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| REMARKS BY: | TOMMY G. THOMPSON, SECRETARY OF HEALTH AND HUMAN SERVICES |
| PLACE: | BIO 2002 Conference, Toronto, Canada |
| DATE: | June 10, 2002 |
Carl (Feldbaum), you have made BIO a key player in almost every major policy discussion in the Administration and on Capital Hill. Thank you so much for your leadership.
I also want to welcome the Wisconsin Team that's here with us today. It's good to see so many friends from my great home state, including our governor, Scott McCallum.
It's a true pleasure for me to address BIO at this tremendous conference. My friends, it is no exaggeration to say that the biotechnology industry is defining innovation in our time … or that BIO is one of the premier industry associations in the world.
On behalf of President George W. Bush and on my own behalf as U.S. Secretary of Health and Human Services, let me thank BIO and its many member companies for your efforts to improve the health and well-being of men, women and children of every nation, and especially those in my country.
I love joining you in the great nation of Canada, where I've been able to spend a fair amount of time since becoming Secretary. My great home state of Wisconsin shares Lake Superior with Canada, and while governor I appreciated working with my Canadian counterparts.
I've always thought Canada is one of the most beautiful nations on earth, and my own country has no truer friend than our wonderful northern neighbor.
Toronto is, of course, home to the Blue Jays, a fine team with a rich tradition. I love the opening months of the baseball season, and earlier this year got to throw the first pitch at a Chicago Cubs game.
Some of us here probably feel like this guy who really loved baseball. He was one of the ultimate fans. He loved the game so much that he told a buddy of his, "If you make it to heaven before I do, you have to somehow get in touch with me and let me know if there's baseball behind the Pearly Gates."
Well, a few years went by and, sadly, the baseball lover's friend died. But true to his word, he managed to get in touch with his friend still here on earth.
"The good news," he said, "is that there is baseball in heaven."
The baseball lover was ecstatic. Eternity on the baseball diamond - what could be better than that?
But his departed friend also said, "I have some bad news, too … you're pitching this Thursday."
Well, I hope none of us have to pitch in a heavenly game for a long time to come. In the mean time, it's good to know that the member companies of BIO are improving so many aspects of life for people in every corner of the globe. The scientific data show that biotechnology can result in healthier foods and be better for the environment.
Biotech foods could improve food yields by up to 25 percent in the developing world and feed the more than three billion people to be born in the next three decades. Put simply, BIO is proof that great advances in technology can also lead to great exercises of compassion.
I'd be remiss not to note that many of your companies have been involved in helping America prepare for future acts of bioterrorism … and that many of you responded with immediate and very practical help following the attacks of September 11th. All America is in your debt for your generous and effective work in the wake of that painful day.
The field of biotechnology is a broad one. There are many issues that challenge us and demand our best efforts in a public-private partnership.
Today, I'll deal with four areas of particular and immediate concern: Stem cell research, FDA policy, the Prescription Drug User Fee Act - also called "PDUFA" - and our commitment to modernizing Medicare.
First, let me touch on stem cell research. When I was Governor of Wisconsin, Jaime Thomson of the University of Wisconsin conducted groundbreaking research into embryonic stem cells. I worked hard to provide funding for his research, and was gratified when, last year, the President authorized research on existing embryonic stem cell lines.
Now, our National Institutes of Health has named 14 laboratories throughout the world that can distribute 78 embryonic stem cell lines that meet President Bush's criteria for federally funded research.
Basic research will be done on these cell lines, and will be done, in part, with the use of federal funds. We have begun issuing grants to companies and academic institutions to study the stem cell lines we have approved.
And we're already beginning to realize the promise of stem cell research. At the Waisman Center at the University of Wisconsin, neural stem cells are being genetically modified to release glial derived neurotrophic factor, or GDNF. GDNF is known to prevent the death of dopamine neurons - the very thing that underlies Parkinson's Disease.
These stem cells have been transplanted into rat and money models of Parkinson's Disease at the Waisman Center and Primate Center. The result: significantly improved motor skills in rats and monkeys with Parkinson's symptoms.
This is very significant - especially, or course, for sufferers of Parkinson's Disease.
There are other amazing developments in the area of adult stem cell research. In January, researchers at the University of Minnesota announced that they made a discovery about an adult stem cell that has the potential to develop into many different cell types in the human body.
Previously, researchers had believed that only embryonic stem cells could be developed into multiple cell types. But it now seems entirely possible that cells from one's own body can be coaxed into replacement organs and tissue that match one's body precisely.
Just two weeks ago, researchers at Duke University Medical School and Artecel Sciences - a member company of BIO - transformed adult stem cells derived from fat into cells that seem to be human nerve cells.
According to Duke's Medical Center, their researchers, working in tandem with Artecel, have been able to reprogram adult stem cells taken from liposuction into bone cells, cartilage and fat. The newest round of research has shown that fat-based stem cells can be transformed into neuronal cells. This is remarkable, and while the research is not final, it offers tremendous promise.
I am passionate about moving forward with this kind of research. So many conditions, from Parkinson's Disease and multiple sclerosis to various types of cancer, could well benefit - could even be defeated - by stem cell research. In my role as Secretary of Health and Human Services, I am doing all I can to promote it.
Stem cell research is only one facet of our commitment to improving the quality of care and the quality of life. Another key aspect of this commitment is the work done by the FDA.
The FDA is being led currently by Dr. Lester Crawford. Dr. Crawford is doing a tremendous job, and is here with us this morning. Lester, please stand so we can recognize you. You're a wonderful public servant, and we all thank you for your great work.
Dr. Crawford and I share a bold new vision for the FDA. We are creating an FDA where risk management is the rule, not the exception. We're putting together extensive risk assessment programs - the most far-reaching in the history of the FDA - to assure that the United States has the purest food supply possible. That, my friends, is a solemn promise.
We're going to achieve this goal through some exciting new initiatives. The risk assessment programs are going to be integrated into all of FDA's centers and operating units … with a special emphasis on the field force, where about half of all FDA employees work.
We're converting the focus of inspections to possible contamination by bioterrorists and to defective product detection. And we've hired over 600 of the 655 new food safety personnel recently funded by Congress. Hiring and training these new inspectors is FDA's top priority.
As these inspectors are trained, FDA will double physical examinations of food imports in 2002 and again next year. We have also asked for an additional $9.7 million just for food safety above the 2003 request.
In addition, I know that your industry has been very clear in its opposition to mandatory labeling of biotech foods. I want to tell you today that I share your opposition. Mandatory labeling would only frighten consumers and play into the hands of those who exploit fear rather than deal in fact.
The Bush Administration believes that mandating the labeling of foods that contain bio-engineered ingredients will be costly both to industry and consumers. It will not provide any useful safety or health information to the public and it seems to imply that bio-engineered ingredients are unsafe.
Also, BIO has taken a strong stance concerning drug reimportation. Let me be clear that we in the Bush Administration are committed to providing seniors with affordable drugs, as I will discuss in a few moments. But affordability must not come at the risk of the public health.
Opening our borders to reimported drugs potentially could increase the flow of counterfeit drugs, cheap foreign copies of FDA-approved drugs, expired and contaminated drugs, and drugs stored under inappropriate and unsafe conditions. In light of the anthrax attacks of last fall, that's a risk we simply cannot take.
All of that said, my friends, pharmaceutical firms need to do more to bring down the price of drugs. We appreciate the good work a number of major firms have done in providing drug discount cards for seniors, but let me ask you to do more.
Pharmaceuticals in the United States have got to become more affordable. If they do not, I fear that those who wish to mandate price controls might eventually win the day, and that would do serious harm to America's entire health care system.
We have also moved forward with rapid approval of useful drugs, in part through the reauthorization of the Prescription Drug User Fee Act, of PDUFA. PDUFA authorizes the collection of user fees for reviewing drug applications.
We in the Administration appreciate BIO's good counsel and input as we crafted the legislation and moved it forward. So, with your help, PDUFA will be stronger and more effective than ever. Both health care consumers and companies like yours will benefit.
The Administration's authorization of $223 million for PDUFA, an increase of $61 million - nearly 40 percent - over the current year, was included in the bioterrorism legislation passed last month by both houses of Congress, and is scheduled to be signed into law by the President today. That's good news for everyone.
Finally, consumers and companies alike depend on the continued viability of one of the most significant social programs our nation has ever had - Medicare.
At the dawn of the 21st century, Medicare's promise is threatened by outdated and inadequate benefits, limited protection against rising medical costs, and a traditional government plan that often fails to deliver responsive services to recipients or ensure high-quality care.
President Bush is committed to the comprehensive modernization of the Medicare program and strengthening it for all seniors, and the President has outlined a visionary, bipartisan plan to that end.
At the heart of this plan is a belief that we must provide better and more efficient delivery of services, and provide a prescription drug benefit in the context of modernizing and improving the entire system.
The President is committed to a Medicare subsidized drug benefit that protects seniors against high, catastrophic drug expenses. And we must also support the continuation of affordable prescription drug coverage now available to many seniors through retiree plans and private health insurance plans.
I know most of you already have your products covered by Medicare, and that many of you are concerned with Medicare pass-through payment policy.
We want to work with you on pass-through drug cost policy. We look forward to getting your input on how we can address this issue effectively. We want to resolve this issue in a fiscally responsible way, and at the same time provide the assistance needed to advance sound policy. So, keep CMS and me appraised of your ideas and concerns and we'll get this done in the right way.
Well, stem cells, the FDA, PDUFA and Medicare are some of the larger items on the horizon of health care policy. And on all of them, and so many more, we need your counsel.
Your input is especially important since innovation is critical to the future of health care around the world. In case there's any doubt, consider the words of a Western Union internal memo that was circulated in 1876.
Let me read a brief excerpt - here it is: "This 'telephone' has too many shortcomings to be seriously considered as a means of communication. The device is of no value to us."
It's easy to laugh at a projection that turns about to be as incredibly wrong as that one, but all of us must be wary of the same attitude when it comes to technology and the prospect for change.
In the context of sound ethics, biotechnology offers such enormous promise it is hard to overstate it. And you - the men and women here in this auditorium - are the pioneers of that innovation.
Thank you for all you have done and continue to do to make our world better. Uncounted millions of people everywhere on earth are in your debt. And President Bush and I look forward to continuing to work with you closely in the days ahead.