The National Institute of health and dr. Scott gottlieb, the commissioner of food and drug. Well have as i mentioned to senator murphy, well have a hearing next wednesday on another important part of the cures act which was the first reorganization of our Mental Health laws in a decade which senator cassidy and senator murphy played a major role in. Senator murray and i will have each an Opening Statement then well introduce our panel of witnesses. Our witnesses will have five minutes of questions. In 2007 doug oliver who is in the front row, i believe, a Computer Programmer began to have trouble seeing and after a near accident had his drivers license taken away and was declared legally behind. The culprit was a rare form of macular degeneration. Doug moved to nashville where his doctor told him while there were no cures, doug could Search Online for a Clinical Trial. Doug found a rejen tiff medicine Clinical Trial in florida where doctors took cells out of the bone marrow in his hip, spun them in a centrifuge and injected these into his eye. Three days later he began to see. His eyesight eventually improved enough to get his drivers license back and enough that he became an advocate for more support for rej medicine don the proper way which we included in the cures act. Doug gave me the cane he used when he was blind and said i dont need it anymore. I treasure it keep it and thank him for his advocacy special we hope others have the same advantage. When Congress Passed the 21st se century cures act we hope to give americans more access to life saving treatments and cures so more americans could experience medical miracles. Its especially appropriate to be having this hearing today because it marks the one Year Anniversary of the Senate Passing cures. When it became law last december, i said that president obama had signed a second christmas miracle, the first one in 2015 was the every students succeeds act, a law fixing no child left behind which came from this committee. Last year it was the 21st century cures act which majority lead leader mcconnell called the most important legislation Congress Passed last year. Ive often said of the every Student Succeeds act the law is not worth the paper its printed on if its not implemented properly. I intend to ensure cures is also implemented properly. We begin with a hearing on october on Electronic Health records provisions. In addition to todays hearing i mentioned that well our oversight next wednesday on the Mental Health provisions. Today were hearing from dr. Collins and dr. Gottlieb on the provisions related to Biomedical Research. Were fortunate to have agencies and are widely respected in congress and capable of getting results. That doesnt always happen. Sometimes you have capable leaders and they dont have any money or new authority. Sometimes you have new authority, new money and the leaders dont have a clue what theyre doing. In this case weve got new authority, new money and two of the most capable leaders we could have. So were delighted with that. While the legislation included provisions to improve Electronic Health care rerecords, resources to fight the Opioid Epidemic and the first update to Mental Health programs in a decade, the major purpose was to provide Additional Resources and authorities to speed drugs and devices through the research and Development Process into Doctors Offices and patients medicine cabinets while ensuring the Gold Standard of safety and efficacy. Taking advantage of breath taking advances. In Biomedical Research. Dr. Collins at a Senate Appropriations subcommittee hearing in 2016, you offered bold predictions, you called them, for future Major Medical advances if we continue funding the National Institutes of health and ensure that the food and Drug Administration has the tools it needs. One prediction is that scientists will find ways to identify alzheimers before symptoms appear, as well as how to slow or even prevent the disease. Alzheimers causes untold family grief and costs 259 billion a year. Another prediction of yours was using a patients own stem cells. Doctors could rebuild his or her heart. This personalized heart would make transplant waiting lists obsolete and put doctors like former senator bill frist out of business. Dr. Collins, you have made other predictions that are because he was a heart transplant surgeon. Dr. Collins, you made other predictions, equally breathtaking. The development of an artificial pancreas for diabetes patients. A zika vaccine. A universal flu vaccine. An hiv aids vaccine. All available within a decade. New addictive pain medicines to help patients as we continue to battle the Opioid Crisis that kills 91 americans every day. You said this week in another hearing, that might happen in as soon as five years. The 21st century cures law put in place policies that will fund a Biomedical Research at a time of limitless opportunity to help make dr. Collins predictions a reality. Today, we want to find out from dr. Collins and dr. Gottlieb those leading the charge, how implementation of the law is going. For example, cures included a surge of onetime funding, of 4. 8 billion for the nih, including money for the Precision Medicine initiative, cancer moon shot and Brain Initiative. I know from talking with Vanderbilt University that the Precision Medicine initiative, the plan to map the genomes of 1 million volunteers to help researchers develop treatments and cures tailored to a patients general ytics, enviro and lifestyle has started enrolling patients one year after the program began. In addition, im curious about how funding has been spent, and when and how you plan to Keep Congress informed of your results. Cures has provided a process to look at burdensome regulations on researchers. I would like to hear if this is helping researchers spend more of their time and money on research and less on administrative tasks. Cures also put in place policies at the fda to move safe and effective treatments and cures through the regulatory process more rapidly and at a lower cost. For example, senators burr, bennett, hatch, worked on a breakthrough provision for devices modeled after a breakthrough provision for drugs. The first breakthrough approval was just last week for an exciting cancer diagnostic. Senators isaacson and casey worked on removing red tape from the review of combination products. I worked with senator murray to make sure the fda had the authority to hire and pay scientists to keep up with the rate of innovation. 21st century cures also added 30 million to support Regenerative Medicine at an accelerated pathway for treatments at fda so we can hear more stories like doug olivers. Fda has begun implementing these provisions. I look forward to hearing how fda and nih are working together to make sure the funding and authorities for Regenerative Medicine are helping to advance this important work while ensuring that bad actors dont take advantage of the hope of this exciting field to harm or defraud patients. Its going to be difficult to cover everything today, but i look forward to hearing about the progress being made to unleash medical innovation and bring new drugs and devices to patients. Senator murray. Thank you so much, chairman alexander. Welcome to our guests today. Thank you for joining us, dr. Collins. Good to have another opportunity this week to talk with you again about the work being done at nih. Dr. Gottlieb, welcome to you, as well. Im looking forward to your updates from fda. Next week marks the one year since the signing of the bipartisan 21st century cures act. As i said at the time of the passage, and ill repeat it now, as much as this law helped to build on americas tradition of leadership in lifesaving Public Health initiatives and medical innovation, cures was really first and foremost about providing hope. Hope to the millions of people and families who are impacted by illness and disease, hope for our communities suffering at the hands of the Opioid Epidemic, for example, and like all of my colleagues, including our guests today, this crisis is something i hear about every day. And i have visited with countless communities back home in my home state of washington that have been devastated by addiction. So while we know we can and must do more, im glad that cures took an important first step and dedicated over 1 billion in new funding above and beyond the budget caps to help states and communities fight back against that crisis. And we secured important changes to ensure this money went directly to the states that need it the most. For far too long, our Health System has failed patients and families seeking treatment and support. That is why in cures we prioritized expanding access to quality care for Mental Illness and Substance Use disorders. And we strengthen coordination between local agencies engaged in crisis intervention. So im looking forward to discussing that work further at a hearing were having next week. On todays topic, im proud of our work in cures to address headon some of the hardest to treat diseases by providing nearly 4. 8 billion in funding for the nih, including support for the beau biden cancer moon shot and Brain Initiatives. All of which i would note are very important to my home state, where we are spiriting much of that new research taking place as a result. Along with these investments, we included provisions in the law to equip nih with tools and authorities needed to meet the demands of Biomedical Research in the 21st century. We made it a priority to include children, women and other underrepresented populations in Clinical Research so the promise of these initiatives like Precision Medicine are extended to all patients. As part of this work, i championed a provision that creates a task force to better support the evaluation of drugs for pregnant and lactating women, and we addressed many of the concerns that have been Holding Back Progress in the Research Community by supporting young researchers and reducing the red tape. Cures also made sweeping reforms to fda and one of my Top Priorities was granting the agents greater hiring authority to recruit and retain qualified individuals who understand the latest science and technology. And im very interested to get an update from you, dr. Gottlieb, on how youre filling those positions, especially in light of the hiring freeze that this year was mandated by the president. We also made sure cures gave fda the authority to ensure medical devices like scopes that caused the outbreak of antibioticresistant infections in my home state of washington are safe for patients. And gave more clarity to Drug Developers combination products and codified key provisions in the agreement, including to ensure patients are included in the drug Development Process. So im glad we have the opportunity today to talk about the ongoing implementation of cures, and i will be very focused on making sure we are committed to strong congressional oversight, rejecting this administrations efforts to roll back and undermine patient protections, and doing more to provide the strong investment needed at nih and fda, not just to support cures, but also to advance 21st century science and innovation. Now in general, im glad that nih and fda have been active and timely in implementing the law, including many provisions that i just talked about. Im encouraged by these efforts. I want us to keep moving in the right direction. And dr. Collins, in light of the extremely concerning direction the Trump Administration has taken when it comes to health care, especially in regards to womens health, i want to hear more about what nih is doing to bolster your researchers work to further science over extreme ideology. Dr. Gottlieb, during your confirmation hearing, you said the 21st century cures is a good road map for what you hope to accomplish as commissioner. Id like to hear about how you at fda are pushing back against this administrations dereg latory approach and making sure cures is being efficiently and faithfully implemented. And specifically, i will be asking more about what fda is doing to ensure the medical devices patients rely on are safe and effective. Again, both nih and fda have made important steps in implementing and meeting cures deadlines this year. But we have a lot more deadlines coming up in 2018, and since we know funding remains an issue, i look forward to hearing from each of you on how we can make sure that were truly putting patients and families first. So, again, welcome to both of you. Thank you for being here. Thank you, senator murray. Each witness will have five minutes to give his testimony. First witness well hear from is dr. Francis collins. Hes been director of the National Institutes of health overseeing the work of the largest supporter of Biomedical Research in the world. Since 2009. The second witness well hear from is dr. Scott gottlieb. Hes commissioner of food and drugs. Ensuring our drugs and medical devices are safe and effective. He was formerly Deputy Commissioner of the same agency. He was confirmed on may 9 of this year. Welcome again to our witnesses. Dr. Collins, lets begin with you. Well, good morning. Thank you, chairman alexander, Ranking Member murray and other distinguished committee members. It is an honor to be here today with my colleague, dr. Scott gottlieb, the commissioner of the fda. As you well know, the 21st century cures act aimed to catalyze a very important goal shared by all americans. To speed the pace at which scientific discoveries are translated into lifesaving treatments and cures. We at nih actually greatly appreciate your leadership in passing this bipartisan act by a vote of 954 in the senate, exactly one year ago today. December 7th. This enhances our authorities and resources in ways that will help us to achieve this goal. Many thoughtful provisions are included in the act, such as reducing administrative burdens, so our scientists can devote more time to research, expanding our ability to award prizes for exceptionally creative ideas. And strengthening measures to protect patient privacy. In my written statement, ive submitted a comprehensive report on how nih has worked quickly to implement the provisions of the act. We are motivated by a sense of urgency to help patients in need of breakthroughs. In my oral statement, id like to focus on the Cures Innovation Fund. Among the vital areas of nihsupported research being accelerated by this fund, are the Brain Initiative, the cancer moon shot, the Regenerative MedicineInnovation Project and the Precision Medicine initiative. Lets begin with the Brain Initiative. This pioneering effort is aimed at revolutionizing our understanding of the most complex structure in the known universe. The human brain. And fiscal year 17 we leveraged our Cures Innovation Funding with our annual appropriation to launch no less than 110 exciting new Brain Research projects. Some of these will develop detailed maps of neural circuits. Others create a census of the cell types in the brain. And still others will create powerful new tools to monitor and modulate brain activity. This will advance efforts to develop new ways of detecting, treating and even preventing many serious brain disorders, including alzheimers disease, parkinsons, schizophrenia, autism, drug addiction, epilepsy, traumatic brain injury. With the help of the Cures Innovation Fund, a Second Research area, the cancer moon shot, is aggressively pursuing a very ambitious goal, to accelerate advances in cancer prevention, diagnosis, treatment and care. To achieve that goal, we must take a variety of innovative steps by creating a Clinical Trials network with an unwavering commitment to data sharing and to move Cancer Treatment programs forward more rapidly. In another of these innovative moves, nih recently joined with the fda and with 12 Bio