[Congressional Record (Bound Edition), Volume 150 (2004), Part 13]
[Senate]
[Pages 18236-18237]
[From the U.S. Government Publishing Office, www.gpo.gov]




                  REIMPORTATION OF PRESCRIPTION DRUGS

  Mr. DORGAN. Mr. President, this morning, again in a Congress Journal, 
it says: ``Frist Decision to Delay Reimportation.'' This is the issue 
of the reimportation of prescription drugs, in order to put downward 
pressure on drug prices, as I mentioned to the majority leader last 
week on the floor of the Senate.
  I harken back to about midnight, March 11, in the Senate, on the 
floor of the Senate, when we were in session very late, to a statement 
put in the Senate Record by the majority leader saying ``the Senate 
will begin a process for developing proposals that would allow for the 
safe reimportation of FDA-approved prescription drugs.''
  I say to the majority leader, I hope very much that his decision on 
what the remaining schedule will be for this Senate will include an 
opportunity for us to, on the floor of the Senate, consider legislation 
dealing with the reimportation of prescription drugs.
  We have bipartisan legislation in the Senate. We also have a House-
passed bill that is on the calendar. As I indicated to the Senator from 
Tennessee last week, it is my intent, and the intent of others--
Republicans and Democrats--to push this issue to the floor. But I hope 
we would not have to push it in light of the statement by the majority 
leader on March 11, 2004.
  I ask the Senator to respond.
  Mr. FRIST. Mr. President, I would be happy to respond. Really, we 
need to clarify because I know a lot of statements have been made to 
the press that I made a commitment to the distinguished Senator to have 
a vote on the floor. I think we need to go to the statement he just 
read and see what was actually both said and the commitment that was 
made.
  Let me read the statement again. He just read it. The statement was--
and this statement made by me--``the Senate will begin a process for 
developing proposals that would allow for the safe reimportation of 
FDA-approved prescription drugs.'' So I do not think it is right for 
Senators on the other side of the aisle to characterize that statement 
as a commitment to bring it to the floor, have a vote on the floor of 
the U.S. Senate. So that is No. 1.
  No. 2, since that statement was made--and I think it was March 11--it 
was with the understanding to do exactly what was said; that is, to 
begin a process that is deliberate, that is thoughtful, that is 
inclusive, that captures the ideas of a whole range of U.S. Senators, 
with experts coming in to testify, to talk, to discuss, in committees, 
outside of committees.
  Since March 11, a tremendous amount has been done. Again, I will come 
back to this whole concept of the safe importation of FDA-approved 
drugs.
  Again, I was looking--because I knew it was going to come up again 
over the course of today--and vigorous process has begun in the Senate. 
If we just look since March 11, the Senate HELP Committee, the Senate 
Judiciary Committee, and the Subcommittee on Investigations of the 
Senate Governmental Affairs Committee have all held hearings--and 
continue to hold hearings--on this matter since that statement on March 
11.
  The HELP Committee, the Health, Education, Labor, and Pensions 
Committee, the committee of jurisdiction, has not yet developed a 
consensus on any approach because they are struggling with this issue 
of putting safety first.
  We know there is broad appeal for people who say: Let's bring in 
cheaper drugs from Canada, maybe from Malaysia, Thailand, India, 
Brazil, because people want less expensive drugs. I am sure all the 
polls and surveys say: Bring in those drugs; that means I can get 
cheaper drugs.
  In good conscience, as someone who recognizes that a few bad pills--
think back to a Tylenol situation where we had five pills, back in the 
1980s, that paralyzed our system, a few counterfeit drugs. The FDA 
tells us right now they cannot guarantee that 60 billion pills coming 
to this country every year can be safe, given the structures we have 
today.
  I say that because it is very difficult. That is the reason I don't 
think we ought to just bring it to the floor without that careful 
consideration which is

[[Page 18237]]

underway today, working through the committee of jurisdiction. It is a 
popular issue. When people say ``politically driven,'' that throws it 
into partisanship, which I don't want it to be. I know that is not the 
intention of the authors. We have people on both sides of the aisle 
supporting specific legislation.
  Before bringing it to the floor, I want to make absolutely sure, in 
this time where we only have 17 days left, when we have an 
appropriations bill we are presently struggling to finish tonight that 
talks about the safety and security of the American people, where we 
have the issue of intelligence reform, where we know we have to look at 
it internally and reorganize this body, the huge task to make sure we 
handle intelligence matters appropriately here, where we have a call 
from the President of the United States over the next 17 days to 
totally reorganize 15 intelligence agencies in the executive branch, 
focusing on the safety and security of the American people as it 
applies to intelligence, I just don't think by bringing this vote up to 
the floor, because it will be sort of the popularly driven vote without 
sufficient attention to safety first, that that is the right thing to 
do, given these 17 days.
  We all want to lower the cost of prescription drugs. They are way too 
high. They are going up too fast. We want to use appropriate tools to 
do that. Reimportation, if it can be safe, may be one of those tools. 
Can it be done safely? That has to be the fundamental question. I know 
both sides of the aisle want the drugs to be safe. They don't want 
drugs coming in cheaply just so we satisfy the demand for cheaper 
drugs. The question is, How do we do that. We don't have the consensus 
yet, I believe, to bring it to the floor and have people voting up or 
down. And then we really don't have time on the floor as we look at 
safety and security, the issues of intelligence, intelligence reform, 
12 appropriations bills, all due in the next 17 days.
  Mr. DORGAN. If the Senator would allow me the courtesy of a reply in 
leader time, the Senator has taken a lengthy period of time to describe 
why this may not happen. Let me make a couple of observations.
  The Senator knows what we discussed at midnight on the floor on about 
six or seven occasions prior to midnight on March 17. There were plenty 
of days left in the session at that point to consider a bipartisan bill 
on the reimportation of prescription drugs. We agreed there would be a 
process for developing proposals that would allow for the safe 
reimportation of prescription drugs, with the understanding that it was 
going to happen this year.
  In the HELP Committee, which the majority leader referenced, there 
have been three markups scheduled and three markups cancelled. That is 
not a process that leads to allowing the reimportation of prescription 
drugs.
  I have great respect for my colleague from Tennessee, but there is no 
safety issue here. Europe does this every day routinely in something 
called parallel trading. The question for this country will be, Will we 
decide to put downward pressure on prescription drugs by allowing 
reimportation or won't we? I believe earlier this year the 
representation was given to the Senate that we would be allowed the 
opportunity on the floor of the Senate to deal with this issue.
  It is my determination, as with others in the Republican and 
Democratic caucuses, to push this issue. We need to make time for this 
in the coming days because this Congress is going to have to consider 
it. I believe we were given a commitment that it was going to be 
considered. Three markup sessions that were scheduled and then canceled 
is not the development of a process that would allow for reimportation. 
If those of us who have developed our bill on a bipartisan basis don't 
push it, we will end this session with no opportunity for reimportation 
of prescription drugs and no opportunity to put downward pressure on 
prescription drug prices.
  This is not a partisan issue for me. It is not a political issue. It 
is about some poor soul out there this morning who is trying to buy 
prescription drugs and using his or her grocery money to do it because 
they are paying double, triple, quadruple, 10 times the price they pay 
when they go north of the border to buy the same drug put in the same 
bottle and made by the same company. It is unfair. We ought to do 
something about it. We have waited far too long.
  I respect the majority leader. I simply wanted to point out there has 
to be time to consider this in the coming 17 days. There was in March, 
and there needs to be now.
  I thank the Senator from Tennessee for his courtesy.
  Mr. FRIST. Mr. President, I don't want things to be misrepresented. I 
want everybody to have a full understanding. The challenges in the HELP 
Committee do reflect the difficulty. When you are talking about safety, 
not just of cheaper drugs, if you give somebody a counterfeit drug that 
doesn't thin their blood and they have a stroke and they die, we have 
done a disservice. I don't want that to happen. I am not saying 
reimportation will cause that to happen, but I will say it is our 
responsibility to put safety No. 1.
  I promise you, I will do that. It is an important issue. We agreed on 
March 11 to put a process in place. Three attempts by the HELP 
Committee were mentioned that were canceled or postponed. Let me just 
say, on Thursday July 22, the Subcommittee on Investigations of the 
Senate Committee on Governmental Affairs held a second hearing on 
purchasing prescription drugs. On July 21, the HELP Committee had 
planned to do the markup. It had to be postponed. That is correct.
  On July 14, the Senate Judiciary Committee held a hearing on the 
implications--that is, safety. They also talked about intellectual 
property trade. But they specifically focused on the drug importation 
legislation.
  On June 23, the Senate GOP HELP Committee had a briefing to help 
educate us broadly. It was not a markup but a briefing to educate us 
broadly to discuss, specifically, importation.
  On June 17, the Subcommittee on Investigations of the Senate 
Committee on Governmental Affairs held a hearing where GAO released two 
new studies that documented how American consumes are able to readily 
obtain prescription drugs, including controlled substances, over the 
Internet without a prescription. In that hearing they talked about 
erroneous dispensing labels, suspicious packaging.
  On May 20, the HELP Committee held a drug importation hearing to 
examine the challenges of developing and implementing drug importation 
legislation.
  The administration has a specific task force on drug importation that 
was set up as a product of the Medicare bill that we passed on this 
floor. They have not yet issued their final report. The report will 
incorporate testimony--this is what the administration is doing--by 
consumer groups, by professionals, by safety experts, by the FDA, by 
leading representatives from health care purchasers, from academic 
scholars. The task force has not yet released their report to us or to 
the American people. We await that. It is a very important initiative 
by the administration that we mandated to them. Off the Hill, a number 
of forums have been held since March.
  I mention all of this because I don't want the impression left that 
this issue, which is important to the American people--and we want less 
expensive drugs, but we want them to be safe drugs--is not being 
addressed by this body or other people concerned. I will continue to 
work with the other side. I know there will be a huge push in these 
next 17 days to get this up for a vote. I just don't think with the 
issue of safety and the amount of attention it is going to require on 
the floor of the Senate, when we are talking about the safety of those 
seniors and others who depend on these lifesaving drugs, I don't think 
we can address it adequately in the next 17 days.
  I yield the floor.

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