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

RT @FDASpox: Also announced by @SGottliebFDA today, #FDA will be evaluating a new framework for opioid approvals in the context… https://t.co/jxnyRSeC6c

We’re grateful to the men and women who defend our nation, often at great personal risk and sacrifice. It’s our honor and duty at #FDA to support our military personnel by ensuring they have access to safe, effective medical products. https://t.co/D8wBobXB2P https://t.co/xcT3Klo1ia

RT @FDAOncology: Two new FDA draft guidances: use of adaptive designs and master protocols https://t.co/6QIEUGmmen https://t.co/tpQyLXEkjG

We treat opioids unique from other drug classes; for example, weighing risks from misuse as part of decisions. We’re now examining how we’d evaluate overall population effects of new opioids as part of a new comparative condition of approval. My statement: https://t.co/NICWpF4Uri https://t.co/kwBecTEMGn

RT @SGottliebFDA: #FDA is evaluating a new framework for opioid approvals to define how we’ll consider benefit and risk of these prod… https://t.co/ABgO9M8z3Z

RT @SGottliebFDA: We treat opioids unique from other drug classes; for example, weighing risks from misuse as part of decisions. We’r… https://t.co/DA1DgIe5FC

Among other things, #FDA is developing science on how to use NRT to address teen addiction to nicotine in view of the tragic epidemic of nicotine use among kids who are becoming regular users of e-cigarettes. We will advance broader policies this month to combat these trends. QT @AP_FDAwriter: FDA to meet early next month on "growing epidemic" of teen vaping. Public meeting set for Dec. 5 at FDA's White Oak… https://t.co/ktc1ORCJgk)

RT @SGottliebFDA: My statement: We’re considering how we should evaluate each new opioid approval not just as an independent review d… https://t.co/qBbKtDm6Ad

The #FDA has committed to prioritizing medical products that are high needs of our military to help the warfighter and to address medical challenges on the battlefield. On Friday, we signed an MOU with the @DeptofDefense to advance these efforts: https://t.co/MbbUBY78LO https://t.co/PrFcKhXAkn

One of the ongoing issues of the opioid epidemic has been this: Whether new opioid approvals pile on to the problem, raising the risk of illicit diversion and abuse, or not. Are new drugs even needed? That’s a critical issue I want to address in today’s #FDA #SundayTweetorial https://t.co/5jZOnwMH5x

RT @SGottliebFDA: #FDA is evaluating a new framework for opioid drug approvals. Specifically, how we consider the benefits and risks… https://t.co/nRIMJTI0fS

It’s long been argued that adding a new opioid to the armamentarium of options for treating pain has little or no effect on the size of the market, i.e., the number of potential patients. It just cuts back on everyone else’s share of the market.

And yet, there may be reason to believe that this common understanding of market forces underestimates the insidious nature of opioid abuse and diversion, an argument I raise in a statement I released last Friday https://t.co/HuJxpRrM2r. https://t.co/6ooQi7DCbb

We’ve begun implementing the SUPPORT Act. Also, we’ve been taking a different approach to the benefit and risk evaluation of these potent pain relievers; such as requesting the withdrawal of reformulated Opana ER, and seeking adcom input for new opioids. https://t.co/MvlrohoI5W https://t.co/XDKqhrGmaT

Congress asked us to think differently about these drugs, giving us new authority to require certain post-market studies to evaluate efficacy; consider risks of misuse and abuse in reg. decisions; require unit-dose packaging; and require safe-disposal packaging for some opioids. https://t.co/LY6HsjDOwg

1) How does the availability of an additional opioid drug benefit the public health through its ability to provide therapeutic differentiation, promote more appropriate access or advance safer use of these medicines? https://t.co/XHxvNpWcKK

Now I’m going further, asking my professional staff to evaluate a new framework for opioid approvals that considers both the individual AND public health impacts of each new application. Questions that I want them to raise include:

We generally consider each new drug approval, including each new opioid, largely on its own merits, asking whether the drug meets standards for safety and effectiveness and whether additional controls are needed to ensure safe use. But opioids are a unique class of medicines.

Adopting this new framework would require us to be more specific in guidance about benefits/risks and what we perceive as unmet medical needs so innovators won’t spin their wheels. We will be clear on what the opportunities for developing new, better drugs that meet our standards https://t.co/1313IZu0eU

2) Does the approval of an additional opioid drug create added risks for diversion, accidental overdose, abuse and misuse or other concerns? https://t.co/7GvR57J8cP

RT @FDASpox: Also announced by @SGottliebFDA today, #FDA will be evaluating a new framework for opioid approvals in the context… https://t.co/jxnyRSeC6c

We’re grateful to the men and women who defend our nation, often at great personal risk and sacrifice. It’s our honor and duty at #FDA to support our military personnel by ensuring they have access to safe, effective medical products. https://t.co/D8wBobXB2P https://t.co/xcT3Klo1ia

RT @FDAOncology: Two new FDA draft guidances: use of adaptive designs and master protocols https://t.co/6QIEUGmmen https://t.co/tpQyLXEkjG

We treat opioids unique from other drug classes; for example, weighing risks from misuse as part of decisions. We’re now examining how we’d evaluate overall population effects of new opioids as part of a new comparative condition of approval. My statement: https://t.co/NICWpF4Uri https://t.co/kwBecTEMGn

RT @SGottliebFDA: #FDA is evaluating a new framework for opioid approvals to define how we’ll consider benefit and risk of these prod… https://t.co/ABgO9M8z3Z

RT @SGottliebFDA: We treat opioids unique from other drug classes; for example, weighing risks from misuse as part of decisions. We’r… https://t.co/DA1DgIe5FC

Among other things, #FDA is developing science on how to use NRT to address teen addiction to nicotine in view of the tragic epidemic of nicotine use among kids who are becoming regular users of e-cigarettes. We will advance broader policies this month to combat these trends. QT @AP_FDAwriter: FDA to meet early next month on "growing epidemic" of teen vaping. Public meeting set for Dec. 5 at FDA's White Oak… https://t.co/ktc1ORCJgk)

RT @SGottliebFDA: My statement: We’re considering how we should evaluate each new opioid approval not just as an independent review d… https://t.co/qBbKtDm6Ad

The #FDA has committed to prioritizing medical products that are high needs of our military to help the warfighter and to address medical challenges on the battlefield. On Friday, we signed an MOU with the @DeptofDefense to advance these efforts: https://t.co/MbbUBY78LO https://t.co/PrFcKhXAkn

One of the ongoing issues of the opioid epidemic has been this: Whether new opioid approvals pile on to the problem, raising the risk of illicit diversion and abuse, or not. Are new drugs even needed? That’s a critical issue I want to address in today’s #FDA #SundayTweetorial https://t.co/5jZOnwMH5x

RT @SGottliebFDA: #FDA is evaluating a new framework for opioid drug approvals. Specifically, how we consider the benefits and risks… https://t.co/nRIMJTI0fS

It’s long been argued that adding a new opioid to the armamentarium of options for treating pain has little or no effect on the size of the market, i.e., the number of potential patients. It just cuts back on everyone else’s share of the market.

And yet, there may be reason to believe that this common understanding of market forces underestimates the insidious nature of opioid abuse and diversion, an argument I raise in a statement I released last Friday https://t.co/HuJxpRrM2r. https://t.co/6ooQi7DCbb

We’ve begun implementing the SUPPORT Act. Also, we’ve been taking a different approach to the benefit and risk evaluation of these potent pain relievers; such as requesting the withdrawal of reformulated Opana ER, and seeking adcom input for new opioids. https://t.co/MvlrohoI5W https://t.co/XDKqhrGmaT

Congress asked us to think differently about these drugs, giving us new authority to require certain post-market studies to evaluate efficacy; consider risks of misuse and abuse in reg. decisions; require unit-dose packaging; and require safe-disposal packaging for some opioids. https://t.co/LY6HsjDOwg

1) How does the availability of an additional opioid drug benefit the public health through its ability to provide therapeutic differentiation, promote more appropriate access or advance safer use of these medicines? https://t.co/XHxvNpWcKK

Now I’m going further, asking my professional staff to evaluate a new framework for opioid approvals that considers both the individual AND public health impacts of each new application. Questions that I want them to raise include:

We generally consider each new drug approval, including each new opioid, largely on its own merits, asking whether the drug meets standards for safety and effectiveness and whether additional controls are needed to ensure safe use. But opioids are a unique class of medicines.

Adopting this new framework would require us to be more specific in guidance about benefits/risks and what we perceive as unmet medical needs so innovators won’t spin their wheels. We will be clear on what the opportunities for developing new, better drugs that meet our standards https://t.co/1313IZu0eU

2) Does the approval of an additional opioid drug create added risks for diversion, accidental overdose, abuse and misuse or other concerns? https://t.co/7GvR57J8cP