Posted on 11/20/2023 1:26:17 PM PST by nickcarraway
"The FDA's regulations related to animal testing no longer fully conform with applicable law," writes the Kentucky senator.
Congress unanimously passed the FDA Modernization Act 2.0 in December 2022. The law allows drug companies to find alternative methods of assessing their products, without testing them on animals or human beings.
The bill was sponsored by Sens. Rand Paul (R–Ky.) and Cory Booker (D–NH). Its goal was to speed up the drug approval process, and to let scientists experiment with approaches methods that are more humane than testing on live subjects. Reason's Elizabeth Nolan Brown aptly summarized the bill's achievements, noting that "previously, all drugs in development were required to undergo animal studies before being tested in human trials. Now, drug companies will still have the option to start testing experimental drugs on animals, but they won't have to."
And yet the Food and Drug Administration (FDA) has not taken action to update the agency's regulations.
"The FDA's regulations related to animal testing no longer fully conform with applicable law," writes Paul in a letter to FDA Commissioner Robert Califf.
Paul's letter, obtained exclusively by Reason, was co-signed by Booker and several other senators from both parties. It notes that the FDA has previously spoken positively about moving away from animal testing. But companies currently submitting applications for drug approval still have to deal with FDA requirements that stipulate human or animal testing—at least on paper.
"These and other regulatory provisions no longer reflect the full scope of the governing statute and should therefore be updated as expeditiously as possible," writes Paul.
The FDA should swiftly update its written requirements for new drugs. Until it does, this is a powerful reminder that even when the Congress, the president, and the agency itself all agree that a regulation should be undone, deregulatory efforts can hit a dead end.
There is no reason to force scientists to experiment on living creatures if better testing methods are available. What's the holdup, bureaucrats?
Why test them at all?
All of the drug testing has been lobbied for by the testing company and put into law by Congress. This is one reason why drugs are so expensive. If you are the only one who does a particular test, as set out in the law, then you can charge whatever you want for that test. Because of the labyrinthian laws there can be no competition. That’s why and he should know that. If he doesn’t, he isn’t paying attention. Therefore, I suspect he’s just soliciting a *ahem*” contribution from said company that does those tests.
There is room for alternative methods in many studies.
Animal research has what it calls the ‘Three Rs’ to reduce animal use and suffering:
Replacement
Reduction
Refinement
These call for replacing animal use with other means when possible (as computer modeling progresses, it can go a long way toward this);
Reducing the number of animals needed to achieve the desired result; and
Refining methods in order to reduce pain and suffering that is not really necessary.
It’s possible that at some time in the future, we may not need animals very much; but for now, we still need them.
Based on COVID why have the gov involved in testing at all? Obviously public good no longer means anything so all we have left is regulation designed to empower government and protect/enrich pharma donors.
Our company is medical device but I can confirm that a lot of animals are wasted during testing. Much of the testing must be done in China due to the enormous cost.
For instance if I made a wound gel and a sponge, both of identical composition, the FDA requires them to be tested separately. You might argue that you could take said sponge, place it in water and break it into the gel both formulas should be considered one in the same.
Scientifically you would be correct.
Not for the FDA. Even if you only sold the sponge but in a different shape, say square instead of rectangular you have to start testing all over.
It’s “final finished product” that matters, not chemical composition.
They have to justify their jobs somehow.
Just test them on Democrat politicians.
I agree with you, but I don’t see how 2.0 really changes the current practices of most major research institutions in the US, with regard to animal use. My experience was in the academic setting, but I was conversant with people who worked in the private. We were inspected twice a year by the FDA, protocols looked at for design and effort to minimize animal use and suffering, animal care analyzed as to coordination with best practices, etc.
Why test them at all?
Indeed ... just sell any crap ... or even force people to take it ... without proving either safety or effectiveness. It worked great for pfizer’s mRNA experiment.
So what do they intend to do, rely upon computer modeling? I’ve already decided no more vaccines for me. And if any new drugs come out I will wait awhile to see if any side effects occur in those taking it. I have no desire to play guinea pig to big pharma like what happened with the covid vaxx.
“Why test them at all?”
You mean like they Didn’t do with the covid poisons
Still waiting to see Fauci”s head in a fly cage.
That will be sweet to see
He is an evil entity
If a new heart drug or cancer drug comes out I’d very much hope that it was first tested on mice and chimps before it was given to me.
“The law allows drug companies to find alternative methods of assessing their products, without testing them on animals or human beings.”
ok. So what if they can’t find alternative methods?
Of course drugs must be tested in animal and humans.
What other method?
I agree with you. I’d want veterinary drugs given to my dog or cat to be tested on live animals, too.
That doesn’t mean that everything needs to be tested on animals; but many things do and that will remain so for quite a while.
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