[Congressional Record (Bound Edition), Volume 151 (2005), Part 3]
[House]
[Pages 4241-4242]
[From the U.S. Government Publishing Office, www.gpo.gov]




                              {time}  1515
                           PRESCRIPTION DRUGS

  The SPEAKER pro tempore (Mr. Dent). Under a previous order of the 
House, the gentleman from Minnesota (Mr. Gutknecht) is recognized for 5 
minutes.
  Mr. GUTKNECHT. Mr. Speaker, I rise again today to talk about the 
issue of prescription drugs and the price that Americans pay relative 
to the rest of the industrialized world.
  Now, I understand that we are a blessed country, and I understand 
that in many respects we as Americans should shoulder more of the 
burden than, for example, the people in Sub-Saharan Africa. But I do 
not think Americans ought to have to subsidize the starving Swiss.
  Let me just show this chart, Mr. Speaker. These numbers are very 
recent in terms of the comparisons of what we pay in the United States 
for name-brand prescription drugs and what the people in Germany pay 
for the same drugs. Let me cite some of these examples:
  Nexium. The next purple pill. It is advertised at every level in the 
United States. A 30-day supply in Rochester, Minnesota, is $145.33. 
That same drug at the Metropolitan Pharmacy in Frankfurt, Germany, is 
$60.25. Exactly the same drug.
  Look at this list. These are the most commonly prescribed drugs in 
the United States. Dropping down to Zocor, Zocor is a commonly 
prescribed drug that reduces cholesterol, particularly for people who 
have had heart problems. In fact, we have a number of our colleagues 
here in Congress who take Zocor.
  The interesting thing is if you buy that drug at the pharmacy in 
Rochester, Minnesota, it is $85.39 for a 30-day supply. If you buy that 
drug in Frankfurt, Germany, it is $23.83.
  What makes that even more interesting is that if you are a Federal 
employee, if you are a Member of Congress, there is now a $30 copay on 
that drug. So in other words, even a Member of Congress pays $30, when 
any German consumer can walk into a local pharmacy and buy it for 
$23.80.
  The interesting thing is if you total up these commonly prescribed 
drugs, in Germany those drugs will cost you $455.57 American. If you 
buy them here in the United States it is $1,040.04. That is a 128 
percent difference.
  What makes this even worse, Members, is that the differences between 
what we pay in the United States and what they pay in Germany has 
actually gotten worse over the last year, and that is at a time when 
the value of the dollar has declined by more than 20 percent. The 
differentials should have gotten less.
  I also want to call Members' attention to an article that appeared 
today in the Chicago Tribune, and it will be on my Web site as soon as 
my people can get it on the Web site. It tells what the FDA is now 
doing. They are, apparently, targeting a program started by the 
Illinois legislature and their Governor, Governor Rod Blagojevich, a 
former colleague of ours, that allows Illinois seniors and others to 
buy prescription drugs from preapproved Web sites in Canada. The 
savings there average over 50 percent.
  Apparently, the FDA is now intercepting these packages. They are 
literally saying that those drugs are illegal simply because they came 
from Canada. Well, in my view, that is an extension of what the law 
actually says, and I do not think the FDA has that power. Worse yet, 
they may have opened a door here now to a class action lawsuit that 
this administration is going to rue the day that this door was opened.
  This is a very high-risk strategy for this administration. First, 
they are clearly putting the health of many

[[Page 4242]]

Americans at risk by seizing prescription drugs en route to patients. 
Second, it underscores the hypocrisy between agencies. The FDA on one 
hand is demanding absolute safety for prescription drugs from Canada, 
notwithstanding the fact that there is no evidence of any danger to the 
public health. Meanwhile, another agency is fighting to reopen the 
border for Canadian beef when worldwide 150 people, including one 
American, have died from Mad Cow Disease. Apparently, the U.S. 
cattlemen do not enjoy the same political clout as the pharmaceutical 
industry.
  Finally, they have opened the door, as I said, to a class action 
suit. Several top lawyers have told me they are drooling at the 
prospect of getting a case into Federal Court. By using discovery 
powers, they could uncover documents and information terribly damaging 
to the administration and the pharmaceutical industry. It is altogether 
likely that the courts will stop the FDA from treating law-abiding 
citizens in the United States like common criminals.
  The law is vague, but congressional intent is clear: the FDA is wrong 
in the law, it is wrong on safety, and the courts and Congress can now 
make that crystal clear.
  Mr. Speaker, I submit for the Record the article from the Chicago 
Tribune to which I earlier referred:

                   U.S. Blocks Drugs Sent From Canada

                  (By John Chase and Christi Parsons)

       The Bush administration has begun selectively seizing 
     prescription drugs imported under a program created by Gov. 
     Rod Blagojevich, ratcheting up pressure to stop a practice 
     that the governor says will save money for consumers but 
     regulators contend is unsafe and illegal.
       The Canadian firm that manages Blagojevich's I-SaveRx 
     initiative says the federal Food and Drug Administration in 
     the first two weeks of February blocked more than one-fourth 
     of the foreign drug shipments it mailed to consumers in 
     Illinois and four other states that participate in the 
     governor's plan.
       ``I won't say the FDA has targeted I-SaveRx, but that's an 
     unbelievable coincidence,'' said G. Anthony Howard, president 
     and CEO of Ontario based CanaRx Services Inc.
       Operators of other Canadian pharmacies that ship drugs to 
     U.S. consumers also said they have noticed an upsurge in 
     seizures in recent weeks.
       The FDA has long opposed drug imports yet has done little 
     to stop them. But the reports could signal an aggressive new 
     phase by regulators in their battle to stop Americans from 
     getting their prescriptions from abroad. Officials involved 
     with Blagojevich's program also fear the sporadic seizures 
     may be designed to deter customers for I-SaveRx by creating 
     uncertainty over whether ordered drugs will actually arrive.
       In the past, ``the FDA has said, `If it is for personal 
     use, we'll allow them to go into the country,''' said Howard. 
     ``Now they're seizing their medication and not allowing it to 
     go through.''
       The FDA and Blagojevich have been battling since 2003 over 
     his push to end restrictions on drug imports from Canada and 
     Europe, where prescriptions cost less because of price 
     controls.
       The Bush administration opposes importation because it says 
     it cannot guarantee the safety of medicine from other 
     nations, but Blagojevich and others argue that much of the 
     medicine is manufactured overseas and the only difference is 
     the price. Pushing the importation issue, they argue, will 
     force drug companies to lower the cost of drugs in the U.S.
       William Hubbard, the FDA's associate commissioner of policy 
     and planning, denied the agency was targeting the program. 
     Though he said the agency considers all of I-SaveRx's 
     shipments illegal, the FDA is focused on seizing drugs from 
     overseas that can easily be counterfeited, such as the 
     cholesterol-lowering drug Lipitor.
       ``The inspectors' instructions are to open and inspect 
     these foreign shipments when they have the time and capacity 
     to do it,'' he said.


                      Failed flu vaccine purchase

       Blagojevich's run-ins with the FDA have extended beyond I-
     SaveRx.
       Last fall, shortly before the November election, he 
     announced that he had purchased millions of dollars in 
     European-made flu vaccine to help ease shortages expected 
     because of the sudden closure of a plant that was to have 
     produced half the U.S. supply.
       His maneuver backfired, however, because the FDA dragged 
     its feet on approving the imports. The flu season remained 
     mild and vaccine shortages never got as bad as feared.
       Blagojevich launched I-SaveRx in October and sold it as a 
     way for all 12 million Illinois residents to save money on 
     their medicine. Since then, Wisconsin, Kansas, Missouri and 
     Vermont have also joined, potentially opening the door to 
     millions more consumers.
       But the drug seizure controversy has highlighted how few 
     people have opted to use the program despite its promise of 
     great savings.
       Howard said the total number of shipments seized for 
     customers in the I-SaveRx states in the first two weeks of 
     February was 54, and that represented 26 percent of all 
     shipments sent to customers of the program during that time 
     frame.
       Since the October start, consumers in the five states have 
     ordered just 4,700 prescriptions.
       Blagojevich spokeswoman Abby Ottenhoff downplayed the 
     number of seizures by the FDA, describing them as 
     ``minuscule'' when viewed in the context of the number of 
     shipments made since the program started.
       ``This is not extraordinary that this would happen at some 
     level,'' she said. ``The program has overwhelmingly been 
     working smoothly. In a few instances where shipments weren't 
     received, they were re-sent at no cost to the consumer.''


                          They had my medicine

       One of those seniors who missed a shipment was Robert 
     Wuerth, a 79-year-old retiree from Arlington Heights.
       Wuerth had been expecting a three-month supply of Lipitor 
     to arrive in the mail, but instead he got a letter from the 
     FDA informing him that it had sent the medicine back to 
     Canada.
       ``I couldn't believe it,'' said Wuerth, who is recovering 
     from three heart procedures. ``I just got this letter telling 
     me they had my medicine.''
       Wuerth said he was lucky he still had medicine left when he 
     learned of the seizure and had time to call CanaRx and ask 
     for a new shipment, which he said is $80 less than U.S. 
     prices.
       Not only did the FDA let that one through, but when it came 
     it bore two labels. One read that it had been rejected for 
     delivery. On top of that was another that said it had been 
     released for delivery.
       Officials with CanaRx fear the FDA might be picking on I-
     SaveRx to embarrass Blagojevich. But officials with other 
     Canadian pharmacies said they too have noticed a considerable 
     upsurge in the number of seizures of their imports, mostly at 
     airports in Los Angeles and Chicago.
       Randy Stephanchew, vice president of standards for the 
     Canadian International Pharmacy Association, which is 
     unaffiliated with the I-SaveRx program, said more than 50 
     shipments from his Winnipeg pharmacy in recent weeks have 
     been detained from customers in California because they were 
     considered an ``unapproved, misbranded drug. ``
       A former official with Health Canada, the Canadian 
     government's equivalent to the FDA, Stephanchew said the FDA 
     has long held a policy permitting individual American 
     citizens to import drugs from foreign countries.

     

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