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

3) If approving another opioid creates added risks, does it differentiate from other drugs in how it benefits certain groups or offers other important clinical benefits that outweigh its risks? How can an #FDA REMS mitigate risks? https://t.co/cf5WhJ2Yac. https://t.co/s5buEKa5GL

While Dsuvia brings another highly-potent opioid to market it fulfills a limited, unmet medical need in treating our nation’s soldiers on the battlefield. That’s why the Pentagon worked closely with the sponsor on developing Dsuvia. FDA committed to prioritize needs of our troops https://t.co/aHojsJKpps

Recognizing the drug’s population-based risks, there are strong limits on its use. It can’t be dispensed to patients for home use and should not be used for more than 72 hours; and it will only be administered by a certified health care provider using a single-dose applicator. https://t.co/vlR5NP21JE

These are issues that I plan to take to my Opioid Policy Steering Committee https://t.co/ZezFxbaR3Y to consider what additional steps we may want to take within our own authority to achieve these goals or whether legislative help might be needed. https://t.co/oijaL9jSyi

#FDA announced a final guidance on the mandatory food recall process as part of the agency’s ongoing commitment to continue improving our recall processes to protect consumers. Read more in our statement https://t.co/o2HPfgg8Ga

FDA’s approval on Friday of Dsuvia https://t.co/JBUqT8Pbus, a highly-potent sublingual form of the opioid sufentanil, is consistent with how this new framework I’ve sketched out might work in assessing the population-based considerations associated with a new approval.

These are important steps to help prevent abuse, misuse and potential diversion. The drug is also reserved for use in patients for whom alternative pain treatment options have not been tolerated or provided adequate relief; or are not expected to do so.

So, #FDA is evaluating a new framework for opioid drug approvals. Specifically, how we consider benefits and risks of new products in the context of the broader public health crisis and the overall therapeutic armamentarium of already available pain drugs https://t.co/NICWpF4Uri https://t.co/3AZL7fHiz5

Whether there’s a need for another powerful opioid in the throes of a massive crisis of addiction is a critical question. As a public health agency, we have an obligation to address this question for patients with pain, for the addiction crisis, for innovators, for all Americans.

My statement: Today the #FDA announced a final guidance on the mandatory food recalls as part of our ongoing commitment to continue improving our regulatory processes to protect consumers. https://t.co/o2HPfgg8Ga https://t.co/wVFEC3mZuq

#FDA announced today its proposed plans to conduct a new survey to collect information that will improve our current understanding of adverse events associated with allergens in cosmetics. If you use cosmetics, we want to hear from you: https://t.co/A9gWVHvV6L https://t.co/Yra73LxOVD

Meet #FDAOncology reviewers and learn about opportunities for patient advocacy at our 2nd annual educational workshop for new cancer patient advocates, Partners in Progress #OCEPIP18 https://t.co/8UuCb2KzdN https://t.co/5iUYUFqKYR

Happy #Diwali⁠ ⁠ https://t.co/vuyj0XibNq

RT @FDA_MCMi: Device manufacturers: Learn about the Special 510(k) Program Pilot program today at 3:00 p.m. ET https://t.co/ytm2JvY1m4 QT @FDAcdrhIndustry: Join us at 3:00pm ET tomorrow for a webinar on the Special 510(k) Program Pilot: https://t.co/OqIHsSckKj #FDA… https://t.co/XkyuzYv1DO)

RT @FDASpox: FLAGGING: Read @SGottliebFDA’s comment on new federal data showing U.S. adult smoking rate at 14% in 2017 – the low… https://t.co/RROnq7gPnv

Efforts to shift the trajectory of tobacco-related disease/death include protecting kids from dangers tobacco and e-cigarette use. We remain concerned about the role characterizing flavors play in attracting children and will advance policy options to address that growing problem

RT @FDAMedia: Statement from FDA Commissioner @SGottliebFDA on new efforts to strengthen FDA’s expanded access program https://t.co/Nq8tje17bq

RT @FDASpox: #DidYouKnow the #FDA has authorized more than 9,000 applications across drugs, biologics & devices through our expa… https://t.co/PLsSnASkRA

THREAD: New @US_FDA, @CDCgov & @theNCI data show U.S. adult smoking rate at 14% in 2017 – the lowest recorded. Continued drop is encouraging. #FDA’s committed to accelerating these declines through our comprehensive approach to tobacco/nicotine regulation: https://t.co/5SEFgT7ICD

We’ve taken steps to render combustible cigarettes minimally/non-addictive, advance a framework to encourage innovation of potentially less harmful products like e-cigarettes for currently addicted adult smokers & support development of novel nicotine replacement drug therapies.

3) If approving another opioid creates added risks, does it differentiate from other drugs in how it benefits certain groups or offers other important clinical benefits that outweigh its risks? How can an #FDA REMS mitigate risks? https://t.co/cf5WhJ2Yac. https://t.co/s5buEKa5GL

While Dsuvia brings another highly-potent opioid to market it fulfills a limited, unmet medical need in treating our nation’s soldiers on the battlefield. That’s why the Pentagon worked closely with the sponsor on developing Dsuvia. FDA committed to prioritize needs of our troops https://t.co/aHojsJKpps

Recognizing the drug’s population-based risks, there are strong limits on its use. It can’t be dispensed to patients for home use and should not be used for more than 72 hours; and it will only be administered by a certified health care provider using a single-dose applicator. https://t.co/vlR5NP21JE

These are issues that I plan to take to my Opioid Policy Steering Committee https://t.co/ZezFxbaR3Y to consider what additional steps we may want to take within our own authority to achieve these goals or whether legislative help might be needed. https://t.co/oijaL9jSyi

#FDA announced a final guidance on the mandatory food recall process as part of the agency’s ongoing commitment to continue improving our recall processes to protect consumers. Read more in our statement https://t.co/o2HPfgg8Ga

FDA’s approval on Friday of Dsuvia https://t.co/JBUqT8Pbus, a highly-potent sublingual form of the opioid sufentanil, is consistent with how this new framework I’ve sketched out might work in assessing the population-based considerations associated with a new approval.

These are important steps to help prevent abuse, misuse and potential diversion. The drug is also reserved for use in patients for whom alternative pain treatment options have not been tolerated or provided adequate relief; or are not expected to do so.

So, #FDA is evaluating a new framework for opioid drug approvals. Specifically, how we consider benefits and risks of new products in the context of the broader public health crisis and the overall therapeutic armamentarium of already available pain drugs https://t.co/NICWpF4Uri https://t.co/3AZL7fHiz5

Whether there’s a need for another powerful opioid in the throes of a massive crisis of addiction is a critical question. As a public health agency, we have an obligation to address this question for patients with pain, for the addiction crisis, for innovators, for all Americans.

My statement: Today the #FDA announced a final guidance on the mandatory food recalls as part of our ongoing commitment to continue improving our regulatory processes to protect consumers. https://t.co/o2HPfgg8Ga https://t.co/wVFEC3mZuq

#FDA announced today its proposed plans to conduct a new survey to collect information that will improve our current understanding of adverse events associated with allergens in cosmetics. If you use cosmetics, we want to hear from you: https://t.co/A9gWVHvV6L https://t.co/Yra73LxOVD

Meet #FDAOncology reviewers and learn about opportunities for patient advocacy at our 2nd annual educational workshop for new cancer patient advocates, Partners in Progress #OCEPIP18 https://t.co/8UuCb2KzdN https://t.co/5iUYUFqKYR

Happy #Diwali⁠ ⁠ https://t.co/vuyj0XibNq

RT @FDA_MCMi: Device manufacturers: Learn about the Special 510(k) Program Pilot program today at 3:00 p.m. ET https://t.co/ytm2JvY1m4 QT @FDAcdrhIndustry: Join us at 3:00pm ET tomorrow for a webinar on the Special 510(k) Program Pilot: https://t.co/OqIHsSckKj #FDA… https://t.co/XkyuzYv1DO)

RT @FDASpox: FLAGGING: Read @SGottliebFDA’s comment on new federal data showing U.S. adult smoking rate at 14% in 2017 – the low… https://t.co/RROnq7gPnv

Efforts to shift the trajectory of tobacco-related disease/death include protecting kids from dangers tobacco and e-cigarette use. We remain concerned about the role characterizing flavors play in attracting children and will advance policy options to address that growing problem

RT @FDAMedia: Statement from FDA Commissioner @SGottliebFDA on new efforts to strengthen FDA’s expanded access program https://t.co/Nq8tje17bq

RT @FDASpox: #DidYouKnow the #FDA has authorized more than 9,000 applications across drugs, biologics & devices through our expa… https://t.co/PLsSnASkRA

THREAD: New @US_FDA, @CDCgov & @theNCI data show U.S. adult smoking rate at 14% in 2017 – the lowest recorded. Continued drop is encouraging. #FDA’s committed to accelerating these declines through our comprehensive approach to tobacco/nicotine regulation: https://t.co/5SEFgT7ICD

We’ve taken steps to render combustible cigarettes minimally/non-addictive, advance a framework to encourage innovation of potentially less harmful products like e-cigarettes for currently addicted adult smokers & support development of novel nicotine replacement drug therapies.