Was the FDA unfair to Catalyst? 

Catalyst Pharmaceuticals had been riding high since December, when the FDA approved its drug to treat the rare neuromuscular disorder LEMS. Sure, its $375,000 price tag drew the wrath of Sen. Bernie Sanders and outraged patients who suddenly lost their access to a similar drug made — and supplied for free — by family-owned Jacobus Pharmaceuticals. That supply dried up with seven years’ exclusivity granted to Catalyst for Firdapse, although some critics seemed mollified by Catalyst’s patient assistance programs to lower out-of-pocket costs. Catalyst stock soared.

But earlier this month, in what looked like a novel workaround, the FDA approved a similar formulation from Jacobus, for children 6 to 17 years old. Which doctors are free to prescribe off-label. Its stock down by some 40%, Catalyst is now exploring the “legality of the FDA’s actions.”

The question is fairness, STAT’s Ed Silverman writes, and the answer turns on whether FDA treated the two companies differently in what it required from each of them.

Read more.