FDA must be mad as all get out over this - more than I even thought - they're boxed in a corner - appeal our case and lose, they lose - don't appeal, they lose - would not be surprised to see Janet's head roll sometime soon:
So now, any other drugmaker frustrated by an FDA block on off-label promotion could follow Amarin's lead and sue the agency in the Second Circuit, said ReedSmith partner Jim Beck, an attorney who also keeps tabs on the FDA via his Drug and Device Law blog.
"If a company is rock solid sure that what it's saying is true, even if the data might not support an application, it can open discussion with the FDA" about off-label marketing and ask for the agency's blessing, Beck said. And thanks to the new ruling, which granted standing to Amarin in New York, "If the FDA barks, the company can bring suit in the Second Circuit. Anyone anywhere could sue the FDA there to be covered by Caronia."
"I can't state strongly enough that the key point is truthfulness," Beck added. "A company has to be certain about what it is saying and that the underlying science supports off-label use it wishes to promote. If they are, there's now a procedure where they can get relief to spite the FDA."
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