[Congressional Record (Bound Edition), Volume 161 (2015), Part 3]
[Senate]
[Pages 3500-3501]
[From the U.S. Government Publishing Office, www.gpo.gov]




   CONTINUING AMERICA'S LEADERSHIP IN MEDICAL INNOVATION FOR PATIENTS

  Mr. ALEXANDER. Mr. President, I ask unanimous consent to have printed 
in the Record a copy of my remarks at the Senate Health, Education, 
Labor and Pensions Committee hearing this week.

[[Page 3501]]

  There being no objection, the material was ordered to be printed in 
the Record, as follows:

   Continuing America's Leadership in Medical Innovation for Patients

       We've got three major objectives in this committee: Fixing 
     No Child Left Behind, Reauthorizing the Higher Education Act, 
     and third--one we're all looking forward to without 
     exception--improving biomedical innovation, including the 
     Food and Drug Administration (FDA) and the National 
     Institutes of Health (NIH).
       Today is the first hearing Ranking Member Murray and I are 
     holding on our bipartisan initiative to examine how we get 
     drugs, devices and treatments from the discovery process 
     through the regulatory process into our medicine cabinets and 
     doctors' offices.
       Today discoveries supported by NIH often do not come to 
     FDA's door for six, eight, ten, or even twelve years. And the 
     average cost to get a single drug from the laboratory through 
     the approval process to the medicine cabinet is, according to 
     some estimates, about $1 billion. Other estimates say it's 
     double that or even more.
       This initiative builds on work the committee has done--
     legislation was passed in 1997 and as recently as 2012--to 
     try to get at the same goal of speeding up review and 
     approval of drugs and devices while still ensuring they are 
     safe.
       This is a subject that has a lot of interest.
       President Obama this year announced his new Precision 
     Medicine Initiative, saying: ``21st 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.''
       In the House, Energy and Commerce Chairman Fred Upton and 
     Representative Diana Degette have been working on parallel 
     tracks on their 21st Century Cures initiative to accelerate 
     the pace of cures in America.
       In late January, Sen. Burr and I released a report titled 
     ``Innovation for Healthier Americans'' that examined the 
     process we have in place today for drug and device 
     development.
       We have received over 80 comments already, and have shared 
     those with the staff of all members on the committee.
       Our committee also has a bipartisan staff working group 
     that has been meeting for around a month now, learning more 
     about the key agencies involved in biomedical research and 
     development.
       We have with us today Dr. Francis Collins, Director of the 
     National Institutes of Health, which funds and enables much 
     of the early stage research that leads to medical 
     breakthroughs. And Dr. Margaret Hamburg, the head of the Food 
     and Drug Administration, which regulates all the medical 
     products we come in contact with.
       Dr. Collins wrote in 2013 that: ``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 wrote that, the number of conditions with 
     defined molecular causes has increased to more than 5,400, 
     yet the number of new drugs approved has not kept pace with 
     these discoveries.
       Dr. Hamburg has said 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.''
       So today's hearing is a perfect place for us to start--with 
     the heads of these two critical agencies, both of whom have 
     sounded the alarm on our existing process for drug and device 
     development.
       This work will affect 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's hoping to run faster and farther with the 
     aid of a new drug.
       I look forward to hearing from the witnesses more about 
     their thoughts on these five issues that Senator Burr and I 
     identified in our report: First, it costs too much to bring 
     medical products through the pipeline to patients. Second, as 
     science and technology advance, the discovery and development 
     process takes too long for medical products to make their way 
     to patients. Third, FDA's responsibilities have grown to 
     include many activities unrelated to the core function of 
     regulating medical products to advance the public health. 
     Fourth, the disparity in scientific knowledge at FDA and the 
     fast pace of biomedical innovation are slowing, and in some 
     cases, stifling innovation in American medicine. Fifth, a 
     working FDA is essential to continuing biomedical innovation 
     in the United States and maintaining America's global 
     leadership in medical innovation.
       In the words of Andrew 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.''
       I look forward to taking the first step toward addressing 
     these important issues. If we do it right, our work here will 
     help improve the lives of every single American.

                          ____________________