Deleted Tweets From Scott Gottlieb, R-D.C.

RT @SGottliebFDA: #FDA is advancing a new initiative to promote the development of medical devices that can treat pain and addiction,… https://t.co/0WTQOuV9yH

RT @tmprowell: If you’re at #ASH18, don’t miss posters & presentations by my @FDAOncology colleagues. Follow @KellyNorsworth2,… https://t.co/kD14KKxZaB

I’m briefing members of Congress this week on #FDAs new effort to modernize the 510K device clearance process. It’s the most sweeping update of this pivotal pathway in a generation; to ensure new devices reflect advances that improve safety and performance https://t.co/aJgNOwZUwJ

RT @FDA_Drug_Info: #ASHP18! On 12/2 @ 9:00a PST, Dr. Michael Kopcha, Director of FDAs Office of Pharmaceutical Quality, will present a… https://t.co/CZx09KLjWQ

RT @MedTechDive: A slate of future FDA medical device regulations listed on the Unified Agenda indicates a major effort to update th… https://t.co/uWYR3vsVDe

RT @USNavy: Fair winds and following seas, Sir. We have the watch. https://t.co/GdGoBmvKKx

RT @RxRegA: Kudos to FDA for coming up with a way to encourage OTC drug development using in-house DFL work. I hope it helps. #naloxone #op… QT @SGottliebFDA: Over-the-counter naloxone could help make this medicine more widely available but requires a consumer-friendly Drug… https://t.co/rNX2EGignN)

Congratulations to #FDAOncology's Dr. Ann T. Farrell, Director of FDA’s Division of Hematology Products, who will receive the #ASH18 “Outstanding Service Award” on December 2nd for her dedication to advancing issues affecting hematology and patient care. https://t.co/XzUN0sfiWz

RT @FDAOncology: This is a good one, put it on your schedule: #FDAHematology reviewers discuss New Drug Approvals in Malignant Hemat… https://t.co/a3lIBwwfgy

As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies to advance these efforts https://t.co/2co2Hz4jUt

RT @cspan: President George H.W. Bush with @danacarvey: "The fact that we can laugh at each other is a very fundamental thing.… https://t.co/u9UIi56v42

"Editorial: FDA crackdown on e-cigs and tobacco is a win" https://t.co/1IwiF7rOFf

What I’m talking about is the use of “real-world data” (RWD) to generate “real-world evidence” (RWE), concepts promoted by Congress in 21st Century Cures Act of 2016 and of great interest to #FDA https://t.co/uuBLVbvfEu. To better understand our efforts, let’s define some terms. https://t.co/ldGAiSSSQq

Here’s why RWD is useful. Traditional RCTs provide the high-quality evidence #FDA needs to determine whether a product is safe and effective for its intended use but not info about long-term outcomes in broader patient groups as the product moves out of the study setting.

RWD are data relating to patient health status and/or delivery of health care routinely collected from a variety of sources, including health insurance claims, electronic health records (EHRs), product and disease registries, lab results, patient-generated data and mobile devices https://t.co/1fxitTuIh6

RWE refers to the clinical evidence about the usage and potential benefits or risks of a medical product derived from an analysis of RWD, analysis that can include randomized trials performed outside of a traditional randomized clinical trial (RCT) and observational studies. https://t.co/mfaVTV3wyX

Also, CTs may be conducted in select hospitals and clinics, provide more intensive medical monitoring and exclude patients at later disease stage on multiple other treatments or with other diseases; even when these are the types of patients who may receive a product if approved. https://t.co/m2qBswZCrt

Careful use of RWD can provide #FDA with a more comprehensive picture of how a product works in broader patient populations outside of a controlled research setting. Our challenge has been how to tap into high-quality RWD in a systematic way to generate RWE. https://t.co/6IPHeIRnYo

The Sentinel System launched in 2008 is our first major routine, large-scale use of RWE. Our partners are insurance companies and health plans who own their claims and pharmacy data, kept in a standard format. They can quickly answer FDA queries while protecting patient privacy https://t.co/cfC8T8dgDO

Sentinel conducts active postmarket risk ID and analysis. When safety questions arise about a medical product, we ask our partners to scan their data (> 292 million unique patient identifiers from 2000-2017) and report to us with a summary of the results. https://t.co/vW8Jexp0YG https://t.co/UCMXuq6w7t

RT @SGottliebFDA: #FDA is advancing a new initiative to promote the development of medical devices that can treat pain and addiction,… https://t.co/0WTQOuV9yH

RT @tmprowell: If you’re at #ASH18, don’t miss posters & presentations by my @FDAOncology colleagues. Follow @KellyNorsworth2,… https://t.co/kD14KKxZaB

I’m briefing members of Congress this week on #FDAs new effort to modernize the 510K device clearance process. It’s the most sweeping update of this pivotal pathway in a generation; to ensure new devices reflect advances that improve safety and performance https://t.co/aJgNOwZUwJ

RT @FDA_Drug_Info: #ASHP18! On 12/2 @ 9:00a PST, Dr. Michael Kopcha, Director of FDAs Office of Pharmaceutical Quality, will present a… https://t.co/CZx09KLjWQ

RT @MedTechDive: A slate of future FDA medical device regulations listed on the Unified Agenda indicates a major effort to update th… https://t.co/uWYR3vsVDe

RT @USNavy: Fair winds and following seas, Sir. We have the watch. https://t.co/GdGoBmvKKx

RT @RxRegA: Kudos to FDA for coming up with a way to encourage OTC drug development using in-house DFL work. I hope it helps. #naloxone #op… QT @SGottliebFDA: Over-the-counter naloxone could help make this medicine more widely available but requires a consumer-friendly Drug… https://t.co/rNX2EGignN)

Congratulations to #FDAOncology's Dr. Ann T. Farrell, Director of FDA’s Division of Hematology Products, who will receive the #ASH18 “Outstanding Service Award” on December 2nd for her dedication to advancing issues affecting hematology and patient care. https://t.co/XzUN0sfiWz

RT @FDAOncology: This is a good one, put it on your schedule: #FDAHematology reviewers discuss New Drug Approvals in Malignant Hemat… https://t.co/a3lIBwwfgy

As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies to advance these efforts https://t.co/2co2Hz4jUt

RT @cspan: President George H.W. Bush with @danacarvey: "The fact that we can laugh at each other is a very fundamental thing.… https://t.co/u9UIi56v42

"Editorial: FDA crackdown on e-cigs and tobacco is a win" https://t.co/1IwiF7rOFf

What I’m talking about is the use of “real-world data” (RWD) to generate “real-world evidence” (RWE), concepts promoted by Congress in 21st Century Cures Act of 2016 and of great interest to #FDA https://t.co/uuBLVbvfEu. To better understand our efforts, let’s define some terms. https://t.co/ldGAiSSSQq

Here’s why RWD is useful. Traditional RCTs provide the high-quality evidence #FDA needs to determine whether a product is safe and effective for its intended use but not info about long-term outcomes in broader patient groups as the product moves out of the study setting.

RWD are data relating to patient health status and/or delivery of health care routinely collected from a variety of sources, including health insurance claims, electronic health records (EHRs), product and disease registries, lab results, patient-generated data and mobile devices https://t.co/1fxitTuIh6

RWE refers to the clinical evidence about the usage and potential benefits or risks of a medical product derived from an analysis of RWD, analysis that can include randomized trials performed outside of a traditional randomized clinical trial (RCT) and observational studies. https://t.co/mfaVTV3wyX

Also, CTs may be conducted in select hospitals and clinics, provide more intensive medical monitoring and exclude patients at later disease stage on multiple other treatments or with other diseases; even when these are the types of patients who may receive a product if approved. https://t.co/m2qBswZCrt

Careful use of RWD can provide #FDA with a more comprehensive picture of how a product works in broader patient populations outside of a controlled research setting. Our challenge has been how to tap into high-quality RWD in a systematic way to generate RWE. https://t.co/6IPHeIRnYo

The Sentinel System launched in 2008 is our first major routine, large-scale use of RWE. Our partners are insurance companies and health plans who own their claims and pharmacy data, kept in a standard format. They can quickly answer FDA queries while protecting patient privacy https://t.co/cfC8T8dgDO

Sentinel conducts active postmarket risk ID and analysis. When safety questions arise about a medical product, we ask our partners to scan their data (> 292 million unique patient identifiers from 2000-2017) and report to us with a summary of the results. https://t.co/vW8Jexp0YG https://t.co/UCMXuq6w7t