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

RT @NCIDirector: Colleagues @NIHDirector & @SGottliebFDA share their perspective on the next phase of human gene therapy oversight—h… https://t.co/6880HNEprA

DRUG SAFETY - THREAD: #FDA is alerting that Sichuan Friendly Pharmaceutical Co. Limited, China, is recalling certain lots of porcine thyroid API due to inconsistent quality of the API - specific to amounts of active ingredients https://t.co/ZMEalsddVS

This API and drug products made from it present a safety risk. We recommend manufacturers and compounders not use Sichuan Friendly’s porcine thyroid API received since August 2015. FDA placed the company on import alert after an inspection but API remains in U.S. supply chain

déchirant. #VaccinesWork https://t.co/YMYoROV0JB

This API is used to make an unapproved drug product, composed of levothyroxine and liothyronine, to treat hypothyroidism. Risks associated with over or under treatment of hypothyroidism could result in permanent or life-threatening adverse health consequences.

RT @SGottliebFDA: Deaths and adverse events from the opioid Kratom are on the rise - Aug 16, The Philadelphia Inquirer. Consumers sho… https://t.co/Y65ZvrYH6e

RT @washingtonpost: FDA approves first generic version of EpiPen https://t.co/AiWBU6IL1r

RT @FDArecalls: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets https://t.co/wSOrNjzSQb

#FDA recommends patients talk to health care professional before stopping combination levothyroxine and liothyronine thyroid medicine. We also recommend patients discuss FDA-approved hypothyroidism treatment options with doctors, as these combination products are not FDA-approved

Consumers want and expect safe, wholesome and affordable food. They deserve nothing less. In today’s #FDA #SUNDAYTWEETORIAL I’m talking about what steps the FDA, the states and produce farmers are taking - in collaboration - to ensure the safety of fresh fruits and vegetables. https://t.co/WXQyVRCVxR

We hear too often about food safety concerns involving fresh fruit and vegetables -most recently the outbreak of E. coli O157:H7 infections associated with romaine lettuce from the Yuma growing region, the largest such outbreak in the U.S. in more than 10 years. https://t.co/TrpMZqr1IJ

From 1998-2008 there were 455 produce-associated food outbreaks, with more than 16,000 people becoming ill, more than twice the number of produce-associated illnesses from 1973-1997. This is a significant public health burden that should be largely preventable.

During my previous tenures at #FDA, preventing and handling outbreaks was frustrating and challenging because we lacked the necessary tools. It taught me the importance of preventive steps and a modern safety framework like FSMA.

FSMA requires #FDA to establish science-based, minimum standards for the safe growing, harvesting, packing and holding of produce on farms to minimize the presence of potentially dangerous contamination that could cause serious adverse health consequences or death.

After extensive public outreach in meetings, webinars, listening session and farm visits, we issued the Nov. 2015 Produce Safety Final Rule https://t.co/BiT9kwYl2B to implement these standards. Congress told us to make the rule practical, flexible and effective, and we did that. https://t.co/i7l47iS0ZB

These trends prompted Congress to pass the Food Safety Modernization Act of 2010 (FSMA) which transformed our food safety system, including our approach to produce safety, from one that responds to contamination to one that prevents it in the first place https://t.co/NmwXXKvF4H https://t.co/u6gYebb8Lw

The new standards address agricultural water quality; employee health and hygiene; soil amendments of animal origin (compost and manure); equipment, tools and buildings; and domesticated and wild animals. These areas were identified as sources of contamination in the past.

But getting the rule ready for prime-time is hard. We’ve learned that some provisions, including agricultural water, require further consideration. We've taken a flexible approach. We’ve pushed back inspections. We’ve created structures for continued collaboration and education.

The 1st major compliance date for large farms was in January. But routine inspections will not begin until spring of 2019 to give time for more guidance, training, technical assistance and planning. Small farm compliance dates are forthcoming https://t.co/Kym48FE5wv. https://t.co/Nlgw0AJzuv

Essential for success is creating an integrated food safety system that emphasizes education and culture change and requires industry, academia, and government to work together to promote best practices and support compliance strategies.

RT @NCIDirector: Colleagues @NIHDirector & @SGottliebFDA share their perspective on the next phase of human gene therapy oversight—h… https://t.co/6880HNEprA

DRUG SAFETY - THREAD: #FDA is alerting that Sichuan Friendly Pharmaceutical Co. Limited, China, is recalling certain lots of porcine thyroid API due to inconsistent quality of the API - specific to amounts of active ingredients https://t.co/ZMEalsddVS

This API and drug products made from it present a safety risk. We recommend manufacturers and compounders not use Sichuan Friendly’s porcine thyroid API received since August 2015. FDA placed the company on import alert after an inspection but API remains in U.S. supply chain

déchirant. #VaccinesWork https://t.co/YMYoROV0JB

This API is used to make an unapproved drug product, composed of levothyroxine and liothyronine, to treat hypothyroidism. Risks associated with over or under treatment of hypothyroidism could result in permanent or life-threatening adverse health consequences.

RT @SGottliebFDA: Deaths and adverse events from the opioid Kratom are on the rise - Aug 16, The Philadelphia Inquirer. Consumers sho… https://t.co/Y65ZvrYH6e

RT @washingtonpost: FDA approves first generic version of EpiPen https://t.co/AiWBU6IL1r

RT @FDArecalls: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets https://t.co/wSOrNjzSQb

#FDA recommends patients talk to health care professional before stopping combination levothyroxine and liothyronine thyroid medicine. We also recommend patients discuss FDA-approved hypothyroidism treatment options with doctors, as these combination products are not FDA-approved

Consumers want and expect safe, wholesome and affordable food. They deserve nothing less. In today’s #FDA #SUNDAYTWEETORIAL I’m talking about what steps the FDA, the states and produce farmers are taking - in collaboration - to ensure the safety of fresh fruits and vegetables. https://t.co/WXQyVRCVxR

We hear too often about food safety concerns involving fresh fruit and vegetables -most recently the outbreak of E. coli O157:H7 infections associated with romaine lettuce from the Yuma growing region, the largest such outbreak in the U.S. in more than 10 years. https://t.co/TrpMZqr1IJ

From 1998-2008 there were 455 produce-associated food outbreaks, with more than 16,000 people becoming ill, more than twice the number of produce-associated illnesses from 1973-1997. This is a significant public health burden that should be largely preventable.

During my previous tenures at #FDA, preventing and handling outbreaks was frustrating and challenging because we lacked the necessary tools. It taught me the importance of preventive steps and a modern safety framework like FSMA.

FSMA requires #FDA to establish science-based, minimum standards for the safe growing, harvesting, packing and holding of produce on farms to minimize the presence of potentially dangerous contamination that could cause serious adverse health consequences or death.

After extensive public outreach in meetings, webinars, listening session and farm visits, we issued the Nov. 2015 Produce Safety Final Rule https://t.co/BiT9kwYl2B to implement these standards. Congress told us to make the rule practical, flexible and effective, and we did that. https://t.co/i7l47iS0ZB

These trends prompted Congress to pass the Food Safety Modernization Act of 2010 (FSMA) which transformed our food safety system, including our approach to produce safety, from one that responds to contamination to one that prevents it in the first place https://t.co/NmwXXKvF4H https://t.co/u6gYebb8Lw

The new standards address agricultural water quality; employee health and hygiene; soil amendments of animal origin (compost and manure); equipment, tools and buildings; and domesticated and wild animals. These areas were identified as sources of contamination in the past.

But getting the rule ready for prime-time is hard. We’ve learned that some provisions, including agricultural water, require further consideration. We've taken a flexible approach. We’ve pushed back inspections. We’ve created structures for continued collaboration and education.

The 1st major compliance date for large farms was in January. But routine inspections will not begin until spring of 2019 to give time for more guidance, training, technical assistance and planning. Small farm compliance dates are forthcoming https://t.co/Kym48FE5wv. https://t.co/Nlgw0AJzuv

Essential for success is creating an integrated food safety system that emphasizes education and culture change and requires industry, academia, and government to work together to promote best practices and support compliance strategies.