I vaguely recall a device CEO (cyberonics?) really tear into the FDA on a call right after some sort of rejection/request for more info. It was something for depression because I recall him yelling about people will be killing themselves because of the FDA. It was actually pretty entertaining for me (OK, maybe I am easily entertained) as I had no position. I think the device eventually got approved.
I think the omnitrope case was not a criticism of FDA. Perhaps FDA was pleased to have the court provide the interpretation of their review authority since it helped clear up the gray areas. I don't think the omnitrope matter hurt NVS' standing with FDA.
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