[Congressional Record (Bound Edition), Volume 150 (2004), Part 4]
[Senate]
[Pages 4299-4300]
[From the U.S. Government Publishing Office, www.gpo.gov]




   THE NOMINATION OF DR. MARK McCLELLAN AND THE REIMPORTATION OF FDA-
                      APPROVED PRESCRIPTION DRUGS

  Mr. DORGAN. Mr. President, we have finished our work on the budget 
resolution early this morning, I guess at 1:30 or so this morning. One 
of the last items of business that was conducted by the Senate this 
morning was the clearing of the nomination of Dr. Mark McClellan. I 
want to talk, just for a moment, about that issue.
  As you know, I had put a hold on his nomination. I want to explain 
the background of that hold and what happened last evening that allowed 
me to withdraw my hold on the nomination and allow his confirmation to 
occur.
  First of all, Dr. McClellan is the head of the Food and Drug 
Administration, and he has been nominated by the President to run the 
organization that administers the Medicare and Medicaid Programs. It is 
a very important position. It is an important position that he held as 
head of the FDA, and the new position is also very important.
  We had asked Dr. McClellan for some months to come to the Senate 
Commerce Committee and testify. The reason we did that is we have a 
very significant debate in this country, and especially in this 
Congress, about the subject of the cost of prescription drugs.
  We have had an abiding, lengthy debate here in the Congress about the 
prospect of importing prescription drugs: Medicines from Canada, for 
example, are the same prescription drugs sold in this country--same 
pill, put in the same bottle, made by the same company. The only 
difference is that they are sold for a substantial discount in Canada 
compared to the price U.S. consumers pay in this country.
  The U.S. consumer pays the highest prices in the world for 
prescription drugs, so many pharmacists and individuals have a desire 
to import that identical drug for a lesser price from other countries. 
They do this in Europe all the time. It is called parallel trading. If 
you are in Spain and want to buy a prescription drug from Germany, you 
order it. If you are in Italy and want to buy a prescription drug from 
France, that is not a problem. So the trade in prescription drugs 
between countries in Europe occurs regularly. The Senate Commerce 
Committee has heard testimony about it. There are no safety issues.
  We have run into a problem because Dr. McClellan as head of the FDA 
decided to wage an aggressive campaign to try to prevent the re-
importation of prescription drugs and to prevent the enactment of 
legislation in Congress that would allow for the re-importation of 
prescription drugs. We asked Dr. McClellan to come to the Senate 
Commerce Committee to discuss this issue, and he was also asked 
repeatedly

[[Page 4300]]

to testify in the House of Representatives. He repeatedly refused to do 
so.
  As a result, I put a hold on his nomination. It was not acceptable to 
me to move Dr. McClellan's nomination unless he was willing to come and 
testify before the Congress on these issues.
  Yesterday, Dr. McClellan did testify before the Commerce Committee. I 
and others, including Senator McCain, asked him a substantial number of 
questions about these issues.
  I had a long telephone conversation with Dr. McClellan last evening. 
I also had a conversation with the Secretary of Health and Human 
Services about these same issues. A couple of things happened as a 
result.
  No. 1, Dr. McClellan has given me a commitment that in his new 
position, when he is asked to testify before the Congress, he is going 
to testify. That is an important principle for this Congress. We ought 
not say to people: We will promote you even though you stiff us.
  I use the term ``stiff,'' which is a term Senator McCain used 
yesterday at the hearing. That is exactly what had happened. Dr. 
McClellan said he has learned from his confirmation experience and when 
asked to testify before relevant committees of Congress in the future, 
he intends to do so. That is No. 1. That is an important step.
  No. 2, when Dr. McClellan's name was cleared last evening, Senator 
Frist put this statement in the Senate Record:

       Mr. President, I announce for the information of my 
     colleagues that, in consultation with the chairman of the 
     Senate Committee on Health, Education, Labor, and Pensions, 
     Senator Dorgan, Senator Stabenow, Senator McCain, Senator 
     Cochran, and other interested Senators, the Senate will begin 
     a process for developing proposals that would allow for the 
     safe reimportation of FDA-approved prescription drugs.

  What is the import of that? The majority leader of the Senate, for 
the first time, has made a commitment: He wants to put together a group 
that will develop proposals that will allow for the safe re-importation 
of prescription drugs. That is a change.
  The question now is not whether we have some mechanism by which we 
can import prescription drugs and, therefore, have access to the 
reduced prices. Instead, the question is how can we do that. The 
majority leader used the word ``allow.'' ``Developing a process that 
will allow for the safe reimportation of FDA-approved prescription 
drugs.'' That is a significant change and a significant commitment. We 
will no longer fight about whether this ought to happen. We will fight 
about, perhaps, the mechanics of how to make it happen. And that is OK 
with me.
  I appreciate Senator Frist's statement and his commitment. Senator 
Frist and I spoke four or five times last evening about this before he 
put his statement in the Record.
  Again, the majority leader has said that he commits to beginning a 
process that will develop proposals that will allow for the safe 
importation of approved prescription drugs. That is a significant 
change and a significant commitment. I appreciate the words and the 
commitment of the majority leader.
  The minority leader, Senator Daschle, has also worked on this issue 
for some long while. Senator Daschle is a supporter of re-importation 
done under conditions that would provide for safety and also for 
savings for American consumers.
  Based on those two things--a commitment from Dr. McClellan that when 
asked to testify, he will testify, and also the commitment by Senator 
Frist to move towards developing proposals that will allow for the re-
importation of FDA-approved drugs--I lifted my hold and Dr. McClellan 
was approved.
  What we have accomplished in the last few days--Senator McCain, 
myself, Senator Snowe, Senator Stabenow, and others--is a significant 
shift, and it will inevitably lead to a change in public policy that 
will allow for the safe reimportation of FDA-approved drugs that will 
allow the American people to get them at a lower price. That is the 
goal.
  I yield the floor.
  The PRESIDING OFFICER. The minority leader.
  Mr. DASCHLE. Mr. President, I congratulate the distinguished Senator 
from North Dakota for his tireless efforts and for the success he has 
now described. Without his persistent leadership, and the effort he has 
made over the last couple of days, we would not be in the position we 
are today. I know I speak for senior citizens and certainly for the 
members of our caucus and many others who care deeply about this issue. 
He has moved the process forward in quite a dramatic way in the last 48 
hours. Were it not for his persistence and the leverage he had with 
regard to this nomination, we would not be in the position we are. I am 
grateful to him for the work he has done.
  As he has just noted, this definitely moves the ball forward. This is 
a significant development that will once again allow the Senate the 
opportunity to consider the issue of drug reimportation in a meaningful 
way.
  I have absolutely no doubt there is growing support for the efforts 
of the Senator from North Dakota and others who have been advocating 
for drug reimportation. In the last couple of days, the Senator from 
Mississippi, Mr. Lott, announced his change of position, and for good 
reason. I talked with him last night about his desire to be supportive 
of the effort. He, too, is troubled by the pharmaceutical rip-off that 
is now going on and the determination among drug companies to hold 
senior citizens captive to high prices for prescription drugs. On a 
bipartisan basis, Senator Lott, and Republicans and Democrats alike, 
have joined Senator Dorgan. This allows us, once again, to look at ways 
with which to address the issue.
  I commend the Senator for his success and applaud him for keeping the 
Senate's focus where it belongs: on bringing lower drug prices to 
seniors.
  I also acknowledge his role in moving the McClellan nomination 
forward. This was a controversial nomination in some ways. I have been 
working with the majority leader over the last couple of days to 
consider the ramifications of either holding up the nomination or 
moving it forward. I will have more to say in a moment about another 
very disturbing bit of news that has just been released this morning.
  But I think because of the extraordinary responsibilities that go to 
the office of CMS Administrator, filling that position is something 
that is important. I supported the effort to try to move this 
nomination forward in spite of some of the misgivings I have, as 
described so well by the distinguished Senator from North Dakota.
  Let me say, though, that when we come back from the recess, I will 
come to the floor to talk more specifically about nominations and the 
process that is currently being employed with regard to the 
consideration of other nominees from this administration. Last night, I 
spoke with the distinguished majority leader about some of the concerns 
I have. There are now over a dozen Democratic nominees, some of whom 
have been held for months by the administration. Their refusal to send 
the nominations to the Senate has caused many of us to be concerned 
about the fairness with which this process has been implemented. It 
will be very difficult for us to move forward on nominees in the future 
if this matter is not resolved.
  I have indicated to the majority leader that I will be providing him 
with the names of those people who have not been given fair 
consideration and whose names have been withheld. And whether it is in 
regard to judges or with regard to other executive appointments, there 
has to be a reciprocal treatment of nominees.
  If we are not able to move these nominees in the future, I think it 
would be very difficult for us to at least consider all of those who 
are being given to us by the administration with an expectation that 
they will be voted upon until this matter is resolved.
  We will have more to say about that when we return from the week 
recess.

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