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.
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.