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I agree for the most part (I tend towards libertarian ideals if you've read any of my comments), but it's a difficult balance to maintain between allowing for m

by pvnick 13y ago

I agree for the most part (I tend towards libertarian ideals if you've read any of my comments), but it's a difficult balance to maintain between allowing for medical innovation and preventing an objectivist distopia a la Bioshock. The government has a legitimate responsibility to ensure that medical technology is used and marketed responsibly, while at the same time giving companies some wiggle room to innovate. Look how smallpox vaccine was discovered. Edward Jenner inoculated a young boy with cow pox, then attempted to infect him with smallpox a dozen times. Obviously we can't go around convincing young children to take infectious doses of deadly viruses. But we also cant send FDA thugs after every Silicon Valley startup pushing the boundaries of genomics research. So where do we draw the line?

deleted 13y ago
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smacktoward 13y ago
Possibly somewhere that takes into account the significant advances in laboratory science since the 18th century?
vasilipupkin 13y ago
There are lots of proposals to simplify FDA's approval process, for example, automatically approve it if it's already approved in a number of Western countries whose approval standards are high on average. But in this specific case, seems FDA isn't being totally unreasonable. For example, from the letter "Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS" seems like a good idea to require companies to do this
ahallock 13y ago
This sounds like a false dichotomy: "The government has a legitimate responsibility to ensure that medical technology is used and marketed responsibly" So either the government ensures the above or it does not get accomplished? There are no third parties that could take this on? I find that hard to believe.
- rocksinsocks 13y ago
  Non-government regulatory agencies aren't a cure all for complex products. For instance, check out the 2008 financial crisis. Sub-prime mortgage derivatives were rated AAA by private ratings agencies. In fact, I would venture they are worse because they have to be paid somehow, and if they are paid by industry, you are ripe for regulatory capture. It can be difficult to get consumers to pay for it unless you include some kind of tax in the product they buy in which case you've arrived at a pseudo-government agency.

by pvnick 13y ago

deleted 13y ago

[deleted]

smacktoward 13y ago

Possibly somewhere that takes into account the significant advances in laboratory science since the 18th century?

vasilipupkin 13y ago

There are lots of proposals to simplify FDA's approval process, for example, automatically approve it if it's already approved in a number of Western countries whose approval standards are high on average. But in this specific case, seems FDA isn't being totally unreasonable. For example, from the letter "Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS" seems like a good idea to require companies to do this

ahallock 13y ago

This sounds like a false dichotomy: "The government has a legitimate responsibility to ensure that medical technology is used and marketed responsibly" So either the government ensures the above or it does not get accomplished? There are no third parties that could take this on? I find that hard to believe.

rocksinsocks 13y ago
Non-government regulatory agencies aren't a cure all for complex products. For instance, check out the 2008 financial crisis. Sub-prime mortgage derivatives were rated AAA by private ratings agencies. In fact, I would venture they are worse because they have to be paid somehow, and if they are paid by industry, you are ripe for regulatory capture. It can be difficult to get consumers to pay for it unless you include some kind of tax in the product they buy in which case you've arrived at a pseudo-government agency.