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

RT @pewhealth: When it comes to fighting superbugs, “we’re at an inflection point in science and innovation,” says @SGottliebFDA. Insights on the @US_FDA’s plan to prevent #antibioticresistance: https://t.co/3ehP1D58IR

Our efforts to modernize the 501K process are aimed at making the process for bringing beneficial innovations to patients more efficient; and making sure newly cleared devices reflect the standard of care when it comes to the safety, performance of devices https://t.co/2cDdRQnsVj

RT @FrankYiannasFDA: In 2018, there were several significant foodborne outbreaks & recalls. 2019 starts off as a blank slate. Let’s all work together on prevention to try to keep it that way & make it food-safe new year. #Prevention matters. https://t.co/NTRR6PXLQt

1/3 We’re alerting consumers and health care providers of a voluntary recall by Aurobindo Pharma of 2 lots of valsartan, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and HCTZ combination tablets due to NDEA impurity in valsartan ingredient.

We’re issuing more guidance today on activities that’ll be continuing during the shutdown because of critical public health need. I recognize the impacts this is having on our workforce and we are taking whatever steps we can to address the personal challenges felt by our people.

2/3 Aurobind is only recalling amlodipine and HCTZ in combination with valsartan. Neither medication is currently under recall by itself.https://t.co/HZb3YT0060

3/3 #FDA continues to evaluate the safety of ARB products and updates the list of products included and not included in the recall on an ongoing basis:https://t.co/EXl8c3HEIU

RT @SeemaCMS: If you haven’t gotten your flu shot yet, be sure to get it ASAP! Flu season has already begun! https://t.co/MrSOUywnwa QT @HHSGov: FLU UPDATE: 11 states have reported widespread flu activity and 19 states have reported regional flu activity. Find… https://t.co/QB8oHNapEB)

RT @pkluetz: Consider following @FDAOncology for 2019. The Oncology Center of Excellence at FDA uses this account for timely pos… https://t.co/kIWxq2yKJq

#FDA will also use carryover funding to support development of medical products. This includes participating in pre-approval discussions with sponsors seeking guidance on how to go forward with clinical research and other ongoing discussions to help advance development programs.

THREAD: #FDA will continue to advance certain policy, consistent with what's permissible under law. Carryover user-fees support important actions, including developing guidance and advancing policies that further FDA’s regulatory oversight of medical products and animal drugs.

However, this doesn't mean it's business as usual at #FDA; the lapse in funding will limit many medical product related activities, including the development of certain guidances. We also cannot accept new applications for medical products that require the payment of a user fee.

This applies to new submissions for which payment of a FY19 fee is required under PDUFA and the Generic Drug User Fee Amendments, Biosimilar User Fee Amendments, Medical Device User Fee Amendments, Animal Drug User Fee Amendments, or the Animal Generic Drug User Fee Amendments.

Specifically, #FDA will not be able to accept any regulatory submissions for FY 2019 for new drugs, medical devices, or biologics that require a fee payment and that are submitted during the lapse period, unless the required user fee was paid before December 22, 2018.

#FDA will accept generic drug submissions for which no fee is required if the product is within the scope of the GDUFA program. These submissions include CBE supplements and prior approval supplements to approved ANDAs, amendments, annual reports, and applications for PET drugs.

During the lapse period, for PDUFA products, FDA will accept new regulatory submissions for which no fee is required. These types of submissions include INDs, annual reports, supplements to NDAs and BLAs, submissions that fall within fee exemptions, and general correspondence.

FDA will accept DMFs, including Type II API DMFs, intended to be referenced in generic applications. FDA won't conduct initial completeness assessments on Type II API DMFs for which the fee hasn't been paid and these new DMFs will not be placed on the Available for Reference List

Regarding the review of medical products that are not within the scope of any of #FDA’s user fee programs: Certain limited categories of medical products regulated by CDER and CBER are not within the scope of any of FDA’s user fee programs.

Accordingly, fee funding is not available to carry out activities with respect to these limited categories of medical products. For example, within CDER, carryover user fee funding is not available for OTC monograph drug activities.

For example, FDA will continue to conduct surveillance for adverse events to determine the potential risk to health from such products and conduct recalls or take other critical actions to protect the safety of human life.

RT @pewhealth: When it comes to fighting superbugs, “we’re at an inflection point in science and innovation,” says @SGottliebFDA. Insights on the @US_FDA’s plan to prevent #antibioticresistance: https://t.co/3ehP1D58IR

Our efforts to modernize the 501K process are aimed at making the process for bringing beneficial innovations to patients more efficient; and making sure newly cleared devices reflect the standard of care when it comes to the safety, performance of devices https://t.co/2cDdRQnsVj

RT @FrankYiannasFDA: In 2018, there were several significant foodborne outbreaks & recalls. 2019 starts off as a blank slate. Let’s all work together on prevention to try to keep it that way & make it food-safe new year. #Prevention matters. https://t.co/NTRR6PXLQt

1/3 We’re alerting consumers and health care providers of a voluntary recall by Aurobindo Pharma of 2 lots of valsartan, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and HCTZ combination tablets due to NDEA impurity in valsartan ingredient.

We’re issuing more guidance today on activities that’ll be continuing during the shutdown because of critical public health need. I recognize the impacts this is having on our workforce and we are taking whatever steps we can to address the personal challenges felt by our people.

2/3 Aurobind is only recalling amlodipine and HCTZ in combination with valsartan. Neither medication is currently under recall by itself.https://t.co/HZb3YT0060

3/3 #FDA continues to evaluate the safety of ARB products and updates the list of products included and not included in the recall on an ongoing basis:https://t.co/EXl8c3HEIU

RT @SeemaCMS: If you haven’t gotten your flu shot yet, be sure to get it ASAP! Flu season has already begun! https://t.co/MrSOUywnwa QT @HHSGov: FLU UPDATE: 11 states have reported widespread flu activity and 19 states have reported regional flu activity. Find… https://t.co/QB8oHNapEB)

RT @pkluetz: Consider following @FDAOncology for 2019. The Oncology Center of Excellence at FDA uses this account for timely pos… https://t.co/kIWxq2yKJq

#FDA will also use carryover funding to support development of medical products. This includes participating in pre-approval discussions with sponsors seeking guidance on how to go forward with clinical research and other ongoing discussions to help advance development programs.

THREAD: #FDA will continue to advance certain policy, consistent with what's permissible under law. Carryover user-fees support important actions, including developing guidance and advancing policies that further FDA’s regulatory oversight of medical products and animal drugs.

However, this doesn't mean it's business as usual at #FDA; the lapse in funding will limit many medical product related activities, including the development of certain guidances. We also cannot accept new applications for medical products that require the payment of a user fee.

This applies to new submissions for which payment of a FY19 fee is required under PDUFA and the Generic Drug User Fee Amendments, Biosimilar User Fee Amendments, Medical Device User Fee Amendments, Animal Drug User Fee Amendments, or the Animal Generic Drug User Fee Amendments.

Specifically, #FDA will not be able to accept any regulatory submissions for FY 2019 for new drugs, medical devices, or biologics that require a fee payment and that are submitted during the lapse period, unless the required user fee was paid before December 22, 2018.

#FDA will accept generic drug submissions for which no fee is required if the product is within the scope of the GDUFA program. These submissions include CBE supplements and prior approval supplements to approved ANDAs, amendments, annual reports, and applications for PET drugs.

During the lapse period, for PDUFA products, FDA will accept new regulatory submissions for which no fee is required. These types of submissions include INDs, annual reports, supplements to NDAs and BLAs, submissions that fall within fee exemptions, and general correspondence.

FDA will accept DMFs, including Type II API DMFs, intended to be referenced in generic applications. FDA won't conduct initial completeness assessments on Type II API DMFs for which the fee hasn't been paid and these new DMFs will not be placed on the Available for Reference List

Regarding the review of medical products that are not within the scope of any of #FDA’s user fee programs: Certain limited categories of medical products regulated by CDER and CBER are not within the scope of any of FDA’s user fee programs.

Accordingly, fee funding is not available to carry out activities with respect to these limited categories of medical products. For example, within CDER, carryover user fee funding is not available for OTC monograph drug activities.

For example, FDA will continue to conduct surveillance for adverse events to determine the potential risk to health from such products and conduct recalls or take other critical actions to protect the safety of human life.