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

We also continue to process, review and classify all high-risk (Class I) and moderate-risk (Class II) medical device recalls. We are then ensuring that the necessary steps are taken for those that pose an imminent threat to human life.

We are also continuing to conduct for-cause inspections of devices facilities when the agency believes an imminent threat to life or health exists, and working to bring back online surveillance inspections of high-risk devices as we have already announced for foods.

I want to personally thank the #FDA colleagues overseeing this important device safety work -- even during these challenging times -- to ensure that our critical consumer protection work continues, and make sure that we are able to secure our public health mandate.

RT @FrankYiannasFDA: THREAD: During this partial lapse in funding, @US_FDA is committed to focusing resources, as permitted by law, on areas of highest potential risk to consumers. https://t.co/Cymn5isKQW

RT @NCIDirector: Great news! https://t.co/QIAG1Ai45n

RT @SGottliebFDA: In calendar years 2017-2018, #FDA approved or tentatively approved a total of 2,048 generic drugs, with two months in Fall 2018 seeing record-breaking generic drug approval totals. https://t.co/HNXuB2tCCs https://t.co/vkJLkOD4z4

RT @TSA_Pekoske: I just popped into @BWI_Airport to recognize the dedication of our officers and thank them their commitment to the… https://t.co/3zeMTq5B5P

RT @TSA_Pekoske: There is an outpouring of industry and public admiration and appreciation for all you’ve done and will continue to… https://t.co/iSB48Ju4RY

Our data continues to demonstrate that flavors are a leading factor in driving youth appeal and use of e-cigs. This use has reached epidemic levels. It should be a concern to all responsible parties, including adults who responsibly benefit from the availability of these products QT @ddiamond: Stopped at a popular I-95 rest stop and spotted this JUUL rack. Me: How’s it selling? Attendant: Much worse since… https://t.co/1rmN8HzNbT)

We have many inquiries regarding user fee funding. We'll update this week with details on remaining balances. We're also closely evaluating when we will cross a threshold, beyond which, we have to declare that we will not be able to meet medical product user fee goals for 2019.

RT @SGottliebFDA: We have many inquiries regarding user fee funding. We'll update this week with details on remaining balances. We're… https://t.co/agcsIMNvYV

We analyzed activities with close input from senior career leaders & public health experts. Our plans always included activities to address immediate threats to human life & safety. But as lapse continues we’re evaluating additional activities we need to except to prevent threats

RT @SGottliebFDA: THREAD: Update on Shutdown - Questions are being raised around FDA’s efforts to support device safety during the partial lapse in funding, especially with respect to post-market surveillance. I want to provide some background:

RT @tmprowell: A peek behind the curtain in #IO #drugdevelopment. https://t.co/xQHAtwhuzk

THREAD - SHUTDOWN UPDATE: The lapse in funding represents one of the most significant operational challenges in FDA’s recent history. But as an agency, we’re committed to fulfilling our consumer protection mandate, to the best of our abilities, under our current configuration.

Expanded monitoring and analysis by the Coordinated Outbreak and Response Evaluation (CORE) Network to include additional food safety and foodborne illness outbreak surveillance, detection, and response activities;

The additional activities may be considered excepted work during a shutdown. Given the prolonged shutdown and compounding risk as time accrues; FDA is working to operationalize additional activities that exceed what we’ve done in past shutdown situations. Activities include:

Expanded inspection activities beyond “for-cause” inspections to also include foreign and domestic food, drug, medical, device and pharmacy compounding surveillance inspections focused on the highest risk products and facilities;

FDA determined after careful analysis and in close consultation with senior career leaders and public health experts that the following activities should be considered excepted, unpaid work because they’re necessary to identify and respond to threats to safety of human life:

Expanded activities related to surveillance and response for recalls (including Class I and Class II) as necessary to identify and respond to threats to the safety of human life;

We also continue to process, review and classify all high-risk (Class I) and moderate-risk (Class II) medical device recalls. We are then ensuring that the necessary steps are taken for those that pose an imminent threat to human life.

We are also continuing to conduct for-cause inspections of devices facilities when the agency believes an imminent threat to life or health exists, and working to bring back online surveillance inspections of high-risk devices as we have already announced for foods.

I want to personally thank the #FDA colleagues overseeing this important device safety work -- even during these challenging times -- to ensure that our critical consumer protection work continues, and make sure that we are able to secure our public health mandate.

RT @FrankYiannasFDA: THREAD: During this partial lapse in funding, @US_FDA is committed to focusing resources, as permitted by law, on areas of highest potential risk to consumers. https://t.co/Cymn5isKQW

RT @NCIDirector: Great news! https://t.co/QIAG1Ai45n

RT @SGottliebFDA: In calendar years 2017-2018, #FDA approved or tentatively approved a total of 2,048 generic drugs, with two months in Fall 2018 seeing record-breaking generic drug approval totals. https://t.co/HNXuB2tCCs https://t.co/vkJLkOD4z4

RT @TSA_Pekoske: I just popped into @BWI_Airport to recognize the dedication of our officers and thank them their commitment to the… https://t.co/3zeMTq5B5P

RT @TSA_Pekoske: There is an outpouring of industry and public admiration and appreciation for all you’ve done and will continue to… https://t.co/iSB48Ju4RY

Our data continues to demonstrate that flavors are a leading factor in driving youth appeal and use of e-cigs. This use has reached epidemic levels. It should be a concern to all responsible parties, including adults who responsibly benefit from the availability of these products QT @ddiamond: Stopped at a popular I-95 rest stop and spotted this JUUL rack. Me: How’s it selling? Attendant: Much worse since… https://t.co/1rmN8HzNbT)

We have many inquiries regarding user fee funding. We'll update this week with details on remaining balances. We're also closely evaluating when we will cross a threshold, beyond which, we have to declare that we will not be able to meet medical product user fee goals for 2019.

RT @SGottliebFDA: We have many inquiries regarding user fee funding. We'll update this week with details on remaining balances. We're… https://t.co/agcsIMNvYV

We analyzed activities with close input from senior career leaders & public health experts. Our plans always included activities to address immediate threats to human life & safety. But as lapse continues we’re evaluating additional activities we need to except to prevent threats

RT @SGottliebFDA: THREAD: Update on Shutdown - Questions are being raised around FDA’s efforts to support device safety during the partial lapse in funding, especially with respect to post-market surveillance. I want to provide some background:

RT @tmprowell: A peek behind the curtain in #IO #drugdevelopment. https://t.co/xQHAtwhuzk

THREAD - SHUTDOWN UPDATE: The lapse in funding represents one of the most significant operational challenges in FDA’s recent history. But as an agency, we’re committed to fulfilling our consumer protection mandate, to the best of our abilities, under our current configuration.

Expanded monitoring and analysis by the Coordinated Outbreak and Response Evaluation (CORE) Network to include additional food safety and foodborne illness outbreak surveillance, detection, and response activities;

The additional activities may be considered excepted work during a shutdown. Given the prolonged shutdown and compounding risk as time accrues; FDA is working to operationalize additional activities that exceed what we’ve done in past shutdown situations. Activities include:

Expanded inspection activities beyond “for-cause” inspections to also include foreign and domestic food, drug, medical, device and pharmacy compounding surveillance inspections focused on the highest risk products and facilities;

FDA determined after careful analysis and in close consultation with senior career leaders and public health experts that the following activities should be considered excepted, unpaid work because they’re necessary to identify and respond to threats to safety of human life:

Expanded activities related to surveillance and response for recalls (including Class I and Class II) as necessary to identify and respond to threats to the safety of human life;