Collaboration and partnership, two key aspects of the Reagan-Udall Foundation for the FDA’s commitment to advancing regulatory science, were on full display when leaders from the FDA, the regulatory science community and the medical community gathered in Washington DC on Friday May 4, 2018 for the Foundation’s annual meeting.
Ellen V. Sigal, Ph.D., Chair of the Foundation’s Board of Directors welcomed the participants and attendees who joined the event in-person and remotely, and reaffirmed the Foundation’s commitment to working with the FDA and industry in creating partnerships and programs that support and advance the important regulatory and scientific work of the FDA and its Centers and Offices.
Following Dr. Sigal’s remarks, current FDA Commissioner, Dr. Scott Gottlieb took to the podium. In his keynote address, Dr. Gottlieb focused on three key priorities for the agency:
- Tobacco work includes the ongoing implementation of the new regulatory framework, reducing use of tobacco products by youth and adults, and enforcement of the existing authority within the agency’s purview.
- In the FDA’s Center for Food Safety and Applied Nutrition, Dr. Gottlieb highlighted upcoming modifications on labeling and nutrition information.
- In drug development, Dr. Gottlieb indicated changes will be coming this summer regarding to the Office of New Drugs where they will be elevating the import of the medical staff, and reshaping some of the roles and responsibilities at CDER.
At the conclusion of the keynote address, Dr. Gottlieb was joined by three former FDA commissioners, Dr. Andrew C. von Eschenbach, Dr. Mark McClellan and Dr. Robert Califf. All four speakers have played key roles in the evolution of FDA science and patient engagement: Gottlieb served on the Senate Federal Health Technology Policy Committee; Califf led the Clinical Trials Transformation Initiative, McClellan was instrumental in Innovation in Medical Evidence Development and Surveillance (IMEDS) and von Eschenbach worked on regulatory pathway modernization through the Critical Path Initiative and the Food Protection Plan.
In this wide-ranging discussion moderated by Susan Dentzer, President and CEO of The Network for Excellence in Health Innovation (NEHI), the commissioners indicated that they see great potential for the Foundation to support appropriate interaction with industry, where important issues can be discussed transparently in order to make progress. Initiatives like the Foundation’s Expanded Access (EA) Navigator, which is intended to make access to investigational drugs easier, more transparent, and more accessible to more patients facing life-threatening illnesses, while maintaining security and privacy protections, is one such innovative program.
In addition, Dr. Gottlieb indicated that the true value of IMEDS as a platform, is to enable deep analysis of data, to get a clearer picture of the trends in areas such as drug safety.
There was agreement that the pace of the science is moving very quickly, with new innovations occurring at much faster rates. But the regulatory science must move quickly as well, to adapt to where the science is taking us and ensure a robust regulatory framework to safeguard these processes, thereby supporting providers and patients.
The changing times require creative thinking, adaptability, transparency, and collaboration, to ensure that the regulators, researchers, providers, and patients are working as effectively and efficiently as possible for the public good. The Reagan-Udall Foundation recognizes its responsibility to support these conversations and create opportunities through its programs and initiatives to support the FDA in their ongoing efforts to, as Ms. Dentzer put it, “get the right treatment, to the right patients.”