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

We will issue more detailed analysis of our carryover user fee balances this week, in response to multiple inquiries that we have received from the press. We are preparing that information, along with analysis about our burn rates.

I admire very much the dedication of #FDA colleagues during these challenging times. This is especially true for field force who perform front-line inspection functions, and incur costs on personal credit cards related to travel. Our new steps are aimed at mitigating those costs.

We're going to be taking other steps, where we can, to reduce the personal burdens on our colleagues.

THREAD: Update on Shutdown - We have many dedicated staff conducting critical inspections of food and drug facilities who are in an “unpaid, excepted status,” meaning they're working on critical public health functions, without pay or reimbursement. This hasn’t gone unnoticed.

We’ll support them in any way we can in their execution of these vital public health functions. Toward these goals we’re adopting new procedures that'll reduce the likelihood that they accrue balances on their government travel credit cards for cost of airfare and hotel/lodging.

THREAD: we’ve received questions from reporters and others related to the generic drug review program at #FDA; and what review activities will continue during the shutdown. I want to provide some information related to these inquiries:

Sponsors who haven’t paid GDUFA facility fees for FY19 shouldn’t remit payment during the lapse period because FDA cannot accept the fees. FDA will accept Drug Master Files, including Type II Active Pharmaceutical Ingredient DMFs, intended to be referenced in generic applications

FDA will accept generic submissions for which no fee is required, if product is within the scope of the GDUFA program. These submissions include, for example: CBE supplements and prior approval supplements to approved ANDAs, Amendments, Annual reports, Applications for PET drugs

During the lapse period, FDA will not accept generic drug submissions that require payment of a fee (e.g., Abbreviated New Drug Applications (ANDAs))

FDA will not conduct initial completeness assessments on Type II API DMFs for which the fee has not been paid and these new DMFs will not be placed on the Available for Reference List.

If the fee is not paid within 20 calendar days of that notice, FDA will not receive the application. At this time, FDA has not determined what approach it will take if the 20 calendar day period expires during the lapse period.

Type II API DMF fees should not be submitted during the lapse period because FDA cannot accept the fees. Fees that are due during the lapse period may be paid as soon as the lapse period ends.

If a generic drug application references, for the first time after Dec 22, 2018, a Type II API DMF for which the fee has not been paid, then FDA will notify the applicant that the fee must be paid within 20 calendar days.

November 2018 and October 2018 saw the same record-breaking generic drug approval totals: 128 each in those months. We are still tallying final numbers for December and will share soon.

1/2 #Flu season is picking up. @CDCFlu reports flu activity continues to increase nationally with some areas seeing sharp increases in activity. Protect yourself, your family and your community – it’s not too late to get your flu vaccine. #VaccinesWork https://t.co/jDOXdrt3YK

2/2 If you are sick with the #flu, see a health care provider ASAP. There are FDA-approved treatments that can help. CDC has put together a symptom checker to help you know when it might be the flu. https://t.co/8HvWg7YgLZ

In calendar years 2017-18, #FDA approved or tentatively approved more than 2,000 generic drugs. #FDA will continue its focus on approving high-quality, lower cost, safe and effective generics for Americans as well as helping to create competition in the marketplace.

My note to our inspectorate today. We’re taking new steps to bill travel costs to a central #FDA account so our field force isn’t burdened by balances on personal government travel cards at a time when they’re not being paid or reimbursed. I’m very grateful for their dedication. https://t.co/ICDMyR7mzP

Politico Pro: “The FDA has changed its internal travel policy in an effort to make the government shutdown less burdensome on inspectors who are working without pay to oversee critical functions like food and pharmaceutical safety.” $ https://t.co/7UM5zcWfhc https://t.co/Jlm5QuVvyt

@adamfeuerstein Since you asked: https://t.co/8nr7GeUzbm

We will issue more detailed analysis of our carryover user fee balances this week, in response to multiple inquiries that we have received from the press. We are preparing that information, along with analysis about our burn rates.

I admire very much the dedication of #FDA colleagues during these challenging times. This is especially true for field force who perform front-line inspection functions, and incur costs on personal credit cards related to travel. Our new steps are aimed at mitigating those costs.

We're going to be taking other steps, where we can, to reduce the personal burdens on our colleagues.

THREAD: Update on Shutdown - We have many dedicated staff conducting critical inspections of food and drug facilities who are in an “unpaid, excepted status,” meaning they're working on critical public health functions, without pay or reimbursement. This hasn’t gone unnoticed.

We’ll support them in any way we can in their execution of these vital public health functions. Toward these goals we’re adopting new procedures that'll reduce the likelihood that they accrue balances on their government travel credit cards for cost of airfare and hotel/lodging.

THREAD: we’ve received questions from reporters and others related to the generic drug review program at #FDA; and what review activities will continue during the shutdown. I want to provide some information related to these inquiries:

Sponsors who haven’t paid GDUFA facility fees for FY19 shouldn’t remit payment during the lapse period because FDA cannot accept the fees. FDA will accept Drug Master Files, including Type II Active Pharmaceutical Ingredient DMFs, intended to be referenced in generic applications

FDA will accept generic submissions for which no fee is required, if product is within the scope of the GDUFA program. These submissions include, for example: CBE supplements and prior approval supplements to approved ANDAs, Amendments, Annual reports, Applications for PET drugs

During the lapse period, FDA will not accept generic drug submissions that require payment of a fee (e.g., Abbreviated New Drug Applications (ANDAs))

FDA will not conduct initial completeness assessments on Type II API DMFs for which the fee has not been paid and these new DMFs will not be placed on the Available for Reference List.

If the fee is not paid within 20 calendar days of that notice, FDA will not receive the application. At this time, FDA has not determined what approach it will take if the 20 calendar day period expires during the lapse period.

Type II API DMF fees should not be submitted during the lapse period because FDA cannot accept the fees. Fees that are due during the lapse period may be paid as soon as the lapse period ends.

If a generic drug application references, for the first time after Dec 22, 2018, a Type II API DMF for which the fee has not been paid, then FDA will notify the applicant that the fee must be paid within 20 calendar days.

November 2018 and October 2018 saw the same record-breaking generic drug approval totals: 128 each in those months. We are still tallying final numbers for December and will share soon.

1/2 #Flu season is picking up. @CDCFlu reports flu activity continues to increase nationally with some areas seeing sharp increases in activity. Protect yourself, your family and your community – it’s not too late to get your flu vaccine. #VaccinesWork https://t.co/jDOXdrt3YK

2/2 If you are sick with the #flu, see a health care provider ASAP. There are FDA-approved treatments that can help. CDC has put together a symptom checker to help you know when it might be the flu. https://t.co/8HvWg7YgLZ

In calendar years 2017-18, #FDA approved or tentatively approved more than 2,000 generic drugs. #FDA will continue its focus on approving high-quality, lower cost, safe and effective generics for Americans as well as helping to create competition in the marketplace.

My note to our inspectorate today. We’re taking new steps to bill travel costs to a central #FDA account so our field force isn’t burdened by balances on personal government travel cards at a time when they’re not being paid or reimbursed. I’m very grateful for their dedication. https://t.co/ICDMyR7mzP

Politico Pro: “The FDA has changed its internal travel policy in an effort to make the government shutdown less burdensome on inspectors who are working without pay to oversee critical functions like food and pharmaceutical safety.” $ https://t.co/7UM5zcWfhc https://t.co/Jlm5QuVvyt

@adamfeuerstein Since you asked: https://t.co/8nr7GeUzbm