Yesterday, the Health Subcommittee of the House Energy and Commerce Committee held a hearing, “Implementing the 21st Century Cures Act: An Update from FDA and NIH,” to receive a status update on the implementation of the 21st Century Cures Act (Cures). The bipartisan medical innovation legislation was a longtime priority issue of ASCRS and the Alliance of Specialty Medicine, with whom we successfully advocated for its passage last December. Not only did the landmark legislation include $6.3 billion to accelerate the discovery, development, and delivery of new cures and treatments, as well as discretionary funding for both the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), but Cures expedites and streamlines the FDA approval process for drugs and devices.
During yesterday’s hearing, Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, provided updates on several aspects of Cures, including: the Oncology Center of Excellence, regenerative medicine, digital health, the breakthrough devices program, patient-focused drug development, drug development tools, clinical trial designs, combination products, and real-world data and real-world evidence. In his statement, Dr. Gottlieb noted that the FDA’s goal in implementing the policies in Cures is “to improve patient access to innovative medical products while continuing to protect those who rely on these products. The provisions help FDA in its commitment to continue taking a fresh look at how we regulate products developed through truly novel medical advances to ensure that FDA is encouraging their development and creating efficient, risk-based pathways.”
In addition to Dr. Gottlieb, National Institutes of Health (NIH) Director Francis Collins, MD, PhD, was a witness at the hearing. Dr. Collins shared an update on the implementation of provisions of Cures under his scope, including: sharing data while also protecting privacy, strengthening the biomedical workforce, NIH’s Innovation Fund, the Precision Medicine Initiative, the BRAIN Initiative, and former Vice President Biden’s “Cancer Moonshot” initiative.
In his opening statement on the one-year anniversary of the House passage of Cures, Health Subcommittee Chairman Michael Burgess, MD (R-TX), said “Today’s hearing marks the Health Subcommittee’s first look into the implementation of what many in the healthcare community called a transformational bill that would positively impact not only the researchers and scientists who are developing the latest breakthrough therapies, but physicians seeking treatments for their patients—giving hope to them, their loved ones, and other advocates.”
The hearing may be viewed in its entirety here. On December 7, the Senate Health, Education, Labor, and Pensions Committee will also hold a hearing on implementation of Cures, focusing on progress and the path forward for medical innovation.