Fireside Chat, Panel
A Conversation with Scott Gottlieb, Commissioner, U.S. Food and Drug Administration
- The FDA will release a platform within a couple of weeks to guide the integration of digital health tools for patient compliance, symptom measurement, and outcome tracking.
- Digital health tools used with drugs are expected to be incorporated into product labeling for promotion, bypassing separate pre-market medical device review.
- Regulatory frameworks aim to facilitate tool development by validating underlying software architecture rather than reviewing specific product iterations.
- Hundreds of new disease-specific guidances are planned as part of a long-term vision to free clinical staff for patient engagement.
- Reforms to the Office of New Drugs are projected to improve productivity by approximately 20%.
- Information regarding the reasoning behind drug approval decisions will likely become available within 48 hours of process conclusion.
- The first phase of a structured, one-digital-template review memo approach will be implemented around the safety portion of the review process.
- A knowledge management system is being developed to allow real-time querying of FDA precedents and public access to consolidated intellectual capital.
- Therapeutic opportunities in novel areas like cell and gene therapy may be foreclosed if reimbursement approaches do not adapt to match innovative drug development paradigms.
- The FDA expects to break records this year for approvals of novel medical devices, novel drugs, and generic drugs.
- Data will soon be released indicating that time to second- and third-to-market innovation in novel orphan categories has significantly increased.
- If policies are executed correctly over a short period, smoking rates are expected to decline dramatically faster than previous trends.
- Detailed regulations regarding tobacco and e-cigarettes will be provided in approximately four weeks.