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

RT @FDAOncology: New #FDAOncology draft guidance provides recommendations to industry on use of #placebos and blinding in randomized… https://t.co/bcKYCuqPyr

As we see more breakthrough drugs showing outsized benefits in carefully selected patients it lets us to advance new, rigorous ways for testing medicines; and makes placebo studies an alternative to be used for right settings rather than a reflexive approach for all cancer trials

FDA’s new guidance clarifies when researchers should use placebos in certain cancer trials. These trials present practical and ethical concerns and where possible drugs should be compared to already-approved standard of care in randomized trials https://t.co/4ExzkOqJVp

RT @FDASpox: #FDA today is announcing that 17 companies who received warning letters in May have ceased sales of liquids used in… https://t.co/Fe6kCyqvSV

RT @JNCI_Now: Between 2008 and 2016, the @US_FDA and @FDAOncology approved 239 oncology & hematology drug applications. #caxtx… https://t.co/IWfO8HKPHQ

Check the lots numbers for any King Bio/Dr. King homeopathic pediatric products that you have, including children’s fever reducer and cough relief, for any recalled products. The full list is available here: https://t.co/ZSqKpbfd4D

PUBLIC HEALTH ADVISORY: Recall notice: King Bio has recalled some of the Dr. King’s homeopathic children and infant products due to potential microbial contamination. A full list is available here: https://t.co/ZSqKpbfd4D

RT @FDASpox: Torrent Pharmaceuticals Limited is expanding its voluntarily recall to all lots of unexpired valsartan-containing d… https://t.co/IzWYomKmuF

King Bio is recalling certain products because of potential microbial contamination. But homeopathic drug products haven’t been proven safe or effective. You can read more about the #FDA’s new enforcement approach to drug products labeled as homeopathic: https://t.co/bOfLo1eKjW

#FDA continues to evaluate the safety of valsartan-containing products and will update the list of products that are included and not included in the recall as more info becomes available 3/3

RT @BioCentury: FDA adds four tropical diseases to Priority Review voucher program https://t.co/yeK9HTL76l

#FDA is also releasing the method we’ve been using to test for NDMA. The gas chromatography-mass spectrometry (GC/MS) headspace method will help manufacturers and regulators to detect and quantify NDMA in valsartan API and finished drug products. https://t.co/HZb3YT0060 2/3

THREAD - PUBLIC HEALTH ADVISORY: #FDA is updating health care professionals and consumers of a voluntary recall for all lots of unexpired valsartan-containing drug products made by Torrent Pharmaceuticals Limited due to the detection of NDMA. https://t.co/HZb3YT0060 1/3 https://t.co/fMpljzm7Qy

While the King Bio homeopathic products recalled are due to a potential microbial contamination issue, products labeled as homeopathic have not been reviewed by the #FDA for safety and effectiveness 2/4

If you rely on insulin, learn about storage alternatives in a power outage. Info from FDA at https://t.co/wKhiGYF1Jc #HurricaneLane https://t.co/f5zm9NeGXG

We’ve seen large uptick in homeopathic products marketed for a wide array of diseases and conditions. Our approach to regulating homeopathic drugs is evolving to reflect the complexity of the market, which is why we’re taking a more active, risk-based approach to enforcement 3/4

THREAD: Recall Update - King Bio is recalling Dr. King’s pediatric homeopathic products, including products for teething, ear aches, stress relief, newborn tonics and more: https://t.co/ZSqKpbfd4D 1/4

We respect that people may choose to use homeopathic products, but #FDA has a public health responsibility to protect consumers from products that may not deliver any benefit and have the potential to cause harm. Our statement on our policy: https://t.co/bOfLo1eKjW 4/4

As we advance better clinical trial designs for proving safety and efficacy; and the #FDA sees more breakthrough drugs that can produce more easily discernible benefits when added to standard of care, it reduces the utility of placebos in randomized trials https://t.co/oUym0qQNhp

RT @endpts: Need a #placebo control group for your next #cancer drug study? Only in certain circumstances, says #FDA… https://t.co/nD7w9gqJmq

RT @FDAOncology: New #FDAOncology draft guidance provides recommendations to industry on use of #placebos and blinding in randomized… https://t.co/bcKYCuqPyr

As we see more breakthrough drugs showing outsized benefits in carefully selected patients it lets us to advance new, rigorous ways for testing medicines; and makes placebo studies an alternative to be used for right settings rather than a reflexive approach for all cancer trials

FDA’s new guidance clarifies when researchers should use placebos in certain cancer trials. These trials present practical and ethical concerns and where possible drugs should be compared to already-approved standard of care in randomized trials https://t.co/4ExzkOqJVp

RT @FDASpox: #FDA today is announcing that 17 companies who received warning letters in May have ceased sales of liquids used in… https://t.co/Fe6kCyqvSV

RT @JNCI_Now: Between 2008 and 2016, the @US_FDA and @FDAOncology approved 239 oncology & hematology drug applications. #caxtx… https://t.co/IWfO8HKPHQ

Check the lots numbers for any King Bio/Dr. King homeopathic pediatric products that you have, including children’s fever reducer and cough relief, for any recalled products. The full list is available here: https://t.co/ZSqKpbfd4D

PUBLIC HEALTH ADVISORY: Recall notice: King Bio has recalled some of the Dr. King’s homeopathic children and infant products due to potential microbial contamination. A full list is available here: https://t.co/ZSqKpbfd4D

RT @FDASpox: Torrent Pharmaceuticals Limited is expanding its voluntarily recall to all lots of unexpired valsartan-containing d… https://t.co/IzWYomKmuF

King Bio is recalling certain products because of potential microbial contamination. But homeopathic drug products haven’t been proven safe or effective. You can read more about the #FDA’s new enforcement approach to drug products labeled as homeopathic: https://t.co/bOfLo1eKjW

#FDA continues to evaluate the safety of valsartan-containing products and will update the list of products that are included and not included in the recall as more info becomes available 3/3

RT @BioCentury: FDA adds four tropical diseases to Priority Review voucher program https://t.co/yeK9HTL76l

#FDA is also releasing the method we’ve been using to test for NDMA. The gas chromatography-mass spectrometry (GC/MS) headspace method will help manufacturers and regulators to detect and quantify NDMA in valsartan API and finished drug products. https://t.co/HZb3YT0060 2/3

THREAD - PUBLIC HEALTH ADVISORY: #FDA is updating health care professionals and consumers of a voluntary recall for all lots of unexpired valsartan-containing drug products made by Torrent Pharmaceuticals Limited due to the detection of NDMA. https://t.co/HZb3YT0060 1/3 https://t.co/fMpljzm7Qy

While the King Bio homeopathic products recalled are due to a potential microbial contamination issue, products labeled as homeopathic have not been reviewed by the #FDA for safety and effectiveness 2/4

If you rely on insulin, learn about storage alternatives in a power outage. Info from FDA at https://t.co/wKhiGYF1Jc #HurricaneLane https://t.co/f5zm9NeGXG

We’ve seen large uptick in homeopathic products marketed for a wide array of diseases and conditions. Our approach to regulating homeopathic drugs is evolving to reflect the complexity of the market, which is why we’re taking a more active, risk-based approach to enforcement 3/4

THREAD: Recall Update - King Bio is recalling Dr. King’s pediatric homeopathic products, including products for teething, ear aches, stress relief, newborn tonics and more: https://t.co/ZSqKpbfd4D 1/4

We respect that people may choose to use homeopathic products, but #FDA has a public health responsibility to protect consumers from products that may not deliver any benefit and have the potential to cause harm. Our statement on our policy: https://t.co/bOfLo1eKjW 4/4

As we advance better clinical trial designs for proving safety and efficacy; and the #FDA sees more breakthrough drugs that can produce more easily discernible benefits when added to standard of care, it reduces the utility of placebos in randomized trials https://t.co/oUym0qQNhp

RT @endpts: Need a #placebo control group for your next #cancer drug study? Only in certain circumstances, says #FDA… https://t.co/nD7w9gqJmq