[Congressional Record (Bound Edition), Volume 149 (2003), Part 18]
[House]
[Page 25369]
[From the U.S. Government Publishing Office, www.gpo.gov]




                        PRESCRIPTION DRUG COSTS

  The SPEAKER pro tempore (Mr. Kline). Under a previous order of the 
House, the gentleman from Indiana (Mr. Burton) is recognized for 5 
minutes.
  Mr. BURTON of Indiana. Mr. Speaker, I come here tonight to set the 
record straight because last night the Food and Drug Administration 
Commissioner, Mr. Mark B. McClellan, made some statements in a speech 
before the National Press Club that I think need to be corrected.
  One of the big problems that we face as a Nation is that 
pharmaceutical products and the cost of them is totally out of line 
with the rest of the world. For instance, and I have used this example 
many times on the floor of the House, a woman who has breast cancer, a 
doctor will tell her the drug of choice is Tamoxifen, and Tamoxifen in 
Canada costs about one-sixth or one-seventh of what it does here in the 
United States. There are a number of other pharmaceutical products that 
cost five, six, or seven times what they cost here in the United 
States. The same thing is true in Germany, in Spain, and France and a 
lot of other countries in the world. So the American people are paying 
five, six, or seven times what it costs in other parts of the world for 
the very same pharmaceutical product.
  The big issue has been whether or not these products, if they are 
reimported into the United States, are safe. Over 1 million, probably a 
million and a half, American citizens have been buying their 
pharmaceutical products from Canada because they can get them so much 
cheaper up there than they can here in the United States. So there was 
a question of safety, are these people being injured by reimporting 
these pharmaceutical products from Canada?
  I had four hearings before my committee and subcommittee on this very 
issue, and we had people from the Food and Drug Administration, Mr. 
Hubbard who is a deputy over there, come and testify before our 
committee about the safety of the reimportation of these pharmaceutical 
products. I asked him on four separate occasions to give us any 
examples of where people had been injured by pharmaceutical products, 
FDA-approved, that had been reimported into the United States. He could 
not find one example, not one, and yet the FDA continues to say that 
there is a safety issue about the reimportation of these pharmaceutical 
products.
  They do not mention that they are supposed to check the food supply 
and the importation of foods from around the world, but 40 percent of 
our orange juice comes from around the world, and that is not checked, 
maybe 1 percent of it is, and raspberries are imported from Guatemala. 
We had 1,024 people either get sick or die from those that we know of, 
and yet we do not mention those, and yet they talk about the safety of 
pharmaceutical products when we have not had one case of people being 
damaged by reimportation of pharmaceutical products from Canada.
  Yet, last night, Mr. McClellan said in his speech, ``But at the same 
time, these Members,'' talking about Members of Congress, ``at the same 
time, these Members'' of Congress ``are clearly out of touch with the 
realities of keeping our drug supply safe, and the clear and present 
dangers to America's drug supply that their bills would create.''

                              {time}  1745

  He is talking about a bill that we passed overwhelmingly here in the 
House that would allow American citizens to buy pharmaceuticals at 
lower cost from other parts of the world because they are costing so 
much here in the United States.
  Now, the Food and Drug Administration, in my opinion, is marching in 
lockstep with the pharmaceutical industry, which is making huge profits 
here, while in other parts of the world they are making very small 
profits. The big profits and the big costs are to the American 
consumer, while the rest of the world does not bear those expenses. I 
just think that is dead wrong.
  The safety issue is a bogus issue. And there is another example that 
I would like to cite that shows that it is not a safety issue. The FDA 
has approved 949 different sites where they produce FDA approved drugs 
in the world. That is 949, and in places like Haiti and India and China 
and elsewhere. There are 949 sites. When they produce drugs in those 
sites, they send them out in large containers. Now, if there is a 
safety issue, it would be at those sites, because they are sending 
these drugs out in large containers where there could be some tampering 
taking place. But when they are sent in in very small amounts from 
Canada or Germany to United States citizens, they are usually in 
containers that are tamper proof, or could be made tamper proof so that 
the people would have absolutely no safety issue to be concerned about.
  So I am very disappointed that the Food and Drug Administration 
continues to say to the American people and is trying to scare senior 
citizens and others that they should not buy their pharmaceuticals from 
Canada or Germany or elsewhere, because the safety issue simply has not 
manifested itself. As a result, many Americans, who cannot afford 
prescription drugs, are going to the pharmacist and saying, How much is 
it? And the pharmacist says, Well, it costs this much; and they say, 
Well, maybe I will come back tomorrow, or they buy half a prescription 
and split the pills, while at the same time they could go to Canada and 
buy the same prescription product at one-sixth or one-seventh what it 
costs here in the United States.
  The Food and Drug Administration ought to be doing everything they 
can to make sure Americans get the best product, the best prescription 
drug at the best price in the world marketplace. World class drugs at 
world class prices. They should not be trying to say there is a safety 
issue when none exists.

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