Thread by @nabarund

🚨 Something huge happened today. 🚨

@US_FDA @DrCaliff_FDA listened to harm reduction programs and made it infinitely easier to purchase #naloxone in bulk. With 100,000+ overdose deaths each year, we need BIG solutions.

w/@RemedyAlliance @ejwheeler9 @coreysdavis
🧵 1/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis The FDA Guidance provides clear federal support for bulk purchase and distribution of naloxone to meet one of the biggest public health challenges of our times.

Full text via link below, but let's break it down.

https://twitter.com/FDA_Drug_Info/status/1572947464793083912?s=20&t=8PucNNbFN9Pf-qjBchCzrg

2/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis This is a watershed moment. Along with low-cost naloxone available through @RemedyAlliance and state standing orders, this Guidance establishes a trifecta of innovations that will help rapidly scale up naloxone distribution.
3/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis We would like to see the intent of this Guidance applied so State Boards of Pharmacy will stop standing in the way of naloxone scale-up. NO MORE EXCUSES.
(I'm looking at you Alabama.)
4/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis Look, we have a 90-10 problem. Nearly everyone in large institutions & local govt are in favor, but compliance officers and lawyers prevent naloxone distro at the last step, citing FDA regs. This negates their reticence. NO MORE EXCUSES.
5/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis Another issue is multi-state orgs stymied in mailing naloxone across state lines by toady uninformed sticklers. @coreysdavis makes it clear this is permissible, and today's Guidance makes more allowance for "harm reduction suppliers." NO MORE EXCUSES.
networkforphl.org/news-insights/…
6/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis We feel the Guidance is consistent with "harm reduction suppliers" now being able to rapidly collect and re-distribute unused near-expiry naloxone from cops and libraries. It creates new efficiencies within the free market. NO MORE EXCUSES.
7/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis Guidance will make it easier for Counties to fund naloxone distro using opioid settlements. And give health departments access to much cheaper naloxone from @pfizer @hikmapharma via @RemedyAlliance. But only orgs who actually reach pop most in need.
8/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma Let's put it in context. Naloxone was liberated by Dan Bigg @ChiRecoveryAlli in 1996. In 2007, MA had first standing order. But, standing orders are inconsistent, amplifying inequities. Score! This Guidance address gaps in procurement not addressed by standing orders.
9/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli Y'all, this Guidance is HUGE because it prevents us having to fix every state standing order that doesn't explicitly allow naloxone procurement! (All but one.) We just saved *years* of advocacy. Now we can get on with scaling up. Use it to advocate locally, creatively.
10/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli How did we get here? Last October, @RemedyAlliance gathered stories from harm reduction programs across the country to document barriers to naloxone access.
cdr.lib.unc.edu/concern/schola…
11/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli In March 2022, harm reduction programs directly told federal officials via @reaganudall why it was difficult to purchase naloxone in bulk. Heart wrenching stories in last hour of this public meeting:
reaganudall.org/news-and-event…
12/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli @reaganudall In April we found a previously unrecognized exemption in federal law and asked FDA to make it clear that we can use this to build a new model for naloxone distribution that removes many of the barriers created by naloxone’s prescription-only status.

cdr.lib.unc.edu/concern/schola…
13/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli @reaganudall The @AmerMedicalAssn called for removing prescription barriers to naloxone distribution, and they chimed in today... the largest group of doctors in the country are telling you to take this Guidance and use it to save lives! NO MORE EXCUSES.
ama-assn.org/press-center/p…
14/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli @reaganudall @AmerMedicalAssn “Throughout the drug overdose epidemic, harm reduction orgs have been at the front lines, offering care and hope. These orgs accomplished amazing work despite shoestring budgets & bureaucratic challenges. @AmerMedicalAssn is grateful FDA recognizes importance of that work."
15/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli @reaganudall @AmerMedicalAssn "The guidance announced today offers regulatory clarity for harm reduction organizations to purchase naloxone so more will be distributed in communities." This is the bottom line.
ama-assn.org/press-center/p…
16/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli @reaganudall @AmerMedicalAssn Amazingly, @iamjohnoliver even contributed to today's major national policy change, calling on FDA to take action! We know who our friends are.

https://twitter.com/iamjohnoliver/status/1508475039431151620?s=20&t=wJ96upp980tvjIa3TsAMyg

17/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli @reaganudall @AmerMedicalAssn @iamjohnoliver And in July @SenatorHassan @RandPaul asked @DrCaliff_FDA to endorse the Remedy Alliance model for expanded naloxone access. Bipartisan support. This issue effects us all.
hassan.senate.gov/news/press-rel…
18/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli @reaganudall @AmerMedicalAssn @iamjohnoliver @SenatorHassan @RandPaul Amazing lifesaving orgs like @NEXTDistro, NASEN, POD, @SmokeWorksBos, and others can use this Guidance. Can you use the intentionally broad definition of "HR supplier" to make nlx vending machines a reality in your community? That is the clear intent.
19/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli @reaganudall @AmerMedicalAssn @iamjohnoliver @SenatorHassan @RandPaul @NEXTDistro @SmokeWorksBos Unfunded programs in hostile environments? We got you! @RemedyAlliance will send you as much naloxone as you can distribute, and with this new Guidance it's totally legit. WOW. This is Dan Bigg's legacy writ large.
20/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli @reaganudall @AmerMedicalAssn @iamjohnoliver @SenatorHassan @RandPaul @NEXTDistro @SmokeWorksBos We will use this Guidance to purchase & provide bulk naloxone. We can finally, realistically, work on saturation. The affordable naloxone shortage was really hard on many of us, but now we can work to transition from scarcity mentality to an expectation of abundance.
21/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli @reaganudall @AmerMedicalAssn @iamjohnoliver @SenatorHassan @RandPaul @NEXTDistro @SmokeWorksBos To turn the tide on overdose deaths, we need long-term solutions and structural changes. To keep people alive until then, we need immediate fixes like massive naloxone distribution, that save lives right now. Thanks to @OpenSociety for steadfast support.
22/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli @reaganudall @AmerMedicalAssn @iamjohnoliver @SenatorHassan @RandPaul @NEXTDistro @SmokeWorksBos @OpenSociety With this Guidance FDA demonstrated a committed to identifying and removing federal barriers to naloxone distro. However, there are still state-level barriers, especially for harm reduction programs. States should quickly remove these barriers to the lifesaving antidote.
23/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli @reaganudall @AmerMedicalAssn @iamjohnoliver @SenatorHassan @RandPaul @NEXTDistro @SmokeWorksBos @OpenSociety This is a huge step. This is what our community asked for, showed the need, and we got. Thanks to the many federal officials who worked behind the scenes to make it real. 💕 And if you're feeling generous, drop [e-mail] a note of thanks. This is important.
24/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli @reaganudall @AmerMedicalAssn @iamjohnoliver @SenatorHassan @RandPaul @NEXTDistro @SmokeWorksBos @OpenSociety And finally, huge fucking props from the bottom of our hearts to all the front line workers out there every day and night, helping take care of our neighbors, and helping them stay in our lives another day longer. Y'all are everything.
25/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli @reaganudall @AmerMedicalAssn @iamjohnoliver @SenatorHassan @RandPaul @NEXTDistro @SmokeWorksBos @OpenSociety More backstory here:

washingtonpost.com/health/2022/08…

filtermag.org/naloxone-short…

theguardian.com/us-news/2021/o…

26/26

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli @reaganudall @AmerMedicalAssn @iamjohnoliver @SenatorHassan @RandPaul @NEXTDistro @SmokeWorksBos @OpenSociety If you found this thread useful, please:

1. Follow me (@nabarund) for more

2. Retweet the 1st tweet below to share this thread

3. Follow @RemedyAlliance for low-cost naloxone for #harmreduction programs and health departments

https://twitter.com/nabarund/status/1573151754266415104

@US_FDA @DrCaliff_FDA @RemedyAlliance @ejwheeler9 @coreysdavis @pfizer @hikmapharma @ChiRecoveryAlli @reaganudall @AmerMedicalAssn @iamjohnoliver @SenatorHassan @RandPaul @NEXTDistro @SmokeWorksBos @OpenSociety @threadreaderapp unroll

Adding to this thread with updates. Here’s @US_FDA official notice

https://twitter.com/us_fda/status/1573303529108049927

Thank you 🙏🏽 @DrCaliff_FDA for listening to the public’s needs and tailoring specific solutions to address our sometimes arcane issues. This Guidance will help immensely and immediately.

https://twitter.com/DrCaliff_FDA/status/1573351505423630336

Acknowledging Dr. Marta Sokolowska for her sincere compassion and leadership. We appreciate you deeply! 💕

https://twitter.com/nabarund/status/1573401182642601992

Here’s the @ONDCP @WhiteHouse announcing the naloxone Guidance last night, along with other massive funding for helping people get treatment they choose to.

whitehouse.gov/briefing-room/…

And shoutout to @deray for being our very first champion on this exactly 1 year ago. Lots of behind the scenes help and strategizing early on. 🙏

https://twitter.com/deray/status/1438869824306925570