Skip to content

Pink Sheet – US FDA’s Amy Abernethy Leaves Behind Legacy Of Tech Modernization, Real-World Data

Pink Sheet – US FDA’s Amy Abernethy Leaves Behind Legacy Of Tech Modernization, Real-World Data

Executive Summary

After slightly more than two years as second-in-command, Abernethy tells the Pink Sheet she’s leaving FDA because the initiatives on which she was focused were starting to develop their own momentum. Abernethy, who also serves as the agency’s acting chief information officer, worked to modernize the FDA’s information technology infrastructure and data capabilities while also exploring ways to confidently use real-world data to support regulatory decision-making.

Amy Abernethy’s decision to leave the US Food and Drug Administration after just more than two years boiled down to two reasons: wanting to see initiatives she helped establish move forward on their own, and having high confidence in the current acting commissioner.

Abernethy, the FDA’s principal deputy commissioner and acting chief information officer, will leave in mid- to late-April, the agency announced on 23 March.

As second-in-command, Abernethy was a stabilizing presence, particularly in the tumultuous last year of the Trump Administration when the agency faced tremendous political pressures in the midst of the COVID-19 pandemic. She served under four different leaders – confirmed commissioners Scott Gottlieb and Stephen Hahn, and acting commissioners Ned Sharpless and Janet Woodcock.

She leaves behind a legacy of work to modernize the agency’s information technology infrastructure and data capabilities, and a re-examination of how the agency uses data, including real-world data, in regulatory decision-making.

‘Getting Out Of The Way’

In an interview with the Pink Sheet, Abernethy said one reason why she decided to leave now is that several big initiatives on which she was focused were starting to develop their own momentum, “and that meant I felt comfortable basically getting out of the way.”

“The kind of work that I do, especially as it relates to reorganizing and preparing the organization for the data and tech modernization work, trying to focus on how do we think new ways [about] real-world data … requires a focus on people and culture and getting budgets and governance right and hiring in the right people,” Abernethy said. “But once I really push on getting those things moving along, it’s really important to get out of the way and let all the great people who are doing that work go for it.”

Agency Is ‘In The Best Hands’

Abernethy’s other major reason for leaving now: “I also sincerely believe the agency is in just the best hands with Janet.”

Woodcock, the longtime director of the Center for Drug Evaluation and Research, has served as acting commissioner since mid-January and is considered a candidate for the permanent post. However, the Biden Administration’s delay in naming a commissioner nominee has raised questions about her prospects.

“I adore working with her,” Abernethy said of Woodcock. “I also feel like she really is the right person to helm the agency, and seeing that and knowing that gave me confidence that such an important organization that means so much to me and actually to all of us is going to keep going.”

In a message to FDA staff, Woodcock said she will miss Abernethy’s “inspiring enthusiasm and her principled and pragmatic approach to problem solving.”

“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,” Woodcock said. “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. This focus on FDA staff and on core operational excellence will ensure that Amy’s impact on the FDA remains long after she leaves the agency.”

‘Turning The Corner’ On IT

Abernethy was tapped in December 2019 by then-commissioner Gottlieb to serve as the agency’s number two leader. (Also see “US FDA Taps Abernethy As Principal Deputy Commissioner; Health IT Exec Brings “Real-World” Expertise” – Pink Sheet, 17 Dec, 2018.) She joined from Flatiron Health Inc., where she was chief medical officer, chief scientific officer and senior VP of oncology. An oncologist and palliative medicine physician by training, she brought to the agency extensive experience in real-world evidence and health information technology.

She played a leading role in efforts to modernize the FDA’s information technology infrastructure and data analytics capabilities through the development and implementation of the Technology Modernization Action Plan, released in September 2019, and the Data Modernization Action Plan, released early this month. (Also see “US FDA IT Modernization Plan Will Lay Groundwork For Real-Time Data Submissions” – Pink Sheet, 21 Sep, 2019.) (Also see “FDA Launches Digital Modernization Plan To Complement Its Technology Modernization Plan” – Medtech Insight, 4 Mar, 2021.)

“We turned the corner from IT as laptops and whether or not you’ve got enough cell signal or you can do your video conferencing, to data and technology as core to how we do our work smarter and we put data to work for us.” – FDA’s Amy Abernethy

“We turned the corner from IT as laptops and whether or not you’ve got enough cell signal or you can do your video conferencing, to data and technology as core to how we do our work smarter and we put data to work for us,” Abernethy said of her time at the FDA. “That’s what I hope my big legacy is – that the agency absolutely uses data differently and the way that the agency uses data differently signals to all the industries we regulate how they can use data differently.”

“People now imagine that we have new ways that we can get more work done and that the technical capabilities are in place not only for us to imagine what that looks like but for us to make it happen,” she said.

Abernethy also thinks there is growing recognition within the agency that clinical trial data and real-world evidence can complement each other and provide a more holistic picture of how a medical product works.

While Abernethy was well-versed in issues related to RWD and RWE from her time at Flatiron, she took a careful, deliberate approach to exploring the use of such evidence in regulatory decision-making.

In August 2019, she told the Pharmaceutical Research and Manufacturers Association meeting that although momentum was building for increased use of RWE, she remained “cautious” about its use in the drug development and regulatory space. (Also see “US FDA’s Abernethy ‘Cautious’ About Real-World Evidence ” – Pink Sheet, 6 Aug, 2019.)

She often spoke of the need for real-world datasets to be fit for use, and for the FDA to be able to understand how to use those datasets and what questions they could answer. She said the agency needs to prepare itself for synthetic data submissions in medical product applications but also highlighted validation concerns with such datasets. (See sidebar for story.)

The COVID-19 Use Case

Abernethy was a big proponent of building “use cases” to test new approaches to addressing practical problems.

The COVID-19 pandemic may go down as the biggest use case of them all, albeit one that was neither planned nor welcome.

“If COVID has taught us anything, it’s that we need to rethink US digital health infrastructure,” Abernethy tweeted. “This transformation will require new ways of working across traditional silos in government & business/tech, ensuring we always put patients first.”

Abernethy has said the public health crisis quickly forced the FDA to step outside its comfort zone when it came to using RWE to inform rapid regulatory decision-making and clinical trial design. (Also see “Real-World Evidence On COVID-19: US FDA Approaching With ‘Sense Of Urgency’” – Pink Sheet, 21 Apr, 2020.)

RWD also has helped the agency understand vulnerabilities in the medical supply chain during the pandemic to help manage and prevent shortages. (Also see “Pandemic Accelerates US FDA’s Use Of Real-World Data From Clinical Trial Design To Supply Chain” – Pink Sheet, 22 Jan, 2021.)

Abernethy was instrumental in the formation and work of the COVID-19 Evidence Accelerator, a joint project of the Reagan-Udall Foundation and the Friends of Cancer Research. Under this public-private partnership, researchers from major data organizations, government, academia and industry engage in weekly meetings to present and critically discuss findings from different RWD sources and to develop research questions that multiple teams can address simultaneously.


“When COVID-19 struck, Amy 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.” – FDA’s Janet Woodcock


“When COVID-19 struck, Amy 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 said. “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.”

Susan Winckler, CEO of the Reagan-Udall Foundation, said Abernethy’s impact was significant and the foundation was pleased to partner closely with her on launching the Evidence Accelerator. “We look forward to continuing that work after her departure, as we still have much to learn, and share, regarding COVID-19,” Winckler said.

Abernethy’s work drew plaudits from former FDAers and other stakeholders.

In a series of tweets, Gottlieb said Abernethy was recruited to the FDA for her deep public health experience, commitment to patients, and “long background bringing innovation to large enterprises in how they used of data to make decisions.”

“FDA is fundamentally an enterprise that brings reliable information to consumers, patients, and providers to inform impactful, science-based decisions,” Gottlieb tweeted. “Dr. Abernethy has expanded those opportunities, and built FDA programs that will leave the public health better.”

The Alliance for a Stronger FDA said the agency’s “greatest challenges is to have information technology and data integration systems to keep pace with the acceleration of scientific knowledge and support effective, timely and complex agency decisions and actions. Dr. Abernethy’s leadership has brought the agency to the point at which substantial increased investment, which is essential, will maximize the benefit to the agency and the American public.”

PhRMA executive VP of science and regulatory advocacy and chief medical officer Richard Moscicki said Abernethy’s commitment to advancing RWE and innovative technologies in regulatory decision-making has made a lasting mark on the FDA. “We wish Dr. Abernethy well in her next venture.”

Feeling ‘Pluripotent’

Abernethy said she is not sure what her next venture will be. She plans to take some time off to spend with family and would like to do some writing, particularly on the intersection of leadership development and career transitions.

She would like to put her skills to work outside the agency on her “personal passion,” which is finding more efficient ways to develop new treatments for patients, she said.

“I feel very pluripotent,” Abernethy said. “A pluripotent stem cell is one that can go in many, many different directions and doesn’t really have a full plan yet, and I’m definitely in the pluripotent mode.”

It seems likely that Abernethy’s roles as principal deputy commissioner and acting chief information officer will be filled on an acting basis pending the confirmation of a new commissioner.

“We will use the next couple of weeks to ensure a deliberate, well-planned transition of Amy’s many responsibilities, including the PDC and CIO roles,” Woodcock said.…