Re:Biohackers Creating Open-Source Insulin
by facepalm on Thursday November 19, 2015 @08:37AM
(#10594639)
The regulations might be partly in place to protect the big players from pesky small competition? I have no way to judge that, though. But if that's the case, perhaps the regulations can be changed.
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Re:Biohackers Creating Open-Source Insulin
by replicatorblog on Thursday November 19, 2015 @09:35AM
(#10594951)
This is definitely the case. There's a term called "Regulatory Capture" that describes this phenomena. I think it's less active scheming to stomp down startups and more a natural outgrowth of a world where the larger companies find it easier to comply with marginal increases in regulatory scrutiny than to fight the PR/lobbying war to oppose them.
Re:Biohackers Creating Open-Source Insulin
by refurb on Thursday November 19, 2015 @11:44AM
(#10595752)
You think big pharma encourages more regulation by the FDA? Jesus, they have a hard enough time getting approved under current rules. It would be a death sentence for them if they made them more stringent.
Every big pharma/biotech I've worked for has always pushed the FDA to make exceptions to the rules. They certainly aren't push for more of them.
Re:Biohackers Creating Open-Source Insulin
by refurb on Thursday November 19, 2015 @09:11AM
(#10594811)
The regulations are in place partly because as soon as any approved drug starts to show serious side effects, people (including Congress) start pointing fingers at the FDA and talk about their failure to protect the public.