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Um, no, it doesn't. What's the FDA going to do if they have additional questions or want additional studies done?
The FDA doesn't approve these drugs for the exact same reason the author doesn't prescribe them.
Lament the situation, sure, but pointing fingers at the FDA seems dumb.
The author is talking about a market category in which successful drugs are worth billions. If these Russian drugs are so effective, why isn't some pharma firm in the US driving them through testing? The answer can't be "because the FDA is capricious and rejects drugs at the last minute", because that problem applies to all drug research, and we obviously have a lot of drug research.
* US pharma is developing a me-too / copycat drug that has very similar molecular structure
* US pharma has tried and it failed before public announcement (oh there are so many of them)
* US pharma negotiated contract and found that the Russians are non-negotiable :)
The author is talking about a market category in which successful drugs are worth billions. If these Russian drugs are so effective, why isn't some pharma firm in the US driving them through testing? The answer can't be "because the FDA is capricious and rejects drugs at the last minute", because that problem applies to all drug research, and we obviously have a lot of drug research.
But if a company spends decades and billions of dollars fighting for the approval of a drug they do not hold the patent on, they are by no means guaranteed making even a single penny of that investment back, even in the best case scenario where it succeeds in getting through the FDA.s
The author is talking about a market category in which successful drugs are worth billions. If these Russian drugs are so effective, why isn't some pharma firm in the US driving them through testing? The answer can't be "because the FDA is capricious and rejects drugs at the last minute", because that problem applies to all drug research, and we obviously have a lot of drug research.
But we have patents, as well. If a major US drug company invents a new superdrug, and spend decades and billions of dollars to get it approved, they can at least be sure that if it gets approved they will get the royalties from its sale. But if a company spends decades and billions of dollars fighting for the approval of a drug they do not hold the patent on, they are by no means guaranteed making even a single penny…
The author is talking about a market category in which successful drugs are worth billions. If these Russian drugs are so effective, why isn't some pharma firm in the US driving them through testing? The answer can't be "because the FDA is capricious and rejects drugs at the last minute", because that problem applies to all drug research, and we obviously have a lot of drug research.
It seems like it might be useful (assuming it isn't already) to separate the rights concerning drug discovery and those demonstrating efficacy/safety to allow costs to be recovered.
Then again, it needs to be weighed against the inevitable rent-seeking that pharma has a name for.
[1] but don't have any evidence handy to back it up, so ICBW.
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Either I completely failed to see sarcasm in your comment, or you completely failed in Reading Comprehention 101. If it's not the former, please re-read the article carefully before criticizing things author is not saying.
Imagine that there were no FDA Iron Curtain and doctors prescribed afobazole because "the paper was good" (or more likely because the money was good). Then people taking this drug got hospitalized left and right (or - shudder - found dead) because of side effects. FDA could not do anything to protect her dear US citizens. She couldn't sue the manufacturer or ask them to do further research or impose black box warning…
The problem isn't (only) that US drug standards are strict. The problem is that the financial burden of testing a new drug, which is significant, lies solely on the manufacturer, who can only recoup those costs by selling patented drugs at high prices. This means that the incentives don't line up for drugs not covered by US patents: because there's no profit in selling them, no manufacturer can justify funding the clinical trials to get them approved. This despite the fact that society would, as a whole, benefit from having those studies done.
One obvious solution would be a government program whose mission is to identify promising treatments for which private incentives don't line up, and shepherd them through the approval process by funding clinical trials and so on. You could also imagine a free-market variant, in which the government just auctions off US patent rights for foreign drugs; the auction winner gets exclusive rights to sell the drug in the US for some limited period of time in exchange for agreeing to fund FDA approval.