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

The #FDA will continue to monitor Zika closely and take action if needed. An increased risk of local mosquito-borne transmission of Zika in a specific geographic area could trigger individual donation testing in that location https://t.co/h62nrBytxe

Hurricane #Beryl Advisory 6A: Beryl Continuing Westward Across the Tropical Atlantic https://t.co/i01kv5HA9n

#FDA recommends consumers avoid raw or undercooked shellfish to prevent foodborne illnesses such as Vibrio, especially people with compromised immune systems who are known to be at high risk of disease complications.

#FDA is actively working with @CDCgov and state partners on a cluster of Vibrio parahemolyticus illnesses identified by Maryland Dept of Health in people who ate raw crabmeat reported to be sourced from Venezuela.

#FDA is actively tracking Hurricane #Beryl and is ready to respond. While the path of #Beryl remains uncertain, #FDA stands to support those who may be affected; including residents of Puerto Rico, who again find themselves in path of a storm. We’re committed to the people of #PR https://t.co/69g2fvb3ug

RT @SGottliebFDA: #FDA is actively working with @CDCgov and state partners on a cluster of Vibrio parahemolyticus illnesses identifie… https://t.co/dE3M4lWO1c

RT @SGottliebFDA: #FDA is actively tracking Hurricane #Beryl and is ready to respond. While the path of #Beryl remains uncertain,… https://t.co/bT8V8yFRbG

A thoughtful, worthwhile read by @ml_barnett and @DrSarahWakeman - we need to expand access to therapy for opioid use disorder and break the stigma sometimes associated with treatment. These treatments work. Every patient deserves access to the three approved therapies for OUD https://t.co/VIX4I5GupD QT @ml_barnett: My latest with the amazing @DrSarahWakeman in @NEJM: we make a case for why mobilizing buprenorphine capacity in th… https://t.co/RFgFxQs5f8)

RT @davidmwessel: Cultivating a vibrant U.S. market for biosimilars: A conversation with FDA’s Scott Gottlieb. July 18. 1:30 p.m.… https://t.co/Gee4GjzBfs

RT @LisaRosenbaum17: Highly recommend this thread/perspective, as well as related perspectives on improving access to treatment for opioid… QT @ml_barnett: My latest with the amazing @DrSarahWakeman in @NEJM: we make a case for why mobilizing buprenorphine capacity in th… https://t.co/RFgFxQs5f8)

In contrast to most drugs, which are chemically synthesized and have well-characterized structures, biological products are typically complex molecules like proteins that are produced in living cells https://t.co/m20ejMleBN https://t.co/3oc4mROB0v

For this week’s #FDA #SUNDAYTWEETORIAL, I want to talk about #biosimilars. It's a critical moment in the development of the market for these products. We'll advance major policy changes in this area soon. Enhancing biosimilar competition is a key to reducing overall drug spending

Congress charged #FDA with maintaining balance between encouraging and rewarding innovation and facilitating robust and timely competition. We must ensure that this balance exists across the spectrum of pharma products; from small molecules to more complex products to biologics

Biologics play a key role in treating many serious illnesses like cancer or genetic disorders. While they offer many therapeutic benefits, biologics often come at high expense. While <2% of US patients use biologics, they represent ~40% of total Rx spend https://t.co/GE25GQJu7F https://t.co/M1PePtdUaQ

The BPCI Act provides a pathway for increased biologics competition to emerge, similar to the pathway created under Hatch Waxman for generic drugs, which has saved the US health care system more than $1.67 trillion in the last decade https://t.co/AcsiJzFyL0 @AccessibleMeds https://t.co/GaLATS3jBf

Recognizing the cost and complexity of biologics and need to enhance access for patients, Congress passed the Biologics Price Competition & Innovation Act, providing an abbreviated pathway for FDA to approve follow-on versions of biologics, aka biosimilars https://t.co/ELRSk2ekYj

Biosimilar sponsors may leverage FDA’s finding of safety and effectiveness for the reference product to support approval of the biosimilar at a lower cost than a development program for an originator product https://t.co/xiApHdNkR7 https://t.co/neJmph71uR

Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved reference product https://t.co/STIbvQm769 https://t.co/KrEfjD7Vma

State-of-the-art technology is used to compare characteristics of the products, such as chemical identity and bioactivity https://t.co/sKom6yuwhX

To demonstrate that its proposed biosimilar is highly similar to the reference product, the sponsor extensively analyzes the structure and function of the reference product and its proposed biosimilar. Minor differences in clinically inactive components are acceptable https://t.co/1nHHf8SeQd

The #FDA will continue to monitor Zika closely and take action if needed. An increased risk of local mosquito-borne transmission of Zika in a specific geographic area could trigger individual donation testing in that location https://t.co/h62nrBytxe

Hurricane #Beryl Advisory 6A: Beryl Continuing Westward Across the Tropical Atlantic https://t.co/i01kv5HA9n

#FDA recommends consumers avoid raw or undercooked shellfish to prevent foodborne illnesses such as Vibrio, especially people with compromised immune systems who are known to be at high risk of disease complications.

#FDA is actively working with @CDCgov and state partners on a cluster of Vibrio parahemolyticus illnesses identified by Maryland Dept of Health in people who ate raw crabmeat reported to be sourced from Venezuela.

#FDA is actively tracking Hurricane #Beryl and is ready to respond. While the path of #Beryl remains uncertain, #FDA stands to support those who may be affected; including residents of Puerto Rico, who again find themselves in path of a storm. We’re committed to the people of #PR https://t.co/69g2fvb3ug

RT @SGottliebFDA: #FDA is actively working with @CDCgov and state partners on a cluster of Vibrio parahemolyticus illnesses identifie… https://t.co/dE3M4lWO1c

RT @SGottliebFDA: #FDA is actively tracking Hurricane #Beryl and is ready to respond. While the path of #Beryl remains uncertain,… https://t.co/bT8V8yFRbG

A thoughtful, worthwhile read by @ml_barnett and @DrSarahWakeman - we need to expand access to therapy for opioid use disorder and break the stigma sometimes associated with treatment. These treatments work. Every patient deserves access to the three approved therapies for OUD https://t.co/VIX4I5GupD QT @ml_barnett: My latest with the amazing @DrSarahWakeman in @NEJM: we make a case for why mobilizing buprenorphine capacity in th… https://t.co/RFgFxQs5f8)

RT @davidmwessel: Cultivating a vibrant U.S. market for biosimilars: A conversation with FDA’s Scott Gottlieb. July 18. 1:30 p.m.… https://t.co/Gee4GjzBfs

RT @LisaRosenbaum17: Highly recommend this thread/perspective, as well as related perspectives on improving access to treatment for opioid… QT @ml_barnett: My latest with the amazing @DrSarahWakeman in @NEJM: we make a case for why mobilizing buprenorphine capacity in th… https://t.co/RFgFxQs5f8)

In contrast to most drugs, which are chemically synthesized and have well-characterized structures, biological products are typically complex molecules like proteins that are produced in living cells https://t.co/m20ejMleBN https://t.co/3oc4mROB0v

For this week’s #FDA #SUNDAYTWEETORIAL, I want to talk about #biosimilars. It's a critical moment in the development of the market for these products. We'll advance major policy changes in this area soon. Enhancing biosimilar competition is a key to reducing overall drug spending

Congress charged #FDA with maintaining balance between encouraging and rewarding innovation and facilitating robust and timely competition. We must ensure that this balance exists across the spectrum of pharma products; from small molecules to more complex products to biologics

Biologics play a key role in treating many serious illnesses like cancer or genetic disorders. While they offer many therapeutic benefits, biologics often come at high expense. While <2% of US patients use biologics, they represent ~40% of total Rx spend https://t.co/GE25GQJu7F https://t.co/M1PePtdUaQ

The BPCI Act provides a pathway for increased biologics competition to emerge, similar to the pathway created under Hatch Waxman for generic drugs, which has saved the US health care system more than $1.67 trillion in the last decade https://t.co/AcsiJzFyL0 @AccessibleMeds https://t.co/GaLATS3jBf

Recognizing the cost and complexity of biologics and need to enhance access for patients, Congress passed the Biologics Price Competition & Innovation Act, providing an abbreviated pathway for FDA to approve follow-on versions of biologics, aka biosimilars https://t.co/ELRSk2ekYj

Biosimilar sponsors may leverage FDA’s finding of safety and effectiveness for the reference product to support approval of the biosimilar at a lower cost than a development program for an originator product https://t.co/xiApHdNkR7 https://t.co/neJmph71uR

Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved reference product https://t.co/STIbvQm769 https://t.co/KrEfjD7Vma

State-of-the-art technology is used to compare characteristics of the products, such as chemical identity and bioactivity https://t.co/sKom6yuwhX

To demonstrate that its proposed biosimilar is highly similar to the reference product, the sponsor extensively analyzes the structure and function of the reference product and its proposed biosimilar. Minor differences in clinically inactive components are acceptable https://t.co/1nHHf8SeQd