@Boerenkool, there are very few areas where I disagree with @docslotnick, but the FDA is one of them. It is true that the FDA process is slow and expensive.But I think that it is true in every western country. While some drugs get approved in other countries faster, some drugs get approved here faster too.
Every medical drug supervision agency has been deeply marked by the thalidomide tragedy of the 1960s. The US largely avoided it because the FDA, through Dr. Frances Kelsey, never approved the drug as it believed that the studies were too incomplete. Since that time, the FDA and every other drug supervision agency have hardened their process to try and avoid another thalidomide horror.
I am not saying by any means that the FDA process is the best it can be, I am sure it could be greatly improved. But, differently from Doc and @Sam, I was born and raised abroad until my grad school years, and have also extensively worked abroad. I have been able to compare first hand bureaucracies around the world, I would say that, in general, US bureaucracy is a lot less bothersome that most any other I have seen. My direct experience includes France, Germany, Italy, Spain, Belgium, Switzerland, and a lot of African and Asian countries. Part of the cause I live here is that very reason.
So, @docslotnick, @Sam, forgive me for snickering a bit when I read your critiques! I would laugh at seeing you tackle the bureaucratic procedures in France or Germany
The French state got totally remade between 1789 and 1815, in a more radical way than you can think… Everyone got “fired” (i.e. decapitated) and all the procedures were restarted from scratch! The state itself had nothing to do with what existed before.
Between the three (France, Germany, US), The US is the oldest and most mature going concern.
The EU has way more regulations for many things than the US, but it’s also why many products there (including things like cosmetics, personal care products, household products) are a lot safer in the EU. Some companies accordingly have separate formulations, and the US version has a lot of questionable ingredients you can’t use in the EU.
It may be true that the EU has even more regulations. I remember the TTIP debate in Europe (haven’t heard about TTIP in a while). We were all going to die of chlorinated chicken from the US or something. In the EU, you can’t use chlorine to desinfect chicken meat.
The others I know are in general much worse. Africa and Asia are mostly extremely corrupt (Ivory Coast, Senegal, Cameroon, Indonesia…), or use state intimidation (China). Spain is so bad that there is a special profession called gestors that deal with administration for you (you have to hire them of course). Italy is even worse, so people don’t even go through the administration and do much of what they need to do through black market — many things can be obtained illegally but in a manner that is accepted because regular way to do things is impossible.
I could go on for much longer. One country whose bureaucracy I don’t know is the UK – may be better?
@Michel I generally agree that the FDA is fairly good on drugs. I even agree with their trepidation over the trials run with FIASP.
But they are a monstrous bureaucracy. How else do you explain how they hold up innocuous devices, or simple changes to already approved devices? Why does Dexcom need FDA approval to make the most simple change to their equipment.
I am all for the government protecting those who are not bright enough to protect themselves. But you end up punishing the capable to avoid someone less able from possibly hurting themselves. Lowest common denominator is not how I want to live.
My experience in private companies is that it us very difficult to design reasonably foolproof processes. I figure it is much harder with gov agencies. Some time ago I was hopeful of privately contracted gov services, but they have been absolute busts Imho, due to dramatic lack of integrity by contractors. So I am not sure there is a perfect solution today:( Less regulation where appropriate is good, of course. But wherever population densities increase it is not possible:(
My guess it’s also that the FDA’s procedures weren’t designed for high tech stuff (especially software), which has constant incremental edits, and they have yet to adapt their protocols to the current marketplace in that respect. They need to figure out a way to separately classify changes that will not effect functionality in any significant way and have them fast-tracked. I know for example for institutional research approval (another giant bureaucratic headache), I have to submit every little stupid thing I change for approval, but the actually stupid things can sometimes get routed through a faster process, depending how it’s set up.