Catalyst Pharmaceuticals has sued the FDA, accusing the agency of violating provisions of the law and its rights to exclusivity for its rare disease drug Firdapse when it approved a lower-cost rival drug, according to healthcare news website STAT.
The lawsuit claims that the FDA "arbitrarily and capriciously" approved Jacobus Pharmacuetical's rival drug Ruzurgi by applying different standards. Further, the lawsuit claims the agency violated its rights to seven years of market exclusivity, which should have been granted to the drugmaker because Firdapse is an orphan drug.
Both drugs treat a rare neuromuscular disorder, Lambert Eaton myasthenic syndrome. Jacobus' drug was approved for children ages 6 to 17, whereas Catalysts' drug is approved for adults.
Although the two drugs are for different age ranges, providers may be able to prescribe Ruzurgi as an off-label drug to treat adult patients, competing with Firdapse.
The controversy surrounding Firdapse, a formerly inexpensive drug, began last December when it hiked the price of the drug to $375,000 a year after the FDA approved it. Patients had formerly received the drug, used off-label to treat the rare disease, for free from various pharmacies.
Jacobus, which secured FDA approval in May, recently said that it would price its drug at less than 50 percent of what Catalyst charges.