Dr. Amy Abernethy Is Leaving FDA

Amy Abernethy, M.D., Ph.D.

Amy Abernethy, M.D., Ph.D., of the U.S. Food and Drug Administration (FDA) will be leaving the agency in the coming weeks, according to an email sent to colleagues by Janet Woodcock, M.D., the acting FDA commissioner.

Abernethy, who spent two and a half years as the FDA’s principal deputy commissioner and acting chief information officer, dedicated herself to information technology and establishing standards for the use of real-world data and evidence.

During her time with the agency, the FDA partnered with numerous health technology companies, including one with Aetion to develop real-world data analytics to answer questions related to COVID-19.

“Evaluation of real-world data has the potential to provide a wealth of rapid, actionable information to better understand disease symptoms, describe and measure immunity and understand available medical product supplies to help mitigate potential shortages,” Abernethy said.

Under Abernethy, the FDA participated in the COVID-19 Diagnostics Evidence Accelerator to advance the development of diagnostics. She believed the accelerator would allow the community to analyze diagnostic and clinical data in real time which could contribute to the scientific evaluation of diagnostic tools and medical interventions for COVID-19.

The FDA also implemented the Technology Modernization Action Plan which consisted of three components: modernization of the FDA’s technical infrastructure and operations, enhancing the agency’s capabilities to develop technology products, and communication and collaboration with stakeholders to drive more seamless progression. The agency prioritized partnerships to drive such progress, including engaging with experts from government, industry, and academia to discuss data sharing, data exchange, putting data to use, and data stewardship and privacy.

"Amy’s innovative spirit is renowned in the medical field and she has a unique understanding of how to harness new technologies for the benefit of patients and the public health. But those who have worked with her directly know that she is also uniquely skilled as a manager and a mentor. 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. More than anything else, this modernization has been about the people behind technology at the FDA and how they can perform their work to best support our mission," Woodcock wrote.

Prior to her stint with the FDA, Abernethy was CMO of Flatiron Health and spent 25 years at Duke University where she directed the university’s career research program and cancer institute.