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

Unlike the generic pathway for small molecules, some clinical studies may be necessary to demonstrate that a product meets the “biosimilarity” standard for approval https://t.co/Z0X9b6Xmlo https://t.co/4hlf5TbNUF https://t.co/9QRqxwLApl

If a product is approved as an interchangeable product, it may be substituted for the reference product without consulting the prescriber https://t.co/BU6Cjzj69W https://t.co/IoB9WWTOVN

An interchangeable product, in addition to being biosimilar, meets additional requirements, for example showing it is expected to produce the same clinical result as the reference product in any given patient https://t.co/rRMRvUxhOA

The reduced need for multiple large clinical outcomes studies as a part of biosimilar product development can significantly lower development costs. This can result in significantly lower prices for patients and payors, as is already seen in Europe https://t.co/ZZTMQgohIZ https://t.co/cJAfGCBblg

We will soon unveil a comprehensive Biosimilars Action Plan (BAP) that will include policies and actions to improve the efficiency of FDA’s review of biosimilar marketing applications and increase regulatory certainty for biosimilar manufacturers and other stakeholders #BAP

#BAP will include elements like enhancing our education campaign for HCPs and patients https://t.co/PQH3YuMpUq, reducing gaming that may delay market competition, strengthening int’l regulatory partnerships and providing clarity for product developers via guidance and meetings

FDA approved 11 biosimilars, including 5 in 2017. Despite this progress I’m concerned patients aren’t seeing the full benefits of competition. We’ll continue to approve biosimilars but appropriate reimbursement and market access are needed to lower prices https://t.co/JzPY99laq5

RT @SGottliebFDA: For this week’s #FDA #SUNDAYTWEETORIAL, I want to talk about #biosimilars. It's a critical moment in the developmen… https://t.co/mEfSebuFhg

I'm looking forward to speaking at @BrookingsInst event on July 18th to discuss #BAP and our new efforts to cultivate a vibrant U.S. market for biosimilars and other efforts to enhance competition and reduce drug costs https://t.co/b9Atotp40R

RT @FDA_Drug_Info: #ChronicPainPFDD meeting begins this morning at 10a EST. FDA wants to hear patient views on chronic pain, treatment… https://t.co/jl1s2Ex9Ld

Although there are barriers to marketing biosimilars outside FDA’s purview, we're committed to advancing policies to facilitate efficient development, approval of biosimilars to reduce costs, enhance access, without reducing incentives to innovate. #BAP will advance these goals

Please use the following link to join the #ChronicPainPFDD webcast: https://t.co/ieDIrd4PHG. You may identify yourself as a “guest” and type in your first and last name (or simply write “anonymous”).

Today #FDA is holding a Patient-Focused Drug Development meeting to hear chronic pain patient perspectives on treatment approaches and challenges/barriers to accessing treatments. Follow along via webcast: https://t.co/VxhCwfBFIe or @FDA_Drug_Info live tweets #ChronicPainPFDD

RT @FDAOncology: Use of #PRO measures to inform tolerability in oncology trials: Implications for clinical review, IND safety report… https://t.co/iKZwsbhNbo

RT @FDA_Drug_Info: #ChronicPainPFDD agenda & materials may be found at https://t.co/Z5vnwFwkOc.

My statement today on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem misuse and abuse of opioids https://t.co/qtfal9XzcE

Today’s Patient-focused Drug Development meeting is one of many steps #FDA’s taking to make sure we protect the needs of patients with chronic and acute pain even as we take new actions to reduce overall prescribing and dispensing of opioid medicines: https://t.co/x4hGdXl6a5

As we address the opioid crisis we won’t lose sight of the needs those living with chronic/end-of-life pain. #FDA is focused on striking right balance between reducing new opioid addiction and providing appropriate access to pain medicines: https://t.co/x4hGdXl6a5

RT @RAPSorg: .@US_FDA Seeks to Strike the Right Balance on Opioid Access | #Regulatory Focus https://t.co/G51yKGE4pY #FDA… https://t.co/UbnlkCljlQ

#FDA will hold an August advisory committee mtg to discuss the transmucosal immediate-release fentanyl medicines’ risk evaluation and mitigation strategy (REMS). This REMS program aims to reduce risk of misuse, abuse, addiction and overdose: https://t.co/RSCEMysENz

Unlike the generic pathway for small molecules, some clinical studies may be necessary to demonstrate that a product meets the “biosimilarity” standard for approval https://t.co/Z0X9b6Xmlo https://t.co/4hlf5TbNUF https://t.co/9QRqxwLApl

If a product is approved as an interchangeable product, it may be substituted for the reference product without consulting the prescriber https://t.co/BU6Cjzj69W https://t.co/IoB9WWTOVN

An interchangeable product, in addition to being biosimilar, meets additional requirements, for example showing it is expected to produce the same clinical result as the reference product in any given patient https://t.co/rRMRvUxhOA

The reduced need for multiple large clinical outcomes studies as a part of biosimilar product development can significantly lower development costs. This can result in significantly lower prices for patients and payors, as is already seen in Europe https://t.co/ZZTMQgohIZ https://t.co/cJAfGCBblg

We will soon unveil a comprehensive Biosimilars Action Plan (BAP) that will include policies and actions to improve the efficiency of FDA’s review of biosimilar marketing applications and increase regulatory certainty for biosimilar manufacturers and other stakeholders #BAP

#BAP will include elements like enhancing our education campaign for HCPs and patients https://t.co/PQH3YuMpUq, reducing gaming that may delay market competition, strengthening int’l regulatory partnerships and providing clarity for product developers via guidance and meetings

FDA approved 11 biosimilars, including 5 in 2017. Despite this progress I’m concerned patients aren’t seeing the full benefits of competition. We’ll continue to approve biosimilars but appropriate reimbursement and market access are needed to lower prices https://t.co/JzPY99laq5

RT @SGottliebFDA: For this week’s #FDA #SUNDAYTWEETORIAL, I want to talk about #biosimilars. It's a critical moment in the developmen… https://t.co/mEfSebuFhg

I'm looking forward to speaking at @BrookingsInst event on July 18th to discuss #BAP and our new efforts to cultivate a vibrant U.S. market for biosimilars and other efforts to enhance competition and reduce drug costs https://t.co/b9Atotp40R

RT @FDA_Drug_Info: #ChronicPainPFDD meeting begins this morning at 10a EST. FDA wants to hear patient views on chronic pain, treatment… https://t.co/jl1s2Ex9Ld

Although there are barriers to marketing biosimilars outside FDA’s purview, we're committed to advancing policies to facilitate efficient development, approval of biosimilars to reduce costs, enhance access, without reducing incentives to innovate. #BAP will advance these goals

Please use the following link to join the #ChronicPainPFDD webcast: https://t.co/ieDIrd4PHG. You may identify yourself as a “guest” and type in your first and last name (or simply write “anonymous”).

Today #FDA is holding a Patient-Focused Drug Development meeting to hear chronic pain patient perspectives on treatment approaches and challenges/barriers to accessing treatments. Follow along via webcast: https://t.co/VxhCwfBFIe or @FDA_Drug_Info live tweets #ChronicPainPFDD

RT @FDAOncology: Use of #PRO measures to inform tolerability in oncology trials: Implications for clinical review, IND safety report… https://t.co/iKZwsbhNbo

RT @FDA_Drug_Info: #ChronicPainPFDD agenda & materials may be found at https://t.co/Z5vnwFwkOc.

My statement today on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem misuse and abuse of opioids https://t.co/qtfal9XzcE

Today’s Patient-focused Drug Development meeting is one of many steps #FDA’s taking to make sure we protect the needs of patients with chronic and acute pain even as we take new actions to reduce overall prescribing and dispensing of opioid medicines: https://t.co/x4hGdXl6a5

As we address the opioid crisis we won’t lose sight of the needs those living with chronic/end-of-life pain. #FDA is focused on striking right balance between reducing new opioid addiction and providing appropriate access to pain medicines: https://t.co/x4hGdXl6a5

RT @RAPSorg: .@US_FDA Seeks to Strike the Right Balance on Opioid Access | #Regulatory Focus https://t.co/G51yKGE4pY #FDA… https://t.co/UbnlkCljlQ

#FDA will hold an August advisory committee mtg to discuss the transmucosal immediate-release fentanyl medicines’ risk evaluation and mitigation strategy (REMS). This REMS program aims to reduce risk of misuse, abuse, addiction and overdose: https://t.co/RSCEMysENz