what should be done: HR, FDA, or Lawyer?


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Check your company policies. (Novartis HR is there to PROTECT the company first)

I'd consult a lawyer if you are sure you have a solid case....he then can represent you with the FDA, if needed.
 








Consult one of these many Lawyer Pharma posts on line as they have the experience dealing with this. They will most likely advise you to file with HR as to make a paper record once they record the materials which you have at same time wait to see the Pharma response, simultaneously contacting FDA for further council into these matters. It does not take much such as: Wrong direction in use of promotional materials, using a piece that was FDA pulled from market, or referral dinners to generate business. First the Lawyer, then HR, and then the FDA. That should get their attention. Good Luck.
 




Consult one of these many Lawyer Pharma posts on line as they have the experience dealing with this. They will most likely advise you to file with HR as to make a paper record once they record the materials which you have at same time wait to see the Pharma response, simultaneously contacting FDA for further council into these matters. It does not take much such as: Wrong direction in use of promotional materials, using a piece that was FDA pulled from market, or referral dinners to generate business. First the Lawyer, then HR, and then the FDA. That should get their attention. Good Luck.

Yeah, that'll get their attention. About as much attention as a fly on a turd.