5 ms·

> How are the laws and regs so unclear that a huge corporation of smart people can't avoid big fines Perhaps they don't really care to? Apparently paying penal

> How are the laws and regs so unclear that a huge corporation of smart people can't avoid big fines Perhaps they don't really care to? Apparently paying penalties is just a part of the business model, net profits/savings made thanks to the violations still exceeding net fines. I'm not sure about Pfizer but I feel almost sure this is the way Google and other big tech corporations providing "free" services work paying huge fines for privacy violations every now and then. Google will still spies on you and records everything it can about you no matter how much do you tweak your settings and how hard does the EU try to protect your privacy rights, doesn't it?

shadowgovt 4y ago
I can't speak to medical specifically, but in one of the spaces I used to work the thinking was "The law is ambiguous because it's reactive; we're so far out on the bleeding edge that nobody actually knows what's legal until someone tries it and someone else makes a case of it. So pushing the envelope is a net positive for society because we end up blazing a trail of bright-line precedent rulings that other companies can follow. You can tell the pioneers because they're the ones with the arrows in their backs." A bit self-serving but there's some meat on the bones of that logic; the real meaning of the law is path-dependent and determined by the rulings, not the words on the paper.
- thatguy0900 4y ago
  In fairness there's Noone you can call up in the government to ask for certain if something is legal or not past a certain point. Only a judge can decide that, and they don't do hypothetical cases.
forgetfreeman 4y ago
It's also worth noting that the parent claim of unclear compliance guidelines is less of a statement of fact and more a commentary on your average pharma industry lawyer. There are more suites of standardized compliance applications than you could shake a stick at, that's not at issue. The problems usually start with a department of contract lawyers who can't be assed to skill up on industry specifics. Throw in a CFO with little or no experience managing CRO's and you've got the perfect recipe to get dumped on by the OIG.

shadowgovt 4y ago

I can't speak to medical specifically, but in one of the spaces I used to work the thinking was "The law is ambiguous because it's reactive; we're so far out on the bleeding edge that nobody actually knows what's legal until someone tries it and someone else makes a case of it. So pushing the envelope is a net positive for society because we end up blazing a trail of bright-line precedent rulings that other companies can follow. You can tell the pioneers because they're the ones with the arrows in their backs." A bit self-serving but there's some meat on the bones of that logic; the real meaning of the law is path-dependent and determined by the rulings, not the words on the paper.

thatguy0900 4y ago
In fairness there's Noone you can call up in the government to ask for certain if something is legal or not past a certain point. Only a judge can decide that, and they don't do hypothetical cases.

forgetfreeman 4y ago

It's also worth noting that the parent claim of unclear compliance guidelines is less of a statement of fact and more a commentary on your average pharma industry lawyer. There are more suites of standardized compliance applications than you could shake a stick at, that's not at issue. The problems usually start with a department of contract lawyers who can't be assed to skill up on industry specifics. Throw in a CFO with little or no experience managing CRO's and you've got the perfect recipe to get dumped on by the OIG.