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

A lot of time and cost is spent between the starting and stopping of the traditional 3 phases. Continuous trials can save time, lower costs and reduce the number of patients. Look for new guidance soon from #FDA on how developers can conduct these “expansion” trials

Surrogate endpoints are another clinical trial modernization tool. These endpoints are often used when clinical outcomes take a long time to study or when the surrogate’s ability to predict clinical benefit, such as reducing the HIV viral load, is well known.

FDA just published a list of surrogate endpoints which were the basis of approval or licensure of a drug or biologic product under accelerated or traditional approval https://t.co/FF7JG1RAzy. It provides useful information for drug developers on endpoints that may be considered. https://t.co/o74ZJzGoUg

Seamless trials, used in oncology for drugs that might qualify for breakthrough therapy designation, are another novel approach https://t.co/yiOpoiLGJf. They compress the traditional 3 trial phases into one large, continuous trial that may be able to speed access for patients. https://t.co/JB1z8K3272

FDA is also looking to real world data collected from device registries and electronic health records to answer important premarket and post market questions potentially allowing sponsors to meet evidence needs in less time, at lower cost. https://t.co/GNLjMGQd7n

MDIC is using computer modeling and simulation to create virtual patients. If validated to be like real patients, future device trials may be able to rely on virtual patient information when appropriate, lessening the burden of enrolling real patients and improving on our rigor

Although I’ve been focusing on modernizing drug clinical trials, we have efforts underway to modernize medical device clinical trials as well, in part through work we are doing with the Medical Device Innovation Consortium (MDIC) on “virtual patients.” https://t.co/vDSi7uqWDT

We need to reduce the burden and cost of advancing care. And we need to make it easier for competition to reach the market once we have a promising new therapy. Our clinical trial advances will ensure that more patients have more safe and effective treatment options available.

Our aim is simple: innovative, advanced evidence generation to assure the timely availability of safe and effective therapies. Our aim is to improve patient care, and give people the assurance of #FDA's gold standard for safety and efficacy in the most efficient way possible

RT @SGottliebFDA: For this weekend's #FDA #SUNDAYTWEETORIAL I’m going to talk about what FDA is doing to modernize clinical trials to… https://t.co/jIb3Esg803

RT @califf001: Great tweetorial on FDA, evidence generation and clinical trials. Integrally linked to real world evidence. @DukeForge http… QT @SGottliebFDA: We need to reduce the burden and cost of advancing care. And we need to make it easier for competition to reach the… https://t.co/9FIwo4QXoP)

THREAD ON NEW ENFORCEMENT ACTION: We’re taking action against manufacturers marketing “vaginal rejuvenation” devices to women by deceptively claiming the procedures treat conditions and symptoms related to menopause, urinary incontinence, & sexual function https://t.co/QsaI1SIm2a

These products have serious risks and don’t have adequate evidence to support their use for these purposes. We’re deeply concerned women are being harmed by these procedures

We’ve also established the Women’s Health Technologies Strategically Coordinated Registry Network (CRN) to provide more complete evidence in clinical areas that are unique to women, such as uterine fibroids and pelvic floor disorders.

RT @lauriemcginley2: Beware claims for "vaginal rejuvenation." FDA says serious injuries can occur. https://t.co/TOPPMdb6GE

Deceptive manufacturers are marketing “vaginal rejuvenation” devices to women, claiming they treat menopausal symptoms and sexual problems. We’re warning the manufacturers, and alerting patients the procedures have serious risks https://t.co/M5u3RGe5dA https://t.co/lstlFLIcKT

This reauthorization of two very successful user fee programs helps ensure timely pre-market review of animal drugs, enhancing veterinarians’ access to the products they need to meet the health needs of the animal community.

RT @FDATobacco: Reminder: By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe to… https://t.co/XzPCdJqLUm

THREAD: I’m pleased that the @HouseFloor & @SenateFloor passed legislation today reauthorizing the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA), which authorizes #FDA to collect fees from animal drug companies to help fund #FDA’s drug review work

#FDA and @USDA collaborate closely on issues related to antimicrobial resistance. Among many joint activities, we work together to gather data on antibiotic use to support policy work. We share a similar philosophy, goals, and means for achieving our joint public health mission. https://t.co/YVPbw0a9gc

A lot of time and cost is spent between the starting and stopping of the traditional 3 phases. Continuous trials can save time, lower costs and reduce the number of patients. Look for new guidance soon from #FDA on how developers can conduct these “expansion” trials

Surrogate endpoints are another clinical trial modernization tool. These endpoints are often used when clinical outcomes take a long time to study or when the surrogate’s ability to predict clinical benefit, such as reducing the HIV viral load, is well known.

FDA just published a list of surrogate endpoints which were the basis of approval or licensure of a drug or biologic product under accelerated or traditional approval https://t.co/FF7JG1RAzy. It provides useful information for drug developers on endpoints that may be considered. https://t.co/o74ZJzGoUg

Seamless trials, used in oncology for drugs that might qualify for breakthrough therapy designation, are another novel approach https://t.co/yiOpoiLGJf. They compress the traditional 3 trial phases into one large, continuous trial that may be able to speed access for patients. https://t.co/JB1z8K3272

FDA is also looking to real world data collected from device registries and electronic health records to answer important premarket and post market questions potentially allowing sponsors to meet evidence needs in less time, at lower cost. https://t.co/GNLjMGQd7n

MDIC is using computer modeling and simulation to create virtual patients. If validated to be like real patients, future device trials may be able to rely on virtual patient information when appropriate, lessening the burden of enrolling real patients and improving on our rigor

Although I’ve been focusing on modernizing drug clinical trials, we have efforts underway to modernize medical device clinical trials as well, in part through work we are doing with the Medical Device Innovation Consortium (MDIC) on “virtual patients.” https://t.co/vDSi7uqWDT

We need to reduce the burden and cost of advancing care. And we need to make it easier for competition to reach the market once we have a promising new therapy. Our clinical trial advances will ensure that more patients have more safe and effective treatment options available.

Our aim is simple: innovative, advanced evidence generation to assure the timely availability of safe and effective therapies. Our aim is to improve patient care, and give people the assurance of #FDA's gold standard for safety and efficacy in the most efficient way possible

RT @SGottliebFDA: For this weekend's #FDA #SUNDAYTWEETORIAL I’m going to talk about what FDA is doing to modernize clinical trials to… https://t.co/jIb3Esg803

RT @califf001: Great tweetorial on FDA, evidence generation and clinical trials. Integrally linked to real world evidence. @DukeForge http… QT @SGottliebFDA: We need to reduce the burden and cost of advancing care. And we need to make it easier for competition to reach the… https://t.co/9FIwo4QXoP)

THREAD ON NEW ENFORCEMENT ACTION: We’re taking action against manufacturers marketing “vaginal rejuvenation” devices to women by deceptively claiming the procedures treat conditions and symptoms related to menopause, urinary incontinence, & sexual function https://t.co/QsaI1SIm2a

These products have serious risks and don’t have adequate evidence to support their use for these purposes. We’re deeply concerned women are being harmed by these procedures

We’ve also established the Women’s Health Technologies Strategically Coordinated Registry Network (CRN) to provide more complete evidence in clinical areas that are unique to women, such as uterine fibroids and pelvic floor disorders.

RT @lauriemcginley2: Beware claims for "vaginal rejuvenation." FDA says serious injuries can occur. https://t.co/TOPPMdb6GE

Deceptive manufacturers are marketing “vaginal rejuvenation” devices to women, claiming they treat menopausal symptoms and sexual problems. We’re warning the manufacturers, and alerting patients the procedures have serious risks https://t.co/M5u3RGe5dA https://t.co/lstlFLIcKT

This reauthorization of two very successful user fee programs helps ensure timely pre-market review of animal drugs, enhancing veterinarians’ access to the products they need to meet the health needs of the animal community.

RT @FDATobacco: Reminder: By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe to… https://t.co/XzPCdJqLUm

THREAD: I’m pleased that the @HouseFloor & @SenateFloor passed legislation today reauthorizing the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA), which authorizes #FDA to collect fees from animal drug companies to help fund #FDA’s drug review work

#FDA and @USDA collaborate closely on issues related to antimicrobial resistance. Among many joint activities, we work together to gather data on antibiotic use to support policy work. We share a similar philosophy, goals, and means for achieving our joint public health mission. https://t.co/YVPbw0a9gc