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

RT @FDAMedia: Statement by FDA Commissioner @SGottliebFDA, Director of FDA’s Center for Drug Evaluation and Research Janet Woodco… https://t.co/zrdIeNHzLr

RT @BioCentury: FDA leaders encourage companies to allow patients to continue expanded access treatments after clinical trials end https://t.co/RdH6S0B9uI

I was truly fortunate to arrive at #FDA at an inflection point in medicine, health, and science – during a time when new discoveries, made right down to the molecular level, offer the potential to transform health, protect consumers, and cure disease in fundamentally novel ways. https://t.co/F4X9BX2WvN

Today’s #FDA #SundayTweetorial is personal. I look back at what we've accomplished at FDA to advance innovations to benefit patients, promote policies to protect consumers, and address public health challenges during the two years I've shared these experiences with my colleagues. https://t.co/08UoGRucaw

Each novel medical technology challenged #FDA to be nimble and creative in its approach to product evaluation so that innovation would not only advance efficiently to benefit patients but do so while strengthening the agency’s gold standard for safety and effectiveness. https://t.co/Y1rq9MFbwj

In August 2017, #FDA approved the first gene therapy product https://t.co/Ske4pV86uz and later two others https://t.co/xddCEkAjNY; https://t.co/Z55H2boAp8. To further encourage innovation, we issued product specific guidance and manufacturing guidance https://t.co/koIOUf3BAP.

Working together, FDA's professional staff succeeded in achieving that balance, time and again. Consider gene therapy https://t.co/Tbc11TjSTj. Researchers had spent decades seeking a way to insert a gene into a patient’s cell instead of using drugs or surgery to address disease. https://t.co/rEE95TVvef

…. flattening our review process, breaking down silos to make our review process more standardized and efficient https://t.co/aer0Ze9thv, lessons learned from our Oncology Center of Excellence https://t.co/BZyjXQ05fu…

Our modernization steps included encouraging clinical trials to be more efficient and potentially less costly by supporting patient-centered endpoints and such innovative trial designs as seamless trials, master protocols and basket trials https://t.co/BlB6SiQnMj... https://t.co/7NrV4bbNic

…and working to harness real-world evidence, including data captured from sources such as electronic health records; registries; and claims and billing data to support regulatory decisions https://t.co/V5vCZZUwcb. https://t.co/DY3ExRSc2D

And with diseases being redefined based on molecular subtype, we took steps to modernize our evaluation of the development process for targeted drugs and devices that are intended to deliver the right drug and device to the right patient at the right time https://t.co/kA4DN2xGks. https://t.co/GjSqmJRuI4

We also advanced a novel framework for the modern and efficient regulation of regenerative medicine; for enabling the prospect of cell and tissue engineering to grow healthy, functional cells, tissues and organs to replace diseased or damaged ones https://t.co/uhmtAWqftA https://t.co/LpDCJExe2q

These many efforts to modernize our approach to innovation have had a positive public health impact over time. #FDA approved a record number of novel drugs and novel devices in 2017; then we set new records in 2018, including approving the most drugs ever for targeted therapy.

…and introduced the Pre-Cert concept, a potential regulatory program for mobile apps and medical devices connected digitally to medical tech, that's better suited to these technologies that receive continuous software updates. We’re currently piloting it https://t.co/eRLMnOx2jI https://t.co/dABSUABfT4

But patients can’t benefit from new medical innovations if they can’t afford them. We’ve worked hard to facilitate robust and timely market competition for lower-cost generic drug products https://t.co/J4b7PwmpUN and biosimilar and interchangeable products https://t.co/zFMjHjSY7R https://t.co/F9R1Ak4Rfh

We also forged a new breakthrough pathway for novel devices https://t.co/IHrFHvFhkZ; undertook new steps to modernize the 510(k) process https://t.co/7rWN7qCJ7x; advanced new approaches for efficiently regulating personal genetic tests https://t.co/xBrNb0dFM4... https://t.co/DjN5sadIXk

And the results bear out these approaches. In 2018, we approved or tentatively approved more than 1,000 generic drugs with record-breaking highs in October and November. First generics accounted for nearly 10% of approvals; and complex generics for 14% https://t.co/nEHX0nb1zv. https://t.co/Mi7rZNLTeq

We’ve streamlined the submission and review process for both generics and biosimilars, facilitated the development of complex generics, and pursued policies to stop gaming by brand manufacturers that sought to extend drug monopolies beyond the time that Congress had intended. https://t.co/zkpIZmfPvj

Other parts of #FDA are adapting to cutting-edge technology as well. Consider the promising new technologies that can edit animal and plant genomes with the potential to improve human/animal health, food productivity, animal well-being and food security https://t.co/9pYiIACEAi. https://t.co/Y51BedPbLE

Our Action Plan advances policy priorities we’ll pursue to clarify our science-and-risk-based approach for product developers; avoid unnecessary barriers to innovation in plant and animal biotechnology; and advance safety and our public health mission https://t.co/iYXfa2kZKn. https://t.co/KsAv8o69od

RT @FDAMedia: Statement by FDA Commissioner @SGottliebFDA, Director of FDA’s Center for Drug Evaluation and Research Janet Woodco… https://t.co/zrdIeNHzLr

RT @BioCentury: FDA leaders encourage companies to allow patients to continue expanded access treatments after clinical trials end https://t.co/RdH6S0B9uI

I was truly fortunate to arrive at #FDA at an inflection point in medicine, health, and science – during a time when new discoveries, made right down to the molecular level, offer the potential to transform health, protect consumers, and cure disease in fundamentally novel ways. https://t.co/F4X9BX2WvN

Today’s #FDA #SundayTweetorial is personal. I look back at what we've accomplished at FDA to advance innovations to benefit patients, promote policies to protect consumers, and address public health challenges during the two years I've shared these experiences with my colleagues. https://t.co/08UoGRucaw

Each novel medical technology challenged #FDA to be nimble and creative in its approach to product evaluation so that innovation would not only advance efficiently to benefit patients but do so while strengthening the agency’s gold standard for safety and effectiveness. https://t.co/Y1rq9MFbwj

In August 2017, #FDA approved the first gene therapy product https://t.co/Ske4pV86uz and later two others https://t.co/xddCEkAjNY; https://t.co/Z55H2boAp8. To further encourage innovation, we issued product specific guidance and manufacturing guidance https://t.co/koIOUf3BAP.

Working together, FDA's professional staff succeeded in achieving that balance, time and again. Consider gene therapy https://t.co/Tbc11TjSTj. Researchers had spent decades seeking a way to insert a gene into a patient’s cell instead of using drugs or surgery to address disease. https://t.co/rEE95TVvef

…. flattening our review process, breaking down silos to make our review process more standardized and efficient https://t.co/aer0Ze9thv, lessons learned from our Oncology Center of Excellence https://t.co/BZyjXQ05fu…

Our modernization steps included encouraging clinical trials to be more efficient and potentially less costly by supporting patient-centered endpoints and such innovative trial designs as seamless trials, master protocols and basket trials https://t.co/BlB6SiQnMj... https://t.co/7NrV4bbNic

…and working to harness real-world evidence, including data captured from sources such as electronic health records; registries; and claims and billing data to support regulatory decisions https://t.co/V5vCZZUwcb. https://t.co/DY3ExRSc2D

And with diseases being redefined based on molecular subtype, we took steps to modernize our evaluation of the development process for targeted drugs and devices that are intended to deliver the right drug and device to the right patient at the right time https://t.co/kA4DN2xGks. https://t.co/GjSqmJRuI4

We also advanced a novel framework for the modern and efficient regulation of regenerative medicine; for enabling the prospect of cell and tissue engineering to grow healthy, functional cells, tissues and organs to replace diseased or damaged ones https://t.co/uhmtAWqftA https://t.co/LpDCJExe2q

These many efforts to modernize our approach to innovation have had a positive public health impact over time. #FDA approved a record number of novel drugs and novel devices in 2017; then we set new records in 2018, including approving the most drugs ever for targeted therapy.

…and introduced the Pre-Cert concept, a potential regulatory program for mobile apps and medical devices connected digitally to medical tech, that's better suited to these technologies that receive continuous software updates. We’re currently piloting it https://t.co/eRLMnOx2jI https://t.co/dABSUABfT4

But patients can’t benefit from new medical innovations if they can’t afford them. We’ve worked hard to facilitate robust and timely market competition for lower-cost generic drug products https://t.co/J4b7PwmpUN and biosimilar and interchangeable products https://t.co/zFMjHjSY7R https://t.co/F9R1Ak4Rfh

We also forged a new breakthrough pathway for novel devices https://t.co/IHrFHvFhkZ; undertook new steps to modernize the 510(k) process https://t.co/7rWN7qCJ7x; advanced new approaches for efficiently regulating personal genetic tests https://t.co/xBrNb0dFM4... https://t.co/DjN5sadIXk

And the results bear out these approaches. In 2018, we approved or tentatively approved more than 1,000 generic drugs with record-breaking highs in October and November. First generics accounted for nearly 10% of approvals; and complex generics for 14% https://t.co/nEHX0nb1zv. https://t.co/Mi7rZNLTeq

We’ve streamlined the submission and review process for both generics and biosimilars, facilitated the development of complex generics, and pursued policies to stop gaming by brand manufacturers that sought to extend drug monopolies beyond the time that Congress had intended. https://t.co/zkpIZmfPvj

Other parts of #FDA are adapting to cutting-edge technology as well. Consider the promising new technologies that can edit animal and plant genomes with the potential to improve human/animal health, food productivity, animal well-being and food security https://t.co/9pYiIACEAi. https://t.co/Y51BedPbLE

Our Action Plan advances policy priorities we’ll pursue to clarify our science-and-risk-based approach for product developers; avoid unnecessary barriers to innovation in plant and animal biotechnology; and advance safety and our public health mission https://t.co/iYXfa2kZKn. https://t.co/KsAv8o69od