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

#FDA’s breakthrough pathway has helped advance important, impactful therapies to patients with unmet medical needs, who in many cases have exhausted available options

For serious conditions with small patient populations (rare diseases) a single trial may be accepted to show safety and efficacy, demonstrating clinical benefit. This has helped result in approvals where there were previously no satisfactory approved drug

Owing to the effectiveness of new drugs, the desire of patients to cross over to promising therapies; leaving dying patients on comparator arms for long periods - to measure survival stats - can be hard. So we're trying to modernize clinical trial design

For life threatening diseases, often where there's no effective therapy, #FDA may use surrogate endpoints to advance market access - such as measuring tumor shrinkage in a cancer trial - and require confirmation of long term benefit in post market studies

Decisions to approve new drugs is complex. It balances medical need with available info on safety and efficacy. For diseases with large patient populations or not considered serious or life-threatening, FDA generally requires at least 2 well-controlled tr

#FDA is committed to a rigorous, thoughtful, modern regulatory approach that assesses the benefits and risks of each medical product in the context of the urgency of the medical need; with our goal to help people whose lives are disrupted and threatened b

RT @CeciConnolly: This is v good news; need more biosimilars on the market 2 spark competition, dr down prices @_ACHP https://t.co/CYdcNA8f… QT @SGottliebFDA: Today #FDA approved a new biosimilar to help reduce the risk of infection during cancer treatment. Bringing new bio… https://t.co/tKFUAyts2t)

2/2 The decision to disband that single adcom of dozens and dozens of advisory committees we maintain was made by FDA career leadership for sound scientific and programmatic reasons; and FDA will always promote science based decision making and seek the c

1/2 In the Sunday @nytimes reporter Coral Davenport cites FDA’s earlier decision to disband a single food advisory committee (one of the 50+ #FDA adcoms the agency maintains) which hadn’t met since 2015 and was replaced by the FDA Science Board as evidenc

RT @JPCincyOnc: Thanks @SGottliebFDA for a transformational process that propels new therapies forward for #ChildhoodCancer & #AYACancer. R… QT @SGottliebFDA: For serious conditions with small patient populations (rare diseases) a single trial may be accepted to show safety… https://t.co/Y2JuPhAfE8)

RT @BlumenthalG: How much needless suffering would occur if multiple trials with survival as the primary endpoint required for drugs… https://t.co/0LSjFHSdF2

#FDA has identified Caito Foods, a company specializing in fresh produce distribution and fresh food processing nationwide, as source of a salmonella outbreak related to pre-cut cantaloupe, watermelon or fruit salad mix with melon. https://t.co/7RR7YMHgiu

Building on our new guidance asserting dietary supplements made of pure or highly concentrated caffeine in powder or liquid forms are generally unlawful when sold directly to consumers in bulk packaging; we sent warning letters to makers of these products

RT @tmprowell: After yesterday’s @nytimes editorial, it might be be worth a pause to remember this experience:… https://t.co/xohWBX2rIz

RT @SportsCenter: How about this UNREAL comeback in the 4x400 to clinch the NCAA Track & Field Championship for USC � #SCtop10 https://t.co/ywe26SC5Kp

RT @CMSGov: Today, CMS published an #OpioidRoadmap w/ our 3-pronged approach to combat the #OpioidEpidemic: (1) focus on preven… https://t.co/SDRbFjOIIj

FDA’s takes new policy steps to advance more competitive, value and outcomes based contracting as a way to lower costs to patients https://t.co/4SkG4tfcZ5

RT @FDAMedia: Statement from FDA Commissioner @SGottliebFDA on efforts to foster discovery and development of new tools to fight… https://t.co/hP4lUjw1F0

RT @steveusdin1: FDA proposes new reimbursement model for antimicrobials. V interesting idea from @SGottliebFDA. Reimbursement of an… https://t.co/8JNUOgaduQ

RT @amcpceo: Value-based health care took a big step forward in @US_FDA final guidance allowing communication of information on… https://t.co/xEUHFdvKD5

#FDA’s breakthrough pathway has helped advance important, impactful therapies to patients with unmet medical needs, who in many cases have exhausted available options

For serious conditions with small patient populations (rare diseases) a single trial may be accepted to show safety and efficacy, demonstrating clinical benefit. This has helped result in approvals where there were previously no satisfactory approved drug

Owing to the effectiveness of new drugs, the desire of patients to cross over to promising therapies; leaving dying patients on comparator arms for long periods - to measure survival stats - can be hard. So we're trying to modernize clinical trial design

For life threatening diseases, often where there's no effective therapy, #FDA may use surrogate endpoints to advance market access - such as measuring tumor shrinkage in a cancer trial - and require confirmation of long term benefit in post market studies

Decisions to approve new drugs is complex. It balances medical need with available info on safety and efficacy. For diseases with large patient populations or not considered serious or life-threatening, FDA generally requires at least 2 well-controlled tr

#FDA is committed to a rigorous, thoughtful, modern regulatory approach that assesses the benefits and risks of each medical product in the context of the urgency of the medical need; with our goal to help people whose lives are disrupted and threatened b

RT @CeciConnolly: This is v good news; need more biosimilars on the market 2 spark competition, dr down prices @_ACHP https://t.co/CYdcNA8f… QT @SGottliebFDA: Today #FDA approved a new biosimilar to help reduce the risk of infection during cancer treatment. Bringing new bio… https://t.co/tKFUAyts2t)

2/2 The decision to disband that single adcom of dozens and dozens of advisory committees we maintain was made by FDA career leadership for sound scientific and programmatic reasons; and FDA will always promote science based decision making and seek the c

1/2 In the Sunday @nytimes reporter Coral Davenport cites FDA’s earlier decision to disband a single food advisory committee (one of the 50+ #FDA adcoms the agency maintains) which hadn’t met since 2015 and was replaced by the FDA Science Board as evidenc

RT @JPCincyOnc: Thanks @SGottliebFDA for a transformational process that propels new therapies forward for #ChildhoodCancer & #AYACancer. R… QT @SGottliebFDA: For serious conditions with small patient populations (rare diseases) a single trial may be accepted to show safety… https://t.co/Y2JuPhAfE8)

RT @BlumenthalG: How much needless suffering would occur if multiple trials with survival as the primary endpoint required for drugs… https://t.co/0LSjFHSdF2

#FDA has identified Caito Foods, a company specializing in fresh produce distribution and fresh food processing nationwide, as source of a salmonella outbreak related to pre-cut cantaloupe, watermelon or fruit salad mix with melon. https://t.co/7RR7YMHgiu

Building on our new guidance asserting dietary supplements made of pure or highly concentrated caffeine in powder or liquid forms are generally unlawful when sold directly to consumers in bulk packaging; we sent warning letters to makers of these products

RT @tmprowell: After yesterday’s @nytimes editorial, it might be be worth a pause to remember this experience:… https://t.co/xohWBX2rIz

RT @SportsCenter: How about this UNREAL comeback in the 4x400 to clinch the NCAA Track & Field Championship for USC � #SCtop10 https://t.co/ywe26SC5Kp

RT @CMSGov: Today, CMS published an #OpioidRoadmap w/ our 3-pronged approach to combat the #OpioidEpidemic: (1) focus on preven… https://t.co/SDRbFjOIIj

FDA’s takes new policy steps to advance more competitive, value and outcomes based contracting as a way to lower costs to patients https://t.co/4SkG4tfcZ5

RT @FDAMedia: Statement from FDA Commissioner @SGottliebFDA on efforts to foster discovery and development of new tools to fight… https://t.co/hP4lUjw1F0

RT @steveusdin1: FDA proposes new reimbursement model for antimicrobials. V interesting idea from @SGottliebFDA. Reimbursement of an… https://t.co/8JNUOgaduQ

RT @amcpceo: Value-based health care took a big step forward in @US_FDA final guidance allowing communication of information on… https://t.co/xEUHFdvKD5