and development dollars from the N.I.H.
then the company decided, well, originally they said \-- and because it
was developed with taxpayers\' money, we won\'t patent it. They thought
about it again, and they said no, I think we will patent it. I guess
they had a right to patent it. But here is what really bothers me. We
bought this drug in Munich, Germany, three weeks ago for 60.33 euros.
Now, on the day, the equivalent \-- the dollar and the euro vary in
value, but that worked out on that day to \$50.05, for this package of
100 tablets, 20 milligrams, Tamoxifen. This same drug. We called a
pharmacy here in Washington, D.C. and asked, how much is 100 tablets, 20
milligrams Tamoxifen? The answer \-- \$360. \$60 in Munich, Germany.
\$360 in the United States. Six times the amount. And here is the real
tragedy. There are American women who need this drug and they can\'t
afford it because what we know \-- there is a new book out.

Mr. Burton: let me interrupt.

Mr. Gutknecht: I yield to the gentleman.

Mr. Burton: How many people die because they simply can\'t afford the
drugs that are prescribed for them?

Mr. Gutknecht: The interesting thing is the FDA does not keep those
records. They're only concerned about drugs being safe and effective.
But one of the top pharmacologists in the world, certainly in America
\-- he has a great quote. He said, "A drug that you cannot afford is
neither safe nor effective." I want to come back to you because it fits
with this point. There is a new book called \"The Big Fix.\" It\'s
written by a woman who has done an amazing amount of research on this.
One of the saddest statistics in this book, she says that 29% of the
prescriptions written to senior citizens in America today go unfilled.

Mr. Burton: 29% go unfilled.

Mr. Gutknecht: I don\'t know if you have ever experienced this. But I
met with morning with a community pharmacist and I asked him this
question. How many of you have had the example where a senior citizen
comes in to buy a drug that they need, and they hand you the
prescription. You tell them how much it is, and they get a real sad look
on their face --

Mr. Burton: and walk away.

Mr. Gutknecht: and drop their head and say, well, maybe I will be back
tomorrow. 29% of the prescriptions written to senior citizens go
unfilled because they can\'t afford them and they are proud people. How
many people \-- how many women in America cannot afford Tamoxifen? Maybe
they could afford \$60, but \$360 starts to get real expensive. And that
goes on and on and on. I am not here to say shame on the pharmaceutical
industry, shame on us because we have the power to change that. You
know, one of my favorite presidents was president Ronald Reagan. He had
some great quotes, and one of them that he used often was that markets
are more powerful than armies. It is time that we open up the markets
and say to Americans, you have legal access. you ought to be able to go
to your local pharmacy. You ought to be able to go to your local
pharmacist who you trust and is an important part of the health care
delivery system \-- you ought to be able to go in there and you ought to
say I need Tamoxifen and he ought to be able to say to you, listen, I
could fill it from my inventory here in the united states on the back
shelf and your price would be \$360, or I can go on-line and I can order
it for you from a pharmaceutical supply house in Geneva, Switzerland, or
Munich, Germany, or Paris, France, as long as they are an industrialized
G-7 type country where we can respect and trust that the equivalent of
their FDA as the Canadians have announced. But he ought to be able to go
on-line for that customer and order that and say, we can have this to
you in three days for 1/6 the price.

Mr. Burton: One of the arguments that we heard when the FDA was before
our committee, and you were there, was that they were concerned about
counterfeit drugs. One of the things that I think is very, very
important \-- and it goes right along with what you are talking about.
Why don\'t you hold that up? I think our colleagues back in their
offices ought to see this. That is a device that guarantees, guarantees
that the package has not been doctored in any way. And if that package
were used in conjunction with a prescription that was filled in some
other part of the world, it would guarantee beyond any doubt that that
product was genuine and it wasn\'t a counterfeit and it was completely
safe. And yet the FDA continues to use that argument when it\'s
absolutely certain that there is a way to make absolutely sure that that
is a safe prescription drug.

Mr. Gutknecht: The interesting thing, chairman Burton, we cannot
guarantee anything. I mean, you cannot guarantee that when you pull into
a gas station and you fill your car up that that is in fact unleaded
gasoline and not buttermilk. The truth is every time you put your key in
your car, every time you do anything, you take a certain amount of risk.
But with modern technology, we can make it absolutely as safe to buy
drugs from Geneva, Switzerland, as it is to go down to your local
pharmacy. As a matter of fact, the FDA has to admit that the only proven
example where someone has tampered with prescription drugs in the United
States happened inside the United States. There are no examples where
contaminated drugs have been shipped from legal pharmacies in other
parts of the world. There just aren\'t any examples.

Mr. Burton: Our colleagues might want to know how you can guarantee that
that wouldn\'t be counterfeit. You recall \-- you pointed this out at
the committee hearing, that that\'s the same technology that is used on
the \$20 billion, that guarantees that they\'re not counterfeit any
longer and it works very well.

Mr. Gutknecht: If this is safe enough for the U.S. Treasury, this is the
same company that has developed these technologies to make
counterfeit-proof packaging \-- I will be introducing a bill sometime in
the next week. I am trying to get hundreds of my colleagues \-- in fact,
the last time we had a vote on this issue of opening up markets, we got
323 votes here in the house. The house has spoken fairly clearly that we
want Americans to have access to world-class drugs at world market
prices. But, you know, if it\'s good enough for the U.S. Treasury, if
they can produce technology to make counterfeit-proof packaging for the
entertainment industry, for video game industry, they certainly \-- and
they are making the packaging for the pharmaceutical industry, and as a
matter of fact, I think there are four or five companies that are
already using this technology, and it goes even further. Last week I was
at a demonstration, and this is a little vial. I can barely see it
looking at it here. But inside this vial, there are 150 tiny, tiny,
almost nano computer chips. The interesting thing is this is the next
UPC code, and they can literally now embed these chips in packaging
because these chips \-- they\'re bringing the cost down to probably less
than a nickel apiece. When you are talking about a prescription drug
package that sells for \$125, that\'s not much to make certain that this
is in fact whatever the drug is and it was made at such a plant on
such-and-such a day and has gone through the channels. As a matter of
fact, when people buy things and they have them shipped by UPS or fed-ex
or even the parcel post system, they put a bar code on that package and
literally you can go to UPS or any of the other package handling
companies and now you can find out where that package is at any point in
the delivery system. Now, as opposed to that, how do you think that the
pharmaceutical companies ship their drugs? Armored cars?

Mr. Burton: No.

Mr. Gutknecht: Do you think they ship them the way they ship everything
else? So the idea that somehow it\'s easier for somebody to contaminate
a drug going via UPS in a sealed package with a bar coded technology
using counterfeit-proof packaging, it\'s easier somehow to adulterate
that drug than it would be to get on to a dock in new jersey, where
it\'s sitting in a container.

Mr. Burton: First of all, we have had no cases that we know of where
people have died from imported products. So first of all, the argument
that there is a big risk involved doesn\'t hold water because they
haven\'t had any proof that it does cause a problem.

Mr. Gutknecht: you are much more likely to die from eating imported
strawberries.

Mr. Burton: You pointed out just thousand that tampering with
pharmaceuticals that are coming into the country is not a problem
because now there is a way where you can absolutely guarantee that that
package has not been tampered with, that it\'s the right package, that
it\'s got the right product in it because it\'s got these sealing
devices that guarantee that it\'s what it\'s supposed to be. And so I
still don\'t understand \-- maybe you can explain to me because you are
pretty learned and you have been working on this for a long time. The
two main arguments that they used was people could be hurt, no evidence
of that, and second that we might be getting counterfeit products that
are inferior, and you\'ve proven that that could be overcome. So what is
the argument the FDA is using beyond those two?

Mr. Gutknecht: The only argument that they use is safety, and they are
\-- as you saw at the hearing, they\'re very oblique even on that issue
because, you know, we can demonstrate that it is safer to buy drugs from
a legal pharmacy. We are not talking about illegal drugs. I want to make
that very clear. We are only talking about FDA-approved drugs that came
from FDA-approved facilities. So we are not going to go down the path of
talking about other drugs because, you know, there are people in south
Miami that import drugs every day. Those are not legal drugs. We are not
talking about any of those. But let\'s talk about what the law actually
says, and this is where they hang their hat. It says \-- let me read
this. Section 381. The secretary of the treasury shall deliver to the
secretary of health and human services upon his request samples of food,
drugs, devices, and cosmetics which are being imported or offered for
import into the united states giving notice thereof to the owner or
consignee who may appear before the secretary of health and human
services and have the right to introduce testimony. Now, this is what
they say. This is where they hang their hats and they keep Americans
from legally buying imported drugs from countries around the world. Here
is the operative sense. If it appears from the examination of such
samples or otherwise that one such article has been manufactured,
processed or packed under unsanitary conditions. There is no evidence
that any of these drugs is packaged under unsanitary conditions. Number
two, that such article is forbidden or restricted for sale in the
country in which it was produced or from which it was exported. There
are all legal drugs. So that one doesn\'t apply. Number three, it says,
such article is adulterated, misbranded, or in violation of section 355
of this title. None of that really applies in my opinion. But that is
the slender reed upon which our own FDA has constructed this wall around
the United States, and that is the reason, ladies and gentlemen, that
American consumers pay \$360 and Germans pay \$60.

Mr. Burton: Let me just \-- we used logical arguments that the FDA has
used or illogical arguments as to why they want to stop importation of
pharmaceutical products from Canada and elsewhere. The arguments they
used don\'t hold water. I think you\'ve made that very clear tonight. So
what is the reason? There is only one reason, and you are reluctant to
say this but I am not, and that is the pharmaceutical industry makes the
biggest share \-- the lion\'s share of their profits right here on the
backs of the American consumer. And that\'s not right. You know,
they\'ll say it\'s research and development, but the research and
development should be shared equally around the world and I think
that\'s something we can deal with. But as far as them making these
inordinate profits on the backs of American consumers, when they\'re
making a profit in Canada, Mexico, Europe and every place else but not
to the degree they are here, it\'s just unconscionable. And it really
bothers me that the almighty dollar, as far as these corporate
executives are concerned, is more important than the health of American
citizens. You made it very clear and I think it is very clear and the
facts bear this out. There are American seniors and others who are going
wanting for pharmaceutical products because they simply can\'t afford
them, whereas the same products being sold for 1/10 the place someplace
else in the world and that in my opinion is criminal and we ought to
hold these pharmaceutical executives and companies accountable. We
cannot let them go on raping the American people, and that's a very
strong word, and I'm using it advisedly, but they\'re raping the
American people while the rest of the world is benefiting from these
lower prices. And it\'s something that should not be tolerated, and we
need to hold them accountable. and the thing that bothers me is that the
FDA comes before our committee with the lame excuses that they used that
don\'t hold water, as you have made so clear here tonight, these lame
excuses, and you say why? They're the regulatory agency that\'s supposed
to protect Americans to make sure that the products are safe, but also
to make sure that they get the products to which they\'re entitled. And
the FDA is blocking, they\'re like a linebacker, like a lineman in a
football game blocking for the pharmaceutical industry. And so you say,
well, why are they doing that? The pharmaceutical industry is making
huge profits on the backs of the American people, but why is the FDA
doing it? Well, the only reason i can come up with is that there\'s some
kind of a subliminal, sweetheart, revolving arrangement between the
people over at FDA and HHS and CDC, and the people at the pharmaceutical
industries and companies. And that\'s something that smacks of being
unethical, at the very least. The FDA and HHS should be concerned first
and foremost about the safety of products, number one, and number two,
to make sure that the American people have access to those products that
are going to protect their health. And they\'ve been blocking and
blocking and blocking for the pharmaceutical industry, and it\'s
something that should not, and hopefully will not, be tolerated in the
future. Now, you don\'t have to say that. I will.

Mr. Gutknecht: Well, I try not to get into that, because first of all,
let me say --

Mr. Burton: But I think we need to get into that.

Mr. Gutknecht: The president of the large pharmaceutical companies,
think don\'t work for us, but the head of the FDA does.

Mr. Burton: That\'s right.

Mr. Gutknecht: I think the presidents of some of these pharmaceutical
companies, they\'re going to have to answer to their shareholders,
they\'re going to have to answer to the public, and one day, they\'re
going to have to answer to god. Let me tell you something. This book and
this research \-- and there\'s more research coming out. And now, the
interesting thing especially after Sarbanes-Oxley, we\'re going to find
out more about how the money actually gets spent, and I think it\'s
going to be pretty embarrassing. I think what we\'re going to find is
more and more of these big pharmaceutical companies are spending more on
marketing and advertising than they are on research and development. One
of the things talked about in this book, there was a study done several
years ago by the \"Boston Globe,\" and they took a close look at the 35
most important and top-selling drugs that the FDA-approved over the
previous five years. All but two of them, there\'s 35 drugs, all but two
of them had been brought through the R&D pipeline with the help of the
NIH or FDA.

Mr. Burton: And that\'s taxpayers\' money.

Mr. Gutknecht: Right. And that happens again and again. I'm
vice-chairman of the science committee. And I think every American ought
to be proud of this. Americans represent something like 6% of the
world\'s population. But we represent over 50% of the basic research
done in the world. And I'm proud of that. I mean it\'s because of
Americans that we have places like mayo clinic, it\'s because of the
American spirit that we do what we do. It's because of the American
spirit that we put men on the moon and returned them safely. I mean it
is something about Americans that we want to do this research. This
year, we will spend roughly \$29 billion taxpayer dollars on research.
The interesting thing is many of the pharmaceutical companies work very
closely with the various research institutes that do this research. And
they pay very close attention. And many times, this research that\'s
done, once the research is completed, that information is available free
of charge. So they get this research free of charge. So in many
respects, we subsidize the pharmaceutical industry with that \$29
billion of taxpayers\' money. There's a second way we subsidize the
pharmaceutical industry. And that is in the tax code. Because even with
the research that they do, they write it off dollar for dollar. Most of
them are in at least a 40% tax breakthrough. So the taxpayers are sub
\-- tax bracket. So the tatch pairs are subsidizing 40% to 50% of the
research. And then they qualify for research credits. I'm not an
accountant, but a credit is better than a deduction. On top of that,
many have moved their facilities to places like Puerto Rico. Puerto Rico
is parts of the United States, as we all know. What some people don\'t
know is if you\'re in Puerto Rico, you pay no federal income taxes.

Mr. Burton: They have the 936 program down there.

Mr. Gutknecht: Exactly. And I think that\'s fine. It helps the Puerto
Ricans, it helps the United States, and I'm not going to argue about the
special benefits.

Mr. Burton: There\'s a problem with that too.

Mr. Gutknecht: The bottom line is we subsidize the development of drugs
through the NIH, through the national science foundation, through the
department of defense, they do a lot of research which ultimately leads
to these miracle drugs, and finally, we subsidize them in the prices we
pay. Now, my bottom line is I think Americans ought to pay. I think it
is part of the American spirit. We believe in finding the new cures. I
mean it\'s just something that makes us Americans. And I think we ought
to pay our fair share. I think it\'s the right thing to do. And frankly,
I think we ought to subsidize people in developing countries. In other
words, I think we ought to pay more than the people do in sub-Saharan
Africa. I think we ought to pay more than the people in Bangladesh, I
think we ought to pay more than some of the people around the world, but
I think it\'s ridiculous that our own FDA makes Americans subsidize the
starving Swiss. I think it\'s time for the Swiss --

Mr. Burton: or the Germans or the English.

Mr. Gutknecht: It\'s time for the German, the French, the Japanese,
it\'s time for them to pay their fair share. I think it\'s time for a
much more clear accounting from the pharmaceutical industry of exactly
how much do you really spend developing a new drug, how much does it
cost to get FDA-approval? How much profit do you really make? I mean
there\'s a report -- and I can\'t confirm this \-- but the president and
CEO of one of the pharmaceutical industries got \$227 million in stock
options. Now, that was above and beyond his salary.

Mr. Burton: His salary, yeah.

Mr. Gutknecht: And most of us could live fairly comfortably on a salary
of \$6 million to \$10 million, which is what the average CEO of the
nine largest pharmaceutical companies make.

Mr. Burton: If the gentleman will yield briefly.

Mr. Gutknecht: I\'ll be happy too

Mr. Burton: Because of the Exxon --

Mr. Gutknecht: Enron.

Mr. Burton: Enron, the Enron debacle and the other corporations around
the country that padded the books, that made it look like they were
making profits when actually they were losing money, and at the same
time, the corporate executives were making tons, because of that, the
Oxley bill that you talked about a few minutes ago set certain
guidelines and standards that they had to meet. I don\'t know why we
couldn\'t propose some kind of legislation that would mandate the same
kind of standard be applied to the pharmaceutical industry as well as
the other corporations around this country. The other thing that I think
we ought to take a hard look at is, you know, when congress \-- you and
I, when we leave here, we can\'t lobby our colleagues for a year. And
the reason we can\'t is because there\'s a concern that there might be
collusion between an incumbent congressman and some corporation out
there where they\'re going to benefit from the judgment and the vote of
a congressman in exchange for him lobbying down the road. And so we make
sure that a congressman has to wait a year before he can lobby his
fellow members. Why can\'t we do the same thing with the FDA and HHS and
CDC? Why can\'t we stop this subliminal revolving door policy that
exists in these health agencies by saying, if you\'re working for a
health agency here in the United States of America, you can\'t work for
a pharmaceutical company where you were sitting in judgment on their
products or on their policies? I know it would be very difficult to
draft a bill like that, but it might send the message if we just
introduced one to the FDA, CDC, and HHS, as well as the pharmaceutical
companies that that kind of chicanery must not exist. I think it\'s
something we ought to take a hard look at, because I can\'t think of any
other reason in the world other than profits that are keeping the
pharmaceutical companies from being able to \-- from people being able
to buy their products here in the United States from places like Canada.
And I can\'t think of any other reason other than the FDA is deeply
involved with the pharmaceutical industry, especially after what you\'ve
said here tonight about the reasons that they used, I can\'t think of
any reason in the world other than profit or collusion for the
pharmaceutical \-- or for the FDA to stand in the way of us being able
to buy those products from Canada or anywhere else. When they sat before
our committee and they looked you and me in the eye, and they said, it
was a safety issue, which we know is not the case, then there\'s got to
be a reason. And I can\'t put my finger on it other than there\'s some
incentive for them to support the pharmaceutical industry\'s position.
And we\'ve got to put a stop to that.

Mr. Gutknecht: Well, if the gentleman will yield back, I think there are
two things we ought to do. First of all, we ought to pass strong
legislation that says that very clearly, as it relates to countries \--
and I have them listed in the bill that we\'re working on \-- countries
like Canada, the European union, Japan, Israel, and a few other
industrialized countries where we know they have very effective
equivalents of our FDA, there\'s no reason in the world that Americans
and their pharmacists should not have the right to import drugs from
those countries. Let's get that passed this year. It ought to be part of
any prescription drug benefit package, because the truth of the matter
is \-- and I didn\'t get to this \-- how big this problem is. The
estimates by our own congressional budget office say that seniors will
spend, now just seniors, these are 65 and over, will spend \$1.8
trillion. \$1.8 trillion. That is a huge number. That\'s on prescription
drugs over the next 10 years. Our estimates, and I think this is the
most conservative of conservative, if we simply implemented and forced
the FDA to do what they ought to do and what we do with virtually every
other product, we could save at least 35%, that\'s minimum. In fact, the
number may be more like 55% or 65%.

Mr. Burton: Well, \$500 billion a year.

Mr. Gutknecht: It\'s \$630 billion over the next 10 years.

Mr. Burton: Over 10 years.

Mr. Gutknecht: Now, if we don\'t do this. I know people are coming up
with discount cards and all the rest, and they\'re going to say, well,
we can get a 20% discount or we can get a 30% discount. A 30% discount
off \$360 is not enough to make this program work. Ultimately, you\'ve
got to have access to markets. I'm not in favor of price controls. And I
don\'t like what a few of the countries do in terms of price controls. I
don\'t want America to have price controls. All I really want is open
markets, because I know what markets do. Markets level. And ultimately,
we will pay less, the Germans will pay more. That's how this will work
long term. And that is fair. That is reasonable and it\'s time we do it.
Now, the second thing, to get to your point, I think what we ought to do
is sick the general accounting office after these guys and try to get
answers to some of these questions, because these are legitimate
questions that our constituents, the American citizens who send us here
to Washington, they have a right to know. Somebody ought to get inside
those books and find out if it\'s true. For example, one of the
arguments the pharmaceutical industry makes is that it costs \$800
million to develop a new drug, but they never back it up. They never
open their books so we can see, yeah, in fact; it really is \$800
million. The truth of the matter is more and more of us are becoming
very skeptical about how much it actually costs to bring a new drug to
market and how much they really spend on research. In fact, this author
believes that they actually spend less on research than they do earn in
profits. And that\'s pretty scary. That's pretty indefensible. And maybe
\-- so maybe what we ought to do is ask the general accounting office to
do a research for us, to get some of the facts and report back to the
congress. Now, I'm not sure what we should do with it, because I believe
in free enterprise, and frankly, if company xyz wants to pay their chief
executive \$227 million, I'm not sure we should do anything about it.
But I'll tell you what we ought to do. We ought to make sure that
everybody knows it. Because I think the pressure from the public is
going to start to say this is lunacy and we shouldn\'t have to pay it. I
yield to my friend.

Mr. Burton: If the gentleman will yield for a second. One of the things
that concerns me about the prescription drug benefits you alluded to a
minute ago is if we pass a prescription drug bill in the congress to
provide benefits for seniors in this country and we don\'t do something,
as you suggested, to make sure that they\'re paying a fair price for
their product, then the taxpayers are going to be paying \$360 for a
product that you could buy in Germany for \$60, six times. And I don\'t
think the taxpayers want to be paying six times the price of a drug in
Germany here in the United States. And it would actually just bankrupt
the United States treasury in a few years if we didn\'t do something
about that. And I'm not for price controls either, but I do believe that
the marketplace ought to dictate the prices in a free market, not only
here in the United States but around the globe. And I think you make a
very valid point. The American people shouldn\'t pay six, seven, eight,
10 times the price that they do in other countries. That's what scares
me about the prescription drug benefit we are going to pass in this
congress this year. I think you and I will be down here debating that
when that bill comes to the floor to make sure that the taxpayers are
getting their dollar\'s worth when we buy these pharmaceuticals for
seniors.

Mr. Gutknecht: I think the people who developed this drug, Glucophage,
are entitled to be rewarded for it. I believe in that. I believe in
intellectual property rights, but I also say, why is it we pay so much
when the Germans can buy it so cheaply? And, again, it\'s not --

Mr. Burton: What is the price comparison?

Mr. Gutknecht: On this particular package the price in the United States
is \$29.95. This is a smaller package. But we bought this in Germany for
\$5.

Mr. Burton: So six times.

Mr. Gutknecht: Six times. Now, I don\'t care what kind of a discount
card you have. The differences are still too huge, and, you know, we
have an obligation to our taxpayers to make certain that if we are going
to have a prescription benefit for people who need that benefit, we have
to make certain, as you say, that we get a fair price. But frankly, as
long as we are at it, why shouldn\'t we get a fair price for all
Americans? Why shouldn\'t we just open up the market as we do to
oranges, or pork bellies? In fact, I have told the story, some people
say how did you get involved in this? And the answer is ironic. It was
the price of hogs. People say the price of hogs has something to do with
the price of drugs? Let me explain. A number of years ago, I had a
meeting with people from some senior citizens groups in my districts,
and they talked about their trips to Winnipeg to buy their drugs. I said
fine, if you want to go to Winnipeg to buy your drugs, that\'s fine with
me and that was it. I didn\'t really think that much more about it. Then
a few months later, the price of hogs in the United States dropped from
about \$50 or 50 cents a pound down to \$9 or nine cents a pound. And
all of a sudden, our hog producers in my area were just going crazy.
They couldn\'t afford to feed the pigs. They couldn\'t afford to
slaughter the pigs. They were going bankrupt they fast, and so they\'re
calling me saying congressman, you have to do something about it. I said
I am not sure what we can do. They said at least slow down the supply of
Canadian hogs that are making our supply-demand situation even worse. So
I called the department of commerce. I called the USDA. I got the same
answer. It's called NAFTA. It's called free trade.

Mr. Burton: Right.

Mr. Gutknecht: All of a sudden, a light bulb went on in my head. I said
wait a second, we have free trade when it comes to pork bellies but we
don\'t have free trade when it comes to Prilosec. This is nuts. One area
where American consumers could save billions and billions and billions
of dollars, and yet our own FDA puts a barrier and says you can\'t do
that.

Mr. Burton: But why?

Mr. Gutknecht: Well, I don\'t know why.

Mr. Burton: I do.

Mr. Gutknecht: I am not going to get into why because all I know is that
I took an oath of office, you took an oath of office, and we are here to
serve the public interest. Now, the pharmaceutical industry doesn\'t
work for me and I don\'t work for them. But the boys over at the FDA,
they do work for us. And they are required to serve the public interest.
And a drug that that little senior citizen who sits there with a
prescription and can\'t afford to have it filled, she deserves somebody
to speak for her, and as long as I am here, as long as I have breath in
my lungs, as long as I can hold these charts, I am going to keep talking
about this. And somebody is going to have to explain why the FDA keeps
American consumers from buying safe and effective drugs from other
countries for a fraction of the price. I am not going to give up on this
because as Winston Churchill said, you know what a fanatic is? A fanatic
is a person who cannot change their mind and will not change the
subject. I am not going to give up on this and neither are you. We are
going to stay on this issue until Americans have access to world-class
drugs at world market prices.

Mr. Burton: Let me say, god bless you for what you are doing and I think
there are seniors and people all across this country who can\'t buy
pharmaceuticals at the proper price who are saying go, man, go. Go,
Gutknecht, go. I am one of them. I've got to tell you, I want to find
out why. You know, my committee of the government reform and oversight
committee was charged with the responsibility of investigating waste,
fraud, and abuse in government, and I was chairman for six years. And we
found that are a lot of abuses in government. I \-- that there were a
lot of abuses in government. I want to find out why the HHS, the CDC,
why these kinds of problems are existing. There is no reason for it. the
purity of the products are guaranteed by the Canadian government as well
as our government. That was stated by their government officials just
this past week they\'re making a profit in those countries, but they\'re
making a huge profit here, eight, nine, 10 times as much in some cases,
and I want to find out why the FDA appears to be protecting this
industry. There's got to be something to that. And you mentioned the
GAO, a GAO investigation. I think a GAO investigation of this entire
area is something that needs to be done, not just the pharmaceutical
companies and whether or not they\'re benefiting from government
largess, from our research dollars, but also I think we ought to have
the GAO investigate what\'s going on at our health agencies and why this
sort of appearance of chicanery exists. So I want to join with you in
the GAO study but I might want to expand it further.

Mr. Gutknecht: I think the time has come, because again as Ronald Reagan
said quoting John Adams, "facts are stubborn things." I am not going to
get into motives. I don\'t care why they do things. I mean, to me,
that\'s not my job. My job is to stand up and speak for those people who
can\'t speak for themselves. When I read that statistic that 29% of
prescriptions written to senior citizens go unfilled, and I've stood in
pharmacies and I've watched them with their little slips and seen the
look on their faces. It seems to me that we have an obligation to say on
behalf of them that we are not going to just sit here and allow this to
go on. This has gone on too long and the worst thing is it's getting and
worse and worse per year. The difference between what we pay and what
the European pays is not getting better, it\'s getting worse. Shame on
us. Shame on the FDA.

Mr. Burton: There is one last thing I would like to bring up. We passed
a law in this congress that allows people to buy imported
pharmaceuticals. You recall that. And the FDA and HHS said no because
there were concerns about the safety of the imported pharmaceuticals.
But the congress of the United States, the house and senate combined,
have spoken on this issue. They want the American people to be able to
buy these pharmaceuticals safely from any place where they can get the
best price. That is a law passed by the congress, and the only thing
that\'s stopping it \-- and this is something we should have started on
earlier. The only thing that\'s stopping is our health agencies who are
saying wait a minute, we want to make sure they\'re safe. Well, you\'ve
proven tonight and I think conclusively that they are safe. There's been
no indication whatsoever, no cases where people have died from imported
pharmaceuticals. And even if there were a problem like that, which there
isn\'t, there is a way to make absolutely sure that the products coming
into the country are safe in a sealed container, where there can be no
tampering. so there\'s no way that we can\'t make sure these products
are safe. And yet the FDA continues to block, and I maintain it\'s
because of this relationship with our pharmaceutical companies. But in
any event, congress has spoken and we need to keep beating on this issue
so that the current law passed by the congress is enforced and FDA and
HHS just gets the hell out of the way.

Mr. Gutknecht: I think that about says it all. As a matter of fact, let
me just close with this. The congress has spoken. When we voted on this
matter in the house the last time, 323 of our colleagues voted with us
on this issue.

Mr. Burton: 324.

Mr. Gutknecht: In this ad, it says look how easy congress has made it
for you to save. That's what it says. The congress has spoken, and
unfortunately we put this language into that bill in the conference
committee, at somebody\'s request, that says as long as they can
guarantee safety. Well, they can\'t guarantee safety on imported
strawberries or pork bellies or plantains. We import hundreds of
thousands of tons of broccoli a year. 2% of the fruits and vegetables
coming into this country are contaminated with food-borne pathogens
including things like salmonella. Salmonella can kill you. It does kill
Americans, and yet what does the FDA do about that? Nothing. But boy, I
tell you what, if you try to save \$45 on a box of coumadin, they will
come after you like stink on a skunk. There is something wrong with the
system. We need to fix it. It's not so much shame on the pharmaceutical
industry. It's shame on us. It's time that we make certain that
Americans have access to world-class drugs at world-class prices. That's
what we want, that\'s what we expect, and we will not stop until we get
it.

Mr. Burton: Let me just conclude my participation in your special order
by saying I am proud to be a member of the Gutknecht army.

Mr. Gutknecht: Well, I thank the gentleman. With that, we yield back the
balance of our time.

The Speaker Pro Tempore: under the speaker\'s announced policy of
January 7, 2003, \--

Mr. Burton: May I be recognized for a special request? Mr. Speaker, I
ask unanimous consent to extend my remarks in the record and to include
therein extraneous material notwithstanding the fact that it exceeds two
pages and is estimated by the public printer to cost \$5,220. It's a
very important report, Mr. Speaker that I think the American people
should be aware of, and I would like for it to be put into the record.