4 ms·
Unelected bureaucrats become nonviolent totalitarians. I for once am grateful to the faceless bureaucrat at the FDA who demanded that Theranos submit their dev
by HarryHirsch 10y ago
Unelected bureaucrats become nonviolent totalitarians.
I for once am grateful to the faceless bureaucrat at the FDA who demanded that Theranos submit their device to FDA for appproval. This unnamed fellow is the Stanislav Petrov of medicine.
- int_19h 10y agoOn the other hand, you also have FDA certification process to thank for the Daraprim monopoly and its consequences (like the ability to raise prices 50x). Which is to say, regulation can be good sometimes, and it can be bad sometimes, even when it's the same exact regulation. The trick is to find a balance that is beneficial to all of us overall.
- HarryHirsch 10y agoIt's unfair to pin Daraprim (and stock price movements when a candidate fails Stage 3 trial) on the FDA. They are tasked with safety. Pricing is an issue outside the remit of the FDA, one that most of the civilized world has dealt with successfully, usually through some form of centralized buying.
- int_19h 10y agoIt is fair to compare FDA to similar agencies in other countries, and ask whether their focus on safety is too extreme, to the point where it hampers other issues of importance. For example, is there any European country in which a generic alternative to Daraprim hasn't been certified yet? If there isn't one, then why is US special in that regard? Centralized buying is only a partial solution to drug prices. Access to cheap generics is also a part of that puzzle. If FDA procedures get in the way of that, it may very well be that the net balance for us is negative.