Priorities for a New FDA | Martin Makary, Vinay Prasad (Jun 2025) Article 

Michael Harrop

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https://jamanetwork.com/journals/jama/fullarticle/2835314

Why does it take more than 10 years for a new drug to come to market? Why are childhood chronic diseases so prevalent? And how can regulators adapt to meet the challenges facing clinicians today? These questions are at the forefront for the US Food and Drug Administration (FDA).

At the FDA, we will examine the role of ultraprocessed foods, food additives, and environmental toxins

We will rapidly usher to market new products with transformational potential.

To reinvigorate innovation, we must become a user-friendly FDA that partners with industry rather than takes a receive-only posture. At the same time, the FDA will guard against a cozy relationship that has characterized the agency in the past and led to allegations of industry capture.

Subsections:
  • Unleashing AI
  • Healthier Food for Children
  • Harnessing Big Data
  • Financial Toxicity
In summary, the FDA will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children, and common-sense approaches to rebuild the public trust.

Sounds like more useless, distracting BS, and that they have no plans to do anything about FMT.
 
Format correct?
  1. Yes
I cant imagine any world where the FDA has FMTs as any kind of priority. It's an incredibly niche topic and there's maybe a couple hundred people who care about legal clarity re: FMT marketplaces.

Personally I think the only way FMT will breach public discourse is if there are famous people who have positiive eperiences with it and decide to champion the cause.

The situation is a bit of a paradox -- can't onboard the necessary people because of legal obstacles, can't pass the legal obstacles without onboarding necessary people...
 
I disagree that FMT is niche and inconceivable as an FDA priority.

This new administration is supposed to be solving the chronic disease crisis. FMT is one of the primary tools to do so. Dr. Martin Makary is well-informed on it: https://forum.humanmicrobiome.info/threads/incoming-trump-admin-with-rfk-signals-new-start-for-fda.706/post-2483

RFK appears to be well-informed on it as well: https://forum.humanmicrobiome.info/threads/incoming-trump-admin-with-rfk-signals-new-start-for-fda.706/post-2927, and a Senator I talked to directly sent him the info.

Dr. Vinay Prasad, head of the FDA biologics division, seems like the kind of person who would do something about FMT (Bernie Sanders supporter, critical of the pharma industry): https://forum.humanmicrobiome.info/threads/top-fda-official-resigns-under-pressure-jul-2025-after-turning-down-se.1133/

The #2 guy at HHS also seems like an ideal person to act on FMT: https://forum.humanmicrobiome.info/threads/incoming-trump-admin-with-rfk-signals-new-start-for-fda.706/post-2719. Yet they have not.

I've spoken to Dr. Bhattacharya a number of times, and he doesn't appear to want to do anything about it, and thus does not seem genuine about ending chronic disease.

If they were genuine about ending the chronic disease crisis, and meant all the things they've publicly said, FMT would be their golden goose. Their behavior so far indicates they're not genuine.

Here is some news coverage presenting some evidence and reasoning for why it's actually BS: https://forum.humanmicrobiome.info/threads/rfk-jrs-maha-project-funnels-millions-from-public-health-to-private-we.1101/
 
I disagree that any of that is evidence that FMT is not a niche topic. I also do not find the case that RFK is not genuine in his goal of ending the chronic disease crisis to be compelling.

Like you and everyone around this parts (I imagine), I have spent many years around "alternative" health circles, having experienced no respite (and much harm) via mainstream medical channels. Despite there being many people who are very open to niche hypotheses, health experiments, etc. that challenge mainstream orthodoxy, FMT has never become a focus in these communities. There's some vague idea that the microbiome is important, yes - but the amount of people who would try or have researched FMTs is VERY small.

Yes, RFK and others would appear to be more sympathetic to this type of idea than most, but it hasn't even breached "alternative health" communities, how could we expect it to be a priority at the FDA?

If the FDA right now made a new classification for FMTs that allowed marketplaces to operate properly, how many people would be excited about that?

How many people in the country have even done FMTs outside of treating c. diff?

The numbers are simply very small. It is a niche topic. Important? Yes. I am fully of the belief it's the most powerful holistic health intervention that exists. But how many people confidently agree with the prior sentence? You could probably fit them all in one house.

That doesn't mean it's impossible for something to change legally. But politicians operate, to a large degree, on constituent sentiment. It is a massive uphill battle if there aren't a lot of people who care about the topic.
 
I think the problem here is that all the possible ways of making this popular or well known are gatekept by institutions that have money invested in big pharma (mutual funds and stuff), and so would suffer financially from cures coming out. Everyone knows how crony capitalism works and then acts surprised when cures are kept hidden. Like, that's literally just how it works. I genuinely don't know where to go from here, but if Michael could get on Joe Rogan that would probably help. No idea at all how to make that happen but it would work. I feel like we live in a world where it's literally impossible to speak to a human being anymore. There is no connection possible, no communication possible.

I'm trying to hold out hope that they're tackling the basics, like the majority of issues, first, and then they'll get around to the more "niche" stuff like this. Although I agree, this really is the cure to nearly all neurological and autoimmune diseases. 73.6% of Americans are overweight, so taking care of diet first is, numerically, a priority. 8% have autoimmune disease. Possibly (assuming they knew about the gut biome) it kind of makes sense if their thinking is that rather than allowing all the obese people to take a shortcut to weight loss (studies show if you FMT a skinny mouse biome into an obese one, they trim down), they try and get people to just live healthy in the first place. I hope that kinda makes sense.

That being said, they should just open the stool banks back up. It would literally be as easy as them saying "hey they're allowed again."

I even recently tried the "healthy eating" diet approach to curing my klebsiella infection in my gut and surprise, it literally just made it worse. Turns out that when you have a gut infection, giving it additional fermentable foods just exacerbates it. FMT is literally the only thing that will work. Maybe bacteriophages, but thats above my pay grade. Antibiotics could potentially work but its a gamble whether it would kill the infection and rebuild without it. I'm back on the garbage tier fast food diet, just with tons of working out and vitamins. I hate that my diet is 90% fast food, but all my inflammation goes away, and my epilepsy dies down, simply because pathological bacteria can't ferment it.

My point is, I genuinely don't think they're working to find cures. At least not right now. I think big pharma KNOWS definitively that these cures exist though and actively suppresses them. If pharmaceutical prices drop so low that they have to look to non-traditional revenue streams, maybe we'd see some action, and supposedly pharma prices are supposed to drop soon (we'll see).
 
how could we expect it to be a priority at the FDA?
As I said, because they know about it and claim they want to make cures available and end chronic disease. The public doesn't need to be well-informed for the FDA, NIH, or HHS to do something about a relatively unknown treatment. There is nothing else that comes close to the power & potential of FMT, so it's not like they have more important priorities.

But politicians operate, to a large degree, on constituent sentiment.
I agree with your statement, but I wouldn't really agree that the heads of the FDA, NIH, and HHS are "politicians". So I don't think that applies to them.

Regardless, I plan to up the pressure and hopefully spread public awareness by making social media videos, confronting Senators: https://forum.humanmicrobiome.info/threads/the-fda-and-fmt-regulation-part-2-jul-2024-humanmicrobes-org-i-met-wit.520/post-2888. If you have feedback or suggestions, feel free to share them.

I agree with @EpilepsyFMTcure. From my observations, everyone is scared of the pharma industry.

That being said, they should just open the stool banks back up.
That's not a solution. The UMN stool donor bank is one of the worst sources of donors in the world.
 
That's not a solution. The UMN stool donor bank is one of the worst sources of donors in the world.

As I've mentioned in other comments, if they open them up they have to be regulated, didn't mean to mislead with my comment by leaving that out.

Edit: Really looking forward to your FMT videos! I've done some on Rumble about epilepsy and the one I did on why the Amish have higher rates of epilepsy got over 2k views. I work in the water supply industry and I can tell you, having shallow wells and non-septic outhouses is a BAD idea.
 
As I've mentioned in other comments, if they open them up they have to be regulated
I think this is a continued misunderstanding of the situation. There is already heavy regulation that the UMN stool bank complies with. The issue is that the person running the stool bank lacks the judgment and motivation to acquire safe and effective donors.
 
I think we're using different language to approximate the same meaning. They shouldn't be using bad donors and bad samples. Who is the person running the bad bank right now?

edit: shouldn't
 
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