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

RT @SGottliebFDA: THREAD - PUBLIC HEALTH ADVISORY: #FDA is updating health care professionals and consumers of a voluntary recall for… https://t.co/UxuuxjCDAi

RT @HHSGov: From 2014 to 2016, @FDATobacco's “The Real Cost” campaign prevented nearly 350,000 teens from starting to smoke – g… https://t.co/DaoBNvFHX3

RT @SGottliebFDA: @Carolynyjohnson The answer is - yes we have. Most recently, in Jan 2018 we issued WLs to 2 homeopathic firms illeg… https://t.co/ibB0kNrdo3

RT @FDASpox: Ever wonder what a real life Wonder Woman looks like?!! Meet Sarah Peddicord on our press office leadership team. O… https://t.co/rLssdifOY6

@Carolynyjohnson The answer is - yes we have. Most recently, in Jan 2018 we issued WLs to 2 homeopathic firms illegally marketing unapproved products with claims about their ability to help in treating opioid addiction and withdrawal. Those companies were King Bio and GUNA https://t.co/9qdU0hdbcC

RT @SGottliebFDA: VALSARTAN UPDATE: #FDA has an extensive chemical analysis program underway to test for the root cause of the NDMA i… https://t.co/CF1E21WGey

In addition to our significant public health concerns related to the risks associated with unsupervised use of any opioid; consumers should also be aware that a very high percentage of Kratom is contaminated with salmonella. This report out of Alaska: https://t.co/c0btlmXw2V

Patients expect and deserve high-quality drugs. In today’s #FDA #SUNDAYTWEETORIAL I’m going to talk about how FDA strives to help assure that medicines are manufactured to meet quality standards so that drug products are safe, effective, & free of harmful defects & contamination. https://t.co/lZe30AAVkS

RT @katebachwsj: In today's WSJ I chat with @SGottliebFDA about why the expensive drugs we should worry about more are the ones that… https://t.co/MLGJigCzgB

Dateline Aug 24: "Police in Chester County, Pa., are sounding the alarm after two men died taking the legal supplement Kratom, known as the herbal opioid." https://t.co/pMZwjlTdd6

To keep pace, #FDA has established an efficient, nimble and modern framework to help assure that all drugs, no matter where manufactured, whether brand name, biosimilar or generic, prescription or OTC, meet the same high-quality standards. https://t.co/SEzaVXz5QK

Drug manufacturing today has become increasingly global. For example, 80% of the FDA-registered manufacturers of active pharmaceutical ingredients (API) are located outside of the United States. https://t.co/6MC3YJpbdO

Moreover, supply chains can now be quite complex. An API for a drug may be manufactured in one country, then shipped to another country for final manufacturing that incorporates ingredients from a third country. The finished product is then imported to the U.S for distribution. https://t.co/rDmPy5bueA

Following an inspection, FDA classifies its findings into 1 of 3 categories: no action indicated; voluntary action indicated; or official action indicated, meaning FDA found objectionable conditions and may pursue regulatory action.

The pre-market inspection looks at whether the facility is capable of manufacturing the drug in the product application; has personnel and procedures in place to preserve the drug’s identity, strength, quality and purity; and has appropriate systems to ensure data reliability.

Making up the cornerstone of this framework is our careful scrutiny of the data submitted in the premarket application as well as our pre- and post-market inspections at the facilities where the drug is manufactured. https://t.co/wvMWsClmbY

During inspections, #FDA determines if the facility is complying with current good manufacturing practice requirements, including quality management systems, operating procedures, use of raw materials, product quality deviations and testing laboratories https://t.co/GcaGmvcGUz https://t.co/gVj4ETfiSD

Once the drug reaches the market, we schedule post-market inspections based on risks to patients. During the inspection, we observe the facilities operations, review records, speak with staff and may collect samples for testing. https://t.co/nD5HllHO7k

The FDA Safety and Innovation Act of 2012 (FDASIA) enhanced this effort, removing set frequencies for domestic inspections. Thanks to this change, we’ve implemented a fully risk-based approach, achieving parity for facility inspections around the world https://t.co/DCLROc25Q6. https://t.co/u9XeAS93Qu

FDA uses a risk-based site selection model to ensure inspections are conducted efficiently and appropriately to protect patient health. Inspections are scheduled prioritizing the sites/processes that pose the greatest risk to patients, regardless of where they are located.

RT @SGottliebFDA: THREAD - PUBLIC HEALTH ADVISORY: #FDA is updating health care professionals and consumers of a voluntary recall for… https://t.co/UxuuxjCDAi

RT @HHSGov: From 2014 to 2016, @FDATobacco's “The Real Cost” campaign prevented nearly 350,000 teens from starting to smoke – g… https://t.co/DaoBNvFHX3

RT @SGottliebFDA: @Carolynyjohnson The answer is - yes we have. Most recently, in Jan 2018 we issued WLs to 2 homeopathic firms illeg… https://t.co/ibB0kNrdo3

RT @FDASpox: Ever wonder what a real life Wonder Woman looks like?!! Meet Sarah Peddicord on our press office leadership team. O… https://t.co/rLssdifOY6

@Carolynyjohnson The answer is - yes we have. Most recently, in Jan 2018 we issued WLs to 2 homeopathic firms illegally marketing unapproved products with claims about their ability to help in treating opioid addiction and withdrawal. Those companies were King Bio and GUNA https://t.co/9qdU0hdbcC

RT @SGottliebFDA: VALSARTAN UPDATE: #FDA has an extensive chemical analysis program underway to test for the root cause of the NDMA i… https://t.co/CF1E21WGey

In addition to our significant public health concerns related to the risks associated with unsupervised use of any opioid; consumers should also be aware that a very high percentage of Kratom is contaminated with salmonella. This report out of Alaska: https://t.co/c0btlmXw2V

Patients expect and deserve high-quality drugs. In today’s #FDA #SUNDAYTWEETORIAL I’m going to talk about how FDA strives to help assure that medicines are manufactured to meet quality standards so that drug products are safe, effective, & free of harmful defects & contamination. https://t.co/lZe30AAVkS

RT @katebachwsj: In today's WSJ I chat with @SGottliebFDA about why the expensive drugs we should worry about more are the ones that… https://t.co/MLGJigCzgB

Dateline Aug 24: "Police in Chester County, Pa., are sounding the alarm after two men died taking the legal supplement Kratom, known as the herbal opioid." https://t.co/pMZwjlTdd6

To keep pace, #FDA has established an efficient, nimble and modern framework to help assure that all drugs, no matter where manufactured, whether brand name, biosimilar or generic, prescription or OTC, meet the same high-quality standards. https://t.co/SEzaVXz5QK

Drug manufacturing today has become increasingly global. For example, 80% of the FDA-registered manufacturers of active pharmaceutical ingredients (API) are located outside of the United States. https://t.co/6MC3YJpbdO

Moreover, supply chains can now be quite complex. An API for a drug may be manufactured in one country, then shipped to another country for final manufacturing that incorporates ingredients from a third country. The finished product is then imported to the U.S for distribution. https://t.co/rDmPy5bueA

Following an inspection, FDA classifies its findings into 1 of 3 categories: no action indicated; voluntary action indicated; or official action indicated, meaning FDA found objectionable conditions and may pursue regulatory action.

The pre-market inspection looks at whether the facility is capable of manufacturing the drug in the product application; has personnel and procedures in place to preserve the drug’s identity, strength, quality and purity; and has appropriate systems to ensure data reliability.

Making up the cornerstone of this framework is our careful scrutiny of the data submitted in the premarket application as well as our pre- and post-market inspections at the facilities where the drug is manufactured. https://t.co/wvMWsClmbY

During inspections, #FDA determines if the facility is complying with current good manufacturing practice requirements, including quality management systems, operating procedures, use of raw materials, product quality deviations and testing laboratories https://t.co/GcaGmvcGUz https://t.co/gVj4ETfiSD

Once the drug reaches the market, we schedule post-market inspections based on risks to patients. During the inspection, we observe the facilities operations, review records, speak with staff and may collect samples for testing. https://t.co/nD5HllHO7k

The FDA Safety and Innovation Act of 2012 (FDASIA) enhanced this effort, removing set frequencies for domestic inspections. Thanks to this change, we’ve implemented a fully risk-based approach, achieving parity for facility inspections around the world https://t.co/DCLROc25Q6. https://t.co/u9XeAS93Qu

FDA uses a risk-based site selection model to ensure inspections are conducted efficiently and appropriately to protect patient health. Inspections are scheduled prioritizing the sites/processes that pose the greatest risk to patients, regardless of where they are located.