RU/Fluridil and why you won't see FDA approval

[bluesmiley]

I expressed similar sentiments about the FDA in another thread related to alternatives to propecia (like Eucapil), but What_a_Pity does a much better job in this thread.

http://www.hairlosshelp.com/forums/mess ... TARTPAGE=3

You'll have to scroll down a bit to read his words, but here's a telling snippet:

Old Baldy, despite the wisdom embodied by the "will of Congress" there are still a lot of snake oil products out there. Avacor, folliguard,****, viviscal, etc. etc. Go to any drug store and you will see all sorts of "cures" for hair loss, such as "nu hair."

But Congress and the FDA have succeeded in making it VERY expensive to bring a new drug to market. The figure is $900 million. So a drug company--which has a responsibility of maximizing profits for its shareholders--has to believe not only that the drug will be economically viable, but that it would yield such a profit that it would cover this huge initial investment.

Drugs that are efficacious but not profitable simply won't be developed. Indeed, as has been noted on this forum several times, Propecia hasn't been profitable for Merck. So future (more effective) versions of propecia simply won't come to market.

People have asked why RU-58841 hasn't made it to market in the US. Others wonder why fluridil hasn't made it to market in the US. Could it be possible that the high regulatory walls are diminishing consumer choice and retarding the discovery of treatments?

 

[viperfish]

I agree! It is not worth it for these products to seek FDA approval. There is just not a market for it and in most cases those who develop these products (eucapil, etc.) would see FDA approval as a complete waste of money. Nor do they have the money to spend trying to get approved in the first place. Hence, the importance of these small scale studies, like the ones conducted for fluridil and published in scientific journals. It is the most we can hope for.

 

[michael barry]

Guys it doesnt cost 900 million or anywhere near that for FDA approval. Phase III studies of the FDA approval process use from 1-5000 test subjects (human beings) and are the expensive portion of the trials.

So basically you give the new product X to maybe 1500 guys and a placebo to 1500 guys and see if product X has any efficiacy in male pattern baldness.

The Research and Development in inventing product X might be pricely because genetic researchers and the labs they work in arent exactly cheap.

However, bringing a drug to market only cost a few millions, not hundreds of millions.

 

[bluesmiley]

Guys it doesnt cost 900 million or anywhere near that for FDA approval. Phase III studies of the FDA approval process use from 1-5000 test subjects (human beings) and are the expensive portion of the trials.

So basically you give the new product X to maybe 1500 guys and a placebo to 1500 guys and see if product X has any efficiacy in male pattern baldness.

The Research and Development in inventing product X might be pricely because genetic researchers and the labs they work in arent exactly cheap.

However, bringing a drug to market only cost a few millions, not hundreds of millions.

Michael, 900 million -may- be an exagerration, but nowhere near as egregious a one as 2 million is.

Taken from
http://www.fdli.org/pubs/Journal%20Onli ... /art18.pdf

"It takes pharmaceutical companies approximately twelve years
and an average of $359,000,000 to discover and develop a new medicine.2 Approximately two years of this development time is devoted to FDA review of the firm’s new drug application (NDA).3 For all this time, effort and expense, the FDA only approved twenty-two new drugs in 1994.4 Even the FDA agrees that there is room for improvement
in this process."5

It's an old article, but I'm fairly certain the numbers haven't gotten any better since then. And, granted, I'm having trouble finding out how much the research portion of this costs versus the pure approval process, but if you make it so it only costs 2 million bucks to get a hair loss drug approved, I guarantee ya we'd be getting better hairloss drugs than minoxidil or propecia.

And that's a moot point because it takes on average 10 years to get approval. How is it going to be profitable for any company to research and develop a new hairloss drug if they're restricted to going through the FDA to do so, only to MAYBE have it approved in 10 years when some other medical procedure has rendered the need for the drug obsolete?

 

[bluesmiley]

And that's a moot point because it takes on average 10 years to get approval. How is it going to be profitable for any company to research and develop a new hairloss drug if they're restricted to going through the FDA to do so, only to MAYBE have it approved in 10 years when some other medical procedure has rendered the need for the drug obsolete?

Oh yeah, and I forgot, it won't be covered by insurance, so it will be way too pricey for Joe Blow, and Joe Blow will still think he can stop hairloss by running to the CVS and picking up some generic minoxidil.