As a former manufacturer of medical devices, who left the industry a few years after the FDA took over medical device approvals, I wholeheartedly agree its time to make the FDA compliance voluntary, if not get rid of FDA altogether.

1976 was the year FDA took over medical devices. They had a campaign showing how many deaths (it was less than 10) could be attributed to faulty medical devices to support their power grab. The original bill required manufacturers to submit their new product offerings for scrutiny by FDA, and FDA had 90 days to turn the application down, OR THE COMPANY COULD MARKET IT. It didnt take long before the rule was changed somehow to forbid marketing UNTIL the FDA approved it. Soon, the approval times ran out to 18 months, effectively shutting out smaller companies from innovating. The worst part was that the application had to show that the "new" product was essentially the same as "existing" products prior to 1976. This was insane, in that it stopped almost anything that was different. If you could not show it was not essentially an "old" product, you had to go through a ridiculous new drug approval process that took years.

Talk about 10-289 applied to research. I got out of the industry as I am an inventor and it was crazy to stay in it and have my inventions "approved" perhaps in 18 months by bureaucrats. The whole deal was designed I think by the big companies that wanted to stop competition from coming in.

It bothers me to this day how stupid people are in believing that the FDA is protecting them somehow. We got FDA inspections, and they were done by untrained people who relied on OUR standards, and fined us if we didnt meet our own standards, however good or bad they were. There was no way these inspectors could even know enough about all the products out there to pass judgment on their safety.

If the FDA wasnt mandatory, but just voluntary (people who went by their inspections and standards could put the FDA stamp on their products), people would be a lot safer. FDA would have to up their game, and there would be room for other supervisory or inspection groups to do a better job.

In all, they lost one inventor (me)- maybe more. I make off-road lighting equipment now that isnt regulated. No more regulation for me.

If the FDA were really concerned about deaths, they'd stop prohibiting life saving drugs from distribution until 10-year or longer trials are complete, even when dying people are willing to take the risk.

I have no problem with the FDA mandating an accurate list of ingredients or even warning labels on some products. But they should not be able to ban any product, or even any health claim that they can't disprove in court.

I have a big problem with the FDA. For years, in the medical industry, I have known about testing procedures that have been in use in other countries (marginal places, like Europe, for example) for a decade before they were permitted to be utilized in the US. How many people died because the test that would have detected their cancer was held up by the FDA?

Then I read about antivenins: Since about 2002, the FDA has not approved any anti-coral-snake antivenin for use in the US; the existing supplies outdated in 2004. Now, if you are bit by a coral snake, all they can give you is anti-rattlesnake antivenin (which should help somewhat, but not for the neurotoxins that are specific for the coral snake).

Yes, I am aware of the colchicine debacle (though I did not know about the other meds, good info, that). I too would like to get my choice of meds from India if I need them...

Medical science, in dealing with the FDA, is like a competitive swimmer trying to win a meet with an anvil tied to his ankle.

Jan

Cronyism is never pure. However, as filthy cronyism goes, this is an outstanding example. It is almost beyond stupid if such a thing can exist. There is hardly anything that the current government, which is comprised of radical left and self-serving weasels, can do that isn't stupid.. (Yeah I know there a few honorable people - very few).

A lot of our bloated government's alphabet soup of departments and agencies need to go away with the FDA.

"Bringing drugs that predate the modern FDA under regulation isn’t a bad idea in principle, "
From the viewpoint of a looter agency that wants absolute power to wreck the lives and finances of millions of people who would otherwise have been fine.
Defund them now.

Good find. The whole war on drugs should be ended

That's the 'Progressive' world for ya...they invented cronyism, racism, the pharmaceutical industrial complex and allopathic medicine that seeks not to cure but to make the most money while your sick...an extension to Sanger thinklessing.

What frame of 'Brain' could think of a system of helping one while 20 die under the same carelessness.