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

Today #FDA is taking new steps to support the development of novel nicotine replacement therapies, regulated as new drugs, to help smokers quit cigarettes. This work is a critical part of our comprehensive framework for regulating nicotine and tobacco: https://t.co/kvPriTO5xg

RT @CBSHealth: If you have a milk allergy, beware... https://t.co/rGzUB8XETl

With novel forms of nicotine delivery being developed, we want to explore new steps we can take to enable opportunities for the innovation of new kinds of NRTs, while making sure products are demonstrated to be safe and effective for their intended use: https://t.co/kvPriTO5xg

2/6 #FDA has sought to ensure that the TIRF REMS is meeting its goals and requirements, but we know that there’s more that needs to be done. Making sure this program is working to mitigate the risks of these medicines and that they’re appropriately prescribed is a high priority.

THREAD: 1/6 We appreciate the #FDA advisory committee’s discussion on the Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products. These products are medically important for a small group of patients but also pose serious risks.

4/6 Important feedback today: there are gaps in data on use of these products and adverse events. We need to use every tool available to examine the real-world impact of these drugs and the REMS program, and align our approach to strike better balance between access and safety

New guidances are part of our work to re-evaluate and modernize #FDA’s approach to development and regulation of NRTs & provide clarity for companies seeking to avail themselves of the pathway to market safe and effective smoking cessation products: https://t.co/kvPriTO5xg

3/6 We share the concerns about how these drugs are being used and whether the REMS program is working as intended. That was an impetus for the AdCom. We’re carefully examining TIRF prescribing to non-opioid-tolerant or non-cancer patients, and adverse outcomes like overdose.

RT @FDAMedia: Statement from FDA Commissioner @SGottliebFDA on new steps the agency is taking to support the development of novel… https://t.co/LW8qpD4WDg

5/6 We held today’s advisory committee meeting as part of broader efforts by #FDA to making sure the TIRF REMS is achieving its public health goal of assuring safe use, providing transparency on what’s working, what’s not, and ultimately addressing shortcomings.

RT @SGottliebFDA: THREAD: 1/6 We appreciate the #FDA advisory committee’s discussion on the Risk Evaluation and Mitigation Strategy (… https://t.co/QDgb9mS99w

6/6 We thank the outside experts and the public for input on the TIRF REMS. #FDA will be taking on the issues raised at the today’s meeting. We’re committed to taking new steps to mitigate risks of misuse, abuse, addiction, overdose, and errors associated with these medicines.

RT @FDAOncology: Congratulations to the OCE Summer Scholars who gave their final presentations today. Excellent job! We enjoyed lear… https://t.co/3qgZEwkGmD

E-cigs may offer an alternative for currently addicted smokers to transition to less harmful forms of nicotine delivery; but that opportunity CANNOT AND WILL NOT come at the expense of addicting a generation of youth on nicotine through these same products https://t.co/2BNYZF0beh

In my #FDA #SUNDAYTWEETORIAL I’m focusing on a pillar of the federal response to the opioid epidemic, medication-assisted treatment (MAT) - medication combined with counseling and behavioral therapies for opioid use disorder (OUD). We'll advance major new policy on MAT this week

Opioid use disorder is a problematic pattern of substance use marked by loss of control, risky use, social problems, the need to use ever higher amounts of drug & withdrawal symptoms when not using (DSM-5). In 2016, 2.1 million people over age 12 had OUD https://t.co/XFvccKK0tz. https://t.co/loEIBJiBm9

Thoughtful article from @lindy2350. How far we’ve drifted. For too long, even when science of vaccine safety was conclusive we answered critics not with decisiveness but by entertaining doubts. It allowed fears to percolate even when evidence debunked them https://t.co/rcX26LlOnd

The FDA has approved three medications for MAT – buprenorphine, methadone, and naltrexone which stabilize brain chemistry; reduce or block the euphoric effects of opioids; relieve physiological cravings; and normalize body functions. https://t.co/BtsIMpVLvw https://t.co/TymiTK70Ea

Evidence also suggests that the risks of overdose mortality and of contracting an infectious disease such as HIV also decrease with MAT. https://t.co/aykD4fPmSM. And MAT is often appropriate for use in pregnant women with OUD.

At proper doses, the three drugs can provide safe and controlled levels of medication without affecting intelligence, mental capability, physical functioning or employability. People can regain control of their lives and end destructive outcomes. https://t.co/HSqCJSyvbY

Today #FDA is taking new steps to support the development of novel nicotine replacement therapies, regulated as new drugs, to help smokers quit cigarettes. This work is a critical part of our comprehensive framework for regulating nicotine and tobacco: https://t.co/kvPriTO5xg

RT @CBSHealth: If you have a milk allergy, beware... https://t.co/rGzUB8XETl

With novel forms of nicotine delivery being developed, we want to explore new steps we can take to enable opportunities for the innovation of new kinds of NRTs, while making sure products are demonstrated to be safe and effective for their intended use: https://t.co/kvPriTO5xg

2/6 #FDA has sought to ensure that the TIRF REMS is meeting its goals and requirements, but we know that there’s more that needs to be done. Making sure this program is working to mitigate the risks of these medicines and that they’re appropriately prescribed is a high priority.

THREAD: 1/6 We appreciate the #FDA advisory committee’s discussion on the Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products. These products are medically important for a small group of patients but also pose serious risks.

4/6 Important feedback today: there are gaps in data on use of these products and adverse events. We need to use every tool available to examine the real-world impact of these drugs and the REMS program, and align our approach to strike better balance between access and safety

New guidances are part of our work to re-evaluate and modernize #FDA’s approach to development and regulation of NRTs & provide clarity for companies seeking to avail themselves of the pathway to market safe and effective smoking cessation products: https://t.co/kvPriTO5xg

3/6 We share the concerns about how these drugs are being used and whether the REMS program is working as intended. That was an impetus for the AdCom. We’re carefully examining TIRF prescribing to non-opioid-tolerant or non-cancer patients, and adverse outcomes like overdose.

RT @FDAMedia: Statement from FDA Commissioner @SGottliebFDA on new steps the agency is taking to support the development of novel… https://t.co/LW8qpD4WDg

5/6 We held today’s advisory committee meeting as part of broader efforts by #FDA to making sure the TIRF REMS is achieving its public health goal of assuring safe use, providing transparency on what’s working, what’s not, and ultimately addressing shortcomings.

RT @SGottliebFDA: THREAD: 1/6 We appreciate the #FDA advisory committee’s discussion on the Risk Evaluation and Mitigation Strategy (… https://t.co/QDgb9mS99w

6/6 We thank the outside experts and the public for input on the TIRF REMS. #FDA will be taking on the issues raised at the today’s meeting. We’re committed to taking new steps to mitigate risks of misuse, abuse, addiction, overdose, and errors associated with these medicines.

RT @FDAOncology: Congratulations to the OCE Summer Scholars who gave their final presentations today. Excellent job! We enjoyed lear… https://t.co/3qgZEwkGmD

E-cigs may offer an alternative for currently addicted smokers to transition to less harmful forms of nicotine delivery; but that opportunity CANNOT AND WILL NOT come at the expense of addicting a generation of youth on nicotine through these same products https://t.co/2BNYZF0beh

In my #FDA #SUNDAYTWEETORIAL I’m focusing on a pillar of the federal response to the opioid epidemic, medication-assisted treatment (MAT) - medication combined with counseling and behavioral therapies for opioid use disorder (OUD). We'll advance major new policy on MAT this week

Opioid use disorder is a problematic pattern of substance use marked by loss of control, risky use, social problems, the need to use ever higher amounts of drug & withdrawal symptoms when not using (DSM-5). In 2016, 2.1 million people over age 12 had OUD https://t.co/XFvccKK0tz. https://t.co/loEIBJiBm9

Thoughtful article from @lindy2350. How far we’ve drifted. For too long, even when science of vaccine safety was conclusive we answered critics not with decisiveness but by entertaining doubts. It allowed fears to percolate even when evidence debunked them https://t.co/rcX26LlOnd

The FDA has approved three medications for MAT – buprenorphine, methadone, and naltrexone which stabilize brain chemistry; reduce or block the euphoric effects of opioids; relieve physiological cravings; and normalize body functions. https://t.co/BtsIMpVLvw https://t.co/TymiTK70Ea

Evidence also suggests that the risks of overdose mortality and of contracting an infectious disease such as HIV also decrease with MAT. https://t.co/aykD4fPmSM. And MAT is often appropriate for use in pregnant women with OUD.

At proper doses, the three drugs can provide safe and controlled levels of medication without affecting intelligence, mental capability, physical functioning or employability. People can regain control of their lives and end destructive outcomes. https://t.co/HSqCJSyvbY