Transcripts For CSPAN3 Medical Product Development Innovati

Transcripts For CSPAN3 Medical Product Development Innovations 20171206

Now we turn to the house energy and Commerce Committee. Who last week heard from the administrator of the fda. And the director of the National Institute of health. About a year after they updated members on some of the medical developments and innovations spurred by the 21st century cure act. Chfts approved by congress a year ago this month. This runs about two and a half hours. Order. Chair recognize himself. A monumental achievement. Cures was the product of a by partisan multiyear effort by the energy and Commerce Committee. To brought the laws into a modern era of medicine. It has been one year since cures was signed into law. I remember remarking at that press conference a year ago to imagine a world in which government was not an obstacle but an ally in helping us deliver drugs and devices to patients cures to patients. Todays hearing marks the Health Subcommittee first look into the implementation of the what many in the Healthcare Community called it transformation bill. That would positively impact not only the researchers and the scientists who are developing the latest breakthrough therapy. But physicians seeking treatment for their patients. Giving home to them, their loved ones and advocates. This morning we will hear from two leader responsible for implementing the Drug Development and medical research provision. Included in cures. I want to welcome francis collins. Director of the National Institute of health. And Scott Gottlieb the commissioner of the food and drug administration. All of us know the demands your schedule put on both of you and we appreciate you coming before us. Today. At the time of the energy and Commerce Committee launch of the 21st serge Century Cures Initiative the statement was made that there were 500 cures and treatments to address. 10,000 known diseases. More progress was needed to alleviate the agony of an incurable disease. While the United States has maintained its Global Leadership in innovation. There existed a bridge in the growing divide between the revolutionary advances in science and technology and a less than adequate system for discovering, developing and delivering new therapy. Members of the committee both this and the Senate Health Committee Held numerous public hearings and round tables. And around the country. Bringing together leading scientists and medical experts. Patient and Disease Group advocates and researchers across multiple sectors. The primary objective of these events was to uncover opportunities to strengthen and steam line the process by which cures are discovered and made available to patients. Cures accelerated the cycle of Discovery Development and delivery of new treatments and ensured the United States remained at the helm of medical innovation. At the National Institute of health the cures act authorized resources to support medical research. And reduce add mrtive burdens and provide almost 5 billion in new funding. To support the agencies for Innovation Projects. The Precision Medicine initiative was thordsed for 1. 4 billion for the National Institute of health to be able to National Data set in order to accelerate Health Research and medical breakthrough. The bill also authorized 1. 5 billion for the Brain Research through advancing innovative Neurotechnology Initiative to better understand the brains fizzology. And coordinate efforts across multiple groups to expedite research for decides like alzheimers. Cures also authorized 1 prnt 8 billion for cancer prevention. Diagnosis, treatment and care. Through the moon shot. Finally the Regenerative Medicine Innovation Project was authorized at 30 million. To support Clinical Research in the field of Regenerative Medicine. And coordination with the food and drug administration. The cures act helped the fda modernize the regulation of medical products throughout its life cycle. Established the innovation act and authorized 500 million in funding to implement title three of the law. Including a broad range of deliverables from the fda. These include creating a mechanism for the collection and incorporation of Patient Perspectives in regulatory decision making. Updating the way medical products are reviewed and approved. Advancing new drug therapy through a review path way for bio markers. Other Drug Development tools to shorten time to maintain the same rigorous standard for safety sdp effectiveness. Also required the fda to establish standards and definitions necessary to develop Regenerative Medicine. Before i close, i recognize the cures act also touched upon other Critical Healthcare priorities such as Mental Health and Health Information technology. Both of these areas should have their over separate hearings. Because of their importance to the medical community and those are on the list for the very near future. I want to welcome our witnesses and thank you for being here. I look forward to your testimony. My time is expired. I will yield to the gentleman from texas. Mr. Green. Five minutes for opening statement. Thank you. I want to thank former chairman and congresswoman for being the original cosponsor of the cures. The one Year Anniversary of the cures act. Being signed into law by president obama. And his last public signing. It was a great achievement. Plrly at a time of gridlock. With the work started long before 2016. In 2014 we set out on a mission to do something positive to boost medical research and accelerate the discovery, development and delivery of new cure and treatment. After countless hours the vote at the round tables and hearings. Cures enjoyed by partisan support and endorsements from over 700 ogss. Representing the full spectrum of stake holders. It dedicated 6. 3 billion in new investment to support priorities. The Brain Initiative the medicine initiative. Within the National Institute of health to combat Prescription Drug abuse. It also provides money to the fda to advance the agency mission. Implement the policy. The influx of investment is solving todays complex science problems geing new treatment to the bedside and improving public health. Specifically the nih provided 4. 8 billion in funding to advance cunning Edge Research initiative. Prosided 500 million over ten years to improve the agency medical product review process. Without compromising the safety and effectiveness standards. In addition to this much needed funding there were so many provisions worthy of support from development of new antibiotics the fight against superbugs and yous of modern Clinical Trial designs to foster the next generation of medical research. While some of the technical in nature, the real world impact they could have is not abstract. Patient, families deserve to have elected officials respond to need and this bill was an attempt to do that. Like all negotiations in compromise we didnt get everything we want. Theres always more than can be done. But today is an opportunity hear from the heads of fda on implementation of things like patient focus Drug Development. Improving science and hiring capacity. It has been a year since passage. These things take time. I know folks in the agencies have been hard at work to get new initiatives off the ground and build on past efforts to advance medical research and development. Not the focus of today hearings cures included 1 billion to combat the Prescription Drug abuse and over dose epidemic. The funding was significant but pails in comparison to what needed. There are more americans dying from this than the height of the aids epidemic. I hope the committee and congress will fulfill the responsibility to the people and provide real and needed funding to fight the epidemic. The cures demonstrates what we can accomplish when we work across the aisle. And hope we can do so again. I look forward to hearing from our witnesses about the ongoing implementation of the cures act. And chairman i want to yield the rest of the time to congresswoman. Thank you. Thank you for all of your work that you did on cures. Ill be sorry not to have you as my seat partner. In the next congress. You have done a wonderful job. Many chairman i want to thank you too for all of the work you did on cures. Fred up ton of course is my partner and he was the chairman at the time. We really want to do something bold and big. When we started conceiving of cures. And i think we achieved that. So im looking forward to hearing from our two witnesses today. Doctor Scott Gottlieb your agency was a key partner. And doctor collins was there. Helping us craft the bill. At one point i remember dr. Collins said to me, we just need to let our young researchers go to conferences. And i said if thats all we do, we will have failed. We did that and we did so much more. And so were eager to hear how this bill has had impact in just one yore. And but were even more eager to hear where we can take it next. Thanks for all you do. Thanks to the committee for working together on this bill. I yield back. Chair recognizes the gentleman from oregon. Thanks for having this over sight hearing. Of an important life saving law. It was some of the finest work this committee has done. I know if you havent had anything else on your plate in the last year. I say that facetiously. Youre doing a marvelous job implementing this vast bill and helping move forward to save lives and improve the lives of families, friends and people well never know. And the consequences of the legislation are not confined to this hearing room. Or the United States. The research and the progress that will be made in the sectors will effect everyone in the world. This is world changing. My colleagues on both sides of the aisle have done marvelous work getting this done. My view is always been that once you pass a law thats just starting place. I know how difficult it was to do this. That was starting point. Today we look and say what is it going forward. Hows this working . Are these tools effective. Are there changes that need to be made. We know youre making great progress and we appreciate the terrific work. I also want to recognize a very special guest here with us today. We have many in the room. I want to draw special attention to somebody part of the journey from the beginning. Thats young mr. Max. Were delighted to have you. Youre an extraordinary young man. And we are so very glad that youre here to share in this special birthday appearance of the cures legislation. And its because of people like you that inspire us to do the best that this committee has to offer. The best work and best legislation. We know human lives are at stake. With that ill put [ applause ] ill submit my opening statement. In to the record. And defer the balance of my time to the former chairman of the committee. The chairman on energy now. And i know there are other members who would like to share. With that i yield back. To the champion of the cures and the improvement of peoples lives around the world. My friend from michigan. Thank you. You know when we began the process of crafting the cures four years ago. We began with one goal in mind. That was helping patients and their families. My great partner on the other side of the aisle and i were inspired to act after hearing from folks in the Research Community. Wels patients in their families. About the need for modernization and more resources. To move quickly bring life saving treatments to market. In all of us had inspiration in the district for me it was two sisters the kennedy sisters. Who have a rare disease called spinal muscular atrophy. Cures provided the fda with billions of dollars in much needed resources so the nations best and brightest could work and finding cures for diseases that impact virtually every sick single family. Whether cancer. Diabetes or Rare Diseases. This hearing is a great thing for lots of reasons. A remirnd of how republicans and democrats came together to get a monumental piece of legislation signed into law despite our divided time. She worked with me on this as we worked for years. And listened and worked to craft the language that would become law. The hearing is reminder we have a lot of work to do. The kennedy girls and max in the front row along with millions of patients and families are counting on us. For that reason i im glad to welcome both dr. Collins and dr. Scott gottlieb on how the law is being implemented and what we can do to help the process along and improve it. I yield to the general lady from tennessee. We do welcome our witnesses. And we take this as an to thank you each. For the help and the guidance that you provided. In what were then your roles and what are now your roles. As we implement 21st century cures. It is so appropriate that we do this hearing. Because as youve heard there was so much more that went into this. Than just saying lets have people go to conferences or lets try. This was a way to change and reform the review and approval process. So that it more adequately meets the innovation that is taking place. And Healthcare Delivery systems. So we welcome you. We welcome max and his by partisan friends. Who have joined him this morning. What a great reminder max they have a reserved seat. Right there on the front row in sharing the success of the day. Mr. Chairman i thank you for the hearing i yield back. The gentleman from new jersey. Five minutes please. Thank you. I want to welcome dr. Collins and dr. Got leeb. To discuss the implementation. While the law addressed several different issues such as the Opioid Epidemic and Mental Health. Were focusing on the ongoing work to implement the provisions of the law. Aimed at improving the discovery and development of new cures. Im proud that the law included funding for the biden cancer moon shot. This Initiative Aims to accelerate Cancer Research and youve the ability to prevent and detect cancer early on. In the hope that one day we might find cures for the different cancer such as pancreatic. Im interested in hearing how theyre working to achieve the goal. New fund in the Brain Initiative and Precision Medicine initiative. The Research Program the funds important rerge r research on Brain Disorders such as alzheimers. Epilepsy and traumatic brain injury. To gather data from one Million People that will lead to the development of Personalized Therapy rather than one size fits all treatment. The cures act aim ts to bolster the medical product review process in order fo get treatment to patients faster while also maintaining fda goal standard for safety and effectiveness. For example the law granted aided thor authority to development and utilize new tools to facility Drug Development. Provide flexibility in the Clinical Trial process and support the development of Continuous Manufacturing. The use of Patient Experience data in the review process and provided with 5 up million in new funding to insure the agency has the necessary resources to recruit the best and brightest scientists. I look forward to hearing about the Progress Agency has made to date. And lastly the cures act marked an important step towards the development of new treatment and cures. Able to Work Together on a basis last congress to pass the monoyoumtal law. I want to thank the chief sponsors. Its critical that with hold hearings like this to insure the law is working as it should and achieving its goals. I look toward to hearing from the witnesses today. Id like to yield the rest of my time to representative. I thank the chairman and Ranking Member for this hearing today. I tharng the witnesses for their attendance. We worked together to pass the addiction and recovery act. Its fair to say it was a compromise. During the debate i pushed and have continued to advocate for more funding and resources it address the deadliest drug crisis in american history. We came together and advanced legislation to o provide 1 billion over two years to strengthen the response to the crisis. Still cures act two year funding window creates planning problems for state and local government. The uncertainty in funding to hire staff or plan beyond two years makes it difficult for peopl

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