Posted on December 7, 2017
“[A] law is not worth the paper it’s printed on if it is not implemented properly. I intend to ensure Cures is… implemented properly... Today we are hearing from Dr. Collins and Dr. Gottlieb on the provisions related to biomedical research. We are fortunate to have two talented leaders who know their agencies, are widely respected in Congress, and capable of getting results.”
WASHINGTON, December 7, 2017—Senate health committee Chairman Lamar Alexander today held a hearing to ensure patients benefit from the 21st Century Cures Act – the law passed last year to boost biomedical research at a time of “limitless opportunity.”
“When the Senate passed Cures one year ago today, we hoped to unleash medical innovation and give Americans more access to life-changing treatments and cures, so more Americans could experience medical miracles,” Alexander said. “It is not an overstatement to say that the 21st Century Cures Act has the potential to affect virtually every American family by taking advantage of breathtaking advances in biomedical research.”
At today’s hearing, Dr. Francis Collins, the Director of the National Institutes of Health (NIH), and Dr. Scott Gottlieb, the Commissioner of Food and Drugs (FDA), testified about the implementation of 21st Century Cures and progress being made in unleashing biomedical innovation. Of the witnesses, Alexander said, “We are fortunate to have two talented leaders who know their agencies, are widely respected in Congress, and capable of getting results.”
Alexander continued: “At a Senate Appropriations subcommittee hearing in 2016, Dr. Collins offered ‘bold predictions’ for future medical advances if we continue funding NIH and ensure FDA has the tools it needs. These predications included a way to identify Alzheimer’s before symptoms appear, the development of an artificial pancreas, a vaccine for Zika virus and HIV/AIDS, and a universal flu vaccine, and new non-addictive pain medicines to help patients as we continue to battle the opioid crisis.”
“Today, I want to find out find out from Dr. Collins and Dr. Gottlieb how implementation of the law is going. I look forward to hearing about the progress being made to unleash medical innovation and bring new drugs and devices to patients.”
Alexander told the story of Doug Oliver, a Nashville resident who regained his sight after participating in a clinical trial: “In 2007, Doug Oliver began to have trouble seeing and was declared legally blind. After moving to Nashville, his doctor at the Vanderbilt Eye Institute told him that while there were no cures, Doug could search online for a clinical trial. Doug found a regenerative medicine clinical trial in Florida, where doctors took cells out of the bone marrow in his hip, spun them in a centrifuge, and then injected those into his eye. Three days later, he began to see. His eyesight eventually improved enough to get his driver’s license back—and enough that he became an effective advocate for more support for regenerative medicine, which we included in the 21st Century Cures Act.
“Cures added $30 million to support regenerative medicine and an accelerated pathway for these treatments at FDA – so we can hear more stories like Doug Oliver’s. FDA has begun implementing these provisions and 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 bad actors do not take advantage of the hope of this exciting field to harm or defraud patients.”
Today’s hearing is the second oversight hearing the committee has held. In October, the committee held a hearing on the Electronic Health Records provisions and will meet next Wednesday to continue over oversight on the mental health provisions.
Alexander’s full prepared remarks are here.