A new decision from the D.C. Circuit illustrates the challenge litigants face when an agency stubbornly refuses to change its mind. Nostrum Pharms ., LLC v. FDA (No. 20-1525).
In that situation, it’s tempting to appeal the agency’s most recent refusal, in case a court later decides that the refusal was final. After all, you don’t want to wait too long and blow the deadline. And there’s usually no downside to being told that you appealed too soon.
But how to decide if it’s worth cost of the precautionary appeal? You might ask whether, in briefing the appeal, you’ll find yourself wanting more time to persuade the agency to change its mind.
That’s what happened in Nostrum. The appellant moved to extend the briefing deadlines because “it continued to push the FDA for relief”; and if it was successful, that would cause its appeal “[to] become moot[.]” Of course, that was precisely the D.C. Circuit’s concern. “That [the appellant] has been pursuing relief simultaneously before the agency and this court shows that the [FDA’s most recent] letter was not a conclusive rejection of its (concededly still-pending) application.”
Now, presumably the appellant took a calculated risk. Maybe it thought that appealing would somehow force the agency’s hand, expose its conduct, or prime the court for a later appeal.
But the point stands. If you’re still haggling with the agency, that’s a good sign you don’t yet have a final, appealable order.