Executive Session

EXECUTIVE SESSION -- (Senate - December 07, 2006)

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Mr. GRASSLEY. Mr. President, my opposition to the cloture motion is as much about whether we are going to be able to fulfill our constitutional responsibilities of oversight of the administrative branch of Government as it is about the particular qualifications of the nominee. I intend to vote against cloture and I hope that Democrats who are listening--particularly those Democrats in the last election who were bellyaching because there wasn't any oversight on the part of Republicans toward the executive branch of Government--would pay attention to the fact that this nominee has something to do with and is an illustration of the lack of cooperation on the part of the executive branch, failure to cooperate with Congress on the issue of congressional oversight.

I have serious concerns about what this cloture vote means, then, to congressional oversight of the executive branch now and in the future, and what it means for Members such as me, who placed a hold on this nominee. This was not a secret hold. I made this hold public.

I am voting against cloture and ask my colleagues to join me because I believe we need to send a message to the executive branch that it is not OK to impede congressional investigations. It is not OK to limit the Senate's access to documents, information, and employees of the executive branch. In his book on congressional government, Woodrow Wilson, before he was President, when he was a professor at Princeton, wrote, in 1885: ``Quite as important as lawmaking is vigilant oversight of the administration.''

Our work as lawmakers does not end with the passage of a bill. This body has a responsibility to the American people to make sure that laws work and that they are being implemented effectively, efficiently, and economically. Congressional oversight serves very important goals, and we should not lose sight. They include reviewing actions taken and regulations adopted by executive agencies to make sure that the agencies are executing law according to the intent of Congress, and, second, ensuring that the Federal Government is not wasting taxpayers' dollars. Oversight work allows us to evaluate the ability of agencies and managers to carry out program objectives and improve the efficiency, effectiveness, and economy of Government programs; next, ensuring that executive policies reflect the public interest and that public interest is expressed in the laws of Congress; and, lastly, protecting the rights and liberties of the American people.

Woodrow Wilson also said in his book that:

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

In America, with our Government, the public's business ought to be public. But when you have coverups and the lack of information going to Congress, as demonstrated by this request for documents, and when we get a document back with practically 57 pages removed, what is in those 57 pages that we ought to have access to? That is just one example of lack of information and the lack of cooperation from this agency.

Throughout history, Congress has engaged in oversight of the executive branch. The right to congressional oversight has been asserted from the earliest days of our Republic. In 1792, the House invoked its authority to conduct oversight when it appointed a committee to investigate the defeat of General St. Clair and his Army by Indians in the Northwest and empowered the ``call for such persons, papers, and records as may be necessary'' for that inquiry.

In fact, the Constitution grants Congress extensive authority to oversee and investigate executive branch activities.

Congressional oversight was also recognized explicitly in the passage of the Legislative Reorganization Act of 1946,
which required the standing committees of Congress to exercise continuous watchfulness over programs of agencies in their jurisdiction. Numerous Supreme Court decisions will support all the precedents for Congress to see all aspects of the Federal Government.

In 1927, in McGrain v. Daugherty, the Supreme Court upheld congressional authority to conduct oversight of the Teapot Dome scandal. Justice Van Devanter writing for the unanimous Court stated:

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

To do oversight, Congress needs access to information and people in the executive branch. And that is what I did not, and still may not, be getting from the FDA under the leadership of Dr. Von Eschenbach--as an example, 47 pages removed; another example, 43 pages removed.

How are you going to conduct oversight when you get answers such as that from the Food and Drug Administration?

I take exception to the statement made in support of the cloture motion. People ought to be ashamed of saying Dr. Andrew von Eschenbach has done a superb job in the position he is currently occupying with an answer such as that to the Congress of the United States. That is an insult. Before you cast your vote in favor of cloture, consider what is at stake--and particularly Members on the other side of the aisle who, during the campaign, in campaign commercial after campaign commercial after campaign commercial, said Congress is not doing its job of oversight, implying that Republicans were covering up wrongdoing by the administration. If you want to preserve your access to information and do the oversight that you think you are going to do, when you are in the majority and you get answers such as that, do you think you are going to be able to do the job of oversight?

In my interactions with the Department of Health and Human Services and the FDA these last 8 months, I have seen a complete and utter disrespect for congressional authority and hence the law. The department and the Food and Drug Administration have repeatedly failed to act in good faith in responding to congressional investigations--and the lack of 43 pages is just one example.

Although the Director's leadership at the FDA has failed to fully comply with two congressional subpoenas that were issued 7 months ago, efforts to accommodate the agency's concerns fall on deaf ears, and I wonder if I am dealing with dysfunction by design. Not only has the NEDA withheld documents that do not appear to be privileged, but it also says what has been withheld and why. The subpoenas compel a privilege log, but the FDA has not provided us with that privilege log.

For Democrats in the majority next year doing the oversight that they said they were going to do because Republicans weren't doing it--they didn't let me--let me ask you this: Are you going to be able to conduct oversight when you get answers such as that? Are you going to be able to conduct oversight when, for 7 months, you don't get your subpoenas responded to? What is the agency's explanation? The FDA has said that many documents have been withheld, that it is unduly burdensome to provide a privilege log. Even in the FDA, general counsel, as recently as Tuesday of this week, could not see why the agency needed to comply with the law and the terms of the subpoena which was issued by the committee.

In denying the committee access to the documents responsive to the subpoena, which the department and the FDA administration have claimed ``prosecutorial deliberative process'' or ``confidential communications'' or ``agency prerogatives'' to determine who will be interviewed and testify before a jurisdictional committee, when those on the other side of the aisle get answers such as that when you are going to be in the majority, what are you going to do about it? Are you going to keep your commitment to the American people when you won the majority? And are you going to be able to do the oversight when you get rationales such as ``prosecutorial deliberative process'' or ``confidential communications'' or ``agency prerogatives?''

I could not talk to a line agent named West because you can't talk to line agents, when 3 months before I talked to line agents? There was someone from the Justice Department before the Judiciary Committee, when Senator Kennedy said, ``I want access to line agents,'' unrelated to what I am talking about: Line Agent West, whom I wanted to talk to and I was told I couldn't talk to because you can't talk to line agents, the official at the Justice Department said to Senator Kennedy:

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

I do not know whether that ever happened. But that was the answer.

When I went around doing my questioning of Justice Department officials, I said: What about my ability to talk to Line Agent West? It just seemed as if I was going to be able to talk to Line Agent West. But yet this very day the Justice Department is advising the Secretary of the Interior that we can't talk to Line Agent West, which is key to whether some of these investigations are allowing dangerous drugs on the market. In Cedar Rapids, IA, I have a family that lost an 18-year-old because of a drug that was on the market then and which is not on the market now.

It seems to me that if you are concerned about the safety of drugs, this information is important, and if you are going to have it covered up in the FDA, you aren't protecting the public. If Congress knows about it, you are not doing your job of oversight.

This past summer I asked the Congressional Research Service to look into the department's policies regarding this matter. And the Congressional Research Service told me that there is ``no legal basis'' for the department's executive branch assertion. The legal analysis provided by Congressional Research Service supports the committee's position that these executive agencies' claims have been consistently rejected and compliance with congressional requests in the past has been forthcoming. The CRS cites numerous court cases which establish and support Congress's power to engage in oversight and investigate activities and its access to executive branch personnel and documents in carrying out our powers of oversight.

The Department of Health and Human Services, the FDA within Health and Human Services, says it has been responsive because the agency made available hundreds of thousands--even millions--of pages of documents to the Finance Committee in response to its subpoena. But the agency can give me all of the books and all the documents housed at the Library of Congress and it won't matter if it is not what I have asked for and the pages are removed.

It is this type of cooperation that I am getting under this Director that you are now going to confirm. I am very concerned about the cooperation, if any, that we have once he becomes a permanent commissioner. Every Member of Congress should be equally concerned if they take their constitutional duty of conducting oversight of the executive branch seriously, and most importantly to the new majority when you are going to carry out your campaign promises to make sure that there is proper oversight, checks and balances against an executive branch of Government you think is exceeding authority. Every Member should be concerned. I cannot emphasis this enough.

A vote for cloture today is a vote against oversight, and that is not what this Senate should be doing. It is not what the American people sent us here to do. We need to step up congressional oversight to protect our Nation's system of checks and balances and not reward those who seek to impede our constitutional authority.

This body should not walk hand in hand with the executive branch and sit idly by as instances of abuse and fraud continue to endanger the health and safety of American people. This Senate needs to make it clear to the executive branch that Congress takes its oversight responsibilities seriously and to vote against cloture. If we do have cloture, I will have other remarks during postcloture debate.

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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 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 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 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.

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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 the RECORD the full text of a letter I sent to the Acting Commissioner in September.

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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.

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