The “21st Century Cures Act” www.congress.gov will bring the promise of cures to people with Alzheimer’s cancer, Parkinson’s, develop new treatments for opioid addiction, and other life threatening diseases.
House and Senate Committees have had conversations with patients, researchers, innovators, and healthcare providers on the steps to take to expedite the discovery, development, and delivery of new treatments and cures.
The Cures Act will provide NIH www.nih.gov with new funding to help advance the Precision Medicine Initiative, drive research into the genetic, lifestyle and environmental variations of disease, provide funds for the “Cancer Moonshot” Initiative, and invest in the BRAIN initiative.
The legislation will also advance new therapies for patients, modernize clinical trials, advance the way safety and efficacy data is accumulated and analyzed, put patients at the heart of the regulatory review process, support broader utilization of biomarkers, and incentivize the development of drugs for pediatric diseases.
The Cures Act emphasizes the need for technology to be used at the right time delivered to the right patients. The Act will help improve delivery by ensuring that EHR systems are interoperable to provide seamless patient care. The Act would establish requirements for the interoperability and certification of health IT and require Medicare and Medicaid authorities to provide telehealth information to Congress.
It is also specified that FDA www.fda.gov establish a program for priority review of breakthrough medical devices. FDA will be required to identify types of medical devices that would not require submission of a report prior to commercial marketing.