Who’s the Real Boss at the FDA?
(www.theamericanconservative.com)
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TLDR: The blogger has it wrong, misattributes the problem, and proposes throwing the baby out with the bathwater. That's a bad idea.
I get the implication. Let's think this through.
Do we need an FDA in the first place? If we didn't have a government regulator ensuring that food and drugs are actually produced safely and not contaminated with whatever your worst fear is, would that be ok? Would the free market handle it? I say yes we need an FDA. Every time you hear about mass salmonella poisoning or E. coli contaminated lettuce, or the latest drug recall because there's a carcinogen in your heart meds, it was the FDA inspections that found it.
If we need such an agency, how do you pay for it? Keep in mind that staff with MDs or PhDs are really expensive. Prior to 1992 and the PDUFA, the FDA was chronically underfunded and understaffed. New drug applications piled up and it would be months if not years before someone actually looked at them. Now imagine your grandparent is dying of cancer, but the treatment isn't coming because some overworked, underpaid bureaucrat isn't going to hustle one iota to get through that never-ending mountain of paperwork on his desk. Keep in mind that the US medical industry is responsible for something like 60% of new drugs and medical devices worldwide. Go back to the old method of funding and the whole world suffers as that innovation pipeline dries up.
So, what's the solution? A good conservative one of course. You tell the guy who wants to use the services that he has to pay for them. You want to use the roads, pay the gas tax. You want to use the rivers to fish in, pay for a license to keep those forestry service guys employed. You want to develop the next Lipitor? Pay the FDA to process that 2,000 page mountain of data you just submitted. The $2 million user fee is chump change to any company that can fund a $10+ million phase 3 clinical trial. And it works. FDA processes 10x what it used to and in less time. We get more innovation as a result. That's a good thing.
Doesn't that lead to regulatory capture like the nice blog-writer said? Not necessarily. Corruption happens as a result of bad employees, not bad customers. Try going to your local Wal-Mart, head to the customer service counter and demand they change their policy to this or that to make it more to your liking. If the employees at your local store are anything like the ones where I'm at, well, good luck. No, you need corrupt employees in the C-suite or upper level management to pull that kind of thing off. Same in government. Regulatory capture happens because the people getting leadership jobs at FDA are all former pharma execs. That's the problem that has to change, not the funding system that simply asks the ones using the gov't services to foot the bill for them.
The solution today is a house cleaning. The decision-makers at FDA, anyone with direct or indirect decision-making authority needs to be fired and replaced. Make all hiring decisions non-political. No political appointees. Period. Food and drug safety is apolitical. Management experience is fine, but not from a pharma company. Pharma experience is fine, but not in management. Get an actual pharmacist, medicinal chemist, some talented research scientists, people with industry experience, and a promising entrepreneurial MBA on the leadership team. And rotate those positions regularly. Say, you get a term of 5 years, may renew one time for a total of 10 years, then you move on with your career to greener pastures. Hire who you need to get the job done. Pharma will pay for it. They don't have a choice.
Good points, but this ignores the U.S. Constitution. There is nothing in the Constitution about regulating drugs or food, and such an idea is not even in the spirit of the Constitution. And don't forget the 10th amendment, which a MAGA congress will no doubt bring back to life.
Anything needing to be done by a government that is not in the U.S. Constitution needs to be done by the state. It would be messier in some ways, but better because of its messiness. It would be way harder to corrupt 50 governments than corrupting one government.
In general, all health stuff needs to be shut down at the federal level, since it's unconstitutional AND gets crooked as shit, and needs to be handled by state health departments carefully monitored by the public. Also, ignoring real causes of health problems needs to end.
I like the idea of it but if there’s 50 fda does that mean the drug conpany needs their drugs approved 50 times?
Yeah - no thanks. Using the example, 50 states (not including the territories) x $2M is now $100M+. All drug prices go up, and it will take even longer - both for waiting for 50+ state approvals, and the drug company submitting 50+ likely different approval packages to the 50+ states/territories.
The FDA needs to be funded by the approval requests and be a quasi-govt agency like the USPS. No federal money would be my preference, but I could also live with a strict limit (enough to fund building maint and electricity) and mandatory raises in approval charges on the pharma company.
I'd still prefer if it was just the "FA" without the drug part though.
The larger issue seems to be how do you prevent corruption from taking place? It almost seems impossible either way whether funding comes from govt or big corps. It will rot eventually.
Yeah I agree, but don't know how to fix that. We (Americans) need to reexamine all of this kind of stuff once everything is over. A ton of stuff is not in the constitution, but some amount of that stuff is certainly required for health and safety, or perhaps national security.
We have to figure out how to eliminate the illegal stuff, fund the necessary stuff, and somehow legislate it to the point it can't be corrupted.
I might have a thought for a solution though. I was a Nuclear Cyber Inspector at the NRC and they had an interesting setup. NRC made their regulations that had to be followed, but the nuclear industry created their own organization (NEI), worked with the NRC to come up with regulations that the NRC and the industry could both live with, and that made regulatory compliance far easier and palatable. It also meant the NRC would not make wholesale changes because of their agreement with NEI, and any new things were talked about between the NRC and NEI. I saw both sides of this being NRC, and later being a cyber security specialist for a nuclear plant responsible for implementing the regulatory requirements.
The same could be done with FDA. Create an industry org for Pharma, and Food, legislate that they have to collaborate, and go from there.
'Fraid so. But states regulate many things, and companies adapt.
Plus, we need FAR less medicine than is sold. And many older medicines without patents work just fine.
For decades we have screwed up our immune systems with antibiotics and vaccine over use including those used in the foods we consume. I am almost convinced that our immune systems are struggling to fight off salmonella, e coli etc. Our foods are getting dirtier, our bodies are weakening.
The solution is not having a chauvinist foreign ethnicity that control things for the interests of its own tribe instead of the interests of society at large.
Thanks for bringing this to us. Dog.
Suspected that for a long time but here is the info.
...doggy winks....
I also ask it to be stickied
...it looks like the Sticky Fairy sprinkled some magic sticky dust on it....
...howls....
How do you spell HUGE CONFLICT OF INTEREST? The FDA does not function in the interest of the consumer.
...just their bosses at mega pharma....