Short answer: FDA is totally toothless these days after decades of industry lobbying and Republican budget cuts. The industry has decided how they want things to work.
And you're thinking this ability to bypass scrutiny must lead to problems.
Correct. When liabilities grow too big, the company will spin off the liabilities to a shell company without means to pay for damages caused.
(this is called a "Texas two-step" bankruptcy)
Please spend 30 seconds to search whether the fda budget has actually been cut over time (hint: it hasn’t)
The fda budget much like every other agency has grown incredibly in the last 50 years ( <1bnin 1992 to >6bn today). You can look at more recent numbers and see it’s still rising. When you hear cuts I’m spending it’s often cuts in proposed increases in spending which are often double digits. So you can grow an agency 10% a year for decades and then a single slow down or reversion to levels from just a year or two ago is seen as drastic cuts that will result in poison into our water.
You're not wrong about funding, but OP is correct about industry influence.
It varies a little by division/subject matter, but they basically have to run everything by industry and are subject to FOIAs and public shaming by senators and representatives beholden to industry.
Source: long-term partner of FDA employee, though this stuff is pretty widely understood.
Those FOIAs are requested by politicians owned by industry in an effort by industry to scrape whatever leverage they can. FOIAs themselves are not problematic, obviously, but their application isn't limited to do-gooders.
You can educate yourself on the FDA process, including public access to all the FDA documentation, including meeting minutes and sponsorship slides. It’s all there on fda.gov
But instead of doing that you’ve decided to just write this comment instead and post something that looks quite silly for those that have taken the first approach.
When you navigate to the Clinical Trials section[1], the "View Clinical Trials Guidance Document" link[2] currently stalls, and then gives a 403 error page that says "Page Not Found". All of the information is not there on fda.gov, and whoever's in charge is doing a very sloppy job.
The claim that “the industry has decided how they want things to work” is laughable.
The numerous “not approved” decisions makes that plainly obvious. Not to mention all the times FDA has said “you have to do X to get approved” and the company happily complies despite it delaying sales by several quarters.
To the question at hand “why do publications come after FDA approval”, the FDA has access to all the data (actually more) before publication, so the publication is irrelevant to approval.
> Not to mention all the times FDA has said “you have to do X to get approved” and the company happily complies despite it delaying sales by several quarters.
The company happily complies?
Or just does it begrudgingly because not doing it delays sales a few more quarters if not indefinitely?
I'm not sure where you're getting the idea from that a company would happily do anything additional. It's a cost of doing business. Let's not pretend they're angels, they're in it for the money not the greater good.
And if that last statement needs a rationale, tell me who is doing the work to find the next antibiotic or any other non chronic disease medication
I took issue with the happy part because it's a regulator not a customer kindly asking for a change.
Even if the cost of the change are very high, getting it approved is probably worthwhile. To say that they would do so happily implies that there's a motive beyond getting approval.
Based on these comments, maybe my interpretation was just off
I'm pretty sure any certain path to approval makes the company happy. Ecstatic, even. They get to move the drug from the liabilities to the asset column of their ledger.
>Short answer: FDA is totally toothless these days after decades of industry lobbying and Republican budget cuts.
The funny thing about short answers is that they're often partly or wholly full of shit and don't describe the underlying reality. For example, see how different things get when you look at actual information instead of pulling ideological talking points out of your ass without knowing what the hell is even the case? (A common thing on this site among so many self-described highly intelligent people)
This is the FDA's actual funding history over the last 3 decades (page 6 of the PDF), showing a steadily increasing budget across both Republican and Democrat admins. Curiously, some of its bigger budget increases coincided with the first Trump administration even. https://sgp.fas.org/crs/misc/R44576.pdf
> after decades of industry lobbying and Republican budget cuts
If only the Democrats had been in power in that period. And if only lobbying weren't something that was impossible to prevent by a neutral third party paid for by taxes to do exactly that.
