Speeches & Floor Statements
Posted on January 29, 2015
The Senator from North Carolina, Senator Burr, and I are here to speak about an important and exciting development that is about to occur in our Health, Education, Labor, and Pensions Committee. What we are talking about and will describe in our remarks today is a report entitled “Innovation for Healthier Americans” which will launch a bipartisan effort to look at how Congress can help to get cutting edge treatments, drugs, and devices to America’s patients more quickly while still preserving this nation’s gold standard for safety and quality. This report and the actions we hope to take will affect virtually every American.
I am especially glad today to be here with the senator from North Carolina. While there are a number of senators in this body who have worked hard on these issues, which in our government are usually dealt with by the Food and Drug Administration and by the National Institutes of Health, but no one has been more effective, no one has worked harder, and no one has had more foresight and vision on these issues than Richard Burr, the senator from North Carolina. The report today is substantially his work product, and he will be deeply involved in the next year as we work with Senator Murray, our Democratic friends, and with President Obama to try to bring this to a result.
In 2013, Dr. Francis Collins, Director of the National Institutes of Health, wrote the following:
Drugs exist for only about 250 of the more than 4,400 conditions with defined molecular causes. And it takes far too long and far too much money to get a new drug into our medicine cabinets. This is an old problem that cries out for new and creative solutions.
Since Dr. Collins said that, the number of conditions with defined molecular causes has increased now to about 5,390, yet the number of new drugs approved has not kept pace with these discoveries.
The president of the United States has recognized this problem. In his State of the Union message a few days ago, President Obama said this:
Twenty-first century businesses will rely on American science, technology, research and development. I want the country that eliminated polio and mapped the human genome to lead a new era of medicine one that delivers the right treatment at the right time.
In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable.
The president said:
Tonight, I'm launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes and to give all of us access to the personalized information we need to keep ourselves and our families healthier.
Senator Murray and I had breakfast yesterday with Secretary Burwell and talked with her about the president's statement and about Secretary Burwell's own desire to help implement that initiative.
Today Senator Burr and I released a report titled “Innovation for Healthier Americans.”
Next, Senator Murray who is ranking member of the Committee on Health, Education, Labor, and Pensions and I will start examining the issues in this report and other issues raised in comments, through a bipartisan HELP Committee staff working group.
I emphasize that we are going to be working together, Democrats and Republicans. We are going to be working with Secretary Burwell, we are going to be working with the president of the United States, and we are going to be on a parallel track with the House of Representatives, where Chairman Upton and his team have been working for several months on what they call 21st century cures. In our committee in the Senate we will begin hearings in March.
We are releasing the report today in order to ask for comments. Surely we missed something in the report. If someone who is listening or reading it may have an idea or solution, we would like to know about that. We have opened an email account just to hear from those outside of Washington, DC, that is email@example.com.
Improving medical device and drug development is not a new topic for the HELP Committee. Legislation was passed in 1997 and different legislation was passed in 2012 to try to get at the same goal of speeding delivery of drugs and devices while ensuring they are still safe. Our goal will be to give bipartisan legislation to the president this year.
It is encouraging to have the House, the Senate, and the president working on such an important common goal that affects virtually every American during the same Congress. That greatly increases our likelihood of securing a result.
We want to improve and modernize how drugs and medical devices are discovered, developed, and approved. We will examine the work of the National Institutes of Health, which funds and enables much of the research that leads to medical breakthroughs and the Food, and Drug Administration which regulates all the medical products we come in contact with.
As I mentioned, this work will touch the life of almost every single American from a very ill patient who has run out of treatment options and is counting on the most cutting edge drug to an active child with asthma who is hoping to run faster and farther with the aid of a new drug.
Today our scientists and researchers are making discoveries at a pace that our development process is not equipped to match. Patients wait while treatments languish in laboratories, going through our drawn out, inefficient, and outrageously expensive development process.
FDA Commissioner Dr. Margaret Hamburg has acknowledged that “we are left relying on the 20th century approaches for the review, approval and oversight of the treatments and cures of the 21st century.”
There is no time to waste in solving this problem. The mapping of the human genome opened a whole new world of individualized medicine in which a person's genetic makeup can drive the doctor’s plan for disease prevention, diagnosis, and treatment.
In the words of Andrew von Eschenbach, the former Commissioner of the FDA and Director of the National Cancer Institute:
We stand on the cusp of a revolution in health care. Advances in molecular medicine will allow us to develop powerful new treatments that can cure or even prevent diseases like Alzheimer's and cancer. Tomorrow's high tech cures can also slash health care costs and eliminate ineffective treatments. What will it take to realize the potential of the new medicine?
Today's report is the first step of our initiative. It seeks to answer the questions: What today is driving innovation? What barriers are standing in the way? What can we improve?
The report has five main themes:
No. 1, it costs too much to bring medical products to patients;
No. 2, as science and technology advance, the discovery and development process takes too long;
No. 3, the Food and Drug Administration's responsibilities have grown to include many unrelated to regulating medical products;
No. 4, science outside the FDA is moving at a faster pace than ever;
No. 5, an effective FDA is essential to maintain the U.S. leadership in biomedical innovation.
Some of the report’s key findings include that complex medical devices approved in the U.S. were available to patients in Europe on average four years earlier than in the U.S., and increased competition for NIH grants may be discouraging researchers from proposing risky projects. Further, the average cost to develop a drug is disputed—some say $1 billion, some say $2 billion, some more—but all agree it is rising, and unpredictable and inconsistent development requirement standards in the FDA review process drive product developers to design clinical trials that are unnecessarily expansive.
Since World War II, the U.S. has dominated the biomedical industry space. Even 20 years ago, studies suggested that the U.S. share of global biomedical research funding was as high as 70-80 percent. However, from 2007 to 2012, the U.S. share of research and development declined from about 51 percent to 45 percent. While the U.S. continued to lead the world in public sector investment during this time, private sector investment shrank by almost $13 billion and largely reallocated to Asia.
This is a chance to step back and look at where we are and how all the different reauthorizations have added up. We need to ensure that legislative efforts over the last 30 years are helping and not getting in the way of having the best treatment and technology available for the right patient at the right time.
Our goal is simple but ambitious – to work in a bipartisan way with members of the HELP Committee to make sure policies support medical innovation and patient access to important medicines and medical technologies.
I ask unanimous consent to have printed in the record the copy of the executive summary from the report that Senator Burr and I are releasing today.
I look forward to the remarks from the Senator from North Carolina. As I have said, no senator has done more on either side of the aisle in this area of helping us think about creative new ways to move treatments, medical devices, and drugs through our safety process into the medicine cabinets and into the hands of patients who desperately need them.
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