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

Two revised draft guidances are coming soon - one relates to insanitary conditions at compounding facilities and a second relates to current good manufacturing practice (CGMP) requirements tailored to the operations of outsourcing facilities. https://t.co/rQHPQNFLCQ

States also would investigate complaints relating to compounded drugs, including reports of serious adverse events or serious product quality issues and notify FDA.

And our revised cGMP guidance will provide a more flexible standard for how we enforce GMP requirements based on risk; to enable smaller compounders who are engaging in activities posing less risk to comply without incurring significant expenses on new equipment, facilities, etc

FDA’s compounding program is a priority. As the revised draft MOU shows, we are balancing the need to preserve access to appropriately compounded drugs for patients who need them with the need to protect patients from poor quality compounded drugs that could cause harm. https://t.co/m7IjbK27xa

In earlier draft MOU, states had to act against compounders for shipping >30% of their compounded drugs out of state. But some said this could impede access to needed drugs from pharmacies that specialize in drugs to treat certain conditions and ship nationwide, so FDA revised.

The #FDA is actively tracking hurricane #Florence and will provide updates on FDA-related issues as they develop. Be prepared. Some advice and safety tips related to FDA-regulated products can be found on the FDA website: https://t.co/sZRYZEr3Bj https://t.co/bHsqLaTCPh

RT @NYFarmer: Cheryl Ann, the cow, just had a calf. Unfortunately, the little girl is trying to nurse on wrong end of cow. (Getti… https://t.co/cmAMaoZbRA

RT @pewhealth: LIVE WEBCAST: @SGottliebFDA announces plans to safeguard public health amid the growing threat of superbugs. How to… https://t.co/A7nYGeJ4Qx

RT @precisionfda: FDA is launching the precisionFDA @theNCI Mislabeling Challenge on September 24! Participants will work to accurate… https://t.co/xrzyrqJTGJ

According to #FDA’s shortages database; the drug in question — which is a liquid formulation of a widely available, and old and less frequently used antibiotic — is also NOT in shortage.

2/2 There are other suppliers of this product and, by its own admission in @FT, the company in question isn’t actively marketing their formulation. Their excessive price, detached from market principles, exists only on a list and should remain there in a competitive marketplace

1/2 Regarding @FT story today @bydavidcrow; there’s no moral imperative to price gouge and take advantage of patients. FDA will continue to promote competition so speculators and those with no regard to public health consequences can’t take advantage of patients who need medicine

RT @SGottliebFDA: 1/2 Regarding @FT story today @bydavidcrow; there’s no moral imperative to price gouge and take advantage of patien… https://t.co/6IhY0C95ZP

We will always remember those who have fallen and the heroes who risked their lives to treat and save others. #September11, #NeverForget https://t.co/LJrMEBE2SU

RT @pewhealth: What’s the U.S. doing to keep the public safe from superbugs? @SGottliebFDA explains in our special live event—tune… https://t.co/qGVOC9xFfy

RT @FDAfood: Prepare now, it’s not too late - FDA's advice on #foodsafety in case you lose power ⇨ https://t.co/alAbvBY80z… https://t.co/CaNXyh0Fql

RT @FDATobacco: Spotlight on Science is a quarterly science and research digest from @FDATobacco. Read the latest on CTP's tobacco… https://t.co/DFY6575Kda

RT @SecAzar: I've signed public health emergency declarations to help support NC and SC as they prepare for Hurricane #Florence.… https://t.co/RvPh0tP7Vk

#FDA, along with other state and federal agencies, are closely tracking the paths of Hurricanes #Florence and #Olivia anticipated to make landfall this week. We stand ready to provide assistance to impacted communities and we will provide updates as the storm develops.

RT @SecAzar: No child should be using any tobacco or nicotine-containing product. The work by @US_FDA to crack down on the sale and marketi… QT @SGottliebFDA: Today #FDA took a series of critical actions to address the epidemic of youth e-cigarette use. We also intend to ta… https://t.co/0uVMrL7O17)

Two revised draft guidances are coming soon - one relates to insanitary conditions at compounding facilities and a second relates to current good manufacturing practice (CGMP) requirements tailored to the operations of outsourcing facilities. https://t.co/rQHPQNFLCQ

States also would investigate complaints relating to compounded drugs, including reports of serious adverse events or serious product quality issues and notify FDA.

And our revised cGMP guidance will provide a more flexible standard for how we enforce GMP requirements based on risk; to enable smaller compounders who are engaging in activities posing less risk to comply without incurring significant expenses on new equipment, facilities, etc

FDA’s compounding program is a priority. As the revised draft MOU shows, we are balancing the need to preserve access to appropriately compounded drugs for patients who need them with the need to protect patients from poor quality compounded drugs that could cause harm. https://t.co/m7IjbK27xa

In earlier draft MOU, states had to act against compounders for shipping >30% of their compounded drugs out of state. But some said this could impede access to needed drugs from pharmacies that specialize in drugs to treat certain conditions and ship nationwide, so FDA revised.

The #FDA is actively tracking hurricane #Florence and will provide updates on FDA-related issues as they develop. Be prepared. Some advice and safety tips related to FDA-regulated products can be found on the FDA website: https://t.co/sZRYZEr3Bj https://t.co/bHsqLaTCPh

RT @NYFarmer: Cheryl Ann, the cow, just had a calf. Unfortunately, the little girl is trying to nurse on wrong end of cow. (Getti… https://t.co/cmAMaoZbRA

RT @pewhealth: LIVE WEBCAST: @SGottliebFDA announces plans to safeguard public health amid the growing threat of superbugs. How to… https://t.co/A7nYGeJ4Qx

RT @precisionfda: FDA is launching the precisionFDA @theNCI Mislabeling Challenge on September 24! Participants will work to accurate… https://t.co/xrzyrqJTGJ

According to #FDA’s shortages database; the drug in question — which is a liquid formulation of a widely available, and old and less frequently used antibiotic — is also NOT in shortage.

2/2 There are other suppliers of this product and, by its own admission in @FT, the company in question isn’t actively marketing their formulation. Their excessive price, detached from market principles, exists only on a list and should remain there in a competitive marketplace

1/2 Regarding @FT story today @bydavidcrow; there’s no moral imperative to price gouge and take advantage of patients. FDA will continue to promote competition so speculators and those with no regard to public health consequences can’t take advantage of patients who need medicine

RT @SGottliebFDA: 1/2 Regarding @FT story today @bydavidcrow; there’s no moral imperative to price gouge and take advantage of patien… https://t.co/6IhY0C95ZP

We will always remember those who have fallen and the heroes who risked their lives to treat and save others. #September11, #NeverForget https://t.co/LJrMEBE2SU

RT @pewhealth: What’s the U.S. doing to keep the public safe from superbugs? @SGottliebFDA explains in our special live event—tune… https://t.co/qGVOC9xFfy

RT @FDAfood: Prepare now, it’s not too late - FDA's advice on #foodsafety in case you lose power ⇨ https://t.co/alAbvBY80z… https://t.co/CaNXyh0Fql

RT @FDATobacco: Spotlight on Science is a quarterly science and research digest from @FDATobacco. Read the latest on CTP's tobacco… https://t.co/DFY6575Kda

RT @SecAzar: I've signed public health emergency declarations to help support NC and SC as they prepare for Hurricane #Florence.… https://t.co/RvPh0tP7Vk

#FDA, along with other state and federal agencies, are closely tracking the paths of Hurricanes #Florence and #Olivia anticipated to make landfall this week. We stand ready to provide assistance to impacted communities and we will provide updates as the storm develops.

RT @SecAzar: No child should be using any tobacco or nicotine-containing product. The work by @US_FDA to crack down on the sale and marketi… QT @SGottliebFDA: Today #FDA took a series of critical actions to address the epidemic of youth e-cigarette use. We also intend to ta… https://t.co/0uVMrL7O17)