Comment · Mon, March 14, 2016 · Ceretropic & Nootropics Depot
How is the nootropic laws in the US going to change?
Original post in this thread
Plasticperson32 · 11 points
Already seeing problems with tianeptine and maybe some peptides. Would love to hear so insight from vendors.
What they were answering
norepinephrinex · 1 points
I agree with a majority of what you're saying. One easy solution might be more cross-pollination between the major national regulatory bodies (FDA, EMEA, etc.) such that a drug approval in Europe, for example, is automatically a drug approval in the States and vice versa. That would seem to incentivize companies while also providing better patient access in the scenario above - e.g., generic firm X wanting to bring tianeptine to the US for depression without having the barrier of doing redundant testing. That also somewhat targets the argument that the US subsidizes the rest of the world's R&D, given firms can charge higher prices in the States rather than EU, Japan, etc. where prices are negotiated by government payers.
Just curious, are there any countries that use the government funding model you're describing? Certainly is an interesting proposal.
u/MisterYouAreSoDumb · Ceretropic & Nootropics Depot
One easy solution might be more cross-pollination between the major national regulatory bodies (FDA, EMEA, etc.) such that a drug approval in Europe, for example, is automatically a drug approval in the States and vice versa.
That would be an interesting proposal. We'd still have the issue of our messed up patent system. Seriously, it's more screwed up than I even thought. We met with a patent firm a couple months ago to discuss patenting some things we came up with. They opened my eyes a lot to why our system is the way it is, and all the crazy shit that makes it not work. Did you know that if a chemical structure is mentioned in any published paper, in any language, even in passing, that excludes it from ever being considered novel for patent purposes? It's nuts. So if some small paper in Slovakia mentions a chemical structure in a single sentence, and nothing else, that chemical is effectively dead from a patent perspective. You can still get use patents for it, if you prove it does something unique. However, you will never get the novelty portion of the patent, and will never be able to defend it properly.
Let's say you come up with a brand new chemical structure, and you find that it works for depression. You go through all the effort to run some trials, and file a patent. Your patent gets approved, and you also file in all the major countries you want to control it in. Then you apply for initial trials, and spend minimum of $100 million to put it through FDA trials, and get it approved. Now that it is approved, you bring it to market, and start selling it. Then you suddenly you get a letter from a Bulgarian company stating your patent is invalid, because they published a paper that mentioned the chemical structure as an intermediate. The paper was in Cyrilic, and you never even knew it existed. However, that does not matter. If the company can prove their paper was published before your patent filing, and it mentioned the chemical structure, you no longer have novelty, and your patent is now at risk.
Obviously this does not happen much, as you pay a patent firm to do deep Markush searching for mentions of structures before filing patents. However, this is why patenting drugs is so costly, and why drug companies push so hard for novel structures. Improving existing structures, or finding new uses for existing compounds, is just not cost effective. You need utility, novelty, and non-obviousness to get a patent and properly defend it.
Just curious, are there any countries that use the government funding model you're describing? Certainly is an interesting proposal.
Yes and no. The US actually spend a lot of taxpayer dollars funding initial research into new drugs. The issue is that we then let the companies have a free for all once they get approved. In reality, US drug companies only spend about 12% of their gross sales on R&D, and only about 18% of that on basic research into discovering new compounds. In the UK and France, their drug companies spend a higher percentage on R&D, because their governments incentivize it. Russia does a lot of government development of new drugs too. The US uses a lot of grants to fund initial R&D, which takes some of the risk off US drug companies. However, we don't put incentives and control on that money. It's just a freebie to the drug companies, essentially. The UK and France do it a lot better, and stipulate controls for the price of drugs, and how much profit companies can make, for helping fund the research. US drug companies spend a lot of money making people think they have to charge high prices to make back their R&D costs. However, that is really not the case. It's really only 12% of gross sales per year. Only 12% of that 12% is spent on trials, screenings, testing, and approval. In fact, most drug companies spend double their R&D budget on advertising. Think about that. There is more money for them in making people think their drug is better, than there is in actually creating a better drug. Only a single company, Roche, spends more on R&D than marketing. That to me is just nuts. Imagine if NASA spent double the money trying to make us think space travel was good, than actually trying to travel to space.