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

The vaping community that supports harm reduction for adults should also focus more of their efforts on select manufacturers that are primarily responsible for the youth epidemic if, like #FDA, they seek to preserve these opportunities as a way to transition adult smokers. 4/5

We’ll apply the new actions we announced to confront these trends. But data I’ve seen raises alarm. There’s no reason manufacturers must wait for #FDA to more forcefully address the epidemic. Yet some already appear to back away from commitments made to FDA and the public. 2/5

SHUTDOWN UPDATE: Our inspection and interdiction work continues at the International Mail Facilities: At Miami airport’s International Mail Facility, #FDA’s Isis Bermudez helps protect U.S. borders from packages potentially containing counterfeit and contaminated drugs. https://t.co/gOOZHY8YtK

#FDA’S Yessica Lopez-Villafane also working at Miami’s International Mail Facility during this lapse in funding to inspect suspicious parcels being sent to the U.S. border. https://t.co/iE53YhVzR6

Many asked if #FDA can accept new medical product applications during the shutdown. The #FDA can't collect FY 2019 user fee payments during the shutdown, which means we can't accept new applications for products under user fee programs: PDUFA, GDUFA, BsUFA, MDUFA, ADUFA, AGDUFA.

#FDA retains limited carryover balances for 21st Century Cures and opioids funding. These balances will only be spent on activities for which the funds are authorized. FDA carryover user-fee funds also allow the agency to continue work on existing user-fee related applications.

RT @SGottliebFDA: #FDA’S Yessica Lopez-Villafane also working at Miami’s International Mail Facility during this lapse in funding to inspect suspicious parcels being sent to the U.S. border. https://t.co/iE53YhVzR6

Images from some of #FDA's critical work that continues: Here FDA on duty at Chicago O’Hare Airport’s International Mail Facility. Consumer Safety Officers John Seale and Yuriy Solovyov support our mission examining potentially violative products attempting to enter US commerce. https://t.co/61cF5KU88u

1/2 We've received lots of questions regarding generic drugs during the shutdown. New GDUFA submissions that'll be processed with carryover user fees include: CBE and prior approval supplements, amendments, annual reports, applications for PET drugs, and general correspondence...

2/2 #FDA will also be accepting Drug Master Files, including Type II Active Pharmaceutical Ingredient (API) DMFs, to be referenced in generic drug applications. However, we can't conduct initial completeness assessments on Type II API DMFs if the fee hasn’t been already paid.

Met with the team at #FDA that’s supporting the communication and technology needs of our employees during the shutdown and helping us maintain critical public health functions. https://t.co/tTsPmNwByp

RT @pewhealth: “Physicians treating serious infections must have up-to-date [information] so they can select the best treatment for their patient’s infection.” - @SGottliebFDA What @US_FDA is doing to ensure this: https://t.co/3ehP1D58IR

RT @califf001: Commissioned core--huge national asset that i knew little about till my time at FDA. They are always on call to help where needed. Talk to young people about volunteering. Great to see recognition by Commish. @dukeforge https://t.co/mHnnCXPbcY

The #FDA’s Operations Office: Mission control today as we operate through the shutdown. https://t.co/HiKswPzOKx

RT @HHSGov: You don't have to wait for new years to #QuitSmoking. Sign up for @SmokefreeUs' daily text message program to get t… https://t.co/mSSzovbR6z

RT @DrMcCance_Katz: The holiday season affords us extra occasions to check in on loved ones. If you have a loved one who is struggling… https://t.co/sJ0dzwkCVM

2/2: For our Center for Drug Evaluation and Research this also includes pausing all OTC monograph drug activities. Only emergency work related to these products will continue.

3/4 The 30-day review clock for any pending, non-emergency IND for a medical product that is not covered by a user fee program will be suspended during the lapse period. The clock will resume when the lapse period is over.

THREAD: We have questions re: drug review work that’s not user fee funded and won’t continue during shutdown. CBER will pause non-emergency work on whole blood, blood components for transfusion, allergenic extracts and HCT/Ps regulated solely under sec. 361 of the PHSA. 1/4

4/4: However, new emergency INDs and IND amendments that relate to the safety of individuals who are participating in clinical trials will continue to be reviewed during the government shutdown, even for products that are not covered by a user fee program.

The vaping community that supports harm reduction for adults should also focus more of their efforts on select manufacturers that are primarily responsible for the youth epidemic if, like #FDA, they seek to preserve these opportunities as a way to transition adult smokers. 4/5

We’ll apply the new actions we announced to confront these trends. But data I’ve seen raises alarm. There’s no reason manufacturers must wait for #FDA to more forcefully address the epidemic. Yet some already appear to back away from commitments made to FDA and the public. 2/5

SHUTDOWN UPDATE: Our inspection and interdiction work continues at the International Mail Facilities: At Miami airport’s International Mail Facility, #FDA’s Isis Bermudez helps protect U.S. borders from packages potentially containing counterfeit and contaminated drugs. https://t.co/gOOZHY8YtK

#FDA’S Yessica Lopez-Villafane also working at Miami’s International Mail Facility during this lapse in funding to inspect suspicious parcels being sent to the U.S. border. https://t.co/iE53YhVzR6

Many asked if #FDA can accept new medical product applications during the shutdown. The #FDA can't collect FY 2019 user fee payments during the shutdown, which means we can't accept new applications for products under user fee programs: PDUFA, GDUFA, BsUFA, MDUFA, ADUFA, AGDUFA.

#FDA retains limited carryover balances for 21st Century Cures and opioids funding. These balances will only be spent on activities for which the funds are authorized. FDA carryover user-fee funds also allow the agency to continue work on existing user-fee related applications.

RT @SGottliebFDA: #FDA’S Yessica Lopez-Villafane also working at Miami’s International Mail Facility during this lapse in funding to inspect suspicious parcels being sent to the U.S. border. https://t.co/iE53YhVzR6

Images from some of #FDA's critical work that continues: Here FDA on duty at Chicago O’Hare Airport’s International Mail Facility. Consumer Safety Officers John Seale and Yuriy Solovyov support our mission examining potentially violative products attempting to enter US commerce. https://t.co/61cF5KU88u

1/2 We've received lots of questions regarding generic drugs during the shutdown. New GDUFA submissions that'll be processed with carryover user fees include: CBE and prior approval supplements, amendments, annual reports, applications for PET drugs, and general correspondence...

2/2 #FDA will also be accepting Drug Master Files, including Type II Active Pharmaceutical Ingredient (API) DMFs, to be referenced in generic drug applications. However, we can't conduct initial completeness assessments on Type II API DMFs if the fee hasn’t been already paid.

Met with the team at #FDA that’s supporting the communication and technology needs of our employees during the shutdown and helping us maintain critical public health functions. https://t.co/tTsPmNwByp

RT @pewhealth: “Physicians treating serious infections must have up-to-date [information] so they can select the best treatment for their patient’s infection.” - @SGottliebFDA What @US_FDA is doing to ensure this: https://t.co/3ehP1D58IR

RT @califf001: Commissioned core--huge national asset that i knew little about till my time at FDA. They are always on call to help where needed. Talk to young people about volunteering. Great to see recognition by Commish. @dukeforge https://t.co/mHnnCXPbcY

The #FDA’s Operations Office: Mission control today as we operate through the shutdown. https://t.co/HiKswPzOKx

RT @HHSGov: You don't have to wait for new years to #QuitSmoking. Sign up for @SmokefreeUs' daily text message program to get t… https://t.co/mSSzovbR6z

RT @DrMcCance_Katz: The holiday season affords us extra occasions to check in on loved ones. If you have a loved one who is struggling… https://t.co/sJ0dzwkCVM

2/2: For our Center for Drug Evaluation and Research this also includes pausing all OTC monograph drug activities. Only emergency work related to these products will continue.

3/4 The 30-day review clock for any pending, non-emergency IND for a medical product that is not covered by a user fee program will be suspended during the lapse period. The clock will resume when the lapse period is over.

THREAD: We have questions re: drug review work that’s not user fee funded and won’t continue during shutdown. CBER will pause non-emergency work on whole blood, blood components for transfusion, allergenic extracts and HCT/Ps regulated solely under sec. 361 of the PHSA. 1/4

4/4: However, new emergency INDs and IND amendments that relate to the safety of individuals who are participating in clinical trials will continue to be reviewed during the government shutdown, even for products that are not covered by a user fee program.