[Congressional Record Volume 148, Number 132 (Wednesday, October 9, 2002)]
[Senate]
[Page S10219]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                    NOMINATION OF DR. MARK McCLELLAN

  Mr. FRIST. Mr. President, just a few moments ago, I joined my 
colleagues on the Health, Education, Labor, and Pensions Committee in 
unanimously approving the nomination of Mark McClellan to be 
Commissioner of the Food and Drug Administration. I rise now to 
strongly urge the Senate to immediately act on the nomination.
  Dr. McClellan is not a stranger to the Senate. During his service on 
the Council of Economic Advisors, many of us have benefitted from his 
expertise, clear-headed analysis, and sound advice concerning health 
policy matters. Dr. McClellan has served the President well and I know 
that he will continue to serve the Nation well as the next Commissioner 
of the Food and Drug Administration.
  Mark McClellan is an excellent choice to lead the FDA. He is a 
talented academician and economist who has helped challenge 
conventional thinking about important health policy matters through 
groundbreaking research. He is a gifted health policy analyst who has 
worked to improve the Nation's health care system for all Americans. 
Perhaps most importantly, he is also a physician who has cared for 
patients and knows first hand that there are few greater callings than 
helping to heal one's fellow man.
  Mark McClellan is uniquely qualified to lead this important agency at 
this critical time.
  The challenges confronting the next Commissioner of the FDA are 
great, perhaps greater than at any other time in our Nation's recent 
history.
  Of course, the FDA has an important, ongoing role to play in ensuring 
the safety and efficacy of drugs, biologics, food, cosmetics, blood 
products, and devices, goods and products accounting for nearly one-
quarter of all consumer spending in the United States. But the FDA 
Commissioner must be more than simply the head of a large, regulatory 
Government agency. He must also provide strong leadership on a broad 
range of critical health policy issues that directly affect the lives 
and well-being of every American.
  I would like to highlight some of the issues on which it is critical 
that the FDA Commissioner provide leadership at this time. The most 
significant issue we have faced over the past year is terrorism. On 
September 11 we endured the most horrendous attack on American soil 
since Pearl Harbor. This week, we mark the 1-year anniversary of the 
worst attack of biological terrorism in this country. We cannot know 
when, where, or in what form the next attack will happen, but we must 
be prepared. This includes speeding the review and approval of rapid 
assays, vaccines, and other necessary bioterrorism countermeasures. 
Numerous scientists and research facilities are working to meet the 
call of the President and Congress to protect our homeland from outside 
threats. The FDA must help fashion an environment in which these 
discussions are encouraged and translated to medical practice.
  At the same time, we cannot ignore naturally emerging threats to the 
safety and sustainability of our blood, tissue and organ supply. Last 
week, it was reported that 40 people were exposed to hepatitis C from a 
single organ and tissue donor and salmonella was transmitted through 
blood transfusions. This is in addition to the growing body of 
knowledge we are amassing on West Nile virus. Considered together with 
the existing shortage of blood, tissue and organ donors, the need to 
speed the development of new screening and purification products is 
clearly illustrated.

  Finally, I would like to highlight the importance of promoting a 
regulatory environment that values innovations to improve patient care 
and consumer safety, while at the same time safeguarding the public 
health. But this must be done without contributing unnecessarily to 
overall rising health care costs or allowing basic medical treatments 
to be forgotten. We presently face just this situation with our 
Nation's vaccine supply. Currently, only four manufacturers produce 
vaccines and they face the multiple challenges of a growing litigation 
crisis and changes in the FDA's regulatory oversight. While most of the 
recent childhood vaccine shortages have been alleviated, our system 
remains vulnerable to future shortages if we fail to act.
  Mark has my full support, the full support of the HELP Committee, and 
I believe the full support of the Senate. It is in not only in our best 
interest to see that his nomination is acted on quickly, but it is in 
the best interest of the entire Nation for the Senate to confirm him as 
the next Commissioner of the Food and Drug Administration. We cannot 
wait or allow the nomination to be delayed.

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