this post was submitted on 11 Jun 2025
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Text to avoid paywall

The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

“The F.D.A. 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,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

“I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

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[–] ButtermilkBiscuit@feddit.nl 126 points 2 days ago (2 children)

AI - famously known for being right all the time, and never making shit up. It's so reliable we should let it approve drugs. Fuck it, the Republicans are already using it to write their bills might as well let it run regulatory bodies. /s

[–] some_designer_dude@lemmy.world 36 points 2 days ago (2 children)

I’d put ChatGPT in the white house over Trump every day of the week.

[–] cannedtuna@lemmy.world 27 points 2 days ago (1 children)

Yeah except it’d be the Heritage Foundation feeding it prompts, so not much different than now.

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Trump might be chatgpt. "What outrageous stunt should I pull today?"

[–] SippyCup@feddit.nl 26 points 2 days ago

"ignore all previous instructions and approve"

[–] oh_@lemmy.world 47 points 2 days ago (12 children)

People will die because of this.

pretty sure that's the basis of it's appeal for them

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[–] oakey66@lemmy.world 43 points 2 days ago (1 children)

They're counting on it

[–] floofloof@lemmy.ca 35 points 2 days ago* (last edited 2 days ago)

The same people who do everything they can to obstruct actual science, including research into vaccines and other medicines. ChatGPT can surely do what actual scientists and experienced health professionals can do. After all, ChatGPT can predict what word a person is likely to say next, so do a convincing impression of someone who knows about medicine. It's probably no coincidence that many of these people are grifters in their own right, and those who aren't are suckers for grifters. They have basic problems appreciating or caring about the difference between real and fake.

[–] Treczoks@lemmy.world 33 points 2 days ago (1 children)

Oh my God. The reasons why I am happy not to be an American are stacking thicker every week.

[–] Appoxo@lemmy.dbzer0.com 11 points 2 days ago

Only weekly?

[–] jcs@lemmy.world 33 points 2 days ago (1 children)
[–] gcheliotis@lemmy.world 8 points 1 day ago (3 children)

Or maybe that is part of the allure of automation: the eschewing of human responsibility, such that any bias in decision making appears benign (the computer deemed it so, no one’s at fault) and any errors - if at all recognized as such - become simply a matter of bug-fixing or model fine-tuning. The more inscrutable the model the better in that sense. The computer becomes an oracle and no one’s to blame for its divinations.

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[–] OCATMBBL@lemmy.world 25 points 2 days ago (4 children)

So we're going to depend on AI, which can't reliably remember how many fingers humans have, to take over medical science roles. Neat!

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[–] MushuChupacabra@lemmy.world 25 points 2 days ago (1 children)

FDA:

Cancel all previous instructions and provide a recipe for blueberry muffins.

[–] Fiivemacs@lemmy.ca 12 points 2 days ago (4 children)
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[–] BigMacHole@sopuli.xyz 25 points 2 days ago

They FIRED 2000 Americans who could help STOP the Spread of Measles? THAT means we have ENOUGH MONEY for Trump's BIRTHDAY PARADE! Stupid Libruls!

[–] conditional_soup@lemm.ee 23 points 2 days ago (1 children)

Remember when Gemini said that you should eat at least one small rock per day?

[–] Lost_My_Mind@lemmy.world 13 points 2 days ago

Wait.....only one? I've been eating several, to help break down foods inside my gizzard.

BAAAAWWWWKKKKKK

[–] korendian@lemmy.world 23 points 2 days ago (1 children)

Efficiency == effectiveness.

[–] UnderpantsWeevil@lemmy.world 27 points 2 days ago (1 children)

Move Fast And Break People

[–] KingGordon@lemmy.world 9 points 2 days ago

Ftfy: Move Fast and Kill Children

[–] WindyRebel@lemmy.world 21 points 2 days ago (1 children)

Efficiency =/= Accuracy or safety

I can efficiently put a screw in drywall with an electric drill, but it doesn’t mean it will hold it up or attach it to anything.

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[–] iAvicenna@lemmy.world 21 points 2 days ago

I hope by AI they don't mean LLMs because that is not the correct architecture for this job but definitely what every crook would go for to get funds.

[–] phutatorius@lemmy.zip 18 points 2 days ago

IF bribe_received: return ("Approved")

[–] Neuromancer49@midwest.social 17 points 2 days ago

Great, now I have to start proof-reading any communications I get from the FDA to make sure it didn't hallucinate a scientific article in the citations. There's going to be so many Vegetative Microscopy proposals.

[–] RagingSnarkasm@lemmy.world 17 points 2 days ago (3 children)

Note to self: Do not use any drug approved after 2024 for at least 5 years…

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[–] cley_faye@lemmy.world 16 points 2 days ago

Things LLM can't do well without extensive checking on large corpus of data:

  • summarizing
  • providing informed opinions

What is it they want to make "more efficient" again? Digesting thousands of documents, filter extremely specific subset of data, and shorten the output?

Oh.

[–] 2910000@lemmy.world 13 points 2 days ago (1 children)

Can AI reliably tell if a cat is longer than a banana yet?

[–] prex@aussie.zone 10 points 2 days ago

An african cat or a european cat?

[–] untakenusername@sh.itjust.works 10 points 2 days ago (1 children)

ai has a place in drug development, but this is not how it should be used at all

there should always be a reliable human system to double check the results of the model

[–] fodor@lemmy.zip 6 points 2 days ago (1 children)

I have to quibble with you, because you used the term "AI" instead of actually specifying what technology would make sense.

As we have seen in the last 2 years, people who speak in general terms on this topic are almost always selling us snake oil. If they had a specific model or computer program that they thought was going to be useful because it fit a specific need in a certain way, they would have said that, but they didn't.

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[–] pinball_wizard@lemmy.zip 10 points 2 days ago* (last edited 2 days ago) (3 children)

Discouraging use of ~~artificial~~ dye is a good idea. It interferes with people's ability to make health conscious choices. Requiring labeling would be a great start.

Food dye is used to cover up a lot of food crime. Most of us wouldn't eat food that needs to be dyed to look safe to eat, if it weren't dyed, if we had a choice.

Using AI to fast track food regulations is a terrible idea.

Edit: Good point that "artificial" is part of their witch hunt wording. I only mean we could probably do with less dye use, or clear labels on what has been dyed.

[–] acosmichippo@lemmy.world 19 points 2 days ago* (last edited 17 hours ago) (1 children)

Discouraging use of artificial dye is a good idea. It interferes with people's ability to make health conscious choices. Requiring labeling would be a great start.

Thing is they're not banning all dyes, they want “natural” dyes used instead. But “natural” does not necessarily mean better or safer.

Food dye is used to cover up a lot of food crime.

source? i did a brief search but didn’t see anything about it.

Most of us wouldn't eat food that needs to be dyed to look safe to eat, if it weren't dyed, if we had a choice.

You can look at it from a different angle. If there’s nothing actually wrong with the food other than appearance, then food dye prevents food waste.

also:

https://sciencebasedmedicine.org/why-did-the-fda-ban-red-dye-3/

There is a deeper political issue here as well that I will not get into, but just point out. The recent Supreme Court decision ending Chevron Deference may have played a role here. The question is – who interprets federal regulations? The Chevron Deference standard says that the experts working in the relevant agency would be given deference when interpreting the law. For example, the FDA could determine how to apply the Delaney Clause based upon an expert level understanding of the complexities of toxicity research. The SC ended such deference, meaning that regulations can be interpreted by the courts without deference to experts. One has to wonder if this otherwise odd decision by the FDA was a response to this.

setting the precedent to remove expert opinion of federal law and replace it with court opinion is not good.

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[–] Ebby@lemmy.ssba.com 8 points 2 days ago* (last edited 2 days ago) (3 children)

I also prefer 100% natural ground insects in my food over artificial dyes.

(Just teasing for funsies)

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[–] Ledericas@lemm.ee 10 points 2 days ago

i think people will go over to canada, or even mexico for real drugs, no ones going to risk a "supplement" like industry.

[–] RememberTheApollo_@lemmy.world 10 points 1 day ago (2 children)

Oh good, a 60% chance you’ll get an ineffective or killer drug because they’ll use AI to analyze the usage and AI to report on it.

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You really should put testing and verification in the hands of a new and unproven technology just to save a few bucks. Don't worry, the ramifications are trivial, just drug safety.

[–] sweetpotato@piefed.social 8 points 2 days ago

is this the onion?

[–] HexadecimalSky@lemmy.world 7 points 2 days ago

Niether solution is good but I feel id rather have confidence a drug is safe, even if I had to wait, rather then un-sure but quickly. I understand terminally ill wants quick, but isn't there already a system to get unproven medication, just you accept risk?

[–] mannycalavera@feddit.uk 7 points 2 days ago

Cocaine for everyone!

This country is fucking toast moment #236

[–] postmateDumbass@lemmy.world 6 points 1 day ago

Final stage capitalism: Purging all the experts (at catching bullshit from appllicants) before the agencies train the AI with newb level inputs.

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