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

#FDA broke its fiscal year record for total generic approvals in 2018 and in October we set a monthly record with a total of 128 approval actions. These Oct. figures include 23 first generics for brands that lacked competition and 17 new complex generics https://t.co/TxYLX6Ge6J https://t.co/IcC9Attcil

Many teens underestimate how easy it is to become addicted to nicotine. The younger teens start using tobacco the more likely they are to become addicted to nicotine. Keep your journey smoke-free. https://t.co/SLxT4OIg2t https://t.co/ZlgF9T1tnZ

CYBERSECURITY UPDATE: #FDA entered a new partnership with @DHSgov to address medical device cybersecurity threats https://t.co/oCOIwvVVZf and issued new guidance on steps manufacturers should take to protect products against different cybersecurity risks https://t.co/x560z2mveC https://t.co/mRY2M0AkuB

RT @SGottliebFDA: With cyberattacks on medical devices rising, among other steps #FDA is turning to ethical hackers to help root out… https://t.co/udGhfSoNA7

#FDA is advancing a new framework to help facilitate a more global filing process for generic drugs; so generic sponsors can more easily submit applications across multiple global markets as a way to promote more drug access and competition. https://t.co/HEWWXpWHik

We look forward to working with @NitaLowey and members Congress on efforts that can help make sure no child starts using a tobacco product. #FDA is advancing aggressive new steps to achieve these goals; but there may be more we can do working together. https://t.co/s0aGccuSeF

With cyberattacks on medical devices rising, among other steps #FDA is turning to ethical hackers to help root out weaknesses that could put patient safety at risk. https://t.co/5CphppfE5Y

We've set a new goal that WE WILL achieve: Ensuring #FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices. This is a top priority. Many have asked me what does that mean? And how will #FDA do that? https://t.co/MRJzLPpL9z

RT @JAMA_current: The FDA and the Department of Homeland Security (DHS) have formally agreed to collaborate more closely to protect m… https://t.co/5rujuS2Kxv

Assuring the safety of medical products is central to FDA’s consumer protection mission. In today’s #FDA #SUNDAYTWEETORIAL I’m going to talk about FDA’s ambitious new safety goal for medical devices and our 510K reforms that, once implemented, will advance safety and innovation. https://t.co/tiCnZHXOlk

First, a little background: #FDA regulates more than 190,000 different medical devices that are manufactured by more than 18,000 companies in more than 21,000 facilities worldwide. We approve, clear or grant marketing authorization to about 12 new or modified devices every day. https://t.co/lUNDWqFKoO

Medical devices can go to market only after the #FDA carefully determines that the devices are safe and effective based on valid scientific evidence. This is a decision that takes into consideration whether the device’s benefits outweigh its risks to the patient. https://t.co/g2gGEAD12d

We also review published studies, order post-market studies in certain cases and inspect manufacturing facilities. But these are “passive tools” that either rely on device users reporting to us, which can result in underreporting, or information flowing in long after the fact.

Unfortunately, #FDA can’t always know the full extent of benefits and risks of every device at time of market entry. Sometimes new signals emerge after a product is used by clinicians and a broad patient population. Even reasonably sized premarket trials can’t tell us everything.

Once a device is on the market, we monitor adverse event reports that are submitted to the #FDA from manufacturers, health care providers, and the general public on devices which may have malfunctioned or caused a serious injury or a death. These are examples of safety signals. https://t.co/bzWmcbZ5vk

We need to create an active surveillance system for medical devices that relies on real-world evidence and timely receipt of robust safety info. That’s why since 2012 #FDA has been moving to put in place an infrastructure that can identify potential problems in near real time.

We began by implementing a unique device identification system (UDI). Each device is given a unique code for its label that allows it to be tracked through distribution and use. These identifiers are stored in a public database – there are now 1.5 million device records in all. https://t.co/DZg7fCkfKi

A public-private enterprise, the NESTcc (Coordinating Center) has already created an early data network by entering into agreements with 12 organizations representing more than 195 hospitals and almost 4,000 outpatient clinics with access to more than 495 million patient records. https://t.co/BKxl2ktH2S

It will soon launch pilot programs testing the use of patient registries and claims data to evaluate total joint and knee replacement surgery, different wound closure techniques and the safety of intervertebral body fusion devices for spinal conditions https://t.co/SeJQhhMjob.

We’re now collaborating on the creation of a national system for gathering real-world evidence: the National Evaluation System for health Technology (NEST). It will leverage a wide range of data systems w/ info from patient registries, payor claims and electronic medical records. https://t.co/SijDOolWZ9

#FDA broke its fiscal year record for total generic approvals in 2018 and in October we set a monthly record with a total of 128 approval actions. These Oct. figures include 23 first generics for brands that lacked competition and 17 new complex generics https://t.co/TxYLX6Ge6J https://t.co/IcC9Attcil

Many teens underestimate how easy it is to become addicted to nicotine. The younger teens start using tobacco the more likely they are to become addicted to nicotine. Keep your journey smoke-free. https://t.co/SLxT4OIg2t https://t.co/ZlgF9T1tnZ

CYBERSECURITY UPDATE: #FDA entered a new partnership with @DHSgov to address medical device cybersecurity threats https://t.co/oCOIwvVVZf and issued new guidance on steps manufacturers should take to protect products against different cybersecurity risks https://t.co/x560z2mveC https://t.co/mRY2M0AkuB

RT @SGottliebFDA: With cyberattacks on medical devices rising, among other steps #FDA is turning to ethical hackers to help root out… https://t.co/udGhfSoNA7

#FDA is advancing a new framework to help facilitate a more global filing process for generic drugs; so generic sponsors can more easily submit applications across multiple global markets as a way to promote more drug access and competition. https://t.co/HEWWXpWHik

We look forward to working with @NitaLowey and members Congress on efforts that can help make sure no child starts using a tobacco product. #FDA is advancing aggressive new steps to achieve these goals; but there may be more we can do working together. https://t.co/s0aGccuSeF

With cyberattacks on medical devices rising, among other steps #FDA is turning to ethical hackers to help root out weaknesses that could put patient safety at risk. https://t.co/5CphppfE5Y

We've set a new goal that WE WILL achieve: Ensuring #FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices. This is a top priority. Many have asked me what does that mean? And how will #FDA do that? https://t.co/MRJzLPpL9z

RT @JAMA_current: The FDA and the Department of Homeland Security (DHS) have formally agreed to collaborate more closely to protect m… https://t.co/5rujuS2Kxv

Assuring the safety of medical products is central to FDA’s consumer protection mission. In today’s #FDA #SUNDAYTWEETORIAL I’m going to talk about FDA’s ambitious new safety goal for medical devices and our 510K reforms that, once implemented, will advance safety and innovation. https://t.co/tiCnZHXOlk

First, a little background: #FDA regulates more than 190,000 different medical devices that are manufactured by more than 18,000 companies in more than 21,000 facilities worldwide. We approve, clear or grant marketing authorization to about 12 new or modified devices every day. https://t.co/lUNDWqFKoO

Medical devices can go to market only after the #FDA carefully determines that the devices are safe and effective based on valid scientific evidence. This is a decision that takes into consideration whether the device’s benefits outweigh its risks to the patient. https://t.co/g2gGEAD12d

We also review published studies, order post-market studies in certain cases and inspect manufacturing facilities. But these are “passive tools” that either rely on device users reporting to us, which can result in underreporting, or information flowing in long after the fact.

Unfortunately, #FDA can’t always know the full extent of benefits and risks of every device at time of market entry. Sometimes new signals emerge after a product is used by clinicians and a broad patient population. Even reasonably sized premarket trials can’t tell us everything.

Once a device is on the market, we monitor adverse event reports that are submitted to the #FDA from manufacturers, health care providers, and the general public on devices which may have malfunctioned or caused a serious injury or a death. These are examples of safety signals. https://t.co/bzWmcbZ5vk

We need to create an active surveillance system for medical devices that relies on real-world evidence and timely receipt of robust safety info. That’s why since 2012 #FDA has been moving to put in place an infrastructure that can identify potential problems in near real time.

We began by implementing a unique device identification system (UDI). Each device is given a unique code for its label that allows it to be tracked through distribution and use. These identifiers are stored in a public database – there are now 1.5 million device records in all. https://t.co/DZg7fCkfKi

A public-private enterprise, the NESTcc (Coordinating Center) has already created an early data network by entering into agreements with 12 organizations representing more than 195 hospitals and almost 4,000 outpatient clinics with access to more than 495 million patient records. https://t.co/BKxl2ktH2S

It will soon launch pilot programs testing the use of patient registries and claims data to evaluate total joint and knee replacement surgery, different wound closure techniques and the safety of intervertebral body fusion devices for spinal conditions https://t.co/SeJQhhMjob.

We’re now collaborating on the creation of a national system for gathering real-world evidence: the National Evaluation System for health Technology (NEST). It will leverage a wide range of data systems w/ info from patient registries, payor claims and electronic medical records. https://t.co/SijDOolWZ9