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

#VaccinesWork https://t.co/4xldPuJ4MN

RT @FDATobacco: Smoking can cause cervical cancer. This #CervicalHealthMonth start your journey to becoming smoke-free. Resources… https://t.co/N9N2e0U4VP

RT @FrankYiannasFDA: Congratulations to Dr. Mindy Brashears for being appointed by @SecretarySonny to serve as Deputy Under Secretary fo… https://t.co/xSNSOqNRIZ

Workshops like this are one part of our ongoing efforts to bring together all stakeholders in the cybersecurity ecosystem to carry out a “whole of community” approach in which we’re all doing our part to ensure devices are secure and patients are protected.

Today’s cybersecurity workshop highlights 3 cornerstones of medical device cybersecurity: Trustworthiness. Transparency. Resilience. When implemented in the premarket phase these principles help ensure stronger device security across a product’s use life https://t.co/BIWpAeikia

Inspectional data from FY2013 – FY2017 actually shows an increase in total domestic and foreign generic inspections, read our FY17 GDUFA report. We expect these trends to continue due to resources from GDUFA II. https://t.co/pUiinhtd6x The # of inspections we conduct is growing. https://t.co/qHaW8OmVcl

At future events – like @Defcon – we encourage manufacturers to increase engagement with the cyber research community through device demos and our #wehearthackers event. This demonstrates a company’s commitment to cyber principles: Trustworthiness. Transparency. Resilience.

I was honored to speak at today’s #FDAcyber workshop on our premarket guidance we released this fall. Thank you to everyone who came to work with us on ways we can design devices that encourage innovation while also protecting patients from potential vulnerabilities. https://t.co/fdwSWnXKli

FDA’s inspections program is a large-scale endeavor. We shared data on our risk-based FY17 inspections in a stmt issued in Sept. 2018: https://t.co/SaiOcLdXmH We also outlined our risk-based program in a #sundaytweetorial last year: https://t.co/WsOyNd9A1t QT @SGottliebFDA: Patients expect and deserve high-quality drugs. In today’s #FDA #SUNDAYTWEETORIAL I’m going to talk about how FDA s… https://t.co/6fJaXOJtSi)

Globalization of drug manufacturing adds new complexities to the U.S. supply chain. API may be manufactured in one country, shipped to another country for final manufacturing that incorporates ingredients from a third country. The finished product is then imported to the U.S. https://t.co/NxhEL4B98A

To maximize inspectional resources and efficiency we’re collaborating with EU to allow drug inspectors to rely on information from inspections conducted by EU https://t.co/RJc6zzBCeG So we’re able to avoid duplication of inspections and focus on sites posing greatest risk. https://t.co/XwgduZzO4j

To keep pace, FDA has established an efficient, nimble and modern framework to help assure that all drugs, no matter where manufactured, whether brand name, biosimilar or generic, prescription or OTC, meet the same high-quality standards.

Post GDUFA #FDA made a concerted effort to inspect every generic facility allowing us to develop a very sophisticated risk-based model to target future inspections; making our inspectional work more focused, more efficient, and more effective.

And for anyone trying to parse a distinction between "surveillance" inspections of existing product lines, and inspections for new products launching for the first time, there's a key fact: new drugs and drugs on market are often made at same sites.....

Pre-approval inspections and surveillance inspections, which are increasing in numbers NOT FALLING, work hand-in-hand as integrated elements of a comprehensive approach to ensuring quality and safety of generics.

RT @SGottliebFDA: And for anyone trying to parse a distinction between "surveillance" inspections of existing product lines, and insp… https://t.co/d19lteli8I

So when FDA goes in and inspects a facility for a new product launch, it's also getting a good look at the whole facility, which can address issues associated with all the other product lines being produced in that same manufacturing site.

@annaedney Important Distinction: New launches and existing drugs are typically made in same plants. When we go in and inspect facility for a new launch we get a look at the entire facility and their systems, which can address systemic issues associated with other products made at the site.

And remember, as manufacturing consolidates, more generics are made in each facility. When we go into these sites, even for pre-approval looks, we’re able to survey a much broader swath of production. The new generic drugs are made in the same plants as existing generic drugs.

RT @SGottliebFDA: There will be impacts from this prolonged lapse in funding. But this agency has always faced challenge, and we’ve a… https://t.co/JtFyGQQEii

#VaccinesWork https://t.co/4xldPuJ4MN

RT @FDATobacco: Smoking can cause cervical cancer. This #CervicalHealthMonth start your journey to becoming smoke-free. Resources… https://t.co/N9N2e0U4VP

RT @FrankYiannasFDA: Congratulations to Dr. Mindy Brashears for being appointed by @SecretarySonny to serve as Deputy Under Secretary fo… https://t.co/xSNSOqNRIZ

Workshops like this are one part of our ongoing efforts to bring together all stakeholders in the cybersecurity ecosystem to carry out a “whole of community” approach in which we’re all doing our part to ensure devices are secure and patients are protected.

Today’s cybersecurity workshop highlights 3 cornerstones of medical device cybersecurity: Trustworthiness. Transparency. Resilience. When implemented in the premarket phase these principles help ensure stronger device security across a product’s use life https://t.co/BIWpAeikia

Inspectional data from FY2013 – FY2017 actually shows an increase in total domestic and foreign generic inspections, read our FY17 GDUFA report. We expect these trends to continue due to resources from GDUFA II. https://t.co/pUiinhtd6x The # of inspections we conduct is growing. https://t.co/qHaW8OmVcl

At future events – like @Defcon – we encourage manufacturers to increase engagement with the cyber research community through device demos and our #wehearthackers event. This demonstrates a company’s commitment to cyber principles: Trustworthiness. Transparency. Resilience.

I was honored to speak at today’s #FDAcyber workshop on our premarket guidance we released this fall. Thank you to everyone who came to work with us on ways we can design devices that encourage innovation while also protecting patients from potential vulnerabilities. https://t.co/fdwSWnXKli

FDA’s inspections program is a large-scale endeavor. We shared data on our risk-based FY17 inspections in a stmt issued in Sept. 2018: https://t.co/SaiOcLdXmH We also outlined our risk-based program in a #sundaytweetorial last year: https://t.co/WsOyNd9A1t QT @SGottliebFDA: Patients expect and deserve high-quality drugs. In today’s #FDA #SUNDAYTWEETORIAL I’m going to talk about how FDA s… https://t.co/6fJaXOJtSi)

Globalization of drug manufacturing adds new complexities to the U.S. supply chain. API may be manufactured in one country, shipped to another country for final manufacturing that incorporates ingredients from a third country. The finished product is then imported to the U.S. https://t.co/NxhEL4B98A

To maximize inspectional resources and efficiency we’re collaborating with EU to allow drug inspectors to rely on information from inspections conducted by EU https://t.co/RJc6zzBCeG So we’re able to avoid duplication of inspections and focus on sites posing greatest risk. https://t.co/XwgduZzO4j

To keep pace, FDA has established an efficient, nimble and modern framework to help assure that all drugs, no matter where manufactured, whether brand name, biosimilar or generic, prescription or OTC, meet the same high-quality standards.

Post GDUFA #FDA made a concerted effort to inspect every generic facility allowing us to develop a very sophisticated risk-based model to target future inspections; making our inspectional work more focused, more efficient, and more effective.

And for anyone trying to parse a distinction between "surveillance" inspections of existing product lines, and inspections for new products launching for the first time, there's a key fact: new drugs and drugs on market are often made at same sites.....

Pre-approval inspections and surveillance inspections, which are increasing in numbers NOT FALLING, work hand-in-hand as integrated elements of a comprehensive approach to ensuring quality and safety of generics.

RT @SGottliebFDA: And for anyone trying to parse a distinction between "surveillance" inspections of existing product lines, and insp… https://t.co/d19lteli8I

So when FDA goes in and inspects a facility for a new product launch, it's also getting a good look at the whole facility, which can address issues associated with all the other product lines being produced in that same manufacturing site.

@annaedney Important Distinction: New launches and existing drugs are typically made in same plants. When we go in and inspect facility for a new launch we get a look at the entire facility and their systems, which can address systemic issues associated with other products made at the site.

And remember, as manufacturing consolidates, more generics are made in each facility. When we go into these sites, even for pre-approval looks, we’re able to survey a much broader swath of production. The new generic drugs are made in the same plants as existing generic drugs.

RT @SGottliebFDA: There will be impacts from this prolonged lapse in funding. But this agency has always faced challenge, and we’ve a… https://t.co/JtFyGQQEii