[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 10725-10752]
[From the U.S. Government Publishing Office, www.gpo.gov]




                       IRAQ SUPPLEMENTAL FUNDING

  Ms. KLOBUCHAR. Madam President, I come to the floor today to express 
my deep disappointment and the disappointment of so many people in my

[[Page 10726]]

State with the President's expected decision to veto the supplemental 
funding bill delivered to him by the bipartisan majority in Congress. 
This bill provided our troops in Iraq and Afghanistan with all the 
equipment and the resources they need to continue the duties they have 
been so bravely performing for more than 4 years. The amount 
appropriated by Congress rose well above the amount the President 
requested to give our soldiers on the battlefield. Let it be clear: 
Congress has given our soldiers on the battlefield all the funding they 
need. It is the President who will now be blocking it.
  A few weeks ago, I was driving in Minnesota. It was a beautiful 
spring day outside of Ortonville, MN, and as has happened too many 
times in my short time as a Senator, I called one of the mothers of the 
Minnesota soldiers who died in this war. Of the 22,000 troops the 
President has included in this surge, 3,000 of them are Minnesota Guard 
and Reserves who were expected to come home in January and February and 
now have been extended. Now the moms I am calling are the moms of these 
soldiers who would have been home in January or February.
  I asked this mother: How are you doing?
  She said: You know, people keep asking me that, and I don't really 
know what to say. Do you have any ideas about what I should say?
  I thought, and I told her: Well, I can tell you what all the other 
mothers have been saying. They have been saying that they wake up every 
morning and they try hard to hang together for their family, and then 
something happens. They see a picture or they remember something, and 
they are never the same for the rest of the day. They have their good 
moments, but their lives will never be the same.
  I told her that her son stood tall, and that now is the time for 
people in Washington to stand tall.
  After 4 years of extensive American military involvement in Iraq, the 
President refuses to accept the prudent change of course recommended by 
the bipartisan Iraq Study Group and supported by a clear majority of 
the American people. By passing this bill, we in Congress fulfilled our 
constitutional duties to, first, continue funding for America's Armed 
Forces in harm's way and, second, to ensure that our Government pursues 
policies in the best interests of our soldiers and of our Nation.
  As we work with the President in the days and weeks and months to 
come, we must continue to advocate for the necessary changes in our 
strategy in Iraq. It is with this spirit that we in Congress continue 
to reach out to the President for a responsible change of course in 
Iraq.
  Last month, I visited Baghdad and Fallujah. I saw firsthand the 
bravery and commitment of our troops. The very best thing we can do for 
these young men and women is not only give them the equipment they 
deserve but to get this policy right. This means sending a clear 
message to the Iraqi Government that we are not staying there 
indefinitely. This means, as recommended by the bipartisan Iraq Study 
Group, that we begin the process of redeploying our troops, with the 
goal of withdrawing combat forces by next year, while acknowledging 
that some troops may remain to train the Iraqi police and special 
forces to provide security for those who remain and to conduct special 
operations. This means not a surge in troops but a surge in diplomacy 
and economy and Iraqi responsibility.
  When I was over in Baghdad and Fallujah, I saw many things, including 
the bravery of our troops. I was struck a few weeks later when another 
delegation of people from Congress went there, and one of the 
Congressmen returned and said he had been visiting a market there. He 
said it reminded him of a farmers market in Indiana.
  Those are not the enduring memories of my trip to Iraq. My most 
enduring memory is standing on the tarmac in the Baghdad Airport with 
nine firefighters from the Duluth National Guard, who called me over to 
stand with them while they saluted as six caskets draped in the 
American flag were loaded onto a plane. As every casket was loaded on, 
they saluted. They were standing tall for their fallen soldiers that 
day. Now is our time for Congress to stand tall. Our troops have done 
everything they have been asked to do. They have deposed an evil 
dictator, and they gave the Iraqi people the opportunity to vote and 
establish a new government. It is now the Iraqi Government's 
responsibility to govern.
  But stability and progress in Iraq depend on the political reforms 
Iraqi leaders have promised many times yet failed to deliver. After 4 
years, despite many promises, Iraq has yet to approve a provincial 
election law. After 4 years, despite many promises, Iraq has yet to 
approve a law to share oil revenues. After 4 years, despite many 
promises, Iraq has yet to approve a debaathification law to promote 
reconciliation. After 4 years, despite many promises, Iraq has yet to 
approve a law reining in the militia. Our men and women in uniform 
cannot deliver these kinds of reforms to Iraq. This is up to the Iraqis 
themselves.
  As the bipartisan Iraq Study Group recommended, Iraqi leaders must 
pay a price if they continue to fail to make good on key reforms they 
have promised the Iraqi people. After 4 years, what have we gotten? 
Benchmarks without progress, promises without results, claims of 
accountability without any consequences. Why should we expect the Iraqi 
leaders to do any better when they know the President continues to 
accept their excuses for inaction and fails to impose any penalties for 
their lack of progress.
  That is why the bipartisan Iraq Study Group made clear that ``if the 
Iraqi government does not make substantial progress toward the 
achievement of milestones on national reconciliation, security, and 
governance, the United States should reduce its political, military, or 
economic support for the Iraqi government.'' That report was issued 5 
months ago. Meanwhile, the President has simply stayed the course he 
has continued to pursue for the past 4 years and, not surprisingly, 
little progress has been achieved in Iraq. The Iraqi Government will 
understand and finally take responsibility only when it is crystal 
clear to them that our combat presence is not indefinite and that 
American combat troops are going to leave. That is the responsible 
change of course we in Congress are seeking. The American people are 
looking to their leaders in Washington at both ends of Pennsylvania 
Avenue to work together to get this policy right.
  Two weeks ago, I went to the White House and met with the President, 
along with three other Senators, including two Republicans. I 
appreciated the time he took to honestly discuss our points of 
agreement and disagreement on the war. I told him that now is the time 
to forge cooperation with our Democrats in Congress. But the President 
has chosen instead to veto this bill.
  As we move forward on the funding of this war, we in Congress will do 
nothing that threatens the safety of American soldiers in the field. 
But we must continue to fulfill our constitutional duty to exercise 
oversight of American policies in Iraq. A critical part of this 
oversight must be demanding accountability for the way in which funds 
are spent on the reconstruction projects in Iraq.
  For the past 4 years, the administration has demanded--and received--
a blank check to spend in Iraq. Now we are seeing the consequences of 
this lack of planning, management, and responsibility.
  On Monday, the Special Inspector General for Iraq Reconstruction 
released a report that details widespread failures in the most basic 
reconstruction projects. The report finds that, in many cases, Iraq's 
infrastructure and utility systems are worse off than they were before 
the war.
  On closer inspection, it turns out that even projects which were 
declared ``success stories'' were considerably less than that. In fact, 
seven out of eight of these projects which were called success stories 
were not operating properly due to plumbing and electrical failures, 
improper maintenance, possible looting, and the fact that expensive 
equipment was available but never used.

[[Page 10727]]

  Prior to the 2003 invasion, Iraq's power system produced 4,500 
megawatts a day. Today, the same system produces 3,832 megawatts a day. 
In Baghdad, the city enjoys an average of 6.5 hours of electricity a 
day. A year ago, Baghdad received 8 hours of electricity a day. Before 
the war, the city received an average of 16 to 24 hours a day.
  Congress has provided $4.2 billion for reconstruction of Iraq's power 
system, and the result has been a more than 50 percent decrease in the 
length of time the citizens of Baghdad have access to electricity on 
any given day.
  Congress has provided nearly $2 billion to provide clean drinking 
water and repair sewer systems. But according to the World Health 
Organization, 70 percent of Iraqis lack access to clean drinking water.
  The Defense Department has estimated that the unemployment rate in 
Iraq is anywhere between 13.6 percent to 60 percent. In a recent 
survey, only 16 percent of Iraqis said their current incomes met their 
basic needs.
  So after 4 years, we are facing a security situation that continues 
to deteriorate, an economic situation that continues to stagnate, and a 
reconstruction effort that cannot provide even the most basic services.
  My colleagues and I have been asking the difficult questions and 
demanding answers from this administration. The supplemental bill 
demonstrates that Congress is reclaiming its rightful role in setting 
Iraq policy and, more broadly, in our system of government. The 
President's veto only strengthens our resolve.
  Madam President, I also wish to speak briefly in support of a few 
other provisions in this bill that I believe respond to critical 
challenges our Nation faces and that the administration has deemed 
unnecessary.
  The White House and many of my friends on the other side of the aisle 
have argued that this bill should not contain funding for anything 
other than the current war. If we were sacrificing funding for our 
troops in order to meet domestic priorities, I would agree. But having 
given our troops all they need and continuing to ignore crises at home 
would be irresponsible.
  Veterans funding is one of the key parts of this bill. This bill adds 
an increase in veterans funding that was long overdue. In the last 2 
years in my State, veterans would come up to me--particularly from the 
Iraq and Afghanistan wars--and they would tell me about how they had 
difficulty getting treatment. They clearly had mental health issues. I 
didn't know if there was truth to this. I wasn't sure, because of the 
state of their minds, whether this was true. Then I got here, and I 
started looking at the numbers.
  In 2005, the Department of Defense estimated that about 24,000 
soldiers coming back from Iraq and Afghanistan would need health care. 
The actual number is four times that amount. Last year, they were 
87,000 soldiers short in their estimate of how many soldiers would need 
help coming back from this war. Now I know why those people were 
wandering around asking for help. It is because they weren't getting 
the help they deserve.
  Another critical problem that has been ignored by this 
administration--and one that is particularly important to the people of 
my State--has been the tremendous damage recent national disasters have 
been inflicting on our farmers and ranchers. The supplemental spending 
bill was a combination of a 2-year effort to secure disaster assistance 
for America's farmers. Minnesota farmers have been hit with heavy 
losses for 2 consecutive years--storms and flooding in 2005 and, again, 
drought in 2006. All told, they lost more than $700 million in crop and 
livestock losses.
  The supplemental funding would have provided $3.5 billion to 
compensate farmers for a portion of their crop and livestock losses 
over the past 2 years. Our farmers have waited too long for this 
disaster relief. I am deeply disappointed that the President has turned 
his back on the urgent need for their assistance.
  The bill we sent to the President of the United States provided the 
resources and support our soldiers need on the battlefield and after 
they return home. A few months ago, I attended a funeral of one of the 
brave men who was killed in the line of duty. The priest stood up, and 
he said to the thousand people in the cathedral: You know, this was a 
good kid. He was 6 feet 2 inches tall, but he was still our child.
  When we send our kids to war and they are 6 feet tall, they are still 
our kids and they are standing tall. We need to stand tall.
  The traumatic brain injury victims I have seen at the veterans 
hospital in Minnesota, even in their wheelchairs, are standing tall.
  Those moms whom I talked to on the phone, as they struggle every day 
just to get out of bed to deal with the loss of their kids who were 
killed in this war, are standing tall.
  Now it is time for the President of the United States to stand tall.
  Madam President, I yield the floor.
  The PRESIDING OFFICER. The Senator from Massachusetts is recognized.
  Mr. KERRY. Madam President, I ask unanimous consent to proceed as in 
morning business.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                                  Iraq

  Mr. KERRY. Madam President, 4 years ago today, as we know, the 
President stood on an aircraft carrier underneath a banner that read 
``Mission Accomplished.'' He declared that the major combat operations 
in Iraq were over. When he spoke those words, 140 American troops had 
been killed in Iraq. Since then, over 3,200 more American troops have 
given their lives. Just today, we learned that April was the deadliest 
month this year, with 104 Americans dead.
  With every passing day, it becomes more obvious that the President 
really should have said: My fellow Americans, major combat operations 
in Iraq are just beginning. On that day, he should have had a plan to 
match the rhetoric with reality. But we are where we are, as the saying 
goes, and it is even more tragically clear to all but a few that if we 
want to accomplish our mission in Iraq--and we all do--if we want an 
Iraq that has any chance of stability and some sense of democracy, any 
sense of it, we have to change course.
  In the past 4 years, we have lost at least 3,342 of our best young 
men and women, and nearly 25,000 others have been wounded and many 
wounded severely. We have spent nearly $400 billion, and the cost is 
rising at a rate of over $2 billion per week. There is no end in sight.
  ADM William Fallon, the top U.S. commander in the Middle East, 
recently said:

       We are losing ground every day.

  And even General Petraeus, the top commander in Iraq, now says that 
we can expect the situation to get worse before it gets better.
  We were treated to a spectacle a week and a half ago with news 
reports, a front-page story, I think, in the Washington Post, that 
Stephen Hadley, the President's security adviser, was casting about to 
find a general to be the sort of supreme organizer, if you will, of the 
war in Afghanistan and the war in Iraq.
  What struck me about that story is here is our Nation at war, here is 
a series of four-star generals whose lives are committed to Nation, to 
service, to duty, and to military, who under normal circumstances would 
be honored to be asked to become the point person to organize our 
Nation's efforts in two wars in a front that is of serious consequence 
to this Nation. Yet all four retired four-star generals said no. One 
was even quoted publicly as saying they don't know what the hell they 
are doing, or they don't know what direction they are going in.
  That is a pretty remarkable statement for a career military person to 
make about the current effort. But we also know the history of what has 
brought us here with retired generals--a whole host of them--who 
publicly rebelled postservice against the leadership of Secretary 
Rumsfeld, who is now gone.
  It is a rather remarkable statement about the lack of planning, about 
the lack of candor, about the scapegoating

[[Page 10728]]

that has gone on, about the unwillingness of people's careers to be 
judged not by their ability to tell the truth but, rather, their 
willingness to tell the civilian leaders what they want to hear.
  As we know from our own intelligence agencies, the war in Iraq has 
increased the threat of terrorism by creating a breeding ground for 
terrorists that didn't exist before the invasion and by serving as a 
rallying point for extremists around the world. In fact, the State 
Department's annual terrorism report released yesterday shows that 
terrorist attacks worldwide were up 25 percent last year after 
increasing nearly fourfold the year before that.
  How does the leadership come to the country and suggest that this war 
is accomplishing our larger goals? How does it help the war on terror 
to be creating more terrorists? How can you tell the American people we 
have made you safer, when the number of terrorist incidents have gone 
up and the number of terrorists who want to kill Americans is larger 
today than it was on 9/11?
  Any businessperson, any tourist, anybody of any curiosity who has 
traveled abroad and who has asked a few simple questions or read the 
newspapers and listened to the news knows that our Nation, which we 
love passionately, is now less followed, less listened to, and less 
feared--less listened to by our friends and less feared by our enemies. 
The fact is, we are less safe as a result. We are less unified at home, 
less respected abroad, and we are less strong as a result.
  Obviously, there is no way we can make up for what has happened in 
the last few years, certainly not in terms of the lives lost and the 
pain and suffering endured by those wounded and by families who have 
suffered those losses, but the fact is, we can find a responsible 
strategy to try to deal with not just Iraq but the whole Middle East 
and, indeed, releverage America's position in the world.
  The President today, tonight, is going to veto crucial funding for 
the troops passed by both Houses of Congress, legislation that gives 
our soldiers all they need to complete the mission and receive the care 
they deserve once they get home. The President is going to veto it, but 
that is not all he is going to do. Then he is going to try to pin the 
blame on those who have pushed for a new direction. He is going to try 
to pin the blame for his failures, for his lack of planning, for his 
lack of leadership on those who are providing the only way to try to 
resolve what is happening in Iraq.
  Instead of pressuring Iraqi politicians, this administration is 
practicing the politics of division at home, a brand of American 
sectarianism that undermines our national unity, a unity required to 
make decisions in time of war.
  Last week, Vice President Cheney accused Senator Harry Reid of 
putting politics ahead of our national security. I suppose we have 
grown used to this Vice President, who has pioneered the politics of 
fear, who oversaw the politicization of the intelligence used to 
mislead the country into war, who claimed that we would be greeted like 
liberators, who told us the insurgency was in its last throws, who 
continues to insist that everything is on track and growing fine, I 
think we have grown used to this Vice President not being candid with 
the American people.
  Clearly, he didn't hesitate to impugn the integrity of the Senate's 
majority leader who is standing for an appropriate new direction with 
respect to our policy in Iraq.
  Certainly, we can disagree about those tactics or strategies without 
impugning the motives and challenging the integrity of those who speak 
those different possibilities.
  If the President insists on continuing down the wrong path, it seems 
to me Congress has no choice but to be as resolute in demanding the 
right path forward for our troops, for our country, and for the Iraqis 
themselves. I believe we have to continue to fight for the legislation 
that gives us the best chance of bringing our troops home with some 
measure of success in the region.
  Four years after ``mission accomplished,'' it is time for us to 
acknowledge the implications of what General Petraeus and every other 
military commander, the Secretary of State and even the President have 
told us. All of them have said there is no military solution to the 
violence in Iraq. I don't know how many times I have heard that on 
Sunday shows, I hear it out here in the corridors with individual 
Senators talking to the press. Everybody mouths the words: ``There is 
no military solution.'' But if there is no military solution and we are 
all agreed on that, then what is the military doing? Why is the 
military and an escalation in the number of troops so critical if there 
is no military solution?
  The administration, even after telling you there is no military 
solution, then gives you a rationale for a military solution, which is: 
We have to put additional troops in to have the security, in order to 
have the compromises. But the fact is, the security which, first of 
all, is proving illusive and probably impossible to secure with the 
troops alone, cannot be secured without the political compromises. This 
is a classic chicken-and-egg situation: Which comes first? You are not 
going to get the security until the stakeholders in this civil struggle 
feel confident enough that what they are struggling about can be 
resolved to their safety and future security. That is sort of a 
fundamental issue. You are not going to change the on-the-ground 
security situation and stop people from bombing and militias from 
killing unless those fundamental stakes are properly addressed and 
defined.
  It is long since time that we started to measure progress on the 
ground in Iraq by the one metric that will ultimately determine our 
success or our failure, and that metric is this: Are the Iraqis making 
the tough political compromises necessary to keep their country 
together?
  It has been nearly a year since the Maliki Government took power. At 
that time, General Casey and Ambassador Khalilzad said that the Maliki 
Government had 6 months to make the political compromises necessary to 
win the public confidence.
  So here we have the commanding general of our forces and our trusted 
Ambassador to Iraq both saying they have 6 months to make the 
compromises. But guess what. The 6 months went by and nothing 
happened--nothing happened in Iraq to make those compromises happened, 
and nothing happened afterwards because the compromises didn't happen. 
That sends a message that there is no consequence to delay, there is no 
consequence to procrastination.
  After that, the Iraqi Government agreed to a set of benchmarks 
because people were growing frustrated and those benchmarks, guess 
what, were pegged to specific dates for making progress toward national 
reconciliation.
  In January, the President announced the troop escalation, and he told 
the American people the following:

       America will hold the Iraqi Government to the benchmarks it 
     has announced. Now is the time to act. The Prime Minister 
     understands this.

  But, once again, no real consequences, no real leverage, no real 
diplomacy. The result is, those benchmarks proved meaningless. You can 
take a look at the benchmarks the Iraqis agreed to. What did they agree 
to do at that point in time?
  October 2006, over 6 months ago, that was the deadline for Iraqis to 
approve a new oil law and a provincial election law. As of today, the 
oil law has yet to even be introduced in Parliament, and that is an 
improvement over the provincial election law which hasn't even been 
drafted yet.
  November 2006 was the deadline for new debaathification law to help 
bring Sunnis into the Government. A draft proposal was recently 
denounced by Ayatollah Sistani and a national commission to oversee the 
process, and guess what. It is nowhere near completion. In fact, 5 
months after the deadline, the Shiite leader of the SCIRI Party 
recently described the Baathists as ``the first enemy of the Iraqi 
people.'' So much for debaathification and reconciliation.
  December 2006 was the deadline for the Iraqis to approve legislation 
to address the militias. To date, absolutely

[[Page 10729]]

no progress has been made on this crucial legislation, and the militias 
continue to wreak havoc.
  January 2007 was the deadline for Iraqis to complete a constitutional 
review process. There was supposed to be a referendum on constitutional 
amendments by March. Guess what. The constitutional committee hasn't 
even drafted the proposed amendments, and the Iraqis remain far apart 
on key issues such as federalism and the fate of the divided city of 
Kirkut.
  We are no closer to a political solution today than we were when the 
Maliki Government took power 1 year ago, but there were more than 940 
additional American troops who gave their lives in that process to wait 
for the Iraqis to procrastinate.
  Did the President actually hold the Iraqi Government to those 
benchmarks as promised? No. I hope the President tonight, when he 
addresses us after the veto, will address the benchmarks and where we 
are with respect to the failure of the Government to make the choices 
they said they had to make while our soldiers continue to die.
  The administration still refuses to get genuinely tough with Iraqi 
politicians. They keep moving the goalposts, deflect the criticism of a 
failed strategy which they refuse to abandon. Instead, we get more 
vague assertions that our presence is not open-ended and outright 
rejection of any proposal that would leverage that threat.
  The administration, it seems to me, has reached a point where it has 
to stop pretending the lack of political will in America is the 
problem. It is not the lack of political will in America that is the 
problem, it is the lack of political will in Iraq that is the problem.
  It is impossible to make any other judgment when you look at that 
entire series of benchmarks. I remember Secretary Rice coming before 
the Foreign Relations Committee, I believe, several months ago now, and 
I asked her the question about the oil law. She said: Oh, yes, the oil 
law is almost done, just about done; wrapped up, we are about to 
proceed forward, we are confident it is going to be done in a few days. 
Here we are, several months later, and there is no oil law. It is not 
even before the Parliament yet.
  The administration needs to accept the basic reality that the 
Congress has acknowledged: Iraqi politicians, if they are capable, if 
they are capable of making these decisions, have shown they will not do 
it without a reason to do it, without a rationale that feels some heat. 
A deadline is the only thing they have responded to so far. It took a 
deadline to be able to get them to do a constitution. It took a 
deadline to have each of their elections.
  Incidentally, they protested against each of the deadlines. Each time 
they said: Don't do this to us; we can't meet it; we can't make it; it 
is too much. But each time, because we set the deadline and kept 
pushing, they did meet it.
  American security is not a security blanket for Iraqis who want to 
procrastinate while American soldiers die. The longer the President 
continues to give them the sense that he is not going to change, he is 
not going to move on them, the more they are secure in the sense that 
they can just continue to jockey and play their political game at the 
expense of American dollars and American interests and American lives. 
Without real deadlines to force them, there is no way to actually 
determine that we can make the progress we need to make. Since January, 
when the President decided to disregard key elements of the Iraq Study 
Group and announced the escalation, over 340 American troops have died, 
and there is still no fundamental progress.
  The legislation we have sent to the President would change this 
dynamic. It would force the Iraqis to either stand up for Iraq and meet 
the political benchmarks they have agreed to or decide they can't do it 
and have their fight.
  It calls for a flexible timetable for the redeployment in 2008, and I 
underscore ``flexible.'' Every time we try to do something, we get into 
this totally phony, polarized debate where the President and his 
henchmen go out and talk about reckless abandonment and surrender and 
defeatism when, in fact, what we are proposing gives the President all 
the discretion in the world--to leave troops there to finish the 
training of Iraqis, which is the fundamental reason we are there; to 
leave troops there to chase al-Qaida, to prosecute the war on terror, 
which is in our interests, and to leave troops to protect American 
forces and protect American facilities. After 6 years of the war, what 
other fundamental mission should there be for American forces?
  It seems to me the real debate is one that should center around the 
failures of this administration to face that reality and the few 
choices we have now to try to achieve success. The most important 
choice that has to be made to achieve success is to engage in full-
throated diplomacy, not dissimilar to the kind of meeting that will be 
held in Sharm el-Sheikh this week. We hope Secretary Rice will take 
advantage of that and that the countries of the region will come 
together around a new security arrangement and a new understanding of 
what has to happen.
  The timetable for the redeployment in the legislation sent to the 
President is not arbitrary, and it is not precipitous. It is consistent 
with the Iraq Study Group's recommendations and with the timeframe for 
transferring control of Iraq to the Iraqis that was set forth by 
General Casey. It also has the schedule agreed upon by the Iraqi 
Government itself. There is nothing arbitrary in a schedule to which 
your own commanding general and the Iraqi Government have agreed.
  Even the President has said, under his new strategy, responsibility 
for security would be transferred to Iraqis before the end of this 
year. So they are willing to set a date. The administration can set a 
date for the transfer of the security, but it is unwilling to set a 
date for the beginning of the drawdown of some troops so you guarantee 
that date for the transfer of security is actually meaningful. The 
President has said it. Our generals have said it. The Iraq Study Group 
has said it. Now it is time for the President to embrace legislation 
that makes those words reality.
  Instead of accepting the change that is necessary, we keep hearing we 
need more of the same; we have to give the surge time to work; the 
Iraqis need just a little more breathing space to start making 
political progress.
  General Petraeus has said, however, that he won't be able to make any 
progress assessment on the ground until September. Guess what. We hear 
that Iraq's Parliament, which has only been able to muster a quorum to 
even consider legislation about once every week or two--the Iraqi 
Parliament plans to take a 2-month vacation this summer, a vacation in 
the middle of a civil war. You sort of wonder what Abraham Lincoln 
would think of that. Iraq is descending further into chaos as thousands 
of Iraqis die each month. If the Iraqis go on vacation without making 
the key political compromises, it will absolutely guarantee that there 
is not going to be any meaningful political progress until next fall. I 
do not believe that America should be sending our troops to die for 
somebody else's vacation.
  How many more American soldiers are going to give their lives without 
any hope of achieving a real political solution? 300? 400? 500? How 
many more doors are going to be knocked on and phone calls made? How 
many more visits to Arlington and other cemeteries across America, 
while the Iraqis procrastinate and refuse to settle their differences?
  How can any of us in the Chamber look in the eyes of the parents of 
any young American killed and tell them: Your son or daughter died so 
the Iraqis can take the summer off?
  With every passing day it becomes clearer this Iraqi Government is 
not going to get the job done. It is not truly a unity government, it 
is a figleaf for politicians who are pursuing sectarian interests 
instead of protecting the nation they are charged with saving. Now it 
is starting to crumble under the weight of its own ineffectiveness and 
corruption.
  Last week some prominent Iraqi legislators came out and said publicly

[[Page 10730]]

that they have lost confidence in the Maliki government. That is not 
surprising since we recently learned that Prime Minister Maliki was 
responsible for a politically motivated purge of Iraqi military leaders 
who had the gumption to actually act against the Mahdi militia.
  Yesterday the largest block of Sunni Arabs in the Parliament 
threatened to withdraw its Ministers from the Shiite-dominated Cabinet 
in frustration over the Government's failure to deal with Sunni 
concerns. As one Sunni legislator said:

       The problem is not just with sectarian practices but with 
     the Government's ineffectiveness.

  This Government we are supporting is spiraling downward into greater 
and greater ineffectiveness. In the process, Iraq is spiraling deeper 
and deeper into its sectarian divide.
  It is not just the Iraqis. Last week we learned that several 
prominent Sunni countries are balking at complete debt relief for Iraq 
because of the lack of progress in political reconciliation. This past 
weekend the Saudis refused to allow Prime Minister Maliki to visit 
their country because he has not delivered on his promise to seek real 
reconciliation with Iraqi Sunnis. How can we expect progress and 
political reconciliation if the Iraqis have lost confidence in the 
Maliki government? How can we expect diplomatic progress when Iraq's 
neighbors have lost confidence in Iraqi leadership? This is a very 
serious issue.
  The administration has finally done what they should have done years 
ago: engaged, this week, in the kind of diplomacy that is desperately 
needed. On the eve of the summit, we learned that some of the major 
players have no confidence in the political process. So if we really 
want to bring about the political and diplomatic solution that is the 
only solution, the time has come now for new leadership in Iraq.
  When I was in Iraq in December, Prime Minister Maliki told me he was 
working on forming a new coalition that would isolate extremists 
unwilling to compromise and empower moderates who were. Since then we 
have heard from time to time that these negotiations continue behind 
the scenes. But nothing has happened. It is time to get out from behind 
the scenes. It is time to have a government that can put the pieces 
back together.
  As one Iraqi Minister said yesterday, Mr. Maliki ``said he was going 
to appoint new Ministers; he needs to do that. . . . What is he waiting 
for?''
  That is a question the U.S. Congress should echo. We simply cannot go 
on like this, day after day, news cycle after news cycle--more bombs, 
more murders, more assassinations, more suicide bombings, more 
killings, more American soldiers dead. We can't go on like this and 
expect the situation to miraculously get better. Time is not on our 
side. Time is not on anyone's side in the end because if this does go 
downward into greater sectarian violence, all of the Iraqis will lose.
  If we are serious about a political solution, we need a fresh start. 
That is why I believe it is time for Prime Minister Maliki to make 
wholesale changes in his Cabinet. He already has to replace the six 
Muqtada al-Sadr Ministers, the Sadrist Ministers who recently resigned. 
He should use that as an opportunity to fire any other Minister who is 
not committed to political reconciliation and replace them with 
Ministers who are.
  We should make it clear this truly is his last chance. If reshuffling 
the Cabinet does not produce meaningful political progress within a 
relatively short period of time, then he should step down and allow a 
new leader to step forward. Putting Mr. Maliki's personal political 
future on the line is perhaps one of the few ways left to try to create 
the leverage necessary to find out if he is capable of moving the 
reconciliation procession forward. If he proves unwilling or unable, 
then clearly someone else should be given a chance--if there is someone 
else.
  This is the moment to put that to the test. I recognize that Iraqis 
must take responsibility for their own future and that any government 
we impose will lack legitimacy with their fellow Iraqis. But we can use 
our own influence behind the scenes to encourage the Iraqis to make the 
leadership changes so clearly needed in order to give their Government 
a chance to succeed. We certainly have a right to make that request, 
given the degree to which that Government is dependent on our troops 
and our money and our presence.
  Congress has finally done what this administration has stubbornly 
refused to do. I am proud of my fellow Members of this body who had the 
courage to vote for this legislation. I know how divisive it can be. I 
know how the other side uses it and how people tend to try to 
personalize and even denigrate people's patriotism and concern for the 
Nation. The fact is, the Congress has done what needed to be done 
because this administration has not done it.
  People say don't micromanage. Someone has to manage. They have 
clearly mismanaged every step of this war, and they have been absent 
from the diplomacy necessary. It is time to have a new strategy, time 
to hold Iraqi politicians responsible for their country's future, time 
to get deadly serious about finding a political solution, and finding 
it now.
  Somehow this President still chooses to take a different tack. If 
President Bush vetoes this bill, which we understand he will, then he 
is the one standing in the way of a bipartisan strategy on Iraq. The 
Iraq Study Group was bipartisan. The Iraq Study Group had former 
Secretary of State Jim Baker, a Republican, a great friend of President 
Bush's father. It had Secretary of State Larry Eagleburger. It had Al 
Simpson, former Senator from Wyoming and Republican leader in the 
Senate. It had Bill Perry, former Secretary of Defense; Chuck Robb; it 
had Ed Meese, former Attorney General and Chief of Staff to a 
Republican President. All of these are moderate, thoughtful, respected, 
trusted voices in foreign policy and in the affairs of our country. 
They all came together in a consensus. That consensus was summarily 
rejected by the President, just pushed aside.
  The President decided to go his own road, which even the generals and 
even Prime Minister Maliki did not want to do. I read one Senator's 
comment that there is no plan B, that there is just plan A, which is 
the surge. I disagree with that. Plan B is what plan B should have been 
all the time, which is to engage in the legitimate kind of intervention 
on a diplomatic level and to put on the table all of the issues of the 
region in a way that proves the kind of sincerity and seriousness of 
purpose that raises the level of credibility of the discussion so 
people can trust that we, in fact, are going to be moving in a common 
direction, which is in their interests.
  The reason Saudi Arabia is sending such public messages of discontent 
for the policies of this administration today is because, given what 
has happened, that is the way they have to play it in order to deal 
with their own politics of the region and their own politics of the 
street and their nation. It is our absence from a creative, diplomatic 
effort, it is our absence from a credible and legitimate diplomatic 
lift that has left no choice even to our friends than to begin to 
distance themselves from our country.
  With this veto, the President will deny our troops the vehicles they 
need, for the time being; he will deny them the basic care they 
deserve, for the time being, because all of us know the Congress will 
come back and we will fund those things. But the most significant thing 
he will deny us is the kind of leadership and the kind of consensus the 
country deserves in order to move forward in our policy in Iraq.
  We honor the lives lost in Iraq, not with words but with lives saved. 
We honor the lives lost in Iraq not with words and with the political 
partisanship here but with a policy that is right for them and for the 
region. We honor their sacrifice by creating a situation in the region 
where we protect America's and the region's interests at the same time 
and begin to recognize the degree to which our presence in Iraq is 
playing into the hands of the terrorists, is advancing the very cause 
we seek to fight, which is diminishing

[[Page 10731]]

the ability of the United States to be able to leverage, not just the 
Middle East issues, but a host of other issues in the world.
  I believe we need to change course, and it is only by changing course 
that we will honor their sacrifice, respect our interests, and bring 
our troops home with honor.
  Madam President, I yield the floor, and suggest the absence of a 
quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  The PRESIDING OFFICER. The Senator from Massachusetts is recognized.
  Mr. KENNEDY. Madam President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. KENNEDY. I want to let our Members know about the substitute that 
has been included, that is before us now. It essentially clarifies the 
FDA's authority to place restrictions on drugs with safety problems; 
applies only to drugs like Thalidomide that could not otherwise be 
approved. We can understand why it is important that the FDA probably 
would not have approved Thalidomide, for all of the dangers it has, but 
it has now approved it to deal with some of the problems of leprosy. We 
want to make sure it is not going to be out there and be utilized in 
terms of expectant mothers. So we have worked this out. I thank Senator 
Coburn for his help on this issue.
  We also make sure the FDA takes into account concerns of rural 
communities in setting safety policies. We have given enhanced 
authority to the FDA in terms of safety policies. We want to make sure 
in the implementation of those, particularly in rural areas, they are 
not going to be so restrictive as to limit the opportunities to get the 
necessary prescription drugs. I thank Senator Harkin and Senator 
Murkowski, who were enormously helpful in working through that issue.
  This also adds a Web portal for FDA so consumers will have a single 
point of access, via the Internet, to drug safety information. I thank 
Senator Gregg for that. That will be very important for consumers who 
are concerned about the safety issues. All of those changes and 
alterations are very helpful and valuable in terms of the legislation 
itself.
  I wish to speak for 3 minutes as in morning business and not under 
the time on the bill.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                      SUPPLEMENTAL APPROPRIATIONS

  Mr. KENNEDY. Madam President, the President is going to be making up 
his mind on the issue of the supplemental and making a judgment in the 
next several hours. President Bush stubbornly clings to the false hope 
that success is just around the corner and that the mission will be 
accomplished. We have heard it all before. Ending the rule of Saddam 
Hussein was supposed to lessen violence and bring a new wave of 
democracy into the Middle East. It has not. Saddam Hussein's capture 
was supposed to quell the violence. It didn't. Free elections and the 
drafting of the constitution were supposed to be a breakthrough. They 
weren't. The surge was supposed to bring stability, essential to 
political reconciliation and economic reconstruction. It has not and it 
will not.
  Only the Iraqi people can save Iraq and it is time for them to do so. 
American military force cannot solve the problems of the Iraqi people. 
It is time for the President to put the Iraqis on notice that our 
military will begin to withdraw. No one in the administration can 
honestly tell the American people we are making progress in Iraq. It is 
time the President listened to the Iraq Study Group, Congress, and the 
American people, and work with us to bring our troops home.
  The President is wrong to veto the Iraq spending bill and reject its 
needed timeline for the orderly, responsible, and safe withdrawal of 
our forces from Iraq. He was wrong to lead us into the war, wrong to 
conduct it so poorly, and wrong to refuse to change course.
  We cannot continue business as usual in Iraq. It is time for America 
to end its participation in the brutal civil war. The message from the 
American people couldn't be louder or clearer: Instead of defying the 
will of the American people, President Bush should listen to their plea 
and begin working with Congress to bring this tragic war to an end.
  The PRESIDING OFFICER. The Senator from Wyoming.
  Mr. ENZI. Madam President, I am going to make even briefer remarks 
than the Senator from Massachusetts did.
  One of the questions I had been asked over the weekend was: Why 
hasn't the President already vetoed the supplemental appropriations 
bill? He promised he would veto the bill because it has all this extra 
spending in it, with directions on the war from people who really are 
not even involved in administering the war.
  Of course, what I found out is the bill has not even been sent to the 
President yet. He cannot veto a bill until he receives a bill. So to 
chastise him for not having already vetoed the bill when there is a 
hold card keeping him from being able to veto the bill I think is 
unconscionable. Hanging on to that bill and not getting it there so the 
decisions can be made on it one way or the other just is not right. 
That is not the way to run the Senate. It is not the way to run the 
country. And it is not the President's fault if he does not have the 
bill to make the decision.
  There can be a lot of debate on what that decision ought to be made 
and how to carry them out. I am certain the President will veto the 
bill; he has been very clear on that. There is a differing philosophy 
on how a war ought to be run. There are a lot of people throwing in the 
towel. It is kind of hard to win at anything if your opponent knows the 
point at which you are going to give up.
  That is where we are in this battle, with the complete direction to 
give up, to throw in the towel, to say what has been done over there 
has not done any good, won't do any good, and to keep calling it a 
civil war. It is not a civil war. It is a religious war that is 
brewing. There is a tremendous difference. It is a religious war that 
involves the entire Middle East, not just Iraq. And in preparation, for 
what the other people in the Middle East have heard said on the Senate 
floor, armies are gearing up in Saudi Arabia and Syria and Israel and 
Iran, ready to move into the vacuum that would be caused by a U.S. 
departure.
  That will not be the first time there has been a religious war in the 
world. If we do not step in, it would probably be the first time we had 
the chance to stop a religious war and did not help. So we could leave, 
have a regional religious war, and then try to decide what we are going 
to do about that.
  Religious wars are not easy things to solve. We have seen that with 
Kosovo with religious genocide. We got to see what happened in Kosovo. 
We helped out in Kosovo just as we are helping in Iraq.
  So, Madam President, I hope we would actually debate the Food and 
Drug Administration bill, which is what we were set out to do this 
week. I hope people who have amendments would bring the amendments to 
the floor.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Madam President, as we know, the supplemental passed 
last Thursday. It is Tuesday today. So the comments I made were 
directed to the fact that the President has announced he is going to 
veto it. I just wanted to comment about that issue.
  Although we differ on that issue, we are together in wanting to get 
the Senate to both debate and dispose of amendments. The afternoon is 
moving along. We had statements yesterday from Senator Enzi and myself 
on this legislation, spelling this out. We had an opportunity in our 
caucus today--I imagine the Senator did as well--to go through the 
details of the legislation. So we have addressed many of the concerns. 
But there are still some concerns that are out there, and this is an 
extremely important piece of legislation. So we are asking our 
colleagues to come to the floor to let us know their amendments, to see 
if we can

[[Page 10732]]

work those out. If not, we would like to have the debate on those 
measures and let the Senate exercise its will. We are ready for those 
amendments, and we urge our colleagues to bring them to our attention 
at the earliest possible time.
  The PRESIDING OFFICER (Ms. Klobuchar). The Senator from Illinois.
  Mr. DURBIN. Madam President, I ask unanimous consent to speak as in 
morning business before addressing the pending legislation.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. DURBIN. Madam President, there have been comments on the floor 
about the fact that in just 2 hours the President of the United States 
will have an opportunity to sign or veto a bill which literally will 
affect the lives of 150,000 soldiers and their families, if not every 
American. It is a bill that was passed by the House and Senate, with 
bipartisan votes in both bodies, and sent to the President. It fully 
funds the troops in Iraq, giving them all the resources they need, and 
more, so they can execute this war and their duties in a safe manner.
  But it also does something significant; it starts to change the 
mission in Iraq. We are in the fifth year of this war. We have lost 
3,351 American lives. I respect very much the Senator from Wyoming. He 
tries to make a point that it is not a civil war. My understanding of a 
civil war is when people of the same nation are at war with one 
another.
  That, sadly, is the reality of what is going on in Iraq today--Iraqis 
killing one another while Americans stand in the midst of the 
crossfire. Had the President of the United States come to this Congress 
in October of 2002 and suggested we send 150,000 soldiers into Iraq for 
the purpose of refereeing a civil war or a religious war that had its 
origins in 14 centuries of anger, had he said to us we must stay as 
long as 5 years and spend $500 billion and risk thousands of American 
lives, with no end in sight, what were the chances we would have passed 
that resolution? None. That is not what the President told us.
  He told us Iraq was a threat to the United States of America with 
weapons of mass destruction, and nuclear weapons, that somehow they had 
been in concert with al-Qaida, that led to 9/11. None of those things 
turned out to be true--not one of them.
  On that basis, we authorized the President to go to war, and he 
decided to take a preventive course of action--not preemptive but 
preventive course of action--and invade this country before they 
threatened the United States. That is what we are in today.
  Within 2 hours, the President will pick up a pen and have a chance to 
start bringing this to an end. If he signs this bill we have sent to 
him, it will mean that American soldiers can start coming home and 
that, equally important, the Iraqis understand it is now their country, 
their war, and their future, that they have to put their lives on the 
line and not rely on the bravery of our soldiers to keep their country 
intact.
  If the President vetoes this bill, exactly the opposite message goes 
to the Iraqis. Its message: Continue business as usual. Continue 
waiting out the political opposition, not resolving your differences, 
really allowing this religious or civil war to become even worse.
  The month of April was the deadliest month for American soldiers this 
year. We continue to see thousands of Iraqis killed each month in this 
country. The President, though he is limited in support for this 
position, continues to argue that with just a few more American 
soldiers, a little longer period of time, some more money, everything 
is going to get better. Many of us are skeptical. The American people 
believe--and I concur with their belief--we do need a timetable to 
start bringing American troops home on a responsible, reasonable basis.
  I hope the President will reconsider. I hope he will sign this bill. 
I hope the troops will be funded and the direction of this war will 
change.
  Madam President, this bill is for the Food and Drug Administration's 
reauthorization. This is an agency which is often overlooked. Madam 
President, $1.7 billion a year in a Federal budget is not a huge amount 
of money. There are many other agencies with less responsibility and 
more resources. The Food and Drug Administration is responsible for 
really determining the safety of so many things American families take 
for granted: when you are buying food, when you are buying drugs, when 
you are buying over-the-counter medicines. Many of the appliances you 
buy really have to be tested to be safe by the Food and Drug 
Administration. We count on this small agency to do a very big job and 
a job that gets bigger by the year.
  The bill that is before us is basically the law which authorizes the 
Food and Drug Administration to do its business. I am glad we brought 
it to the floor. I salute Senator Enzi on the Republican side and 
Senator Kennedy on the Democratic side for their leadership.
  The Food and Drug Administration is an essential guardian of the 
public's health and safety in America. In recent years, their 
reputation has been at risk because of incidents of drug safety 
problems and questions about their independence. The FDA has been 
faulted for neglecting its drug safety responsibilities and for failing 
to respond to concerns raised by its own drug safety specialists.
  Experts have warned that the FDA does not have adequate authority to 
pull dangerous drugs off the market, mandate changes in drug labels, or 
sanction drug companies that do not monitor drug safety.
  The most glaring example of a drug safety problem is the handling of 
Vioxx, a painkiller that was found to increase the risk of heart attack 
and stroke and was used by 20 million people across America. Merck was 
aware--the company that made Vioxx--that product raised the risk of 
cardiovascular problems, and they continued to market it, nevertheless, 
long before it stopped selling the drug in 2004. The episode has raised 
serious questions about FDA's ability to react quickly to signs of 
safety problems with drugs already on the market.
  Listen to what one of FDA's own drug safety experts said in testimony 
before the Senate Finance Committee. I quote:

       I would argue that the FDA, as currently configured, is 
     incapable of protecting America against another Vioxx. We are 
     virtually defenseless.

  That is quite a statement. It troubles me.
  That concern of that individual does not stand alone. A survey of FDA 
scientists conducted last year by the Union of Concerned Scientists 
found the following: 47 percent of FDA scientists said their FDA office 
is less effective than it was 5 years ago; nearly 40 percent said the 
FDA is not acting effectively to protect public health; more than one-
third of FDA scientists said FDA officials care more about approving 
new drugs and devices than ensuring they are safe; and 15 percent said 
they personally have been inappropriately asked to exclude or alter 
information or conclusions for nonscientific reasons. That is a 
horrible comment on an agency with the responsibility of the Food and 
Drug Administration.
  Our priority must be to take this reauthorization as an opportunity 
to change the FDA. The bill does that. It restores balance between 
timely approval of innovative drugs and safety and effectiveness.
  Problems with drug safety in recent years highlight the limits of 
FDA's ability to monitor and respond to safety problems that arise 
after approval. Safety problems may not be detected prior to FDA 
approval because the clinical trials FDA relies upon often involve only 
a few thousand people.
  This bill, S. 1082, responds to this problem by making postapproval 
monitoring of drugs a core responsibility of the FDA, strengthening and 
clarifying the tools it has to make their products safer. The bill 
requires active monitoring for drug safety problems through the use of 
Federal and private databases. It creates a system for approving drugs 
with a specific strategy for evaluating and mitigating their risks. It 
promotes greater transparency by disclosing information on clinical 
trials.

[[Page 10733]]

  These and other provisions in this bipartisan bill will help to 
restore public confidence in the FDA. S. 1082 will help FDA fulfill its 
crucial and complex mission. I look forward to supporting it.
  One of the things most people do not realize is the major 
responsibility the Food and Drug Administration has for the food we 
eat.
  Now, let me tell you at the outset, I am not capable, having served 
on Capitol Hill for a few years, to describe to the people who follow 
this debate what we call the food safety system in America. Imagine, if 
you will, that we have 12 to 15 different Federal agencies responsible 
for food safety. Imagine 30 different laws and legal standards for food 
safety, 40 or 50 different committees on Capitol Hill with 
jurisdiction, hundreds, if not thousands, of lobbyists and special 
interest groups hovering over this whole scene. Add to that thousands 
of Government workers and bureaucrats who are protecting their turf, 
and we have a system that is virtually out of control--not just when it 
comes to drugs, as important as they are, but when it comes to the food 
we eat.
  I thank Chairman Kennedy and Senator Enzi and others for partnering 
with me on an amendment which I will offer as soon as I am given the 
green light by the chairman and the ranking member on the issue of food 
safety. I thank them for working with my staff for several months to 
come up with language to the deal with some serious challenges.
  For too long, we have gone without updating the resources and 
authorities of the FDA in the area of food safety. I think our system 
has broken down. Now is the time for an appropriate amendment to close 
some of the gaps we have in our current system.
  In the larger picture, I have been working on this issue for a long 
time. I said, over 10 years ago, we need a single food safety system.
  I see Senator Lieberman from Connecticut on the floor. His House 
colleague, Congresswoman Rosa DeLauro, herself a victim of food 
poisoning at an early age, has been my ally in this effort. We believe 
a single food safety system, based on science and not on politics, is 
the only answer. We need to do that and do it soon.
  The amendment which I am going to offer does not reach that level. It 
does not achieve all of the goals we wanted to on a legal basis, but it 
moves us forward.
  How important an issue is food safety? The Centers for Disease 
Control estimates that as many as 76 million people suffer from food 
poisoning each year. Thirty-two thousand Americans will be hospitalized 
each year for food poisoning; 5,000 will die. With emerging pathogens, 
an aging population, and an increasing volume of food imports, this 
situation isn't going to improve without decisive action.
  I agree with Chairman Kennedy and Senator Enzi that we should proceed 
with the broad issue of food safety within general order, and I 
appreciate their willingness to work with me. The amendment is not what 
I hoped for in creating a single food safety agency, but it is a step 
forward.
  The most recent news, of course, is about pet food, but believe me, 
it hasn't been that long ago when we talked about salmonella-
contaminated peanut butter and E. coli-contaminated spinach. If it 
seems as if these food crises are occurring more frequently, they are. 
We may have the safest food supply in the world, but the fact is, every 
parent, every family wants to have peace of mind that when they buy 
something at the grocery store, they can put it on the table, feed it 
to their family, and no one will get sick. There are questions that are 
being raised almost on a daily basis about whether we can have that 
confidence.
  The issue that came up recently was on pet food. Batches of wheat 
gluten and rice protein concentrate contaminated with a chemical called 
melamine were imported from China by several shipping companies. We 
just learned over the last few days from stories printed in the press 
that melamine is regularly added to animal feed in China.
  Why would they add a chemical called melamine to something they are 
going to feed to livestock? Well, it is a way to increase the value of 
the product. If there is more protein in the feed, then they can charge 
a higher price. When the food product is tested to see if there is 
protein, you look for the presence of nitrogen. The chemical, melamine, 
when added, tests for higher nitrogen levels, therefore they argue 
higher protein levels, therefore they argue they should be paid more. 
So it is an economic fraud. They have argued that this is a product 
that doesn't hurt people. We are not sure of that, but we do know that 
the animals that died as a result of contaminated pet food, some of 
them were found to have melamine in their system. It is a serious 
question as to whether it is toxic.
  We know now that this pet food contamination has resulted in the 
deaths of more than 4,000 animals across America. This contaminated 
product came into America without inspection or without suspicion. The 
FDA did not have a memorandum of understanding with China or a 
certification that their standards for food safety were even close to 
those of the United States. The product made its way from the importer 
ChemNutra into various manufacturers of pet food. Menu Foods is a 
Canadian company. They make pet food under a dozen different labels. 
They learned on February 20 there was a problem. How did they know 
there was a problem? The cats and dogs told them. They stopped eating 
their food and they started getting sick.
  So you own a company that has dozens of different pet food labels, 
and you notice that animals are getting sick. What is the responsible 
thing for a company to do at that time? Pull the product off the shelf 
and notify the Federal Government. They waited 3 weeks before they sent 
out a notification. By the time the Food and Drug Administration 
learned about this, there were millions of cans of pet food and other 
products under different labels spread all across America with this 
contaminated product. Three weeks they waited. Why? Because the law 
does not currently require them to report on a timely basis.
  I asked the FDA last week: What is the penalty against Menu Foods for 
waiting 3 weeks? They said: Well, we are considering. We are talking to 
our counsel. We will get back to you. Months have passed. Nothing has 
happened. Menu Foods waited 3 weeks instead of reporting on a timely 
basis. By then, the product was all across America.
  In the case of rice protein concentrate, there is less certainty. 
Importer Wilbur Ellis purchased product from the Binzhou Futian Company 
in China. It then distributed the product to a host of companies that 
produce pet food. These brands and labels have been recalled in a 
haphazard way over the past 3 weeks--again, delays in reporting. The 
FDA has even refused to name several companies for more than a week 
trying to get to the bottom of this investigation because the records 
process is so broken down at this agency.
  One or more of the manufacturers sold some refuse pet food that it 
produced using contaminated product to hog farms in California and 
other States. These farms fed their hogs the contaminated feed, some of 
which was sold to consumers and much more of it has been quarantined 
and is slated for destruction.
  In addition, we just learned this week that 38 poultry farms in 
Indiana received contaminated feed. So the plot thickens, and the 
safety issue grows as we wonder if what was originally pet food is now 
being fed to livestock, and if humans consume the food what impact it 
will have.
  There is a mystery importer involved as well from China that we have 
heard about but we can't identify yet. Supposedly this second importer 
purchased rice protein from the Chinese firm in question in larger 
quantities than the firm Wilbur Ellis.
  In terms of the investigation in China, the FDA said: We want to send 
inspectors to China to see what they are sending to us. Well, first the 
Chinese said: We deny you the visas for your FDA inspectors. Imagine 
that.

[[Page 10734]]

Millions of dollars worth of foodstuffs coming in from China, 
contaminated and poisoned, killing off pets, threatening human 
consumption, and when we say to the Chinese that we want to take a look 
at their production facilities, they denied us visas. I joined with 
Congresswoman DeLauro and sent a letter to the Chinese Embassy, and 
they reversed their position, offering the visas. We have to make it 
clear to China and every other country that if they want to do business 
with the United States, they will do it on our terms when it comes to 
health and safety. We will never allow them to compromise the safety 
and health of American citizens in the process.
  The amendment I am going to offer--and I hope it will be accepted--
does several things based on what we have learned over the last 6 
weeks. First, during this recall, consumers, veterinarians, and 
retailers, among others, expressed concern about the scope of the 
recall, what products were included, or what not to feed to domestic 
animals. The FDA was slow, uneven, and inconsistent in sharing 
information on the recall. While there are mechanisms in place to 
proactively track human food-borne illnesses and then share 
information, no similar system exists for companion animals.
  I visited the FDA pet food recall Web site the day before the March 
12 Agriculture appropriations hearing and found a jumble of corporate 
press releases. It was virtually unintelligible. I said to the FDA: 
Can't you make this information clearer so consumers can have the 
information they need to purchase these products? They took it to heart 
and made the changes. That is good.
  In addition, following the recall, the FDA checked the records of 
companies such as Banfield, the largest privately owned veterinary 
hospital chain in the United States. The records kept showed a 
statistically significant increase in the instances of renal failures 
of cats. A system in place to track these events might have caught 
something like melamine earlier. So the amendment creates an early 
warning and surveillance system for companion animals and directs the 
Secretary to work with professional organizations, veterinarians, and 
others to disseminate information.
  While we are at it, the amendment would direct the FDA, in cases of 
both pet food and human food, to keep up-to-date, comprehensive, 
searchable recall lists on their Web site.
  Second, the amendment closes the gap that FDA itself identified in an 
earlier draft framework posted on its Web site in December of 2006. The 
guidances and practices that govern the pet food industry are currently 
generated by the American Association of Feed Control Officers, known 
as AAFCO. The guidelines on best practices and ingredient lists are 
updated annually and implemented on a voluntary basis by manufacturers 
and State departments of agriculture. However, there is no requirement 
under the law for States to adopt these practices, and they don't have 
the force of Federal guidelines. Inspections are not coordinated State 
to State, and some States have different standards. While the FDA 
participates in the AAFCO process, it does not provide a list of 
ingredients and additives. AAFCO's list is more comprehensive than the 
FDA's. Our amendment would direct the FDA to work with AAFCO and other 
stakeholders to give these guidelines the force of law.
  Third, the amendment closes a loophole that this contamination has 
exposed with regard to our imports of food. The source of the 
contamination we know of was wheat gluten and rice protein concentrate 
originating in China. Neither shipment was inspected by the FDA. If you 
have some peace of mind or belief that a Federal inspector is watching 
food as it comes into the United States, the odds are 99 to 1 you are 
wrong. Only about 1 or 1.5 percent of all the shipments of food 
products coming into the United States are actually inspected.
  As imports have increased the number of inspectors have decreased. 
This is an indication of U.S. food imports by country. As you can see, 
there have been dramatic increases in these fiscal years showing that 
the amount of food coming into the United States is increasing in 
volume. The number of inspectors who watch for this food to protect our 
families and consumers across America just hasn't kept pace.
  In 2003, the United States imported $45.6 billion worth of 
agricultural products--in 2003; today, $64 billion. Agricultural 
imports from China have almost doubled in that period of time, from 
$1.2 billion to $2.1 billion. Due to flat budgets and increasing 
responsibilities, the overall number of FDA inspectors looking at these 
shipments and at domestic food processors has actually decreased from 
2003 to the present time; imports up, inspectors down.
  Are we surprised at what has happened? The FDA doesn't have the 
resources or the authority to make sure what we are bringing in from 
overseas is safe. We need to tackle it in a larger bill.
  What our amendment does is close the loophole by improving data 
collection and reporting. It creates an FDA database of food 
adulterants that would be filled by FDA inspectors as well as importers 
of food. The extra series of data points would better pick out trends 
and help FDA do a better risk-based inspection job. It also creates a 
system in which adulterations are reported quickly so as to prevent 
contamination from spreading. This would have helped in this most 
recent case, but because of delays in reporting it led to an expansion 
of recalled product into dozens of different companies and got 
perilously close to the human food chain. The data would then be used 
by the Secretary to issue import alerts, blocking similar risky 
products.
  I have also pursued a separate track on the issue of resources for 
FDA by sending a letter to Chairman Kohl of Wisconsin and Senator 
Bennett of Utah requesting additional resources for food inspection at 
the Food and Drug Administration. I hope my colleagues will join me in 
that effort.
  Also, I am filing an amendment that would authorize a study on user 
fees for food producers. It is vital that we explore various revenue 
streams for the FDA in light of the shortage of resources they have for 
inspection.
  The last two items in my amendment are a sense of the Senate and a 
clarification that companies are required to maintain records and make 
them accessible to the FDA as part of an investigation. This latter 
item would prevent delays that keep contaminations from being known as 
quickly as possible. In the case of recalled peanut butter this past 
winter, an FDA report showed that inspectors were denied documents when 
they were requested. The language would clarify that when the FDA makes 
the inspection, it will have access to those documents needed for 
purposes of safeguarding the food supply.
  The sense-of-the-Senate language goes beyond this amendment and this 
bill, stating that it is vital to update resources, direction, and 
authorities of the FDA to better safeguard our food supply. The sense 
of the Senate directs the FDA to work with our trading partners to 
establish cooperative agreements.
  Several weeks ago, Robert Brackett, Director of the FDA's food arm, 
said:

       These outbreaks point to a need to completely overhaul the 
     way the agency does business.

  I am thankful the sponsors of this legislation for the 
reauthorization of the Food and Drug Administration understand that 
expanding the scope of our debate on this bill to include food safety 
is overdue.
  Mr. Brackett went on to say:

       We have 60,000 to 80,000 facilities that we are responsible 
     for in any given year. We have to get out of the 1950s 
     paradigm.

  Dr. Stephen Sundlof, Director of the Center for Veterinary Medicine 
of FDA, which has jurisdiction for pet food, implied as much when he 
was quoted last month as saying:

       In this case, we're going to have to look at this after the 
     dust settles and determine if there is something from a 
     regulatory standpoint that we could have done differently to 
     prevent this incident from occurring.

  I couldn't agree more. This is a situation where we need one food 
safety agency, not driven by the politics of

[[Page 10735]]

Washington but driven by science, to make sure the food fed to our 
children, the food fed to our pets, or any food served in America is as 
safe as possible. As we import more food with fewer inspectors, the 
risk increases.
  I might add that we have looked at the pet food contamination and 
others from the aspect of greed and negligence. In the instance of 
China, they were adulterating their product with a chemical so that it 
was worth more in the marketplace. That is economic fraud. In the 
instance of spinach and peanut butter, we are dealing with negligence--
negligence that results in a deadly product being sold across America. 
But we can't stop there, unfortunately. In the world we live in, with 
the vulnerabilities we have, food could also become a terrorist weapon. 
That may sound far-fetched to some, but when Governor Tommy Thompson 
left the Bush Cabinet, he said in parting that he found it hard to 
imagine why the terrorists had not attacked our food supply. He said he 
worried about it on a regular basis.
  We have to have inspection standards in place that mitigate against 
greed and negligence and the possibility of someone intentionally 
contaminating our food supply, causing terrible suffering and death 
across America.
  That is why this amendment is a step in the direction for a safer 
food supply. I sincerely hope my colleagues on both sides of the aisle 
will support my efforts.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Connecticut is recognized.
  Mr. LIEBERMAN. Madam President, I ask unanimous consent that I be 
able to speak as in morning business.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                      Supplemental Appropriations

  Mr. LIEBERMAN. Madam President, I rise this afternoon to encourage 
President Bush to go ahead and veto the supplemental appropriations 
bill that Congress has sent him this afternoon because of the language 
in that bill on Iraq that I consider to be bad for our troops and 
dangerous for our country.
  The legislation that Congress has passed, in my opinion, represents 
the worst of all worlds. As I have said before, if people feel the war 
in Iraq is lost, or if people feel it is not lost but not worth 
fighting for, then what they ought to do is act to end the war. This 
legislation would do no such thing. It would not end the war in Iraq. 
It will not require the withdrawal of all American troops from Iraq. It 
will not cut off funding for the war in Iraq.
  On the contrary, what this legislation proposes to do is something 
far worse. It would handcuff our soldiers with an inflexible and 
arbitrary set of restrictions--restrictions that would take life-and-
death decisions about how, when, and where our troops can fight away 
from those troops and their commanders. It would substitute the 
judgment of politicians in Washington for the judgment of our military 
commanders on the ground. That is wrong.
  What is more, this legislation will impose on our soldiers in Iraq a 
binding deadline of October 1, 2007--5 months from today--to begin 
withdrawal. That withdrawal would be required to begin regardless of 
conditions on the ground, regardless of the recommendations of our 
military leaders, regardless of the opinions of our allies in the 
region--in short, regardless of reality--on October 1, 2007.
  This is a deadline as arbitrary as it is inflexible. It is a deadline 
for defeat--defeat for America and a defeat for the hopes of the 
majority of the Iraqi people for a better, freer future.
  I know we have heard from some supporters of this legislation that by 
ordering a withdrawal we will encourage the Iraqis to make political 
compromises. Where is the evidence of this?
  According to the legislation this Congress has now sent to the 
President, the withdrawal must begin regardless of what the Iraqi 
Government does. Where, then, is the incentive for the Iraqis to 
reconcile? On the contrary, there is every reason to conclude this 
legislation will have exactly the opposite effect that its sponsors 
claim for it.
  Listen to the latest National Intelligence Estimate on Iraq, which 
has been saluted by Members of this Chamber on both sides of the 
question of what to do now in Iraq. That latest National Intelligence 
Estimate predicted that a withdrawal of American troops in the months 
ahead would ``almost certainly lead to a significant increase in the 
scale and scope of sectarian violence, intensify Sunni resistance, and 
have adverse effects on national reconciliation.''
  How do the supporters of this legislation explain that National 
Intelligence Estimate? For that matter, how do they justify this 
legislation, in light of what we all heard directly from GEN David 
Petraeus, the commander of our forces in Iraq, when we spoke with him 
and he spoke with us last week?
  General Petraeus told us very clearly that we have achieved progress 
since our new strategy in Iraq--the so-called surge--began. Consider 
the situation in Anbar Province to the West of Baghdad, which has 
dramatically improved. That has been documented not by representatives 
of the administration or people who support the current policy but on 
the front pages of the New York Times and USA Today in the last few 
days.
  At a moment when Sunnis in Anbar are finally helping us in targeting 
al-Qaida terrorists, this legislation would require us to abandon them.
  Madam President, what message are we sending to our friends and our 
foes with this ill-advised legislation? We have heard from some that we 
need to abandon Iraq because it is not part of the war on terror. But 
here again, listen to General Petraeus, who is on the ground, one of 
the most outstanding generals of our military that I have met since I 
have been a Senator, confirmed unanimously by the Senate a short while 
ago. Here is what General Petraeus warned us:

       Iraq is, in fact, the central front of al-Qaida's global 
     campaign against us.

  Let me repeat that. General Petraeus said:

       Iraq is, in fact, the central front of al-Qaida's global 
     campaign against us.

  If we withdraw, as this legislation would require us to begin to do, 
al-Qaida wins--the same al-Qaida that attacked America on September 11, 
2001, killing 3,000 innocents, the same al-Qaida that intends to attack 
us again, the same al-Qaida that has made very clear to us what its 
plans for domination and control of large sectors of the world are.
  Madam President, the violence we are seeing in Iraq today, the 
suicide bombings in Baghdad, the chemical weapons attacks in Anbar 
Province, the targeted assassinations of Iraq's leaders--these are all 
primarily the work of al-Qaida. So the big question, then, for me--and 
I ask my colleagues to consider it--is whether we respond to al-Qaida's 
terrorism by pulling out, as it hopes we do, and as this legislation 
would require us to do--abandoning the future of Iraq, the Middle East, 
and ultimately our own American security, to the very people 
responsible for the terrible atrocities and suicide bombings we see in 
Iraq today.
  The alternative to pulling out is standing up and fighting. That is 
what we are doing now in Iraq and doing with some success in Baghdad 
and Anbar Province. Rather than undermining General Petraeus and 
handing al-Qaida a victory, Congress should take swift and responsible 
action to get General Petraeus and our troops in the field the support 
they need to prevail.
  The Iraq war is not lost. But if this supplemental became law, it 
would be lost and America would suffer the consequences of that defeat 
for generations.
  President Bush, veto this bill.
  I yield the floor, and I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. KENNEDY. Madam President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. KENNEDY. Madam President, we are still looking for amendments. It 
is

[[Page 10736]]

true that there are probably four important areas where negotiations 
are going on with the principals in a bipartisan way, and progress is 
being made. It does seem to us that we ought to continue that progress. 
We will describe in greater detail those procedures tomorrow.
  We are urging our colleagues who have amendments to get in touch with 
us. We know this is complex legislation, but it is enormously 
important, and we have a lot of business in the Senate. Our leaders 
have indicated that they wanted us to be ready to move ahead on 
amendments. Senator Enzi and I are quite prepared to do so.
  I understand the Senator from Michigan, Ms. Stabenow, has an 
amendment she is going to speak to and offer later on. We will look 
forward to her presence.
  We want to again underline the importance that if Members have 
amendments, notify us as soon as possible, so we can work on them and 
accept them if we can. We want to be able to conclude this legislation 
in a timely way in the not-too-distant future.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Wyoming is recognized.
  Mr. ENZI. Madam President, I thank the Senator from Massachusetts for 
his comments. I'll make a slight addition to what he said. For some, it 
may not look as if there is a lot of progress being made, but I assure 
you there is a lot of progress being made. One of the secrets to our 
committee operation--which used to be one of the most contentious 
committees in the Senate, and now it works productively on issues such 
as this to get things done--is that we recognize if somebody brings an 
amendment to the floor and we have not heard about it before, it 
creates difficulty. When the amendment is filed, we don't have a real 
good process for amending an amendment. Technically, we can, but it 
requires a lot of time and votes. In the meantime, it polarizes people. 
Instead, we take a look at them, talk about them, and we use the body 
of knowledge we have gained from a lot of hearings on the issue to show 
where there could be inconsistencies and problems with the amendment. 
We get the problems ironed out so the amendment can have a logical 
chance for inclusion if it adds to what we are doing.
  That is what is going on as we are speaking. The Kennedy staff and 
the Enzi staff, and those Senators with amendments are meeting together 
and working out difficulties. We will accept many of them. Some of them 
are already in the substitute bill we have. So a lot of progress has 
already been made on this bill. We want to get the remaining things 
cleared up. We would like to get it done tonight and tomorrow, if 
possible. I think we are getting a long way down the list now on 
problems that people had with it, and we are getting those cleared up 
in a way that I think both sides can agree on.
  So that is why this is not quite as controversial as some people 
might expect or perhaps even want. I thank the Senator from 
Massachusetts, Mr. Kennedy, for all his cooperation on this and the 
tremendous effort of all the staff. We need people to come down with 
amendments, particularly if they have something new that we have not 
heard about.
  I yield the floor and suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. GREGG. Mr. President, I ask unanimous consent the order for the 
quorum call be rescinded.
  The PRESIDING OFFICER (Mr. Salazar). Without objection, it is so 
ordered.
  Mr. GREGG. Mr. President, I rise to speak today on this FDA bill that 
has been brought forward by Chairman Kennedy and Senator Enzi. I begin 
by thanking them for their cooperative, collegial, and inclusive 
approach over the last couple of weeks to get this bill in a form that 
makes it much more effective, accomplishing the goals we all have.
  Senator Kennedy and Senator Enzi for a long time have been great 
advocates of making sure we have a strong and effective FDA. Senator 
Kennedy, of course, has been involved in this for many years and has 
played a huge role in the success of the FDA, which is, as we know, one 
of the extraordinarily successful agencies in the Federal Government. 
It gives the American people confidence, when they go into a grocery 
store and purchase food or when they go into a pharmacy and purchase a 
pharmaceutical product or have a prescription filled, that they are 
going to receive goods which are safe and effective and that they are 
not going to be at risk of harm as a result of adulteration, fraud, 
abuse, or misuse of those goods.
  It is one of the most amazing successes of our Federal Government in 
the area of protecting consumers. It arose out of the early 1900 period 
when there were serious issues relative to food safety in this country, 
and has evolved into clearly one of the finest agencies, not only in 
our Government but in the world. It is respected around the world as 
the gold standard for protecting American citizens and citizens who use 
the products made by American companies.
  This bill builds on that success. I congratulate the Senator from 
Massachusetts and the Senator from Wyoming for doing such a strong job 
of building on that success. This bill continues the effort to make 
sure we have a prompt but safe procedure for getting drugs approved in 
this country, something called PDUFA, which basically allows drug 
companies to pay a fairly significant portion of the cost of the 
approval of new drugs, which has expedited dramatically the rate of 
approval of new drugs. That means pharmaceuticals and biologics come to 
the market, which help people, which save lives, which basically makes 
life better. That is the good news.
  In addition, there is, for devices, the MDUFMA proposals, which deal 
with devices, medical devices the way we deal with pharmaceuticals, 
setting up a fee system for the approval of medical devices. This is 
something, when I was chairman of this committee, I had the good 
fortune to be involved in developing. These two initiatives are the 
essence of how we maintain a vibrant drug and medical device approval 
process in this country. It is absolutely critical they be 
reauthorized, and this bill does it in an effective way.
  In addition, the bill takes on a number of other issues which are 
timely and appropriate. The most significant, from my perspective, 
although there are a lot of significant ones here, is the issue of drug 
safety and how we make sure the drugs which do come to the market are 
safe. This involves not guesswork but finding out what the science is 
and what happens when people start using these drugs and medical 
devices. The concept behind that in this bill is that we should set up 
a regime that basically collects information from all sorts of 
different sources. There are literally thousands of different sources, 
but there are some very big ones that we develop information about the 
reactions people have when they take drugs. We have the tremendous 
database of the Medicare system, for example. We have the tremendous 
database of provider groups, such as the Kaiser Permanente fund out in 
California. These different provider groups have a huge amount of 
information on what is happening when somebody takes some form of 
medication. But what happens is that information, although it is 
collected, is not effectively screened and is not effectively 
evaluated.
  What this bill does, essentially, is create a regime that allows us 
to more effectively, first, collect the data; second, when there are 
red flags popping up on that data that say there is a reaction here or 
reaction there or something occurs here that was not expected, that 
information becomes more visible under this regime and more available; 
and then, third, if it is clear there is something that is not going 
right here, that there is a series of aberrations nobody expected, then 
it sets up a process where we take that information out and we give it 
to selected groups of specialists in the academic and private world who 
have the ability to evaluate that information and tell us what is going 
on.

[[Page 10737]]

  There are centers at MIT and I believe at Duke, for example, that do 
exactly this. The idea, of course, is to first collect the information 
effectively; second, make sure when those aberrations or red flags 
start to show up they are noted; and, third, when there is a certain 
critical mass of information that reflects something that may not be 
correct or is out of kilter, it makes sure we have that information 
evaluated in a very science-based, professional way by people who 
specialize in this and who have the ability to do it--something which 
FDA does not have the resources, necessarily, to do right now.
  With that information in hand, with that science in hand, then you 
can make decisions. This bill creates a new regime for making those 
decisions--as to what a company must tell people or tell providers when 
they are using these different drugs and medications. But it will be a 
science-based decision, and that is the key here. All of this will key 
off of science that is hard and that is effectively reviewed and 
evaluated in order to come to the conclusion that certain actions must 
be taken in how you distribute this medication and how you communicate 
what the implications of this medication are. So this new safety and 
surveillance regime, which is known as mining the information, and then 
pulling it together and taking advantage of it, validating it and 
integrating it--this new regime is at the essence of the safety 
concerns which are involved in this bill.
  It is very positive. It opens a new world of review in the area of 
pharmaceuticals and medicines, a postmarket review process which will 
be based on science and which will be very healthy to the system as a 
whole. I congratulate and thank both Senator Kennedy and Senator Enzi 
for evolving this process in this bill.
  In addition, there is the pediatric language in this bill. There is 
the BSE program, which is the program which basically rewards companies 
that are willing to go out and do extra research to see how a drug 
might affect a child. Historically, drugs will be brought to the market 
and you would never know--because all the clinical exams have been done 
on adults--how they would affect children. Some of these drugs, 
obviously, if given to a child, could have a significant negative 
impact and, if given in the wrong doses, might have an extraordinarily 
adverse effect. Some could actually be very positive if given in the 
right dosage. So it became a guessing game as to when these 
pharmaceuticals, when these medications, were good for children, in 
many instances. As a result, doctors and prescribers simply didn't know 
whether to make them available, in many instances, to children.
  This BSE pharmaceutical procedure said essentially, We will give you, 
the producer of this pharmaceutical, of this medication--we will give 
you an extra 6 months of exclusivity in exchange for your testing this 
and making sure it will work effectively, or finding out if it will not 
work effectively, on children. The practical effect of that, of giving 
that incentive, has been that hundreds of new drugs have been made 
available to children which were not available before. This has had a 
very positive impact on children and the ability of children to get 
pharmaceuticals.
  With the BSE program, we also developed a program called the 
Pediatric Research Equity Act, which essentially takes the opposite 
approach from the BSE program. It creates a mandate where, in certain 
instances, certain medications have to be tested on children. They have 
to go through a process of seeing if they will work for children. The 
two together basically work in tandem and the idea is they will feed 
off of each other, and you will create an atmosphere out there where 
the two different approaches--one basically being a carrot and the 
other being a stick--will lead to better medications being available 
for children.
  It has worked amazingly well. The key to this, of course, is to keep 
these two in tandem. In order to accomplish that, they both, in my 
opinion--and fortunately in the opinion of the chairman and the ranking 
member of the committee now, at least--have to be on the same 
wavelength. They have to be dealt with the same way relative to things 
such as their sunsets, when they get reviewed and when they don't get 
reviewed, because if you were to have one sunsetted at a different time 
than the other or one sunset and the other not sunset, you wouldn't get 
an effective review of the two together, and they both work, as I said, 
together.
  This bill makes sure they are treated the same way in that area, and 
that is a major step in the right direction toward making sure children 
get proper pediatric care. There is still going to be an issue 
tomorrow, I understand, on exclusivity, which is going to be brought up 
by another Senator; that is, the length of the exclusivity that is 
necessary in order to get pharmaceutical companies to pursue proper 
research on children is an issue. But I happen to think what we have 
now has been shown to work, and why fix something that is not broken, 
in my opinion. So I believe we should stay with what we have for the 6-
month exclusivity period.
  In addition, there are a number of other issues floating around this 
bill. This bill, obviously being a major health care bill, attracts a 
lot of other concerns. One of them that I have filed as an amendment--
but I don't intend to bring it up unless we move into the issue of 
reimportation, which may be brought up on the floor--is the question of 
safety of Internet pharmacies. I believe very strongly, when somebody 
goes on line and purchases a pharmaceutical product over the Internet--
which is happening more and more often as people become more 
comfortable with dealing with the Internet on a variety of different 
levels, but certainly senior citizens as people age into their senior 
citizenship years who had been dealing with the Internet for quite a 
few years and are comfortable with it--I believe it is critical we have 
in place a system which allows people, when they look at the site on 
the Internet, to know whether that Internet pharmacy is selling the 
product they say they are selling and whether the product they say they 
are selling has received FDA approval.
  The problem we have here is a lot of these pharmacies will represent 
that they are selling some sort of pharmaceutical good and it turns out 
that product is, in many cases, adulterated or inappropriately made, in 
which case people end up getting a pharmaceutical product which is bad 
for them. In some cases it can actually lead to death. So it is 
critical that we have a way so when somebody goes on the Internet and 
looks at a site on the Internet, they know that Internet pharmacy they 
are looking at is legitimate and the products they sell are legitimate 
and have been through the FDA approval process.
  In order to accomplish that, we need to set up a whole new regime, 
basically, and we need to pay for it. This amendment which I have put 
in accomplishes that. It essentially gives the FDA the authority to 
review pharmacy sites on line, to meet with the people who have set up 
those sites, to make sure to set up a certification process where they 
are guaranteed the sites are meeting the conditions of selling 
pharmaceutical products or medications which have met the FDA approval, 
and then to put sort of a Good Housekeeping seal on that site, which is 
tamperproof, which says this site has FDA-approved products. It would 
be a huge step forward in safety for American citizens using Internet 
pharmacies.
  It is complicated, though, in its enforcement. It is simple to state 
but complicated to enforce because it means the FDA needs the resources 
to deal with these sites and also to deal directly with these 
pharmaceutical Internet sales places which may be somewhere other than 
the United States. Second, you have to have in the United States a 
point at which you can deal with the site if something goes wrong, a 
responsible representative on the ground in the United States who has 
the economic wherewithal to basically bond the site, for all intents 
and purposes.
  Setting up that type of regime will be expensive. The language of 
this

[[Page 10738]]

amendment puts in place a fee system which allows that to be paid for 
so we can be assured that the FDA has the resources necessary to review 
these sites and accomplish this goal of making sure these Internet 
pharmacy sites are safe for Americans to use. I think this would be a 
tremendous step forward in safety for all Americans, especially as we 
move toward a much more Internet-oriented purchasing process in this 
country.
  Another issue which is going to be discussed here, and which I 
understand from the chairman may be held over for conference or come 
into play in some area, is a crucial issue of follow-on biologics or 
similar biologics.
  We know we can produce a generic pharmaceutical and do it with a fair 
amount of predictability. We know that if a generic company brings on a 
pharmaceutical product which has run its course, it has proper patent 
coverage, that that generic is going to be safe and effective and be 
essentially the same thing as the pharmaceutical because they are 
chemical compounds.
  In the biologics area, this is not the case because you are dealing 
with a much more complex process of producing the biological 
medication. It is a fermentation process, it involves proteins, it 
involves mutation of proteins, which depends to a great extent on a 
huge number of factors which are very uniquely identified with the way 
that that vat of medication was evolved through the process.
  Anyone who has been to one of these facilities can see how complex it 
is to maintain consistency, even within the facility that is producing 
the medication. If you stepped out of that facility and tried to 
reproduce that medication, the complexities would even be more 
difficult to replicate.
  It is critical that as we move into this biologic area, we understand 
we are not dealing with generic pharmaceuticals. You know, when you put 
the title ``generic pharmaceuticals'' on something that is sort of a 
motherhood term, that is a good idea. It is a good idea if it works. 
But if you put the generic title on biologics, you are probably going 
to mislead a lot of people and, in the process, potentially produce 
medicines which can be extremely harmful or could not accomplish the 
purposes.
  So as we move down this road of looking at biologics and how we give 
the opportunity to produce similar biologics to people after the patent 
life has run, we have to be very careful that we don't oversimplify the 
exercise in the name of getting something, as ``motherhoodish'' as 
generics; rather, we have to make sure we put in place a process which 
allows those biologics, when they are produced as similar biologics, to 
have been properly reviewed to be sure they accomplish what they claim 
they are going to accomplish.
  This means that almost in every instance of an individual biologic, 
you are going to have to have clinical trials for the similar biologic. 
There are going to be very rare instances where you can actually bring 
to the market something that doesn't go through clinical trials in this 
area, in my opinion, and you have to be very sure that you demonstrate 
safety and effectiveness of the similar product before you step into 
this arena of awarding the authority to go ahead and sell that product 
in the market generally.
  You will also need very aggressive postmarket surveillance in this 
area because you do not know, in many instances--you hope you know, but 
you do not necessarily know--how individuals will react to taking this 
type of medication, which is developed as a similar medication, as 
versus the basic medication which is trying to be replicated.
  This area of biologics is a complex one. It should not be rushed 
into. I know there is a great desire to step forward and say: We have a 
huge victory for the American people, we can now have generic 
biologics. But if we rush into this exercise and create a process with 
approval which does not adequately account for the significantly, the 
exponentially more complex process of bringing online a biologic when 
compared to a chemical pharmaceutical, then we will not have done our 
job as policy people but will simply have given ourselves a good press 
release and in the end probably have given ourselves a very dangerous 
process relevant to protecting the American people in the area of 
biologics.
  As we move down this road of generics, I do hope we will move in a 
way that understands there is a significant difference in 
pharmaceuticals and that those differences are going to require a much 
more detailed and a much more complex approval process than we 
presently have in moving in the generic pharmaceutical area.
  Those are some of the concerns I have relative to other issues that 
might be brought up in this bill. But I do again wish to congratulate 
the Senator from Wyoming, I wish to congratulate the chairman from 
Massachusetts for once again bringing to the floor a very strong piece 
of legislation, which will significantly improve the capacity of the 
FDA to continue its extraordinary record of protecting the American 
people relevant to food and drug safety.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Wyoming is recognized.
  Mr. ENZI. Mr. President, I wish to thank the Senator from New 
Hampshire, Mr. Gregg, for the tremendous effort he put into this bill. 
He spent years on the committee. He became chairman of the committee. 
He used those years with the institutional memory and the experience 
with a great deal of diligence and creativity which he has always used 
on that committee to provide us with fuller explanations and wording 
for several of the provisions that are in this bill.
  I thank him for helping us to perfect those and the diligence he 
always has on all of the issues we bring up in the committee. I also 
appreciate the work he has done on Internet safety. This is not 
something he just developed now. He has been working on it for at least 
3 years that I am aware, to make that as safe a system as possible if 
we ever have to put it into place.
  I am hoping we will not have to have that full debate at this time 
and appreciate his submitting it in case we need to have that debate.
  I also appreciate the explanation he gave on the follow-on biologics. 
It is a hard thing for people on the committee who have been through a 
number of hearings to understand. I am sure the public as a whole has 
an even greater difficulty with it. But it is a whole new phase of 
medications. By the name, ``biologics,'' it is alive. That makes it a 
lot more complicated than a set of chemicals that are ground up and put 
together in a particular order. Even with the chemicals that are ground 
up and put together in a particular order, if they aren't done quite 
right, they would not dissolve and people do not get any benefit from 
them. That is why we are doing the bill. Then we will be working on 
biologic similars to see if there is some way that that can be done 
effectively and safely. I thank the Senator for his comments and his 
tremendous work.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, I would add a note of thanks to the 
Senator as well. We are strongly committed to information technology, 
the use of information technology eventually. We have that on our list. 
We passed it unanimously through this body a couple of years ago, but 
the House didn't act and we are going to act further.
  But what we are talking about in the database, which the Senator from 
New Hampshire talked about, is using the information technology and 
database in terms of the postmarketing or approval surveillance. This 
makes a great deal of sense. That is a key aspect of safety in the 
legislation. The Senator from New Hampshire is very interested in 
shaping that.
  The second is to make sure we are going to bring the latest 
information on drug safety to the consumers; that is more scattered at 
the present time than it should be.
  We have accepted the recommendation of Senator Gregg to include one 
what they call portal in the Internet to make sure that that 
information will

[[Page 10739]]

be collected and available to the consumers on safety, which is a 
useful addition. So these are important. I thank him for his strong 
support for this legislation. This is very helpful.
  Now we are beginning to see, we have got broad support on our side 
and on both sides of the aisle for this legislation. We are working 
hard to clear up some of the--still a few of the outstanding items, but 
we are moving ahead. We want to indicate to our colleagues again that 
we want to try and respond to many of their amendments, but we want to 
do it in a timely way. We were in here yesterday afternoon with the 
presentation. We welcomed suggestions during the course of the evening 
last night, and we have done so during the course of the day. We are 
moving along we hope that anyone who has any other further amendments 
would be in close touch with us because we are giving every opportunity 
to our colleagues to make any recommendations they have or would like 
to move along to conclusion at a reasonably swift time.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Louisiana.


                           Amendment No. 1004

  Ms. LANDRIEU. Taking that advice to heart, Mr. President, I call up 
amendment No. 1004.
  I would like to speak about that amendment now.
  The PRESIDING OFFICER. The clerk will report.
  The legislative clerk read as follows:

       The Senator from Louisiana [Ms. Landrieu] proposes an 
     amendment numbered 1004.

  The amendment is as follows:

  (Purpose: To require the Food and Drug Administration to permit the 
sale of baby turtles as pets so long as the seller uses proven methods 
                    to effectively treat salmonella)

       At the end of the bill, add the following:

              TITLE __--DOMESTIC PET TURTLE MARKET ACCESS

     SEC. __. SHORT TITLE.

       This title may be cited as the ``Domestic Pet Turtle Market 
     Access Act of 2007''.

     SEC. __. FINDINGS.

       Congress makes the following findings:
       (1) Pet turtles less than 10.2 centimeters in diameter have 
     been banned for sale in the United States by the Food and 
     Drug Administration since 1975 due to health concerns.
       (2) The Food and Drug Administration does not ban the sale 
     of iguanas or other lizards, snakes, frogs, or other 
     amphibians or reptiles that are sold as pets in the United 
     States that also carry salmonella bacteria. The Food and Drug 
     Administration also does not require that these animals be 
     treated for salmonella bacteria before being sold as pets.
       (3) The technology to treat turtles for salmonella, and 
     make them safe for sale, has greatly advanced since 1975. 
     Treatments exist that can nearly eradicate salmonella from 
     turtles, and individuals are more aware of the causes of 
     salmonella, how to treat salmonella poisoning, and the 
     seriousness associated with salmonella poisoning.
       (4) University research has shown that these turtles can be 
     treated in such a way that they can be raised, shipped, and 
     distributed without having a recolonization of salmonella.
       (5) University research has also shown that pet owners can 
     be equipped with a treatment regiment that allows the turtle 
     to be maintained safe from salmonella.
       (6) The Food and Drug Administration should allow the sale 
     of turtles less than 10.2 centimeters in diameter as pets as 
     long as the sellers are required to use proven methods to 
     treat these turtles for salmonella.

     SEC. __. SALE OF BABY TURTLES.

       Notwithstanding any other provision of law, the Food and 
     Drug Administration shall not restrict the sale by a turtle 
     farmer, or wholesaler commercial retail seller of a turtle 
     that is less than 10.2 centimeters in diameter as a pet if--
       (1) the State or territory in which such farmer is located 
     has developed a regulatory process by which pet turtle 
     farmers are required to have a State license to breed, hatch, 
     propagate, raise, grow, receive, ship, transport, export, or 
     sell pet turtles or pet turtle eggs;
       (2) such State or territory requires certification of 
     sanitization that is signed by a veterinarian who is licensed 
     in the State or territory, and approved by the State or 
     territory agency in charge of regulating the sale of pet 
     turtles;
       (3) the certification of sanitization requires each turtle 
     to be sanitized or treated for diseases, including 
     salmonella, and is dependant upon using the Siebeling method, 
     or other such proven method, which uses an antibiotic to make 
     the turtle salmonella-free; and
       (4) the turtle farmer or commercial retail seller includes, 
     with the sale of such a turtle, a disclosure to the buyer 
     that includes--
       (A) information regarding--
       (i) the possibility that salmonella can re-colonize in 
     turtles;
       (ii) the dangers, including possible severe illness or 
     death, especially for at-risk people who may be susceptible 
     to salmonella poisoning, such as children, pregnant women, 
     and others who may have weak immune systems, that could 
     result if the turtle is not properly handled and safely 
     maintained;
       (iii) the proper handling of the turtle, including an 
     explanation of proper hygiene such as handwashing after 
     handling a turtle; and
       (iv) the proven methods of treatment that, if properly 
     applied, keep the turtle safe from salmonella;
       (B) a detailed explanation of how to properly treat the 
     turtle to keep it safe from salmonella, using the proven 
     methods of treatment referred to under subparagraph (A), and 
     how the buyer can continue to purchase the tools, treatments, 
     or any other required item to continually treat the turtle; 
     and
       (C) a statement that buyers of pet turtles should not 
     abandon the turtle or abandon it outside, as the turtle may 
     become an invasive species to the local community, but should 
     instead return them to a commercial retail pet seller or 
     other organization that would accept turtles no longer wanted 
     as pets.
       (b) FDA Review of State Protections.--
       The Food and Drug Administration may, after providing an 
     opportunity for the affected State to respond, restrict the 
     sale of a turtle only if the Secretary of Health and Human 
     Services determines, that the actual implementation State 
     health protections described in subsection (a) are 
     insufficient to protect consumers against infectious diseases 
     acquired from such turtles at the time of sale.

  The PRESIDING OFFICER. The Senator from Louisiana is recognized.
  Ms. LANDRIEU. This amendment, I will discuss briefly at this time, 
and then according to the leaders on how they would like to go ahead 
and proceed with these amendments, it can be voted on at another time.
  Mr. President, sometimes we offer amendments that affect large 
industries and millions and millions of people in large industries. 
Sometimes they are smaller industries but very important industries 
that we have to stand for as well.
  One of them is a small, relatively small industry in my State. That 
is the industry of turtle farmers who grow and produce and trade and 
sell turtles to be used in a variety of different ways. One of the ways 
is by selling them for pets. In 1975, the FDA banned the sale of small 
turtles for pets domestically but allowed those sales to continue 
internationally.
  So there is a group of farmers, turtle farmers, in Louisiana 
particularly, but I am sure there are others around the country, who 
have maintained their business by selling overseas. Recently, because 
of the competition and development of overseas markets, they are 
getting very constricted in what they can sell because they have now 
gotten competition from the countries in which most of these sales 
occur.
  There has been a great deal of pressure to try to reopen the domestic 
market. That is what this amendment will do. It will open a domestic 
market again because the science has caught up with the regulations. We 
now have developed a vaccine, universally-tested and proven, that can 
keep those small turtles nearly free of salmonella, and with the right 
licensing procedures this amendment calls for and the right information 
that is required when these turtles are sold for pets, either to a 
wholesaler or retailer or to a family who might purchase them, I 
believe the safeguards are in place, as the science and technology have 
caught up with the problem.
  There are many wonderful aspects about technology. Sometimes we can 
think our way through a problem. That is basically what has been done 
over the last 35 years. I am proud of the role that LSU, Louisiana 
State University, has played in developing these treatments. I am proud 
the industry survived through a very difficult time and proud they are 
now proposing very strict rules and regulations.
  I might add that when this ban went into place for this particular 
reptile, there was no such ban for other reptiles that also can carry 
salmonella, which are still continuing to be sold on the domestic 
market. So on behalf of this industry, which is small but important, 
mainly in Louisiana, and I am

[[Page 10740]]

certain there are turtle farmers in many places, I offer this amendment 
to repeal this 1975 ban in light of the new technology and new 
opportunities that are out there to give protection to our general 
public.
  That is the essence of the amendment. I would like to set it aside 
now and speak to it at a later time when votes are scheduled.
  Mr. KENNEDY. Mr. President, I thank the Senator.
  We are reviewing the proposal. I understand the State of Louisiana 
has had a very strong regulatory process in terms of safety, which has 
been recognized and commended for some period of time.
  Ms. LANDRIEU. Mr. President, the Senator is correct, because I 
understand, as I am learning more about this industry, it is more 
robust in the State of Louisiana than elsewhere. So I think our 
legislature has put the appropriate restrictions, licensing, 
information, as well as keeping the research going, that could develop 
the appropriate ways to treat these reptiles so we can maintain an 
industry, allow people to make a living, and keep our population safe 
as well.
  Mr. KENNEDY. Mr. President, I thank the Senator. We are reviewing the 
proposal. We will work very closely with the Senator, and we will be 
back in touch making a recommendation, working with her. We thank the 
Senator very much.
  Ms. LANDRIEU. Mr. President, I thank the Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. HATCH. Mr. President, I rise in support of S. 1082, the Food and 
Drug Administration Revitalization Act.
  This legislation addresses many critical issues, including the need 
for provide proper incentives and support for the development and 
review of pharmaceuticals and medical devices, including products for 
children, and the need for heightened efforts to assure the safety of 
medications.
  As we debate this legislation, let us remember we all have the same 
goals in mind.
  We want Americans to benefit from life-saving, life-enhancing drug 
and device products.
  We want Americans to have access to drugs that are safe and 
effective.
  We want Americans to have all the relevant safety information 
available on their drugs.
  And, indeed, we want Americans to know that the Food and Drug 
Administration, the agency responsible for ensuring drug and device 
safety, has the resources to do its job.
  That is what this bill is all about protecting Americans and giving 
the FDA the tools to do its job.
  The legislation before us reauthorizes both the Prescription Drug 
User Fee Act, better known as PDUFA, and the Medical Device User 
Modernization Fee Act, better known as MDUFMA.
  It is of critical importance that both programs be authorized by the 
end of the fiscal year. This legislation embodies the agreements 
reached by both industries and the FDA, along with refinements added by 
the Congress.
  Let me make clear that I am supportive of these reauthorizations. It 
is fair to say that I had reservations about PDUFA when it was enacted 
in 1992, questioning the wisdom of whether an industry should be 
required to support a governmental function. To a certain extent, I 
still have those reservations. That being said, it has become 
abundantly clear that there are not the resources in the Agriculture 
Appropriations bill to support these review functions absent a user 
fee, and thus I recognize their necessity.
  With regard to MDUFMA, I have been particularly concerned about the 
impact that user fees could have on small medical device manufacturers, 
many of which are located in Utah. Indeed, I am proud that there are 
over 100 medical device companies in Utah, companies that represent the 
best in American innovation. They are true world leaders in their 
industry.
  The changes made in the last reauthorization at my request, along 
with the new structure of the user fee in FDARA and the improved 
trigger provision satisfy me that the manufacturers are being fairly 
treated by the user fee program in this bill. And, indeed, this is a 
serious concern.
  In February of 2006, the Lewin Group prepared a report for the FDA 
entitled ``Medical Device Industry Perspectives on MDUFMA. That report 
revealed that senior industry experts felt FDA is generally doing an 
excellent job in premarket regulation of medical devices and that the 
industry was generally supportive of the purpose and goals of MDUFMA. 
However, key among the findings was the fact that the industry 
perceived little or no evidence of attaining the main intent of the 
program or in realizing a favorable return on investment from user 
fees. In fact, whenever I return to Utah to meet with medical device 
executives, I hear the same concern. And it is a concern I share.
  Indicative of that concern is the astounding fact that 70 percent of 
responding device manufacturers perceived that MDUFMA goals have not 
resulted in meaningful improvements in either the predictability or 
timeliness of reviews. In fact, when I reviewed the device approval 
times, I understood those concerns. For some classes of devices, FDA 
had made great progress. For others not. This was disturbing to me, 
since we would all hope that progress would have been made across the 
board.
  It is my hope with the new fee structure embodied in S. 1082, we will 
make better progress in achieving the approval time goals. I am pleased 
that Chairman Kennedy and Senator Enzi included provisions at my 
request which make certain the fees for smaller companies are 
affordable.
  Let me turn to the issue of direct-to-consumer advertising, or DTC. 
This is an issue on which our colleague, the senior Senator from 
Kansas, Mr. Pat Roberts, has shown great leadership, both in the HELP 
Committee, and here in the Senate Chamber. Senator Roberts has led the 
charge to eliminate the 2-year moratorium on prescription advertising 
for newly approved drugs. He has expressed constitutional concerns 
about such a moratorium. I share those concerns. He is right to bring 
this up.
  In general, I believe we should be guided by a very simple rule. 
Advertising about products the FDA regulates should be truthful and not 
misleading.
  I do understand the arguments that some in this body make with 
respect to pharmaceutical advertising. Some nights, when I watch 
television, those ads do become tiresome. But I could say that about a 
lot of ads.
  Some have argued we need to be particularly careful about what 
pharmaceutical advertising is allowed, because we have limited 
knowledge about drugs, especially when they come on the market.
  Those who make such arguments fail to recognize that FDARA will 
guarantee that consumers have access to greater clinical and safety 
information about medications because it gives the FDA more authority 
to review and react to drug safety data. User fees created by S. 1082 
will bolster the FDA office responsible for reviewing drug 
advertisements.
  The FDA has told my office and others that drug manufacturers 
cooperate fully with the FDA when a concern is raised about an 
advertisement. That would be my preference for how these ads should be 
handled.
  I am hopeful we will be able to address this issue and I am 
encouraged by recent discussions involving the Senator from Kansas and 
others members of the Senate HELP Committee.
  The bill's drug safety provisions are probably its most important 
component. Indeed, shortly after the Institute of Medicine issued its 
report on this issue, we all began to see a floor of letters in support 
of efforts to improve the drug safety program.
  Members of the HELP Committee undertook serious discussions on how to 
address the problems that have been identified, and the result is this 
legislation developed by Senator Enzi and Chairman Kennedy. The Enzi-
Kennedy bill has benefited from the guidance of our colleagues, former 
Chairman

[[Page 10741]]

Gregg and Senator Burr, who have pointed out the necessity for more 
flexibility in determining when a risk evaluation mitigation plan--or 
REMS--is needed. Senator Coburn added greatly to the discussion by 
raising issues relating to the access of our constituents in rural 
areas to needed pharmaceuticals.
  I believe the product of these discussions strikes the appropriate 
balance. It requires, for example, that determining whether the FDA 
should further assess the safety of a drug should be based on 
scientific evidence. To me, that is probably the most integral part of 
this bill--when concerns are raised about drugs, these concerns must be 
based on scientific evidence and not on innuendos or hearsay. This 
approach allows proper evaluation of relevant information and gives the 
FDA greater authority to warn consumers when there are problems.
  In addition, the drug safety title strengthens the FDA's existing 
authority to monitor drugs once they have been approved by making it 
clear that evaluation must occur before and after approval. One of the 
most important components of this legislation is that more drug safety 
information will be made more available to the public. I believe that 
is an important victory for the American consumer.
  I also want to take a few minutes to talk about the pediatric testing 
and research provisions included in this bill. I have supported both 
the Best Pharmaceuticals for Children Act and the Pediatric Research 
Improvement Act. In fact, I have supported these efforts since our 
former colleague from Ohio, Senator Mike DeWine, brought the need for 
additional pediatric testing of prescription drugs to our attention 
during consideration of the FDA Modernization Act of 1997. He fought 
long and hard to encourage drug companies to conduct clinical trials on 
pediatric uses of their drugs. His efforts paid off and this program 
has been extremely successful.
  My good friend and colleague from Connecticut, subcommittee Chairman 
Chris Dodd, has also shown great leadership on this issue when FDAMA 
was being considered in 1997. He held a hearing on this issue earlier 
this year with his ranking Republican member, Senator Lamar Alexander. 
That hearing was very insightful and I believe that many of us are 
trying to do the right thing as we reauthorize both programs.
  I urge my colleagues not to lose sight of the purpose of these two 
programs as we make decisions on this part of the bill. We want good, 
solid information about the safest way to prescribe drugs for children. 
And by giving companies market exclusivity to conduct clinical trials, 
we will know the safest dosage levels for children. So let us not lose 
sight of the original propose of these programs--to help children have 
the safest dosages for prescriptions. I am hopeful that we will be able 
to work out our differences on these provisions on these very important 
issues.
  Food safety is another issue that is on nearly everyone's mind these 
days. When I was a kid, we were always told to eat our spinach so we 
could grow muscles like Popeye. Peanut butter is almost a staple for 
most Americans. And yet these ordinary, common foods have harmed rather 
than helped. Pets are getting sick and we have discovered that their 
food has been contaminated. Something needs to be done.
  I have worked with Senators Kennedy, Enzi, Durbin and Allard to 
figure out a constructive approach to these important issues. I think 
that we have made a lot of progress and I look forward continuing those 
discussions as the bill progresses toward enactment.
  One factor that is not discussed enough is the need to appropriate 
more funding for inspectors and inspector training, especially abroad. 
I can recall over a decade though when Jim Phillips, a former 
investigator for the FDA, brought to our attention the woefully lacking 
FDA resources for foreign inspections. We were shocked then, and 
unfortunately, we are shocked now.
  Today, only one percent of imported food is inspected. I believe this 
issue needs to be carefully reviewed by Congress so people no longer 
have to worry about whether food for them or their pets is safe.
  I offered and withdrew an amendment during the HELP Committee 
consideration of this bill that would address another important issue. 
My amendment had several provisions which encouraged innovation and 
development of safe antibiotics, required the FDA to convene a meeting 
to determine how the Orphan Drug Act should be applied to antibiotics, 
and reauthorized the grant programs for the Orphan Drug Act. Finally, 
my amendment provided for a 5-year exclusivity for enantiomers of 
previously approved racemic drugs if and only if, one, they are 
approved for new therapeutic uses and, two, a completely new data set 
has been created for approval of this enantiomer. It is my expectation 
that our current discussions on these provisions will lead toward their 
adoption later in the week.
  I also want to point out that there have been many discussions on 
ways to ensure that citizens' petitions do not unfairly delay generic 
drug approvals. I believe this is a problem, although I do not believe 
it is of a magnitude as some would suggest. I do not oppose making 
changes to ensure that any abuses in this area are stopped, as long as 
FDA still has the ability to do the appropriate scientific and legal 
review of abbreviated new drug approval applications in the timeframe 
it desires.
  Let me turn now to one provision which is not in the bill: language 
authorizing a pathway for the Food and Drug Administration to approve 
copies of biologics. This is commonly referred to as the 
``biosimilars,'' ``biogenerics,'' or ``follow-on biologics'' 
legislation. Senator Gregg spoke so well about this subject just a few 
minutes ago.
  While language on this issue is not included in the bill we consider 
today, I want to make perfectly clear that it is my intention to work 
toward development of an acceptable compromise that can be included in 
the final version of FDARA and signed into law. It is my hope Senators 
will refrain from offering any amendments on this issue until we have 
time to develop consensus. And I do believe consensus can be developed 
without delay. It is my intention to do so.
  As my colleagues are aware, I am the Hatch of Hatch-Waxman. I have a 
serious interest in making certain the law Chairman Waxman and I 
developed in 1984, the Drug Price Competition and Patent Term 
Restoration Act, is used as the basis for development of legislation to 
provide an abbreviated pathway for approval of follow-on biological 
products. In so doing, we must make certain we include the appropriate 
incentives for development of those products. Indeed, that is my high 
priority.
  By any estimate, the Hatch-Waxman law has done consumers tremendous 
good by fostering today's modern generic drug industry. It has saved 
patients literally billions of dollars. Similarly, using it as a basis 
for development of a pathway for follow-on biologics will help 
consumers with access to the innovative, life-affirming biologic 
products. But in so doing, we must be mindful of the fact that we need 
to encourage and nurture the innovation that provides the biologics 
that the generic companies seek to copy. This is a tremendously 
complicated task, but it is one worth doing.
  In 1984, when Chairman Waxman and I undertook a series of 
negotiations that led to approval of the Drug Price Competition and 
Patent Term Restoration Act, it was a very different time.
  There were no cell phones, no DVDs, almost no one had a personal 
computer, and a stamp cost 20 cents
  It was a much less complicated time. Generic drugs were a small, 
struggling industry, with no discernible footprint in the 
pharmaceutical world. The innovators had yet to respond to their first 
paragraph IV certification. In 1984, brands versus generics largely an 
American endeavor. Today, the pharmaceutical market--both innovator and 
generic--is an international marker--for research, development and 
marketing.
  Biological products were not an issue in 1984. Today, they are 
becoming an increasingly larger part of pharmaceutical spending.

[[Page 10742]]

  It is my strong belief that we can learn from this experience and 
build another solid law that will help consumers--both by supporting 
the incentive to discover and develop new biologics, and by fostering a 
climate that will lead to lower prices. This is a classic win-win 
situation.
  And why is that so important?
  A February report by the Center for Medicare and Medicaid Services 
paints the picture very well: America's health care spending in the 
next 10 years will double to $4.1 trillion. Or, to look at it another 
way, that is 20 cents out of every dollar spent. We spend about $7,500 
per capita on health care in the U.S. Yet in 2016, that will rise to an 
astounding $12,800 per person. Greater spending for pharmaceuticals is 
expected to fuel much of the increase, the report's authors concluded.
  And there it is in a nutshell. The good news and the bad news.
  Not much worries Congress more than the costs of medical care--both 
from the perspective of a balanced budget, and from the view of our 
constituents' pocketbooks.
  In many ways, it is an embarrassment of riches.
  We have exciting new therapies to treat our medical ills--new drugs, 
new devices, stem cell treatments. Their potential to improve human 
health and well-being is almost limitless.
  And yet the cost of those treatments, the impact they have on the 
budget, at times seems equally limitless. In fact, in 2005, 
prescription drug spending was estimated at $214 billion, a healthy 
amount by anyone's measure. That same year, spending on biologics was 
estimated at $32 billion.
  Since biologicals are generally more expensive products, ways to 
reduce their costs interest policymakers and other stakeholders in 
expenditure of the health care dollar, foremost among them employers, 
insurers, pharmacy benefits managers, and of course, the government.
  Comes now the generic drug industry, which has been proven to provide 
alternative, safe and effective therapies in a much more cost 
beneficial manner. We look to them to be part of the solution to this 
problem. And they, in turn, look to us to help them be part of that 
solution.
  It is no secret that several senators have been meeting to develop a 
bill that would establish a pathway for biosimilar products to be 
approved by the Food and Drug Administration. We had hoped to have it 
ready for inclusion in FDARA, but it was not, despite the talks of the 
four Senators. I am referring to Health, Education, Labor, and Pensions 
Committee Chairman Ted Kennedy, the committee's ranking Republican, 
Mike Enzi, Senator Hillary Clinton, and me. All members of the HELP 
Committee, we have worked to develop consensus on what legislation 
would include.
  Senator Kennedy and I began these talks several months ago. He is 
committed to developing a bill on a priority basis. Our staffs 
literally have been working night and day.
  Our work has been aided immeasurably by the leadership of Chairman 
Waxman, and in the Senate, Senator Chuck Schumer and Senator Clinton, 
who have introduced the companion to the Waxman bill. Their 
legislation, the Access to Life-Saving Medicine Act, H.R. 1038/S. 623, 
provides a solid starting point for discussions. It is an important 
work that has added immeasurably to the congressional dialogue.
  It is my hope that our discussions will also be informed by the work 
of Representatives Jay Inslee, Gene Green and Tammy Baldwin, who 
recently introduced the Patient Protection and Innovative Biologic 
Medicines Act of 2007, H.R. 1956, and by the views of the many, many 
stakeholders in this legislative effort.
  The time to develop a pathway for approval of biosimilar products is 
long past overdue. It should be our priority, and it should be our high 
priority, to get it done this year. But, we should get it done right. 
Our deliberations must be based on science. The original balance of the 
law must be maintained, but we must also recognize the emerging 
realities of this new world.
  And what are those realities? First, biotechnology products are not 
drugs; they are very complicated molecules that are not easily 
reproduced. An inadvertent change in the structure of that molecule can 
lead to very devastating consequences.
  Second, today, it is unlikely that any follow-on company will be able 
to produce an exact copy of a biotech molecule, a generic biologic if 
you will, at least at first.
  Third, because science advances, and because American researchers are 
very good at advancing science--stem cell research is one example that 
comes readily to mind--we must hold open the possibility that one day 
there will be true biogenerics.
  And we must also develop a pathway so that biosimilar products can be 
approved without a full biologics license application, a time-consuming 
and expensive process.
  But whatever policy we develop, it must be based on soundness of 
science, rather than the practicalities of politics.
  Fourth, we must take into account the unique nature of today's 
industry. This is so much more than an exercise between big Pharma and 
the generics, or even between big bio and the generics.
  Indeed, there are about 1,400 biotech companies in the United States. 
How many of them are profitable? Astoundingly, only 20.
  Many of these companies are small, with revenues of under a million 
dollars per year. Many do not even have a product on the market.
  We must examine closely the issue of who will be making biosimilars? 
Will it be the Barr Labs and Tevas of the world? Undoubtedly.
  But it may also be generic subsidiaries of innovator companies.
  It is also very likely to be companies in India and China. As we have 
seen with the recent concerns over pet food, inspecting foreign 
manufacturing plants has historically been a problem for the resource-
constrained Food and Drug Administration.
  Fifth, we must use the framework of Hatch-Waxman where we can, but we 
must recognize there may be ways to improve it.
  There are obvious differences between regulating a pathway for 
biosimilars and for copies of chemical drugs. For example, as I 
mentioned, today's science will probably not allow identical copies of 
today's biologics. So, the concept of bioequivalence cannot be imported 
into this debate. Instead, we must work carefully to define 
biosimilarity.
  Another difference today is the fact that process patents are much 
more integrally tied to the manufacture of biologics. Current law does 
not require listing of process patents in the orange book.
  Waxman-Hatch is inherently a litigious process. But its framework--
the patent holder or drug manufacturer--v. the generic--does not easily 
translate to a system in which multiple patent holders may exist, 
including, for example, major universities and research centers.
  Sixth, the incentives for development of biotech products must be 
maintained, enhanced where it advances public policy. But at the same 
time, we cannot seed a new generation of roadblocks that preclude 
biosimilar entry. This is the nub of the key, crucial balance.
  Seventh, the role of the FDA must be carefully evaluated. We must 
empower the agency to evaluate pure, safe and potent copies of biotech 
products, but we must all recognize that there must be a bright line 
that separates a safe copy from a new product which should be subject 
to a full biologic license application.
  We need to free the agency and provide it with the flexibility to 
evaluate the adequacy of a biosimilar submission based on good science, 
but we must also recognize that, as Commissioner von Eschenbach has 
said, there may be some products which cannot be copied safely with 
today's science.
  Eighth, we must make certain the resources are there for the FDA to 
do the job right. I must note that negotiations between the agency and 
the pharmaceutical industry on the Prescription Drug User Fee Act 
reauthorization, or PDUFA, took over one year.

[[Page 10743]]

Every indication I have is that review of a biosimilar application is 
very likely to be more complex and time consuming than that for a new 
biologics license application.
  There must be authority for a fee to be collected that reflects this 
complex workload. If we do not provide adequate resources to the FDA, 
then review of new products could suffer at the expense of cheaper 
copies as reviewers become siphoned off from new products to the 
biosimilars. We should not design a system in which this occurs.
  And I must digress at this point to underscore that the FDA is 
already cash-strapped and that situation simply must be corrected. The 
dire FDA resources issue appears to have manifested iself in such 
recent revelations as to the inadequacy of food inspections for some of 
the most ubiquitous products in American life, including pet food and 
peanut butter.
  Federal policymakers must take this into account when legislating, 
and the Food and Drug Administration Revitalization Act is a good place 
to start.
  Enacting follow-on biologics legislation is a top priority for me. I 
want us to finalize a bill on a priority basis, and it is my hope it 
can be included in the final version of FDARA that emerges from the 
conference committee.
  Before I close, I want to talk about one other issue that is often 
debated when FDA-related legislation is considered on the floor: 
importation of prescription drugs. This morning, I listened to our 
colleague, the Senator from North Dakota, Mr. Dorgan, talk about his 
legislation which allows prescription drugs from other countries to be 
imported into the United States from other countries. My colleague 
refers to this as drug reimportation which I believe gives people the 
false impression that these drugs are originally manufactured in the 
United States, exported to another country and then imported back to 
the United States. I just want to clarify that is not typically the 
case.
  In addition, I saw the Senator from North Dakota hold up two bottles 
of Lipitor and say that there is no difference between a drug 
manufactured in Ireland and a drug manufactured in the United States. 
He suggested that the pills may be different colors but the bottles are 
the same and the medicine in the bottle is the same.
  That may be true for the two bottles of drugs that he had on the 
Senate floor. But how could we be assured that is always the case? Can 
we always guarantee that pills in a bottle labeled from Ireland are 
actually manufactured in Ireland? I don't think so.
  This issue is the crux of the problem--unless the FDA has approved 
these medications, we have no way of knowing what is actually in the 
bottle. In fact, when I served as chairman of the Senate Judiciary 
Committee, I held a hearing on drug importation and this issue was 
raised by one of the members of the committee. At that July 14, 2004, 
hearing, one Senator specifically asked about a prescription drug 
bottle labeled as being from Canada. William Hubbard, the Associate 
Commissioner for Policy and Planning for the FDA, told her that even 
though the label said the bottle was from Canada, the FDA had no idea 
where that bottle had originated.
  In fact, at that hearing, Mr. Hubbard said:

       Although some purchasers of drugs from foreign sources may 
     receive genuine product, others may unknowingly buy 
     counterfeit copies that contain only inert ingredients, 
     legitimate drugs that are outdated and have been diverted to 
     unscrupulous resellers, or dangerous sub-potent or super-
     potent products that were improperly manufactured. 
     Furthermore, in the case of foreign-based sources, if a 
     consumer has an adverse drug reaction or any other problem, 
     the consumer may have little or no recourse either because 
     the operator of the pharmacy often is not known, or the 
     physical location of the seller is unknown or beyond the 
     consumer's reach. FDA has only limited ability to take action 
     against these foreign operators.

  On a related issue, I would like to share Mr. Hubbard's insights on 
the safety of drugs that have been imported from other countries.

       FDA remains concerned about the public health implications 
     of unapproved prescription drugs from entities seeking to 
     profit by getting around U.S. legal standards for drug safety 
     and effectiveness. Many drugs obtained from foreign sources 
     that either purport to be or appear to be the same as U.S.-
     approved prescription drugs are, in fact, of unknown quality. 
     Consumers are exposed to a number of potential risks when 
     they purchase drugs from foreign sources or from sources that 
     are not operated by pharmacies properly licensed under state 
     pharmacy laws. These outlets may dispense expired, subpotent, 
     contaminated or counterfeit product, the wrong or a 
     contraindicated product, an incorrect dose, or medication 
     unaccompanied by adequate directions for use. The labeling of 
     the drug may not be in English and therefore important 
     information regarding dosage, warnings and side effects may 
     not be available to the consumer. The drugs may not have been 
     packaged and stored under appropriate conditions to prevent 
     degradation, and there is no assurance that these products 
     were manufactured under current good manufacturing practice 
     (cGMP) standards. When consumers take such medications, they 
     face risks of dangerous drug interactions and/or of suffering 
     adverse events, some of which can be life-threatening. More 
     commonly, if the drugs are subpotent or ineffective, they may 
     suffer complications from the illnesses that their 
     prescriptions were intended to treat, without ever knowing 
     the true cause.

  Mr. President, this was a sobering hearing and I urge my colleagues, 
especially those who support the importation of prescription drugs into 
this country, to take the time to review the testimony from the July 
14, 2004, hearing. We had many witnesses who provided valuable insights 
on this issue.
  To address Senator Dorgan's other point regarding the cost of 
prescription drugs, I want to make one thing perfectly clear--I want 
Americans to have access to affordable drugs, but I also want these 
drugs to be safe and effective. As one of the authors of Hatch-Waxman, 
I understand the problem of pharmaceutical costs, and I have a record 
of working to find solutions. But bringing potentially unsafe 
medicines, medicines uncertified by the FDA, into the United States is 
not a solution.
  In conclusion, I ask my colleagues who are skeptical about this bill 
to reserve judgment and listen carefully to the debate. While I 
supported this bill when it was considered by the Senate HELP Committee 
2 weeks ago, I honestly believe that members of the HELP Committee have 
worked hard together to make the reported bill even better. So I urge 
my colleagues to take the time to review the bill because there are a 
lot of good provisions in it.
  I would like to take this opportunity to recognize the hard work of 
the staffs of both our committee chairman, Senator Kennedy, and our 
ranking minority member, Senator Enzi. I would specifically like to 
thank Amy Muhlberg and David Dorsey for their dedication and hard work 
on this issue--they have been working on drug safety legislation for 
over 2 years and I want both of them to know how much all of us 
appreciate their efforts. I also want to recognize Shana Christrup and 
David Bowen for their leadership in helping their bosses get this bill 
to the floor under very difficult time constraints. All of the HELP 
Committee members' staff have worked long hours and many weekend hours 
and I just want you to know how much I appreciate all of you.
  Mr. President, I yield the floor.
  The ACTING PRESIDENT pro tempore. The Senator from West Virginia is 
recognized.


                                  iraq

  Mr. BYRD. Mr. President, 4 years ago, I stood in this very spot and 
warned against an ill-advised invasion of Iraq. Today, the situation in 
Iraq has spiraled out of control, into a bloody, deadly, sectarian 
civil war. Yet the President and his team continue to hold fast to 
their ``stay the course'' nonsense. While they do, thousands of brave 
young Americans place their lives in jeopardy every day. That reality 
is one this Nation and the world did not have to experience. It is a 
tragic reality, brought on by a war of choice and an occupation that 
has yielded neither stability nor reconciliation.
  Four years ago today, the President landed on the deck of the USS 
Abraham Lincoln to declare, ``Mission accomplished.'' Four years ago--
it feels like an age. For thousands of our soldiers and their families, 
and likely for the Iraqi people, it feels like a lifetime.

[[Page 10744]]

How wrong our President was then, and how wrong our President continues 
to be today.
  Ralph Waldo Emerson said:

       A foolish consistency is the hobgoblin of little minds, 
     adored by little statesmen and philosophers and divines.

  No matter how many times the President wishes it were so, peace in 
Iraq will not be found at the barrel of an American gun. No matter how 
hard the President hopes that it will happen, sectarian violence will 
not be quelled with U.S. forces occupying the Iraqi nation. Cross your 
fingers, pull out your lucky rabbit's foot, even nail a horseshoe over 
the Oval Office door, but hoping for luck will never change the deadly 
dynamic in Iraq.
  Peace demands an Iraqi-led political solution to transcend the ethnic 
and sectarian divisions that are splitting the country apart--a 
political effort which, to date, the Iraqi Government has been unable 
or unwilling to take on. Our legislation could have spurred that 
progress, but President Bush has defiantly said no. This White House 
clings to its ``foolish consistency.''
  When he took office as President more than 6 years ago, George W. 
Bush issued a call for renewed responsibility in government. Where are 
the echoes of that call today? What is responsible about clinging to 
this failed course in Iraq and refusing to consider a new path? What is 
responsible about the President continuing to foster and manipulate the 
fears of the American people?
  Faced with the tragic consequences of its misjudgments in Iraq, the 
Bush administration is paralyzed, unwilling to acknowledge, much less 
remedy, its catastrophic blunders. President Bush has gone so far as to 
say that the way out of Iraq will be decided by future Presidents.
  What an outrageous abdication of responsibility. It is unacceptable 
to pass this buck to future leaders while our brave troops fight and 
die today in the crosshairs of this Iraqi civil war. The time to begin 
rectifying this dreadful blunder is now, not in 2 years, not with the 
next President but now.
  With the supplemental bill, Congress responded to the call of the 
American people. We offered a new beginning in reconstruction and 
stability for Iraq. Our proposal could have generated political 
reconciliation and economic security in Iraq. Our bipartisan plan 
shifted the responsibility for the Iraqi nation's long-term success to 
the Iraqi people themselves. But plainly Congress offered a plan that 
could have meant a brighter future for Iraq, a future controlled by the 
Iraqi people themselves with continued support from the United States. 
But the President has flatly rejected that plan. It is a sad day for 
our Nation and for the world.
  Before the war began, I urged the President to think through the 
consequences. There was no doubt as to the military outcome of the war 
between the United States and Iraq. Our military might was certainly 
unquestioned. I was very concerned about the repercussions that would 
follow this certain military victory. Tragically, the repercussions I 
feared all have come to pass. Oh, how I wish, yes, how I wish that I 
had been wrong.
  Once again, I urge the President to think through the consequences of 
his choices, the consequences of his rejection of this new plan for 
Iraq, the consequences of clinging to false hopes, for that is what 
this veto does. This veto endorses the falsehoods that took us to war. 
It cements failed policy in place. This veto ensures that hundreds, 
maybe thousands, more will die in Iraq without any true plan for peace. 
It forces our military to continue to pursue a mission impossible, 
creating democracy at the point of a gun.
  I am sorry this day has come to pass. I am so sorry the horrors of 
this deadly and mishandled occupation have become the stuff of 
political gamesmanship. There is ample blame to go around for that 
fact.
  I have seen clashes between the legislative and executive branches. I 
have seen Presidents make mistakes in the past. Everyone, yes everyone, 
makes mistakes. I certainly have made mistakes, but I have never seen 
such arrogance in a White House that seals its eyes and ears and 
blindly sends so many people to their doom. I pray for our troops, for 
our President--yes, I do--and I pray for our country, yes, for our 
country, and for the people of Iraq.
  President Bush has chosen to hold hostage $100 billion for our troops 
to his, President Bush's, policies, his failed policies. But his 
choice, his choice, is not the last word. Congress will get to work on 
a new version of the supplemental appropriations conference report. We, 
with the Lord's will, will not delay, but we also will not stop our 
efforts to stand for what is right and to craft policies that reflect 
the true strength of America: humility, modesty, honesty.
  We will continue to press for a strong, intelligent foreign policy 
that does not rely on military might alone. And we will not stop in our 
efforts to bring peace to Iraq and our troops home from war, so help me 
God.
  I yield the floor.
  The PRESIDING OFFICER (Mr. Menendez). The Senator from North Dakota 
is recognized.
  Mr. DORGAN. Mr. President, what is the pending business?
  The PRESIDING OFFICER. S. 1082 is before the Senate. The Landrieu 
amendment is currently pending.
  Mr. DORGAN. Mr. President, I ask unanimous consent that the Landrieu 
amendment be set aside and that I may be able to offer an amendment.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                           Amendment No. 990

  Mr. DORGAN. I have amendment No. 990 at the desk. I ask for its 
consideration.
  The PRESIDING OFFICER. The clerk will report.
  The assistant legislative clerk read as follows:

       The Senator from North Dakota [Mr. Dorgan], for himself, 
     Ms. Snowe, Mr. Grassley, Mr. McCain, Ms. Stabenow, Mr. Nelson 
     of Florida, Mr. Pryor, Mr. Sanders, Mr. Whitehouse, and Mrs. 
     McCaskill, proposes an amendment number 990.

  Mr. DORGAN. Mr. President, I ask unanimous consent that the reading 
of the amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (The amendment is printed in today's Record under ``Text of 
Amendments.'')
  Mr. DORGAN. I offer this amendment on behalf of myself and Senator 
Snowe and other cosponsors, including Senator Stabenow, Senator 
Grassley, Senator McCain, Senator Pryor, Senator Sanders, Senator 
Whitehouse, and Senator McCaskill.
  This amendment comes from a piece of legislation we have previously 
introduced dealing with the reimportation of prescription drugs, FDA-
approved, lower priced prescription drugs that are sold in other parts 
of the world for much lower prices than they are priced in the United 
States. There are 33 cosponsors on the bill as it was introduced in the 
Senate. It seems clear to me that the best approach to advancing this 
legislation is to offer it as an amendment to the legislation that 
reauthorizes the Food and Drug Administration. Inasmuch as this subject 
deals with the FDA, it would provide funding for the FDA, guidelines 
for the FDA on reimportation of drugs. I am not going to speak at 
length today. I spoke earlier today. I intend to come back tomorrow 
morning to speak at some greater length.
  I know my colleagues, Senator Snowe and Senator Grassley and Senator 
Stabenow and Senator Sanders--I have talked to him--I know others will 
wish to come and speak as well. But suffice it to say, we have a 
situation in this country today in which the U.S. consumer is charged 
the highest prices in the world for prescription drugs. That is just a 
fact. Today I held up two pill bottles on the floor of the Senate, 
identical bottles that contained the same prescription drug medicine 
made in Ireland. It was called Lipitor, for controlling cholesterol. 
The tablets were made in a manufacturing plant, FDA-approved plant in 
Ireland. The two bottles I held up today were different only in that 
one was sent to Canada and one was sent to the United States.
  The one sent to the United States was priced nearly double the price 
of the medicine sent to Canada. But that is not unusual. The same thing 
would

[[Page 10745]]

be true with respect to medicine that was sold in Germany or Italy or 
France or Spain or England. They all pay much lower prices for the same 
prescription drug, the identical drug made in the identical plant--FDA-
approved, sold all around the world, except the U.S. consumer is given 
the privilege of paying the highest prices in the world, in some cases 
80 or 90 percent higher, in some cases 120 percent higher than others 
pay for the identical prescription drug.
  Our point with this amendment simply is that if the global economy is 
going to work, why doesn't it work for everybody? How about the little 
guy who is buying prescription drugs and is paying the highest prices 
in the world.
  We have put together a piece of legislation with very significant 
safety precautions so that there are no safety issues at all. I 
mentioned today that Europe does this routinely. They have a parallel 
trading system in Europe. They have had it for a couple of decades. If 
you are in Germany and want to buy a prescription drug from France, no 
problem. If you are in Italy and want to buy it from Germany, no 
problem.
  They have a parallel trading system that allows the consumers to 
access the best prices. It is only the American consumer that is 
disadvantaged by a sweetheart deal that allows the prescription drug 
industry to engage their own price controls, which means that we pay 
the highest prices in the world.
  We have offered an amendment. We have 33 cosponsors on the underlying 
legislation. The amendment I offer on behalf of myself and Senator 
Snowe, bipartisan legislation, as I indicated--Senators Grassley and 
McCain, Stabenow, Pryor, Sanders, Whitehouse, McCaskill.
  This is a good amendment. It is good public policy. I know the 
prescription drug industry, the pharmaceutical industry doesn't like 
it. I understand that. I do not come here with a grievance against that 
industry. I just do not like their pricing policy. I do not like the 
fact that they say to the American people: You pay the highest prices 
in the world.
  That is not fair. It ought to change. Our amendment is aiming to 
change it.
  Mr. President, I will speak at greater length on the subject 
tomorrow.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Utah is recognized.
  Mr. HATCH. As usual, my dear friend from North Dakota is articulate, 
and he deserves to be listened to, but I disagree with him.
  The Dorgan amendment allows individuals to import a qualifying drug, 
and this will pose an overwhelming set of resource burdens for the FDA, 
Customs, and other agencies, especially the FDA. It would, as I have 
mentioned before, create very significant safety concerns.
  This amendment establishes a complicated system for the regulation of 
imported drugs. Now this system that he suggests is so vast, it would 
take and require a lot of money, more than all of the proposed fees 
could support.
  Where would an already strapped Federal agency such as FDA get these 
additional dollars? So far we have not given it to them. There have 
been estimates that these dollars would amount to so much that there is 
no way that we could give them enough money.
  This amendment allows foreign-imported products to be approved for 
distribution in the United States even when they may not be 
bioequivalent to the FDA-approved products. Now the reason I cite that 
is because the letter from the FDA, this letter was sent to the 
Honorable Byron L. Dorgan, Senator Dorgan. This letter was sent April 
10, 2007.
  I ask unanimous consent that this letter be printed at the conclusion 
of my remarks.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (See exhibit 1.)
  Mr. HATCH. In that letter, just to mention a couple of things, the 
Acting Deputy Commissioner for Policy, Randall W. Lutter, Ph.D.--let me 
just mention a couple of sentences.
  He said:

       Nevertheless, the Agency continues to have concerns with 
     enacting such a sweeping importation program and fears that 
     intermediaries would likely swallow the bulk of cost-savings, 
     preventing the American consumers from enjoying much, if any, 
     practical benefit from such a program.

  On safety concerns, he said:

       We have safety concerns related to both the identification 
     of unsafe or non-complaint drug products and about the 
     substitutability for domestic products.

  On identifying unsafe/noncompliant drug products, he said:

       The section of the bill that would allow individuals to 
     import a qualifying drug from a registered exporter would 
     likely pose an overwhelming resource burden for the Agency 
     and create significant safety concerns.

  Just reading at random:

       S.242 would establish a complicated system for the 
     regulation of imported drugs. This complex system is so vast 
     that it would be enormously resource-intensive, likely much 
     greater than the proposed registration fees and inspection 
     fees could support.

  On a lack of substitutability, he said:

       The proposed bill provides a mechanism for foreign imported 
     products to be approved for distribution in the U.S. even 
     though these products may not be bioequivalent to the FDA-
     approved product.
  This letter is a serious letter. I don't think we should ignore 
letters such as these in our zeal to resolve problems. I believe the 
distinguished Senator from North Dakota is very well intentioned. I 
have a tremendous regard for him and for his ability to explain things 
on the floor of the Senate.
  I also ask unanimous consent to have printed in the Record excerpts 
of the testimony before the Senate Judiciary Committee on July 14, 
2004, entitled ``Examining the Implications of Drug Importation,'' of 
Mr. William Hubbard, Associate Commissioner for Policy and Planning of 
the U.S. FDA.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

       Testimony: United States Senate Committee on the Judiciary


     Examining the Implications of Drug Importation, July 14, 2004

 Mr. William Hubbard, Associate Commissioner for Policy and Planning, 
                   U.S. Food and Drug Administration


                              INTRODUCTION

       Mr. Chairman and Members of the Subcommittee, I am Mr. 
     William K. Hubbard, Associate Commissioner for Policy and 
     Planning at the U.S. Food and Drug Administration (FDA or the 
     Agency). With me is John M. Taylor, Associate Commissioner 
     for Regulatory Affairs at FDA. We appreciate having this 
     opportunity to discuss with you the issues relating to the 
     importation of prescription drugs into the United States and 
     the use of the Internet to facilitate the sale of these 
     drugs.
       At FDA, our statutory responsibility is to assure the 
     American public that the drug supply is safe, secure, and 
     reliable. For more than 60 years, the Federal Food, Drug, and 
     Cosmetic (FD&C) Act has ensured that Americans can be 
     confident that, when they use an FDA-approved drug, the 
     medicine will be safe and effective and will work as intended 
     in treating their illness and preventing complications. In 
     carrying out this responsibility, FDA is working to do all we 
     can under the law to make medicines accessible and help 
     doctors and patients to use them as effectively as possible, 
     through such steps as expanding access to generic medicines, 
     reducing the time and cost of showing that new medicines are 
     safe and effective, and providing up-to-date information for 
     health professionals and patients to obtain the benefits and 
     avoid the risks associated with powerful medicines. That is 
     the primary mission of the thousands of dedicated staff, 
     including leading health care experts, doctors, economists 
     and scientists who work tirelessly at FDA in public service 
     for the American people. FDA remains strongly concerned about 
     counterfeit, and/or illegally imported pharmaceuticals whose 
     safety (and effectiveness cannot be assured because they are 
     distributed outside the legal structure and regulatory 
     resources provided by Congress.


                   IMPORTATION OF PRESCRIPTION DRUGS

       Sixty-five years ago, Congress responded to widespread 
     instances of unsafe drugs by directing FDA to implement a 
     system for assuring that Americans have a drug supply they 
     can trust will not harm them. Over forty years ago, Congress 
     required that legal drugs be proven to be effective as well, 
     because modern medicines--when they are produced, 
     distributed, prescribed, and used properly--should not only 
     be safe but effective in the treatment of disease. More 
     recently, in 1988, Congress enacted the Prescription Drug 
     Marketing Act (PDMA) to establish additional safeguards to 
     prevent substandard, ineffective, or counterfeit drugs from 
     entering the U.S. Under PDMA, it is illegal for anyone other 
     than the drug's original manufacturer to re-import a 
     prescription drug into the U.S. that was manufactured in the 
     U.S. This law was enacted with strong bipartisan

[[Page 10746]]

     support because of high-profile cases of unsafe and 
     ineffective drugs entering the U.S. in large volumes. In one 
     instance, over 2 million unapproved and potentially unsafe 
     and ineffective Ovulen-2l ``birth control'' tablets from 
     Panama were distributed into the U.S. as ``American goods 
     returned.'' In another case, a counterfeit version of Ceclor, 
     a widely used antibiotic at the time, found its way into the 
     U.S. drug distribution from a foreign source. Over the years, 
     FDA has employed PDMA and other authorities to build a drug 
     safety infrastructure to ensure that Americans enjoy the 
     highest-quality drug supply in the world.
       Unfortunately, the drug supply is under unprecedented 
     attack from a variety of increasingly sophisticated threats. 
     This is evident in the recent significant increase in efforts 
     to introduce counterfeit drugs into the U.S. market. FDA has 
     seen its number of counterfeit drug investigations increase 
     four-fold since the late 1990s. Although counterfeiting was 
     once a rare event, we are increasingly seeing large supplies 
     of counterfeit versions of finished drugs being manufactured 
     and distributed by well-funded and elaborately organized 
     networks. At the same time, inadequately regulated foreign 
     Internet sites have also become portals for unsafe and 
     illegal drugs. For example, FDA recently worked with domestic 
     and international authorities to shut down a website that was 
     advertising ``FDA-approved'' and safe ``European'' birth 
     control pills and other drugs, but was actually responsible 
     for importing ineffective, counterfeit drugs. Evidence 
     strongly suggests that the volume of these foreign drug 
     importations is increasing steadily, presenting an 
     increasingly difficult challenge for Agency field personnel 
     at ports-of-entry, mail facilities, and international courier 
     hubs, and our laboratory analysts and border and law 
     enforcement partners.
       FDA is doing its best to use its limited resources and 
     international authorities to stop the increasing flow of 
     violative drugs into this country, but the task is daunting. 
     FDA's Office of Regulatory Affairs has inspectors working in 
     the field who perform investigations pertaining to imported 
     prescription drugs, a job that is not limited to inspections 
     at ports-of-entry. Each day, however, thousands of individual 
     packages containing prescription drugs are imported illegally 
     into the U.S., simply because the sheer volume has grown to 
     exceed the capability of FDA field personnel to properly 
     process.


                SAFETY CONCERNS RELATING TO IMPORTATION

       FDA remains concerned about the public health implications 
     of unapproved prescription drugs from entities seeking to 
     profit by getting around U.S. legal standards for drug safety 
     and effectiveness. Many drugs obtained from foreign sources 
     that either purport to be or appear to be the same as U.S.-
     approved prescription drugs are, in fact, of unknown quality. 
     Consumers are exposed to a number of potential risks when 
     they purchase drugs from foreign sources or from sources that 
     are not operated by pharmacies properly licensed under state 
     pharmacy laws. These outlets may dispense expired, subpotent, 
     contaminated or counterfeit product, the wrong or a 
     contraindicated product, an incorrect dose, or medication 
     unaccompanied by adequate directions for use. The labeling of 
     the drug may not be in English and therefore important 
     information regarding dosage, warnings and side effects may 
     not be available to the consumer. The drugs may not have been 
     packaged and stored under appropriate conditions to prevent 
     degradation, and there is no assurance that these products 
     were manufactured under current good manufacturing practice 
     (cGMP) standards. When consumers take such medications, they 
     face risks of dangerous drug interactions and/or of suffering 
     adverse events, some of which can be life-threatening. More 
     commonly, if the drugs are subpotent or ineffective, they may 
     suffer complications from the illnesses that their 
     prescriptions were intended to treat, without ever knowing 
     the true cause.
       Patients also are at greater risk because there is no 
     certainty about what they are getting when they purchase some 
     of these drugs. Although some purchasers of drugs from 
     foreign sources may receive genuine product, others may 
     unknowingly buy counterfeit copies that contain only inert 
     ingredients, legitimate drugs that are outdated and have been 
     diverted to unscrupulous resellers, or dangerous subpotent or 
     super-potent products that were improperly manufactured. 
     Furthermore, in the case of foreign-based sources, if a 
     consumer has an adverse drug reaction or any other problem, 
     the consumer may have little or no recourse either because 
     the operator of the pharmacy often is not known, or the 
     physical location of the seller is unknown or beyond the 
     consumer's reach. FDA has only limited ability to take action 
     against these foreign operators.
       The Agency has responded to the challenge of importation by 
     employing a risk-based enforcement strategy to target our 
     existing enforcement resources effectively in the face of 
     multiple priorities, including homeland security, food safety 
     and counterfeit drugs. However, this system, as it works 
     today, is already overwhelmed by the number of incoming 
     packages, and this presents a significant ongoing challenge 
     for the Agency.
       Recent spot examinations of mail shipments of foreign drugs 
     to U.S. consumers revealed that these shipments often contain 
     dangerous or unapproved drugs that pose potentially serious 
     safety problems. In 2003, inspectors found that the majority 
     of the packages examined in these ``blitzes'' contained 
     illegal drugs. Last summer, FDA and the U.S. Customs and 
     Border Protection agency (CBP) conducted blitz examinations 
     on mail shipments at the Miami and New York (JFK Airport) 
     mail facilities in July, and the San Francisco and Carson, 
     California, mail facilities in August. In each location, the 
     agencies examined packages shipped by international mail over 
     a 3-day time span. Of the 1,153 shipments examined, the 
     overwhelming majority (1,019 packages, or 88 percent) 
     contained unapproved drugs. The drugs arrived from many 
     countries. For example, 16 percent entered the U.S. from 
     Canada; 14 percent were from India 14 percent came from 
     Thailand, and 8 percent were shipped from the Philippines.

  Mr. HATCH. These are serious statements by serious people. I don't 
think we should ignore them. It is one thing to argue that you don't 
like the pharmaceutical companies, and many don't. It is another thing 
to argue that these drugs that are going to be imported or reimported 
are absolute identical copies of what they represent. I would pay 
attention to what these people are saying.
  I also ask unanimous consent to print in the Record the statement of 
a Customs officer who came and testified on the 14th.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

  U.S. Senator Orrin G. Hatch (R-UT) Holds Hearing on Drug Importation

       Mr. HATCH. Ms. Durant.
        Ms. DURANT. Mr. Chairman, members of the committee, thank 
     you for this opportunity to testify.
       I'm Elizabeth Durant, director of trade compliance and 
     facilitation in the Office of Field Operations at the Bureau 
     of Customs and Border Protection.
       Today I'd like to discuss with you CBP's efforts to address 
     the ever-increasing trend of personal and bulk importation of 
     pharmaceutical products and controlled substances into the 
     United States.
       Although the main focus of the CBP has shifted to 
     protecting the United States from terrorist attacks, we also 
     enforce over 400 requirements for more than 40 other federal 
     agencies at U.S. borders. These include the laws that 
     prohibit the importation of illegal or unapproved 
     pharmaceuticals that fall under the jurisdiction of the Food 
     and Drug Administration, as well as those controlled 
     substances that are under the jurisdiction of the Drug 
     Enforcement Administration.
       The issue of U.S. consumers buying prescription drugs from 
     foreign sources has become a significant concern. A growing 
     number of Americans obtain their medications from foreign 
     locations. However, the safety of drugs purchased from these 
     sources cannot be insured. Drugs produced outside the United 
     States may be counterfeit. Counterfeiting can apply to both 
     brand name and generic drugs where the identity of the source 
     is deliberately and fraudulently mislabeled in a way that 
     suggests that it is the authentic approved product.
       The CBP is concerned with three avenues that 
     pharmaceuticals are imported: Those that are purchased 
     through the Internet and shipped through our international 
     mail express courier facilities; those carried into the 
     States by individuals transiting our land borders; and bulk 
     shipments of adulterated or counterfeit pharmaceuticals. 
     During the course of the past year we have taken several 
     steps to address each of these areas.
       Millions of packages come through the mail and express 
     courier facilities every year. Thousands of packages, 
     particularly in the mail, are found to contain illegal and 
     approved pharmaceuticals. We also estimate that 10 million 
     people cross the land border annually carrying unapproved 
     products.
       Additionally, we have found bulk pharmaceutical shipments 
     that were attempted to be imported through the mail 
     potentially indicating that these products could be making 
     their way to pharmacy shelves.
       In order to address what is clearly a growing threat to 
     this public health, CBP has been working cooperatively with 
     the DEA, the FDA, our own U.S. Immigration and Customs 
     Enforcement, ONDCP and the Department of Justice attorneys in 
     an interagency working group directed at addressing issues 
     related to the importation of prescription drugs and 
     miscellaneous pharmaceuticals.
       The working group has conducted regular meetings since 
     January 2004 and has achieved several key accomplishments 
     since its inception, including conducting a joint interagency 
     enforcement operation known as Operation Safety Cap, which 
     was designed to look at passenger importations of 
     pharmaceuticals from Mexico.
       Operation Safety Cap was an interagency plan to enforce 
     laws related to the importation of prescription drugs at the 
     border. Both FDA and ICE participated in the enforcement 
     operation. The plan began with a public outreach, followed by 
     an enforcement effort at the Ports of Andrade, Yuma, Tecate,

[[Page 10747]]

     San Luis and Calexico. The purpose was to evaluate compliance 
     with laws related to the importation of prescription drugs.
       During the course of the operation there were several 
     troubling instances of returning U.S. residents receiving 
     different medications than the ones they thought they were 
     being prescribed.
       In one instance there was no active ingredient in the 
     unmarked, undeclared bottle that was brought into the U.S. 
     The overall seizure detention rate was nearly 7 percent of 
     the number of individuals inspected, which was significant 
     enough to warrant additional enforcement efforts at our land 
     borders.
       Based on an operation nicknamed ``Operation Safeguard'' 
     that we have carried out over the last couple of years, we 
     have found the volume of pharmaceuticals shipped through 
     international mail to be enormous. We have also found a 
     significant number of these products do not contain an active 
     pharmaceutical ingredient, but merely contain substances such 
     as starch or sugar.
       Other problems include expired materials, unapproved 
     products, improper use instructions and products made in 
     facilities not under proper regulation. The vast majority of 
     the pharmaceuticals that enter the United States via the mail 
     do so in a manner that according to FDA violates present FDA 
     and other requirements.
       It is clear that the importation of pharmaceuticals and 
     controlled substances remains an overwhelming problem for 
     CBP. We are working with the FDA, the DEA, ICE and other 
     regulatory agencies to develop a more practical and workable 
     approach to solve this huge problem.
       I want to thank you and the members of the committee for 
     considering Customs and Border Protection in your review of 
     the importation of pharmaceuticals and controlled substances. 
     This is an issue that speaks directly to our mission. We will 
     continue to make every effort possible to work with the 
     Congress and our fellow inspection agencies to address the 
     health and safety concerns of the American people.
       Thank you, Mr. Chairman, I look forward to responding to 
     any questions today.

  Mr. HATCH. It was a startling statement. I know at least one 
Democratic Senator, who takes matters very seriously and who was for 
importation or reimportation of drugs, was shocked at some of the 
testimony because she did not believe things could be as bad as they 
represented and was kind of shocked that they made a pretty darn good 
case that these matters are much more serious than some are taking 
them.
  I don't have anything more to say at this time, but I hope we will 
think this through before we saddle the American people with something 
that can be disastrous in their lives. I am familiar with how some of 
these drugs that people think are good drugs that come into this 
country are adulterated. Some are made with contaminated water, do not 
have any efficacy in them at all. Yet they look identical to what our 
U.S. manufacturers are making or what other qualified manufacturers are 
doing. We can't ignore these things. I think even if we could give FDA 
all the money--and it would amount to trillions of dollars, certainly 
hundreds of billions of dollars but I think trillions of dollars--to 
handle this, there is still no way FDA can take care of all the 
problems that would come up.
  We have a pretty good system here. I have to admit, I wish we could 
get drug prices down. As the author of the Hatch-Waxman Act, we worked 
hard to get the generic business into action. At the time we did Hatch-
Waxman, generics were no more than 17 or 18 percent of the total 
marketplace. Today they are over 50 percent. Hatch-Waxman is the reason 
they are there. In every case, every year we have saved at least $10 
billion for the consumers. What many in this body seem to ignore is 
that it costs these innovator companies upwards of $1 billion to create 
one of these drugs. Most of them go through at least 6,000 failed 
experiments before they arrive at one of these drugs. We can't ignore 
that fact. The only way they can recoup that money is within the few 
years that are left of their patent life.
  This is the only industry I know of--there may be others, but I can't 
think of any--where if you create a widget, you have 20 years of patent 
life, market exclusivity. In this industry, a lot of that is eaten up 
by the FDA process. It means that the innovator companies have very few 
years in which to recoup that billion dollars, upwards of a billion 
dollars. A few years ago, it was $800 million, which was astounding to 
me. Now it is approaching a billion; in some cases, maybe even more.
  It is one thing to throttle the pharmaceutical companies in the 
interest of politics. It is another thing to ignore reality and ignore 
what happens here.
  One reason for Hatch-Waxman was because one side wanted all drug 
price competition. They wanted 100 percent generics if they could get 
them. The problem is, there would not be any generics if you don't have 
the innovator companies doing the innovative drugs.
  Mr. DORGAN. Will the Senator yield for a question?
  Mr. HATCH. Sure.
  Mr. DORGAN. My friend from Utah did not mean to suggest those of us 
who are offering this amendment on a bipartisan basis are doing so for 
the purpose of politics, as he said. My expectation is, he would think 
this would be a serious and thoughtful amendment that he disagrees 
strongly with, but I hope he would not suggest the motive is politics. 
CBO has suggested this bill will save $50 billion for the American 
consumer, $5 billion of which is for the Federal Government. This is a 
serious issue and a thoughtful issue. One might disagree, but I hope 
that one would not ascribe motives of politics to those of us on a 
bipartisan basis who are offering this amendment.
  Mr. HATCH. I have heard some who I believe are using it politically 
in the Congress. But I would never ascribe that type of attitude to the 
distinguished Senator from North Dakota. I believe he is very sincere. 
I believe he is truly trying to represent the consumers in the best 
possible way. I just believe he is ignoring some of these comments and 
statements made under oath before committees of the Senate that fly in 
the face of what is being said here. I would like to see drug prices 
reduced. There is no question about it. I worked hard to get them 
reduced. That is what Hatch-Waxman is all about. But there are two 
sides to that. One was drug price competition, to make sure we could 
get drugs in generic form immediately, once they come off patent, which 
we did. The other, of course, is the patent term restoration so that we 
could give innovator companies some restoration of patent life or 
market exclusivity so they could recoup the moneys, the extraordinary 
costs that are involved.
  When I say I have heard some in the Congress who I think have 
exploited this for political purposes, I would never say that about my 
friend from North Dakota. I don't particularly want to disparage 
anybody else, but I can say this: There have been some who have used 
this issue politically, and there is no doubt about it. I believe the 
Senator from North Dakota is articulate and means what he says and is 
doing so for the right reasons. Having said that, I don't think we 
should ignore the testimony of these top people in the administration 
who say this could be a disaster for the American consuming public. I 
don't think you can ignore those comments. I am suggesting that I hope 
people will read these comments, and I will put more into the record 
before we are through with this debate. We are all interested in 
getting drug prices down. There is no question about it. I don't think 
there is anybody in this Congress who has done more to bring drug 
prices down than I have, through Hatch-Waxman and my friend Henry 
Waxman over in the House and others who supported that bill. There is 
no question about it. I am as interested as anybody in making sure the 
consumer public is not ripped off.
  On the other hand, these innovative drugs cost a lot of money to 
develop. When we get into follow-on biologics, it apparently costs even 
more for these large-molecule drugs that may not be readily duplicated. 
In fact, under current science, they are not readily duplicated. I am 
very concerned about this whole issue. I am very concerned about making 
sure that the record shows that we have brought out how serious this 
issue is and how serious the consequences are if people are wrong, if 
they happen to get this type of legislation through.
  Let me add one other thing. I would suggest to my friend from North 
Dakota that the President has already

[[Page 10748]]

said that if this language is in this bill, he is going to veto it. I 
believe that veto would be sustained. I think it should be sustained. 
It is one thing to come out and argue for something such as this, but I 
would hope that he will withdraw his amendment because I would hate to 
see a bill as important to our country as this drug safety bill, a bill 
that has brought together Democrats and Republicans from the left to 
the right, a bill that would help to save as many lives as this bill 
will do, a bill that will help bring to the forefront the FDA in a way 
that it should be brought, a bill that has the MDUFA and PDUFA moneys 
in, a bill that has children's programs in, I would hate to see this 
bill vetoed, but I would not blame the President one bit if he vetoes 
it based upon the testimony of scientists who have testified before our 
committees.
  Frankly, I would think he would be right if he vetoed it. But be that 
as it may, I am only one Senator, and I think most people know I am 
very sincere in this area. I work very hard in these areas. I have a 
record of accomplishment in these areas. I just want to make sure that 
our consuming public has every protection they possibly can. 
Unfortunately, it costs a lot of money to give them that protection. I 
wish there was some way we could bring those prices down.
  Having said that, back in the early 1990s, I helped put through this 
body the FDA Revitalization Act. Among the purposes of that act was to 
create a unitary campus for FDA rather than have over 30 different 
locations in the greater metropolitan area around the District of 
Columbia, to have a central campus, state-of-the-art equipment, the 
highest technology we can, with an incentive to bring the very best 
scientific minds we can into FDA. We all know the White Oak complex is 
being built now. It didn't start until about 5 or 6 years ago. It is 
going to take another 10 years and probably cost a lot more than it 
would have had we done what that bill said we could do immediately. It 
was only an authorizing bill. The appropriators did not appropriate the 
funds to develop that campus. But we have to find a way of helping FDA. 
The sooner we get that campus and they have all of the integral online 
services and equipment and top-of-the-line approaches that they can 
bring to bear, we should be able to bring drug prices down through 
that. But we are a long way from the completion of White Oak, as we 
stand here today.
  Frankly, at least we are doing it. At least we are going somewhere. I 
wish to attribute some of that to the distinguished Senator from 
Maryland, Barbara Mikulski, and others in the House who have worked 
very hard to make sure that the FDA revitalization approach finally 
comes to fruition.
  One of the biggest problems we have in Government today is to get top 
scientists at FDA. We can't pay them commensurate with scientists at 
the major pharmaceuticals or even the major generic companies. In fact, 
they can start at three times or more what we pay at FDA. So we have a 
very difficult time continuously getting top scientists to come and 
work at FDA. That is a big problem. It is a blessing that we do have 
some of the best scientists in the world working there who are willing 
to sacrifice to do what they consider to be the important work of the 
Food and Drug Administration. This bill will help the Food and Drug 
Administration to do a better job, to go forward with more backing from 
the Congress and, in the end, benefit all of us who benefit so much 
from the work of the Food and Drug Administration.
  I yield the floor.

                               Exhibit 1

         Department of Health and Human Services, Food and Drug 
           Administration
                                    Rockville, MD, April 10, 2007.
     Hon. Byron L. Dorgan,
     Chairman, Subcommittee on Interstate Commerce, Trade and 
         Tourism, Committee on Commerce, Science, and 
         Transportation, U.S. Senate, Washington, DC.
       Dear Senator Dorgan: Thank you for the opportunity to 
     testify at the March 7, 2007, hearing entitled, ``Policy 
     Implications of Pharmaceutical Importation for U.S. 
     Consumers,'' before the Senate Subcommittee on Interstate 
     Commerce, Trade, and Tourism. The Food and Drug 
     Administration (FDA or the Agency) is responding to address 
     the March 9, 2007, correspondence you sent in follow-up to 
     that hearing.
       Your correspondence included statements made by former FDA 
     Commissioner, David Kessler, at an April 19, 2005, hearing 
     entitled, ``Examining S. 334, to amend the Federal Food, 
     Drug, and Cosmetic Act with respect to the importation of 
     prescription drugs,'' held by the Senate Committee on Health, 
     Education, Labor, and Pensions. Dr. Kessler's statements 
     focused on the issues of safety, resources, supply chain 
     security, and standards for approval of foreign versions of 
     FDA-approved drugs. You asked that I explain my views on the 
     ``Pharmaceutical Market Access and Drug Safety Act'' in the 
     context of these issues. The bulk of this response details 
     our views about these issues.
       I would like to start, however, by commending you for your 
     efforts to address American consumers' concerns regarding 
     access to affordable prescription medications. Nevertheless, 
     the Agency continues to have concerns with enacting such a 
     sweeping importation program and fears that intermediaries 
     would likely swallow the bulk of cost-savings, preventing 
     American consumers from enjoying much, if any, practical 
     benefit from such a program. We expect such a result might 
     lead consumers to continue to look for substantial savings on 
     their prescription medications by seeking products outside 
     the legalized importation system, just as some do now. We 
     continue to observe that many consumers buy drugs from 
     foreign Internet sources even though generic versions of 
     those products are approved by FDA and such products are 
     generally cheaper in the United States than abroad.
       We note that legalizing commercial importation may have 
     unintended effects on protection of intellectual property and 
     may reduce incentives for research and development, as noted 
     in the 2004 report issued by the Health and Human Services' 
     (HHS) Task Force Report on Drug Importation.


                            safety concerns

       We have safety concerns related to both the identification 
     of unsafe and or non-compliant drug products and about the 
     substitutability of foreign products for domestic products.
     Identifying unsafe/non-compliant drug products
       The section of the bill that would allow individuals to 
     import a qualifying drug from a registered exporter would 
     likely pose an overwhelming resource burden for the Agency 
     and create significant safety concerns. Under such a program, 
     the anticipated high volume of products would make it 
     extremely difficult for FDA and U.S. Customs and Border 
     Protection officials to examine adequately all of the 
     personally imported drug products to ensure that they comply. 
     In fact, the HHS Task Force estimated that it would have cost 
     $3 billion annually to examine and process each of the 10 
     million packages that entered the U.S. in 2003. Even if a 
     lower level of examination were considered adequate, the 
     costs to FDA would still be very high.
       Despite its registration and inspection fee provisions, the 
     bill likely provides inadequate resources to conduct such 
     examination on a routine basis. Resources are limited to 2.5 
     percent of the total price of qualifying drugs imported by 
     registered exporters, an amount likely to be a small fraction 
     of the cost of inspecting packages at international mail 
     facilities. This is a particular concern because, once 
     personal importation is given the appearance of legality, 
     consumers may be less vigilant in scrutinizing the drug 
     shipments they receive from abroad.
       S. 242 would establish a complicated system for the 
     regulation of imported drugs. This complex system is so vast 
     that it would be enormously resource-intensive, likely much 
     greater than the proposed registration fees and inspection 
     fees could support. The bill and its associated fees also do 
     not appear to account for the costs of the increased volume 
     of packages likely to inundate the U.S., or address the 
     accompanying and likely substantial enforcement work that 
     will arise as a result of legalized importation as more 
     unscrupulous vendors set up shop to circumvent the new U.S. 
     system.
     Lack of substitutability
       The proposed bill provides a mechanism for foreign imported 
     products to be approved for distribution in the U.S. even 
     though these products may not be bioequivalent to the FDA-
     approved product. This mechanism seems to by-pass the 
     existing drug approval process for drug products that are not 
     bioequivalent to an FDA-approved product, which is through 
     the submission of a new drug application (NDA) that is 
     thoroughly reviewed for safety and efficacy. Ultimately, the 
     bill appears to establish for imported drugs an alternative 
     to FDA's existing generic drugs program.
       The bill would allow non-bioequivalent products to be sold 
     in the U.S. as approved ``variations'' of the innovator 
     product under the existing NDA, which would create confusion 
     for doctors and pharmacists in prescribing or dispensing, 
     respectively. Dr. Todd Cecil of the U.S. Pharmacopeia 
     testified at the April 2005 Senate HELP hearing regarding 
     pharmaceutical equivalence and bioequivalence and his 
     concerns with this bill. In addition, doctors cannot 
     anticipate which version of a drug product their patients 
     will

[[Page 10749]]

     receive, and pharmacists may not know which version of a drug 
     the doctor intended to prescribe. The possibility of 
     confusion is significant and poses a real public health 
     concern as this increases the chance of error in prescribing 
     and/or dispensing of medications. In addition, the domestic 
     and foreign versions of prescription drugs may become 
     commingled in the drug supply chain. It is unclear whether a 
     patient will be able to specify if he wants the foreign 
     version or the original FDA-approved version when he gets his 
     prescription filled at the pharmacy or receives medication at 
     a hospital or other medical treatment facility.


                          Inadequate Resources

       It is uncertain whether the anticipated fee revenues will 
     be realized because the market response to legalization of 
     importation cannot be accurately predicted. This uncertainty 
     could pose problems for FDA's program, because large costs of 
     starting and developing a program to regulate imports will 
     have to be incurred even if the volume of legalized imports 
     is initially low. Although the bill does assume certain sales 
     volumes in the first several years for purposes of collecting 
     inspection fees, with only a few registered importers and 
     exporters participating initially, the high pro rata share of 
     fees may actually discourage participation and make it 
     difficult for FDA to collect fees at the designated levels. 
     Even once a program is developed, the bill is not likely to 
     provide the necessary funds to continue an adequate 
     regulatory program if inspection fees are low because imports 
     do not reach the anticipated levels.


                         Supply Chain Security

       We are proud of FDA's efforts with supply chain 
     stakeholders and states to maintain a safe and secure drug 
     supply in the U.S. that is premised on a closed, tightly 
     regulated system. The type of drug importation program in the 
     bill would increase the number of foreign entities FDA would 
     have to monitor and regulate. It can be difficult for FDA 
     enforcement to reach foreign entities violating our laws and 
     regulations. This bill would open the door to more entities 
     outside our domestic legal framework. We also have grave 
     concerns for consumers who may be harmed from products from 
     these foreign sources. The bill does not take into account 
     protecting the rights of the consumer if they are injured 
     after using one of these products.
       As we all agree, counterfeit drugs must be kept out of the 
     U.S. drug supply chain. FDA is currently using its resources 
     and authorities as efficiently as possible to secure the drug 
     supply chain and protect American consumers from counterfeit 
     and diverted drugs. Opening the U.S. drug distribution system 
     to foreign markets would provide more opportunity for 
     counterfeit drugs to enter our currently closed system and 
     would significantly complicate FDA's efforts to investigate 
     irregularities in the drug supply chain.
       Conducting foreign investigations and prosecutions is 
     inherently costly and difficult and often is complicated by 
     language barriers and issues of extraterritorial jurisdiction 
     and extradition. We are concerned that the bill does not 
     provide sufficient enforcement tools and penalties to deter 
     foreign entities from introducing counterfeit or otherwise 
     substandard drugs into the U.S. drug supply chain.


                      Approval of Foreign Versions

       We believe the bill creates complicated application and 
     inspection requirements for imported ``foreign'' versions of 
     FDA-approved products. These requirements would be difficult 
     to implement, as each foreign country has its own regulatory 
     scheme and requirements for the information necessary to 
     approve a drug product. FDA would essentially have to review 
     foreign information in a foreign format, all in less time 
     than is required for review of traditional NDAs. In addition, 
     the bill would require imported ``foreign'' versions of a 
     drug bear the labeling associated with the original FDA-
     approved product. This practice would essentially legalize 
     the misbranding of these products, and raises concerns for 
     FDA not only in the approval context but also in the 
     counterfeits context. It is difficult enough for FDA and 
     other federal enforcement agencies to detect counterfeit drug 
     products and packaging; creating a mechanism that would allow 
     persons to label foreign drugs with reproductions of FDA-
     approved labeling would make it even harder to distinguish 
     between ``legal'' foreign products and counterfeits.
       U.S. consumers currently have a number of options available 
     to them when looking for affordable medications within the 
     closed U.S. drug distribution system. Many essential drugs 
     have a generic alternative and some even have many generics, 
     which are generally less expensive than the brand product. We 
     continue to find that many consumers currently buying foreign 
     products are actually trying to purchase, or are unknowingly 
     receiving, a foreign product that often is more expensive 
     than the U.S. product. In addition, the consumers are at risk 
     when receiving foreign drug products, as there are documented 
     cases where the wrong medication was received (the 
     haloperidol case mentioned in my testimony). Many 
     pharmaceutical companies and Pharmaceutical Research and 
     Manufacturers Association of America offer discounts and 
     sometimes even free medications for consumers who cannot 
     afford them. Medicare Part D has also helped some seniors cut 
     their prescription costs. Consumers should not feel 
     restricted to higher priced innovator (brand) products.
       Consumers must also understand that if a medication is 
     costly, they should discuss other treatment options with 
     their doctor and pharmacist, as most often there are lower-
     cost alternatives available. We will continue to strive to 
     make more affordable medicines available to consumers, but we 
     remain concerned about the implications of legalizing drug 
     importation as one of those options.
       In conclusion, I would like to reiterate concerns about the 
     economic implications of prescription drug importation, as 
     stated in the 2004 HHS Task Force Report on Drug Importation. 
     Even if all the safety concerns could be allayed, these 
     concerns would remain: that savings to U.S. consumers would 
     be small as a percent of total drug spending; that 
     implementing such a program would incur significant costs; 
     and that legalized importation would likely adversely affect 
     the future development of new drugs for American consumers. 
     In 2004, the HHS Task Force Report noted that generic drugs 
     account for most prescription drugs used in the U.S. and that 
     these are usually less expensive in the U.S. than abroad. We 
     thus have a well-functioning system of intellectual property 
     rights that balances the short-term interests of consumers 
     with the long-term research incentives.
       Thank you for the opportunity to address some of our 
     concerns with S. 242.
           Sincerely,
                                                Randall W. Lutter,
     Acting Deputy Commissioner for Policy.
                                  ____


  The ACTING PRESIDENT pro tempore. The Republican leader is 
recognized.
  Mr. McCONNELL. Mr. President, I ask unanimous consent to proceed as 
in morning business.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.


                      Exoneration of Senator Frist

  Mr. McCONNELL. Mr. President, a great injustice has come to an end. I 
rise to recognize the clearing of a good man's name.
  Former Senator Bill Frist, with whom I and my Republican colleagues 
had the honor of serving for 12 years in the Senate, was cleared last 
week of every allegation of wrongdoing related to his ownership and 
sale of stock while serving as majority leader.
  I rise because, with the exception of an editorial in this morning's 
Wall Street Journal, the clearing of this good and honorable man's name 
has gone largely unreported.
  It is a sad fact of political life in America that the mere 
allegation of wrongdoing--the mere allegation of wrongdoing--has the 
power to tarnish someone's name and dog them for years. But worse still 
is the silence that so often greets the vindication of the accused.
  I remember the rush to judgment that followed the allegations. I 
remember the memo Democrats sent out attacking Bill on ethical grounds. 
The authors were later forced to apologize, but the piece had its 
intended effect.
  Republicans knew then--and everyone now knows--those allegations were 
absolutely false. But the damage, of course, was already done. As the 
Journal writers put it today:

       Despite flimsy evidence, the media storm cast a shadow over 
     [Frist's] office . . . [and] the Nashville heart surgeon 
     chose . . . to take a sabbatical from public life.--
       [And] Dr. Frist now joins a long line of public servants to 
     be smeared on page one and [then] exonerated next to the 
     classifieds, only to wonder if anyone noticed.

  Well, his friends noticed. Still, it is hard not to lament the damage 
these reckless claims have caused--caused for Bill, his family, and 
potentially our political system.
  The Founders envisioned a nation in which citizen legislators would 
be willing to leave the plow and the workbench to serve.
  Bill embodied this ideal by leaving his profession and the comforts 
of private life for a career of public service. He graced this body 
with his intelligence, his thoughtfulness, and his vision.
  We can only hope that future citizen legislators, and judges, are not 
deterred from entering and elevating politics because of the threat of 
similar treatment.
  A great American statesman once said:


[[Page 10750]]

       Reputation is like fine china and glass--easy to crack, but 
     hard to mend.

  We hope a political culture that allowed the abuse of Bill Frist's 
good name for political gain does not deter others from choosing the 
same path that he chose--and so honorably followed.
  Mr. President, I ask unanimous consent that the editorial entitled 
``Frist's Vindication'' from today's Wall Street Journal be printed in 
the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

              [From the Wall Street Journal, May 1, 2007]

                          Frist's Vindication

       When insider-trading allegations against former Senate 
     Majority Leader Bill Frist surfaced back in 2005, they were 
     splashed on the pages of major newspapers from coast to 
     coast. Now that Dr. Frist has been vindicated, the silence is 
     instructive. Is anybody out there?
       Senator Frist was alleged to have received an insider tip 
     and then sold shares in a hospital company run by members of 
     his family. The Securities and Exchange Commission and 
     Justice Department investigated for 18 months, and last week 
     the SEC announced that it had closed its probe without taking 
     action--that is, the doctor was cleared. Thanks in part to 
     his meticulous email archives, Dr. Frist was able to show 
     that he had begun the process of selling his HCA stock in 
     April of 2005, months before he was alleged to have received 
     the inside whispers.
       The controversy surrounding his involvement in health care 
     was a perennial bugaboo for Dr. Frist. For years he was 
     harassed by such liberal lobbies as Public Citizen, and 
     Citizens for Responsibility and Ethics in Washington, which 
     alleged conflicts of interest. These groups objected even to 
     those stocks he held in the blind trust he had created to 
     avoid the appearance of a conflict of interest. Yet when he 
     sold those stocks, with a possible eye on higher office, he 
     was pilloried for doing what the ethicists had asked him to 
     do all along.
       Today, even this muted absolution is surely a relief to Dr. 
     Frist. Yet it's impossible to undo the damage to his 
     political career. Despite flimsy evidence, the media storm 
     cast a shadow over his office, derailing any thought of a 
     Presidential bid this year. The Nashville heart surgeon chose 
     instead to ``take a sabbatical from public life.''
       Democrats naturally cared less about the actual facts than 
     about pinning another scandal on Congressional Republicans in 
     the run-up to the fall elections. But what about others who 
     thought it clever or funny or perhaps mandatory to get their 
     share of media attention by confusing accusation with proof 
     of wrongdoing?
       American University Professor James Thurber got his name in 
     the paper for quipping that Senator Frist ``came in like 
     Jimmy Stewart and was leaving like Martha Stewart.'' What a 
     card. As for the press corps, it ran off in a braying 
     stampede in pursuit of the theme dujour, which was Abramoff-
     DeLay-GOP corruption. The accusations against Dr. Frist fit 
     that template, so there was no need for the herd of 
     independent minds to inspect the evidence and make 
     distinctions. A Washington Post editorial from the day now 
     looks especially embarrassing--and unfair.
       As a medical professional with strong Tennessee roots, Bill 
     Frist was the kind of person we'd hope would occasionally 
     choose to participate in politics, as opposed to the 
     permanent political class that now dominates Congress. That 
     his previous engagement in the real world, even carefully and 
     transparently managed, made him an unfair target of political 
     attacks shows why so few people of accomplishment run for 
     office. These are the kind of people that the goo-goo 
     Naderites and their media acolytes end up driving from public 
     life.
       Dr. Frist now joins a long line of public servants to be 
     smeared on page one and exonerated next to the classifieds, 
     only to wonder if anyone noticed. As former U.S. Secretary of 
     Labor Ray Donovan asked after his legal ordeal, ``Which 
     office do I go to to get my reputation back?''

  Mr. McCONNELL. Mr. President, I yield the floor.
  The ACTING PRESIDENT pro tempore. The assistant majority leader is 
recognized.


                           Iraq Supplemental

  Mr. DURBIN. Mr. President, about 1 hour ago, the President of the 
United States vetoed the supplemental appropriations bill for the war 
in Iraq. It was a bill that we have worked on in Congress since its 
arrival in the middle of February. It was the subject of lengthy 
deliberations. There were long debates on the floor of the House and 
Senate. There was a lot of compromise that led to the final work 
product and a bipartisan vote which sent it to the President.
  There were people who were skeptical as to whether the Senate and the 
House of Representatives could rise to this challenge. In a nation that 
is so divided on so many political issues, in a nation where the war in 
Iraq is the biggest issue by far, there were serious doubts as to 
whether this Congress, with scant majorities of Democrats in both the 
House and the Senate, could produce a bill for President Bush to 
consider.
  Congress rose to that occasion. With the leadership of Speaker Pelosi 
and the leadership of our majority leader, Harry Reid of Nevada, we 
produced a bill which attracted not only the overwhelming support of 
the Democratic caucus but also the support of Republican Senators who 
joined us in passing this bill.
  It was our hope that our work product would be considered seriously 
by the President. It was sent to him this afternoon. A few hours after 
receiving it, the President vetoed it and announced his veto in a 
public press conference.
  I am disappointed. The President had a chance to sign a bill that 
would have funded the troops in this war. More importantly, it was a 
bill he could have signed which could have changed the course of this 
war--something that is long overdue.
  I listened in my office as the President gave his veto message to the 
American people. It was short, direct but, in many ways inadequate when 
you consider the awesome responsibility we face in Congress and in the 
White House.
  The President referred to our timetable to start bringing American 
troops home as a date for failure. It is ironic the President would 
make that statement on the fourth anniversary of his appearance on the 
USS Lincoln aircraft carrier under a banner announcing, 4 years ago, 
that our mission was accomplished. For the President to announce 
success and failure, accomplishment and lack of accomplishment, leaves 
something to be desired after that experience 4 years ago.
  I am particularly troubled as well by the President's notion of what 
this bill was all about. You see, he said, at one point, for us to set 
a timetable to bring American troops home would--in the President's 
words--``demoralize the Iraqi people.'' Those were his words.
  Mr. President, excuse me, but I am not as interested in building up 
the morale of the Iraqi people as I am in inspiring the leaders of the 
nation to stand up and lead. For too long now, with the protection of 
the U.S. troops, this Iraqi Government has failed to make even basic 
progress in taking control of their country. They have failed to 
address the key political issues that would lead to stability.
  So the President is arguing that if we continue to send 150,000 or 
more American soldiers to risk their lives, it will build up the morale 
of the Iraqi people to seek nationhood, stability, and peace. So we 
expect American soldiers to stand in this crossfire of a bitter 
religious and civil war, hoping that the Iraqi people will be inspired 
enough to ask their Government for leadership?
  Mr. President, 3,351 American soldiers have fought and died in Iraq, 
as I stand here today. Mr. President, 3,351 American lives should be 
enough to inspire the Iraqi people and their Government. How many more 
American lives will it take for that inspiration the President is 
looking for?
  I am troubled by this notion that unless we will sacrifice our 
treasure and the lives of our brave soldiers, the Iraqis cannot rise to 
the occasion and lead themselves out of this morass.
  I also listened to the President when he characterized the money that 
we added in Congress to his budget request. He called it--and I will 
quote--``billions in nonemergency spending that has nothing to do with 
fighting the war on terror.''
  I wonder if the President's staff put the bill in front of him for 
him to take a close look at, in the few hours he had it before vetoing 
the bill.
  Is the President arguing to the American people that providing $2 
billion more in equipment to keep our troops safe in Iraq has nothing 
to do with fighting the war on terror?
  Is the President arguing that the $1 billion in our supplemental 
appropriations bill--the $1 billion to replenish National Guard 
equipment destroyed

[[Page 10751]]

and lost in the war in Iraq--that $1 billion has nothing to do with the 
war on terror?
  Is the President arguing that the $2 billion in this bill for 
military hospitals--such as Walter Reed, so we do not relegate our 
fallen soldiers and those who were injured to a flophouse motel across 
Georgia Avenue from Walter Reed Hospital--is he arguing that the $2 
billion that is in the bill for military hospitals has nothing to do 
with the war on terror?
  Perhaps the President is not aware of the fact there was $2 billion 
in this bill for veterans hospitals all across America, for those who 
have come home with post-traumatic stress disorder, traumatic brain 
injury, and amputations who need the services of the VA hospitals. Is 
the President arguing that money for VA hospitals has ``nothing to do 
with the war on terror''? That is what he said. That is an exact quote.
  This bill has add-ons that relate to real emergencies in America. I 
have outlined a few related directly to the war on terror, directly to 
our troops, directly to our national security.
  There is money, as well, for the base closing commission, which it is 
my understanding the President wanted included. There is money, as 
well, for Hurricane Katrina. Here we are, a year and a half after that 
terrible tragedy, still trying to put New Orleans back on its feet and 
rebuild Louisiana and Mississippi and areas affected by Katrina and 
Rita. Yes, there is money in the bill for those emergency purposes.
  For the President to dismiss this as billions in nonemergency 
spending suggests his staff did not do their job, they did not spell 
out to the President what was in that bill before he vetoed it.
  Well, the President knows--and he said as much--we do not have the 
votes to override his veto. That is a reality. It takes 67 votes in the 
Senate. We have been able to rally 51 or 52 votes on a good day to 
question the President's policies in Iraq. Two or three Republican 
Senators have stood by our side on the Democratic side of the aisle. 
Few others have been willing to do so. So the thought of reaching 67 
votes is probably a bridge too far. I think we know that reality.
  But this much I will say: Congress cannot override the President's 
veto, but the President cannot override the reality of Iraq. The 
reality of Iraq is this: We are in the fifth year of a war. We have 
seen 3,351 American lives sacrificed, 25,000 or more injured, 7,000 or 
8,000 seriously injured with traumatic brain injury and amputations.
  Americans have sacrificed from their hard work and earnings $500 
billion for this war and for rebuilding Iraq. That is the reality of 
Iraq today.
  The reality is, this last month of April was the deadliest month this 
year for American soldiers. The reality is, this President has no plan 
to exit that country and bring our troops home. That is the reality. We 
may not be able to override this veto, but the President cannot 
override those realities.
  Now it is time for the American people to understand what happens 
next.
  We will fund these troops. We have made that promise, and we will 
keep it. They will not be bargaining chips in our policy debate in 
Washington. But we will continue, through this bill and through other 
legislation this year, to continue to put the issue of the Iraq war in 
front of the President, in front of the American people. They expect 
nothing less.
  For those who are frustrated by the President's veto today, I join 
them in that frustration. But I join them, as well, in believing that 
as the American people speak out on this issue, the likelihood that 
Republicans will cross this aisle and join us increases.
  The time will come--I am not sure when but I hope soon--that tipping 
point will be reached where the Republicans finally say to their 
President: Enough. We cannot ignore the reality of this war and what it 
has done to America. Then they will join us. Then this will truly 
become a bipartisan effort. Then we will be able to override vetoes and 
pass legislation that will make a meaningful change in the policy of 
this war.
  I encourage those across America seeking a new direction in Iraq, do 
not be discouraged by this veto. There will be another day. There will 
be another bill. There will be another chance for us to change this 
policy. We need to keep our forces together--the forces for change in 
Iraq on the Democratic side and on the Republican side. We cannot allow 
the President's veto pen to be the last word on this war in Iraq. We 
have to stand together, and we have to work together.
  The President comes up with rosy reports on what is happening in 
Iraq. But we know the reality. Sectarian deaths are down, he said. 
Well, I guess they are down slightly, a small percentage, of those 
innocent civilians killed last month. There were fewer this month. I 
guess that is progress. But those who are there say the violence is 
subsiding while the surge is underway, and they are afraid it will 
return. I am, too.
  We need to pass a bill for the troops, and sometime soon. We will 
work hard to try to find a way with the President. He has invited the 
leadership of the Senate and the House to meet with him tomorrow in the 
White House. I have been to those meetings before. There have been 
little results to point to for the time we have met and the dialog we 
have exchanged. But I go tomorrow with the hope that things will be 
different. I hope this President, after his moment in the sun with this 
veto, will now understand that we face the grim reality of Iraq, and 
the reality that we have no exit plan. This failed policy in Iraq must 
come to an end. We will continue to fight, with this democratic 
Congress, to make a change in that policy. We will stand by our 
soldiers, but we will not stand by a failed policy. I am encouraged by 
the fact that so many of my colleagues are ready to continue this 
fight, and I encourage the American people: Don't give up. Don't lose 
heart. This democracy works when you work with us to bring the will of 
the people to the law of the land.
  Mr. President, I yield the floor.
  The ACTING PRESIDENT pro tempore. The senior Senator from New York is 
recognized.


                           Iraq Supplemental

  Mr. SCHUMER. Mr. President, tonight is a sad night for America, but 
what the President's veto indicated was not that Democrats don't want 
to support the troops--we do--but that he does not want a change in 
direction, a change in mission, a change in course. It indicates the 
President is still in his bunker thinking everything is going fine in 
Iraq, and it clearly isn't.
  The bottom line is very simple: We can do two things at once. We can 
support the troops and at the same time we can change our mission. The 
bottom line is simple, and that is that the present policies have 
failed. Everyone except a handful of supporters of the President, and 
the President and the Vice President themselves, know that, but 
unfortunately they stubbornly cling to staying on the same course, to 
the detriment of about everybody else in this country and the world.
  The bottom line is very simple: that President Bush, when he asked 
Americans to go to war, never talked about policing a civil war, and 
yet that is the largest part of our efforts in Iraq. We on this side of 
the aisle hope to change that direction so that we are fighting 
terrorism and directing counterterrorism and not simply policing a 
civil war.
  The next few weeks will be momentous in our history. Frankly, when 
these few weeks began, the President, with his bully pulpit, his harsh 
rhetoric, his idea that he was trying to persuade people we didn't 
support the troops, many thought he would win the fight--the fight here 
in this Chamber and in the minds of public opinion. But that hasn't 
happened at all. In fact, the American people are so disgruntled by 
this war in Iraq, that the old name-calling, the old kneecapping, the 
old attempts to instill fear in people who disagreed with him don't 
work for this President anymore. He has only one choice. That choice is 
a simple one, which is to change the course of the war in Iraq. It is 
inevitable. It will happen. It will happen sooner or it will happen 
later, but it must happen because failed policies can never continue on 
and on and on.
  They have asked us to have faith in the surge. If it won't work with 
150,000

[[Page 10752]]

troops, it won't work with 180,000 troops, and it won't work because 
the Government in Iraq does not have the support of the people, is 
unable to accomplish any goals, is unable to bring Sunnis, Shiites, and 
Kurds together. It doesn't matter how many troops we have there; the 
bottom line is simple. Our President is in the twilight days of his 
administration, and he has only two choices. One is to do what his 
predecessor Ronald Reagan did: See that things have gone off course and 
seek a correction. Ronald Reagan did that in 1986, and by 1988 the wall 
came down and Ronald Reagan had restored the faith of the American 
people. Why this President can't see the necessity to do the same when 
his policies, if anything, are in far worse shape than those of 
President Reagan, speaks either to an inability to sense what is going 
on or a stubbornness despite the facts. We can't tolerate that.
  We here tonight make a pledge to the American people. We will 
continue this struggle to change our direction in Iraq. We will not run 
away from fighting terrorism. We believe it every bit as fervently as 
anybody else, but we will also not run away from fighting terrorism 
smartly, which is what we are not doing here.
  So we will continue to try to reach a compromise with this President, 
to try to figure out a way we can both support the troops and change 
the course of the war in Iraq in maybe a different way, but we will not 
give up on our mission. The American people demand no less and we will 
not disappoint them.
  Mr. President, I yield the floor, and I suggest the absence of a 
quorum.
  The ACTING PRESIDENT pro tempore. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  The ACTING PRESIDENT pro tempore. The majority leader is recognized.
  Mr. REID. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.


                      senator frist's vindication

  Mr. REID. Mr. President, I had the good fortune of working with 
Senator Bill Frist for 4 years as a leader. He was a leader. There were 
times he and I had some political disagreements, and that is an 
understatement, but on a personal basis we had no misunderstandings. He 
was in public service for the right reason. He was a very fine, 
outstanding, nationally recognized transplant surgeon. He comes from a 
good family. He and I had many discussions, personal in nature. He was 
always available to anyone in the Senate. When there were any medical 
problems involved, he was always there to give advice and counsel. I 
went to him on many occasions about situations involving my friends and 
he would lay things out for me and head me in the right direction.
  Senator Frist had a situation arise front page in many of the 
newspapers, problems with the Securities and Exchange Commission. 
Senator Frist comes from a family that has done well. They have been 
involved in health care for many years. He and I had conversations 
about this and he said at the time it was unfair. He had to spend a lot 
of money hiring lawyers and accountants and consultants.
  This matter was closed yesterday, but the closing of this in the 
newspapers and on the news was certainly not the top story, not at the 
top of the newspaper. It was buried some place in the back. At no time 
during my conversations with Senator Frist or in my dealings with 
Senator Frist did I ever have any doubt about his integrity.
  His wife Karen and my wife are good friends. They worked together on 
a number of activities that Senate spouses work on. They had to do 
things because Senator Frist and I were the two leaders of the Senate 
and they did them together based on our relationship.
  I extend to Senator Frist my congratulations on getting this put 
behind him. I want the Record to be spread with the fact that I know 
this was a difficult time for him on occasion, but never at any time 
did I doubt his integrity, his honesty. I will long remember Senator 
Frist and I appreciate my dealings with him over these many years.


                             cloture motion

  Mr. REID. Mr. President, I send a cloture motion to the desk.
  The ACTING PRESIDENT pro tempore. The cloture motion having been 
presented under rule XXII, the Chair directs the clerk to read the 
motion.
  The legislative clerk read as follows:

                             Cloture Motion

  We, the undersigned Senators, in accordance with the provisions of 
rule XXII of the Standing Rules of the Senate, hereby move to bring to 
a close debate on the Dorgan amendment No. 990 to S. 1082, the FDA 
Revitalization bill.
         Byron L. Dorgan, Dick Durbin, Claire McCaskill, John 
           Kerry, Ted Kennedy, Amy Klobuchar, Sherrod Brown, Ken 
           Salazar, Mark Pryor, Daniel K. Inouye, Chuck Schumer, 
           Harry Reid, Ron Wyden, Dianne Feinstein, Carl Levin, 
           Blanche L. Lincoln.

  Mr. REID. Mr. President, this is a cloture motion on Senator Dorgan's 
longstanding endeavor to allow Americans to go to other countries for 
the importation of cheaper drugs. We know people are going to Canada 
now from around the country who live on the border, and it works pretty 
well. But if you are someone who lives in Nevada, you certainly need 
these drugs as well as someone living in Minnesota, and it makes it 
much more difficult. Nevadans go to Mexico a lot of times for cheaper 
drugs. It is unfortunate.
  Senator Dorgan is right. He has worked on this very hard for a number 
of years. This is an effort to bring this matter to a close. I hope the 
Senate votes to invoke cloture so we can have a vote on this amendment. 
It is important. I am confident it will pass if cloture is invoked. It 
is something that has been needed for such a long time to help in one 
way to lower the cost of medicine for the American public.

                          ____________________