How is the nootropic laws in the US going to change?

However, things piracetam went off patent decades ago - so if they were sold in drug stores, it'd be under the purview of a generic firm. I wonder though - what ultimately is the policy if a drug has been approved by FDA equivalents overseas and a generic wants to file an ANDA for it in the US? Are there any real precedents here?

No, we only have orphan drug status, and that is for rare diseases that only affect a small number of people, and have no current treatment. A Canadian company recently tried to approve Tianeptine for Rhett's Syndrome, for example. However, Tianeptine is never going to be approved as a generic drug for depression, as nobody will fund the trials in the US. Even though we know it is better than SSRIs, and is safely used in France, it's all about the money with FDA trials. If you can't patent it, nobody will pay for approvals. That is why we see such a huge push in investment into novel blockbuster drugs. The money is in finding a completely new molecule that can be patented, and will bleed dry a certain portion of the population that has no choice to use it. Try turning down the $40,000 cancer medication you need to stay alive. We should not have to put people in that position. Finding a novel antidepressant, or ADHD med, is a big money maker too. Drug companies don't want to sell generic Piracetam. They want to risk it big on a completely new molecule, that they can either sell for insane amounts to people that have no choice, or to an insane amount of people for something like depression. Investors in Neuralstem were jumping at the chance of getting a new antidepressant to market with NSI-189.

What we need is a system that uses government funding to have safety trials for drugs like Piracetam and Tianeptine. Then let the generic drug companies bring them out and compete. Until we realize that our system is not suited to providing what is best for patients, and is there to provide what is best for investors, we will sit here with drugs that the general public will never have access to. Not to keep beating the same dead horse, but look at NSI-189. Its initial development was funded by DARPA, using our tax dollars. If NSI-189 is eventually approved, those same tax payers who need an antidepressant are going to get financially raped till the patent runs out. That is not right in my opinion. If you use government funds to develop something, the public has a vested financial stake in a fair price being levied on it down the line.

Finally, as to a system that promotes human advancement - it's certainly an interesting dilemma in that it brings into question a larger philosophical discussion over capitalism.

I think capitalism can work just fine, with appropriate government oversight. What we have now is an oligarchy, where our laws are controlled by money. Why can we not treat drug development and approval as a public investment, like NASA? We use public funds to develop new drugs, and trial them for safety. Then those patents are turned over to the private sector as a whole, who can then compete to bring the best solution for consumers. Space X is benefiting from NASA's discoveries over the last few decades, and trying to improve upon them. That is in the best interest of the public as a whole, and still allows companies to use what makes capitalism great, while not letting its drawbacks slow the progress of humanity. Using the US government to create insane barriers of entry only slows progress. I want safety and effectiveness studies to be run. I just think the barriers to properly running them now are ridiculous. Use government for what it is good at, and leave private entities to do what they are good at.