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

On a day when we honor and remember the contributions of an inspirational leader; I want to also pause to celebrate the inspiration of the contributions made by federal workers who serve this nation and especially my colleagues at the FDA. #MartinLutherKing #HonoringGreatness https://t.co/Nr55Rpo8uA

THREAD: A key focus of #FDA is “First generics.” These are just what they sound like - an approval that permits a manufacturer to market a generic drug in the U.S. for the first time. First generics are important to public health, and FDA prioritizes review of these submissions. https://t.co/9lnTZzaPss

As the productivity of generic review process rose, we worked off a backlog of applications and increased the # of new generic approvals. Going forward, we're focusing on policies to lower barriers to generic entry to help make it more efficient for approved products get launched https://t.co/M7RCtSsm15

RT @MinorityHealth: This Dr. Martin Luther King, Jr. Day, we take the time to reflect on his achievements and devotion to being a leader through service to others. #MLKDay https://t.co/oyaNl3TtKi

RT @RAPSorg: .@US_FDA Fleshes Out Guidance on Susceptibility Breakpoints for Antimicrobial Drugs, Devices | #Regulatory Focus https://t.co/fML62P62ST #FDA #guidance

Among the many new policy steps that we’ve taken in recent years, we’re prioritizing generic approvals until there are four drugs in each drug category; because we know the big price breaks that promote patient access happen after the third generic drug enters the market. https://t.co/8RdRmhVGMw

We’ve increased the pace of biosimilar approvals, and in 2019 we'll unveil new policies to promote competition. Biosimilars represent an area of tremendous opportunity for advancing access. We must solve market impediments that prevent approved products from launching. https://t.co/rYx5p85Ag4

@JInterlandi Insulin has been historically regulated like a small molecule drug not a biologic, and making a full generic copy under the drug pathway was hard. We're moving insulins to our biologics pathway, where making "biosimilar" copies of insulin should be more straightforward, efficient

THREAD: We've received multiple inquiries about which critical food operations continue during the shutdown. Examples of the work that we're still doing include: 1) High-risk domestic food surveillance inspections; 2) foodborne illness surveillance and outbreak investigations;

RT @CNN: A person infected with measles attended a Portland Trail Blazers home game in Oregon last week amid an outbreak tha… https://t.co/PYDruLHoWj

3) Execution of high-risk food recalls; 4) Inspection of foreign food facilities; and 5) Sampling of imported food samples (including sampling for antibiotic residue contamination and decomposition analysis). These are among critical activities ongoing by dedicated, unpaid staff.

#FDA dedicated scientists are at work conducting sample analyses, to the extent permitted by law, during shutdown at Northeast Food and Feed Laboratory in NY. This regulatory field laboratory is responsible for performing lab analysis of regulated domestic and imported products https://t.co/y2ADa8wAgx

THREAD: We announced two more steps in efforts to modernize FDA’s 510(k) path for medical devices. https://t.co/lKy4axxpWa 510(k) devices coming to market should account for advances in technology that improve safety or performance or meet modern safety and performance criteria.

RT @mcipriano93: CDER Director Janet Woodcock champions platform trials at Expanded Access Summit. Says they would "profoundly" help to solve issues with EA.

Our final guidance issued today establishes an approach whereby manufacturers of certain devices may be able to demonstrate that their products meet objective safety and performance criteria that are based on modern technological principles.

THREAD: @US_FDA today issued a draft guidance for industry recommending international standards for nonclinical safety studies in the development of certain pediatric medicines in the U.S. Comment here. https://t.co/iXSAL0CSyb

The regulatory guidance promotes scientifically-based and harmonized technical requirements for pharmaceutical development under the International Council for Harmonization, @ICH_news. FDA is a founding member of ICH.

We’re also seeking comment on steps we could take to further encourage development of innovations that enhance the safety of 510(k) devices, including whether we should post a list of #FDA-cleared devices that demonstrated substantial equivalence to older predicate devices.

The guidance is intended to outline proper use of and design of animal toxicity studies, and potentially reduce the use of animals in research conducted in support of pediatric clinical trials.

We believe these steps would create more transparency about these technologies, with the goal of driving device manufacturers to offer patients devices with the latest improvements. We look forward to reviewing feedback on these approaches.

On a day when we honor and remember the contributions of an inspirational leader; I want to also pause to celebrate the inspiration of the contributions made by federal workers who serve this nation and especially my colleagues at the FDA. #MartinLutherKing #HonoringGreatness https://t.co/Nr55Rpo8uA

THREAD: A key focus of #FDA is “First generics.” These are just what they sound like - an approval that permits a manufacturer to market a generic drug in the U.S. for the first time. First generics are important to public health, and FDA prioritizes review of these submissions. https://t.co/9lnTZzaPss

As the productivity of generic review process rose, we worked off a backlog of applications and increased the # of new generic approvals. Going forward, we're focusing on policies to lower barriers to generic entry to help make it more efficient for approved products get launched https://t.co/M7RCtSsm15

RT @MinorityHealth: This Dr. Martin Luther King, Jr. Day, we take the time to reflect on his achievements and devotion to being a leader through service to others. #MLKDay https://t.co/oyaNl3TtKi

RT @RAPSorg: .@US_FDA Fleshes Out Guidance on Susceptibility Breakpoints for Antimicrobial Drugs, Devices | #Regulatory Focus https://t.co/fML62P62ST #FDA #guidance

Among the many new policy steps that we’ve taken in recent years, we’re prioritizing generic approvals until there are four drugs in each drug category; because we know the big price breaks that promote patient access happen after the third generic drug enters the market. https://t.co/8RdRmhVGMw

We’ve increased the pace of biosimilar approvals, and in 2019 we'll unveil new policies to promote competition. Biosimilars represent an area of tremendous opportunity for advancing access. We must solve market impediments that prevent approved products from launching. https://t.co/rYx5p85Ag4

@JInterlandi Insulin has been historically regulated like a small molecule drug not a biologic, and making a full generic copy under the drug pathway was hard. We're moving insulins to our biologics pathway, where making "biosimilar" copies of insulin should be more straightforward, efficient

THREAD: We've received multiple inquiries about which critical food operations continue during the shutdown. Examples of the work that we're still doing include: 1) High-risk domestic food surveillance inspections; 2) foodborne illness surveillance and outbreak investigations;

RT @CNN: A person infected with measles attended a Portland Trail Blazers home game in Oregon last week amid an outbreak tha… https://t.co/PYDruLHoWj

3) Execution of high-risk food recalls; 4) Inspection of foreign food facilities; and 5) Sampling of imported food samples (including sampling for antibiotic residue contamination and decomposition analysis). These are among critical activities ongoing by dedicated, unpaid staff.

#FDA dedicated scientists are at work conducting sample analyses, to the extent permitted by law, during shutdown at Northeast Food and Feed Laboratory in NY. This regulatory field laboratory is responsible for performing lab analysis of regulated domestic and imported products https://t.co/y2ADa8wAgx

THREAD: We announced two more steps in efforts to modernize FDA’s 510(k) path for medical devices. https://t.co/lKy4axxpWa 510(k) devices coming to market should account for advances in technology that improve safety or performance or meet modern safety and performance criteria.

RT @mcipriano93: CDER Director Janet Woodcock champions platform trials at Expanded Access Summit. Says they would "profoundly" help to solve issues with EA.

Our final guidance issued today establishes an approach whereby manufacturers of certain devices may be able to demonstrate that their products meet objective safety and performance criteria that are based on modern technological principles.

THREAD: @US_FDA today issued a draft guidance for industry recommending international standards for nonclinical safety studies in the development of certain pediatric medicines in the U.S. Comment here. https://t.co/iXSAL0CSyb

The regulatory guidance promotes scientifically-based and harmonized technical requirements for pharmaceutical development under the International Council for Harmonization, @ICH_news. FDA is a founding member of ICH.

We’re also seeking comment on steps we could take to further encourage development of innovations that enhance the safety of 510(k) devices, including whether we should post a list of #FDA-cleared devices that demonstrated substantial equivalence to older predicate devices.

The guidance is intended to outline proper use of and design of animal toxicity studies, and potentially reduce the use of animals in research conducted in support of pediatric clinical trials.

We believe these steps would create more transparency about these technologies, with the goal of driving device manufacturers to offer patients devices with the latest improvements. We look forward to reviewing feedback on these approaches.