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

Expanded monitoring and evaluating medical device adverse event and malfunction reports to include additional types of medical devices;

It is not business as usual at FDA. Many key functions aren't getting done. But we're focused on maintaining core activities that directly impact consumer safety and save lives. My priority is to our consumer protection mission and the people executing mission critical functions

Surveillance sampling of imported high-risk foods, drugs, and devices, and the logistical coordination and laboratory support for allowable inspections and evaluation;

These actions are being taken in close consultation with, and based on direct feedback from, senior career leadership of FDA, our program officers, and our range of experts. Our mission is focused squarely on securing consumer safety and protecting Americans during these times.

In the coming days, we’ll update on some additional activities that the #FDA plans to continue undertaking, especially activities related to veterinary health issues that have a direct impact on human life and safety.

#FDA is alerting pet owners not to feed their dogs certain A+ Answers Straight Beef Formula because it may be contaminated with Salmonella. Specifically, Lot 2018 20/08 20, tested positive for Salmonella by Nebraska state officials. Salmonella can be harmful to humans and animals

The company recalled the product from distribution and retail locations in Nebraska late last month but has not recalled the product nationwide. Read more here: https://t.co/xD7k9U9m91.

Last week #FDA investigators at the JFK Airport's International Mail Facility in New York intercepted and destroyed counterfeit and/or misbranded drugs totaling more than a half ton of illegal products. #OnTheJob #MissionCritical https://t.co/ozCJ8Nviqh

A garbage truck crushed the violative products, which were then incinerated — keeping potentially dangerous products out of the hands of unsuspecting consumers. https://t.co/xzMRH3jmVY

RT @SGottliebFDA: UPDATE ON FOOD INSPECTIONS AND OTHER INSPECTION ACTIVITY: The response from our outstanding field force and inspect… https://t.co/Mn55HAemax

RT @SGottliebFDA: Behind the efforts of our dedicated field force, we'll be restarting inspections of high risk food and medical prod… https://t.co/lvm26Tav9C

THREAD: We’re getting many questions about when #FDA can continue to accept medical product applications during the lapse in funding. The questions tonight relate to one particular biotech firm. However, I'm addressing the issues generally, and not specific to one product.

More specifically, for products not covered by a user fee program, like most blood and allergenic extract products, FDA does not have carryover user fee funding to continue reviewing pending or accepting new applications.

However, during the lapse, FDA cannot accept new medical product applications that require a fee payment. We are not allowed to accept new user fees. In these cases, sponsors will need to wait until the lapse is over to submit their applications to FDA for review.

RT @BySheilaKaplan: F.D.A. Says It Will Resume Inspecting Some High-Risk Foods https://t.co/4w5nKas7Of

For products covered by a user fee program, if the product sponsor submitted the application and paid any required fees before the lapse, FDA can use its limited carryover user fee funding to continue reviewing the application.

These product categories are not associated with a user fee program. As a result, during the lapse, FDA activities for products are limited to emergency work involving safety of human life, such as monitoring for adverse events and, if warranted, taking action to protect patients

We’ve seen some innacurate narratives. I want to reaffirm that we’re here to answer inquiries from press and working hard to communicate. As the challenges grow, I fear that we’ll see more parties inadvertently or deliberately blame the shutdown.

A note to reporters: There are a lot of hardships created by the shutdown, especially for patients and consumers who rely on the products and protections FDA helps provide. But there are also some parties who are using the excuse of the shutdown to advance misleading narratives.

It’s key we work together to separate the facts from those narratives that aren’t true so we understand the true hardships being created for consumers. We are dedicated to transparency and doing our best to respond quickly on short staff. So please check with us. We’re working!

Expanded monitoring and evaluating medical device adverse event and malfunction reports to include additional types of medical devices;

It is not business as usual at FDA. Many key functions aren't getting done. But we're focused on maintaining core activities that directly impact consumer safety and save lives. My priority is to our consumer protection mission and the people executing mission critical functions

Surveillance sampling of imported high-risk foods, drugs, and devices, and the logistical coordination and laboratory support for allowable inspections and evaluation;

These actions are being taken in close consultation with, and based on direct feedback from, senior career leadership of FDA, our program officers, and our range of experts. Our mission is focused squarely on securing consumer safety and protecting Americans during these times.

In the coming days, we’ll update on some additional activities that the #FDA plans to continue undertaking, especially activities related to veterinary health issues that have a direct impact on human life and safety.

#FDA is alerting pet owners not to feed their dogs certain A+ Answers Straight Beef Formula because it may be contaminated with Salmonella. Specifically, Lot 2018 20/08 20, tested positive for Salmonella by Nebraska state officials. Salmonella can be harmful to humans and animals

The company recalled the product from distribution and retail locations in Nebraska late last month but has not recalled the product nationwide. Read more here: https://t.co/xD7k9U9m91.

Last week #FDA investigators at the JFK Airport's International Mail Facility in New York intercepted and destroyed counterfeit and/or misbranded drugs totaling more than a half ton of illegal products. #OnTheJob #MissionCritical https://t.co/ozCJ8Nviqh

A garbage truck crushed the violative products, which were then incinerated — keeping potentially dangerous products out of the hands of unsuspecting consumers. https://t.co/xzMRH3jmVY

RT @SGottliebFDA: UPDATE ON FOOD INSPECTIONS AND OTHER INSPECTION ACTIVITY: The response from our outstanding field force and inspect… https://t.co/Mn55HAemax

RT @SGottliebFDA: Behind the efforts of our dedicated field force, we'll be restarting inspections of high risk food and medical prod… https://t.co/lvm26Tav9C

THREAD: We’re getting many questions about when #FDA can continue to accept medical product applications during the lapse in funding. The questions tonight relate to one particular biotech firm. However, I'm addressing the issues generally, and not specific to one product.

More specifically, for products not covered by a user fee program, like most blood and allergenic extract products, FDA does not have carryover user fee funding to continue reviewing pending or accepting new applications.

However, during the lapse, FDA cannot accept new medical product applications that require a fee payment. We are not allowed to accept new user fees. In these cases, sponsors will need to wait until the lapse is over to submit their applications to FDA for review.

RT @BySheilaKaplan: F.D.A. Says It Will Resume Inspecting Some High-Risk Foods https://t.co/4w5nKas7Of

For products covered by a user fee program, if the product sponsor submitted the application and paid any required fees before the lapse, FDA can use its limited carryover user fee funding to continue reviewing the application.

These product categories are not associated with a user fee program. As a result, during the lapse, FDA activities for products are limited to emergency work involving safety of human life, such as monitoring for adverse events and, if warranted, taking action to protect patients

We’ve seen some innacurate narratives. I want to reaffirm that we’re here to answer inquiries from press and working hard to communicate. As the challenges grow, I fear that we’ll see more parties inadvertently or deliberately blame the shutdown.

A note to reporters: There are a lot of hardships created by the shutdown, especially for patients and consumers who rely on the products and protections FDA helps provide. But there are also some parties who are using the excuse of the shutdown to advance misleading narratives.

It’s key we work together to separate the facts from those narratives that aren’t true so we understand the true hardships being created for consumers. We are dedicated to transparency and doing our best to respond quickly on short staff. So please check with us. We’re working!