Holy Shit! New Law: Drug Companies exempt from Lawsuits -Supreme Court Ruling

[Fantastic Anarchist]

25. Okay, I have some more information.

I should have qualified the fact that I work as a Productivity & Operations Analyst, so my knowledge on the medical side is rather limited. I just talked to a CRA (Clinical Research Associate), and from what I could gather is this:

Any adverse events (including serious adverse events) which are drug-related (which is decided by the PI <Principle Investigator> ) have to be reported to the IRB (Institutional Review Board), which then passes the information to the FDA. The FDA takes all data and essentially acts like a marketing firm if the drug is safe.

Now, with regard to the generic drug, the firm has to go through its own clinical trial (phase I), to test that its particular molecular structure is effective and safe.

I'm still not sure that the generic manufacturer has to have the same labeling requirements as the name brand manufacturer (considering the above - they could have differing results from the original).

I'll have to talk to our Drug Safety expert when he returns from vacation to gather more information.

But it stands to reason, that in either case, either company should be held culpable for off warning reactions, no?