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Move quickly but safely: A view from inside the FDA

At a recent talk on campus, Amy Abernethy, an FDA principal deputy commissioner, discussed her career and her work to facilitate clinical advances.

Amy Abernethy, MD, PhD, is looking to the future. At a recent discussion on campus with cardiologist and researcher Mintu Turakhia, MD, Abernethy, the principal deputy commissioner of food and drugs and the acting chief information officer for the U.S. Food and Drug Administration, discussed her career path and how the FDA evaluates new technologies.

Attendees of her talk included software engineers, clinicians, and researchers, from technology, health care, and academia. 

Abernethy began by describing her career, which led her from academia to a position as chief medical officer at Flatiron Health, an oncology technology firm, and then on to the FDA. She explained that her trajectory was the result of a question she kept asking herself: "How do we accelerate the process of clinical evidence generation?" 

Academia, she explained, tended to be slow, and so she "took a right hand turn" into industry to try to solve the same problems she'd been tackling in academic medicine. But after realizing that having clear regulatory guideposts was key to having the work go faster and that these guideposts were largely set by the government, she came to the FDA.

Abernethy explained that at the FDA she approaches her deputy commissioner role and her CIO role with the goal of "making sure the FDA is as state-of-the-art and cutting edge as possible without getting too far ahead." She said that she wants to modify the famous tech adage "move fast and break things" to instead "move as quickly as possible while also remaining as safe as possible." 

Working successfully with large amounts of data and the swiftly moving industry behind it has become an important component of her job, as well as a challenge, Abernethy said. 

 "We don't have a very clear mechanism in place for how we interface with data and the tech industry," she explained. 

She told attendees that one of the things she learned during her various career moves was that, "solving problems required all the key people to be at the same table, taking the input of one another seriously." That also involves bringing together stakeholders from diverse sectors -- and their data -- together. 

When the discussion moved to the new frontier of technology and device regulation, Abernethy reminded the audience that the Center for Devices and Radiological Health, a branch of the FDA, has jurisdiction over many medical devices and AI. Broadly, "the core principle is that we're going to need to understand the performance of these products over time," she said. And that means taking the time to examine the data sets -- and their underlying biases -- behind the devices.

Abernethy also reminded those present that issues related to data ownership may transcend FDA's purview but, "that's something we have to grapple with more and more as a society." What the FDA does do, she explained, is try and promote competition within industry. In addition, the FDA is striving to streamline clinical development by working with industry and academic medicine to revise or adapt new regulations governing clinical trials. 

Abernethy said she and other agency leaders are also working to "modernize the FDA," involving industry and academia in larger conversations about how medicine and medical technology can best serve the public.  "It's all about moving the health care delivery process forward."   

Photo by Cassie Myers

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