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Comment by tomohelix | Hacker News Reader

A good introduction but it is too narrow on the "science" side and not enough on the regulatory side.

I can say this with pretty strong confidence: had the FDA not being so strict about its trials, lots of these experimental type of antibodies would have already received massived research and commercialization. But it is simply so much harder and so much more expensive to push something so different through the pipeline. A million things can go wrong, and even the biggest biopharmas can't handle that level of risk. Drug development, especially biologics, is so expensive it becomes incredibly conservative and resistant to changes.

Five guys in a garage can make a tech company that shakes the world. But 10 guys in a lab worth one million dollars trying to make a biologic drug will likely declare bankruptcy by the end of the year, at best. I would say by the end of the month is more likely.

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>I can say this with pretty strong confidence: had the FDA not being so strict about its trials, lots of these experimental type of antibodies would have already received massived research and commercialization

If the FDA was not so strict in requiring evidence, medicine would look like the supplement aisle, and the incentive to actually do the stupidly hard work of developing effective drugs & proving their efficacy would disappear.

Why even bother investing in developing a complex new antibody if you can sell some mushroom powder from a beach and claim whatever you want about it, ala Tim Ferris & "BrainQUICKEN".

There are plently of valid "incremental" critiques about the FDA. IMO, their devices and diagnostics divisions are weaker than CDER and CBER. Even those two (drug focused) divisions can be too slow moving and occasionally capricious about when they want more evidence. But their final decisions are generally pretty good, with a few exceptions. And most of those exceptions are drugs that they approved that they shouldn't have (e.g. Aduhelm) - not vice versa.

Can you point at a promising drug candidate with statistically solid efficacy data that CDER or CBER has rejected?

Also - note that there are approved scFVs and VHHs and mimetics - as stated in the article. Each is useful in particular situations, but none is some sort of wild medical breakthrough. There is just no evidence that any of these modalities would be attracting extraordinary investment "if only it weren't for the FDA".

You are twisting the words. I said "trials", you turned it into "evidence" and assumed things I never said.

Evidence is still needed. Safety and efficacy are still required. But how and why those happened doesn't have to be as strict. Where the drug came from, how it was made, etc.

The FDA already did it once with the COVID vaccine. It skipped or rushed almost the entire process and it turned out mostly fine. But anything else it asks for everything, down to the minutiae like how many seconds did the cells get thawed out or excessive requirements like proving production quality can remain stable for months while a drug batch is produced in only 2-3 weeks.

The FDA basically say drugs has to be produced in their way and their way only. Any deviation or attempt to try something new carries too much risk of rejection. Following their way usually give good results. But not everything can be forced into that narrow path, especially for something like biologics that involve living cells. Even something as tried and true like a mAb still routinely get rejected internally because the cells producing it simply can't keep making them without some additives that are either too expensive or not yet approved for the current process. Biology is messy and it isn't easy getting things to work even when they are supposed to work, so making something "new" to work in a specific way is too risky. That is my point.

The FDA approves new modalities that do things “in their own way” all of the time!

Yescarta, Kymriah, the mRNA vaccines, the approved VHH, scVF and “mimetics” in the article. Here’s a whole page of cell/gene therapies, many of these were produced “in their own way” or in ways that didn’t exist at all 10 years ago. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-t...

Warp speed did accelerate review of COVID vaccines, but it didn’t change trial design nor manufacturing requirements - I’m not sure that supports your argument. I have seen the FDA be quite receptive to innovative trial design - baysean protocols, conditional endpoints, genetic diagnostics in inclusion criteria, etc

If you think there is a whole wave of innovation being held back by the FDA - can you point to examples of drugs it rejected or innovations happening in any other country that should be happening here?

Lots of stem cell “medicine” is happening in Korea where the requirements on cellular medicine are more lax… none of that is translating to effective medicine here afaik.

As you say, biology is hard and messy! And it is the job of the FDA to prevent five 20 year olds in a garage from injecting desperate cancer patients with some hacked together MVP. We’re agreed on that.

But I just don’t see any evidence of a giant pool of untapped innovation at the preclinical level that the FDA is blocking.

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