Dr. Amy Abernethy
@DrAbernethyFDA
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Former Principal Deputy Commissioner and Acting CIO at @US_FDA. This account is now archived.
Silver Spring, MD
Joined March 2019
"Data empathy" - an overdue concept in #healthIT and #bigdata work. Below is essential reading on key considerations in #RWE data/inquiries. Credit to @DrAbernethyFDA, mentioned herein, who taught us data empathy years ago @DukeCancer
timmermanreport.com
“Their story — yours, mine — it’s what we all carry with us on this trip that we take, and we owe it to each other to respect our stories and learn from them.” — Dr. William Carlos Williams to Dr....
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.@DrAbernethyFDA departing advice on FDA leadership hole....
Re: Woodcock, she says: "There’s no question in my mind she’s the right person to run the agency. I think she’s got the experience within the agency, she knows how to get it done.” "...I don’t think at a time like the pandemic we can take the risk of not getting that right."
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As for my next steps...I am going to spend some time with my family and do some brainstorming, reading & writing. I’ll be back at it soon, but in the meantime, I am just so grateful to everyone @US_FDA for trusting me to help advance the agency’s mission. 5/5
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If COVID has taught us anything, it’s that we need to rethink US digital health infrastructure. This transformation will require new ways of working across traditional silos in government & business/tech, ensuring we always put patients first. 4/5
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A thank you to all who came before me, mentors & colleagues who encouraged me to take this position, & who also helped me make the considered decision to leave once I knew we had all of the elements in place for continued growth. I am so honored to have had your wise counsel.3/5
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Thank you to @DrWoodcockFDA for your guidance, your leadership, and your unwavering focus on safety and efficacy in service of the patient. The country has been well-served and in excellent hands with you as our acting Commissioner. 2/5
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The last 2+ yrs @US_FDA have been some of the most explorative & enlightening of my career. We stood up the tech & data modernization programs, helped launch the #COVID19 Evidence Accelerator, made real progress in big areas like CBD...the list goes on.1/5
statnews.com
In an exclusive interview, Abernethy told STAT she believes she has laid the groundwork for long-lasting changes in the way that the FDA uses information technology, reframing the way the FDA uses...
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By unleashing the power of real-world evidence, we can accelerate medical product development and bring new innovations and advances faster and more efficiently to the patients who need them, without compromising patient safety. #FDAVoices
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Our new Data Modernization Action Plan is great news for the agency, public health and our stakeholders & it’s the next step in FDA’s overhaul of its approach to technology and data. #FDAVoices
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FDA’s Data Modernization Action Plan leverages the foundations laid by our Technology Modernization Action Plan: a modern, cloud-forward technical infrastructure; a product-oriented approach and enhanced collaboration. #FDAVoices
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FDA is focused on data & tech modernization that supports real-time analyses to inform regulatory work. E.g., yesterday we launched part 2 of a pilot to use AI to enhance our ability to identify violative imported seafood products ("stinky fish").
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Kevin Fu has joined FDA as an expert in residence, our first acting director of medical device cybersecurity in the Center for Devices and Radiological Health (CDRH). Welcome to the FDA team. #becybersmart #cybersecurity
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Cybersecurity isn't just a tech issue - it is a health issue. Health tech has cyber-risks. Many medical devices include software and can connect to the internet; they are at risk of security breaches. FDA has many efforts to reduce risk. #becybersmart
fda.gov
Cybersecurity information related to medical devices and radiation-emitting products.
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Top line summary from this updated FDA guidance is that patients who receive COVID vaccines & other medical products authorized under EUA do not need to be excluded from clinical trials of investigational products. Great news for patients! There are caveats, so read the guidance.
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FDA updated the guidance on conduct of clinical trials during this pandemic. New Q#27 addresses whether receipt of a vaccine or other COVID-19 medical product authorized under EUA automatically excludes a person from any other clinical trial.
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FDA has completed our investigation of the 2020 leafy greens E.coli outbreak. We found the presence of a recurring strain of E. coli in the growing region, which could serve as a potential source associated with future contamination events. https://t.co/4EYzCkTf5S
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Producing or distributing drugs that don’t meet FDA quality standards poses a serious risk of harm to patients. This will not be tolerated. Compounders should know their bulk drug substance or API supplier in case quality concerns arise.
FDA issues warning letter to Professional Compounding Centers of America for receiving and distributing adulterated and misbranded active pharmaceutical ingredients (APIs). https://t.co/5sGkglKXr3
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Real-world data/evidence (RWD/E) isn't a new field rather an updated name/concept for an evolving field & specific areas of focus. Observational/outcomes research -> comparative effectiveness research/ pharmacoepidemiology -> patient-centered outcomes research/etc -> RWD/E
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Real-world data/evidence is the contemporary iteration of observational research (OR) / outcomes research / clinical epidemiology. The name evolved as data/analytic capabilities evolved, the focus of the research question shifted, and new outcomes were variables added.
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