The 21st Century Cures Act, and its effect on next hair treatments

[Trouse5858]

But again, the law could reduce the timeline for release of a successful treatment.

We've never had a successful treatment. New laws are not going to change anything

I understand what you're saying but you're missing the larger point. It's true that the Science has to be there for the passing of this bill to have a real effect, but the current FDA timelines are a legitimate barrier to potential entrants who could possibly come up with the science down the line for a new treatment. The incredibly long timeframes also necessitate a huge window for private companies to be able to raise and re-raise capital for clinical trials that are largely excessive. So long as companies have a stamp of approval from a safety standpoint, I would be thrilled to test the efficacy of their product myself when it's on the open market. The chances are that something will be produced in the near future that outperforms fin with a much better safety profile.

[bigentries]

I understand what you're saying but you're missing the larger point. It's true that the Science has to be there for the passing of this bill to have a real effect, but the current FDA timelines are a legitimate barrier to potential entrants who could possibly come up with the science down the line for a new treatment. The incredibly long timeframes also necessitate a huge window for private companies to be able to raise and re-raise capital for clinical trials that are largely excessive. So long as companies have a stamp of approval from a safety standpoint, I would be thrilled to test the efficacy of their product myself when it's on the open market. The chances are that something will be produced in the near future that outperforms fin with a much better safety profile.

Again, I don't buy it. Otherwise we would have seen something coming out of Cuba in the last 30 years.

I understand people being upset at FDA corruption, which I guess is why people tend to have so emotional responses against them. But I've never seen any evidence that bureaucracy is stoping or slowing any advancements when it comes to hair loss research. And quite frankly some over here end up advocating ruthless unethical clinical trials from time to time.

We just don't have the knowledge to deliver a treatment at this point, simple as that. Once someone finds a reliable, consistent treatment in the research phase, money or timelines will not be a problem, there are people eager to sell a baldness cure ASAP

[It's2014ComeOnAlready]

Here's an article that explains the effect the 21st Century Cures will have on clinical trials and drug development. It's long, but explains everything quite well.

http://www.raps.org/Regulatory-Focus...ury-Cures-Act/

[burtandernie]

There is never a point arguing with pessimists because the glass is always half empty no matter how many times or ways you try explaining something. There are numerous like 4 or 5 treatments pretty far into trials already so I mean its hard to argue there not some things that are working to some degree right now. I would argue patents are almost equally important. All this new stuff popped up like a few years after propecia patent expired seems pretty coincidental.
I would agree though curing most problems like MPB is not at all an easy thing to do and that has always been the biggest show stopper on anything new.

[burtandernie]

When do we know or do we ever how the timelines on any of this changes if the bill did speed it up? Is this something that was passed but takes 5 years to actually implement and enforce? I dont really believe its going to make a difference until companies start announcing real concrete timeline changes. Until then its just government bureaucracy at its finest in my eyes. Can we see Seti in 1 year?

[It's2014ComeOnAlready]

When do we know or do we ever how the timelines on any of this changes if the bill did speed it up? Is this something that was passed but takes 5 years to actually implement and enforce? I dont really believe its going to make a difference until companies start announcing real concrete timeline changes. Until then its just government bureaucracy at its finest in my eyes. Can we see Seti in 1 year?

If and when this bill is signed into law, it becomes law within 10 days. I've read an article that they won't be able to implement all of the changes right away, because the budget for 2016 has already been decided. However, different trial designs, fda review process, or use of biomarkers isn't something that should cost money, since it's more of a policy change.

It is my opinion that we could see Seti in a year. This drug has had 8 clinical trials, thousands of patients with strong safety data, and even made it through a phase 3. Technically, it has made it through trials, but they want to test it for a different application, and using the same method (oral medication). I've read all of the literature on the proposed changes, and Setipiprant strikes me as an excellent example of a drug that could really be accelerated under the new laws.

There is a proposed change to the law that would allow drugs that are repurposed to hit the market without trials, but with more strict feedback and market review once it's hit the market. I think a drug like Setipiprant *could* be released once the law is signed without going through at least 1 trial, because it has gone through 8 trials, and a phase 3 (which technically means passing the FDA rules), but I doubt it.

The provision for use of biomarkers could also really speed things up, because they could easily answer the question - does setipiprant reduce pgd2 levels to normal in the scalp? They could test that with technical equipment, rather than having participants take the drug for 6 months. There has been some controversy over biomarkers with regards to treating cancer, and does a particular drug actually treat the cancer, as opposed to just shrinking a tumor etc etc. BUT this is hair loss. Excess PGD2 in the scalp or not, we are all otherwise healthy.

[noisette]

21st Century Cures Bill Close to Congressional Agreement

"The U.S. Senate and House of Representatives are close to agreeing on a bipartisan package of bills called the 21st Century Cures bill ".

"According to an April 6, 2016 RAPS (Regulatory Affairs Professionals Society) posting, while the FDA is likely to look favorably on the total bill "

source: https://ryortho.com/breaking/21st-ce...form=hootsuite