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Public Statements

Combating Autism Act of 2006

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Date:
Location: Washington, DC


COMBATING AUTISM ACT OF 2006 -- (Senate - December 07, 2006)

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Mr. KENNEDY. Mr. President, at 5:45, in just 15 minutes, we will have an opportunity to vote on the nominee to head the Food and Drug Administration. I want to first of all commend my friend, the chairman of our human resource committee, Senator Enzi, for his leadership over this period of time in giving the assurance to the agency, and much more importantly to the American people, that we are going to have someone in charge of this agency able to exercise executive decisions, to make sure the agency itself is going to fulfill its role in protecting the health of the American people. So first of all, I thank my colleague and friend, Senator Enzi, for making sure we are going to get an opportunity to vote.

I thank the majority leader, Senator Frist, for making sure that we were not going to leave this session without having a final vote on the nominee.

In the last 5 years, only in one of those years did we have a head of the FDA. The rest of the time, they were ``acting.'' A good deal of the time, there was virtually no presence. This is the most important health agency that guides and guards American's health, the health of our children, the health of the elderly, and the health of families in our Nation. So this is a very important point, and I welcome the opportunity to urge the Senate to approve Andrew von Eschenbach for this position.

As I mentioned, the Food and Drug Administration oversees the products that account for fully a quarter of the entire U.S. economy. Every day, the agency makes decisions that mean the difference between life and death for countless patients. Millions of Americans rely on drugs the FDA approves to protect them from sickness, and every family in America counts on the FDA to see that the food they eat is free from contamination.

Now we are in the life science century, and the opportunities for breakthroughs with new drugs is unlimited. With the progress we have made in the Human Genome Project and the sequencing of the genes, the research that is being done across this Nation, the possibilities are virtually unlimited. But it is all new science. We have to make sure that this agency which is going to make the judgments and decisions about approval or disapproval is going to have the best in terms of scientists, the best in terms of leadership. That is at issue here if we do not have someone who is going to be the head of the FDA to make sure the agency that has responsibility for the safety of prescription drugs is going to work in ways to protect the American consumer; that the agency that is in charge of the food safety in this country is going to work to ensure that it is going to be effective for the American people.

Now the agency itself, the FDA, urgently needs treatment. For too long, it has been without a confirmed leader. It has become a ship without a captain, lacking the initiative and confidence that only a confirmed commissioner can bring. Year after year, under this administration, the FDA has been allowed to drift, and year after year the challenges that face the agency have grown.

Think of the controversies--about antidepressants, about the withdrawal of Vioxx, about the sale of Plan B over the counter, about adequate review of drugs on the market. The agency has had to struggle unfairly with difficult scientific questions, inadequate resources and authority, and political pressures to ignore the science that must be--good science has to be at the heart of its mission.

Finally, the day is here when the Senate can act to confirm a commissioner whose job No. 1 will be to restore the leadership to this essential agency and begin the process of addressing the many major concerns that have gone unmet for so long.

Dr. von Eschenbach is a good choice to lead the FDA. At the National Cancer Institute, he led bold initiatives on the human genome and nanotechnology. As a physician for patients with cancer and a survivor of cancer himself, he brought an indispensable patient-centered perspective to the Cancer Institute, and he will bring that to the Food and Drug Administration as well.

Dr. von Eschenbach was able to find a solution to the controversy about allowing the over-the-counter sales of Plan B. We may never know the battles he had to fight and win to achieve that solution, but his integrity and tenacity in achieving a solution speak volumes for his character and his commitment to public health.

FDA has long been regarded as the gold standard in regulatory work. That will continue to be true only if it makes independent, science-based decisions, in both fact and appearance, and under Dr. von Eschenbach's leadership, we expect FDA to make those discussions solely on the basis of science and in the best interests of public health. To do

the job we expect----

The PRESIDING OFFICER. The time of the Senator has expired.

Mr. KENNEDY. I ask, if there is no objection, that I be able to proceed for another 4 minutes?

The PRESIDING OFFICER. Without objection, it is so ordered.

Mr. KENNEDY. Mr. President, we have to make sure the agency itself is going to have the adequate resources that are going to be necessary to protect the public interest. What we are talking about here is making sure they have the best, in terms of science--in terms of prescription drugs and the new breakthroughs. We have the whole range of new medical devices which are out there. The United States is leading the way. We want to make sure they are safe and effective. The agency has important responsibilities in terms of the safety of our food supply. We have given it additional kinds of responsibilities to deal with the challenges of the war on terror.

This agency has enormous responsibilities in terms of the consumers and the families of this Nation. It needs the strong leadership which I think the nominee can bring, and it needs the kind of support from the Congress that will permit it to be the true gold standard for safety and for improving the health of the American people.

As other agencies are set up around the world--in Western Europe and now even in Asia--the place they look is at the FDA, and for very good reason. We want this agency to be the best. It can be the best. With a new leader and hopefully with the new Congress giving the agency the kind of support it should have, we can make sure the health of the American people in these important areas is going to be secure for the future.

Again, I thank my friend and colleague from Wyoming for his persistence and tenacity in making sure where we are this evening. We would not be here if it had not been for his good work on this issue, as in so many others. I thank him, and the American people ought to know that this is an enormously important vote to protect their interests. I hope this nominee is approved overwhelmingly.

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