[Congressional Record Volume 152, Number 134 (Thursday, December 7, 2006)]
[Senate]
[Pages S11404-S11411]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                       Protecting American Values

  Mr. FRIST. Mr. President, I will be very brief. I want to speak on 
another matter. I know we want to get to the hour of pre-vote time here 
shortly.
  Hopefully, tomorrow will officially end the 109th Congress. At the 
end of the day tomorrow, if we do our work today successfully, and 
tonight, the Senate will be able to adjourn. That will also mark, once 
we adjourn, this official change in leadership and change in the Senate 
agenda. I know many of my colleagues and many of my conservative allies 
view this change with a bit of trepidation, but change is good, change 
is constructive. It can be difficult, it can be painful, and it can be 
messy, but change forces us all to reexamine who we are, where we are, 
and where we want to go; what we know, what we believe.
  I believe it is our responsibility to protect traditional, 
commonsense American values. I believe when we give the American people 
the freedom to invest their money as they choose, the economy is going 
to flourish. It is going to have more freedom to grow. At the end of 
the day, I believe good leaders don't talk about principles--don't talk 
about them--but good leaders lead on principle. They act, and they act 
with solutions, even if they don't know that the outcome is going to be 
100-percent successful every time a bill is taken to the floor.
  I think that is one of the things that at least I tried to do, is not 
say let's only take to the floor what will necessarily pass but what is 
the right thing to do, on principle; what is the right thing for us to 
be considering.
  During my tenure in public office, it is what I tried to do, to lead 
on principle and act with solutions. It does come from that surgical 
approach of fixing things, of operating, of action.
  For example . . . for 10 years, we grappled with the issue of 
Internet gambling. We watched the industry mushroom from a $30 million 
industry in 1996 to a $12 billion industry today. We watched an 
addiction undermine families, dash dreams, and fray the fabric of a 
moral society.
  So we acted with a solution . . . by passing the Internet Gambling 
Prohibition and Enforcement Act to provide new enforcement tools to 
prosecute illegal Internet gambling.
  Let me give you a few more recent examples of how we have led on 
principle, and acted with solutions.
  We passed the Adam Walsh Child Protection and Safety Act . . . which 
creates a national sex offender registry, strengthens measures to 
prevent child pornography, and reinforces laws against child porn.
  We passed the Trafficking Victims Protection Reauthorization Act, 
which renewed the first federal law to strengthen prosecution efforts 
against human traffickers.
  We passed legislation securing the right to prayer in U.S. military 
academies.
  We passed legislation protecting the Mount Soledad Memorial Cross.
  We passed the Broadcast Decency Enforcement Act, which allows for the 
10- fold increase of FCC fines for indecency violations.
  We passed Cord blood legislation that harnesses the power of stem 
cells in cord blood to develop new cures for life-threatening diseases.
  We passed the Fetus Farming Prohibition Act, which prohibits the 
gestation of fetal tissue in order to use it for research.
  We passed the Stem Cell Research Alternatives bill, which provides 
federal funding for a variety of stem cell research that do not involve 
destroying human embryos.
  And perhaps most notably . . . we confirmed John Roberts Chief 
Justice of the Supreme Court . . . and Samuel Alito as an associate 
Justice of the Supreme Court.
  We confirmed 18 Circuit court nominees and 87 District court judges, 
including six previously obstructed nominees. America needs judges who 
are fair, independent, unbiased, and committed to equal justice under 
the law . . . and we made sure that's what America got.
  Over the past 12 years, what Republicans have done has changed our 
economy, our country, and our way of life for the better.
  Our record of success, combined with the lessons of November's 
election, ensures that our party will rededicate itself to serving the 
interests of America, both here at home and around the world.
  That vision--optimistic, forward-looking, hopeful--will be grounded 
in the fundamentals of commonsense conservative values best found on 
Main Street and in families with whom we have the privilege of 
interacting all across the country.
  The PRESIDENT pro tempore. Under the previous order, there will be 60 
minutes for debate prior to the cloture vote, with time divided as 
follows: the Senator from Wyoming, Mr. Enzi, or his designee, 30 
minutes; the Senator from Iowa, Mr. Grassley, 20 minutes; the Senator 
from Louisiana, Mr. Vitter, 10 minutes.
  Who yields time? The Senator from Wyoming is recognized.
  Mr. ENZI. Mr. President, I rise to discuss the pending nomination of 
Dr. Andrew von Eschenbach to be the Commissioner of Food and Drugs. The 
FDA has a very broad and critical mission in protecting our public 
health. The Commissioner of Food and Drugs is in

[[Page S11405]]

charge of an agency that regulates $1 trillion worth of products a 
year. The FDA ensures the safety and effectiveness of all drugs, 
biological products such as vaccines, medical devices, and animal drugs 
and feed. Let me repeat that: the safety and effectiveness of all 
drugs, biological products such as vaccines, medical devices, animal 
drugs and feed. It also oversees the safety of a vast variety of food 
products, as well as medical and consumer products including cosmetics.
  As Commissioner of Food and Drugs, Dr. von Eschenbach would be 
responsible for advancing the public health by helping to speed 
innovations in its mission areas, and by helping the public get 
accurate, science-based information on medicines and food. Dr. von 
Eschenbach has a strong record. He is an accomplished scientist, a 
proven manager, and a man with a vision. He is also a cancer survivor, 
and he has brought that perspective, and the compassion that goes with 
it, to his Government service. He gave up a job he loved, a challenging 
but rewarding post directing the National Cancer Institute, to offer 
his service for what I believe is a much more challenging and 
definitely thankless job of leading the FDA.
  The FDA has been without a confirmed Commissioner for all but 18 
months of the last 5\1/2\ years. Have you ever seen a business that can 
run for 5\1/2\ years without a boss except for 18 months? And that was 
a tenuous 18 months. I believe we can all agree that we need a strong 
leader at the FDA now, and one who has a mandate to act. He needs full 
authority to bring back the morale of the Department and get the job 
done. We must be forward looking. There are many items before the FDA 
that require the immediate attention of an FDA Commissioner vested with 
full authority. But that authority flows directly from the act of 
Senate confirmation. Without a Senate-confirmed leader, we can't expect 
the FDA to be as effective as we need it to be. I urge my colleagues to 
consider this.
  I know some of my colleagues on and off the committee are not 
completely satisfied with their interactions with the FDA during Dr. 
von Eschenbach's tenure. Some would urge that the Food and Drug 
Administration move quickly on certain matters before it. However, I am 
not sure that holding up a nomination over single products or single 
issues is the right way to achieve faster action and to ensure that 
agency processes are free from the pressure of politics. In fact, I 
strongly believe the opposite would occur. I think this is a position 
that has more Catch-22s than any other position in Government.
  I do respect the right of my colleagues to disagree with the 
President's choice for this position or the policies a President's 
nominee might pursue. If our disagreements with the President's choice 
are so strong, we ought to vote against the nominee. But, in light of 
the trillion dollars worth of drugs and products overseen by the FDA 
and hundreds of drug approvals reviewed every year, I think we would be 
setting a dangerous precedent if any of us hold up the President's 
choice for FDA Commissioner over decisions made involving one product 
or one issue or something extraneous, even, to the Food and Drug 
Administration. It would be an especially dangerous precedent at this 
point.
  We have a lot on our plate with respect to the FDA during the 110th 
Congress. We have to reauthorize both the drug and device user fee 
programs, address two expiring pediatric programs, and improve our drug 
safety system.
  The FDA needs a leader with the backing and mandate that Senate 
confirmation provides in order to be our partner in these efforts. Dr. 
von Eschenbach has received significant support from the HELP 
Committee. This man could serve patients in many different ways, and 
has offered to serve them by running this critically important agency. 
I am talking about a doctor with cancer expertise, management 
expertise, and vision, who has agreed to run this agency at what we pay 
because he wants to give back to his country.
  I urge my colleagues who are not on our committee to give Dr. von 
Eschenbach a chance to effectively run the FDA with full statutory 
authority, so I urge my colleagues to accept the President's nominee, 
Dr. Andrew von Eschenbach, and vote to confirm him as the next 
Commissioner of Food and Drugs. Voting yes on this cloture vote will be 
the first step voting on a permanent head to oversee our Nation's food 
and drug system.
  I reserve the remainder of my time.
  The PRESIDENT pro tempore. The Senator from Iowa.
  Mr. GRASSLEY. Mr. President, my opposition to the cloture motion is 
as much about whether we are going to be able to fulfill our 
constitutional responsibilities of oversight of the administrative 
branch of Government as it is about the particular qualifications of 
the nominee. I intend to vote against cloture and I hope that Democrats 
who are listening--particularly those Democrats in the last election 
who were bellyaching because there wasn't any oversight on the part of 
Republicans toward the executive branch of Government--would pay 
attention to the fact that this nominee has something to do with and is 
an illustration of the lack of cooperation on the part of the executive 
branch, failure to cooperate with Congress on the issue of 
congressional oversight.
  I have serious concerns about what this cloture vote means, then, to 
congressional oversight of the executive branch now and in the future, 
and what it means for Members such as me, who placed a hold on this 
nominee. This was not a secret hold. I made this hold public.
  I am voting against cloture and ask my colleagues to join me because 
I believe we need to send a message to the executive branch that it is 
not OK to impede congressional investigations. It is not OK to limit 
the Senate's access to documents, information, and employees of the 
executive branch. In his book on congressional government, Woodrow 
Wilson, before he was President, when he was a professor at Princeton, 
wrote, in 1885: ``Quite as important as lawmaking is vigilant oversight 
of the administration.''
  Our work as lawmakers does not end with the passage of a bill. This 
body has a responsibility to the American people to make sure that laws 
work and that they are being implemented effectively, efficiently, and 
economically. Congressional oversight serves very important goals, and 
we should not lose sight. They include reviewing actions taken and 
regulations adopted by executive agencies to make sure that the 
agencies are executing law according to the intent of Congress, and, 
second, ensuring that the Federal Government is not wasting taxpayers' 
dollars. Oversight work allows us to evaluate the ability of agencies 
and managers to carry out program objectives and improve the 
efficiency, effectiveness, and economy of Government programs; next, 
ensuring that executive policies reflect the public interest and that 
public interest is expressed in the laws of Congress; and, lastly, 
protecting the rights and liberties of the American people.
  Woodrow Wilson also said in his book that:

       It is the proper duty of a representative body to look 
     diligently into every affair of Government and to talk much 
     about what it sees. It is meant to be the eyes, the voice and 
     embody the wisdom and the will of its constituents.

  In America, with our Government, the public's business ought to be 
public. But when you have coverups and the lack of information going to 
Congress, as demonstrated by this request for documents, and when we 
get a document back with practically 57 pages removed, what is in those 
57 pages that we ought to have access to? That is just one example of 
lack of information and the lack of cooperation from this agency.
  Throughout history, Congress has engaged in oversight of the 
executive branch. The right to congressional oversight has been 
asserted from the earliest days of our Republic. In 1792, the House 
invoked its authority to conduct oversight when it appointed a 
committee to investigate the defeat of General St. Clair and his Army 
by Indians in the Northwest and empowered the ``call for such persons, 
papers, and records as may be necessary'' for that inquiry.
  In fact, the Constitution grants Congress extensive authority to 
oversee and investigate executive branch activities.
  Congressional oversight was also recognized explicitly in the passage 
of the Legislative Reorganization Act of 1946,

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which required the standing committees of Congress to exercise 
continuous watchfulness over programs of agencies in their 
jurisdiction. Numerous Supreme Court decisions will support all the 
precedents for Congress to see all aspects of the Federal Government.
  In 1927, in McGrain v. Daugherty, the Supreme Court upheld 
congressional authority to conduct oversight of the Teapot Dome 
scandal. Justice Van Devanter writing for the unanimous Court stated:

       We are of the opinion that the power of inquiry with the 
     process to enforce it is an essential and appropriate 
     auxiliary to the legislative function.

  To do oversight, Congress needs access to information and people in 
the executive branch. And that is what I did not, and still may not, be 
getting from the FDA under the leadership of Dr. Von Eschenbach--as an 
example, 47 pages removed; another example, 43 pages removed.
  How are you going to conduct oversight when you get answers such as 
that from the Food and Drug Administration?
  I take exception to the statement made in support of the cloture 
motion. People ought to be ashamed of saying Dr. Andrew von Eschenbach 
has done a superb job in the position he is currently occupying with an 
answer such as that to the Congress of the United States. That is an 
insult. Before you cast your vote in favor of cloture, consider what is 
at stake--and particularly Members on the other side of the aisle who, 
during the campaign, in campaign commercial after campaign commercial 
after campaign commercial, said Congress is not doing its job of 
oversight, implying that Republicans were covering up wrongdoing by the 
administration. If you want to preserve your access to information and 
do the oversight that you think you are going to do, when you are in 
the majority and you get answers such as that, do you think you are 
going to be able to do the job of oversight?
  In my interactions with the Department of Health and Human Services 
and the FDA these last 8 months, I have seen a complete and utter 
disrespect for congressional authority and hence the law. The 
department and the Food and Drug Administration have repeatedly failed 
to act in good faith in responding to congressional investigations--and 
the lack of 43 pages is just one example.
  Although the Director's leadership at the FDA has failed to fully 
comply with two congressional subpoenas that were issued 7 months ago, 
efforts to accommodate the agency's concerns fall on deaf ears, and I 
wonder if I am dealing with dysfunction by design. Not only has the 
NEDA withheld documents that do not appear to be privileged, but it 
also says what has been withheld and why. The subpoenas compel a 
privilege log, but the FDA has not provided us with that privilege log.
  For Democrats in the majority next year doing the oversight that they 
said they were going to do because Republicans weren't doing it--they 
didn't let me--let me ask you this: Are you going to be able to conduct 
oversight when you get answers such as that? Are you going to be able 
to conduct oversight when, for 7 months, you don't get your subpoenas 
responded to? What is the agency's explanation? The FDA has said that 
many documents have been withheld, that it is unduly burdensome to 
provide a privilege log. Even in the FDA, general counsel, as recently 
as Tuesday of this week, could not see why the agency needed to comply 
with the law and the terms of the subpoena which was issued by the 
committee.
  In denying the committee access to the documents responsive to the 
subpoena, which the department and the FDA administration have claimed 
``prosecutorial deliberative process'' or ``confidential 
communications'' or ``agency prerogatives'' to determine who will be 
interviewed and testify before a jurisdictional committee, when those 
on the other side of the aisle get answers such as that when you are 
going to be in the majority, what are you going to do about it? Are you 
going to keep your commitment to the American people when you won the 
majority? And are you going to be able to do the oversight when you get 
rationales such as ``prosecutorial deliberative process'' or 
``confidential communications'' or ``agency prerogatives?''
  I could not talk to a line agent named West because you can't talk to 
line agents, when 3 months before I talked to line agents? There was 
someone from the Justice Department before the Judiciary Committee, 
when Senator Kennedy said, ``I want access to line agents,'' unrelated 
to what I am talking about: Line Agent West, whom I wanted to talk to 
and I was told I couldn't talk to because you can't talk to line 
agents, the official at the Justice Department said to Senator Kennedy:

       You can talk to line agents. We will get them for you.

  I do not know whether that ever happened. But that was the answer.
  When I went around doing my questioning of Justice Department 
officials, I said: What about my ability to talk to Line Agent West? It 
just seemed as if I was going to be able to talk to Line Agent West. 
But yet this very day the Justice Department is advising the Secretary 
of the Interior that we can't talk to Line Agent West, which is key to 
whether some of these investigations are allowing dangerous drugs on 
the market. In Cedar Rapids, IA, I have a family that lost an 18-year-
old because of a drug that was on the market then and which is not on 
the market now.
  It seems to me that if you are concerned about the safety of drugs, 
this information is important, and if you are going to have it covered 
up in the FDA, you aren't protecting the public. If Congress knows 
about it, you are not doing your job of oversight.
  This past summer I asked the Congressional Research Service to look 
into the department's policies regarding this matter. And the 
Congressional Research Service told me that there is ``no legal basis'' 
for the department's executive branch assertion. The legal analysis 
provided by Congressional Research Service supports the committee's 
position that these executive agencies' claims have been consistently 
rejected and compliance with congressional requests in the past has 
been forthcoming. The CRS cites numerous court cases which establish 
and support Congress's power to engage in oversight and investigate 
activities and its access to executive branch personnel and documents 
in carrying out our powers of oversight.
  The Department of Health and Human Services, the FDA within Health 
and Human Services, says it has been responsive because the agency made 
available hundreds of thousands--even millions--of pages of documents 
to the Finance Committee in response to its subpoena. But the agency 
can give me all of the books and all the documents housed at the 
Library of Congress and it won't matter if it is not what I have asked 
for and the pages are removed.
  It is this type of cooperation that I am getting under this Director 
that you are now going to confirm. I am very concerned about the 
cooperation, if any, that we have once he becomes a permanent 
commissioner. Every Member of Congress should be equally concerned if 
they take their constitutional duty of conducting oversight of the 
executive branch seriously, and most importantly to the new majority 
when you are going to carry out your campaign promises to make sure 
that there is proper oversight, checks and balances against an 
executive branch of Government you think is exceeding authority. Every 
Member should be concerned. I cannot emphasis this enough.
  A vote for cloture today is a vote against oversight, and that is not 
what this Senate should be doing. It is not what the American people 
sent us here to do. We need to step up congressional oversight to 
protect our Nation's system of checks and balances and not reward those 
who seek to impede our constitutional authority.
  This body should not walk hand in hand with the executive branch and 
sit idly by as instances of abuse and fraud continue to endanger the 
health and safety of American people. This Senate needs to make it 
clear to the executive branch that Congress takes its oversight 
responsibilities seriously and to vote against cloture. If we do have 
cloture, I will have other remarks during postcloture debate.
  The PRESIDING OFFICER (Ms. Murkowski). The Senator from Wyoming.
  Mr. ENZI. Madam President, I want to briefly comment.
  I understand the frustration. I have been working with him trying to 
get documents, trying to get the interview

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with Mr. West. I want you to put yourself in Dr. Von Eschenbach's 
position. He has not been confirmed. He does not have the full 
authority to run that department. So what he has to do is rely on the 
Department of Justice, as the Senator mentioned. The Department of 
Justice tells him what he is supposed to do. I don't think he has 
authority to go beyond what the Department of Justice says.
  The Senator is one of the most diligent Members to hold oversight 
hearings of anybody that I know. I appreciate the depth that you go to 
for individuals as well as groups. I know it is what you are doing on 
this one. Unless we give him full authority, he has to rely on the 
Justice Department. The way one has to take on the Department of 
Justice is through the Judiciary Committee and bring them to task for 
giving him that kind of advice. I think he is just following the advice 
he has gotten from those he has to rely on until he has authority. I 
think it will be different when he has full authority.
  I yield 2 minutes to the Senator from Alaska.
  The PRESIDING OFFICER. The Senator from Alaska.
  Mr. STEVENS. Madam President, during my time of almost 7 years as 
chairman of the Appropriations Committee, I have met with Dr. Von 
Eschenbach quite often. We had many requests for documents. I can't 
remember once that he refused. But beyond that, I came to the floor 
today to say that I have gotten to know Dr. Von Eschenbach personally, 
and I can't think of a more qualified man at this time to be confirmed 
to this position. I hope the Senate will vote cloture and we will 
confirm Dr. Andrew von Eschenbach as requested by the President. I 
thank the Chair.
  Mr. ENZI. Madam President, I yield 10 minutes to the Senator from 
Texas.
  The PRESIDING OFFICER. The Senator from Texas.
  Mrs. HUTCHISON. Madam President, I thank Senator Enzi for giving me 
this time. I am pleased to rise to support Dr. Andrew von Eschenbach's 
nomination for Commissioner of the Food and Drug Administration. I am 
speaking about a person whom I know. I know him as a person. I know him 
as a human being. I can say, with full confidence, there is no one more 
qualified and more well suited to lead this very important agency.
  I was very pleased the committee overwhelmingly, unanimously, 
supported his nomination. Not only is Dr. Von Eschenbach a wonderful 
friend of mine, but he is so qualified for this position. His 
experience and integrity make him the right choice to lead the FDA.
  He is a nationally recognized urologic surgeon, medical educator, and 
cancer advocate. He is a three-time cancer survivor. There is no one 
who can understand what it is like to go through a fight against cancer 
than someone who has done it. So many doctors haven't had that 
experience, one might not get the impression that they really 
understand what a patient is going through. Not Dr. Andy von 
Eschenbach. He has been through the hard time of being told he has this 
dreaded disease and fighting it with all his might. He does relate to 
patients' struggles.
  During his 25 years at the University of Texas M.D. Anderson Medical 
Center, he led a faculty of 1,000 cancer researchers and clinicians. He 
was the chief academic officer at this great cancer institution. He was 
also the founding director of M.D. Anderson's Prostate Cancer Research 
Program. In this position, he developed integrated programs to study, 
treat, and prevent prostate cancer. Before arriving at M.D. Anderson, 
he served his country as lieutenant commander in the U.S. Navy Medical 
Corps from 1968 to 1971. In 1976, he joined M.D. Anderson as a urologic 
oncology fellow. He became part of the faculty and was named chairman 
of the Department of Urology in 1983.
  When he left M.D. Anderson in 2002, he became Director of the 
National Cancer Institute. At the time, he was president-elect of the 
American Cancer Society which, of course, is one of the leading 
organizations in our country that fights for victims of cancer.
  He has, also, been published in more than 200 publications. This 
year, Time Magazine named Andy von Eschenbach as one of the 100 people 
who shape our world.
  The FDA is fortunate to have Dr. von Eschenbach. It is one of the 
Nation's oldest and most respected consumer protection agencies. It 
regulates $1 trillion worth of products available to American 
consumers, and it makes sure the products are safe and effective.
  Dr. Von Eschenbach is the right person to lead the FDA's mission. I 
completely trust him. I cannot think of a more qualified candidate. I 
hope we will put politics aside in this very important nomination and 
we will confirm this very qualified individual. He is balanced. He has 
good judgment. He will continue to be a cancer advocate as well as a 
patient advocate.
  He knows, also, from the FDA standpoint, of the issues involved with 
the drug approval process--that products face extensive testing and 
studies compared to other countries. I have talked to him about this. 
Of course, their first and foremost responsibility is safety. That is 
why they have this arduous and comprehensive process of approving 
drugs.
  On the other hand, he also knows you need to make drugs available for 
patients who otherwise may not survive. He realizes these concerns from 
every angle. He knows it from the research angle, from the academic 
angle, from the Government angle, and from the patient advocate angle.
  It would be a tragedy if we did not give him the full authority and 
the full congressional confirmation he deserves. He deserves it because 
he left the private sector at a world renowned cancer research 
institution to serve his country and the responsibility it takes in a 
high public policy position.
  Sometimes I wonder how we attract such qualified academics and people 
who are not experienced in this arena. They are not used to the 
compromise of politics. They have been researchers and in academia all 
their lives. They come into public service and all of a sudden they are 
hit with the public exposure and scrutiny. Sometimes they are unfairly 
characterized in a way they never dreamed.
  Yet we have someone of the caliber of Andy von Eschenbach willing to 
take all of that to do something better for our country and for cancer 
patients in the country and in the world. We owe him the ability to 
have this position without any further delay, with the complete 
imprimatur of the Senate as well as the President of the United States. 
He deserves it.
  I hope our colleagues will look at this, not from a political prism 
but from the standpoint of a qualified individual who is trying to help 
medical research and safety in this country go forward, who is a 
patient advocate, first and foremost.
  I thank Senator Enzi and Senator Kennedy for working together to 
bring this nomination to the Senate. We should have a bipartisan vote 
in confirming Dr. Andrew von Eschenbach.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Louisiana.
  Mr. VITTER. Madam President, I rise today to speak against the 
cloture motion to confirm Dr. Andrew von Eschenbach as Commissioner of 
the FDA. I have had a public hold on this nomination and have been very 
upfront about it. Because my serious concerns have not been addressed 
in any significant way, I will vote against cloture. If cloture is 
invoked, I will vote against the nomination.
  In doing so, I want to be clear I have nothing against Dr. Von 
Eschenbach's technical credentials or professional experience. They are 
very impressive in many ways. I strongly object to this nomination 
because the FDA and Dr. Von Eschenbach, acting on orders from the 
administration, has had a complete and utter lack of action creating a 
reasonable, safe system for reimportation of prescription drugs from 
Canada and elsewhere.
  Clearly, this nomination making him the permanent head of the FDA 
will only further delay that reasonable implementation of a good, safe 
reimportation policy. In fact, at my extensive meeting with Dr. Von 
Eschenbach, my discussion with him made that perfectly clear. I give 
him credit, I suppose, for being very direct about that, although I am 
not sure he fully understood my serious interest in reimportation. It 
is for this reason I will vote against cloture. If cloture is invoked, 
I will vote against the nomination.

[[Page S11408]]

  The FDA is completely capable of setting up a reimportation system, 
one that is safe and effective. The FDA can do this. It is not a matter 
of technical ability. We have great technical and other resources in 
this country. It is a matter of political will. At any time, the FDA 
could act and set up this safe and reasonable system.

  My hold on this nomination, as I said, was very public, upfront, and 
clear. I made it clear I would lift it, contingent on a very simple 
request to implement some sort of prescription drug reimportation 
plan--perhaps beginning with personal reimportation from Canada, 
including Internet and mail order sales. The FDA could do this. It is 
fully capable of doing this. It has the know-how to do this. It simply 
will not because of lack of political will.
  The need for this is very obvious to me. Every time I talk to 
consumers in Louisiana, particularly seniors, it becomes more and more 
obvious. As obvious and as important is the growing support for this--
not just out in the country where that support has always been strong 
but in the Congress, in the Senate, in the House.
  The House passed comprehensive drug reimportation language in 2003. 
It passed it by an overwhelming majority. More recently, the Senate 
passed my amendment coauthored by Senator Bill Nelson of Florida by a 
vote of 68 to 32. That was this past July. That was a significant 
breakthrough because it was the first time we had a meaningful, 
straight up-or-down vote on a reimportation issue in the Senate. Again, 
the vote was clear. It was overwhelming. That important amendment 
passed 68 to 32.
  All this shows that the majority of Americans strongly support 
allowing all Americans to purchase safe, cheaper prescription drugs 
from Canada and elsewhere. Yet the administration absolutely refuses to 
budge. Not only does the administration refuse to budge, it even went 
so far as to quietly implement a new policy last year at U.S. Customs 
and Border Protection to go after individual American citizens crossing 
back into the United States from other countries--mostly Canada--with 
medicine, actually seizing their packages containing legal medication 
at those border checkpoints. That is a very high-handed policy, when 
these citizens are doing nothing but trying to get absolutely necessary 
prescription drugs at a reasonable cost.
  Coupled with the FDA and the administration's stubborn reluctance to 
implement even the most modern program, this has led me to conclude 
that no change would be made with the confirmation of this nominee.
  Again, this is an issue of utmost importance to every American family 
and, of course, it particularly impacts seniors. I talk to affected 
families and affected seniors in Louisiana about this all the time. 
They tell me, at a time when pharmaceutical companies are making record 
profits, the costs of prescription drugs are still skyrocketing and the 
very same medicines usually manufactured by the very same companies are 
sold at a fraction of the costs a few miles north of the border in 
Canada or in other countries around the world. Louisianians see that 
and they are very skeptical. They should be. I share that attitude. I 
share that skepticism.
  Opposing the right of an American to buy prescription drugs, FDA-
approved medication they intend to use for themselves, is a wrong 
policy. We pay the highest prices in the world for prescription drugs 
in America. Our prices subsidize not only rockbottom prices in almost 
every other country but also sky-high and escalating profits of the 
pharmaceutical companies. That is not fair. That should not be allowed 
to continue. That is why we need to pass this important policy of 
reimportation.
  Many of my colleagues have spoken about this significant issue in the 
Senate.
  In September, my colleague from Michigan spoke of her bus trips with 
her constituents to Canada where they were able to buy safe, FDA-
approved drugs at a fraction of the U.S. cost: Lipitor, a very 
important cholesterol-lowering drug, for 40 percent less; Prevacid, an 
ulcer medication, for 50 percent less; antidepression medications such 
as Zyprexa for 70 percent less.
  In June, my colleague from North Dakota spoke eloquently about the 
need to allow the reimportation of safe drugs as a way to pressure U.S. 
pharmaceutical companies to lower prices here. That is the key, not 
just offering this option of cheaper drugs from another source but 
breaking up the present system that allows companies to charge 
dramatically different prices for the same drug around the world. And, 
of course, the highest prices in the world by far are right here in the 
United States. That system will not be able to withstand reimportation. 
That system will fall with reimportation.
  So that is why I continue this fight. That is why it is so important. 
Although certainly this nominee may very well be confirmed by the 
Senate today, I am very optimistic that, as we make progress on this 
issue, we march to a very certain victory, probably next year, on the 
issue.
  Again, we have been making steady progress. My amendment this past 
summer--the first vote on the floor of the Senate--was a breakthrough 
vote that showed overwhelming support here on the floor of the Senate 
for reimportation. Previous House votes, similarly, showed not just 
majority support, overwhelming support for this change in policy. Just 
recently, I again joined with Senator Bill Nelson of Florida to put up 
another important amendment to the Agriculture appropriations bill that 
would go a step further. We will continue to pursue that. Then, next 
year, I fully expect a full-blown reimportation plan to be here on the 
floor of the Senate for a full debate and a fair vote.
  So as I oppose cloture, as I oppose this nomination, I do so in that 
spirit and with real optimism that we are not only making progress, but 
we will, in fact, win on this issue in the near future. Next year, I 
expect my bill to be fully debated. In this Congress, that bill is S. 
109, the Pharmaceutical Market Access Act. I believe it will reach the 
floor and will get a full debate with other significant bills on the 
issue next year.
  I look forward to that continued progress. I look forward to that 
ultimate victory because Americans, particularly seniors, all across 
our country, including in Louisiana, need this very important relief. 
We can give them this relief in a safe, reliable way to dramatically 
bring down prescription drug prices.
  With that, I yield back the floor.
  The PRESIDING OFFICER (Mr. Thomas). The Senator from Wyoming.
  Mr. ENZI. Mr. President, I wish to acknowledge the intense, 
enthusiastic, and persistent work of the Senator from Louisiana, Mr. 
Vitter, for drug importation. I do not know that I have seen anybody 
lead as much on an issue or work as hard on an issue. Around here, that 
is a talent which is very much appreciated.
  I do want to mention that, again, Dr. Von Eschenbach has not been 
confirmed, so he does not have full authority to run the Department or 
to do what he would like to do or might need to do. He has to rely on 
the advice of other people, particularly until he is confirmed. After 
that, even then, he will have to abide by the laws.
  I would point out that drug importation is illegal right now, and it 
is Congress, not the FDA, that has determined that. So until we change 
the law, until we do some or all of the things the Senator from 
Louisiana is suggesting, Dr. Von Eschenbach would really be stepping 
out of bounds to do drug importation. So I hope we do not hold that 
against him or hold up his nomination for that reason. We should hold 
him accountable for what is within his control, but urge him to work 
with Congress.
  I have had dozens of meetings with him on a variety of issues, as 
Senators have brought them up. Most of them have been resolved. Those 
within the law, those the Department of Justice has not contested, have 
been resolved.
  Mr. VITTER. Will the Senator yield very briefly?
  Mr. ENZI. Yes.
  Mr. VITTER. Just very briefly, first of all, I appreciate your kind 
comments. Very briefly, my comments regarding his and FDA's ability to 
move forward on this is based on current law, including the Medicare 
Modernization Act, which says that if they institute a safety regime 
and certify the safety of these drugs, they can, in fact, move forward 
with the reimportation regime.

[[Page S11409]]

So under present law, that is possible, and that is what I was 
referring to. But I respect the Senator's point of view.

  Mr. ENZI. I appreciate that comment. If you were a person who was in 
a catch-22 position, a very qualified doctor, and you really wanted to 
do a good job with FDA and you knew that half the people or a third of 
the people or even 10 percent of the people did not want drug 
importation and you were the guy in charge of maybe making this 
determination for the first time--even though 6 or 8 years previously 
Congress had opposite opinions on it--I do not think you would want to 
put yourself in that position.
  He has just had a number of catch-22 positions where he can irritate 
half or more of us by making a decision, and nobody is going to make a 
decision in their confirmation process that way.
  It is actually the Health and Human Services Secretary who has to 
certify under the new law as well.
  So I hope we can get him confirmed and then do the kind of oversight 
we need to do to make sure he does everything that is possible to make 
sure we have safe food and drugs.
  Mr. President, I yield up to 10 minutes to the Senator from Utah.
  The PRESIDING OFFICER. The Senator from Utah.
  Mr. BENNETT. Mr. President, I did not plan to talk about drug 
reimportation, but coming on the heels of this conversation, I simply 
want to make this one observation: The key statement made by the 
Senator from Louisiana was safe drug reimportation. And the key problem 
here is certifying that the drugs coming across the border--after they 
have been sent and then are reimported are, in fact, the same drugs, 
they are, in fact, safe.
  The Congress has said the drugs can be reimported back into the 
United States as soon as the Secretary can certify that they are, in 
fact, safe. I have seen the sample runs, if you will, that have been 
made on this issue. They have found again and again that a certain 
percentage of the drugs coming back are, in fact, not drugs 
manufactured in the United States. They have been manufactured 
elsewhere, packaged in Canada or Mexico or wherever, and then sent back 
to the United States fraudulently, as if they were, in fact, the 
original drugs.
  Now, they have not yet killed anybody that I know of. They are not so 
unsafe that they have, in fact, poisoned anybody. Overwhelmingly, the 
history has been that the dosage in the drugs is simply not the same as 
advertised in the drugs manufactured in the United States. They have 
traces of whatever the drug might be in the fraudulent packages, but 
the dose control is not the same, and it is dangerous to the individual 
taking the drug if he or she assumes they are getting a certain dosage 
and, in fact, they are getting less.
  That has been the challenge. That has been the problem. And until the 
Secretary of HHS, be it Donna Shalala or Michael Leavitt, can come 
forward and certify that all of these are, in fact, as advertised, it 
is the law that they cannot be brought into the United States. I think 
that is an appropriate law protecting people in the United States.
  I agree with the Senator from Wyoming that it really is not 
appropriate to hold up Dr. Von Eschenbach's confirmation on this issue 
because it has to be decided by the scientists and those who are doing 
the sampling of the shipments rather than the head of the FDA.
  I have gotten to know Dr. Von Eschenbach as the chairman of the 
Agriculture Appropriations Subcommittee. You usually think of 
agricultural appropriations in terms of crop supports and USDA 
activities. But for whatever reason, in its wisdom, Congress at one 
point put jurisdiction over the Food and Drug Administration into that 
subcommittee. So, if you will, I have been in the position of dealing 
with this man as he has come begging.
  As we are in the Appropriations subcommittees, everybody who has 
responsibility over which we have control comes begging; that is, they 
come asking for things, they come outlining their position, and they 
come describing what they will do with the money. All of us who have 
been on the Appropriations Committee have had this experience with a 
wide variety of people from the executive branch. I have never seen 
anyone who has come before our subcommittee better prepared, with a 
better understanding of how the money will be spent, and with more 
vision as to where the money ought to be spent to take the agency into 
the future than Dr. Von Eschenbach.
  We have not just sat and discussed budget issues; we have not just 
sat and talked about dollars and cents--what are you going to spend 
here and what are you going to spend there--he has outlined for me in 
our conversations where he thinks the FDA of the future ought to be and 
what it will cost to get it there.
  I have been very struck and impressed by his vision for the FDA. This 
is not a man who is content to simply superintend what he has on his 
plate. This is a man who has the capacity to look to the horizon, and 
maybe even over the horizon, to see where America ought to be.
  In the practice of medicine right now, drug therapy is the cutting 
edge. Yes, we are developing new operations. We are developing new 
surgical procedures to try to push the envelope out further as far as 
health care is concerned. But the major breakthroughs are coming 
through drug therapy. There are all kinds of situations now where it 
can be handled with drug therapy that obviates the need for an 
operation or any kind of surgical intrusion. The implications of that 
are huge, and the role of the FDA in that kind of medical revolution of 
the future is paramount. We absolutely have to have at the head of the 
FDA, in that kind of revolution, a man who is visionary, a man who 
looks to the future, and a man who understands the potential that lies 
in the area which he superintends.
  Dr. Von Eschenbach, I am convinced, is such a man. I have his resume. 
We have heard it outlined here. It is an outstanding resume. But people 
with good resumes can come before us all the time and, in fact, have no 
vision. They spend their time tending what is on their own plate. This 
is a man with vision. This is a man who sees what can happen and who 
desperately wants to take the FDA in that direction.
  He said to me: Senator, I don't feel that I can institute these kinds 
of long-term changes as long as I am acting. I feel--I think 
appropriately, from my point of view--that I cannot make these kinds of 
structural changes in FDA's mission and direction until I have the 
imprimatur of the U.S. Senate and full confirmation.
  The longer we hold up his nomination, the longer we keep him from 
being confirmed, the longer we will wait for that kind of vision to be 
established in that agency. I think we have waited too long. I salute 
the majority leader for his persistence in bringing this nomination to 
the floor. At this time, with all the other things we have to do before 
this Congress comes to an end, this is one he could easily have put 
off. I am grateful that he did not. I am grateful that he filed a 
cloture motion to hold our feet to the fire on this one and say: It is 
time for us to act. It is time for us to give this man the imprimatur 
of our confirmation vote so he can move forward, he can infuse the 
agency with the kind of vision and excitement that I know he has.
  I have spent enough time with him, I have had enough conversation 
with him--have talked to his peers outside of the agency to know that 
the President has made an outstanding choice in Dr. Von Eschenbach. We 
as a country would be well served to have him in this place, and I urge 
the Senate to invoke cloture and confirm this nomination as quickly as 
we possibly can.
  Mr. HATCH. Mr. President, to me it is simply unconscionable that the 
Food and Drug Administration, one of the best little agencies in 
Government, has gone leaderless for such a period of time.
  Here we have an agency that governs, by some estimates, 25 cents out 
of every consumer dollar, and yet we treat it as a stepchild. We do not 
provide it with the funding it needs. We allow it to exist without a 
confirmed commissioner for months and months on end, for repeated 
periods. And yet we expect it to be the vital consumer watchdog agency 
it was intended to be.
  When you think about what this agency does, what the daily business 
of the FDA is, you can see how dire the situation really is.
  This is an agency that makes certain the drugs and medical devices we 
use

[[Page S11410]]

are safe and effective, that the cosmetics, dietary supplements, and 
over-the-counter medications we count on are sold safely, with truthful 
and nonmisleading claims. This agency regulates animal drugs and 
radiological devices and so much more. Yet, time after time, it does 
without a confirmed commissioner. And this is the absolutely wrong time 
for that to happen.
  Think about the key FDA issues we are facing: the safety of the food 
supply, how to improve drug safety, instituting a new system of 
mandatory adverse event reporting for serious events associated with 
the use of dietary supplements and nonprescription drugs, extending the 
user fee programs for drugs and devices, and the incentives for 
pediatric drug testing--and I have named only a few of the issues. We 
are facing all these pressing public policy issues, and yet we expect 
the agency to do its job without a confirmed commissioner. That is not 
right. It is simply not right.
  The President has nominated a well-qualified, more-than-capable 
medical doctor to the position of Commissioner of Food and Drugs.
  I know Dr. Von Eschenbach well. He is a man of integrity. He is a 
good manager. He is a good listener. He knows the importance of working 
well with Congress, and I believe he will work well with us.
  I urge my colleagues--no, I implore my colleagues--to do what is 
right and vote to invoke cloture on this nomination. It is what Dr. Von 
Eschenbach deserves. It is what the agency deserves. And it is what the 
American people deserve.
  The PRESIDING OFFICER. The Senator from Wyoming.
  Mr. ENZI. Mr. President, I thank the Senator from Utah for his 
delightful comments. He speaks so clearly and explains things so well. 
I know of his contacts with Dr. Von Eschenbach. I hope people will 
follow his advice and vote for cloture.
  Dr. Von Eschenbach's qualifications are excellent. He is supported by 
many organizations. We had received a number of letters in support of 
his nomination prior to his confirmation hearing. Those were duly 
entered in the hearing record. However, since then we have received 
additional letters of support.
  I ask unanimous consent that those letters be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                                       Omeris,

                                     Columbus, OH, August 2, 2006.
       Hon. Michael B. Enzi,
     Chairman, Committee on Health, Education, Labor and Pensions, 
         Dirksen Senate Office Building, Washington, DC.
     Hon. Edward M. Kennedy,
     Ranking Member, Committee on Health, Education, Labor and 
         Pensions, Russell Senate Office Building, Washington, DC.
       Dear Chairman Enzi: On behalf of Omeris, Ohio's bioscience 
     membership and development organization, and our member 
     companies, I am writing in support of the nomination of Dr. 
     Andrew von Eschenbach to be Commissioner of the Food and Drug 
     Administration.
       Dr. von Eschenbach is an excellent choice to head the FDA. 
     He has an outstanding career as a physician, researcher, and 
     administrator in both the public and the private sectors. As 
     a physician, he has treated cancer patients for almost thirty 
     years. As a researcher, he has published more than 200 
     articles and books and was the founding director of M.D. 
     Anderson's Prostate Cancer Research Program. As an 
     administrator, he has served as the president-elect to the 
     American Cancer Society.
       It is critically important to our industry and to the 
     nation that the position of the FDA Commissioner be filled. 
     Strong leadership is essential if the FDA is to most 
     effectively fulfill its mission of assuring the food 
     Americans eat is safe and healthful, that the drugs they take 
     are safe and effective, and that the medical devices they 
     rely on for cures and treatment are safe and effective and 
     represent the latest and best that our industry can offer. 
     Experience has shown that a permanent director continued by 
     the Senate is necessary to assure that the agency has the 
     authoritative leadcrship it needs to respond promptly and 
     effectively to all the challenges it faces.
       Prompt confirmation of Dr. von Eschenbach is especially 
     important in view of the issues that are currently facing the 
     FDA. Next year, both the medical device and drug user fee 
     programs must be renewed by Congress, and the agreements 
     between industry and the FDA that will be the starting point 
     for the reauthorization are being negotiated right now. The 
     critical path initiative, which offers so much potential for 
     speeding the development and approval of safe and effective 
     products) is just getting off the ground and needs a strong 
     advocate. The challenge of determining how FDA can most 
     effectively conduct postmarket surveillance to assure the 
     safety and effectiveness of approved products is an issue 
     that needs strong leadership from the top. The continuing 
     challenges of food safety and preparation for a pandemic or 
     bioterrorist attack need a strong FDA voice.
       Omeris members, Ohio's bioscience companies, help 
     revitalize our state's economy while developing critical 
     tools, treatments, and technologies that benefit the world. 
     Omeris is a focal point for the bioscience and biotechnology 
     community, providing networking and educational events, 
     continually developing web-based resources, addressing public 
     policy, and analyzing resource and funding issues.
       We respectfully urge you to support Dr. von Eschenbach's 
     prompt confirmation. Thank you for considering this request.
           Sincerely,
                                                Anthony J. Dennis,
     President & CEO.
                                  ____

                                                    New York State


                            Cancer Programs Association, Inc.,

                                      Buffalo, NY, August 3, 2006.
     To: Senate Health, Education, Labor and Pensions Committee.
     From: Dr. Edwin A. Mirand, Secretary-Treasurer, NYSCPA.
     Subject: Nomination of Dr. Andrew von Eschenbach as Permanent 
         Commissioner of Food and Drug Administration.
       The New York State Cancer Program Association, Inc. 
     supports the nomination by President Bush as permanent 
     Commissioner of Food and Drug Administration (FDA) Dr. Andrew 
     von Eschenbach.
       Dr. von Eschenbach's experience as a researcher and 
     physician will provide the FDA with a better focus to 
     confront the challenges and new opportunities facing the 
     agency. Dr. von Eschenbach will lead the agency and 
     strengthen the credibility of its decision-making process.
                                                  Edwin A. Mirand,
     Secretary.
                                  ____

                                           The Amyotrophic Lateral


                                        Sclerosis Association,

                                    Washington, DC, July 24, 2006.
     Hon. Michael Enzi,
     Chairman, Health, Education, Labor and Pensions Committee, 
         U.S. Senate, Washington, DC.
     Hon. Edward Kennedy,
     Ranking Member, Health, Education, Labor and Pensions 
         Committee, U.S. Senate, Washington, DC.
       Dear Chairman Enzi and Ranking Member Kennedy: The ALS 
     Association strongly supports the nomination of Andrew von 
     Eschenbach, M.D., to be Commissioner of the Food and Drug 
     Administration and we urge the Committee to favorably report 
     the nomination to the full Senate.
       The ALS Association is the only national voluntary health 
     association dedicated solely to the fight against Amyotrophic 
     Lateral Sclerosis (ALS), more commonly known as Lou Gehrig's 
     disease. Our mission is to improve the quality of life for 
     those living with ALS and to discover a treatment and cure 
     for this deadly disease.
       We believe that strong leadership at the FDA is essential 
     so that the Agency can fulfill its mission and not only 
     ensure that drugs and medical devices are safe and effective, 
     but also that people have timely access to the latest medical 
     technologies. This is especially important for people with 
     ALS, for there is no known cause or cure for ALS, and only 
     one drug available to treat the disease. That drug, approved 
     by the FDA in 1995, provides only modest benefits, prolonging 
     life by just a few months.
       Dr. von Eschenbach would provide the vital leadership that 
     is needed at the FDA. Moreover, his diverse background as a 
     physician, educator and advocate will be a tremendous asset 
     to the Agency and to the Nation, for he can view the Agency's 
     mission from many different perspectives and help to foster 
     the collaboration that is so important to advancing medical 
     science and quality health care.
       The ALS Association is pleased to offer our strong support 
     for this nomination and again urge the Committee and the 
     Senate to support Dr. von Eschenbach as the next Commissioner 
     of the Food and Drug Administration.
           Sincerely,

                                                 Steve Gibson,

                                                   Vice President,
     Government Relations and Public Affairs.
                                  ____



                                        Cancer Cure Coalition,

                          Palm Beach Gardens, FL, August 25, 2006.
     Senator Michael B. Enzi,
     Chairman, U.S. Senate Committee on Health, Education, Labor 
         and Pensions, Washington, DC.
       Dear Senator Enzi: The Cancer Cure Coalition is supporting 
     the nomination of Dr. Andrew VonEschenbach as commissioner of 
     the U.S. Food and Drug Administration and we have today 
     issued a press release announcing our support. Attached is a 
     letter from the coalition to Dr. VonEschenbach which gives 
     the reasons for our support.
       The Cancer Cure Coalition supports

     changes at the FDA which will improve

     its operation. We believe the appointment

     of Dr. VonEschenbach will lead to that

     result. If it would help your committee in

     its decision on Dr. VonEschenbach's appoint-

     ment I would be pleased to appear before

     the committee to testify. My bio appears

     on the Cancer Cure Coalition's website


[[Page S11411]]

     www.cancercurecoalition.org and I am attaching a copy of it 
     for you to review.
       If you need any further information please feel free to 
     contact me.
           Sincerely,
                                              Charles A. Reinwald,
                                                        President.

  Mr. ENZI. Those letters are from Omeris, Ohio's bioscience membership 
and development organization; the New York State Cancer Association; 
the ALS Association; the Cancer Cure Coalition, and there are others. 
These groups recognize the absolute necessity of having a Senate-
confirmed Commissioner of Food and Drugs. I understand some of my 
colleagues are not satisfied. They seek to use this nomination as 
leverage to accomplish some other agendas. That is something you can do 
in the Senate. However, I urge them to consider the consequences of 
those actions. In the upcoming year we face an exceptionally full 
agenda with respect to the FDA. We need this man in place. This man 
could work anywhere in America, probably anywhere in the world, and do 
much better than what we are offering.
  I appreciate his sense of wanting to give back. He is a three-time 
cancer survivor and understands a lot about food and drugs outside of 
being a doctor.
  I ask my colleagues to join me in getting cloture so that we can get 
the confirmation accomplished.
  I yield back the remainder of our time.
  The PRESIDING OFFICER. Who seeks time?
  Mr. ENZI. It is my understanding that the previous speakers did yield 
their time back. So all time is yielded back.