3 ms·

> The FDA approval comes based on trial data submitted by the pharmaceutical company, so it's worth noting that published peer-reviewed reports are yet to be pu

by merek 1y ago

> The FDA approval comes based on trial data submitted by the pharmaceutical company, so it's worth noting that published peer-reviewed reports are yet to be published. Peer-reviewed publications often follow regulatory approvals, not precede them, which is common in the field of ophthalmology and dermatology. Does anyone know the reason that data is published after approval rather than before? Seems illogical at face value, but I'm obviously missing something.

mentalfist 1y ago
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.
- mentalfist 1y ago
  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)
  - hulitu 1y ago
    > And you're thinking this ability to bypass scrutiny must lead to problems. Of course not. Side effects ? Which side effects ? /s
  - deleted 1y ago
    [deleted]
- refurb 1y ago
  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.
  - dmos62 1y ago
    Do you have any insights?
    - refurb 1y ago
      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.
      - hvb2 1y ago
        > 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
        rendall 1y ago
        Do you feel that the happiness of the company is salient to GP's arguments? That is, by refuting that part, do you refute the entire?
        hvb2 1y ago
        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
- robertlagrant 1y ago
  > 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.
- bko 1y ago
  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. https://www.google.com/search?hl=en&q=fda%20budget https://www.google.com/search?hl=en&q=fda%20budget
  - scrozart 1y ago
    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.
    - trogdor 1y ago
      > and are subject to FOIAs How is that relevant?
      - scrozart 1y ago
        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.
- southernplaces7 1y ago
  >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 https://sgp.fas.org/crs/misc/R44576.pdf
tguvot 1y ago
probably influence on stock market and stuff.
refurb 1y ago
It’s because the publishing process takes more time than the FDA review process. Once the pivotal trial reads out, companies usually submit within a month or two to the FDA. Much of the submission dossier (trial design, product description) can be written ahead of time, so it’s really the results that need to be drafted. The FDA can approve in as little as 3-4 months for an accelerated approval, but it can take up to 12 months. Compare that with a paper being written and reviewed across multiple authors (3-6 months if you’re lucky), then submitting to multiple journals for review and feedback (6 months), then final submission and peer review (1-2 months), then any additional edits (1 month), then final slating for publication after article is type set, all figures are sized, article laid out and final version (1-2 months). So all in the FDA takes less time (3-12 months) than publishing (12-17 months).
naveen99 1y ago
You aren’t allowed to sell / distribute / market to “peers” until fda approval.

by merek 1y ago

mentalfist 1y ago

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.

mentalfist 1y ago
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)
- hulitu 1y ago
  > And you're thinking this ability to bypass scrutiny must lead to problems. Of course not. Side effects ? Which side effects ? /s
- deleted 1y ago
  [deleted]
refurb 1y ago
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.
- dmos62 1y ago
  Do you have any insights?
  - refurb 1y ago
    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.
    - hvb2 1y ago
      > 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
      - rendall 1y ago
        Do you feel that the happiness of the company is salient to GP's arguments? That is, by refuting that part, do you refute the entire?
        hvb2 1y ago
        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
robertlagrant 1y ago
> 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.
bko 1y ago
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. https://www.google.com/search?hl=en&q=fda%20budget https://www.google.com/search?hl=en&q=fda%20budget
- scrozart 1y ago
  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.
  - trogdor 1y ago
    > and are subject to FOIAs How is that relevant?
    - scrozart 1y ago
      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.
southernplaces7 1y ago
>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 https://sgp.fas.org/crs/misc/R44576.pdf

tguvot 1y ago

probably influence on stock market and stuff.

refurb 1y ago

It’s because the publishing process takes more time than the FDA review process. Once the pivotal trial reads out, companies usually submit within a month or two to the FDA. Much of the submission dossier (trial design, product description) can be written ahead of time, so it’s really the results that need to be drafted. The FDA can approve in as little as 3-4 months for an accelerated approval, but it can take up to 12 months. Compare that with a paper being written and reviewed across multiple authors (3-6 months if you’re lucky), then submitting to multiple journals for review and feedback (6 months), then final submission and peer review (1-2 months), then any additional edits (1 month), then final slating for publication after article is type set, all figures are sized, article laid out and final version (1-2 months). So all in the FDA takes less time (3-12 months) than publishing (12-17 months).

naveen99 1y ago

You aren’t allowed to sell / distribute / market to “peers” until fda approval.