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

I say this is a watershed moment because once insulin products are deemed to be licensed under the PHSA, products that are biosimilar to, or interchangeable with, these insulins can then come to market.

But once an insulin product is approved and available as an interchangeable under the PHSA, it may be substituted for the reference product at the pharmacy, potentially leading to increased access and significantly lower costs for patients. https://t.co/Di2ja3vcwN

Today there are no approved generic insulin products that can be substituted at the pharmacy, in part because it is hard to bring a substitutable insulin to market under the conventional drug pathway.

Interchangeables are biosimilars that meet additional requirements including that they can be expected to produce the same clinical result as the reference product in any given patient. Therefore, they may be substituted at the pharmacy level. https://t.co/l3bjBtvRjw https://t.co/O2ksBsEJsw

Access to affordable insulin is a matter of life & death for the 7 million diabetics who require daily insulin injections to maintain their blood glucose level. https://t.co/ujPB7aSPOD And yet the average list price has increased by 15%-17% per year from 2012-2016. https://t.co/k0HK8DwLog

The fact is, limited competition keeps insulin prices artificially high – three companies control 90% of the global market and produce all of the insulin used in the U.S., according to the Congressional Research Service. https://t.co/W2XDn5v3xY https://t.co/JT7kkJIufA

We’ve heard frequent reports of patients rationing insulin and, in some cases, dying because they can’t afford the injections. These tragic stories aren’t isolated occurrences and they’re not acceptable for a drug that’s nearly a century old.

We’re at a crucial stage in developing a competitive market for biological products. As you’ve seen, FDA is committed to making the development of biosimilars and interchangeable products more efficient. These changes are long overdue. https://t.co/bRPSZqyMyT

You can’t pin high prices on manufacturing challenges. Initially, insulin was made with great difficulty & expense from cow & pig pancreas cells after its discovery in 1921. But since the 1980s, recombinant DNA technology has allowed for efficient production from microorganisms. https://t.co/v0ArV4O68s

Given our long experience regulating insulin products and the high interest among sponsors who are proposing to develop interchangeable insulins, we’re confident an interchangeable insulin will be attainable after the transition in March 2020.

RT @FDAOncology: Read the #FDAOncology draft guidance on Hematologic Malignancies: Regulatory Considerations for Use of Minimal Resi… https://t.co/xDICGL6MqQ

RT @tmprowell: Check it out! #CompassionateUse of investigational drugs is about to get a lot simpler for patients & busy clinicia… https://t.co/BT7sRLojBq

RT @US_FDA: If you react strongly to caffeine, there are certain foods and drinks you may want to avoid altogether. Learn how d… https://t.co/BNlkmfkgdr

For what’s going on with food policy, food safety, innovation, and outbreak response at #FDA follow FDA’s Deputy Commissioner for Food Policy and Response @FrankYiannasFDA

RT @SGottliebFDA: #FDA’s partnership with @Scholastic to provide school administrators and teachers resources to help them engage wit… https://t.co/kOwKQh2sJt

RT @SGottliebFDA: As part of #FDA’s campaign to educate kids about the dangers of e-cig use we joined with @Scholastic to provide res… https://t.co/WCv8GiHCIV

RT @FDATobacco: FDA’s policy framework strikes a careful balance between making flavored tobacco products—especially e-cigs—less ac… https://t.co/GLLa1kkmQI

RT @SGottliebFDA: Therapeutic biologics play a critical role in the treatment of many serious illnesses and are responsible for a sig… https://t.co/vmLcvKBYnt

#FDA has announced a series of actions to combat an epidemic growth in teen use of e-cigarettes; including actions we took last month to cut down on sales to minors, limit access to flavors, and first ever public campaign informing kids of risks of e-cigs https://t.co/THzkUay0rA

THREAD: New data from @NIDANews’ Monitoring the Future survey reaffirm concerning trends of youth e-cig use. We must continue to address these epidemic-level increases to ensure children aren’t started down a path to nicotine addiction and tobacco use: https://t.co/eN9QXwfB5C https://t.co/5ttmJyR6ng

Similar to the National Youth Tobacco Survey numbers we released last month with @CDCgov, these new numbers estimate a shocking one-year increase of approximately 1.3 million additional eighth, 10th and 12th graders who used e-cigarettes in 2018, compared with 2017.

RT @FDATobacco: FDA’s new policy framework strikes a careful balance between making flavored tobacco products—especially e-cigarett… https://t.co/XJ0ZWt6MKS

RT @NCIDirector: Congrats, @dramyabernethy! Look forward to continued collaborations with @SGottliebFDA, Amy & others at FDA to work on behalf of patients.

RT @FDAMedia: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic framework to advance use of real-world… https://t.co/ajmwuE8rIW

#FDA is committed to ensuring tobacco products, incl. e-cigarettes, aren’t being marketed to, sold to or used by kids. We’ve taken numerous actions under our Youth Tobacco Prevention Plan, including a series of proposed new steps outlined last month: https://t.co/Zs18yU7EVx

RT @DrMcCance_Katz: We must be committed to encouraging our loved ones to seek the help they need when they need it. To find hotline an… https://t.co/X0nmeAaBFd

RT @NCIDirector: Great hire! @dramyabernethy named @US_FDA Deputy Commissioner. Amy is a longtime cancer researcher, accomplished da… https://t.co/xDB1M6rmTp

RT @zakkohane: Truly momentous news. Dr. Abernathy is a clear thinker about the promise of biotechnology without blinding by the hype. Simi… QT @matthewherper: Some big news for FDA and @flatironhealth ! @US_FDA is naming Flatiron exec @dramyabernethy as deputy commissioner,… https://t.co/1tBqvLAf2T)

#FDA applauds steps by the #SG to bring attention to the epidemic of youth use of e-cigs, and we’ll continue to implement actions we outlined last month to reduce the access and appeal that tobacco products have to kids; principally by targeting flavors. https://t.co/SWLdt3clVJ

Educating teens and arming educators with resources to help engage students on dangers of e-cigarette use align with significant new steps #FDA proposed this Fall to protect kids by preventing youth access to flavored tobacco products. Details on our plan: https://t.co/ABg3gJ0tiM https://t.co/5IKiyAaeur

The Monitoring the Future Survey confirms the epidemic use of e-cigs by kids that #FDA first identified in September and took action to reverse in November by limiting the access and appeal of these products to children; by targeting the role of flavors. https://t.co/qaGmKJHXVp

This new survey confirms data from the National Youth Tobacco Survey and affirms what we’ve known - that youth use of e-cigarettes is at an epidemic proportion. This is why #FDA has taken new steps to curtail the access and appeal of these products to kids https://t.co/x5bjMer6Xx

New technology such as genomic interrogation of human and food samples are enabling us to better identify outbreaks. The tools for doing more effective track and trace to isolate contaminated products and implement more targeted recalls need to catch up https://t.co/L617dxvqso

RT @US_FDA: We continue to focus on approving high-quality, lower cost, safe & effective generics. On the heels of the Oct. rec… https://t.co/2zDXJWi8SU

RT @HHSGov: The opioid epidemic is one of HHS's top priorities. @SecAzar explains how the Department is working to combat the c… https://t.co/S7np2gBZtW

#FDA’s new guidance is aimed at applying modern and efficient oncology trial designs, as well as explore novel endpoints, such as minimal residual disease. https://t.co/SO7b5PKZRQ

RT @DepSecHargan: On behalf of @SecAzar, thanks to our scientific & public health experts at @HHSGov who worked w/ our partners @EPA… https://t.co/jfZ8hcBsLk

RT @US_FDA: Congratulations to these three FDA executive leaders on their recognition by the @WhiteHouse! https://t.co/YcOQ5wuILp QT @SGottliebFDA: We're honored that three #FDA Executives were recognized by @WhiteHouse with 2018 Executive Presidential Rank Award… https://t.co/dO1QOOosHM)

RT @tmprowell: Hot off the press! New #FDAOncology Guidance on design of #ClinicalTrials & endpoints to support approval of… https://t.co/Dj53HSmX9L

The letters to the 20 firms stated that it has come to our attention that they appear to be engaging in activities that are subject to regulatory requirements.

#Essure will no longer be sold in U.S. after Dec.31, but #FDA will continue to evaluate product’s long-term safety profile. I’m providing important updates on those efforts. https://t.co/ts3JrE7DBq

#FDA taking new steps to revise and strengthen manufacturer’s postmarket study, to ensure we collect long-term safety information on #Essure; the study will now follow women for five years instead of three: https://t.co/ts3JrE7DBq

RT @ArthurCaplan: Infections put 12 people in hospitals after they received unapproved stem cell products @CNN https://t.co/Tdjnhq1aQR

Following Essure’s removal from the market, the FDA will continue to monitor women with device; we’re working to implement surveillance system and registries to answer crucial questions on devices for women’s health. https://t.co/ts3JrE7DBq

RT @SGottliebFDA: #FDA taking new steps to revise and strengthen manufacturer’s postmarket study, to ensure we collect long-term safe… https://t.co/ElNVbFujwl

RT @SGottliebFDA: Following Essure’s removal from the market, the FDA will continue to monitor women with device; we’re working to im… https://t.co/KffFZaFlP4

RT @NBCNewsHealth: FDA warns some antibiotics can cause serious heart damage https://t.co/geAusAL5QX

RT @DrNancyM_CDC: As of December 14, 2018, more than 166 million doses of #flu vaccine had already been distributed in the U.S. This… https://t.co/oQKZtfy2Ps

RT @FDAanimalhealth: Wishing you happy howlidays from FDA's Center for Veterinary Medicine. https://t.co/OEhjEsdzqY

One of our core missions is to protect the U.S. blood supply; one of the world’s safest. That’s due in part to dedicated #FDA staff who monitor and quickly respond to any potential threats. Thanks to those working through the shutdown to uphold our gold standard of blood safety. https://t.co/pUbDIG67Lj

I say this is a watershed moment because once insulin products are deemed to be licensed under the PHSA, products that are biosimilar to, or interchangeable with, these insulins can then come to market.

But once an insulin product is approved and available as an interchangeable under the PHSA, it may be substituted for the reference product at the pharmacy, potentially leading to increased access and significantly lower costs for patients. https://t.co/Di2ja3vcwN

Today there are no approved generic insulin products that can be substituted at the pharmacy, in part because it is hard to bring a substitutable insulin to market under the conventional drug pathway.

Interchangeables are biosimilars that meet additional requirements including that they can be expected to produce the same clinical result as the reference product in any given patient. Therefore, they may be substituted at the pharmacy level. https://t.co/l3bjBtvRjw https://t.co/O2ksBsEJsw

Access to affordable insulin is a matter of life & death for the 7 million diabetics who require daily insulin injections to maintain their blood glucose level. https://t.co/ujPB7aSPOD And yet the average list price has increased by 15%-17% per year from 2012-2016. https://t.co/k0HK8DwLog

The fact is, limited competition keeps insulin prices artificially high – three companies control 90% of the global market and produce all of the insulin used in the U.S., according to the Congressional Research Service. https://t.co/W2XDn5v3xY https://t.co/JT7kkJIufA

We’ve heard frequent reports of patients rationing insulin and, in some cases, dying because they can’t afford the injections. These tragic stories aren’t isolated occurrences and they’re not acceptable for a drug that’s nearly a century old.

We’re at a crucial stage in developing a competitive market for biological products. As you’ve seen, FDA is committed to making the development of biosimilars and interchangeable products more efficient. These changes are long overdue. https://t.co/bRPSZqyMyT

You can’t pin high prices on manufacturing challenges. Initially, insulin was made with great difficulty & expense from cow & pig pancreas cells after its discovery in 1921. But since the 1980s, recombinant DNA technology has allowed for efficient production from microorganisms. https://t.co/v0ArV4O68s

Given our long experience regulating insulin products and the high interest among sponsors who are proposing to develop interchangeable insulins, we’re confident an interchangeable insulin will be attainable after the transition in March 2020.

RT @FDAOncology: Read the #FDAOncology draft guidance on Hematologic Malignancies: Regulatory Considerations for Use of Minimal Resi… https://t.co/xDICGL6MqQ

RT @tmprowell: Check it out! #CompassionateUse of investigational drugs is about to get a lot simpler for patients & busy clinicia… https://t.co/BT7sRLojBq

RT @US_FDA: If you react strongly to caffeine, there are certain foods and drinks you may want to avoid altogether. Learn how d… https://t.co/BNlkmfkgdr

For what’s going on with food policy, food safety, innovation, and outbreak response at #FDA follow FDA’s Deputy Commissioner for Food Policy and Response @FrankYiannasFDA

RT @SGottliebFDA: #FDA’s partnership with @Scholastic to provide school administrators and teachers resources to help them engage wit… https://t.co/kOwKQh2sJt

RT @SGottliebFDA: As part of #FDA’s campaign to educate kids about the dangers of e-cig use we joined with @Scholastic to provide res… https://t.co/WCv8GiHCIV

RT @FDATobacco: FDA’s policy framework strikes a careful balance between making flavored tobacco products—especially e-cigs—less ac… https://t.co/GLLa1kkmQI

RT @SGottliebFDA: Therapeutic biologics play a critical role in the treatment of many serious illnesses and are responsible for a sig… https://t.co/vmLcvKBYnt

#FDA has announced a series of actions to combat an epidemic growth in teen use of e-cigarettes; including actions we took last month to cut down on sales to minors, limit access to flavors, and first ever public campaign informing kids of risks of e-cigs https://t.co/THzkUay0rA

THREAD: New data from @NIDANews’ Monitoring the Future survey reaffirm concerning trends of youth e-cig use. We must continue to address these epidemic-level increases to ensure children aren’t started down a path to nicotine addiction and tobacco use: https://t.co/eN9QXwfB5C https://t.co/5ttmJyR6ng

Similar to the National Youth Tobacco Survey numbers we released last month with @CDCgov, these new numbers estimate a shocking one-year increase of approximately 1.3 million additional eighth, 10th and 12th graders who used e-cigarettes in 2018, compared with 2017.

RT @FDATobacco: FDA’s new policy framework strikes a careful balance between making flavored tobacco products—especially e-cigarett… https://t.co/XJ0ZWt6MKS

RT @NCIDirector: Congrats, @dramyabernethy! Look forward to continued collaborations with @SGottliebFDA, Amy & others at FDA to work on behalf of patients.

RT @FDAMedia: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic framework to advance use of real-world… https://t.co/ajmwuE8rIW

#FDA is committed to ensuring tobacco products, incl. e-cigarettes, aren’t being marketed to, sold to or used by kids. We’ve taken numerous actions under our Youth Tobacco Prevention Plan, including a series of proposed new steps outlined last month: https://t.co/Zs18yU7EVx

RT @DrMcCance_Katz: We must be committed to encouraging our loved ones to seek the help they need when they need it. To find hotline an… https://t.co/X0nmeAaBFd

RT @NCIDirector: Great hire! @dramyabernethy named @US_FDA Deputy Commissioner. Amy is a longtime cancer researcher, accomplished da… https://t.co/xDB1M6rmTp

RT @zakkohane: Truly momentous news. Dr. Abernathy is a clear thinker about the promise of biotechnology without blinding by the hype. Simi… QT @matthewherper: Some big news for FDA and @flatironhealth ! @US_FDA is naming Flatiron exec @dramyabernethy as deputy commissioner,… https://t.co/1tBqvLAf2T)

#FDA applauds steps by the #SG to bring attention to the epidemic of youth use of e-cigs, and we’ll continue to implement actions we outlined last month to reduce the access and appeal that tobacco products have to kids; principally by targeting flavors. https://t.co/SWLdt3clVJ

Educating teens and arming educators with resources to help engage students on dangers of e-cigarette use align with significant new steps #FDA proposed this Fall to protect kids by preventing youth access to flavored tobacco products. Details on our plan: https://t.co/ABg3gJ0tiM https://t.co/5IKiyAaeur

The Monitoring the Future Survey confirms the epidemic use of e-cigs by kids that #FDA first identified in September and took action to reverse in November by limiting the access and appeal of these products to children; by targeting the role of flavors. https://t.co/qaGmKJHXVp

This new survey confirms data from the National Youth Tobacco Survey and affirms what we’ve known - that youth use of e-cigarettes is at an epidemic proportion. This is why #FDA has taken new steps to curtail the access and appeal of these products to kids https://t.co/x5bjMer6Xx

New technology such as genomic interrogation of human and food samples are enabling us to better identify outbreaks. The tools for doing more effective track and trace to isolate contaminated products and implement more targeted recalls need to catch up https://t.co/L617dxvqso

RT @US_FDA: We continue to focus on approving high-quality, lower cost, safe & effective generics. On the heels of the Oct. rec… https://t.co/2zDXJWi8SU

RT @HHSGov: The opioid epidemic is one of HHS's top priorities. @SecAzar explains how the Department is working to combat the c… https://t.co/S7np2gBZtW

#FDA’s new guidance is aimed at applying modern and efficient oncology trial designs, as well as explore novel endpoints, such as minimal residual disease. https://t.co/SO7b5PKZRQ

RT @DepSecHargan: On behalf of @SecAzar, thanks to our scientific & public health experts at @HHSGov who worked w/ our partners @EPA… https://t.co/jfZ8hcBsLk

RT @US_FDA: Congratulations to these three FDA executive leaders on their recognition by the @WhiteHouse! https://t.co/YcOQ5wuILp QT @SGottliebFDA: We're honored that three #FDA Executives were recognized by @WhiteHouse with 2018 Executive Presidential Rank Award… https://t.co/dO1QOOosHM)

RT @tmprowell: Hot off the press! New #FDAOncology Guidance on design of #ClinicalTrials & endpoints to support approval of… https://t.co/Dj53HSmX9L

The letters to the 20 firms stated that it has come to our attention that they appear to be engaging in activities that are subject to regulatory requirements.

#Essure will no longer be sold in U.S. after Dec.31, but #FDA will continue to evaluate product’s long-term safety profile. I’m providing important updates on those efforts. https://t.co/ts3JrE7DBq

#FDA taking new steps to revise and strengthen manufacturer’s postmarket study, to ensure we collect long-term safety information on #Essure; the study will now follow women for five years instead of three: https://t.co/ts3JrE7DBq

RT @ArthurCaplan: Infections put 12 people in hospitals after they received unapproved stem cell products @CNN https://t.co/Tdjnhq1aQR

Following Essure’s removal from the market, the FDA will continue to monitor women with device; we’re working to implement surveillance system and registries to answer crucial questions on devices for women’s health. https://t.co/ts3JrE7DBq

RT @SGottliebFDA: #FDA taking new steps to revise and strengthen manufacturer’s postmarket study, to ensure we collect long-term safe… https://t.co/ElNVbFujwl

RT @SGottliebFDA: Following Essure’s removal from the market, the FDA will continue to monitor women with device; we’re working to im… https://t.co/KffFZaFlP4

RT @NBCNewsHealth: FDA warns some antibiotics can cause serious heart damage https://t.co/geAusAL5QX

RT @DrNancyM_CDC: As of December 14, 2018, more than 166 million doses of #flu vaccine had already been distributed in the U.S. This… https://t.co/oQKZtfy2Ps

RT @FDAanimalhealth: Wishing you happy howlidays from FDA's Center for Veterinary Medicine. https://t.co/OEhjEsdzqY

One of our core missions is to protect the U.S. blood supply; one of the world’s safest. That’s due in part to dedicated #FDA staff who monitor and quickly respond to any potential threats. Thanks to those working through the shutdown to uphold our gold standard of blood safety. https://t.co/pUbDIG67Lj