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

I believe consumers who use cigars/pipe tobacco products should be informed about the risks, similar to any tobacco product consumer. We’ll continue to defend litigation contesting these warnings & pursue these practical, public health requirements: https://t.co/1ixstXWvVV

We take this work very seriously. I also want to reassure consumers that we are not seeing an increase in the number or scope of recalls.

THREAD: #FDA and partners continue investigating possible Salmonella contamination of an ingredient used in several popular foods. #FDA is onsite investigating the AMPI facility and we’re working to identify if any other food may be contaminated. https://t.co/2hPPxd8Ti8

There are no confirmed illnesses related to these products. But we know these products are consumed daily across our country, often by children, which is why we’re alerting consumers.

FDA’s new draft guidance clarifies evidence necessary to  demonstrate effectiveness of drugs for slowly progressive, low-prevalence rare diseases associated with substrate deposition and are caused by single enzyme defects (e.g. Gaucher, Pompe, Tay Sachs): https://t.co/yLdDPgAGY3

The American food supply is safer than ever before thanks to the preventive measures set forth in the landmark #FDA Food Safety Modernization Act and advances in technology that help us detect and respond to problems.

RT @Surgeon_General: We care. We care about stopping addiction. And one of things we need to do is tackle stigma. No one should be afrai… https://t.co/cZKiKAve82

RT @FDAfood: Stay informed about upcoming #NutritionInnovation Strategy policy by following @FDAfood, @SGottliebFDA, and @DrMayneFDAFood.

RT @FDA_Drug_Info: #FDA is publishing a list of surrogate endpoints which were the basis of approval or licensure of a drug or biologi… https://t.co/JYPySzRiqz

RT @US_FDA: What data are submitted to support a product’s demonstration of biosimilarity? Learn more about requirements for bi… https://t.co/65FsjcYUOP

Today marks the 1 year anniversary of #FDA #Digitalhealth Innovation Action Plan. We’ve made significant progress in every area that we promised—from bringing more expertise to our digital team, to issuing guidances & starting our #FDAPrecert pilot https://t.co/3PkWQ6SXNT https://t.co/tpG6aJVg3k

...so pharmacists may be able to provide a refill of valsartan medication from batches that that are not affected by the recall, or doctors may prescribe a different medication that treats the same indications.

Patients taking valsartan from a recalled batch should continue taking their current medicine until their doctor or pharmacist provides a replacement or a different treatment option. It's important to know that not all valsartan products contained the impurity known as NDMA...

THREAD: #FDA provided a new update today on the valsartan recalls and the agency's analysis of the impurity found in these recalled products; and the risk it could have posed to patients who received the maximum exposure to a drug containing the impurity https://t.co/0WLUlwtqfI

While these numbers suggest the additional risk from taking the recalled medicine is very low, the assessment led to FDA’s decision to have these batches recalled. #FDA is committed to ensuring the quality of approved drugs and will act quickly when issues arise affecting safety

FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full four years the drug was marketed, there may be one additional case of cancer over the lifetimes of these 8,000 people.

The 1 in 8,000 figure represents one additional case of cancer across all 8,000 people, over the entire lifetime of these 8,000 people, and under a circumstance where they all used products with the highest levels of impurity for the maximum time these products were on the market

Amounts of NDMA found in the recalled batches of valsartan exceeded these acceptable levels. The new analysis is an attempt by #FDA to put some context around the actual potential risk posed to patients who used versions of valsartan that may have contained high levels of NDMA

NDMA is found in some water and foods. Consuming up to 96 nanograms NDMA/day is considered reasonably safe for humans. It's estimated that over the course of a person’s life, consuming this amount would result in less than one additional case of cancer for every 100,000 people.

The amounts of NDMA found in the recalled batches of valsartan exceeded these acceptable levels. The new analysis is an attempt by FDA to put some context around the actual potential risk posed to patients who used versions of valsartan that may have contained high levels of NDMA

I believe consumers who use cigars/pipe tobacco products should be informed about the risks, similar to any tobacco product consumer. We’ll continue to defend litigation contesting these warnings & pursue these practical, public health requirements: https://t.co/1ixstXWvVV

We take this work very seriously. I also want to reassure consumers that we are not seeing an increase in the number or scope of recalls.

THREAD: #FDA and partners continue investigating possible Salmonella contamination of an ingredient used in several popular foods. #FDA is onsite investigating the AMPI facility and we’re working to identify if any other food may be contaminated. https://t.co/2hPPxd8Ti8

There are no confirmed illnesses related to these products. But we know these products are consumed daily across our country, often by children, which is why we’re alerting consumers.

FDA’s new draft guidance clarifies evidence necessary to  demonstrate effectiveness of drugs for slowly progressive, low-prevalence rare diseases associated with substrate deposition and are caused by single enzyme defects (e.g. Gaucher, Pompe, Tay Sachs): https://t.co/yLdDPgAGY3

The American food supply is safer than ever before thanks to the preventive measures set forth in the landmark #FDA Food Safety Modernization Act and advances in technology that help us detect and respond to problems.

RT @Surgeon_General: We care. We care about stopping addiction. And one of things we need to do is tackle stigma. No one should be afrai… https://t.co/cZKiKAve82

RT @FDAfood: Stay informed about upcoming #NutritionInnovation Strategy policy by following @FDAfood, @SGottliebFDA, and @DrMayneFDAFood.

RT @FDA_Drug_Info: #FDA is publishing a list of surrogate endpoints which were the basis of approval or licensure of a drug or biologi… https://t.co/JYPySzRiqz

RT @US_FDA: What data are submitted to support a product’s demonstration of biosimilarity? Learn more about requirements for bi… https://t.co/65FsjcYUOP

Today marks the 1 year anniversary of #FDA #Digitalhealth Innovation Action Plan. We’ve made significant progress in every area that we promised—from bringing more expertise to our digital team, to issuing guidances & starting our #FDAPrecert pilot https://t.co/3PkWQ6SXNT https://t.co/tpG6aJVg3k

...so pharmacists may be able to provide a refill of valsartan medication from batches that that are not affected by the recall, or doctors may prescribe a different medication that treats the same indications.

Patients taking valsartan from a recalled batch should continue taking their current medicine until their doctor or pharmacist provides a replacement or a different treatment option. It's important to know that not all valsartan products contained the impurity known as NDMA...

THREAD: #FDA provided a new update today on the valsartan recalls and the agency's analysis of the impurity found in these recalled products; and the risk it could have posed to patients who received the maximum exposure to a drug containing the impurity https://t.co/0WLUlwtqfI

While these numbers suggest the additional risk from taking the recalled medicine is very low, the assessment led to FDA’s decision to have these batches recalled. #FDA is committed to ensuring the quality of approved drugs and will act quickly when issues arise affecting safety

FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full four years the drug was marketed, there may be one additional case of cancer over the lifetimes of these 8,000 people.

The 1 in 8,000 figure represents one additional case of cancer across all 8,000 people, over the entire lifetime of these 8,000 people, and under a circumstance where they all used products with the highest levels of impurity for the maximum time these products were on the market

Amounts of NDMA found in the recalled batches of valsartan exceeded these acceptable levels. The new analysis is an attempt by #FDA to put some context around the actual potential risk posed to patients who used versions of valsartan that may have contained high levels of NDMA

NDMA is found in some water and foods. Consuming up to 96 nanograms NDMA/day is considered reasonably safe for humans. It's estimated that over the course of a person’s life, consuming this amount would result in less than one additional case of cancer for every 100,000 people.

The amounts of NDMA found in the recalled batches of valsartan exceeded these acceptable levels. The new analysis is an attempt by FDA to put some context around the actual potential risk posed to patients who used versions of valsartan that may have contained high levels of NDMA