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

Our work is having an impact on drug prices. And per CEA, from Jan. ‘17 to July ‘18, Americans saved $26B on prescription drugs from generics https://t.co/ql20E8L6LG. Per AAM, over the last decade, FDA-approved generic drugs have saved consumers more than $1.7 trillion

Ensuring access to lower cost biosimilars also remains a top priority. Our Biosimilars Action Plan improves the efficiency of the biosimilar and interchangeable product development and approval process and increases scientific and regulatory clarity https://t.co/kCAWoNSaYj

Our generics and biosimilars programs will however be impacted should the lapse in funding continue. We continue to operate the programs using carryover user fees, and we'll prioritize work that impacts public safety, as this is our foremost priority.

In 2018, we approved a record number of biosimilar products: Seven in all, for a total of 16 approved biosimilars. And #FDA currently has 70 biosimilar development programs ongoing and we see a robust trend in the # of new biosimilar programs under development.

In 2019, we'll continue to advance policies to help promote more generic and biosimilar competition, including efforts to reduce gaming tactics; promote more efficient development, submission and review of generic and biosimilar applications; and enhance transparency.

@MadisonAlworth About 400 total staff, vast majority are inspectors and others are to support inspectors. About 150 of 400 are focused on food inspections, rest are focused on other aspects of mission including medical devices (about 100 staff), drugs (about 70 staff) and biologics (90 staff).

THREAD - UPDATE ON INSPECTIONS: We’re being asked for details on the number of inspectors and support professionals who’ve returned to their posts from furlough to re-initiate high risk surveillance inspections across our food and medical product programs.

This includes about 100 staff focused on inspections of high risk medical device manufacturing facilities; about 70 staff focused on inspections of high risk drug manufacturing facilities; and about 90 staff focused on inspections of high risk biological manufacturing facilities.

About 400 total staff are being engaged in this mobilization. The vast majority are inspectors and others are professionals who work in support inspectors. About 150 of the 400 are focused on food inspections, the rest are focused on other aspects of our mission.

THREAD: In 2019, #FDA plans to introduce new policy guidance and other advances in our drug development framework and today, we’re previewing that policy agenda as it relates to cell and gene therapy products. Read our statement https://t.co/Y6IhqaHDNW

@MadisonAlworth Nothing was missed. None were scheduled. Normally the schedule for the first week back from Christmas would have been reduced, but unclear how many we would have scheduled but for the shutdown. Not many. Maybe a few dozen. They’ll be scheduled going forward, starting today.

RT @FDAMedia: Statement from FDA Commissioner @SGottliebFDA and Peter Marks, M.D., Ph.D., Director of the Center for Biologics Ev… https://t.co/aRKKnFO1TU

RT @lisamjarvis: FDA expanding cell & gene therapy review group. Agency says by '20, will have >200 cell or gene therapy INDs per y… https://t.co/NPTkNdcur0

At this time, the work described in our statement is covered by limited carryover user fee balances. During this period without a FY19 appropriation for FDA, we’ll continue to update the public on how we’re approaching our work to advance public health and protect consumers.

The rapid development of this area of medical discovery underscores the importance #FDA efforts aimed at helping innovators proactively address potential risks, while we outline a modern and efficient pathway for the continued development of these innovations.

Delighted to join @Surgeon_General today to discuss the risks of e-cig use in kids and how we balance opportunities to use these products to help currently addicted adult smokers quit cigarettes with forceful steps that keep these same products out of the hands of children. https://t.co/r0VMdYnAXW

#FDA plans to add about 50 clinical reviewers dedicated to oversight of cell and gene therapies products, about a 50% increase over current levels, and advance new initiatives to promote development of gene therapy. https://t.co/aGzhhfJlJp

#FDA is witnessing a surge of cell and gene therapy products entering early development. We anticipate the # of product approvals for these therapies will grow in the coming years, reflecting significant scientific advancement and clinical promise of these new innovations.

PDUFA is our most vulnerable program and will run out of money first. We’ll get into February but how far into Feb is still very fluid. We’re trying to free resources to extend its runway. We said 4/5 weeks counting this week. That could change but is our rough estimate right now https://t.co/WqYqCAhjFN QT @dgingery: )

RT @HHSGov: Help is available to successfully overcome #opioid addiction. Find resources, information and more: https://t.co/aEedCQC2Gf #TuesdayThoughts https://t.co/gJ6ofU6lIx

Our work is having an impact on drug prices. And per CEA, from Jan. ‘17 to July ‘18, Americans saved $26B on prescription drugs from generics https://t.co/ql20E8L6LG. Per AAM, over the last decade, FDA-approved generic drugs have saved consumers more than $1.7 trillion

Ensuring access to lower cost biosimilars also remains a top priority. Our Biosimilars Action Plan improves the efficiency of the biosimilar and interchangeable product development and approval process and increases scientific and regulatory clarity https://t.co/kCAWoNSaYj

Our generics and biosimilars programs will however be impacted should the lapse in funding continue. We continue to operate the programs using carryover user fees, and we'll prioritize work that impacts public safety, as this is our foremost priority.

In 2018, we approved a record number of biosimilar products: Seven in all, for a total of 16 approved biosimilars. And #FDA currently has 70 biosimilar development programs ongoing and we see a robust trend in the # of new biosimilar programs under development.

In 2019, we'll continue to advance policies to help promote more generic and biosimilar competition, including efforts to reduce gaming tactics; promote more efficient development, submission and review of generic and biosimilar applications; and enhance transparency.

@MadisonAlworth About 400 total staff, vast majority are inspectors and others are to support inspectors. About 150 of 400 are focused on food inspections, rest are focused on other aspects of mission including medical devices (about 100 staff), drugs (about 70 staff) and biologics (90 staff).

THREAD - UPDATE ON INSPECTIONS: We’re being asked for details on the number of inspectors and support professionals who’ve returned to their posts from furlough to re-initiate high risk surveillance inspections across our food and medical product programs.

This includes about 100 staff focused on inspections of high risk medical device manufacturing facilities; about 70 staff focused on inspections of high risk drug manufacturing facilities; and about 90 staff focused on inspections of high risk biological manufacturing facilities.

About 400 total staff are being engaged in this mobilization. The vast majority are inspectors and others are professionals who work in support inspectors. About 150 of the 400 are focused on food inspections, the rest are focused on other aspects of our mission.

THREAD: In 2019, #FDA plans to introduce new policy guidance and other advances in our drug development framework and today, we’re previewing that policy agenda as it relates to cell and gene therapy products. Read our statement https://t.co/Y6IhqaHDNW

@MadisonAlworth Nothing was missed. None were scheduled. Normally the schedule for the first week back from Christmas would have been reduced, but unclear how many we would have scheduled but for the shutdown. Not many. Maybe a few dozen. They’ll be scheduled going forward, starting today.

RT @FDAMedia: Statement from FDA Commissioner @SGottliebFDA and Peter Marks, M.D., Ph.D., Director of the Center for Biologics Ev… https://t.co/aRKKnFO1TU

RT @lisamjarvis: FDA expanding cell & gene therapy review group. Agency says by '20, will have >200 cell or gene therapy INDs per y… https://t.co/NPTkNdcur0

At this time, the work described in our statement is covered by limited carryover user fee balances. During this period without a FY19 appropriation for FDA, we’ll continue to update the public on how we’re approaching our work to advance public health and protect consumers.

The rapid development of this area of medical discovery underscores the importance #FDA efforts aimed at helping innovators proactively address potential risks, while we outline a modern and efficient pathway for the continued development of these innovations.

Delighted to join @Surgeon_General today to discuss the risks of e-cig use in kids and how we balance opportunities to use these products to help currently addicted adult smokers quit cigarettes with forceful steps that keep these same products out of the hands of children. https://t.co/r0VMdYnAXW

#FDA plans to add about 50 clinical reviewers dedicated to oversight of cell and gene therapies products, about a 50% increase over current levels, and advance new initiatives to promote development of gene therapy. https://t.co/aGzhhfJlJp

#FDA is witnessing a surge of cell and gene therapy products entering early development. We anticipate the # of product approvals for these therapies will grow in the coming years, reflecting significant scientific advancement and clinical promise of these new innovations.

PDUFA is our most vulnerable program and will run out of money first. We’ll get into February but how far into Feb is still very fluid. We’re trying to free resources to extend its runway. We said 4/5 weeks counting this week. That could change but is our rough estimate right now https://t.co/WqYqCAhjFN QT @dgingery: )

RT @HHSGov: Help is available to successfully overcome #opioid addiction. Find resources, information and more: https://t.co/aEedCQC2Gf #TuesdayThoughts https://t.co/gJ6ofU6lIx