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

RT @SGottliebFDA: THREAD: In 2019, #FDA plans to introduce new policy guidance and other advances in our drug development framework and today, we’re previewing that policy agenda as it relates to cell and gene therapy products. Read our statement https://t.co/Y6IhqaHDNW

RT @JohnCendpts: Gottlieb, Marks detail plans to advance development of cell and gene therapies https://t.co/lJLrMIU4M2

RT @RAPSorg: .@SGottliebFDA, Marks Detail Plans to Advance Development of Cell and Gene Therapies | #Regulatory Focus… https://t.co/izguOoM5NS

Behind the collective dedication of our professional staff in our inspectorate and our programs, we’re focused on the core aspects of our consumer protection role https://t.co/aJOhlIRWwm

This is requiring hard operational decisions. We’re focused on preserving the function of our programs for as long as we can. We’re closely monitoring the burn rates of all of our user programs, but we’re the most concerned about the PDUFA balances, which have the lowest runway.

RT @HCA_News: @dramyabernethy's appointment to the second-highest position at the @US_FDA is a good indication of the agency’s po… https://t.co/ucC33Lwly9

THREAD: Today we’re issuing a new draft guidance document to support companies seeking final approval for tentatively approved generic drug applications (ANDAs) to promote timely access to safe and effective generic medicines https://t.co/mr9dG81MBl and help bolster competition.

…. I also know the promise of back pay doesn’t erase current hardships. And I know that this time has been especially hard on those of you on furlough, who’ve been disconnected from the important work you do on behalf of Americans, your colleagues, and friends at #FDA....

RT @MDMagazine: "We know there has been past interest in developing a #generic alternative to this product… Today's action demonstrates that there is an open pathway to approving products like this one,” said FDA Commissioner @SGottliebFDA https://t.co/EDquFjtF6h

THREAD: To my #FDA Colleagues: A bill was signed into law today to guarantee that federal workers who are furloughed or working without pay will be compensated for the period of funding lapse. I know that as this shutdown continues, the personal impacts on you are mounting …..

It's part of #FDA’s efforts to promote drug competition and increase patient access to high-quality, safe, affordable medicines. We’ve advanced many policies aimed at making it more efficient for companies to bring generic competition to the market.

..... We’ll continue to post information to our website and will be updating you soon on operational decisions we need to consider as the shutdown continues. Go to https://t.co/rS8FWwbri1 to keep up with issues related to the shutdown.

THREAD: Developing a drug or biologic for a rare disease can be especially challenging so it’s important that #FDA provides clear info to companies so they can plan modern, efficient drug development programs that will be successful. Read our FDA in Brief: https://t.co/iINHjj0sXo

RT @pewhealth: “Physicians treating serious infections must have up-to-date [information] so they can select the best treatment for their patient’s infection.” - @SGottliebFDA What @US_FDA is doing to ensure this: https://t.co/3ehP1D58IR

..... My focus remains on FDA’s people – all of them – and our collective mission. This is a moment of challenge for the #FDA. We’ll continue to protect the agency, it’s people, our mission, and the core values that bind us together in a common pursuit...

During the lapse in funding, #FDA continues to advance certain policy, consistent with what's permissible under law. Like today’s guidance, supported by carryover user-fees, to advance the development of treatments for rare diseases.

Earlier this year, #FDA highlighted this drug, along with many others, on a list of off-patent, off-exclusivity branded drugs without approved generics, to clarify that there were no patents or exclusivities that should impede its approval. https://t.co/O9vjK75Eba

THREAD: #FDAapproves first generic version of Sabril (vigabatrin) tablets: https://t.co/oWcMq0w1CF

But it’s not enough just to approve a record number of generics. We also want to see these products launched so that patients can benefit from their availability and we intend to take steps to advance these goals.

Prioritizing the approval of generic drugs to compete with medicines that face little or no competition is a key part of our efforts to support access and reduce drug costs to patients. https://t.co/oWcMq0w1CF

RT @SGottliebFDA: THREAD: In 2019, #FDA plans to introduce new policy guidance and other advances in our drug development framework and today, we’re previewing that policy agenda as it relates to cell and gene therapy products. Read our statement https://t.co/Y6IhqaHDNW

RT @JohnCendpts: Gottlieb, Marks detail plans to advance development of cell and gene therapies https://t.co/lJLrMIU4M2

RT @RAPSorg: .@SGottliebFDA, Marks Detail Plans to Advance Development of Cell and Gene Therapies | #Regulatory Focus… https://t.co/izguOoM5NS

Behind the collective dedication of our professional staff in our inspectorate and our programs, we’re focused on the core aspects of our consumer protection role https://t.co/aJOhlIRWwm

This is requiring hard operational decisions. We’re focused on preserving the function of our programs for as long as we can. We’re closely monitoring the burn rates of all of our user programs, but we’re the most concerned about the PDUFA balances, which have the lowest runway.

RT @HCA_News: @dramyabernethy's appointment to the second-highest position at the @US_FDA is a good indication of the agency’s po… https://t.co/ucC33Lwly9

THREAD: Today we’re issuing a new draft guidance document to support companies seeking final approval for tentatively approved generic drug applications (ANDAs) to promote timely access to safe and effective generic medicines https://t.co/mr9dG81MBl and help bolster competition.

…. I also know the promise of back pay doesn’t erase current hardships. And I know that this time has been especially hard on those of you on furlough, who’ve been disconnected from the important work you do on behalf of Americans, your colleagues, and friends at #FDA....

RT @MDMagazine: "We know there has been past interest in developing a #generic alternative to this product… Today's action demonstrates that there is an open pathway to approving products like this one,” said FDA Commissioner @SGottliebFDA https://t.co/EDquFjtF6h

THREAD: To my #FDA Colleagues: A bill was signed into law today to guarantee that federal workers who are furloughed or working without pay will be compensated for the period of funding lapse. I know that as this shutdown continues, the personal impacts on you are mounting …..

It's part of #FDA’s efforts to promote drug competition and increase patient access to high-quality, safe, affordable medicines. We’ve advanced many policies aimed at making it more efficient for companies to bring generic competition to the market.

..... We’ll continue to post information to our website and will be updating you soon on operational decisions we need to consider as the shutdown continues. Go to https://t.co/rS8FWwbri1 to keep up with issues related to the shutdown.

THREAD: Developing a drug or biologic for a rare disease can be especially challenging so it’s important that #FDA provides clear info to companies so they can plan modern, efficient drug development programs that will be successful. Read our FDA in Brief: https://t.co/iINHjj0sXo

RT @pewhealth: “Physicians treating serious infections must have up-to-date [information] so they can select the best treatment for their patient’s infection.” - @SGottliebFDA What @US_FDA is doing to ensure this: https://t.co/3ehP1D58IR

..... My focus remains on FDA’s people – all of them – and our collective mission. This is a moment of challenge for the #FDA. We’ll continue to protect the agency, it’s people, our mission, and the core values that bind us together in a common pursuit...

During the lapse in funding, #FDA continues to advance certain policy, consistent with what's permissible under law. Like today’s guidance, supported by carryover user-fees, to advance the development of treatments for rare diseases.

Earlier this year, #FDA highlighted this drug, along with many others, on a list of off-patent, off-exclusivity branded drugs without approved generics, to clarify that there were no patents or exclusivities that should impede its approval. https://t.co/O9vjK75Eba

THREAD: #FDAapproves first generic version of Sabril (vigabatrin) tablets: https://t.co/oWcMq0w1CF

But it’s not enough just to approve a record number of generics. We also want to see these products launched so that patients can benefit from their availability and we intend to take steps to advance these goals.

Prioritizing the approval of generic drugs to compete with medicines that face little or no competition is a key part of our efforts to support access and reduce drug costs to patients. https://t.co/oWcMq0w1CF