(Image courtesy of the FDA)
Dr. Amy Abernethy, a top FDA official who was reportedly considered for the commissioner’s job, plans to leave the agency by the end of April.
As principal deputy commissioner, Abernethy helps oversee the FDA’s day-to-day functioning and directs initiatives that cut across its regulatory centers covering drugs, medical devices, tobacco and food. She is also its acting chief information officer, overseeing the agency’s data and technical vision and execution.
In an interview with STAT News, Aberbnethy said she believes that she has helped the FDA improve the way it uses IT and data in general and that she might make the leap to industry to have a bigger impact. Abernethy also endorsed Woodcock to be President Biden’s choice to lead the agency.
Woodcock announced Aberbethy’s departure in a memo to FDA staff.
“I’m very sorry to see the FDA lose a talented and inspiring senior leader like Amy, but I take heart in Amy’s enduring accomplishments at the agency,” Woodcock wrote. “Throughout multiple commissioner transitions and a historic pandemic, Amy’s focus on the FDA’s core technology operations has resulted in a remarkable modernization of the agency’s technology and data practices.”
Abernethy’s agency bio describes her as a hematologist/oncologist and palliative medicine physician, a clinical data expert and clinical researcher with expertise in cancer data, real-world evidence, clinical trials, health services research, patient-reported outcomes, clinical informatics and patient-centered care. She joined the agency in 2019 after serving as chief medical officer, chief scientific officer, and senior VP for oncology at Roche’s electronic health records firm Flatiron Health, where she led the research oncology, clinical operations and data science teams.
Abernethy’s legacy at the FDA will be long-lasting, according to Woodcock, who credited Abernethy’s leadership in modernizing the agency’s use of data and analysis as a saving grace during COVID-19.
Abernethy “rapidly assembled flexible teams and projects to understand how novel data and rigorous analysis techniques could be deployed in support of the FDA’s response to the pandemic,” Woodcock wrote. “Amy’s insight that a diverse group of public health and data experts from multiple sectors could come together to work on pandemic-related analysis projects in a transparent, collaborative setting led to the creation of the COVID-19 Evidence Accelerator, which has emerged as a unique and promising model for advancing the science of public health.”
Abernethy could not be reached for comment, but wrote a series of tweets about her departure.
