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

RT @FDASpox: Earlier today, @SGottliebFDA spoke to @foodanddruglaw’s annual Enforcement, Litigation, and Compliance Conference.… https://t.co/JPJLXX1jle

Consumers who have this Kotex tampon product should stop using immediately and contact company. No other Kotex tampons are subject to this recall. #FDA remains committed to ensuring women have access to safe, effective and innovative devices. https://t.co/2VsaXVTSlv

@AlecGaffney We’ve committed to modernizing the purple book, including adding more information on exclusivities and making the information more accessible. Stay tuned. There’s a lot more we plan to do in 2019 to make this information resource a more practical tool to promote competition.

The #FDA is working with the company to uncover the reasons for this device malfunction and will take appropriate steps to protect consumers from further issues with Kotex tampons and provide updates. Women are urged by the FDA to stop using this product. https://t.co/IPcZJ0LFzW

RT @SGottliebFDA: ALERT: FDA wants women to be aware of voluntary recall: U by Kotex Sleek Tampons, Regular Absorbency; product may u… https://t.co/rv2rcbIgPN

RT @RAPSorg: Biomarker Qualification: @US_FDA Drafts Guidance | #Regulatory Focus https://t.co/9tHT6yhTgj #FDA #guidance #biomarkers

RT @SecAzar: Proud to learn the Partnership for Public Service has recognized @HHSGov as the #2 best large agency to work for in… https://t.co/c7RBdGXLMu

RT @FDASpox: ICYMI – DOJ news release on the NECC case. FDA continues to work to ensure that drugs are made under high quality c… https://t.co/39urCr6Pv0

RT @MedResJourno: .@_jacquie_lee is interviewing @SGottliebFDA for an upcoming @blaw interview. #FDA #drugs #pharms https://t.co/doWo9c3FHF

RT @FDAMedia: FDA takes new steps to advance risk-based regulation of digital health tools. https://t.co/K3QpP34Qeq

Today #FDA issued a final rule to amend our regulations on medical device classification procedures, codifying the change of procedure of using administrative orders, rather than rulemaking, to reclassify medical devices. https://t.co/aVw2maxbKy

This change has made our processes more efficient, and the new rule will provide increased clarity and predictability for device manufacturers, which ultimately will result in patients having more timely access to safe and effective medical devices.

ROMAINE INVESTIGATION UPDATE: #FDA and @CDCgov have identified one source for the E. coli romaine outbreak as the reservoir used by Adams Bros. Farms in CA. However, romaine lettuce from other farms could be affected. We will continue to investigate: https://t.co/mfyTq31bRM https://t.co/NN5mJJUkQ3

REVISED CONSUMER ADVICE: With new info, #FDA can revise our recommendations on romaine lettuce. No need to avoid lettuce from San Luis Obispo, Santa Cruz & Ventura Counties harvested after 11/23. If you can’t confirm your romaine is from an unaffected source, discard immediately https://t.co/TKTFrkyrRh

The farm identified is cooperating and hasn’t shipped any romaine since 11/20. They will recall all products that may have been affected and we are working with them on corrective actions before their next growing season. To date, 59 people have become sick in 15 states.

RT @HHSGov: You don't have to wait for new years to #QuitSmoking. Sign up for @SmokefreeUs' daily text message program to get t… https://t.co/OzVKGrO4iU

RT @SecAzar: Wanted to share some of my conversation from #Axios360 yesterday about the work we’re doing to address the opioid e… https://t.co/yzDhu0o7yr

RT @FDAfood: ⚠️#OUTBREAK UPDATE: Further information from the FDA in the investigation into outbreak of E. coli O157:H7 infectio… https://t.co/JQXc5mcH8q

RT @FrankYiannasFDA: New findings & updated consumer advice on E. coli O157:H7 outbreak linked to romaine lettuce. We’ll continue to use… https://t.co/fbeDitLkXo

RT @SenAlexander: Vaccines take deadly, awful, ravaging diseases from horror to history. Vaccines save lives. https://t.co/kewCNQTslM

RT @SGottliebFDA: ROMAINE INVESTIGATION UPDATE: #FDA and @CDCgov have identified one source for the E. coli romaine outbreak as the r… https://t.co/Kks8vmPi1J

Working quickly with #CDC and state partners allowed us to efficiently find one source of the outbreak. Romaine lettuce will now be labeled on store shelves with the date and harvest origin, making it easier for us to give targeted info regarding future outbreaks.

FDA continues to focus on approving high-quality, lower cost, safe & effective generics - In Nov. FDA approved & tentatively approved 128 generic drugs - with 13 first generics for brands that lacked competition & 20 complex generics https://t.co/PTxhJIE5Zw

The NECC case is a tragic reminder of why compounding and compounded drugs can present serious risks. #FDA has taken significant steps to ensure the quality of compounded drugs and improve patient safety in order to prevent another calamity like this https://t.co/I2x0SGwYPQ

We do not want to see another tragedy like the one we saw in 2012. FDA will continue taking steps to promote quality products for consumers who rely on compounded drugs https://t.co/I2x0SGwYPQ

Over the past 2 years #FDA has approved record numbers of generic drugs: Nov 2018 had the same number of approval actions as record-breaking Oct, which was highest ever in a single month - a total of 128. We’ll continue our efforts to increase competition https://t.co/PTxhJIE5Zw https://t.co/9ptGPi4Bf8

@BlumenthalG @pkluetz @tmprowell Couldn’t leaf it alone. I’m green with envy over the wit and charm!

RT @CDCDirector: Influenza activity will increase and is likely to peak during December-February. Protect yourself against the #flu… https://t.co/7Zr66vgiLJ

RT @SGottliebFDA: OMB Director Mick Mulvaney has been a principled partner to the #FDA and deeply public health minded in all of his engage… QT @MickMulvaneyOMB: This is a tremendous honor. I look forward to working with the President and the entire team. It’s going to be a gr… https://t.co/ee0Odre2Ma)

We’re also eager to work with Congress on a new framework that would give the FDA more ability to update old generic labels, an idea that was proposed by Senators Hatch and Bennet and advanced by others including @CancerResrch https://t.co/aivxZY4rZa

OMB Director Mick Mulvaney has been a principled partner to the #FDA and deeply public health minded in all of his engagements with us; and we are absolutely delighted to have the opportunity to work with Mr. Mulvaney in this important new role. QT @MickMulvaneyOMB: This is a tremendous honor. I look forward to working with the President and the entire team. It’s going to be a gr… https://t.co/ee0Odre2Ma)

RT @FDAOncology: #FDADISCO hosts Dr Abhi Nair & Dr Sanjeeve Bala talk about cancer drug approvals at https://t.co/bYTWyABy8q or on i… https://t.co/9EsaDRzJnv

Unlike small molecule drugs made from chemicals, biologics are generally large, complex molecules that may be derived, through biotechnology, from a living system such as a microorganism or a plant or animal cell. https://t.co/vp3Pw9lals

FDA Withdraws Proposed Rule That Would Have Exposed Generic-Drug Makers to Liability - WSJ https://t.co/SYSpHfvzC2

RT @SGottliebFDA: Our goal is to facilitate and streamline the patient experience with our expanded access program; to create concie… https://t.co/cksz0Q1IIq

Our goal is to facilitate and streamline the patient experience with our expanded access program; to create concierge-like service for providers and patients who are trying to get access drugs. We want to make the entire process more efficient and robust. https://t.co/IJwF1Mtw1p

Therapeutic biologics play a critical role in the treatment of many serious illnesses and are responsible for a significant percent of rising drug prices. Today’s #FDA #SundayTweetorial is about what FDA is doing to improve patient access to insulin and other essential medicines. https://t.co/XT4dydqBUb

About one out of every three new drugs approved by the FDA is a biologic but they accounted for 70 percent of the growth in drug spending from 2010 to 2015, according to a study conducted by the RAND Corp. https://t.co/Ipu4DAxjhB.

Competition drives prices lower. The 1984 Hatch Waxman Act created an abbreviated path to market for generic versions of drugs. Today, generics account for 90% of the scripts written, saving patients about $1 trillion over the past decade.

Examples include monoclonal antibodies (targeted therapies for cancer & other diseases), cytokines involved in immune response, growth factors that affect cell growth, and enzymes that speed up biochemical reactions https://t.co/Liah9AAoDx. https://t.co/xO1cKQGmRO

Until recently, biologics lacked this sort of competition. To market their product, sponsors submit a biologics license application (BLA) under the Public Health Service Act (PHSA). The PHSA had no abbreviated pathway to market for biologics prior to 2010 https://t.co/ruat5gnpOa.

To speed competition we issued a Biosimilars Action Plan in July to improve product development and approval process efficiency; increase scientific & reg. clarity; provide addt’l communications and outreach & address brand co. “gaming” of FDA requirements https://t.co/4g2yZDke1L https://t.co/EN8Qxa5PAr

The biosimilar pathway allows applicants that meet approval requirements to rely on FDA’s finding of safety, purity & potency for the biological reference product. As a result, it is generally less costly to develop a biosimilar https://t.co/lo67mXzpDJ.

The Biologics Price Competition & Innovation Act of 2009 (BPCIA) created an abbreviated pathway for biological products that are biosimilar or interchangeable to an FDA-approved reference product. https://t.co/Hvu3LgNYmF. https://t.co/nLMYZvGZnw

While the U.S. market for biosimilars is still maturing, FDA research suggests that after market entry, biosimilars have the potential to offer significant savings. This is especially true after 2 or more biosimilars are approved and on the market.

Since the BPCIA became law, we’ve approved 16 products including a record 8 in the last year https://t.co/8ymjFnVIFt and there are currently more than 60 biosimilar development programs underway. But only a fraction of the biosimilars approved by the FDA have launched. https://t.co/RvSAcDoG9r

Some biologics – including insulin - have historically been approved under the drug pathway. The BPCIA requires that these approved products will be deemed to be licensed under the PHSA on March 23, 2020. The guidances out last week describe how we plan to go about doing so. https://t.co/zzUMPK0hCw

Last week we announced additional steps including a draft Q&A regarding companies that use and sometimes abuse limited distribution systems to delay or derail an applicant’s access to reference product samples needed for testing to support an application https://t.co/lDCp8zTpBz.

And, in what I believe is a watershed moment for insulin products and for people with Type 1 diabetes, we issued two guidance documents outlining how we plan to transition insulin from a drug approval pathway to a biologics approval pathway. Let me explain. https://t.co/BGiDmOXvHR

To speed competition, we issued a Biosimilars Action Plan in July to improve product development & approval process efficiency; increase scientific & reg. clarity; provide addt’l communications & outreach & address brand co. “gaming” of FDA requirements. https://t.co/4g2yZDke1L https://t.co/2vi2H84RPL

RT @FDASpox: Earlier today, @SGottliebFDA spoke to @foodanddruglaw’s annual Enforcement, Litigation, and Compliance Conference.… https://t.co/JPJLXX1jle

Consumers who have this Kotex tampon product should stop using immediately and contact company. No other Kotex tampons are subject to this recall. #FDA remains committed to ensuring women have access to safe, effective and innovative devices. https://t.co/2VsaXVTSlv

@AlecGaffney We’ve committed to modernizing the purple book, including adding more information on exclusivities and making the information more accessible. Stay tuned. There’s a lot more we plan to do in 2019 to make this information resource a more practical tool to promote competition.

The #FDA is working with the company to uncover the reasons for this device malfunction and will take appropriate steps to protect consumers from further issues with Kotex tampons and provide updates. Women are urged by the FDA to stop using this product. https://t.co/IPcZJ0LFzW

RT @SGottliebFDA: ALERT: FDA wants women to be aware of voluntary recall: U by Kotex Sleek Tampons, Regular Absorbency; product may u… https://t.co/rv2rcbIgPN

RT @RAPSorg: Biomarker Qualification: @US_FDA Drafts Guidance | #Regulatory Focus https://t.co/9tHT6yhTgj #FDA #guidance #biomarkers

RT @SecAzar: Proud to learn the Partnership for Public Service has recognized @HHSGov as the #2 best large agency to work for in… https://t.co/c7RBdGXLMu

RT @FDASpox: ICYMI – DOJ news release on the NECC case. FDA continues to work to ensure that drugs are made under high quality c… https://t.co/39urCr6Pv0

RT @MedResJourno: .@_jacquie_lee is interviewing @SGottliebFDA for an upcoming @blaw interview. #FDA #drugs #pharms https://t.co/doWo9c3FHF

RT @FDAMedia: FDA takes new steps to advance risk-based regulation of digital health tools. https://t.co/K3QpP34Qeq

Today #FDA issued a final rule to amend our regulations on medical device classification procedures, codifying the change of procedure of using administrative orders, rather than rulemaking, to reclassify medical devices. https://t.co/aVw2maxbKy

This change has made our processes more efficient, and the new rule will provide increased clarity and predictability for device manufacturers, which ultimately will result in patients having more timely access to safe and effective medical devices.

ROMAINE INVESTIGATION UPDATE: #FDA and @CDCgov have identified one source for the E. coli romaine outbreak as the reservoir used by Adams Bros. Farms in CA. However, romaine lettuce from other farms could be affected. We will continue to investigate: https://t.co/mfyTq31bRM https://t.co/NN5mJJUkQ3

REVISED CONSUMER ADVICE: With new info, #FDA can revise our recommendations on romaine lettuce. No need to avoid lettuce from San Luis Obispo, Santa Cruz & Ventura Counties harvested after 11/23. If you can’t confirm your romaine is from an unaffected source, discard immediately https://t.co/TKTFrkyrRh

The farm identified is cooperating and hasn’t shipped any romaine since 11/20. They will recall all products that may have been affected and we are working with them on corrective actions before their next growing season. To date, 59 people have become sick in 15 states.

RT @HHSGov: You don't have to wait for new years to #QuitSmoking. Sign up for @SmokefreeUs' daily text message program to get t… https://t.co/OzVKGrO4iU

RT @SecAzar: Wanted to share some of my conversation from #Axios360 yesterday about the work we’re doing to address the opioid e… https://t.co/yzDhu0o7yr

RT @FDAfood: ⚠️#OUTBREAK UPDATE: Further information from the FDA in the investigation into outbreak of E. coli O157:H7 infectio… https://t.co/JQXc5mcH8q

RT @FrankYiannasFDA: New findings & updated consumer advice on E. coli O157:H7 outbreak linked to romaine lettuce. We’ll continue to use… https://t.co/fbeDitLkXo

RT @SenAlexander: Vaccines take deadly, awful, ravaging diseases from horror to history. Vaccines save lives. https://t.co/kewCNQTslM

RT @SGottliebFDA: ROMAINE INVESTIGATION UPDATE: #FDA and @CDCgov have identified one source for the E. coli romaine outbreak as the r… https://t.co/Kks8vmPi1J

Working quickly with #CDC and state partners allowed us to efficiently find one source of the outbreak. Romaine lettuce will now be labeled on store shelves with the date and harvest origin, making it easier for us to give targeted info regarding future outbreaks.

FDA continues to focus on approving high-quality, lower cost, safe & effective generics - In Nov. FDA approved & tentatively approved 128 generic drugs - with 13 first generics for brands that lacked competition & 20 complex generics https://t.co/PTxhJIE5Zw

The NECC case is a tragic reminder of why compounding and compounded drugs can present serious risks. #FDA has taken significant steps to ensure the quality of compounded drugs and improve patient safety in order to prevent another calamity like this https://t.co/I2x0SGwYPQ

We do not want to see another tragedy like the one we saw in 2012. FDA will continue taking steps to promote quality products for consumers who rely on compounded drugs https://t.co/I2x0SGwYPQ

Over the past 2 years #FDA has approved record numbers of generic drugs: Nov 2018 had the same number of approval actions as record-breaking Oct, which was highest ever in a single month - a total of 128. We’ll continue our efforts to increase competition https://t.co/PTxhJIE5Zw https://t.co/9ptGPi4Bf8

@BlumenthalG @pkluetz @tmprowell Couldn’t leaf it alone. I’m green with envy over the wit and charm!

RT @CDCDirector: Influenza activity will increase and is likely to peak during December-February. Protect yourself against the #flu… https://t.co/7Zr66vgiLJ

RT @SGottliebFDA: OMB Director Mick Mulvaney has been a principled partner to the #FDA and deeply public health minded in all of his engage… QT @MickMulvaneyOMB: This is a tremendous honor. I look forward to working with the President and the entire team. It’s going to be a gr… https://t.co/ee0Odre2Ma)

We’re also eager to work with Congress on a new framework that would give the FDA more ability to update old generic labels, an idea that was proposed by Senators Hatch and Bennet and advanced by others including @CancerResrch https://t.co/aivxZY4rZa

OMB Director Mick Mulvaney has been a principled partner to the #FDA and deeply public health minded in all of his engagements with us; and we are absolutely delighted to have the opportunity to work with Mr. Mulvaney in this important new role. QT @MickMulvaneyOMB: This is a tremendous honor. I look forward to working with the President and the entire team. It’s going to be a gr… https://t.co/ee0Odre2Ma)

RT @FDAOncology: #FDADISCO hosts Dr Abhi Nair & Dr Sanjeeve Bala talk about cancer drug approvals at https://t.co/bYTWyABy8q or on i… https://t.co/9EsaDRzJnv

Unlike small molecule drugs made from chemicals, biologics are generally large, complex molecules that may be derived, through biotechnology, from a living system such as a microorganism or a plant or animal cell. https://t.co/vp3Pw9lals

FDA Withdraws Proposed Rule That Would Have Exposed Generic-Drug Makers to Liability - WSJ https://t.co/SYSpHfvzC2

RT @SGottliebFDA: Our goal is to facilitate and streamline the patient experience with our expanded access program; to create concie… https://t.co/cksz0Q1IIq

Our goal is to facilitate and streamline the patient experience with our expanded access program; to create concierge-like service for providers and patients who are trying to get access drugs. We want to make the entire process more efficient and robust. https://t.co/IJwF1Mtw1p

Therapeutic biologics play a critical role in the treatment of many serious illnesses and are responsible for a significant percent of rising drug prices. Today’s #FDA #SundayTweetorial is about what FDA is doing to improve patient access to insulin and other essential medicines. https://t.co/XT4dydqBUb

About one out of every three new drugs approved by the FDA is a biologic but they accounted for 70 percent of the growth in drug spending from 2010 to 2015, according to a study conducted by the RAND Corp. https://t.co/Ipu4DAxjhB.

Competition drives prices lower. The 1984 Hatch Waxman Act created an abbreviated path to market for generic versions of drugs. Today, generics account for 90% of the scripts written, saving patients about $1 trillion over the past decade.

Examples include monoclonal antibodies (targeted therapies for cancer & other diseases), cytokines involved in immune response, growth factors that affect cell growth, and enzymes that speed up biochemical reactions https://t.co/Liah9AAoDx. https://t.co/xO1cKQGmRO

Until recently, biologics lacked this sort of competition. To market their product, sponsors submit a biologics license application (BLA) under the Public Health Service Act (PHSA). The PHSA had no abbreviated pathway to market for biologics prior to 2010 https://t.co/ruat5gnpOa.

To speed competition we issued a Biosimilars Action Plan in July to improve product development and approval process efficiency; increase scientific & reg. clarity; provide addt’l communications and outreach & address brand co. “gaming” of FDA requirements https://t.co/4g2yZDke1L https://t.co/EN8Qxa5PAr

The biosimilar pathway allows applicants that meet approval requirements to rely on FDA’s finding of safety, purity & potency for the biological reference product. As a result, it is generally less costly to develop a biosimilar https://t.co/lo67mXzpDJ.

The Biologics Price Competition & Innovation Act of 2009 (BPCIA) created an abbreviated pathway for biological products that are biosimilar or interchangeable to an FDA-approved reference product. https://t.co/Hvu3LgNYmF. https://t.co/nLMYZvGZnw

While the U.S. market for biosimilars is still maturing, FDA research suggests that after market entry, biosimilars have the potential to offer significant savings. This is especially true after 2 or more biosimilars are approved and on the market.

Since the BPCIA became law, we’ve approved 16 products including a record 8 in the last year https://t.co/8ymjFnVIFt and there are currently more than 60 biosimilar development programs underway. But only a fraction of the biosimilars approved by the FDA have launched. https://t.co/RvSAcDoG9r

Some biologics – including insulin - have historically been approved under the drug pathway. The BPCIA requires that these approved products will be deemed to be licensed under the PHSA on March 23, 2020. The guidances out last week describe how we plan to go about doing so. https://t.co/zzUMPK0hCw

Last week we announced additional steps including a draft Q&A regarding companies that use and sometimes abuse limited distribution systems to delay or derail an applicant’s access to reference product samples needed for testing to support an application https://t.co/lDCp8zTpBz.

And, in what I believe is a watershed moment for insulin products and for people with Type 1 diabetes, we issued two guidance documents outlining how we plan to transition insulin from a drug approval pathway to a biologics approval pathway. Let me explain. https://t.co/BGiDmOXvHR

To speed competition, we issued a Biosimilars Action Plan in July to improve product development & approval process efficiency; increase scientific & reg. clarity; provide addt’l communications & outreach & address brand co. “gaming” of FDA requirements. https://t.co/4g2yZDke1L https://t.co/2vi2H84RPL