Regulating Health Technologies in a Post-FDA World
Explore the landscape of health technology regulation beyond the FDA, with insights on current events, FDA's primary purposes, institutional contexts, and hypothetical scenarios reshaping the regulatory framework. Consider the implications of moving towards safety-only approvals and the potential impacts on insurers and evidence generation. Delve into a world with or without FDA, weighing the dynamic effects of approvals versus bans in the healthcare technology domain. Uncover key questions driving the conversation on the future of health technology regulation.
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Presentation Transcript
Regulating Health Technologies in a Post-FDA World Rachel Sachs, JD, MPH, Professor of Law, Washington University in St. Louis 1 1
Overview Current events FDA s primary purposes The institutional ecosystem for regulating healthcare technologies Presenting hypothetical scenarios Reconstituting the functions of FDA 2
FDAs Primary Purposes Consumer protection Efficient review of product applications Information generation 4
FDAs Institutional Context Insurance companies and physicians International regulators Non-profit organizations 5
Getting to a Post-FDA World Decimating state capacity Moving to a safety-only approval standard Pure political control 6
Where Do We Go From Here? What s the impact on insurers? What s the impact on evidence generation? What are better and worse scenarios? 7
Additional Issues A world without FDA or without other institutions as well? Approvals versus bans Dynamic effects 8
