[Congressional Record Volume 152, Number 134 (Thursday, December 7, 2006)]
[Senate]
[Pages S11422-S11425]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
Senate Service
Mr. DAYTON. Mr. President, it has been almost 6 years since I was
sworn in as Minnesota's 33rd U.S. Senator with my friend and colleague
Paul Wellstone at my side. I began my term hopeful and optimistic. The
Senate was evenly divided, with 50 Democrats and 50 Republicans, and
President-elect George W. Bush was promising to change the tone in
Washington with a new era of bipartisan cooperation.
Our country enjoyed peace and relative prosperity. Outgoing President
Bill Clinton, a Republican-controlled Congress, and over 6 years of
economic expansion had combined to create the first annual surpluses in
the Federal Government's on-budget account in 39 years, and they were
projected by OMB to continue for at least the next decade.
The Social Security trust fund's annual surpluses were going to be
saved in a lockbox for the upcoming retirements of a large baby boom
generation. There was even discussion of paying down the national debt
to further strengthen our financial position. Yet we still would be
able to increase funding for such essential needs as public education,
affordable health care, seniors' drug coverage, and infrastructure
improvements.
Just 6 years later, our country's condition has changed drastically,
and mostly for the worse. We are mired in a disastrous war in Iraq
despite the heroic efforts and sacrifices by our Armed Forces. The
fiscal integrity of the Federal budget has been destroyed, with record-
high annual deficits continuing, despite budget gimmickry and a modest
economic recovery. The Federal tax base has been decimated by huge tax
giveaways to the rich and superrich that will burden our children and
grandchildren. The Social Security trust fund's surpluses have been
spent every year on what the nonpartisan Concord Coalition has called
``the most reckless fiscal policy'' in our Nation's history.
The Bible says if the leaders don't lead, the people perish.
Unfortunately, the Bush administration and the Republican majority in
Congress have not led this country well, and our people are suffering
the consequences: lost jobs, businesses, and farms; lost incomes,
standards of living, and security; and lost loved ones killed or maimed
in Iraq.
We have lost the national unity which followed the terrible
atrocities of September 11, 2001, and the Bush administration has lost
the world's support which they had after that awful attack. The
President's decision to invade Iraq unilaterally, the absence of
weapons of mass destruction that had been the initial justification for
that invasion, and his administration's disastrous mismanagement of
Iraq following the overthrow of Saddam Hussein has squandered most of
our national unity and international goodwill.
The Congressional Record will show that I opposed those failed
policies and supported other and better alternatives. I was 1 of 23
Senators to vote against the Iraq war resolution. I opposed the large
tax giveaways to the rich and superrich. In fact, during my 6 years in
the Senate, I voted 29 times to raise my own taxes. Why? Because our
country needs those tax revenues, and I can darn well afford to pay my
fair share of them, as can all other Americans with my good fortune.
I tried seven times unsuccessfully to get the Senate to honor its 30-
year promise to school districts and schoolchildren and fully fund
special education. The Senate did pass my ``Taste of Our Own Medicine''
amendment limiting Members of Congress's prescription drug coverage to
what they provided to senior citizens through Medicare. However, my
amendment was discarded by the House-Senate conference committee.
It has pained me deeply to see the Senate's majority lead our country
into what I consider the wrong direction. Our Nation's founding
principle was ``we the people,'' and it remains so today. If we are not
always united by the common cause, we are bound together by a shared
destiny. If the laws this Senate passes are successful, ``we the
people'' benefit together. If those laws fail, we suffer together. Some
Americans will suffer more than others as unfair victims of social and
economic injustices, but ultimately all Americans cannot escape our
common national fate. United we stand and succeed; divided we fall and
fail. I regretfully believe that during my Senate term this
administration and its congressional followers have caused too many
divisions, declines, and failures.
Thus, I leave the Senate with strong feelings of frustration and
disappointment. I have been unable to pass most of what I believe was
most important to Minnesota, to our country, and to the world. I remain
convinced that those policies would improve the lives of most Americans
far better than what the majority here enacted.
A cornerstone of democracy, which I honor, is that the majority
prevails. Winning, however, does not make them right and,
unfortunately, it does not make them wise. In those decisions with
which I have disagreed, time will tell us and the American people who
was right and who was wise.
I do want to thank my colleagues on both sides of the aisle for the
privilege to serve these last 6 years with them. I am grateful for the
friendships I have made, which I hope will continue after my departure.
I thank my excellent staff, those here in Washington and those in
Minnesota, for their tremendous dedication and many hours of hard work.
Most of the successes I have enjoyed here have been the result of their
dedication and their abilities, and I thank them again for their
support.
I especially want to thank the people of Minnesota who gave me this
extraordinary opportunity to serve them in the Senate. Our democracy
is, through all of human history, throughout the entire world, the most
advanced and successful form of self-governance that human beings have
ever devised. It is far from perfect, but it is far better than
anything else. We who are elected as its leaders and its stewards have
sacred duties to uphold its principles, to elevate its policies, and to
improve its practices before we bequeath them to our successors. I have
done my very best to fulfill those duties before I pass them on to my
outstanding successor, Senator-elect Amy Klobuchar. We in the Senate
and in the House of Representatives also have the duty to serve the
best interests of all Americans. To be successful and sustainable, our
Government must improve the lives of all of our citizens.
Unfortunately, here in Washington, the people who already have the
most keep getting more than anyone else. The excessive influences of
their money and political power on the Federal Government are serious
threats to our democracy. They skew decisions and laws in favor of the
rich and powerful, often at the expense of other Americans: the hard-
working people who pay their taxes and hope their elected
representatives will look out for them in Washington. It isn't too much
for them to expect. However, it is too often more than they are
getting.
They are told repeatedly that new laws and policies will improve
their lives. Yet their real lives become worse, not better. They
experience a deep disconnect between what they are told will happen and
what is actually happening to them.
In attempts to hide those disparities, the words used in Washington
are often carefully selected by very clever people in order to disguise
reality rather than to describe it. For example, legislation that
stripped many Americans of their bankruptcy protections for major
medical expenses was named the Bankruptcy Abuse Prevention and Consumer
Protection Act. Another bill that would have increased industrial
pollution was entitled the Clear Skies Act. No Child Left Behind has
knowingly underfunded Head Start, title I, and special education, which
has left millions of schoolchildren behind.
These discrepancies and the disparities they create will be even more
destructive to the American people's trust in their Government in the
years ahead. That is because the choices facing Congress will become
even more difficult as the needs of an aging population grow but
revenues do not. In
[[Page S11423]]
about a decade, the Social Security trust fund's large annual surpluses
will be replaced by deficits, and its IOUs from the general fund will
add to that fund's own chronic deficits. If combined with today's
enormous and unsustainable balance of trade deficits and a continuing
erosion of our manufacturing job base, the consequences could be
catastrophic.
That somber forecast has replaced my hope and optimism of 6 years ago
to my deep regret. Following the wisdom of ``speak truth to power,'' I
present my truth to the world's most powerful legislative body, the
U.S. Senate, and one of the two institutions that must act to keep our
Nation strong. I hope that you will. I will pray for your wisdom to
discern what is right, for your courage to act accordingly, and for
your success on behalf of our great Nation and the world.
Mr. President, I yield the floor, and 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. GRASSLEY. Mr. President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER (Mr. Vitter). Without objection, it is so
ordered.
Mr. GRASSLEY. Mr. President, for one final time, I wish to address
the nominee before us, Dr. Von Eschenbach, who is up for Commissioner
of the Food and Drug Administration and who I think should not be
approved for the position by the Senate.
I have considered Dr. Von Eschenbach's performance on the job for
more than a year now because he was appointed Acting Commissioner in
September of 2005. In fact, over the last year I have closely monitored
his actions, reactions, and his public and private comments to the FDA
staff and to the public.
This nominee inherited a Food and Drug Administration plagued by
cultural and structural and personnel problems, and I surely do not
blame him for the problems, but I have to look at whether he is the
person to correct those problems. Because this agency is plagued by
these cultural and structural and personnel problems, FDA is in
desperate need of a leader, a leader who can not only restore the
public's confidence in the agency but also restore the agency's
confidence in itself.
I met with Dr. Von Eschenbach more than once. We talked, and he
seemed to be very nice. He has, of course, without dispute, excellent
credentials. He promised me full cooperation in my oversight work I was
doing and the investigations I was doing, but, in fact, it did not
happen. Instead, I had to issue two subpoenas. So far, he has not
complied with those subpoenas which were issued 7 months ago. This
reflects a lack of respect for the authority of Congress conducting its
constitutional responsibility of oversight of the executive branch of
Government.
In addition, under Dr. Von Eschenbach's leadership, the FDA remains
in a state of denial about all these cultural problems to which I have
referred. A coherent action plan to address the problems is nowhere to
be found. Dr. Von Eschenbach has told me that there is room for
improvement in the area of technology, but it does not appear that he
understands the depth and breadth of problems affecting the Food and
Drug Administration.
The FDA is in serious trouble, and I am not the only one saying so.
Over the last year, we have heard from the Government Accountability
Office, the Union of Concerned Scientists, and just a few months ago we
had a scathing report from the Institute of Medicine.
The Institute of Medicine completed a $3 million, 15-month study and
set forth 25 recommendations. This report by the Institute of Medicine
conveys a sense of urgency to fix the problems. Just last month at the
Health, Education, Labor, and Pensions Committee hearing, the chairman
of the Institute of Medicine committee that produced the report said:
If there ever was a time that it was critical to address
these issues, it is now.
The next Food and Drug Administration Commissioner must be a person
who not only has excellent credentials, as I have said he has, but who
also will accept the criticism of the agency and develop coherent
solutions.
Here is what the Institute of Medicine reported:
The committee believes that cultural changes are urgently
needed to support a stronger, more systematic and more
credible approach to drug safety in the Center of Drug
Evaluation and Review and it recommends solutions to the
problems created or exacerbated by the elements of the
Center's management, structure and environment.
Now a short quote:
Many have observed signs of an organizational culture in
crisis.
Another quote:
The Center's leaders have to be prepared to address the
underlying cultural problems that divide and impair the
optimal functioning of the Center's staff and effectively use
the existing and new authorities and resources to achieve the
Center's public health and regulatory mission.
These criticisms of the Food and Drug Administration have come from
outside the agency, not from whistleblowers reporting to me. But I also
continue to hear from these employees inside and also from managers
inside the Food and Drug Administration who were concerned about the
integrity of the Food and Drug Administration's work. What is also
troubling is that some of these employees have experienced intimidation
or reprisals for voicing legitimate concerns.
I have fought long and hard over the last two decades to protect the
rights of numerous whistleblowers who expose fraud, waste, and abuse.
When I met with Dr. Von Eschenbach in March, he told me that he was
``committed to whistleblowers.'' Yet his actions seem to suggest
otherwise.
The worst example may be when Dr. Von Eschenbach ordered a meeting
with the FDA staff after the press reported information that was
critical of how the FDA handled safety issues with the drug Ketek. I
keep referring to Ketek because it is a drug involved in the death of
an 18-year-old boy in Cedar Rapids, IA. As I understand it, Dr. Von
Eschenbach sent a clear message at this staff meeting. Some suggested
that this attempt was simply to boost morale among FDA employees, but
some longtime FDA employees saw it differently. They took his word that
anybody who spoke ``outside the locker room'' might find themselves
``kicked off the team''--literally. And I don't blame them for taking
offense at that. People are trying to do their job, and you talk about
what is wrong and you might be fired for it? People like that ought to
be upheld and honored. In the final analysis, they ought to have their
concerns addressed within the agency and not have to come to those of
us in Congress because they are not getting any ear in the agency. So
they took his message to mean: Your career is in jeopardy if you happen
to come to Senator Grassley or outside the agency or to any Member of
Congress. To me, it shows his poor judgment and intolerance for
dissenting opinions and also for what is basic to American government,
that the public's business ought to be public.
Dr. Von Eschenbach also told me that he was a man of ``discipline,
rigor and precision.'' Those are his words. He used those same words in
a speech:
We will retain all the rigor, all the discipline and all
the precision of regulation, but our efforts will be geared
so that things can move faster rather than slower.''
We can all agree that new drugs and devices should be available to
the public as soon as possible, but there is also the issue of safety
and the protection of the public. The FDA must do its job and ensure
that the drug's benefits outweigh its risks before approval.
My other concern regarding Dr. Von Eschenbach is that he assured me
of his commitment to respond promptly to requests from Congress. That
is a promise which was never kept. So do I have a reason to be
concerned about this person, regardless of the very good credentials he
has? My oversight of the FDA has consequently been slowed by inaction
on the part of his agency. In fact, he has not responded to a letter I
sent to him 9 months ago, and my requests for interviews with some FDA
officials were ignored for more than 3 months and some still have not
been scheduled. As Acting Commissioner, he has ignored congressional
requests, and I do not expect that will change if he is confirmed by
the Senate.
Before I close my remarks, I ask unanimous consent to have printed in
[[Page S11424]]
the Record the full text of a letter I sent to the Acting Commissioner
in September.
There being no objection, the material was ordered to be printed in
the Record, as follows:
U.S. Senate,
Committee on Finance,
Washington, DC, September 20, 2006.
Andrew C. Von Eschenbach, M.D.,
Acting Commissioner, U.S. Food and Drug Administration,
Rockville, MD.
Dear Dr. Von Eschnbach: As a senior member of the United
States Senate and as the Chairman of the Committee on Finance
(Committee), it is my constitutional duty to conduct
oversight into the actions of executive branch agencies. For
nearly three years, I have been investigating matters related
to, among other things, the safety and efficacy of products
regulated by the Food and Drug Administration (FDA or
agency).
I have reviewed and questioned how the FDA handles the pre-
market review and postmarket surveillance of drugs,
biologics, devices and veterinary medicines to assess whether
or not the agency is fulfilling its mission to protect the
public health. Additionally, I have worked to give voice to
the concerns of a number of rank-and-file scientists and FDA
managers who share a common complaint: a deep-seated cultural
divide exists within the FDA, and it has led to systemic
problems that plague the agency. Together we have shed
sunlight on how frequently differences of scientific opinion
are quashed, the nature of the cozy relationship between the
FDA and the industries it is supposed to regulate, and the
failure of the agency to be adequately transparent and
accountable to the public.
Others also have identified serious leadership problems at
the FDA. Editorial pages of publications across the nation,
including a number of the most esteemed scientific journals,
have recognized and expressed outrage at the FDA's failures
in recent years. The Government Accountability Office (GAO),
the independent and non-partisan agency that works on behalf
of Congress and the American people, has also identified
serious and systemic problems at the FDA. Still, the most
powerful messages come from the increasing numbers of current
and former FDA personnel, who often come forward at great
personal and professional expense to express their
disenchantment that the FDA has lost its way and ``sold out''
to the industries it is charged to regulate.
In the face of such criticism, the FDA appears to be
focused on damage control rather than addressing its core
problems. As a science-based agency, the FDA is remarkable
for its lack of introspection, second-guessing, and failure
to assess its own performance and capabilities in a
systematic way. Despite all the recent criticism, the
agency does not have a comprehensive plan of action in
place to address its weaknesses. Instead, the FDA comes
off as an agency in denial that chooses to keep its head
in the sand in the hope its problems will go away. I am
writing this letter to encourage you to establish and
implement a resuscitation plan to restore the FDA's
credibility in the mind of its own employees and the
American public. An agency that hemorrhages whistleblowers
is an agency needing critical care. The following concerns
are by no means comprehensive, but they illustrate several
common themes of my oversight of the FDA.
Suppression of Scientific Dissent
I am very troubled by FDA's attempts to suppress scientific
dissent by muzzling its own scientists. Such actions by the
FDA show a lack of respect for the dedicated scientists
working at the agency and a lack of respect for the
scientific process.
In February 2004, the FDA held an advisory committee
meeting to discuss whether or not there was a link between
some antidepressant drugs and suicidal behavior in children.
Dr. Andrew Mosholder, the FDA's expert on this matter,
concluded that there was a link. However, his FDA supervisors
disagreed and canceled Dr. Mosholder's presentation to the
advisory committee. Instead, Dr. Mosholder was given a script
by his supervisors to read if he were asked why he was no
longer presenting before the advisory committee.
Similarly, in February 2005, Dr. David Graham was finishing
a study on Medicaid patients taking COX-2 inhibitors and was
told by his supervisors that he could not present his
findings regarding these drugs at an upcoming advisory
committee meeting. The scientific process ultimately
prevailed, but only after then-Acting Commissioner Lester
Crawford overruled Dr. Graham's supervisors to allow him to
present his findings. This was not the FDA's first attempt,
however, to muzzle Dr. Graham. Several months prior to the
advisory committee meeting, Dr. Graham went public with
allegations about the FDA's mishandling of the COX-2
inhibitor Vioxx, which was manufactured by Merck & Co, Inc.
(Merck). According to Dr. Graham himself, as well as
information and documents obtained by the Committee, senior
FDA officials attempted to intimidate him so he would not
testify about the adverse cardiac effects of Vioxx before
Congress. The FDA also tried to prevent the publication of
Dr. Graham's findings in Lancet.
In July 2005, the FDA approved the Vagus Nerve Stimulation
(VNS) Therapy System, a medical device for treatment-
resistant depression (TRD), even when FDA scientists could
not determine if the device worked. Rather than allow the
scientific process to dictate FDA's decision, a senior FDA
official overruled a team of more than 20 FDA scientists,
medical officers, and management staff who recommended
against approval of the device based on their comprehensive
scientific evaluation of the sponsor's application. In
addition, while the FDA has publicized differences of
scientific opinion within the agency regarding controversial
regulatory decisions in the past, in this case, the FDA did
not publicize scientific dissent regarding the effectiveness
of the VNS Therapy System for TRD.
More recently, my office was approached by yet another FDA
scientist who is being prohibited from submitting an article
to a major scientific journal despite the fact that an
appropriate disclosure statement would be made.
Cozy Relationship with Industry
I have frequently criticized the FDA for its relationship
with the industry, which I believe is far too cozy. The FDA
needs to distance itself from the industry and return to its
role as regulator, not a facilitator. Despite findings from a
Merck study that heart attacks were five times higher for
Vioxx patients than for patients on another drug, nearly two
years passed before label changes were made. The overriding
concern of the FDA should have been the health and safety of
the American people. However, while the FDA was negotiating
label changes with the company, patients and doctors remained
largely unaware of the cardiovascular risks. In addition,
Merck was aggressively marketing Vioxx during that time.
Another troubling example of FDA's coziness with industry
is the removal of Dr. Victoria Hampshire, a drug safety
reviewer, from the review of ProHeart 6, a heartworm
prevention drug for dogs. Dr. Hampshire was reassigned
following the drug company's presentation of findings from
its private investigation of Dr. Hampshire after the company
met with then-Commissioner. It appears the purpose of that
investigation was retaliatory and an effort to discredit Dr.
Hampshire. The company's investigation led to a criminal
investigation by the FDA; however, the investigation resulted
in no action taken against Dr. Hampshire. In fact, Dr.
Hampshire subsequently received an award for her job
performance related to ProHeart 6.
Unfortunately; it appears that Dr. Hampshire is not the
only FDA employee who was the target of a company's campaign
to discredit individuals who may present impediments to its
agenda. Two months ago, I wrote to the Department of Health
and Human Services Office of Inspector General (HHS OIG) to
investigate whether or not one or more FDA employees
conspired with Merck to discredit Dr. Graham and/or call into
question Dr. Graham's allegations regarding the safety and
efficacy of Vioxx. FDA's handling of the antibiotic Ketek is
another example where the FDA appears to have accommodated a
drug company despite the fact that the company submitted
fraudulent data from a safety study to the FDA and repeatedly
provided incomplete safety information. What baffles me even
more is the fact that the FDA continued to cite Study 3014 in
publicly released safety information for Ketek even after its
Division of Scientific Investigations concluded that Study
3014 involved ``multiple instances of fraud'' and that ``the
integrity of data from all sites involved in [the] study . .
. cannot be assured with any degree of confidence.''
Pressure to Alter or Exclude Information
Not only has the FDA disregarded and downplayed important
concerns and warnings from its own scientists, but FDA
supervisors have also pressured some of these scientists to
change their findings or conclusions regarding the safety
and/or efficacy of a product. Most notably Dr. Mosholder and
Dr. Graham, among others, have been pressured by their
supervisors to soften their safety findings or conclusions
regarding antidepressants and Vioxx, respectively. In
addition, a survey released by the Union of Concerned
Scientists (UCS) and the Public Employees for Environmental
Responsibility (PEER) on July 20, 2006, found that
approximately one-fifth of the nearly 1,000 FDA scientists
surveyed said that they had been asked, for nonscientific
reasons, to inappropriately exclude or alter technical
information or their conclusions. One-fifth said that they
have been asked explicitly by FDA decision-makers to provide
incomplete, inaccurate or misleading information to the
public, industry, the media and government officials. My
Committee staff are presently reviewing such allegations
in ongoing investigations.
Pressure to Approve Products
Throughout numerous investigations by my Committee staff,
FDA employees have also stated that they are under constant
pressure to approve drugs within deadlines established by the
Prescription Drug User Fee Act. For example, during the
Committee's investigation into the delay in labeling changes
regarding blindness risks for Viagra, the safety evaluator
for that drug informed my staff that the Office of New Drugs
is under such time pressure to approve new drugs that safety
concerns were often ``fit in'' wherever they could. According
to a survey by the HHS OIG in 2002, nearly one in five
scientists polled said that they had been pressured to
approve or recommend approval of a new drug despite concerns
about its safety, effectiveness, or quality. This needs to be
[[Page S11425]]
corrected immediately, and FDA needs to resume its science-
based mission.
Atmosphere of Fear of Reprisal
According to the FDA, there are regulations and procedures
in place to help resolve organizational and individual
disagreements. However, my Committee staff continues to hear
from FDA employees who experience intimidation and
reassignments when they raise concerns about the integrity of
FDA's work. In addition, the 2006 UCS and PEER survey found
that over one-third of the FDA scientists who responded to
the survey said they could not openly express any concerns
about public health within FDA without fear of retaliation.
Moreover, the GAO found that the dispute resolution processes
for disagreements over postmarket drug safety decisions
``have not been used and may not be viewed as sufficiently
independent.''
Your recent meeting with FDA staff involved in the review
of Ketek is a disturbing example that FDA's internal dispute
resolution processes are not working. Instead of reassuring
FDA employees that they can raise concerns without being
subjected to retaliation or intimidation, the meeting itself
appears to be an act of intimidation. Scientists who speak up
about problems and concerns, whether internally or
externally, help ensure that our government operates
efficiently, effectively, and in the best interest of the
American people. FDA employees need to hear from the leader
of the agency that they can freely voice their concerns
without fear of reprisal.
Organizational Challenges
The GAO report released on April 21, 2006, calls for long
overdue reform at the FDA. Under the current FDA review
system, patient safety takes a back seat to the fast approval
of products. For example, the drug safety office, now known
as the Office of Surveillance and Epidemiology, is under the
thumb of the Office of New Drugs (OND), which is hampered by
real and perceived conflicts of interest. According to the
GAO report, the drug safety office is under-funded, lacks
independence and lacks decision-making responsibility. OND--
which is responsible for approving or disapproving drug
applications in the first place--is the office responsible
for taking regulatory actions related to the safety of drugs
already on the market, not the drug safety office.
To improve the decision-making process for postmarket drug
safety, the GAO has recommended that Congress expand the
FDA's authority to require drug companies to conduct
postmarket studies when additional data is needed. A number
of us in Congress have repeatedly asked the FDA what
additional authorities and/or resources are needed to enable
the agency to achieve its mission. In a related matter,
during private meetings with FDA management, the need to have
pharmaceutical companies submit their applications for new
drugs and other requests electronically comes up repeatedly
as critical to improving the efficiency and effectiveness of
the FDA. Yet, the FDA continuously denies the need for
greater authority and resources. Why the FDA is resisting
such offers from Congress is a mystery to me.
Lack of Leadership
The FDA has been without a permanent leader more often than
not in recent years. The agency needs and deserves a strong,
permanent Commissioner who is unequivocally committed to the
scientific process and can make the administrative reforms
necessary to ensure greater transparency and accountability.
While you are not the permanent Commissioner of the agency,
you are nevertheless in the position, as Acting Commissioner,
to turn things around and restore public confidence in the
FDA. I sincerely hope you seize the opportunity to do just
that.
Sincerely,
Charles E. Grassley,
Chairman.
Mr. GRASSLEY. The letter lays out the major problems at the FDA. I
encourage my colleagues to read it and, maybe more important, emphasize
again reading the Institute of Medicine's criticism of the Food and
Drug Administration.
The FDA needs a permanent commissioner to tackle these problems.
Unfortunately, I believe the nominee is not the person for the job.
Over the past year, the nominee has failed to step to the plate and
failed to keep his assurances to me. He has said the agency needs to be
a facilitator, but think what the word ``facilitate'' means or what
``being a facilitator'' means. It could mean a cozy relationship
between the FDA and industry. What is called for is someone who
recognizes that the FDA is supposed to be a regulator, not a
facilitator.
I am also afraid he will allow FDA management to continue pressuring
FDA scientists to change their findings or conclusions and to approve
the products despite concerns about the safety and efficacy of the
product. Dr. Von Eschenbach is not prepared to provide the leadership
necessary to restore confidence in the FDA.
Given these concerns, I hope my colleagues will take them in
consideration before they vote. I intend to vote no. I hope my
colleagues will so that we can have a person in this position who will
change the culture but also cooperate with the constitutional
responsibilities of the Congress of the United States to oversee the
executive branch.
I yield the floor.
The PRESIDING OFFICER. The Senator from Wyoming is recognized.
Mr. THOMAS. Mr. President, I would like to take just 5 minutes as in
morning business.
The PRESIDING OFFICER. Without objection, it is so ordered.