21st Century Cures Act Says Drug Approval Can Be Expedited In Cases Of Unmet Need.

[nameless]

Here's an article that indicates that the new 21st Century Cures Act allows drugs to be approved sooner if there is an unmet need. This article is very recent so it looks like this provision was in the final version of the bill.

https://www.statnews.com/2016/12/01/21st-century-cures-act-fda-approval/

In another article I read awhile back the term unmet need was defined as a situation where current treatments for a medical condition are nonexistent or they don't work well.

There are treatments available for hair loss but they don't work well.

 

[Blackber]

Here's an article that indicates that the new 21st Century Cures Act allows drugs to be approved sooner if there is an unmet need. This article is very recent so it looks like this provision was in the final version of the bill.

https://www.statnews.com/2016/12/01/21st-century-cures-act-fda-approval/

In another article I read awhile back the term unmet need was defined as a situation where current treatments for a medical condition are nonexistent or they don't work well.

Who knows if they would consider hair loss an "unmet need". Unfortunately, as we all know, the world views it as a cosmetic issue and doesn't realize the mental effects of hairloss.

 

[nameless]

Who knows if they would consider hair loss an "unmet need". Unfortunately, as we all know, the world views it as a cosmetic issue and doesn't realize the mental effects of hairloss.

The term "unment need" is not about the severity of the health issue. It's about the quality of the available treatments. Unmet need applies where currently available treatments don't exist or don't work well.

 

[Blackber]

The term "unment need" is not about the severity of the health issue. It's about the quality of the available treatments. Unmet need applies where currently available treatments don't exist or don't work well.

What I'm saying is I'm not sure they would consider it a "health" issue.

I forget which hair loss researcher said it but recently a forum member posted an article/interview from one of them stating that since hair loss was considered a cosmetic issue the FDA was less likely to approve treatment that had any side effects.

Also, unmet need is really someone's opinion. Everyone here believes finasteride and minoxidil are ineffective treatments (myself included) but some shot caller at the FDA might not think that. Although the fact a new hair loss treatment hasn't been approved in 20 years helps us.

Overall I think this bill is a good thing and a step in the right direction but I wouldn't be so quick to think this bill is an "A + B = C" solution - "C" being a new treatment. It's more complicated than that. Japan approved their version of this bill back in 2014 and they're still working out the kinks, just look at how long it took Shisiedo to get their trial approval.

Just because the new rules allow the process to happen faster doesn't mean it will - I recommend cautious optimism.

 

[nameless]

What I'm saying is I'm not sure they would consider it a "health" issue.

I forget which hair loss researcher said it but recently a forum member posted an article/interview from one of them stating that since hair loss was considered a cosmetic issue the FDA was less likely to approve treatment that had any side effects.

Also, unmet need is really someone's opinion. Everyone here believes finasteride and minoxidil are ineffective treatments (myself included) but some shot caller at the FDA might not think that. Although the fact a new hair loss treatment hasn't been approved in 20 years helps us.

Overall I think this bill is a good thing and a step in the right direction but I wouldn't be so quick to think this bill is an "A + B = C" solution - "C" being a new treatment. It's more complicated than that. Japan approved their version of this bill back in 2014 and they're still working out the kinks, just look at how long it took Shisiedo to get their trial approval.

Just because the new rules allow the process to happen faster doesn't mean it will - I recommend cautious optimism.

Oh yea, I'm not saying that the FDA will definitely apply the provision I referred to in the case of hair loss. They may not. We need time to go by to see how this plays out.

 

[mghrs]

but then how many phases are required to get the treatment to market ? we still want trials, other wise the market would be full of scams on a higher level (like for example doctors claiming say bimatoprost works when it doesn't) and we will be left to do the guessing? we will become the trial participants while actually paying.

 

[plisk]

for this to happen you would have to convince the FDA that finasteride and minoxidil are ineffective treatments.

I'm going to enjoy watching the fervent finasteride defenders begrudgingly start to admit that finasteride is an absolutely underwhelming treatment.

 

[Folliman]

for this to happen you would have to convince the FDA that finasteride and minoxidil are ineffective treatments.

I'm going to enjoy watching the fervent finasteride defenders begrudgingly start to admit that finasteride is an absolutely underwhelming treatment.

finasteride is pretty good though, it's not perfect but it will make you less bald, and buy you about 5 years of maintenance. I'm just waitng for seti to be accessible to ditch it, lol.

 

[mghrs]

if this is effective, most companies would want to take advantage of it. most companies who are trialing hair loss are in phase 2 now. I think after this phase they can release their product if proved effective. bimatoprost, setipiprant, histogen and replicel. honestly i am more interested in combining methods. follica ability to introduce new follicle and then histogen or repicel or even both to turn them into terminal hairs and maybe a tumor might grow as well (joking). 2017-2018 should be interesting. I think there should be an interview or emails to those companies to see if they plan to take advantage of this new regulation like replicel did in japan.

 

[nameless]

finasteride is pretty good though, it's not perfect but it will make you less bald, and buy you about 5 years of maintenance. I'm just waitng for seti to be accessible to ditch it, lol.

For starters, the FDA is not going to force hair loss treatments to go through all 3 phases of studies because one man, Folliman, doesn't need treatment right away.

 

[project100]

finasteride is pretty good though, it's not perfect but it will make you less bald, and buy you about 5 years of maintenance. I'm just waitng for seti to be accessible to ditch it, lol.

Not necessarily. It bought me exactly 0 years of maintenance, lol. Been using it for 2 years. Either I'm a really bad receiver, or else finasteride actually prevented me from going completely bald at 21. Not risking it to find out, though.

 

[nameless]

but then how many phases are required to get the treatment to market ? we still want trials, other wise the market would be full of scams on a higher level (like for example doctors claiming say bimatoprost works when it doesn't) and we will be left to do the guessing? we will become the trial participants while actually paying.

If the "unmet need" provision is applied to hair loss then I think that treatments would have to complete phase 2 in order to be marketed. The company would still have to do phase 3 studies but they could do those phase 3 studies after marketing the drug. They would have to complete the phase 3 studies within a specific time frame.

 

[Folliman]

If the "unmet need" provision is applied to hair loss then I think that treatments would have to complete phase 2 in order to be marketed. The company would still have to do phase 3 studies but they could do those phase 3 studies after marketing the drug. They would have to complete the phase 3 studies within a specific time frame.

I just hope it applies to hair loss in the first place.