04.28.15

Murray Calls for Continued Progress in Medical Innovation, Focus on Safe and Effective Treatment for Patients

(Washington, D.C.) – Today, Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Patty Murray (D-WA) delivered remarks at a HELP Committee hearing on Continuing America’s Leadership: The Future of Medical Innovation for Patients. In her opening statement, Murray called for Congress to work to find ways to advance the development of new medical products for patients, while continuing to ensure the highest standards of medical safety and effectiveness.  Murray also called for bipartisanship to continue support and investment in biomedical innovation to maintain the United States’ leadership, and help families and communities stay healthy.  Murray highlighted her home state of Washington---which has been a leader in biomedical innovation---and the work being done there to find new life-saving cures and treatments.

Key excerpts from Senator Murray’s opening statement:

“I’m proud to represent a state that is a leader in biomedical innovation. I see maintaining our country’s central role in the life sciences as a top priority. And I believe we need to be doing everything we can to make sure the next life-saving, world-changing cures and treatments are developed right here in the United States.”

“I had the chance to visit the Fred Hutchinson Cancer Research Center in my home state of Washington recently.  As I always am when I visit my state’s world-class research facilities—I was struck both by how far we’ve come in terms of medical and technological advancement and also by how much more there is to discover.”

“Over the last half century our medical system has taken huge leaps forward. We’ve moved from a system in which many patients had no idea whether medical products would help them, hurt them, or do nothing at all, to one in which FDA-approved treatments are the global gold standard for safety and effectiveness—a standard that patients and families have come to trust when making decisions about their health.”

“Today, medical experts are continuing to push the limits of science and technology. We now increasingly have the capability to treat patients based on their own unique characteristics and medical histories. In my home state alone, scientists supported by the NIH are exploring ways to stop cancerous cells from metastasizing, which is the number one cause of cancer deaths and develop 3D analysis of internal biological surfaces so devices like joint replacements can be better integrated into the human body.”

“Our task in Congress, and in our bipartisan effort to support medical innovation for patients—is to support this work, and ensure that our country continues to uphold the highest standards of medical safety and effectiveness.”

“Over the last few years, Congress has put in place tools like FDA’s breakthrough designation and accelerated drug approval, which have helped patients and families get treatment more quickly for serious and unmet medical needs…This focus on regulatory flexibility, where appropriate, is helping patients and families get the care they need when they need it—and I’m hopeful we can continue to make progress on this.”

“Another area where I hope we can be helpful is finding ways to advance the development of new medical products for patients…I am hopeful that as our discussions continue, we can find ways to support efforts to tackle difficult scientific challenges in the development process, and in addition, explore innovative ways to determine which products are really going to make a real difference for patients and families, and weed out products that are not, earlier on in the process.”

Full text of Senator Murray’s opening statement:

“Thank you, Chairman Alexander. And thank you to everyone here today, especially our witnesses, for joining us.

“I’m proud to represent a state that is a leader in biomedical innovation. I see maintaining our country’s central role in the life sciences as a top priority. And I believe we need to be doing everything we can to make sure the next life-saving, world-changing cures and treatments are developed right here in the United States.

“The conversation we’re having this morning, about the future of medical innovation for patients and families, is a really important part of this effort.

“I had the chance to visit the Fred Hutchinson Cancer Research Center in my home state of Washington recently.  As I always am when I visit my state’s world-class research facilities—I was struck both by how far we’ve come in terms of medical and technological advancement and also by how much more there is to discover.

“Over the last half century our medical system has taken huge leaps forward. We’ve moved from a system in which many patients had no idea whether medical products would help them, hurt them, or do nothing at all, to one in which FDA-approved treatments are the global gold standard for safety and effectiveness—a standard that patients and families have come to trust when making decisions about their health.

“Clinical research has of course been a key contributor to this progress. I’m pleased that recently there has been increased focus on the need for clinical trials to include women, children, and other patients from all backgrounds. This is critical—because we need to understand how products work for every patient and family. And I will continue to make this a priority as we look for ways to advance medical innovation.

“Today, medical experts are continuing to push the limits of science and technology. We now increasingly have the capability to treat patients based on their own unique characteristics and medical histories.

“In my home state alone, scientists supported by the NIH are exploring ways to stop cancerous cells from metastasizing, which is the number one cause of cancer deaths and develop 3D analysis of internal biological surfaces so devices like joint replacements can be better integrated into the human body.

“These are just a couple of the many incredible examples of scientific work being done today. Our task in Congress, and in our bipartisan effort to support medical innovation for patients—is to support this work, and ensure that our country continues to uphold the highest standards of medical safety and effectiveness. 

“The two questions I am especially interested in exploring today are: what more can Congress do to help get patients the best, safest treatments more quickly? And in general, what role can Congress play in realizing this goal, by helping to move the ball forward on the most difficult scientific challenges?

“Over the last few years, Congress has put in place tools like FDA’s breakthrough designation and accelerated drug approval, which have helped patients and families get treatment more quickly for serious and unmet medical needs.

“One example is FDA’s accelerated approval of a new drug to treat breast cancer in women. NIH estimates that, in 2014, more than 230,000 women were diagnosed with breast cancer in the United States, and 40,000 died from the disease.

“Until this February, there hadn’t been a new drug approved for a particularly common form of breast cancer in over 15 years.  FDA granted ‘breakthrough therapy’ designation to help speed development of a new drug, based on preliminary evidence that the drug may offer a substantial improvement over available therapies.   Then, based on a single phase 2 study of 165 women, FDA used its accelerated approval authority to approve the drug. Now this treatment is available to patients while the sponsor completes a Phase 3 study.

“This focus on regulatory flexibility, where appropriate, is helping patients and families get the care they need when they need it—and I’m hopeful we can continue to make progress on this.

“Another area where I hope we can be helpful is finding ways to advance the development of new medical products for patients. We’ve heard from Dr. Hamburg that FDA has the fastest drug approval times in the world.   But the private sector development of new medical products can take years before those products ever reach the FDA’s door. 

“I am hopeful that as our discussions continue, we can find ways to support efforts to tackle difficult scientific challenges in the development process, and in addition, explore innovative ways to determine which products are really going to make a real difference for patients and families, and weed out products that are not, earlier on in the process.

“This would reduce spending on dead ends and bring down development costs. And much more importantly, it would help direct private sector resources to the research and development that will get the best results for patients and families.

“I look forward to hearing from Dr. Woodcock and Dr. Shuren about how FDA’s existing tools are working, and what other steps might be helpful. And I am also eager to hear from Dr. Austin and Dr. Pettigrew about how our work in Congress can help break through difficult science in the development process.

“I want to thank all of our witnesses again for coming and sharing your expertise with us.

“I’m confident that with your insight, our bipartisan effort to advance innovation for patients will be better equipped to: help tackle the medical challenges our country faces, and help families and communities stay healthy.

“And now I’ll turn it back over to Chairman Alexander.”

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