An incensed Catalyst Pharma sues the FDA, accusing agency of bowing to political pressure and breaking federal law
After hinting it was exploring the legality of the FDA’s approval of a rival drug from family-run company Jacobus Pharmaceuticals, Catalyst Pharmaceuticals on Wednesday filed a lawsuit against the health regulator — effectively accusing the agency of bowing to political pressure surrounding skyrocketing drug prices.
Before Catalyst’s Firdapse (which carries an average annual list price of $375,000) was sanctioned for use in Lambert-Eaton myasthenic syndrome (LEMS) by the FDA, hundreds of patients had been able to access a similar drug from compounding pharmacies for a fraction of the cost, or Jacobus’ for free, as part of an FDA-ratified compassionate use program. But the approval of the Catalyst drug — accompanied by market exclusivity spanning seven years — effectively precluded Jacobus and compounding pharmacies from selling their versions.
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