A Columbia University study estimates that imposing social-distancing measures one week earlier would have saved 36,000 lives. If so, then the Food and Drug Administration’s (FDA) decision to block reliable SARS-CoV‑2 diagnostic tests for nearly two months could easily have cost twice as many lives. Rather than speed diagnostic tests to market, the FDA created additional barriers to entry that proved not only unnecessary but deadly.
Please join us at this event where leading scholars will discuss how the FDA regulates diagnostic tests and other medical products, the effect of those regulations on public health, and how respecting the right to test would have helped contain COVID-19 where the FDA failed.