It's hard to form an opinion on that case without knowing more about Pandremix. How many people did it help? Is the illness it treats worse than narcolepsy? How many people are wrongly prescribed it?
I also wonder what kind of study found such a tiny effect size. 1 in 60,000 would require a staggeringly powerful study to successfully link it to Pandremix.
Not saying you're wrong about any of that, and I suppose I could go research these questions myself. But based solely on what you wrote I don't think there's any way to tell if that decision was good or bad.
As I understand it FDA didn't approve Pandemrix, while EU regulators did give it fast track appeal.
Pandemrix causes narcolepsy in 1 in 60,000 people who take it. (so, for the entire US that's about 5000 with a life long debilitating illness that requires constant care.) The risk is very low, but it's there and we need to be careful about exposing a population of hundreds of millions to these risks just because we have an ideological opposition to any form of government regulation.