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

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

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.

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

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

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

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

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.

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

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

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

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.

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

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

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).

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.

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

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

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.

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

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

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

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.

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

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

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

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

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.

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

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

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

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.

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

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

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).

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.

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

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

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.

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

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