[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.