Will The 21st Century Cures Act Speed Up Hair Treatments

[MoreHairpls]

It seems now that the 21st century cures act is going to pass, and I think soon as well? (any input on this appreciated)... So my question is, does anyone know or could give an educated guess as to whether or not this legislation being passed would allow for new hair treatments to come a lot quicker? For instance, the treatments that normally would have to take 5+ years of trials before being released, would we then see those much much sooner? I am very curious, because if we could get Histogen/replicel(shiseido)/tsuji/follica/RT1640 (rivertown's compound) etc..to come out in the United States much earlier, that would obviously be fantastic!

 

[Pavi]

Only if the treatment involves stem cells

 

[Blackber]

It seems now that the 21st century cures act is going to pass, and I think soon as well? (any input on this appreciated)... So my question is, does anyone know or could give an educated guess as to whether or not this legislation being passed would allow for new hair treatments to come a lot quicker? For instance, the treatments that normally would have to take 5+ years of trials before being released, would we then see those much much sooner? I am very curious, because if we could get Histogen/replicel(shiseido)/tsuji/follica/RT1640 (rivertown's compound) etc..to come out in the United States much earlier, that would obviously be fantastic!

Only if the treatment involves stem cells

I don't believe the 21st Century Cures Act has anything to do with stem cell based treatments, only traditional medicines.

A quick scan of the act summary here does not mention anything about stem cells:

https://www.congress.gov/bill/114th-congress/house-bill/6

It was sent to the Senate today: http://www.healthcaredive.com/news/21st-century-cures-act-heads-to-the-senate-today/431660/

 

[Pavi]

I don't believe the 21st Century Cures Act has anything to do with stem cell based treatments, only traditional medicines.

A quick scan of the act summary here does not mention anything about stem cells:

https://www.congress.gov/bill/114th-congress/house-bill/6

It was sent to the Senate today: http://www.healthcaredive.com/news/21st-century-cures-act-heads-to-the-senate-today/431660/

I stand corrected. Thanks.

 

[pegasus2]

It actually deals with both regenerative medicine and traditional drugs. It passed the Senate yesterday, and just needs the President's signature. This should speed things up a lot.

https://www.wired.com/2016/12/future-regenerative-medicine-inject-see/

Under the act, the FDA would have the authority to grant accelerated approval for regenerative medicines, skipping straight from animal models and safety trials, over efficacy testing in humans, to post-market review. The new laws would also compel the FDA to update its regulations for such products.

 

[Folliman]

So now what does it mean for us? Will we have seti, replicel, follica, etc. sooner?

 

[Gone]

It passed the Senate??? Are you sure you don't mean the House

 

[Gone]

Well I checked and you're right, holy sh*t that was fast.

 

[Blackber]

Well I checked and you're right, holy sh*t that was fast.

The wired.com article that @pegasus2 posted said that this is the out going administration's number 1 priority right now.

 

[Gone]

From the link: "The real thorn is simply the reality of being human."

I know that feel

 

[Gone]

So, how many years off of approval times are we looking at?

 

[hairblues]

So, how many years off of approval times are we looking at?

This President outgoing is going to sign it so it will be implemented.

 

[Gone]

I mean approval time off of drug trials

 

[hairblues]

I mean approval time off of drug trials. The wired article mentioned going straight to phase 3, so I imagine some drugs might only take 3 years max

You can google and do some research. I don't think anyone knows that here.
If you come up with answers please share.

 

[MoreHairpls]

I've read a little bit on it. It seems that they are trying to relax FDA regulations on new medical treatments and devices coming to market in general. I won't pretend to know everything it does, it's been described as a "labyrinthine bill", but I have a feeling that this would help our case for hair treatments. If it does, man that would be so exciting to see all the new treatments released way sooner! Here's two small excerpts from an article I read on the winners and losers of the new bill:

Winner: 'Real world evidence'
The Cures Act directs the FDA to evaluate the use of "real world evidence" for approval of new indications for FDA-approved drugs. Proponents see this as a way to apply useful and timely information learned from observational studies, patient input, anecdotal data, and other research to drug and device approval.

Loser: Randomized clinical trials
Currently the gold standard for testing drugs and devices for safety, the adoption of real world evidence standards may indicate that randomized clinical trials will become less important for drug and device approval.

"Among other measures, the legislation calls for the use of “data summaries” to support the approval of certain drugs for new indications, rather than full clinical trial data. The Cures Act will also allow drug companies to promote off-label uses to insurance companies, allowing them to expand their markets."

 

[Folliman]

Promote off label use? It will be easier to get fevipiprant then