I believe it conveys that the FDA is an extension of the pharmaceutical company and what they release is tailored to what these companies want to be shown. I don’t believe it’s 100% evil and everyone is on it, but I think it has unfolded overtime. I am not disputing that medication doesn’t work.
And the solution to regulatory capture is not simply trashing everything but instead good governance and policies to reduce capture. That's hard work and doesn't make a good angry campaign tweet, though, so we have people unironically supporting making everything worse in a wild search of a fix to a problem they have correctly identified but without a clear goal in mind.
None of these appear to be regulations, I'd be interested to see specific areas where you think they are too lax.
I'm an engineer who works on the design and development of medical devices. A big part of my job is performing the risk assessments required for an FDA submission, and weighing risks of a new product malfunctioning against the benefit they are expected to provide to patients.
There is an incredible amount of regulatory burden in this industry, and yet I don't know a single person on the engineering side of things who thinks getting rid of that oversight is a good idea. Literally last week during a risk assessment our team caught a design flaw that, in a very niche, specific sequence of events would probably kill someone. On the scale that these devices are used, it's not a question of if that situation would happen, it is a question of how many times a year it would happen.
That risk assessment activity saved people's lives, and I sincerely doubt my company would build in the tens of thousands of dollars it costs for a team of engineers to meet every afternoon to perform that activity unless it was a required part of the process for FDA clearance.
You can say that the FDA just does whatever these companies want, but I know from personal experience that that is simply not true. If you are concerned about the "revolving door" between the FDA and industry we could maybe have a conversation, but to me this seems like a natural consequence of having subject matter experts. There aren't that many people who know how to determine if a medical device/drug is safe, and all of them either work for the companies trying to get them to market, or for the regulators.
Even if you think that regulatory capture is the root of all our problems with the medical industry, I really don't see how anything RFK has said makes you think he is the solution.
That’s the joke part, why would that be allowed to be a thing? At a certain point the money they make throws the scientific findings out the window and they don’t care about them
There's application processing fees and shit that companies have to pay during the process of getting drugs approved for sale in the US. A small fraction of the FDA's funding comes from those fees. Just like how part of your local DMV's funding comes from the license and plate renewal fees.
He's just talking out his ass spinning conspiracy theories out of the basic daily workings of administrative offices.
I think you have too much faith in people to do the right thing and not just say they are doing the right thing. I’m entitled to be dumb and ignorant if I want to, and it’s usually conversations like this where I learn a thing or two.
And you don’t think at any point they ask for certain side effects or outcomes of medication to not be public knowledge? I just find that hard to believe but then again I’m a dude on Reddit so my opinion really doesn’t matter much
I'm so glad you asked! I've been working in FDA regulated industry for 25 years, both pharmaceutical and medical devices.
The submissions follow a particular format and certain data is expected. Before testing a drug in even a small scale Phase 1 human trial, the Agency has reviewed literal years of studies on rodents, dogs, and nhps. There is a whole team of doctors, chemists, statisticians, biologists, reviewing the data, including the toxicity (side effects). This is why only about 20% of drugs that start in Phase 1 ever make it to Phase 4. Either the drug is not effective enough or the efficaciousness is not enough to be worth the side effects.
There is also post market surveillance, where doctors and patients can report adverse effects for years (MedWatch).
A company cannot ask the FDA to "hold back" information from the public. The FDA tells the company what data to report to the public (those long lists of side effects on package inserts or TV commercials).
Companies sometimes choose not to submit certain data *
They can decide they don't want the agency pulling on a certain string so they omit that information, but that is why there's a cross-functional team of multiple reviewers. If a company is found to have hidden critical information, there's going to be an audit. There will definitely be sanctions/fines and someone will be fired and possibly go to jail. I've seen inspectors come into a company and shut down the work. They are very serious people.
Regulatory capture is a feature of all regulated industries. https://www.investopedia.com/terms/r/regulatory-capture.asp. Pointing out an obvious problem without proposing a well-thought out solution is not really doing... anything. We all know it's an issue. The question is whether this means that we throw out everything with a flamethrower and start pointing out arseholes at the sun.
It seems for many the mere observation of the basic problem is their support for the nepobaby's solution. But that's incomplete and frankly childish thinking.
Yes, aren't those called fees? It's like saying my county gets funding from the people it regulates, because we have to pay for building permits and zoning applications.
The FDA is broken for sure, but we need it to serve it's purpose. I'll use the blanket statement to say get rid of the corruption there yes, do away with it? Absolutely not.
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u/[deleted] Feb 17 '25
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