[Congressional Record (Bound Edition), Volume 151 (2005), Part 12]
[Senate]
[Pages 16224-16229]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           EXECUTIVE SESSION

                                 ______
                                 

NOMINATION OF LESTER M. CRAWFORD TO BE COMMISSIONER OF FOOD AND DRUGS, 
                DEPARTMENT OF HEALTH AND HUMAN SERVICES

  The PRESIDING OFFICER. Under the previous order, the Senate will now 
proceed to executive session to consider Executive Calendar No. 172, 
which the clerk will report.
  The legislative clerk read the nomination of Lester M. Crawford, of 
Maryland, to be Commissioner of Food and Drugs, Department of Health 
and Human Services.
  The PRESIDING OFFICER. There will now be 30 minutes of debate equally 
divided prior to the vote.
  The Senator from Wyoming.
  Mr. ENZI. Mr. President, I yield myself 5 minutes.
  I rise to discuss the pending nomination of Dr. Lester Crawford to be 
the Commissioner of Food and Drugs. I particularly thank all of the 
people who have been involved in this nomination process. It has been a 
great bipartisan effort. It has been thoroughly explored and we finally 
are at a point where we can have an actual FDA Commissioner approved. 
It will be a tremendous relief to me and to the Nation, I am sure.
  I particularly want to thank Senator Kennedy for his efforts in 
proceeding through the different hearings that we have had and all of 
the other work that we have had to do. The Food and Drug Administration 
is tasked with the broad and critical mission of protecting public 
health. The FDA Commissioner is in charge of an agency that regulates 
$1 trillion worth of products a year.
  The agency ensures the safety and effectiveness of all drugs and 
biological products like vaccines, medical devices, and animal drugs 
and feed. It also oversees the safety of a vast variety of food 
products as well as medical and consumer products, including cosmetics.
  In addition, the Commissioner is responsible for advancing the public 
health by helping to speed innovations in its mission areas and by 
helping the public get accurate, science-based information on medicines 
and foods. The FDA has been without a confirmed Commissioner for more 
than a year.
  In January of this year, 17 members of the Senate Committee on 
Health, Education, Labor and Pensions sent a bipartisan letter to the 
President urging him to nominate a Commissioner to provide the agency 
with greater clarity and certainty in its mission to protect our food 
and drug supplies. Recent breakthroughs in medical science and 
technology show how quickly science and technology are changing our 
lives each and every day.
  The FDA is at a critical point in its history. The potential benefits 
from our medical research are staggering. A fully confirmed FDA 
Commissioner is essential to ensuring that these medical breakthroughs 
can be brought to the market safely and effectively. Consumers deserve 
to have a fully functional FDA that can oversee the industry with 
confidence and authority and harness the technical achievements that 
can improve and save lives.
  I believe the President's nominee, Dr. Lester Crawford, has the right 
qualifications to lead the FDA and to bring about the necessary reforms 
to maintain consumer confidence in our Nation's drug safety. Clearly we 
need someone at the helm of the FDA who can direct the agency and work 
with Congress to find the answers to these and many other difficult 
issues that will continue to come before us.
  Dr. Crawford has been Acting Commissioner of FDA since March of 2004. 
He has a long and distinguished career in private and public service. 
He worked at the FDA in other capabilities before joining the agency 
again in 2002.
  The show of support for Dr. Craw-
ford's nomination has been strong. In the runup to Dr. Crawford's 
confirmation hearing in March, my committee received letters of support 
from more than 100 individuals and organizations. It is high time we 
had this debate and this vote. We waited many months for President Bush 
to send us a qualified nominee for the post.
  In response to our bipartisan letter to the President, the President 
nominated Dr. Crawford. We have waited long enough. I think we can all 
agree that we need a strong leader at the FDA right now and one who has 
a mandate to act. We must be forward looking. There are many items 
before the FDA that require the immediate attention of an FDA 
Commissioner vested with full authority.
  The authority flows directly from the act of Senate confirmation. 
Without a Senate-confirmed leader, we cannot expect the FDA to be as 
effective as we need it to be.
  Dr. Crawford's nomination was reported favorably out of the Committee 
on Health, Education, Labor and Pensions on June 15. So I am pleased 
that we are now ready to confirm Dr. Crawford so that he can take 
charge, take action, and take responsibility for leading the FDA in the 
best interests of the public health.
  I yield the floor and reserve the remainder of my time.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, I congratulate my friend and chairman of 
the Committee on Health, Education, Labor, and Pensions for his 
leadership in ensuring that the Senate will have an opportunity to vote 
on Dr. Crawford and, hopefully, approve his nomination.
  During one time or another during 3 of the last 4 years we have not 
had a head of the Food and Drug Administration. As Chairman Enzi has 
pointed out, this agency has enormous power, influence, and say-so on 
many of the different issues that affect every family in this country. 
It regulates food, cosmetics, drugs, medical devices, even televisions 
and cell phones a full quarter of every dollar consumers spend. And FDA 
really sets the standard for the rest of the world in how it regulates 
these products. The rest of the world looks to our Food and Drug 
Administration as the gold standard, and, as Chairman Enzi pointed out, 
we have not had a permanent Commissioner for 3 of the last 4 years. I 
think we have suffered because of it.
  Now we have the opportunity, with Dr. Crawford, to fill that job, and 
I will

[[Page 16225]]

explain in just a few moments why I think he is eminently qualified.
  I agree with those who believe that we are in the life science 
century. We have seen a commitment to the promise of the this century 
by the Congress and by administrations in recent times when we 
effectively doubled the NIH budget. We have seen the sequencing of the 
gene, the progress that we have made with DNA, the real possibility of 
breakthrough drugs, and the debates we are having on stem cell 
research. This is truly the life science century.
  Quite frankly, the most important position in this life science 
century is who is heads the Food and Drug Administration, because we 
will want to have these breakthrough drugs and other treatments 
available to people at the earliest possible time, and that is FDA's 
job. We want to make sure these treatments are safe and effective. That 
is going to be an enormous responsibility, but I believe the 
possibilities and the meaning for families will be breathtaking.
  So that is why this position, and the FDA, is so important. There are 
many things that we do in this body, and many people who are directly 
involved say this or that thing is the most important thing that we are 
going to do in the session. Well, this might not be the most important 
thing that is done in this session, but having a responsible, informed, 
enlightened, future-looking, tough-minded administrator at the Food and 
Drug Administration is enormously important for all Americans. That is 
what this debate and discussion is about.
  It has also been about the importance of following science. This is 
enormously important, and I will say an additional word about that. It 
is important for the FDA to have the confidence of the American people 
that the FDA is calling the important decisions it makes as the science 
reveals that ideology and politics have not become involved.
  I rise in support of Dr. Crawford to be the Commissioner of the Food 
and Drug Administration. Modern drugs, vaccines, and medical devices 
can work miracles but only if FDA does its job to see that they are 
safe and effective. We use food and food products from around the world 
and we count on the FDA to see that they are not contaminated.
  FDA touches the lives of every American every day. As I said before, 
a full quarter of consumer products are regulated by the FDA. That is 
why it is so important the FDA have a full-fledged Commissioner. I 
fully support Dr. Crawford's nomination for the position.
  His impressive record and clear commitment to public health will 
serve the agency well. He has dedicated his life to public service and 
to public health. He is trained as both a veterinarian and a 
pharmacologist and has many years of experience in government, 
industry, and the academic world.
  His leadership experience at FDA dates back to 1978 when he headed 
the Center for Veterinary Medicine. Over the years since then, he has 
led the Food Safety and Inspection Service at the Department of 
Agriculture, headed a major association on veterinary medical 
education, and most recently served as Deputy Commissioner and Acting 
Commissioner of the Food and Drug Administration itself.
  Under Dr. Crawford's leadership at FDA, we have seen stepped up 
efforts to monitor drug safety and to inform patients and doctors about 
the risks of drugs. We have recently seen increased scrutiny of drug 
advertising. FDA also made Herculean efforts to seek and permit the use 
of flu vaccines from other sources after the vaccine shortage last 
year, and I am hopeful that these efforts will pay off this year and in 
the following years in new manufacturers of flu vaccine for the U.S. 
market.
  Clearly, more must be done. With a Commissioner in place, we can work 
much more effectively on the key issues facing the agency, from how FDA 
monitors drug safety to ways to address the flu vaccine shortage, to 
how it handles the conflicts of interest on its advisory committees and 
how it has acted on Plan B.
  I intend to work with Chairman Enzi and the other members of our HELP 
Committee to see that these issues are addressed, to help Dr. Crawford 
make any changes at the agency that are needed, and to help craft 
legislation that will allow FDA to do its vital job more effectively.
  On drug safety, FDA can only request drug companies to take action to 
protect the public. It is obvious that companies often have conflicts 
of interest and the FDA needs the authority to require better labels 
and insist on clinical trials of drugs already on the market, not just 
request them.
  We need to improve the post-market monitoring of drug safety. 
Clinical trials before approval can and do detect many safety problems, 
but they should not end FDA's responsibility for the safety of drugs 
already on the market. When needed, new clinical trials should be 
required.
  I just mention at this time that we intend to report out information 
technology legislation from the HELP Committee, hopefully this week. 
With information technology, we will be able to better monitor how 
drugs are used and the adverse reactions to those drugs, and hopefully 
have those reports promptly so that we will be able to provide greater 
protection to the public. That legislation will hopefully come out of 
our committee with a strong bipartisan commitment and with new 
leadership, and the opportunities that are out at the FDA with these 
new breakthrough drugs, it can make an enormous difference in terms of 
the quality of health care and the safety of treatments for the 
American people.
  Above all, FDA needs enough resources to do its job effectively. The 
Office of Drug Safety does not even have computer systems capable of 
analyzing data as thoroughly as possible, and it cannot always purchase 
access to drug usage databases that could identify safety problems. It 
inspects less than 2 percent of imported food, and this much only 
because of a large increase in funds to FDA for that purpose after 9/
11.
  I note my friend and colleague, the Senator from Utah, Mr. Hatch, 
when he was chairman of the Health and Human Resources Committee, we 
worked together to try to help make sure the FDA would get the kind of 
resources to modernize itself and develop the kinds of technology to 
deal with a number of these issues.
  I know of Dr. Crawford's concern for these problems and look forward 
to working with him to address them. I also commend Senator Murray and 
Senator Clinton for their leadership in addressing the FDA's refusal to 
act on Plan B. Thanks to their leadership, the FDA has committed to 
making a decision on this application by September 1. I commend 
Secretary Leavitt and Dr. Crawford for this commitment.
  I commend Chairman Enzi of the HELP Committee, who both in committee 
and on the floor has been even handed yet persistent in pursuing Dr. 
Crawford's nomination to be Commissioner. Once again, he has shown the 
leadership that will serve our committee well. I look forward to 
working with him to assist Dr. Crawford and the agency in its important 
public health work.
  Dr. Crawford is well qualified to be Commissioner. He deserves to 
have full authority as Commissioner. It is time for the Senate to give 
him the title as well as the responsibility. I support his 
confirmation. I urge my colleagues to do so as well and I look forward 
to working with him in the years ahead.
  The PRESIDING OFFICER. Who yields time?
  Mr. ENZI. Mr. President, I yield 5 minutes to the Senator from Utah, 
Mr. Hatch, a former chairman of the committee that handles this. He has 
handled these confirmations before.
  The PRESIDING OFFICER. The Senator from Utah.
  Mr. HATCH. Mr. President, I rise in strong support of the nomination 
of Dr. Lester Crawford for the Commissioner of Food and Drugs.
  I am pleased that the Senate is finally considering Dr. Crawford's 
nomination and urge my colleagues to support his nomination.
  I want to stress that tonight's vote is extremely important--not only 
for the FDA--but for all Americans.
  FDA needs a permanent Commissioner--in fact, the agency has not had a 
Commissioner since May 2004.

[[Page 16226]]

  The FDA needs someone to lead on important matters where the agency 
has oversight--such as drug safety, food safety, approval for drugs and 
medical devices, and counteracting biological attacks.
  Dr. Crawford is that man.
  Since Dr. Crawford has been the Acting Commissioner of the FDA, he 
has had many accomplishments of considerable note.
  Under his leadership, the FDA has undergone the most significant 
consolidation of FDA expertise in history with the physical facility 
moves to the Harvey Wiley building--the FDA's Center for Food Safety & 
Applied Nutrition near University of Maryland--and the White Oak 
campus.
  As a result of Dr. Crawford's personal intervention and involvement, 
the most at-risk Americans were able to receive a safe and effective 
flu vaccine last year during the shortage crisis.
  Dr. Crawford steered the FDA through one of the most difficult times 
in its history with the various drug safety issues of last year 
resulting in the creation of a new Drug Safety Oversight Board and Drug 
Watch internet page for consumers. This is a landmark milestone in drug 
safety and a paradigm shift for the FDA to one of openness and 
transparency.
  Dr. Crawford has led the FDA on a series of important decisions that 
have transformed the regulation of food in the United States.
  Under his leadership, the FDA fully implemented the Bioterrorism Act 
of 2002 a law that helps make our food supply safe on a daily basis. We 
have much more work to do and I am pleased to say you are helping to 
lead in that regard, Mr. President, and I am very appreciative of that.
  Dr. Crawford implemented a risk management plan for the shell eggs 
industry that reduces dramatically the probability of salmonella.
  Dr. Crawford is personally responsible for the complete overhaul and 
reform of good manufacturing practices for drugs, foods, and dietary 
supplements. When all of these major regulations are fully implemented, 
Dr. Crawford will be successful in creating the best quality control 
system in the world for regulating these consumer products.
  Most recently, he assured me that the agency's final action on 
dietary supplement GMPs will be forthcoming in the near future. I 
welcomed his decision and the finality he has promised to this long 
overdue process.
  Dr. Crawford has overseen user fee programs for both medical devices 
and veterinary drugs.
  Dr. Crawford has led the agency in the development of the ``critical 
path'' that promotes a plan for bringing novel discoveries to market 
through the FDA system to fight such diseases as cancer.
  I am convinced that Dr. Crawford is the best person for the job and 
the sooner we get him confirmed, the better.
  On a personal note, I have known Dr. Crawford for many years.
  He is a man of integrity.
  He is a strong leader.
  He is accessible.
  He is someone who understands both science and public policy.
  I believe that Dr. Crawford has all the qualities necessary to be the 
best Commissioner the FDA has ever had.
  I urge my colleagues to vote in favor of Dr. Crawford today, a vote 
so long overdue.
  I yield the remainder of my time to the distinguished chairman.
  The PRESIDING OFFICER. Who yields time?
  Mr. ENZI. Mr. President, I yield 2 minutes to the Senator from Iowa, 
Mr. Grassley.
  The PRESIDING OFFICER. The Senator from Iowa is recognized for 2 
minutes.
  Mr. GRASSLEY. Mr. President, I have considered Dr. Crawford's 
experience and performance on the job for well over a year now. In 
fact, Dr. Crawford has been the man in charge at FDA since I began 
taking a hard look at the FDA. It has been a long year for the FDA and 
I have taken a long look at Dr. Crawford's efforts to address FDA's 
problems.
  I know Dr. Crawford is intimately familiar with how the FDA operates. 
He has twice served as acting Commissioner, most recently since March 
2004, and his lengthy service at the FDA is commendable. Dr. Crawford 
and I have met on a couple occasions. He is a gentleman and seems to 
have the best of intentions. He told me personally that he understands 
there are problems at the FDA that need to be fixed. I believed at one 
point that he was capable of fixing those problems. However, as the 
saying goes, ``the proof is in the pudding.'' Today, I am here to say 
that I cannot vote for Dr. Crawford to be the next Commissioner of the 
FDA.
  During the last 18 months, this country's confidence in the FDA has 
been shaken. It has been shaken not because of one isolated incident or 
one isolated whistleblower. It has been shaken because multiple drug 
safety concerns have been exposed by more than one courageous 
whistleblower. My oversight of the FDA leads me to the conclusion that 
there are cultural and systemic problems at the FDA. Unfortunately, Dr. 
Crawford has long been part of that same culture and system. The 
evidence is overwhelming that the FDA must change to better protect the 
American people. Dr. Crawford does not appear willing to be the man to 
change the FDA.
  During Dr. Crawford's tenure, I have witnessed the suppression of the 
scientific process and the muzzling of scientific dissent. First, with 
Dr. Mosholder finding a link between anti-depressants, children and 
suicide. And second with Dr. Graham's allegations regarding the FDA, 
Vioxx and post-marketing safety generally. Dr. Graham's testimony 
before the Finance Committee suggests that the problems are systemic. 
Oversight of the FDA exposed the cozy relationship that exists between 
the FDA and the drug industry. It revealed that the FDA negotiated for 
almost 2 years with Merck about how to change the Vioxx label so people 
would know about the risk of heart attacks.
  But the problems are not isolated to the Center for Drug Evaluation 
and Research. My staff continues to interview FDA staff across the 
agency, employees who are doing important work on drugs, devices, and 
biologics. It is becoming more and more obvious to me that FDA is 
plagued by structural, personnel, cultural, and scientific problems. 
Those problems should be equally obvious to Dr. Crawford. But under the 
leadership of Dr. Crawford, the FDA appears to be in a state of denial. 
Over the past 18 months, Dr. Crawford has not stepped up to the plate. 
I have seen no recognition of the depth and breadth of the problems at 
the FDA. I have only seen a few short-term band-aids.
  The systemic problems at the FDA demand visionary leadership. Dr. 
Crawford has not shown me that he is the leader to fix the FDA.
  Mr. HARKIN. Mr. President, I rise in favor of the nomination of Dr. 
Lester Crawford to be the Commissioner of the Food and Drug 
Administration. I do this because I believe it is important for the FDA 
to have stable, permanent leadership at this critical time in its 
history. Dr. Crawford has valuable experience both in and out of 
government and has a background that makes him qualified for this 
position.
  I want to highlight several issues where I would like to work with 
Dr. Crawford in the future. First, Congress passed the Dietary 
Supplement Health and Education Act, DSHEA, in 1994 to ensure the 
availability and safety of dietary supplements that millions of 
Americans rely on. Under the leadership of Dr. Crawford as Acting 
Commissioner, FDA has made significant progress in implementing and 
enforcing it. There is still work to be done on this issue, and I look 
forward to continuing to work with FDA to fully implement DSHEA, and to 
make sure that U.S. consumers have access to safe, effective, and 
affordable dietary supplements. ,
  Second, given the Nation's obesity epidemic, I appreciate the efforts 
Dr. Crawford and the agency are making to improve consumer education 
and information regarding nutrition choices. I urge Dr. Crawford to 
follow-up and implement recommendations contained in the FDA report on 
obesity, ``Calories Count.'' In particular, Dr. Crawford

[[Page 16227]]

should direct the entire restaurant industry to follow the 
recommendation to develop a nationwide and point-of-sale nutrition 
information campaign for consumers to include information on calories.
  However, I am also voting in favor of Dr. Crawford's nomination in 
full support of the efforts of my colleagues, Senators Murray and 
Clinton, to obtain a commitment from Dr. Crawford prior to his 
confirmation that the FDA will act promptly and in a scientifically 
appropriate manner on the sale of emergency contraception. I understand 
they have secured that commitment. I share Senator Murray's and Senator 
Clinton's concern about the FDA's handling of the application for over-
the-counter sale of emergency contraception, or the ``morning after'' , 
pill. There is absolutely no dispute that emergency contraception is 
safe and effective. The FDA's own advisory panel concluded unanimously 
in December 2004 that emergency contraception was both safe and 
effective. I strongly disagree with the FDA's decision last year to 
deny over the counter status to emergency contraception. Over the 
counter sale is about prevention. The morning after pill prevents the 
need for abortions, a goal that every Member of this body supports.
  I am voting in favor of Dr. Crawford today. However, with this vote, 
I urge the FDA to address some fundamental challenges facing it in the 
future. The FDA must continue to take action to address post-market 
safety of the drugs it approves. In several high profile cases, the 
public's trust in the agency has been eroded. I look forward to working 
with Dr. Crawford on safety issues in the future.
  Mr. KOHL. Mr. President, I rise in support of the nomination of 
Lester Crawford to serve as Commissioner of the Food and Drug 
Administration, FDA. The FDA has been without a permanent director for 
too long. I believe Lester Crawford is qualified to head the FDA and 
hope the establishment of permanent leadership can put to rest some of 
the uncertainty and delayed decisions that have been plaguing the 
agency for the last year.
  While I remain concerned about resistance by the FDA to allow the 
reimportation of prescription drugs to ensure that our seniors have 
access to affordable prescription drugs, I have expressed my concerns 
to Dr. Crawford. The reality is that drug importation is already 
happening. It's time to stop defending the status quo and setting up 
new roadblocks, and I am hopeful that Dr. Crawford will work with 
Congress to give Americans the price relief and safety assurances they 
need.
  I am also hopeful that the appointment of Dr. Crawford will help 
restore the agency's focus on ensuring that safe and effective drugs 
reach the market in a timely manner, and that recent issues that have 
plagued the FDA, such as questions regarding drug safety, advisory 
committee conflicts of interest and drug advertisements, to name only a 
few, will be addressed.
  Mrs. CLINTON. Mr. President, I rise today to oppose the nomination of 
Lester Crawford to be Commissioner of the Food and Drug Administration.
  The FDA is a vitally important agency, charged with ensuring that the 
products we rely on for our health and well-being are safe and 
effective. Having a strong leader at the helm is essential to a well-
functioning agency.
  Ultimately, after weighing the facts and considering the events that 
have occurred under Dr. Crawford's watch as Acting Commissioner, I came 
to the conclusion that I cannot support this nominee.
  As I said during Dr. Crawford's confirmation hearing and during the 
HELP Committee's consideration of his nomination, Dr. Crawford's tenure 
at the FDA has been marked by controversy. The agency has faced 
scrutiny over its response to various crises: the failure to adequately 
warn us of the possibility of an influenza vaccine shortage, the 
failure to heed concerns about drug safety raised by both agency 
employees and outside scientists, and the failure to adequately 
separate science from what is viewed as ideology-driven decisionmaking.
  As a result, public confidence in the ability of the FDA to ensure 
the safety and efficacy of drugs is failing. The dedicated scientists 
and civil servants who work at the agency are losing morale. They have 
clearly identified the need for reform, for change, and for 
improvements at the agency.
  In December 2004, the Office of the Inspector General of the 
Department of Health and Human Services released the results of a 
survey that found two-thirds of FDA scientists do not believe the 
agency adequately monitors the safety of prescription drugs.
  In March 2005, Dr. Sandra Kweder, Deputy Director of the Office of 
New Drugs at the FDA, testified that it ``would be helpful'' to change 
FDA authority, and give them the power to require changes in drug 
labels, rather than have to negotiate such changes in a lengthy back-
and-forth process with manufacturers.
  And just last week, Dr. Janet Woodcock, Deputy Commissioner of 
Operations at the agency, told an Institute of Medicine panel:

       This system has obviously broken down to some extent, as 
     far as the fully informed provider and the fully informed 
     patient.

  But Dr. Crawford's response to these concerns has been less than 
adequate. He has maintained that the agency ``is fully capable of 
carrying out its mission under its current regulatory and statutory 
authority,'' despite statements and evidence to the contrary from both 
those inside and outside the agency.
  His attempts to address the clear issues faced by the agency have 
been inadequate to the task. For example, despite his November 2004 
announcement that the FDA would fill the position of Director of Office 
of Drug Safety, this position is still vacant--at a time when concerns 
over drug safety have been at the forefront of news about the FDA.
  At a time when the FDA needs a strong leader to restore its 
reputation, Dr. Crawford represents an unacceptable status quo. I fear 
that his record demonstrates that he lacks the vision and the drive 
necessary to ensure that the FDA is the gold standard of drug 
regulation. He has failed to address the concerns raised by his own 
employees about the needs of the agency. And he cannot provide 
assurances that the FDA will place science, not ideology or other 
interests, as the cornerstone of its decisionmaking.
  In addition, I am deeply concerned about the interference of personal 
beliefs over science in the decisionmaking process surrounding 
emergency contraception. By now, the details are all too familiar: the 
FDA's scientific advisory committees voted 23 to 4 in favor of the drug 
being made available over the counter. More than 70 organizations, 
including the American Academy of Physicians, American Associations of 
Family Physicians, American College of Obstetrics and Gynecologists, 
and the American Medical Association, submitted testimony in support of 
Plan B being made available over the counter.
  Press reports later revealed that internal FDA memos indicated that 
career professionals at the agency had recommended unconditional 
approval of the application. And according to a May 8, 2004, article in 
the New York Times, several former FDA officials said they ``could not 
remember another instance in which Dr. Galson, a career officer in the 
public health service or any of his predecessors had overruled both an 
advisory committee and staff recommendations.''
  In May, both The Nation and the Washington Post reported that Dr. 
Hager, a member of the Reproductive Health Advisory Committee, had 
stated, on videotape that he was asked to write a minority report 
arguing that Plan B should not be made available over the counter.
  And the result, up until Friday, was foot dragging by the FDA. That 
is why my colleague, Senator Murray, and I felt it necessary to hold up 
Dr. Crawford's nomination. We wanted to send a strong message that the 
FDA needed to act on this application, which it has had for more than 2 
years. We believed, and still do, that the American people have a right 
to an answer.
  On Friday, we received a letter stating that the FDA would make a 
decision on Barr Laboratory's application

[[Page 16228]]

to move Plan B to over-the-counter status by September 1, 2005. This is 
a giant step forward, but it does not erase the missteps under Dr. 
Crawford's watch.
  That is why I cannot in good faith support Dr. Crawford to be 
Commissioner of the FDA. Like so many Members of this body, I want the 
FDA to have a permanent Commissioner, and I think it is high time for 
that. But that Commissioner must be someone who can restore the drug 
approval and safety processes to the gold standard that the New Yorkers 
who I represent and the Americans who rely on this process for their 
health and, even their lives, deserve.
  I vote ``nay'' and I urge my colleagues to do the same.
  Ms. MIKULSKI. Mr. President, I rise before you today to discuss the 
nomination of Lester Crawford as Commissioner of the FDA.
  I first want to say that I love the FDA. FDA is in my home State of 
Maryland. It employs over 10,000 of my constituents. It is right down 
the road from the NIH. I am proud to have all that research at NIH, and 
then have FDA in Maryland standing up for the food safety of the 
American people, looking out to make sure that the drugs and the 
technologies that we use are safe.
  Over the years I have fought for the right facilities, the right 
resources, and now the right leadership at the FDA. But I tell you, 
today is a very sad day for me because I cannot bring myself to support 
Lester Crawford as the Commissioner, and it is because I am so 
enthusiastic about FDA.
  While I agree the agency has needed someone in charge, Dr. Crawford 
has not been in charge. His stewardship of the agency going back to 
2002 has been both tepid and passive.
  For example, under Dr. Crawford's leadership, the drug Vioxx was 
found to have increased risk of heart attacks long before FDA took any 
action. FDA was slow to reveal the knowledge of increased rates of 
suicides among teenagers taking antidepressants. There was delay. There 
is the politicizing of science as exemplified by the endless dispute 
over emergency contraception. And then there has been a ``just say no'' 
attitude to imported drugs.
  And all of those people looking at homeland security tell us that our 
food supply is vulnerable to terrorist attacks. And what do we get from 
the FDA? We get passivity.
  I am particularly concerned about the issue of drug safety. The FDA 
has been and must remain the gold standard in maintaining drug safety. 
Yet today there is a crisis of confidence over drug safety in the 
public's mind. At Dr. Crawford's nomination hearing in the HELP 
Committee earlier this year, he suggested that the newly formed Drug 
Safety Board within the FDA will be a way to guarantee this safety. I 
asked him how he could guarantee this board--which will exist within 
the FDA--will be able to provide independent review.
  He gave me the bureaucratic answer and bureaucratic structure. I 
asked if he would be in charge of this important guarantee. He said 
``no,'' he was going to delegate that to an Assistant Commissioner. I 
asked ``Why?'' He said: ``Because I would have to be involved in 
personnel and budgets.'' Well--that is his job, isn't it? That is 
exactly the kind of answer we are talking about. You cannot preside 
over FDA. You have to run FDA.
  The nations of the world that cannot afford it look to our FDA to be 
the gold standard. Physicians and other allied health people who are 
prescribing drugs or using technologies need to know that they have an 
FDA that they can count on. And also we, the patients of the United 
States of America, need to know that we can count on the FDA. And the 
pharmaceutical industry has to have an FDA that provides evenhanded 
regulatory authority. That is why I cannot support Lester Crawford as 
Commissioner.
  It is with great reluctance that I have come to this decision, but it 
is because I love FDA and its mission, and know that the people of 
America are counting on it. Whether you are a doctor, or whether you 
are a patient, we need the FDA, and we need strong leadership. 
Therefore, regretfully, and reluctantly, and sadly, I am going to vote 
``nay''.
  The PRESIDING OFFICER. The Senator from Wyoming.
  Mr. ENZI. Mr. President, I yield myself 2 minutes.
  I thank everybody who has made comments today. I wish to address the 
last few comments that were made because our committee has oversight 
over the Food and Drug Administration. We are concerned about any 
situation that would give people less than full confidence in the 
medicines they are taking.
  What we have been faced with for the last 18 months, which has been 
mentioned, is kind of giving a person a job. We have not given him the 
job, we have kind of given him the job. Anybody who has read 
transcripts from previous confirmation hearings would know that this is 
an extremely difficult position to ever get confirmed from. There are a 
lot of viewpoints from both sides. We have to have somebody in charge 
who has full authority, who has the right to look at the science and 
make decisions, who has full authority to make structural changes. I 
would say that Senator Kennedy and I have been looking at that, doing 
the oversight.
  With respect to drug safety, I want my colleagues to know that I take 
the recent drug safety concerns seriously. Senator Kennedy and I are 
working together with our fellow committee members to develop 
comprehensive FDA drug safety legislation in this Congress and to bring 
that bill before the Senate so there can be those changes.
  We will act, but we will act in a way that is mindful of the 
importance of weighing the risks of drugs and the benefits of the drugs 
on the same scale. Every drug has risks, and we would do the American 
people a grave disservice if we overreact to recent controversies.
  The PRESIDING OFFICER. Who yields time? The Senator from 
Massachusetts.
  Mr. KENNEDY I yield myself 2 minutes.
  Mr. President, I agree with the Senator from Iowa that the Vioxx 
incident was an important failure for FDA. But that was not the failure 
of Dr. Crawford or even of FDA. The main problem is the FDA does not 
have the resources necessary to do the kind of work that is required. 
It happens to be the case. The main problem at FDA is one of resources. 
The FDA does not have the money it needs to address drug safety, to do 
the monitoring of drugs, the post-approval surveillance that it should. 
The Office of Drug Safety needs better computers and better access to 
the databases that are out there that can tell us about how drugs are 
being used and what happens when they are used. Congress needs to give 
the FDA more resources to do this.
  With respect to the antidepressants, the FDA quite legitimately 
worked to better understand the issue before it required the label 
change. With respect to the Vioxx label change, the Senator is correct 
that it took too long, but that is because we in Congress have not 
given FDA the authority to require label changes. We need to change 
that.
  The FDA does not have all of the kinds of authority it needs to 
regulate drugs after they are approved. I will be glad to work with the 
Senator from Iowa because, as one who has been interested since I have 
been in the Senate about strengthening the FDA, we have not given them 
the authority and the power to be able to do that kind of job.
  Mr. HATCH. Will the Senator yield on that point?
  Mr. KENNEDY. Yes.
  Mr. HATCH. Isn't it true we passed the FDA revitalization bill back 
in 1989 to create this central campus where we could have the best 
state-of-the-art equipment? We had 48 different locations where FDA was 
located all over the greater Washington area; is that true?
  Mr. KENNEDY. The Senator is correct.
  Mr. HATCH. We have treated the FDA like a wicked stepsister instead 
of giving it the money it needs. It handles more than 25 percent of all 
consumer products in America, right?

[[Page 16229]]


  Mr. KENNEDY. The Senator is correct.
  Mr. HATCH. No matter who is FDA Commissioner, under those 
circumstances it is very difficult to get a handle on everything that 
needs to be addressed by the FDA.
  Mr. KENNEDY. The Senator is correct. I look forward to the 
opportunity of working with the Senator from Utah, the Senator from 
Wyoming, and the Senator from Iowa. We ought to give this agency the 
authority, the power and the responsibility, as well as the resources 
to use it effectively. I know under Chairman Enzi we will have the 
oversight to make sure the agency is doing what it should.
  But I do believe this nominee deserves to be the Commissioner. I 
think it is about time we have a Commissioner. Then let's all work 
together to make sure he and the agency meet his and its 
responsibilities.
  The PRESIDING OFFICER. The time of the Senator has expired. Who 
yields time?
  Mr. ENZI. Mr. President, as we move to a vote on the nomination of 
Dr. Lester Crawford to serve as Commissioner of Food and Drugs, I want 
to remind my colleagues of the important role the Food and Drug 
Administration plays in protecting and promoting the public health.
  The FDA's mission is broad. The FDA regulates food, drugs, biologics, 
medical devices, animal feed, and cosmetics. The FDA regulates 
everything from cellular phones to cell tissue and gene therapies. In 
fact, Americans spend more than 25 cents of every dollar on products 
regulated by the FDA.
  And as science progresses, the challenges of regulation grow. For 
instance, the FDA regulates a host of new products that blur the FDA's 
traditional boundaries. Today, the FDA is charged with regulating drug-
delivery devices, such as coronary stents coated with drugs that 
contribute to keeping arteries open. Then there are next- generation 
orthopedic implants with biologic products built into them to stimulate 
tissue growth.
  All of these new innovations require a nimble and responsive agency 
to regulate them, and they require resources to match. Today, in fact, 
Senator Kennedy and I are introducing legislation to protect and 
strengthen a critical user-fee program. This program provides FDA with 
a stable stream of revenues to support the agency's mission to review 
and approve new medical devices. Without our action, that program would 
expire at the end of this fiscal year.
  I believe that is just one expression of bipartisan support for FDA. 
Is FDA perfect? Of course not. FDA is staffed by human beings, and from 
time to time they make mistakes--as do we all.
  But the FDA plays a critical role in our Nation's public health, and 
an important agency such as FDA needs to have a strong leader with the 
power vested in him by Presidential nomination and Senate confirmation.
  So I urge my colleagues to accept the President's nominee, Dr. Lester 
Craw-
ford, and to vote to confirm him as the next Commissioner of Food and 
Drugs.
  Mr. KENNEDY. Will the Senator yield another minute? Am I right, we 
have until a quarter of?
  The PRESIDING OFFICER. The Senator from Wyoming has a minute 20 
seconds remaining, the Senator from Massachusetts has 2 minutes 40 
seconds.
  Mr. KENNEDY. May I ask the Senator for a minute?
  Mr. ENZI. Yes.
  Mr. KENNEDY. Seeing who is in the chair, does the Senator not agree 
with me that one of the additional important responsibilities of the 
FDA is going to be bioterrorism? We are going to need a Commissioner at 
the FDA to lead this important work to prepare us against a 
bioterrorist attack. That is going to be enormously important. The HELP 
Committee has had our recent briefings on this issue, and bioterrorism 
is certainly an important area on which we will need the leadership of 
the FDA. I know the Senator from Wyoming is concerned about this 
bioterrorism, and the BioShield legislation, to make sure we have the 
vaccines and other medical products on line to respond to the dangers 
of bioterrorism. Bioterrorism is a pressing area in which we are going 
to have to work, and we need a leader at FDA to help us.
  Mr. ENZI. The Senator is absolutely correct. The Presiding Officer is 
chairing that subcommittee and holding extensive hearings on that and 
bringing together some great experts to help us resolve that.
  Mr. HATCH. Will the Senator yield also for just a moment? We 
introduced the bioshield II, the Lieberman-Hatch bill that has gone a 
long way to resolving this matter, and I intend to work with the 
Senator from North Carolina and the distinguished chairman and ranking 
member to see if we can bring this to a conclusion that works.
  I thank the chairman.
  Mr. ENZI. Mr. President, I yield any remaining time we have. I ask 
for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second? There is a 
sufficient second. The question is, Will the Senate advise and consent 
to the nomination of Lester M. Crawford, of Maryland, to be 
Commissioner of Food and Drugs, Department of Health and Human 
Services. On this question, the yeas and nays have been ordered. The 
clerk will call the roll.
  The legislative clerk called the roll.
  Mr. McCONNELL. The following Senators are necessarily absent: the 
Senator from Oklahoma (Mr. Coburn), the Senator from Arizona (Mr. 
McCain), and the Senator from Alaska (Ms. Murkowski).
  Mr. DURBIN. I announce that the Senator from New Jersey (Mr. 
Corzine), the Senator from Connecticut (Mr. Dodd), and the Senator from 
Arkansas (Mrs. Lincoln) are necessarily absent.
  The PRESIDING OFFICER (Mr. Cornyn). Are there any other Senators in 
the Chamber desiring to vote?
  The result was announced--yeas 78, nays 16, as follows:

                      [Rollcall Vote No. 190 Ex.]

                                YEAS--78

     Akaka
     Alexander
     Allard
     Allen
     Bayh
     Bennett
     Biden
     Bingaman
     Bond
     Brownback
     Bunning
     Burns
     Burr
     Byrd
     Carper
     Chafee
     Chambliss
     Cochran
     Coleman
     Collins
     Conrad
     Cornyn
     Craig
     Crapo
     DeMint
     DeWine
     Dole
     Domenici
     Ensign
     Enzi
     Feingold
     Feinstein
     Frist
     Graham
     Gregg
     Hagel
     Harkin
     Hatch
     Hutchison
     Inhofe
     Inouye
     Isakson
     Jeffords
     Johnson
     Kennedy
     Kerry
     Kohl
     Kyl
     Landrieu
     Leahy
     Levin
     Lieberman
     Lott
     Lugar
     Martinez
     McConnell
     Nelson (FL)
     Nelson (NE)
     Pryor
     Reed
     Reid
     Roberts
     Rockefeller
     Salazar
     Santorum
     Sarbanes
     Sessions
     Shelby
     Smith
     Specter
     Stevens
     Sununu
     Talent
     Thomas
     Thune
     Voinovich
     Warner
     Wyden

                                NAYS--16

     Baucus
     Boxer
     Cantwell
     Clinton
     Dayton
     Dorgan
     Durbin
     Grassley
     Lautenberg
     Mikulski
     Murray
     Obama
     Schumer
     Snowe
     Stabenow
     Vitter

                             NOT VOTING--6

     Coburn
     Corzine
     Dodd
     Lincoln
     McCain
     Murkowski
  The nomination was confirmed.
  The PRESIDING OFFICER. The President will be notified of the Senate's 
action.

                          ____________________