Fireside Chat, Interview
Food, Drugs, and Tech: 100 years of Public Health
- The FDA anticipates increasing volume of applications in digital structured data formats to enable scalable review and continuous product surveillance.
- Infrastructure modernization is required to support the transition toward structured data and digital application processing.
- Scientific decision-making will remain risk-based to calibrate the extent of review and expectations according to the specific risk profile of each product.
- New treatment development initiatives will focus on pain management and addiction therapies.
- Inspection protocols at borders will likely evolve from a rules-based "PREDICT program" to machine learning models, contingent on experimental validation of superior performance.
- Regulatory approaches for N-of-one therapies will balance risk exposure based on whether applications are individualized or scalable to broader populations.
- Manufacturing processes will require enhanced consistency controls as therapies become increasingly individualized.
- Ethical considerations within clinical settings will continue to be monitored despite lacking direct regulatory authority under current statutes.
- Distinctions between Phase One, Two, and Three clinical trials may blur, with potential for approval based on Phase One data or expansion cohorts.
- The agency will evaluate platform trials to assess multiple investigational products simultaneously within a single clinical trial setting.
- Real-world data and evidence will be utilized post-approval to construct a totality of evidence, supported by provisions in the 21st Century Cures Act.
- Software update preconditions will be developed to ensure algorithmic changes with robust quality controls avoid redundant review levels.
- Pilot projects will continue to facilitate software update cycles to align with rapid software development timelines.
- Global regulation of software products supporting life sciences remains indirect, though these products must demonstrate signals of strong software controls.
- A chief privacy role may be established at the agency to address re-identifiable data risks not covered by existing HIPAA laws.
- The agency is exploring the use of synthetic data to preserve privacy and advance data handling techniques.
- Genome databases maintained in concert with the CDC and international partners will be used to accelerate the tracking of foodborne outbreaks.
- Blockchain and distributed ledger technologies are being considered for tracing food supply chains from farm to grocery store.
- Consumer-facing applications may be developed to allow users to scan produce, such as peaches, to verify monitored supply chain integrity.
- Future operations will rely heavily on digital infrastructure and constant data integration to inform decision-making.
- Automation will be expanded to prioritize agency resources on critical activities requiring immediate attention.
- Long-term product performance data will be analyzed to optimize and right-size approved indications.