Amy Abernethy, MD, PhD, has announced that she plans to resign from her roles as principal deputy commissioner and acting chief information officer at the U.S. Food and Drug Administration (FDA) in mid-to-late April.
Two years ago, Dr. Abernethy launched a plan to change the way the agency’s $325 million budget for enterprise information technology is used. She also helped to establish standards for “real world” information about drugs, medical devices, and other products collected outside of clinical trials. During Dr. Abernethy’s tenure, she created systems that allow safety analysis to be completed more rapidly, developed infrastructure allowing for the use of artificial intelligence, and introduced servers and software to move more of the agency’s work to the cloud.
Prior to these changes, the FDA would not have been prepared technologically to operate remotely during the COVID-19 pandemic, acting FDA Commissioner Janet Woodcock, MD, told STAT.
Dr. Abernethy told STAT that she believes she can make a greater impact on data science in medicine by working elsewhere, potentially in industry, and recommended that Dr. Woodcock become the next FDA commissioner.