OSE's annual report details Sentinel efforts during COVID pandemic - Regulatory Focus (May 14, 2021)
The US Food and Drug Organization’s (FDA’s) Office of Surveillance and Epidemiology issued its first-ever annual report summing up the office’s work.
The scope of the office’s charge meant that during the pandemic, staff effort was largely directed toward addressing the global public health emergency of the COVID-19 pandemic, noted Gerald Dal Pan, director of FDA’s Office of Surveillance and Epidemiology (OSE).
However, OSE also continued its efforts in other arenas. These are divided across four core functions: pharmacovigilance, pharmacoepidemiology, medication error prevention and analysis, and risk management. “Everything in OSE is tied to these four core functions,” wrote Dal Pan in his forward to the report.
Pandemic responses at OSE included keeping track of safety and supply issues for both novel COVID-19 therapeutics and repurposed drugs. The office advised other units within FDA about how risk evaluation and mitigation strategies (REMS) could be adapted to continue to provide safeguards during the pandemic.
The office also consulted with agencies outside of FDA, including the National institutes of Health and the Centers for Disease Control and Prevention (CDC); OSE also provided safety and epidemiological findings with the COVID-19 Evidence Accelerator. Working internationally, OSE collaborated in developing common protocols to monitor the safety of COVID-19 therapeutics.