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vwinsyee | 11 years ago
Amusingly, the top comment on a front page HN post [1] right now concerns one of the first court cases [2] that gave FDA some real power. Before this case, companies could sell a poison like emetic tartar and market it as a hangover drug. Selling stuff like this still happens today in countries without an FDA equivalent. [3] It even happens in countries with a drug regulatory body, but one that's weak. [4]
As with all regulation, there's a balance between benefit/risk. As you point out, there is a financial and time burden of regulation. But with warts and all, the work that the FDA has done and currently does far outweighs these burdens.
> The only good thing I can find to say about the bureaucrats at the FDA is that they respond to regional regulatory arbitrage - to medical tourism - by loosening their grip and letting things through. Or at least they do when said treatments are so widely available elsewhere in the world that the risk of looking bad by continuing to block them in the US is worse than the risk of looking bad because one of the outcomes of a normal, low error rate in medicine gets picked up by the press. Look at simple stem cell transplants, now available in the US these last couple of years, for a good example of this in practice.
I'm not quite sure how to respond to this rant. But I'll point out findings from a 2012 NEJM study comparing the FDA to the EU's EMA and Canada's Health Canada: [5]
"RESULTS: There were 510 applications for novel therapeutic agents approved from 2001 through 2010 — 225 by the FDA, 186 by the EMA, and 99 by Health Canada; among the applications, there were 289 unique agents. The median length of time for completion of the first review was 303 days (interquartile range, 185 to 372) for applications approved by the FDA, 366 days (interquartile range, 310 to 445) for those approved by the EMA, and 352 days (interquartile range, 255 to 420) for those approved by Health Canada (P<0.001 for the comparison across the three agencies). The median total review time was also shorter at the FDA than at the EMA or Health Canada (P=0.002). Among the 289 unique novel therapeutic agents, 190 were approved in both the United States and Europe (either by the EMA or through the mutual recognition process), of which 121 (63.7%) were first approved in the United States; similarly, 154 were approved in both the United States and Canada, of which 132 (85.7%) were first approved in the United States."
[1] https://news.ycombinator.com/item?id=7758508
[2] https://en.wikipedia.org/wiki/United_States_v._11_1/4_Dozen_...
[3] http://ijp-online.com/article.asp?issn=0253-7613;year=2007;v...
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