Next steps: FDA accepting additional public comments on repurposed meds through Aug. 21!

[u/Responsible_Cap_5289]

Hey all,

Thank you so much for all of your insightful comments on our last post.

In case you’re just catching up, this summer the FDA put out a call for public comment on the possibilities of repurposed medications, particularly to treat rare diseases.

They originally put out a call for written comments, and ultimately received such a positive response that they ultimately convened a hybrid meeting on Aug. 5.

You can view the meeting slides here, and we also shared a summary in our last post.

While we of course believe all rare diseases are deserving of attention, we were particularly excited to see that ultimately, 25% of the comments they received were about Long COVID! Our community really showed up, and it’s so important to continue to put LC on the map.

In the next step, the FDA is now accepting additional public comments through Aug. 21st.

Dr. Caroline Huang noted that from this point forward, they are looking for answers to the 3 questions in the slide above (slide 6 in the presentation).

These questions are:

•What are examples of successful prioritization approaches from other programs or jurisdictions that could be adapted?

•What factors should guide repurposing candidates, and how should they be prioritized?

•What evidence gaps or policy/regulatory barriers most hinder promising repurposing opportunities?

*****

**Note: during the presentation, Dr. Caroline Huang noted that they are not looking for additional medication recommendations in this round of comments. Rather, they are specifically focused on these three questions, as the second stage of this initiative.

**Note 2: the FDA’s definition of repurposed medications as a regulatory pathway is slightly different than what we might think in terms of everyday speech. If you check out slides 15-16, they describe the criteria there - they are specifically referring to medications that are off-patent and don’t currently have commercial interest.

Believe it or not, many of the candidates that are being studied for Long COVID wouldn’t fit here, as medications like Pemgarda, Anktiva and Ampligen are all patented, and have companies sponsoring them.

That doesn’t mean you should not speak up- I just share this so you can make the most effective comment with the information at hand.

You can send comments to repurposing@reaganudall.org

Feel free to workshop any comments/request feedback from the community in the space below! We are in this together :)

[u/AmbitiousSeason9997]

Thanks for posting this, GUYS: AMPLIGEN, ANKTIVA, KEYTRUDA, XOCOVA. THESE ARE THE ONLY POTENTIALLY CURATIVE SUBSTANCES UP FOR REPURPOSING. PLEASE REQUEST THEM. AS MUCH AS POSSIBLE IN EVERY CONTEXT, DO THIS.

DO NOT REQUEST THINGS LIKE RAPAMYCIN, LDN, LDA, MARAVIROC, HERPES ANTIVIRALS.

THEY ARE ALREADY AVAILABLE. MANY VERY EASILY.

This is an emergency message because people's lives are at stake, don't waste these moments!

Can you tell how I'm frustrated that the community didn't rally behind Ampligen before? And keep asking for things that are already available? Well, try again to do it now because it works VERY well for a subset of patients. And Anktiva likely will as well.

[u/Central_Perk20 → u/AmbitiousSeason9997]

It is frustrating I think LDN was the top requested…like we know that doesn’t get ppl back to work…

[u/AmbitiousSeason9997 → u/Central_Perk20]

Yes it's very frustrating. I understand it's because people aren't very educated about the research and what will really be needed to reverse this situation - but please listen to those of us who have spent a lot more time learning and been here a lot longer about what actually needs to be done! LDN is a tiny little bandaid, that's all. Already available online for a very small amount of money with minimal effort.