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

The new law provides for facility, equipment, laboratory, security, & technology improvements in the IMFs to increase & improve detection & capacity. It also allows FDA to more easily detain, refuse & destroy illegal and dangerous drugs, including opioids. https://t.co/Fu4BRDn7UK

We can also require that some opioids be put in unit-dose blister packs or other special packaging to encourage prescribers to write RX scripts of shorter duration, which may help lower new addiction rates & leave fewer leftover pills for abuse by others https://t.co/4IeCLwmDMR. https://t.co/rC7wLhqLNu

SUPPORT includes one other measure to prevent any unused opioids from being abused by children and others in the household. It allows FDA to require that opioids be dispensed with a mail-back pouch or other safe disposal option.

FDA recently gave a grant to the National Academies of Sciences, Engineering and Medicine to help advance evidence-based prescribing guidelines on acute pain. NASEM will examine existing guidelines looking for gaps in evidence and suggest new research https://t.co/r0c0weJ2Ex. https://t.co/psT6Ef7KEg

Finally, SUPPORT clarifies FDA’s authority to require post-market studies on the efficacy of prescription drugs under some circumstances, including using opioids to treat chronic pain. More research is needed to understand their long-term efficacy & impact on addiction.

Development of evidence-based opioid prescribing guidelines for treating acute pain also gets a boost in the new law. Such guidelines would advance rationalized prescribing and help reduce the rate of over-prescribing opioids, an approach FDA is already pursuing.

While not an FDA provision, we’re heartened the law encourages > use of medication-assisted treatment (MAT) + behavioral counseling for opioid-abuse disorder (OUD), substance abuse marked by loss of control, risky use, social problems & need for > amounts of drug. https://t.co/gqIHgCOVaL

Other good news last week: FDA announced an advisory committee meeting for Dec. on barriers to accessing naloxone, the life-saving medication that can reverse the effects of an opioid overdose, usually within minutes, if quickly administered https://t.co/rP2BxoiTyM.

There are 3 types of FDA-approved drugs for MAT - buprenorphine, methadone and naltrexone. These products stabilize brain chemistry; reduce or block the euphoric effects of opioids; relieve physiological cravings; & normalize body functions https://t.co/BtsIMpVLvw. https://t.co/or7frwiHTj

However, only about 20% of persons with OUD currently receive any kind of treatment, according to the Substance Abuse and Mental Health Services Administration. The new law increases the number of health care providers that can prescribe or dispense MATs. https://t.co/RtNpvGjDym

We’ve been working hard to improve naloxone availability, w/ FDA-approved naloxone in injectable form for healthcare settings & auto-injector & intranasal forms for lay use; & a product-specific guidance to aid in the development of a generic naloxone nasal spray. https://t.co/BlPwLBSgf6

FDA is committed to using our regulatory authority to change the opioid crisis trajectory. We’re grateful for the SUPPORT ACT and will soon create a plan to implement the law’s important new tools that will help us better protect the health and safety of Americans. https://t.co/D8C5KV1nPk

#FDA issued draft guidance today on development of dried plasma products – building upon recent steps we’ve taken, through work with @DeptofDefense, to advance development and availability of medical products to help save lives of American soldiers. https://t.co/I1B4G2E2TM

Over-the-counter naloxone could help make this medicine more widely available but requires a consumer-friendly Drug Facts Label (DFL) https://t.co/IFWSxhHC1n. We’re laying the groundwork by creating a model DFL. The results of our label comprehension testing will be out soon.

At the upcoming adcom, we’ll discuss the OTC product, what government and nongovernmental groups are doing to improve naloxone access & whether naloxone should be co-prescribed with all or some opioid prescriptions to help reduce the risk of an overdose.

RT @SGottliebFDA: Last week saw concrete action to combat the devastating crisis of opioid addiction plaguing our nation. In today’s… https://t.co/sU5gpfdCK6

RT @paspears88: Good summary slides @tmprowell after a long, interesting workshop on #OptimizeEarlyBC #bcsm @FDAOncology https://t.co/CPySV6A8HT

RT @HHSGov: Up to 80% of strokes are preventable—and that starts with small changes over time. Learn how you can start today fr… https://t.co/xdDuvOQH8O

We hope by developing guidelines, to expedite the development and approval of safe and effective dried plasma products which can be reconstituted and administered quickly - even in remote areas, including places where our military may be deployed. https://t.co/I1B4G2E2TM

RT @FDASpox: Curious about the science behind genome editing in animals? As part of our Action Plan issued today, #FDA is hostin… https://t.co/LcpESK25mh

The new law provides for facility, equipment, laboratory, security, & technology improvements in the IMFs to increase & improve detection & capacity. It also allows FDA to more easily detain, refuse & destroy illegal and dangerous drugs, including opioids. https://t.co/Fu4BRDn7UK

We can also require that some opioids be put in unit-dose blister packs or other special packaging to encourage prescribers to write RX scripts of shorter duration, which may help lower new addiction rates & leave fewer leftover pills for abuse by others https://t.co/4IeCLwmDMR. https://t.co/rC7wLhqLNu

SUPPORT includes one other measure to prevent any unused opioids from being abused by children and others in the household. It allows FDA to require that opioids be dispensed with a mail-back pouch or other safe disposal option.

FDA recently gave a grant to the National Academies of Sciences, Engineering and Medicine to help advance evidence-based prescribing guidelines on acute pain. NASEM will examine existing guidelines looking for gaps in evidence and suggest new research https://t.co/r0c0weJ2Ex. https://t.co/psT6Ef7KEg

Finally, SUPPORT clarifies FDA’s authority to require post-market studies on the efficacy of prescription drugs under some circumstances, including using opioids to treat chronic pain. More research is needed to understand their long-term efficacy & impact on addiction.

Development of evidence-based opioid prescribing guidelines for treating acute pain also gets a boost in the new law. Such guidelines would advance rationalized prescribing and help reduce the rate of over-prescribing opioids, an approach FDA is already pursuing.

While not an FDA provision, we’re heartened the law encourages > use of medication-assisted treatment (MAT) + behavioral counseling for opioid-abuse disorder (OUD), substance abuse marked by loss of control, risky use, social problems & need for > amounts of drug. https://t.co/gqIHgCOVaL

Other good news last week: FDA announced an advisory committee meeting for Dec. on barriers to accessing naloxone, the life-saving medication that can reverse the effects of an opioid overdose, usually within minutes, if quickly administered https://t.co/rP2BxoiTyM.

There are 3 types of FDA-approved drugs for MAT - buprenorphine, methadone and naltrexone. These products stabilize brain chemistry; reduce or block the euphoric effects of opioids; relieve physiological cravings; & normalize body functions https://t.co/BtsIMpVLvw. https://t.co/or7frwiHTj

However, only about 20% of persons with OUD currently receive any kind of treatment, according to the Substance Abuse and Mental Health Services Administration. The new law increases the number of health care providers that can prescribe or dispense MATs. https://t.co/RtNpvGjDym

We’ve been working hard to improve naloxone availability, w/ FDA-approved naloxone in injectable form for healthcare settings & auto-injector & intranasal forms for lay use; & a product-specific guidance to aid in the development of a generic naloxone nasal spray. https://t.co/BlPwLBSgf6

FDA is committed to using our regulatory authority to change the opioid crisis trajectory. We’re grateful for the SUPPORT ACT and will soon create a plan to implement the law’s important new tools that will help us better protect the health and safety of Americans. https://t.co/D8C5KV1nPk

#FDA issued draft guidance today on development of dried plasma products – building upon recent steps we’ve taken, through work with @DeptofDefense, to advance development and availability of medical products to help save lives of American soldiers. https://t.co/I1B4G2E2TM

Over-the-counter naloxone could help make this medicine more widely available but requires a consumer-friendly Drug Facts Label (DFL) https://t.co/IFWSxhHC1n. We’re laying the groundwork by creating a model DFL. The results of our label comprehension testing will be out soon.

At the upcoming adcom, we’ll discuss the OTC product, what government and nongovernmental groups are doing to improve naloxone access & whether naloxone should be co-prescribed with all or some opioid prescriptions to help reduce the risk of an overdose.

RT @SGottliebFDA: Last week saw concrete action to combat the devastating crisis of opioid addiction plaguing our nation. In today’s… https://t.co/sU5gpfdCK6

RT @paspears88: Good summary slides @tmprowell after a long, interesting workshop on #OptimizeEarlyBC #bcsm @FDAOncology https://t.co/CPySV6A8HT

RT @HHSGov: Up to 80% of strokes are preventable—and that starts with small changes over time. Learn how you can start today fr… https://t.co/xdDuvOQH8O

We hope by developing guidelines, to expedite the development and approval of safe and effective dried plasma products which can be reconstituted and administered quickly - even in remote areas, including places where our military may be deployed. https://t.co/I1B4G2E2TM

RT @FDASpox: Curious about the science behind genome editing in animals? As part of our Action Plan issued today, #FDA is hostin… https://t.co/LcpESK25mh