[Congressional Record Volume 152, Number 134 (Thursday, December 7, 2006)]
[Senate]
[Pages S11411-S11414]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                             Cloture Motion

  The PRESIDING OFFICER. If all time is yielded back, under the 
previous order, pursuant to rule XXII, the clerk will report the motion 
to invoke cloture.
  The assistant 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, 
     do hereby move to bring to a close debate on Executive 
     Calendar No. 907, the nomination of Andrew von Eschenbach, of 
     Texas, to be Commissioner of Food and Drugs, Department of 
     Health and Human Services.
         William H. Frist, Michael B. Enzi, Richard Burr, Thad 
           Cochran, George V. Voinovich, Robert F. Bennett, Tom 
           Coburn, Norm Coleman, Conrad R. Burns, Jon Kyl, Pat 
           Roberts, Mel Martinez, John Ensign, Lamar Alexander, 
           Elizabeth Dole, Christopher Bond, John Cornyn.

  The PRESIDING OFFICER. By unanimous consent, the mandatory quorum 
call has been waived.
  The question is, Is it the sense of the Senate that debate on 
Executive Calendar No. 907, the nomination of an Andrew von Eschenbach, 
of Texas, to be Commissioner of Food and Drugs, Department of Health 
and Human Services, shall be brought to a close?
  The yeas and nays are mandatory under the rule.
  The clerk will call the roll.
  The assistant legislative clerk called the roll.
  Mr. McCONNELL. The following Senators were necessarily absent: the 
Senator from Utah (Mr. Hatch) and the Senator from Alabama (Mr. 
Shelby).
  Mr. DURBIN. I announce that the Senator from Delaware (Mr. Biden), 
the Senator from Vermont (Mr. Jeffords), and the Senator from 
Massachusetts (Mr. Kennedy) are necessarily absent.
  I further announce that, if present and voting, the Senator from 
Massachusetts (Mr. Kennedy) would vote ``yea.''
  The PRESIDING OFFICER (Mr. Ensign). Are there any other Senators in 
the Chamber desiring to vote?
  The yeas and nays resulted--yeas 89, nays 6, as follows:

                      [Rollcall Vote No. 273 Ex.]

                                YEAS--89

     Akaka
     Alexander
     Allard
     Allen
     Bayh
     Bennett
     Bingaman
     Bond
     Boxer
     Brownback
     Bunning
     Burns
     Burr
     Byrd
     Cantwell
     Carper
     Chafee
     Chambliss
     Clinton
     Coburn
     Cochran
     Coleman
     Collins
     Conrad
     Cornyn
     Craig
     Crapo
     Dayton
     DeMint
     Dodd
     Dole
     Domenici
     Dorgan
     Durbin
     Ensign
     Enzi
     Feingold
     Feinstein
     Frist
     Graham
     Gregg
     Hagel
     Harkin
     Hutchison
     Inhofe
     Inouye
     Isakson
     Johnson
     Kerry
     Kohl
     Kyl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lincoln
     Lott
     Lugar
     Martinez
     McCain
     McConnell
     Menendez
     Mikulski
     Murkowski
     Murray
     Nelson (FL)
     Nelson (NE)
     Obama
     Pryor
     Reed
     Reid
     Roberts
     Rockefeller
     Salazar
     Sarbanes
     Schumer
     Sessions
     Smith
     Snowe
     Specter
     Stabenow
     Stevens
     Sununu
     Talent
     Thomas
     Thune
     Warner
     Wyden

                                NAYS--6

     Baucus
     DeWine
     Grassley
     Santorum
     Vitter
     Voinovich

                             NOT VOTING--5

     Biden
     Hatch
     Jeffords
     Kennedy
     Shelby
  The PRESIDING OFFICER. On this vote, the yeas are 89, the nays are 6. 
Three-fifths of the Senators duly chosen and sworn having voted in the 
affirmative, the motion is agreed to.
  Mr. ENZI. Mr. President, I thank the Chamber for allowing us to do 
the cloture vote. With the strong support shown by the cloture vote, I 
would highly recommend that we get this man confirmed so he can 
actually have the opportunity to do the kinds of things that have been 
expected of him in the debate we have had. I also thank Senator Kennedy 
for his tremendous help. We have had a number of meetings, a number of 
hearings. This is the second confirmation of an FDA Director we have 
worked on. It will be nice to have somebody actually in the position, 
but I do thank Senator Kennedy and all of his staff.
  I do want to mention the staff person who has directed my health 
issues. Stephen Northrup is on the floor, and I thank him particularly 
for all of the work on all of the health issues we have had. Anybody 
who has looked at the list of those we have done will find it has been 
a very productive session in the health area, and we are still working 
on another half dozen issues that could pass yet in this session before 
the week ends. So I thank Stephen for all of his tremendous help. I ask 
that people support the nomination of Dr. Von Eschenbach.
  Mr. President, I yield the floor.
  The PRESIDING OFFICER. The Senator from Iowa is recognized.
  Mr. GRASSLEY. Mr. President, I spoke earlier this morning against 
cloture. Cloture passed, which for the public listening means there are 
60 percent or more in support of stopping debate, and there is under 
the rules the possibility of 30 hours of debate. I don't intend to 
probably speak for more than a half hour, so if anybody is interested 
in how long postcloture debate might go on, it won't go on very long 
from my point of view. But I do want to take some time to tell people, 
even though it is quite obvious this nominee will be approved, why I 
think he should not be approved.
  I placed a hold on this nominee for quite a few weeks. That hold 
obviously was ignored by the leader when he filed cloture, which is his 
right to do. I voted against cloture because I take my constitutional 
duty to conduct oversight of the executive branch of Government very 
seriously, and I think the nominee is standing in the way of Congress 
doing its oversight of the agency of which he is now Acting Director 
and will probably soon be the confirmed Director. That sort of lack of 
cooperation violates the separation of powers and the checks and 
balances within our constitutional system.
  I hope my colleagues know that I take a great deal of time to make 
sure that we do both jobs we have the responsibility to do here in the 
Congress. One is to pass laws. But the one we are never taught much 
about in political science classes is the constitutional job of 
oversight, which is the responsibility to make sure the laws are 
faithfully executed and money is being spent according to congressional 
intent, and the overseeing of the administrative branch of Government. 
So I take a great deal of my time in the Senate trying to make 
Government work not just by passing laws but by making sure they are 
faithfully executed. I don't do that all by myself as a single Senator. 
I have good staff. I charge my staff to conduct oversight rigorously 
and to investigate any areas where the Federal Government is failing to 
be transparent, accountable, and effective. Transparency is so 
important, because the public's business, which is everything about the 
Federal Government, ought to be public. If the work of the executive 
branch fails the

[[Page S11412]]

sniff test and the law is not being faithfully executed or the public's 
business is not being made public, that is when it is my constitutional 
responsibility to blow the whistle.
  Quite frankly, I don't want to take credit for what I am able to blow 
the whistle on, because there are a lot of good, patriotic employees in 
the executive branch of Government who also know it is their 
constitutional responsibility to execute the laws and spend the money 
right. When they see it isn't happening, and particularly when they go 
up the chain of command and don't get results, or when taxpayers monies 
are being wasted and it seems nobody cares, then they exercise the 
right they have under laws to blow the whistle to Members of Congress.
  So we obviously count on whistleblowers--in other words, patriotic 
Federal employees--who report something wrong when people above them 
don't care. They care enough to come to us and give us a lot of good 
information. So today I am blowing the whistle on this nominee. In good 
conscience, I did put a hold on the nominee, and I will not vote in 
favor of him for the reasons I have given before and reasons that will 
be more spelled out now. A vote for this nominee would be an 
endorsement of the stonewalling, but, more importantly, the disrespect 
for Congress he has shown by not cooperating with congressional 
oversight. I can say this not only because of his actions but because 
of his words which are on the record.
  In response to a nomination question in which I asked this nominee if 
he would cooperate with congressional oversight, Dr. Von Eschenbach 
identified a number of ``executive branch interests'' as a basis for 
not complying with congressional requests, including ``matters pending 
before the agency.'' And ``predecisional deliberative process 
information,'' and ``open investigation information.'' You get this 
sort of gobbledegook as excuses for not giving information to Congress 
as they promised to do but, outside of that, that the Constitution 
requires they do; that is if you believe in the checks and balances of 
our Government and if you believe it is backed up by Supreme Court 
decisions. It seems to me it has a good basis.
  This nominee was not well-served by whoever counseled him on these 
matters. He should know that during my years in the Senate, my 
investigators have obtained access to every single one of these 
categories of so-called confidential information. I would say to the 
distinguished chairman of the HELP Committee who is watching over this 
nomination process--confirmation process--he said to me before the vote 
on cloture it would help if we got Dr. Von Eschenbach approved because 
now he is an acting and maybe he can't do all the things that he can do 
as Director, and that may be true. But not once in my discussions or my 
staffs' discussions with people at FDA was there ever a hint from the 
nominee himself that once approved, he would be able to give us all of 
these documents. I use this chart as an example: You get an answer to a 
request and you get 57 pages removed. Another chart I had up here 
showed 43 pages were removed. And what is in those pages? Who knows 
what is in them. We don't even know why they were removed, and we don't 
know who made the decision to remove them.

  That is cooperation with Congress? Not once, I say to Senator Enzi, 
did he ever tell me or my staff or people who are working for him that 
if we could get this confirmation over, we will be able to satisfy what 
you want done. So I don't see anything better, with a vote of approval 
by the Senate, of cooperation with us than before.
  But he wasn't well-served by those who counseled him. He should know 
that during my years in the Senate, my investigators have obtained 
access to every single one of these categories of so-called 
confidential information. His answer is at odds with my belief that 
congressional oversight is one of the best ways to shake things up at a 
government agency and expose the truth. The truth will make Government 
look better, or if the truth doesn't make Government look better, at 
least you are being candid with the American people. Besides, it is the 
public's business, and whether it is good news or bad news, it ought to 
be public.
  Dr. Von Eschenbach's answers happen to be at odds with my belief that 
congressional oversight is one of the best ways to get to the bottom of 
things. This is true not just of the FDA; it is true of any Government 
agency. If an agency is not doing the right thing, typically behind it 
there is an effort to keep information suppressed, an effort to keep 
people from doing what they think ought to be done, an effort to keep 
people from doing what their job requires them to do, or to not let 
them put out that information. The muzzling of dissent and information 
is too common throughout our Government. Things that should be 
transparent in Government simply are not. And under Dr. Von Eschenbach, 
the FDA has not only avoided transparency, it also has threatened those 
who are trying to desperately expose the truth.

  That is not just under Dr. Von Eschenbach. For years before him, 
there has been intense pressure brought to bear upon scientists who 
want to do the scientific process. I say ``do the scientific process'' 
because the scientific process answers itself or gives the answer. That 
is what we want: answers on safety and efficacy of drugs.
  There is a culture there--even prior to Dr. Von Eschenbach, for any 
serious Director who wants to change it--that is going to make it very 
difficult to change because you have an agency that is more interested 
in its public relations and how they look to the public-at-large than 
what their job is. That is when they end up getting egg on their face, 
when they are more concerned about their public relations than just 
doing the job. In most instances, if these agencies do what they are 
supposed to do, things get done and get done effectively, and then the 
public relations takes care of itself. Good policy, good administering 
of law, is good public relations. It will take care of itself.
  I met with this nominee after the White House sent his nomination to 
the Senate last March. I hoped he would provide the kind of strong, 
permanent leadership this agency needs to change its culture, where 
scientists are intimidated from doing their work. Over the next 9 
months, this nominee showed me that he is unlikely to provide that kind 
of leadership. My belief is what you see is what you get. I fear what 
we will get from this nominee is what we got from him where he is now 
as the Acting Commissioner. Let me tell you why, with just a few 
examples.
  First, the doctor failed to live up to his word. In our meeting, he 
said he respected and understood the important role Congress plays as 
an equal branch of Government. But it didn't take long after that 
meeting before the first red flags appeared.
  In April, the committee began its investigation of the Food and Drug 
Administrations's approval and postmarket surveillance of the Ketek 
drug, an antibiotic that came under renewed scrutiny last January. It 
looks as though it is another drug where the FDA was caught flatfooted. 
The Finance Committee issued two subpoenas in May after the FDA refused 
to provide documents related to Ketek. I referred to a family in Cedar 
Rapids, IA, who lost an 18-year-old son.
  During this time, the Food and Drug Administration also refused 
access to Food and Drug Administration officials. The Finance Committee 
was forced to issue a subpoena to a special agent in the FDA's Office 
of Criminal Investigation. The FDA refused to allow my staff to speak 
to this Federal employee, citing a policy against providing access to 
line agents. Yet, only months before, just a few weeks before that, my 
staff interviewed two line agents from the Food and Drug Administration 
on another case. What rule was in place when I interviewed them, but a 
few weeks later you couldn't interview another? Apparently, the policy 
was abruptly changed. I have seen it change over the years with other 
investigations. This policy is not law, and it is typically enforced 
when the stakes are at their highest and there is something to hide.
  I took this matter seriously enough that I went to the Department of 
Health and Human Services to meet with this agent. I was told that if 
this agent wanted to speak to me, he would have to assert his status as 
a whistleblower under Federal law. I ask today

[[Page S11413]]

what I asked that day: Why does this Government employee have to become 
a whistleblower to talk to me or anybody else in Congress if the 
public's business is really public?
  So I have to ask my colleagues, is that acceptable? When you are 
doing your constitutional responsibility of oversight, is it acceptable 
to the rest of you in the Senate that they thumb their noses?
  Also, this Government employee's supervisors put him in a no-win 
situation, and because of that he risked being in contempt of Congress. 
This is an agent who put a doctor in jail for fraud in the Ketek study.
  You understand, I said this started back in January with Ketek and 
our getting involved in the oversight. There was fraud in this Ketek 
study. Did the agent do the right thing? It is a closed case. We want 
to talk to him about the closed case, and the Food and Drug 
Administration says no. So I have to ask, what does the FDA have to 
hide or cover up?
  There are enough instances of political leaders and public servants 
being ruined by coverup. Can't lessons be learned, that when, in this 
town, two people know something about it, it is no longer a secret?
  Under this Acting Commissioner, the Food and Drug Administration has 
also attempted to hide and cover up documents. The Finance Committee 
has received hundreds of pages that say, as I indicate here, ``57 pages 
removed.'' There is another poster behind it that looks exactly the 
same: ``43 pages removed.'' Other documents have whole pages, 
paragraphs, or sentences redacted, with no explanation as to why. 
Sometimes documents are marked ``redacted.'' Other times they are not 
marked, even when it is evident that information is missing. There is 
no explanation for what documents have been withheld or redacted. It is 
incomprehensible, and it looks like the work of the Keystone Cops 
rather than an agency responsible to the American public for the safety 
of drugs and devices and the efficacy of drugs and devices.
  One of the Food and Drug Administration's most incompetent and absurd 
moments was when it sent one of my own request letters back to me with 
information redacted out of it. Let's get this clear. You folks are 
defending a person who is running an agency from which I asked for 
information and they redacted the letter I sent to them. The letter I 
wrote came back as part of the information. Does that meet the 
commonsense test? Does that meet the test of competency?
  Recently, I wrote Secretary Leavitt and Attorney General Gonzales to 
explain the basis for some of these redactions. I don't know whether 
you call a blank page a redaction because you don't know what has been 
there to redact, but obviously there is no information on a blank page 
unless it is about the competency of the people who work within the 
agency.
  Again, two copies of the same document were redacted differently. 
Think of this. They want to keep us from getting information. They send 
us two copies. One copy has one sentence redacted, and the other copy 
doesn't redact that sentence but redacts another sentence. So we got 
the whole document but presumably a basis for things we were not 
supposed to know but now we know. Do you think this guy with a medical 
degree, with this sort of background, is going to go in and change that 
culture even if there was nothing wrong with him? Even if he cooperated 
with me? So it calls into question the good-faith basis for redaction 
at all.

  I could go on and on with examples showing the stonewalling and the 
withholding of information from legitimate congressional requests, 
pursuing our constitutional responsibility of oversight. What it boils 
down to is that this nominee has demonstrated he does not understand 
that Government truly is the people's business. He doesn't seem to 
understand that the people who finance it, the taxpayers, have a right 
to know what their Government is doing and how their money is being 
spent.
  I will give one final example. I have been a longtime champion of 
whistleblowers. I was the lead Senate sponsor of the 1986 whistleblower 
amendments to the False Claims Act. Back then, we were interested in 
dismantling a too-cozy relationship between defense contractors and the 
Pentagon. Today, whistleblowers are once again the key to dismantling 
the cozy relationship between some drug companies and the Food and Drug 
Administration.
  In June, Dr. Von Eschenbach held a meeting of FDA staff involving 
this drug I have been investigating, questioning how it was handled--
Ketek. FDA employees who were present say that he used a lot of sports 
metaphors regarding being a ``team player'' and keeping opinions 
``inside the locker room.'' Basically, he said to not criticize the FDA 
outside the locker room, ``outside the locker room'' being his words. 
Apparently he stated that anyone who spoke outside the locker room 
might find themselves ``off the team.''
  How are you going to do your job of congressional oversight if you 
have somebody you are getting confirmed who says that if you want to 
talk to anybody, they better not talk to you, at least not talk off 
note, because they are no longer on the team? Just think of the 
intimidation that brings throughout the Federal bureaucracy.
  This nominee held this meeting in the midst of this ongoing 
congressional investigation of this drug Ketek. He called the meeting 
after a number of critical reports in the media about the FDA's 
handling of Ketek. A number of FDA employees interviewed by the 
committee were offended by his comments, found them highly 
questionable, inappropriate, and potentially threatening. I don't think 
there was any ``potential'' about it, they were meant to be 
threatening, and I agree with the employees.
  Leaders of an agency should not hold a meeting to suggest that 
dissenters will be kicked off the team, particularly when the lives of 
American people are at stake, when drugs are going to be put on the 
line and they might not be safe. I can refer to the death of an 18-
year-old in Cedar Rapids, IA. His is the type of action that shows the 
true stripes of the nominee. He broke his word that he respected 
whistleblowers--that is what he told me; quite obviously he doesn't 
respect whistleblowers--and that he would never raise even the 
appearances of retaliation. If this meeting isn't an example of 
retaliation, I don't know what it is. When it comes to health care and 
public safety, we need to empower whistleblowers more than ever. They 
demonstrate extraordinary courage in the face of extraordinary 
adversity. It is extremely difficult to be a whistleblower. As I like 
to say, they are about as welcome as a skunk at a picnic. Yet it is 
whistleblowers in Government who put their job security on the line to 
come forward and expose fraud or wrongdoing for the public good. My 
Finance Committee staff has been investigating serious allegations 
raised by whistleblowers at the FDA on various issues over a period of 
3 years. Many of these allegations are very serious and call into 
question whether the Food and Drug Administration is fulfilling its 
mission to protect the health and safety of Americans. The way the Food 
and Drug Administration under this nominee has handled the 
investigation of Ketek shows the agency would like to keep its business 
secret. It doesn't want these issues made public or subjected to 
scrutiny. The culture at the FDA has been we will let the public know 
what we think they need to know.

  The American people do not want the government making decisions about 
what is good for them behind closed doors.
  The goal of the Finance Committee's oversight has been 
straightforward. As chairman, I wanted to bring out in the open the 
decisions made by the FDA. For too long the agency has been making its 
decisions behind closed doors.
  This nominee is not likely to serve well because he just does not 
seem to get it. He has placed media relations over the mission of the 
FDA. First and foremost, he is supposed to do the right thing on behalf 
of Americans. Dr. Von Eschenbach has other interests to serve and they 
are not always the interests of John Q. Public.
  I hear from time to time from other agencies that particular 
documents are especially sensitive or that the release of certain 
documents could jeopardize a criminal investigation--I understand that. 
But in those circumstances, I have reached accommodations. 
Unfortunately, in this case, my efforts to work with Dr. Von Eschenbach 
and his subordinates have been all but summarily dismissed.
  As I am sure you know, I intend to keep pressing the FDA for greater

[[Page S11414]]

transparency and openness. I think there is going to be new leadership 
in the Congress which is going to be even more aggressive and has a 
history of being more aggressive in this area. I have been welcoming 
and I continue to welcome that sort of help.
  As I continue with my constitutional duties to conduct oversight, I 
look forward to working with my colleagues to ensure transparency, 
accountability, and effective governance by the executive branch. The 
bottom line is Congress needs to stay committed to oversight of the 
executive branch. The public depends on Congress to fulfill its duty 
and hold executive agency leadership accountable. To sum up, that is 
what congressional oversight is all about.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Colorado.
  Mr. ALLARD. Mr. President, I ask unanimous consent to speak as if in 
morning business.
  The PRESIDING OFFICER. Without objection, the Senator is recognized.