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

Unfortunately, the rise of AMR has not spurred a corresponding uptick in new antimicrobials, including those that fight bacteria that are resistant to existing therapies. Recent reports, including one from the @WHO warn that there’s a critical global need for such products.

Antimicrobials take as much work to develop as other drugs but aren’t as profitable. Novel drugs are reserved for last-line use when first-line drugs fail, cutting into early revenues when return on investment is sought most. So most pharma cos are exiting https://t.co/W8BMsx2S5e https://t.co/vHPFdrxL8q

Consider human antibiotics: It's estimated that at least 46% of oral antibiotics prescribed by urgent care centers for respiratory symptoms are unnecessary, often prescribed for asthma, allergies, colds or flu not caused by bacteria. https://t.co/iSXb39rEcV https://t.co/8qSPNVWZu7

Similarly, inappropriate antibiotic use in animals – both companion and food-producing animals – can contribute to the emergence of antibiotic-resistant bacteria; and these resistant bacteria may then be transmitted to people and cause infections that are difficult to treat. https://t.co/6WM6qYPppJ

Bacteria may naturally develop resistance to antimicrobials, usually through genetic changes. But the misuse and overuse of antimicrobials is accelerating this process.

The 21st Century Cures Act created the Limited Population Pathway for Antibacterial and Antifungal Drugs or LPAD to help advance human antimicrobial development. We issued a draft guidance in June and we’re seeing meaningful early interest from innovators. https://t.co/q0ZUK0mNxY

We have some tools now to facilitate human drug development for antimicrobials. Using GAIN, we can designate Qualified Infectious Disease Products. If approved, they'll get a 5-year exclusivity extension. As of August, the #FDA has approved 15 QIDPs. https://t.co/Rd3j7sK1iU

The FDA strategy calls for fostering product development; supporting antimicrobial stewardship; enhancing AMR surveillance and monitoring; and finally, advancing regulatory science to help facilitate product development. https://t.co/eCp4Bz9m0A

#FDA is also working to advance the development of non-traditional antimicrobial products including bacteriophages (as shown), which destroy bacteria, microbiome-based therapies (e.g., fecal microbiota transplantation) https://t.co/OSMCTEB2S3 and vaccines. https://t.co/5B6DvwkQDl

To slow the pace and reduce the impact of AMR on human and animal health, I believe we need an all-hands-on deck, multi-faceted initiative. That’s why last week I unveiled FDA’s 2019 Strategic Approach for Combating AMR, which builds on our previous efforts.

CVM will also devise a strategy to ensure that all medically-important antimicrobials used in animal feed and water are labeled with appropriate durations of use. Look for an FDA public meeting on the 5-year plan sometime this fall.

Antibiotic stewardship in veterinary medicine promotes the judicious use of antibiotics in food animals, which includes the concept that medically-important antimicrobial drugs should only be used in animals when necessary for treatment, control or prevention of specific diseases

This approach has eliminated production use of medically-important antimicrobials and brought the therapeutic use of such drugs in animal feed and water under veterinary oversight https://t.co/azYUGncJGA. https://t.co/VtVhOwQalZ

FDA’s Center for Veterinary Medicine’s new 5-year plan builds on existing progress. It would bring the remaining 5% of medically-important antimicrobials approved for use in animals, such as certain injectable antimicrobials, under the oversight of vets. https://t.co/7pMGD4zo8m https://t.co/62zsLfjpKx

Also, we’re refining industry reporting of animal antimicrobial sales data to better understand how these products are used on farms. To track hospital resistance, we’re planning to leverage IVD data standards to enhance real-time infectious disease/AMR surveillance with labs.

Improvements in the National Antimicrobial Resistance Monitoring System, with our @USDA and @CDCgov partners is one way to get better data. It tracks and provides information on AMR in food borne bacteria in humans, retail meats and food-producing animals. https://t.co/876UemxwJl https://t.co/QNON4oF01B

To support stewardship in human medicine, we’re working with manufacturers on new generation diagnostics that may reduce from days to hrs. the time to separate viral from bacterial infections, and rapidly ID the cause and appropriate antibiotic treatment for some infections.

Having good data is essential to understanding the drivers of resistance in human and vet settings and formulating appropriate responses. But acquiring that data is complicated. It requires collaboration with USDA, CDC, NIH and others.

Improvements in the National Antimicrobial Resistance Monitoring System, with our @USDA and @CDCgov partners is one way to get better data. It tracks and provides information on AMR in foodborne bacteria in humans, retail meats and food-producing animals. https://t.co/876UemxwJl https://t.co/ShVj4yWJuu

To help us identify research areas where regulatory science can support new antibacterial drug development, the #FDA is soliciting public input. For more information on our Request for Information and other AMR activities, check out our new AMR web page. https://t.co/rLsI2udeXl https://t.co/R4H4vsyv3f

Unfortunately, the rise of AMR has not spurred a corresponding uptick in new antimicrobials, including those that fight bacteria that are resistant to existing therapies. Recent reports, including one from the @WHO warn that there’s a critical global need for such products.

Antimicrobials take as much work to develop as other drugs but aren’t as profitable. Novel drugs are reserved for last-line use when first-line drugs fail, cutting into early revenues when return on investment is sought most. So most pharma cos are exiting https://t.co/W8BMsx2S5e https://t.co/vHPFdrxL8q

Consider human antibiotics: It's estimated that at least 46% of oral antibiotics prescribed by urgent care centers for respiratory symptoms are unnecessary, often prescribed for asthma, allergies, colds or flu not caused by bacteria. https://t.co/iSXb39rEcV https://t.co/8qSPNVWZu7

Similarly, inappropriate antibiotic use in animals – both companion and food-producing animals – can contribute to the emergence of antibiotic-resistant bacteria; and these resistant bacteria may then be transmitted to people and cause infections that are difficult to treat. https://t.co/6WM6qYPppJ

Bacteria may naturally develop resistance to antimicrobials, usually through genetic changes. But the misuse and overuse of antimicrobials is accelerating this process.

The 21st Century Cures Act created the Limited Population Pathway for Antibacterial and Antifungal Drugs or LPAD to help advance human antimicrobial development. We issued a draft guidance in June and we’re seeing meaningful early interest from innovators. https://t.co/q0ZUK0mNxY

We have some tools now to facilitate human drug development for antimicrobials. Using GAIN, we can designate Qualified Infectious Disease Products. If approved, they'll get a 5-year exclusivity extension. As of August, the #FDA has approved 15 QIDPs. https://t.co/Rd3j7sK1iU

The FDA strategy calls for fostering product development; supporting antimicrobial stewardship; enhancing AMR surveillance and monitoring; and finally, advancing regulatory science to help facilitate product development. https://t.co/eCp4Bz9m0A

#FDA is also working to advance the development of non-traditional antimicrobial products including bacteriophages (as shown), which destroy bacteria, microbiome-based therapies (e.g., fecal microbiota transplantation) https://t.co/OSMCTEB2S3 and vaccines. https://t.co/5B6DvwkQDl

To slow the pace and reduce the impact of AMR on human and animal health, I believe we need an all-hands-on deck, multi-faceted initiative. That’s why last week I unveiled FDA’s 2019 Strategic Approach for Combating AMR, which builds on our previous efforts.

CVM will also devise a strategy to ensure that all medically-important antimicrobials used in animal feed and water are labeled with appropriate durations of use. Look for an FDA public meeting on the 5-year plan sometime this fall.

Antibiotic stewardship in veterinary medicine promotes the judicious use of antibiotics in food animals, which includes the concept that medically-important antimicrobial drugs should only be used in animals when necessary for treatment, control or prevention of specific diseases

This approach has eliminated production use of medically-important antimicrobials and brought the therapeutic use of such drugs in animal feed and water under veterinary oversight https://t.co/azYUGncJGA. https://t.co/VtVhOwQalZ

FDA’s Center for Veterinary Medicine’s new 5-year plan builds on existing progress. It would bring the remaining 5% of medically-important antimicrobials approved for use in animals, such as certain injectable antimicrobials, under the oversight of vets. https://t.co/7pMGD4zo8m https://t.co/62zsLfjpKx

Also, we’re refining industry reporting of animal antimicrobial sales data to better understand how these products are used on farms. To track hospital resistance, we’re planning to leverage IVD data standards to enhance real-time infectious disease/AMR surveillance with labs.

Improvements in the National Antimicrobial Resistance Monitoring System, with our @USDA and @CDCgov partners is one way to get better data. It tracks and provides information on AMR in food borne bacteria in humans, retail meats and food-producing animals. https://t.co/876UemxwJl https://t.co/QNON4oF01B

To support stewardship in human medicine, we’re working with manufacturers on new generation diagnostics that may reduce from days to hrs. the time to separate viral from bacterial infections, and rapidly ID the cause and appropriate antibiotic treatment for some infections.

Having good data is essential to understanding the drivers of resistance in human and vet settings and formulating appropriate responses. But acquiring that data is complicated. It requires collaboration with USDA, CDC, NIH and others.

Improvements in the National Antimicrobial Resistance Monitoring System, with our @USDA and @CDCgov partners is one way to get better data. It tracks and provides information on AMR in foodborne bacteria in humans, retail meats and food-producing animals. https://t.co/876UemxwJl https://t.co/ShVj4yWJuu

To help us identify research areas where regulatory science can support new antibacterial drug development, the #FDA is soliciting public input. For more information on our Request for Information and other AMR activities, check out our new AMR web page. https://t.co/rLsI2udeXl https://t.co/R4H4vsyv3f