I wish someone would convince RFK that prescription drug ads are bad for his brand of quack medicine. We could at least get rid of that societal cancer while the rest is torn down.
alejohausner · 1h ago
I’ve heard RFK say that it’s hard to ban TV ads for drugs. They are “speech” according to the 1st amendment, or something like that.
Too bad. News broadcasts are full of those ads, and hence TV journalists are loath to investigate the people that pay their salaries.
vel0city · 43m ago
There's loads of precedent pointing to commercial speech such as marketing as having some specific carve outs on the right to free speech. After all we have limits on tobacco marketing and food labeling requirements.
dmm · 3h ago
Reading "Bottle of Lies" by Katherine Eban, I'd argue that the collapse of the FDA was well underway before the current administration. The FDA was completely unable to regulate overseas drug manufacturers, resulting in many, many problems. Sincere attempts to inspect overseas drug makers with random inspections universally results in shutdowns, which cause politically unpopular drug shortages, making enforcement politically difficult.
sorcerer-mar · 2h ago
Sooo that sounds like there's a whole lot of ways for it to get way, way, way worse.
The existence of problems does not imply there cannot be more plentiful, more diverse, and more severe problems in the near future.
kelseyfrog · 38m ago
If Chesterton's fence doesn't have a working latch, then it's appropriate to remove it entirely.
satvikpendem · 29m ago
Or fix the latch? Or was this a sarcastic comment?
I know what Chesterton's fence is, my question was specifically about why one would throw it away if the latch doesn't work.
cosmicgadget · 2h ago
That seems more like an "underfunded and underjurisdictioned" problem for a portion of what they do, rather than collapse of the agency.
teepo · 1m ago
It feels to me like the tyranny of small differences. The fact that the various watchdogs amplified such specific issues greatly overshadowed their support of the mission. From what I've read, the FDA is a backwater from a funding perspective, and yet a punching bag from a regulatory point-of-view.
*He and his colleagues had also been engaged in a decades-long debate with a sprawling community of watchdogs — mostly doctors, lawyers and scientists from outside the agency — who were often broadly supportive of the agency’s mission but who fought with officials like Califf, sometimes bitterly, over the specifics: How should the F.D.A. be financed? What kind of evidence should new drugs and medical devices require? How should regulators weigh the concerns of industry against the needs of doctors, patients and consumers?*
Skates1616 · 1h ago
I’m very familiar with this space, specifically parenteral manufacturing.
The real challenge lies in the expectations the FDA has set for manufacturing. Over time, the regulatory space has been heavily influenced by academic-driven theoretical scenarios for microbiological contamination. While well-intentioned, these theoretical risks often drive overly stringent requirements that don’t always reflect real-world manufacturing risks.
As a result, it’s becoming prohibitively expensive to manufacture drugs for the U.S., especially sterile injectables.
And truly it gets worse every year…
zer00eyz · 8m ago
Chiron: 2004, the UK government shut down their flu vax plant (it was in the UK). It later came out that the FDA knew what was up and basically let it slide. It was one of the early ani-vax movements torches... Crunchy moms pissed about shots for kids and parents on Oxycodone were not happy with Pharma (or corporations in general: Enron etc..)
> politically unpopular drug shortages ...
Ask your ADHD friends about how they get their meds.
One side wants to keep it, the other side wants to get rid of it. No one wants to fix the problem.
clumsysmurf · 3h ago
“FDA’s war on public health is about to end,” Kennedy wrote. “This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma."
Anyone know what chelating compounds he is talking about?
He mentions clean foods, but the Trump EPA is protecting corporations from regulations more than its protecting citizens from pollution.
hinterlands · 3h ago
It's about EDTA. It can be legitimately used to treat heavy metal poisoning, plus some other things. Some people (who are probably misguided) want to self-medicate. The FDA won't let you. Hence, drama.
Metacelsus · 2h ago
yeah, because unless you legitimately have heavy metal poisoning, the side effects DEFINITELY aren't worth it
hinterlands · 2h ago
Probably, but the process doesn't work that way. The default is that you can't sell medication to people, period. Some pharmaceutical company applied to have a specific form of EDTA approved as a prescription drug, and that was that.
Separately from this, substances that meet the criteria of being "natural" can be sold as supplements as long as you don't claim they cure anything. EDTA is naturally-occurring and you can buy it as a supplement in the US, although the FDA has some beef with this, which I think is what the original remark might be alluding to.
EDTA is also a common food additive and a laboratory reagent, so people who want to use it can buy it easily, which makes the whole debate basically performance art.
sorcerer-mar · 2h ago
So in summary, the FDA prevents you from marketing something as a medicine unless you have gone through the approval process and developed all the regulatory apparatus around a medicine (e.g. packaging, suppliers, prescription guidelines, etc)?
hinterlands · 2h ago
Yes. Look, I'm not arguing this is bad, I'm just trying to respond to the original question and capture the essence of the debate.
There are three pertinent points: (1) it's EDTA; (2) it's not that EDTA is safe or not safe, it's that no one applied to have it approved as an OTC medication; (3) you can still (probably) sell EDTA as a supplement in the US, but the FDA grumbled about it, which angered various chelation cranks.
Aloisius · 2h ago
Iron, copper, zinc, cobalt, manganese and selenium are "heavy metals."
stevenAthompson · 2h ago
"We do our peers, countrymen, students, and children a grave disservice by admonishing them to think for themselves without also giving them the critical thinking tools to do so, for in so doing we foster a culture where "independent thought" is equated with "contrarian thought". This gives rise to an anti-intellectual, anti-science paradigm that supports an idea not because it meets a basic standard of evidence, but rather simply because it opposes established thought. This is worse than the intellectual calcification that stagnant "herd thinking" would give rise to, because it doesn't simply halt progress — it puts it in full retreat."
frosted-flakes · 1h ago
Excellent statement, but who is the "great man" who once said this?
Too bad. News broadcasts are full of those ads, and hence TV journalists are loath to investigate the people that pay their salaries.
The existence of problems does not imply there cannot be more plentiful, more diverse, and more severe problems in the near future.
The real challenge lies in the expectations the FDA has set for manufacturing. Over time, the regulatory space has been heavily influenced by academic-driven theoretical scenarios for microbiological contamination. While well-intentioned, these theoretical risks often drive overly stringent requirements that don’t always reflect real-world manufacturing risks.
As a result, it’s becoming prohibitively expensive to manufacture drugs for the U.S., especially sterile injectables.
And truly it gets worse every year…
> politically unpopular drug shortages ...
Ask your ADHD friends about how they get their meds.
One side wants to keep it, the other side wants to get rid of it. No one wants to fix the problem.
Anyone know what chelating compounds he is talking about?
He mentions clean foods, but the Trump EPA is protecting corporations from regulations more than its protecting citizens from pollution.
Separately from this, substances that meet the criteria of being "natural" can be sold as supplements as long as you don't claim they cure anything. EDTA is naturally-occurring and you can buy it as a supplement in the US, although the FDA has some beef with this, which I think is what the original remark might be alluding to.
EDTA is also a common food additive and a laboratory reagent, so people who want to use it can buy it easily, which makes the whole debate basically performance art.
There are three pertinent points: (1) it's EDTA; (2) it's not that EDTA is safe or not safe, it's that no one applied to have it approved as an OTC medication; (3) you can still (probably) sell EDTA as a supplement in the US, but the FDA grumbled about it, which angered various chelation cranks.