Here are five things to know about Dr. Abernethy:
1. Dr. Abernethy will join the FDA as the principal deputy commissioner for food and drugs in early 2019, where she will oversee drug, medical device, tobacco and food regulation initiatives across the agency’s offices. The role marks the highest position at the FDA that’s not a political appointment, according to Forbes.
2. Dr. Abernethy is a trained oncologist who currently serves as CMO of Flatiron Health, an oncology EHR vendor that Swiss pharmaceutical company Roche acquired for $1.9 billion earlier this year. Part of Flatiron Health’s business model focuses on using “real-world evidence” to improve cancer treatments, chiefly by analyzing patient data it collects from its EHR.
3. Dr. Abernethy serves on the board of directors for athenahealth, according to her profile on Flatiron Health’s website.
4. Dr. Abernethy told Bloomberg Law a few priorities she wants to tackle at the FDA include precision medicine, using clinical evidence to make approval decisions about medical products and ensuring “we keep the patient at the center of everything we do.”
5. In a memo to FDA staff announcing Dr. Abernethy’s appointment, FDA Commissioner Scott Gottlieb, MD, said her ethics review was still pending, according to Forbes. Although Dr. Abernethy will be involved in shaping regulations related to how data is collected from clinical practice, which might affect companies like Flatiron Health, she said her background poses a benefit.
“I happen to be a methods expert in data, that is what my expertise is in, full stop,” she said.
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