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

Many companies making/selling FDA-regulated products comply with #FDA rules to protect the public. But some firms willfully disregard them, prompting us to take action. In today’s #FDA #SundayTweetorial, I’ll highlight a # of FDA’s key enforcement actions during my 2-year tenure. https://t.co/Edk6HTzyEt

@TheJusticeDept FDA has many tools to use against bad actors, depending on the violation: warning letters (WLs) that cite violations and seek corrective actions, mandatory recall (for some products), seizure, injunction, civil penalties, and criminal prosecution. And we’re not shy to use them! https://t.co/PErgQUcfjC

@TheJusticeDept We’ve pursued a series of escalating actions against these outfits, culminating in federal cases for permanent injunctions to stop two stem cell clinics from marketing their products without #FDA approval and for major deviations from CGMP requirements https://t.co/05r2joAsFC https://t.co/DKIYmdV8l8

@TheJusticeDept Enforcement is a priority. #FDA worked together to confront numerous health fraud scams and worked on the successful prosecution of companies and individuals who marketed dietary supplements with dangerous ingredients during the last two years https://t.co/6PsCNB89P4. https://t.co/XPCnzMbZVg

@TheJusticeDept Consider these stats from FY 2018: FDA issued 14,285 WLs, oversaw 7,562 recalled products, initiated 14 injunctions and 1 product seizure, issued 231 import alerts to detain potentially violative products and made 317 criminal arrests. We also make sure to publicize bad actors.

@TheJusticeDept We consider enforcement - protecting consumers from those who would prey on them with bogus claims and fraudulent products - to be the cornerstone of our consumer protection mission. We’ve dedicated new resources to this work https://t.co/4usiypxrWo. https://t.co/w5wNAs0Fws

@TheJusticeDept Our aggressive actions against bogus stem cell clinics, where bad actors have been leveraging the scientific promise of cell-based regenerative medicine to peddle unapproved treatments that risk patient’s health and even harm them, provides a good example of our efforts. https://t.co/TLJ1ZMUnog

@TheJusticeDept As part of our new risk-based enforcement approach to drug products labeled as homeopathic, we’ve taken action against companies marketing such unapproved products with claims they can treat addiction and chronic pain and/or other conditions https://t.co/wVyeDA0L1V. https://t.co/0JJQDu3ygu

@TheJusticeDept Most recently we sent 17 WLs to companies illegally marketing Alzheimer’s disease products, often sold on websites and social media platforms. Such health fraud preys on vulnerable populations, wastes money and often delays proper medical care https://t.co/2IVt6RghMM. https://t.co/QJTu4VZe9Y

@TheJusticeDept We’ve also taken action against companies marketing pills and capsules labeled as dietary supplements with unproven drug claims about protecting consumers from harms that come from sun exposure https://t.co/l0Qk7I7GLy. They put consumer’s health at risk and provide false security https://t.co/lLTvSlqUKh

@TheJusticeDept And we’ve been vigilant in going after companies that market fraudulent cancer products, issuing > a dozen WLs in 2017, including 4 WLs to companies marketing unproven products purporting to contain cannabidiol (CBD) claiming to treat/cure cancer https://t.co/DZXFLHmSZK. https://t.co/2nZQgdEuUN

@TheJusticeDept The company had marketed their neurovascular device for unapproved and potentially dangerous surgical uses, gave sales reps quotas and bonuses for selling the device for such uses and trained their reps to instruct physicians on the unapproved use of these devices.

@TheJusticeDept #FDA has also sought to protect the public from online pharmacies that purport to sell cheaper versions of drugs from Canada, Britain or Australia but may actually get drugs from other countries, increasing the risk consumers may buy counterfeit drugs https://t.co/sJoeNo9pWX. https://t.co/RauigIbxtt

@TheJusticeDept Congress responded by updating our authority for overseeing compounders (who provide medications to patients when there is no FDA-approved drug). Since 2012, we’ve issued more than than 220 WLs, overseen > 230 recall events and have continued going after the industry’s bad actors https://t.co/fB3WPJmCMK

@TheJusticeDept In 2012, 750 people developed fungal meningitis across multiple states and over 60 died after they were injected with contaminated compounded steroid drugs. Enforcement was an integral part of our approach to this tragedy and it remains integral in our work with compounders. https://t.co/HHCRfxlJxl

@TheJusticeDept A key part of #FDA’s efforts to promote safe and effective medical devices is our enforcement work related to unsafe practices and bad actors. In December, an FDA criminal investigation resulted in a guilty plea & fines for medical device maker ev3 Inc https://t.co/nEzbwZJcDm https://t.co/a7c4Mh3eEy

@TheJusticeDept This month, working with #DOJ, we obtained a permanent injunction against a company for making supposedly sterile injectable drugs in insanitary conditions whose eye injections resulted in impaired vision https://t.co/cee6olPDhj. https://t.co/hNwYagQog8

@TheJusticeDept #FDA has moved to block the flow of opioid drugs on the web, recently warning 23 networks operating > 450 websites illegally marketing potentially dangerous, unapproved, and misbranded opioid medications, including tramadol and oxycodone https://t.co/80bZNAznjm. https://t.co/VHvRvzFWfu

@TheJusticeDept Enforcement has been an essential tool in tackling the opioid epidemic, especially illicit opioids, which are accounting for a sharply increasing percentage of the total exposure to these drugs and fueling a growing addiction crisis https://t.co/5aTCwmo8gb https://t.co/ny1RQJORxh

@TheJusticeDept We’ve increased our interdiction at the nation’s 9 International Mail Facilities where illegal counterfeit and unapproved drugs flow in https://t.co/eqQDXEzO32 and have begun implementing new authority making it easier for us to stop illegally imported drug articles https://t.co/gjpgrCHAhS

Many companies making/selling FDA-regulated products comply with #FDA rules to protect the public. But some firms willfully disregard them, prompting us to take action. In today’s #FDA #SundayTweetorial, I’ll highlight a # of FDA’s key enforcement actions during my 2-year tenure. https://t.co/Edk6HTzyEt

@TheJusticeDept FDA has many tools to use against bad actors, depending on the violation: warning letters (WLs) that cite violations and seek corrective actions, mandatory recall (for some products), seizure, injunction, civil penalties, and criminal prosecution. And we’re not shy to use them! https://t.co/PErgQUcfjC

@TheJusticeDept We’ve pursued a series of escalating actions against these outfits, culminating in federal cases for permanent injunctions to stop two stem cell clinics from marketing their products without #FDA approval and for major deviations from CGMP requirements https://t.co/05r2joAsFC https://t.co/DKIYmdV8l8

@TheJusticeDept Enforcement is a priority. #FDA worked together to confront numerous health fraud scams and worked on the successful prosecution of companies and individuals who marketed dietary supplements with dangerous ingredients during the last two years https://t.co/6PsCNB89P4. https://t.co/XPCnzMbZVg

@TheJusticeDept Consider these stats from FY 2018: FDA issued 14,285 WLs, oversaw 7,562 recalled products, initiated 14 injunctions and 1 product seizure, issued 231 import alerts to detain potentially violative products and made 317 criminal arrests. We also make sure to publicize bad actors.

@TheJusticeDept We consider enforcement - protecting consumers from those who would prey on them with bogus claims and fraudulent products - to be the cornerstone of our consumer protection mission. We’ve dedicated new resources to this work https://t.co/4usiypxrWo. https://t.co/w5wNAs0Fws

@TheJusticeDept Our aggressive actions against bogus stem cell clinics, where bad actors have been leveraging the scientific promise of cell-based regenerative medicine to peddle unapproved treatments that risk patient’s health and even harm them, provides a good example of our efforts. https://t.co/TLJ1ZMUnog

@TheJusticeDept As part of our new risk-based enforcement approach to drug products labeled as homeopathic, we’ve taken action against companies marketing such unapproved products with claims they can treat addiction and chronic pain and/or other conditions https://t.co/wVyeDA0L1V. https://t.co/0JJQDu3ygu

@TheJusticeDept Most recently we sent 17 WLs to companies illegally marketing Alzheimer’s disease products, often sold on websites and social media platforms. Such health fraud preys on vulnerable populations, wastes money and often delays proper medical care https://t.co/2IVt6RghMM. https://t.co/QJTu4VZe9Y

@TheJusticeDept We’ve also taken action against companies marketing pills and capsules labeled as dietary supplements with unproven drug claims about protecting consumers from harms that come from sun exposure https://t.co/l0Qk7I7GLy. They put consumer’s health at risk and provide false security https://t.co/lLTvSlqUKh

@TheJusticeDept And we’ve been vigilant in going after companies that market fraudulent cancer products, issuing > a dozen WLs in 2017, including 4 WLs to companies marketing unproven products purporting to contain cannabidiol (CBD) claiming to treat/cure cancer https://t.co/DZXFLHmSZK. https://t.co/2nZQgdEuUN

@TheJusticeDept The company had marketed their neurovascular device for unapproved and potentially dangerous surgical uses, gave sales reps quotas and bonuses for selling the device for such uses and trained their reps to instruct physicians on the unapproved use of these devices.

@TheJusticeDept #FDA has also sought to protect the public from online pharmacies that purport to sell cheaper versions of drugs from Canada, Britain or Australia but may actually get drugs from other countries, increasing the risk consumers may buy counterfeit drugs https://t.co/sJoeNo9pWX. https://t.co/RauigIbxtt

@TheJusticeDept Congress responded by updating our authority for overseeing compounders (who provide medications to patients when there is no FDA-approved drug). Since 2012, we’ve issued more than than 220 WLs, overseen > 230 recall events and have continued going after the industry’s bad actors https://t.co/fB3WPJmCMK

@TheJusticeDept In 2012, 750 people developed fungal meningitis across multiple states and over 60 died after they were injected with contaminated compounded steroid drugs. Enforcement was an integral part of our approach to this tragedy and it remains integral in our work with compounders. https://t.co/HHCRfxlJxl

@TheJusticeDept A key part of #FDA’s efforts to promote safe and effective medical devices is our enforcement work related to unsafe practices and bad actors. In December, an FDA criminal investigation resulted in a guilty plea & fines for medical device maker ev3 Inc https://t.co/nEzbwZJcDm https://t.co/a7c4Mh3eEy

@TheJusticeDept This month, working with #DOJ, we obtained a permanent injunction against a company for making supposedly sterile injectable drugs in insanitary conditions whose eye injections resulted in impaired vision https://t.co/cee6olPDhj. https://t.co/hNwYagQog8

@TheJusticeDept #FDA has moved to block the flow of opioid drugs on the web, recently warning 23 networks operating > 450 websites illegally marketing potentially dangerous, unapproved, and misbranded opioid medications, including tramadol and oxycodone https://t.co/80bZNAznjm. https://t.co/VHvRvzFWfu

@TheJusticeDept Enforcement has been an essential tool in tackling the opioid epidemic, especially illicit opioids, which are accounting for a sharply increasing percentage of the total exposure to these drugs and fueling a growing addiction crisis https://t.co/5aTCwmo8gb https://t.co/ny1RQJORxh

@TheJusticeDept We’ve increased our interdiction at the nation’s 9 International Mail Facilities where illegal counterfeit and unapproved drugs flow in https://t.co/eqQDXEzO32 and have begun implementing new authority making it easier for us to stop illegally imported drug articles https://t.co/gjpgrCHAhS