An Iron Curtain Has Descended Upon Psychopharmacology
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 or pull the drug out of the market because it was simply beyond their jurisdiction. Doing any of that would constitute a version of the Iron Curtain.So FDA is doing the right thing to prevent this from even happening by requiring the manufacturer to have everything in place before the drug sees the market.Furthermore, a randomized controlled trial is no synonym of "drug is good to use". Do they work on US populations? How big is the sample size? Is the methodology sound? What is the side effect profile? Is there any long-term data (like 1 year after using the drug)? These are answered for FDA-approved drugs, but not necessarily for non-approved ones, especially if you are not a healthcare professional that speak Russian (even then, they have teams of professionals looking at drug applications, are you sure you're not overlooking anything?).