Deleted tweets for Administration Official Scott Gottlieb, R-D.C. (Page 80)

SteveFDA (R-D.C.)
@SGottliebFDA

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RT @medpagetoday: The @US_FDA has called for hand sanitizers used by food handlers to be regulated differently from other hand saniti… https://t.co/Q0mfK72mbJ

Deleted after 53 weeks at 12:10 PM on 18 Dec 19. Original tweet by @medpagetoday.

SteveFDA (R-D.C.)
@SGottliebFDA

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In February, #FDA will hold a public meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss surgical mesh to treat pelvic organ prolapse. Those interested in attending can learn more here: https://t.co/QuLbbsaaSK

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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RT @endpts: #FDA will allow observational studies as part of a push for real world evidence, new framework says https://t.co/AXlwnCaLGQ via @rapsorg

Deleted after 53 weeks at 12:10 PM on 18 Dec 19. Original tweet by @endpts.

SteveFDA (R-D.C.)
@SGottliebFDA

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Follow me on Instagram at my account #ScottGottliebMD for updates on policy & public health https://t.co/JmMlCvSOA3

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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RT @Fleurence: Important statement by Commissioner Gottlieb on the FDA’s new strategic framework to advance use of RWE to support… https://t.co/pglub1QeFQ

Deleted after 53 weeks at 12:10 PM on 18 Dec 19. Original tweet by @Fleurence.

SteveFDA (R-D.C.)
@SGottliebFDA

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RT @BlumenthalG: New draft guidance! Developing and Labeling In vitro CDx Devices for a Class of Oncology Targeted Therapies. cc… https://t.co/tDeu1OYdhv

Deleted after 53 weeks at 12:10 PM on 18 Dec 19. Original tweet by @BlumenthalG.

SteveFDA (R-D.C.)
@SGottliebFDA

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Some IVDs are used in laboratories or other health professional settings; other tests are for home use, such as blood glucose meters for people with diabetes. #FDA was given IVD oversight responsibility in the Medical Device Amendments of 1976 (MDAs) https://t.co/2tZBBvXuti. https://t.co/rrpfoKSCwD

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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Patients and their doctors rely on lab tests to detect disease; monitor overall health; and help cure, treat or prevent diseases. In today’s #FDA #SundayTweetorial I’m going to talk about what FDA wants to do to ensure that ALL tests are safe & effective. https://t.co/Z83Ld2w6yK https://t.co/Loa1WoD2mF

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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RT @Fleurence: We will learn a lot from NEST’s first test-cases on medical devices which include label expansion, post-market surv… https://t.co/cZiHFDFcxH

Deleted after 53 weeks at 12:10 PM on 18 Dec 19. Original tweet by @Fleurence.

SteveFDA (R-D.C.)
@SGottliebFDA

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When you visit your doctor, you may have your blood drawn, your mouth swabbed or be asked to provide a urine sample. Tests performed on such bodily samples are known as in vitro diagnostics (IVDs), which are medical devices by law. They are essential tools of medicine. https://t.co/3VqjaJ5C3h

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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RT @Fleurence: Key point: critical work continues around “the interpretation the FDA’s evidentiary standard in the context of toda… https://t.co/YhzWY9Klb5

Deleted after 53 weeks at 12:10 PM on 18 Dec 19. Original tweet by @Fleurence.

SteveFDA (R-D.C.)
@SGottliebFDA

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There are two broad categories of clinical tests: those that are developed by conventional device manufacturers and sold for use in clinical labs, hospitals, doctors’ offices, or at-home; and laboratory developed tests (LDTs) that are developed and used by a single laboratory.

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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Most conventional IVDs undergo FDA premarket review to ensure they meet rigorous standards for analytical validity (a test’s ability to identify a characteristic) and clinical validity (a test’s accuracy in identifying a patient’s state of health). https://t.co/GisPWX5fe3

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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Today, there are thousands of tests available. They vary in complexity and risk, from old tests that measure the amount of hemoglobin in the blood to tests that can identify subsets of disease, driving a transformation in medical care and drug development. https://t.co/gxHLIUoU5m

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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Because LDTs were initially simple, low-risk tests used on few patients when the MDAs were enacted, FDA exercised “enforcement discretion,” meaning FDA did not enforce premarket review, adverse event reporting and other regulatory requirements against LDTs https://t.co/rseP8j8aSC

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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We believe the best regulatory approach to protect patient safety, support innovation and keep pace with rapidly evolving technology that’s helping us find new treatments for disease is a unified framework for ALL in vitro clinical tests (IVCTs), both LDTs and conventional IVDs

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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Such a framework would work well across all types of tests and the patients who need them. It would focus our review resources; provide strong post-market authorities; require performance transparency; and incorporate third-party review and inspection.

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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As a result, most LDTs have not undergone #FDA premarket review, yet many are now complex and higher risk, including those used to identify and measure the presence of molecular markers guiding medical treatment. Today, LDTs can often compete with FDA-reviewed tests. https://t.co/vIQzYElsJJ

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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But there’s no good data available on how well most LDTs perform because they haven’t been reviewed by FDA. Such transparency is critical. Everyone, including patients, should have access to info about performance claims, regulatory status and adverse events. https://t.co/9KObzcV9uw

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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There should not be different standards for the same type of test made by a clinical lab and one made by a manufacturer. This discourages investment in innovative tests, inhibits payor coverage and generates increasing marketplace uncertainty, potentially limiting patient access. https://t.co/cFHu4xnioA

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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After seeking comments from patient groups, providers, professional societies and test developers, last week Congress released the Verifying Accurate Leading-edge IVCT Development (VALID) Act, a discussion draft that proposed just such a framework https://t.co/zyXGX9MiUG.

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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It would reserve individual premarket reviews for the tests that are novel, higher risk, marketed directly to consumers, used at home or cross-labeled for use with a drug/biologic. We estimate that’s < 10% of all tests. https://t.co/kfDoMuevYF

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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Moreover, it would leverage, not duplicate, the current regulatory framework that applies to clinical labs under the Clinical Laboratory Improvement Amendments (CLIA) https://t.co/RqPHQgnUNK that give #CMS oversight authority over staff training and laboratory quality. https://t.co/iOsy4ksKSD

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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To improve efficiency, reviews would focus on a test’s analytical and clinical validity and any unique issues (such as the consumer’s ability to understand how to use the test or whether there is sufficient data to support claims on dosing based on test results).

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

This framework would recognize that lab developers seek to continuously improve their tests. It wouldn’t stifle this cycle of innovation with overly burdensome pre-market review requirements and would make the route to market more efficient for new, breakthrough technologies.

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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For some 40% to 50% of all tests, the best premarket pathway would be a pre-certification program. #FDA would evaluate the test developer and its ability to design and validate a test, which would serve as an umbrella marketing authorization for related tests. https://t.co/R0ZGXpdrFQ

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

All other tests – low-risk, low-volume, custom, manual, rare disease, forensic, and public health surveillance tests – would be exempt from premarket review, provided there were provisions allowing #FDA to take action against problematic tests to protect patients from harm. https://t.co/4uitOUsrJ1

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

To be fair to those labs with tests already on the market, existing LDTs would not automatically need an #FDA review unless they are substantially changed. In certain circumstances, involving safety and effectiveness, #FDA could require a submission.

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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We appreciate the time and attention Congress has devoted to how best to regulate IVCTs and look forward to continuing to work on these issues. https://t.co/DYPvpXBX7T

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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RT @thehill: CDC warns against eating raw cookie dough before the holidays https://t.co/cLcM7Ocoym https://t.co/4vFvoQDLou

Deleted after 53 weeks at 12:10 PM on 18 Dec 19. Original tweet by @thehill.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

With the right framework for IVCTs we can give doctors and patients more of the information they need to pursue the right treatment at right time. #FDA would have better tools to protect patients from tests that could cause harm and novel tests would reach patients more quickly https://t.co/OHxxYtxIsa

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

RT @SGottliebFDA: Patients and their doctors rely on lab tests to detect disease; monitor overall health; and help cure, treat or pre… https://t.co/Y3z0Rzleej

Deleted after 53 weeks at 12:10 PM on 18 Dec 19. Original tweet by @SGottliebFDA.

SteveFDA (R-D.C.)
@SGottliebFDA

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RT @FDA_Track: FDA clears mobile medical app to help those with #opioid use disorder stay in recovery programs https://t.co/ewsCWO8bju

Deleted after 53 weeks at 12:10 PM on 18 Dec 19. Original tweet by @FDA_Track.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

@LimOpinion That’s bitter! I’m just getting started. Give a guy a break‍♂️

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

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RT @FDAMedia: Statement from FDA Commissioner @SGottliebFDA and Deputy Commissioner Anna Abram on new efforts to assure the qual… https://t.co/DiVY6FsJoM

Deleted after 53 weeks at 12:10 PM on 18 Dec 19. Original tweet by @FDAMedia.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

My statement today, along with #FDA Deputy Commissioner Anna Abram, on new agency efforts to assure the quality of compounded drugs: https://t.co/vYsIc8AUuA. https://t.co/N6b9B7fx2E

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

RT @FDAMedia: FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs https://t.co/LmlPTlRqcP

Deleted after 53 weeks at 12:10 PM on 18 Dec 19. Original tweet by @FDAMedia.

SteveFDA (R-D.C.)
@SGottliebFDA

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RT @MDMagazine: "As part of our efforts to address the misuse and abuse of #opioids, we're especially focused on new tools and ther… https://t.co/IMZI0gj7IG

Deleted after 53 weeks at 12:10 PM on 18 Dec 19. Original tweet by @MDMagazine.

SteveFDA (R-D.C.)
@SGottliebFDA

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RT @US_FDA: “New medical breakthroughs are altering how diseases are treated in ways that seemed unimaginable just a decade ago… https://t.co/drl34xpJ03

Deleted after 53 weeks at 12:10 PM on 18 Dec 19. Original tweet by @US_FDA.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

RT @LyndsayMMeyer: Today's news from @SGottliebFDA hit close to home. My grandfather will sometimes ration his insulin. As a proud for… https://t.co/TaDNxX8cEE

Deleted after 53 weeks at 12:10 PM on 18 Dec 19. Original tweet by @LyndsayMMeyer.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

RT @FDASpox: Big news coming out of the #FDACMS summit this morning. @SGottliebFDA outlined new policies on how we plan to trans… https://t.co/wonqiWvBfh

Deleted after 53 weeks at 12:10 PM on 18 Dec 19. Original tweet by @FDASpox.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

RT @SGottliebFDA: THREAD: #FDA has worked with device makers, providers and health systems to protect patients from infections from d… https://t.co/qCkmqzrYRY

Deleted after 53 weeks at 12:10 PM on 18 Dec 19. Original tweet by @SGottliebFDA.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

RT @SecAzar: As I told #RyanWhite2018, we're committed to removing barriers to treatment, battling stigma & improving the care o… https://t.co/N1pFpZeqI8

Deleted after 53 weeks at 12:10 PM on 18 Dec 19. Original tweet by @SecAzar.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

RT @FDASpox: To help address growing problem of abuse/misuse, FDA approved changes to the packaging/labeling of Imodium Multi-Sy… https://t.co/9xMtddo5zs

Deleted after 53 weeks at 12:10 PM on 18 Dec 19. Original tweet by @FDASpox.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

We’re continuing our investigation into the root cause of these impurities and have information for consumers on our website. We’ll continue to update the public as frequently as possible.https://t.co/xJZFL67gRA

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

We’ve issued a warning letter to Zhejiang Huahai, the manufacturer of the API found in valsartan that’s been part of our ongoing impurities investigation. The issues cited in the warning letter are associated with the impurities found in recalled ARBs. https://t.co/MhgHt0rxIT

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

We’re working with the company to learn more about the reasons for this device malfunction and will take appropriate steps to protect consumers from further issues with this product. We will keep you informed. https://t.co/2VsaXVTSlv

Deleted after 52 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

ALERT: FDA wants women to be aware of voluntary recall: U by Kotex Sleek Tampons, Regular Absorbency; product may unravel/come apart when removed, causing vaginal irritation, injury & minor infections. https://t.co/2VsaXVTSlv

Deleted after 52 weeks at 12:10 PM on 18 Dec 19.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

RT @FDAMedia: Statement from FDA Commissioner @SGottliebFDA on the agency’s efforts to improve drug quality through vigilant over… https://t.co/RlnvyeEjZw

Deleted after 52 weeks at 12:10 PM on 18 Dec 19. Original tweet by @FDAMedia.

SteveFDA (R-D.C.)
@SGottliebFDA

Politwoops no longer follows this account.

Thanks @FortuneMagazine for helping spread the word about safe food practices this season and year-round! https://t.co/wTslAIosRM

Deleted after 53 weeks at 12:10 PM on 18 Dec 19.

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

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