E-drug: USA parallel importing legislation (cont)
-------------------------------------------------------------------
[copied from PHARM-POLICY with thanks]
Here is Senator Byron Dorgan's Senate speech on his new
parallel importing legislation. This is from the Congressional
Record.
Jamie
[[Page S6793]]
By Mr. DORGAN (for himself, Mr. Wellstone, Ms. Snowe, and Mr.
Johnson):
S. 1191. A bill to amend the Federal Food, Drug, and Cosmetic Act
to provide for facilitating the importation into the United States of
certain drugs that have been approved by the Food and Drug
Administration, and for other purposes; to the Committee on Health,
Education, Labor, and Pensions.
INTERNATIONAL PRESCRIPTION DRUG PARITY ACT
Mr. DORGAN. Mr. President, I rise to introduce a piece of legislation
on behalf of myself, Mr. Wellstone, Ms. Snowe, and Mr. Johnson. These
three Senators, and I hope others as well, have joined me in
introducing this bill, the International Prescription Drug Parity Act,
today.
This piece of legislation deals with the question of prescription
drugs. By consent of the Chair, I would like to show on the floor of
the Senate today examples of the issue that is addressed by this piece
of legislation.
With your consent, I will show two bottles of the drug Claritin, a
medication most people are familiar with. Claritin is a popular anti-
allergy drug. These two bottles contain the same pills, produced by the
same company, in the same strength, in the same quantity. One
difference: a big difference in price. This bottle is purchased in the
United States--in North Dakota, to be exact. This bottle of 10
milligram, 100 tablets cost North Dakotans $218, wholesale price.
This bottle--same drug, same company, same strength, same
quantity--was purchased in Canada. They didn't pay $218 in Canada;
they paid $61. Why the difference for the same drug, same dosage,
same quantity, same company? In Canada, it costs $61; U.S. consumers
pay $218. Here is another example--and I have a lot of examples. But
with the consent of the Chair, I will only use two today.
This is Cipro, a prescription drug to treat infections. Both bottles
are made by the same company. We have the same number of pills, 500
milligram, 100 tablets--same drug, same company, same pill. In North
Dakota, the wholesale price for this bottle is $399; in Canada, it is
$171. The North Dakotan pays--or the U.S. consumer pays because this is
true all over our country--$399, or 233 percent more than for the same
drug in Canada. The question is, Why? The question is, With a global
economy, why would a pharmacist simply not drive up to Canada and buy
the same drugs and offer them for a lower price to their customers? The
answer to that is, there is a law that restricts the importation of
drugs into this country, except by the manufacturers of the drug
themselves. That is kind of a sweetheart law, it seems to me. We want
to change that.
If the manufacturer that produces these pills has been inspected by
the Food and Drug Administration and the same drugs are marketed
everywhere, why on Earth, in a global economy, cannot our consumers
access a lesser price? Incidentally, this pricing inequity does not
just exist with Canada; it is the same with Mexico, Germany, France,
Italy, England, Germany--you name it. It is true around the world. We
pay a much higher price for most prescription drugs than consumers
anywhere else in the world. The United States is the consumer that pays
a much higher price for the same pill, in the same bottle, produced by
the same manufacturer.
With our bill we say, let's decide that what is good for the goose is
good for the gander. If the pharmaceutical companies can access the raw
materials which they use to produce their medicine from all around the
world and produce a pill and put it in a bottle, it seems to me that
the customer here in the United States ought to also benefit from free
trade, as long as the drug is FDA approved and comes from a plant that
is inspected by the FDA.
The drug industry will say that safety is an issue. It is no issue
with respect to my bill. Safety is not an issue here at all. I am
saying--and my colleagues are as well--if medicine approved by the FDA
and produced in a plant inspected by the FDA is to be marketed around
the world, but the American is to pay the highest price--in some cases
by multiples of four and five --let us use the global economy to let
U.S. pharmacists and prescription drug distributors access that
medicine wherever it exists at a lower price, and pass along those
savings to American consumers.
Back in 1991, the General Accounting Office studied 121 drugs and
found that, on average, prescription drugs in the United States are
priced 34 percent higher than the exact same products in Canada. I just
did a comparison of the retail prices on both sides of the border of 12
of the most prescribed drugs, and discovered that, on average, U.S.
prices exceeded the Canadian prices by 205 percent.
I mentioned before that Claritin costs the American consumer 358
percent more. We American consumers pay 358 percent more than the
consumer does north of the border. And incidentally, the Canadian
prices have been adjusted to U.S. dollars. Does this make sense? Of
course not. Studies show that the same drug that costs $1 in our
country costs 71 cents in Germany, 65 cents in the United Kingdom, 57
cents in France, and 51 cents in Italy. All we are saying is that if
this global economy is good for companies that produce the drugs, it
ought to be good for the consumer.
In 1997, the top 10 pharmaceutical companies had an average profit
margin of 28 percent. The Wall Street Journal reported that profit
margins in the drug industry are the ``envy of the corporate world.''
The manufacturers produce wonderful medicines, and I am all for it. But
I want them at an affordable price for the American consumer. I am flat
sick and tired of the American consumer being the consumer of last
resort who pays a much higher price than anybody else in the world for
the same drug, in the same bottle, produced by the same company. It
doesn't make sense.
Mr. President, how much time have I consumed?
The PRESIDING OFFICER. The Senator has consumed 7 minutes.
Mr. DORGAN. Let me go for another minute, and then I will yield to my
colleague from Minnesota, who will have 7 minutes remaining on the 15
minutes.
As I have indicated, Senator Johnson from South Dakota and Senator
Snowe from Maine are also cosponsors. We expect other cosponsors to
join us. Frankly, the reason we have introduced this legislation is
that there is an unfair pricing practice that exists with respect to
prescription drugs in this country. It is fundamentally unfair for a
pharmaceutical manufacturer to say that we will produce a drug, and, by
the way, when we decide to sell it we will sell it all around the
world, but we will choose to sell it to the American consumer at a much
higher price than any other customer in the world.
That is unfair to the American consumer.
What prevents the local corner pharmacist from going elsewhere to buy
these prescription drugs in France or in Canada or elsewhere? A law
that says you can't import a drug into this country unless it is
imported by the manufacturer. What a ridiculous piece of legislation
that was passed over a decade ago.
If this global economy works, let's make it work for the consumers
and not just for the big companies.
Our legislation only pertains to this circumstance: If the drug has
been approved by the FDA and the facility where that drug is bought are
inspected by the FDA, then those drugs have a right to come into this
country not just by the manufacturer but by local pharmacists and
distributors who want to access that drug at a less expensive price in
other parts of the world and pass along the savings to American
consumers. That makes good sense to me.
I have a lot more to say, but I will say it at a later time. I yield
my remaining time to my colleague, Senator Wellstone from Minnesota,
who is joined by Senator Johnson of South Dakota and Senator Snowe of
Maine as cosponsors of this legislation.
The PRESIDING OFFICER. The Senator from Minnesota.
Mr. WELLSTONE. Mr. President, let me first of all say to my colleague
from North Dakota that I am really pleased to join him in this effort,
along with Senator Snowe and Senator Johnson.
The International Prescription Drug Parity Act makes prescription
drugs more affordable for millions of Americans by applying the
principles of free trade and competition.
I want to give special thanks to a wonderful grassroots citizen
organization from Minnesota called the Minnesota Senior Federation. If
we had organizations such as this all around the country, we would have
such effective citizen politics, and I guarantee we would be passing
legislation that would make an enormous positive difference in the
lives of the people in our country.
This legislation provides relief from price gouging of American
consumers by our own pharmaceutical industry. Those who really pay the
price are those who are chronically ill. Many of those who are
clinically ill are the elderly. It is not uncommon anywhere in our
country to run across an elderly couple or single individual who is
paying up to 30, 40, or 50 percent of their monthly budget just for
prescription drug costs.
In my State of Minnesota, only 35 percent of senior citizens have any
prescription drug cost coverage at all.
This legislation is very simple. I say to Senator Dorgan that what I
liked the best about this legislation, and the reason I think it will
command widespread support, is its eloquent simplicity.
We are just saying that if you have drugs which are FDA approved and
manufactured in our country, and now they are in Canada, for example,
and cost half of what they cost senior citizens to pay for that drug in
our own country, it shouldn't just be the pharmaceutical companies that
can bring those drugs back in. You ought to enable pharmacists or
distributors to go toCanada and purchase these drugs which have been
FDA approved, and then bring them back to our country and sell these
drugs at a discount rate for our citizens in our country.
This is the best of competition. This is the best of what we mean by
free trade.
I want to be clear. This legislation will amend the Food, Drug and
Cosmetic Act. The FDA Commissioner was in Minnesota 2 weeks ago and
senior citizens were pressing her on this question. She was cautious.
But what she was saying was that we would need some legislation; we
would need some change to be able to do what Senator Dorgan is talking
about. We would amend this piece of legislation to allow American
pharmacists and distributors to import prescription drugs into the
United States as long as these drugs meet strict FDA standards. That is
it. The FDA isn't directly involved, but the FDA is critically involved
in the sense that these drugs have to meet all the FDA standards.
This piece of legislation is simple. It is straightforward. It is
very proconsumer, very pro-senior citizen, very procompetition, very
pro-free trade. As I think about the gatherings that I go to in my
State--I bet this applies to New Jersey, I see Senator Torricelli here,
and Senator Reed of Rhode Island--anywhere in the country. You can't go
to a community meeting, and you can't go in into a cafe and meet with
people without having people talk about the price of prescription
drugs. It is just prohibitively expensive. This piece of legislation
will make an enormous difference.
It could be that there is some opposition to this piece of
legislation. I can see some vested economic interests who may figure
out reasons to be opposed to it, but I will say that this piece of
legislation would go a long way in dealing with the problem of price
gouging right now and making sure that these prescription drugs that
can be so important to the health of senior citizens, the people in the
disabilities community and other citizens as well that they will be
able to purchase these drugs, and they will be able to afford these
drugs, which can make an enormous difference in improving the quality
of their health.
I introduce this legislation, along with Senator Dorgan, and we are
joined by Senator Johnson and Senator Snowe. I believe we will have
strong bipartisan support for this bill.
Mr. President, how much time do we have left?
The PRESIDING OFFICER. The Senators have a total of 9 minutes 54
seconds.
Mr. DORGAN. Mr. President, if I might just make a comment to the
Senator from Minnesota, all of us have the experience of going around
our States and talking to especially senior citizens, who take a
substantial amount of prescription drugs--many of them wonderful,
lifesaving drugs but at a substantial cost. Many of them have no health
insurance coverage for these costs.
Let me say at the outset, lest anyone think I don't appreciate what
goes on, that the research done at the Federal level and the research
done by the pharmaceutical companies have produced lifesaving,
remarkable medicines. I commend all of those folks for that, including
these companies. I am only debating the price issue here.
I ran into a woman one day. She was in her eighties. She had heart
disease, diabetes, and was living on somewhere around $400 a month of
total income. She said to me: Mr. Senator, I can't afford to take the
drugs the doctor says I must take for my heart difficulties and for my
diabetes. What I do is buy the drugs, and then I cut the pills in half
and take half of the dose so it lasts twice as long. It is the only
way. Even then I can hardly afford to pay for food.
That is what the problem is here. The problem is that these
pharmaceutical drugs are overpriced relative to what every other
consumer in the rest of the world is paying for them. I am talking of
other consumers in France, in Germany, Italy, England, Canada, and
Mexico--you name it. That doesn't make any sense to me. Why should our
senior citizens--all consumers for that matter--be paying 300-percent
more for the same drug in virtually the same bottle produced by the
same company inspected by the FDA than a consumer 20 miles north in
Canada is paying?
I just came from a meeting near the border of North Dakota and
Canada. I was talking to people, again, about that disparity. The
Senator from Minnesota has exactly the same situation.
The pharmacists at the corner drugstore are saying: Why can't I go up
there and buy some of these medications? I know that it is the same
pill which comes from the same plant.
The reason is the law prevents him from bringing it back, and we want
to change that.
Mr. WELLSTONE. Mr. President, I say to my colleagues, when we talk
about citizens becoming frustrated and sometimes angry, either two
things are going on.
First of all, you can find people to talk to everywhere, especially
senior citizens who are paying 30, 40, or 50 percent of their monthly
budget just for these costs. They cut the pill in half and take only
half of what they need, or they cut down on food. It is drugs versus
food, or versus something else. They should not be faced with those
choices.
But what adds insult to injury is to then know that the same drug
manufactured quite often in the same place with the same FDA approval
purchased in Canada costs half the price.
We are simply saying let our pharmacists and let our distributors in
our country be able to purchase those prescription drugs in Canada and
bring them back and sell them at a discount to our consumers. That is
what this legislation says.
If you want to talk about a piece of legislation that speaks to the
interests and circumstances of people's lives, I think this legislation
will make an enormous difference.
I am prepared to fight very hard to make sure that we pass this
legislation.
--
James Love, Director, Consumer Project on Technology
I can be reached at love@cptech.org, by telephone 202.387.8030,
by fax at 202.234.5176. CPT web page is http://www.cptech.org
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.