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Kennedy Discusses Critical Issues Facing Biotechnology Industry In Massachusetts And Around The World

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Location: Boston, MA


KENNEDY DISCUSSES CRITICAL ISSUES FACING BIOTECHNOLOGY INDUSTRY IN MASSACHUSETTS AND AROUND THE WORLD

Senator Edward M. Kennedy today addressed the 2007 BIO International Conference held at the South Boston Convention and Exhibition Center. Due to scheduled votes on his FDA revitalization bill, Kennedy delivered his remarks from Washington. Senator Kennedy discussed the critical importance of investment in life science research, including life-saving stem cell research to unlock the doors of discovery to Parkinson's, Alzheimer's, heart disease and cancer. Kennedy also discussed his efforts in Congress to revitalize the FDA and to increase consumer and patient safety.

"The challenge of this new century must be to see that the benefits of the biotechnology revolution are shared by all citizens of the world, not just those fortunate enough to live in America and other developed nations," said Senator Kennedy. "The legislation I am fighting for today will improve patient access to new therapies. Some have argued that any increase in safety will inevitably decrease access - but that's a false comparison. At the heart of our proposal is a modern system for improving patient safety - not through additional layers of bureaucracy, but through a flexible structure that emphasizes post-market surveillance."

Senator Kennedy's legislation, the "Food and Drug Administration Revitalization Act" faces a final vote in the United States Senate this week. Kennedy's legislation would improve surveillance to catch problems in drug safety early, implement safety management strategies and increase patient access to new and innovative therapies.

Biotechnology industry leaders from around the world gathered in Boston from May 6-9 for their annual conference. The Biotechnology Industry Organization (BIO) represents more than 1,100 biotech companies and research institutes from the United States and 31 other countries. Along with Senator Kennedy, the keynote speakers who addressed the convention were Her Majesty Queen Noor of Jordan and actor Michael J. Fox.
REMARKS OF SENATOR EDWARD M. KENNEDY
BIO CONFERENCE
MAY 7, 2007

(As Prepared for Delivery)
It's a deep honor to be invited to be with all of you today, but I hope that you will grant me an excused absence. The fate of our FDA legislation rests with the Senate's actions today, so I hope you will join me in urging the Senate to move forward on this vital legislation.

I'm a strong believer that innovation is the spark of human progress. I've appreciated the chance to work closely with my friends in the biotechnology sector in Massachusetts because you are at the forefront of that innovation.

I'm reminded of the inspiring words of the poet Robert Browning that our reach should exceed our grasp. And that should be our calling today.

We must overcome the limits to our vision and work each day to make progress a reality in the lives of our citizens. Innovation is essential to our economic progress, improving our environment, the ability to care for our families, and even our national security.

During a recent visit to NIH, I heard where the life sciences can take us. Scientists have unlocked the secrets of the genetic code and can use the techniques of recombinant DNA technology in ways that were unimaginable in years past.

Science is doing the same in agriculture as we use recombinant DNA to help derive bio-fuels from corn and other crops, so that we can one day be free of the need for foreign oil. Science is bringing that same progress to energy as researchers are trying to find ways to make engines work as efficiently as enzymes. Science is transforming environmental protection as we investigate whether DNA techniques can make trees grow more quickly and with more leaves to alleviate global warming by capturing carbon dioxide from the atmosphere more efficiently.

The technologies of the last century - steel, oil, and chemicals - improved standards of living, but too often left environmental devastation in their wake. The technology of this new century can help repair the damage. Recombinant DNA technology can improve the ability of plants to absorb harmful greenhouse gasses and to let bacteria disable environmental toxins, to help clean lakes and oceans of dangerous pollutants.

In health care, the prospects for advances are limitless. We are witnessing the dawn of personalized medicine, where treatments can be tailored to an individual patient's genetic code.
The complement to these breakthroughs in DNA research is the extraordinary new field of stem cell science. Together, these two branches of discovery offer new hope for spinal injury, Parkinson's Disease, diabetes, and many other illnesses.

But this bright future is in jeopardy if our laws fail to keep pace with our technology. All the benefits of genetic medicine depend on one step - the willingness of patients to undergo genetic tests that can improve their health. That willingness should be straightforward - but too often, patients fear that their genetic information may be misused to deny them health insurance or a job.

If Congress enacts clear protections against genetic discrimination, all Americans will be able to enjoy the benefits of genetic research. The House of Representatives has acted and we have passed the bill out of the health committee that I chair. We now must get it to the finish line.

We all had to fight hard to create the extraordinary medical innovations we enjoy today, and we have to fight just as hard now to maintain that progress. A culture of innovation and discovery does not just happen. It must be nurtured or it will wither.

The United States has a long tradition of being a global innovative leader - but we can't take our leadership for granted. Today, it's at risk. Thirty years ago, U.S. researchers published 90 percent of all scientific literature on information technology. Today, it's less than half. Unless we invest in the life sciences, the story will soon be the same for biotechnology.

While Asian countries continue to increase investment in basic science, our percentage of the GDP spent on basic research continues to fall. Today, only 52 percent of all U.S. industrial patents are requested by Americans.

We must take action to respond to the challenge of globalization. The wrong way is through a race to the bottom where nations compete to see who can provide the lowest protections for workers and the cheapest wages. The right way is to invest in the education and training needed to help American workers compete.

We've seen the benefits of wise government investments in innovation. In the 1990's, Congress doubled the budget of the NIH. And we reaped the results of that investment with new breakthroughs. The benefits of this funding were not confined to labs at hospitals and universities, but were multiplied by private investment in the dynamic biotechnology firms that help bring the breakthroughs in the laboratory to the bedsides of the patients.

Unfortunately, instead of building on this progress, the current Administration is undermining it. Under the President's budget proposal, NIH will receive a billion dollars less next year than is needed to keep up with inflation.
If these budget recommendations are enacted, more than 4 out of 5 new grant proposals will have to be rejected┬Śnot for lack of merit, but for lack of funds. We erode our culture of innovation by failing to invest in the discoveries of tomorrow.

The legislation that keeps me in Washington today will also make a major contribution to your progress. The bill that Senator Mike Enzi and I have brought before the Senate will bring the work of the FDA into the twenty-first century.

Every day that a medicine is delayed needlessly in the review process is another day in which the innovations of this remarkable industry are denied to the patients who need them. Every time a test or clinical trial is ordered needlessly is an added cost that ultimately must be paid by patients.

At the heart of our proposal is a modern system for improving patient safety - not through additional layers of bureaucracy, but through a flexible structure that emphasizes post-market surveillance.
As we developed this bipartisan legislation, there were some who urged us to load every conceivable requirement onto the drug review system. They asked us to create a separate office of safety to serve as a check against rapid approvals.

We rejected those calls, and adopted a balanced approach that brings the power of information technology to safety surveillance. Under our proposal, FDA will have access to a new array of data about drug safety - not from costly clinical trials but from existing databases and electronic records. This is a proposal that former FDA Commissioner Mark McClellan refers to as "health IT for drug safety." Currently, FDA might need to request an expensive clinical trial to get information about a drug's action or safety, but under our legislation, that same information could be available at the touch of a button. Already, systems like the Mayo Clinic and the VA can pinpoint the effects of using specific drugs in particular patients without having to do new clinical trials - and FDA should have that ability too.

The legislation I am fighting for today will improve patient access to new therapies. Some have argued that any increase in safety will inevitably decrease access - but that's a false comparison.
Consider the situation now when FDA is confronted with a new drug that may pose safety risks or where additional study may be required. Today's FDA might conclude that the risks of approving the drug are too great. But under our legislation, FDA could allow patients access to the drug, knowing that effective safety measures were in place.

The proposal I am fighting for in Washington also establishes a public-private partnership at the FDA, the Reagan-Udall Foundation. We have heard time and again that there is a need for better research tools to aid FDA in evaluating the safety of drugs and to help researchers move through the long process of developing drugs more effectively.

The Reagan-Udall Foundation sets up a way to develop these new tools - not so they can help just one researcher or one company, but to aid the entire research enterprise.

Our legislation also includes a commitment to the nation's children by renewing the important incentives to encourage testing of medicines for children.
Our work together won't be over when the current debate concludes. Our committee will soon take up the important question of follow-on biologics. We've heard important testimony on the European system, and I've received excellent recommendations on a policy that is led by science, protects safety, and values innovation. My door is always open to you, and I welcome your expertise and your views as our deliberations continue.

Our FDA legislation also includes a novel proposal from Senator Brownback and Senator Brown to encourage the development of new therapies for neglected diseases. Companies that develop new therapies or vaccines for tropical diseases will receive a credit entitling them to a priority review at FDA for a product of their choosing.

The proposal will not raise costs to consumers, nor will it change FDA safety standards. But by allowing a company to move one of its products to the head of the line for review, it will provide a responsible incentive for the development of new medicines.

That proposal is but a start, but we need to go much farther. The United Kingdom and many other European nations have created innovative advance market commitments and other financial incentives to spur development of new ways of treating diseases of the poorest nations, and we should learn from their example.

We must lead in compassion as we have led in innovation. The greatness of our hearts must match the greatness of our inventions. Biotechnology can help break down one of the highest barriers between rich nations and poor - the crushing burden of disease that thwarts the progress of billions around the world.
The challenge of this new century must be to see that the benefits of the biotechnology revolution are shared by all citizens of the world, not just those fortunate enough to live in America and other developed nations.

Countless lives and the potential of a continent have been lost to the ravages of AIDS, TB, malaria and other infectious diseases in Africa. I believe that it is within the capability of the extraordinary assembly of talent at this convention to cure each of these scourges within the next two decades. Already, doctors are exploring new ways to deliver vaccines that do not require refrigeration, which is unavailable in so many parts of the world.
Your industry must take as its challenge the needs not only of the developed world, but of those nations where disease has held back progress. The life sciences era must belong to all the citizens of the world.

The awesome task before the biotechnology industry then is not simply to innovate -and that is challenging enough - but to innovate in ways that help make your miracle products more affordable and more accessible to those who need them so urgently.
This conference is both a celebration and a call to action. You are right to celebrate a breathtaking record of achievement - and right to call for action from your colleagues and from government to create and sustain a culture of responsible innovation for the people of America and the world.

Thank you for inviting me to be part of this distinguished gathering. And thank you for all you do!


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