https://www.medpagetoday.com/publichealthpolicy/healthpolicy/110925?xid=nl_mpt_morningbreak2024-07-03&mh=22c3cd8ebe0a923b5ca6e6e20f1222e0
Many of you probably know about the overturning of the Chevron case by SCOTUS. And this is a GOOD THING. It is the first step at eliminating agencies from imposing rules/fines/etc on the public without government approval. While some may see this as “oh no more government” ruling our lives, it is actually a good thing. A great example I read is that the state level cannot impose a huge fee for you to get a commercial fishing license to go shrimp fishing, a big corporation can afford to pay it but the little guys cannot afford it. If the license costs $15,000 the little guys cannot afford it, but the big corporate people can. It eliminates competition and funnels business to the big boys, eliminating entrepreneurial people from entering the market. The state would set a limit on a license, rather than fish and game making their own rules.
Well, the people in healthcare have their pants in a wad about this. Why? Because this removes the ability of people like the FDA from making their own unilateral rules. It requires governmental approval. So many agencies have been allowed to just do whatever they want to with minimal government oversight despite receiving money from taxpayers. That had to end.
This article is a great doomsday whining about “the world is going to end” thanks to the Chevron case overturning. If the big boys are mad…..you know it benefits the little people.
What is one of their big whining points? FDA drug approval. “The FDA might reject a new product from a company targeting a rare disease on the grounds that it hasn't met the agency's standard of an "adequate and well-controlled investigation," she said, explaining that drugs for rare diseases usually need some regulatory flexibility given the small population that needs them.” Regulatory flexibility?? Kind of like the covid shot was? We need HONEST TRIALS not more FLEXIBLITY!
Now, the drug company can challenge the FDA's interpretation of its own standard, she pointed out. The problem is magnified for approvals in areas where the FDA doesn't yet have a clear standard written in statute, such as laboratory-developed tests, artificial intelligence, and digital health technologies, Ramachandran said. "That's where a challenge can immediately occur."
The pipeline to immediate approval, and the ability for pharma to fudge whatever they want to, has been curtailed. The FDA/Pharma in bed together relationship is in jeopardy, as they cannot just pay their way out of something. If this was facebook, their relationship status would be listed as “it’s complicated”. Don’t forget the in bed together pipeline that the FDA and big pharma have had. That is now in jeopardy.
It will be fun to watch this play out! I hope they all burn down.
I too channel Guy Fawkes on this issue. As a former Fed, I got to watch totally unqualified people make decisions and implement rules that were completely unsupported by legislation. The no liquids through the Security Checkpoint at airports was a great example. That came about because someone on the Administrator's Staff watched the movie Heist one night. Gene Hackman smuggles a tiny handgun through an airport Checkpoint in a cup of coffee. So the next day the staffer mentions this and we are still living with it today. I guess airport concessions is happy. They've sold a lot of $5.00+ bottles of water since then.
As far as the exorbitant fee thing goes, price of entry isn't the only concern. Sure it excludes the "little guy", but it isn't the big corporation that pays for the shrimp license. It is the people who eat shrimp who pay. Yup, it is all passed to us. The true beneficiaries are whatever Government slush fund the license fee ends up in. Those bureaucrats need bonuses at the end of the year!
Burn, baby, burn!