Lawsuit against FDA claims Bernie Sanders played role in approval of rival drug
pharmafile | February 17, 2020 | News story | Research and Development, Sales and Marketing |Â Â Bernie, Bernie Sanders, Catalyst Pharmaceuticals, FDA, TRUMP FDA, US FDAÂ
Catalyst Pharmaceutical is attempting to show in court that pressure from US Senator Bernie Sanders led to the approval of a rival treatment.
In June 2019, Catalyst filed a lawsuit against the FDA over their decision to approve a rival treatment for Lambert-Eaton Myasthenic Syndrome (LEMS) by Jacobus Pharmaceuticals. Partially redacted emails from the FDA show that issues arose over the $375,000 list price for Catalysts Firdapse (amifampridine), which led Sanders to allege the company was price gouging.
Firdapse was the first approved drug for treating LEMS, which Catalyst says granted them Orphan Drug status, which should have provided it with market exclusivity. However, in May the FDA awarded Jacobus’ drug Ruzurgi (amifampridine) approval which is the only medication for the condition approved for patients between the ages of 6 to 17.
Senator Sanders had given scathing criticism to Catalyst, saying their price point for the drug was allowing patients to die as they could not afford the treatment. He then promised to conduct inquiries into the company and urged the FDA to approve the Jacobus medication which previously had only been part of the FDA’s compassionate use program.
Catalyst is asking the court to provide unredacted access to the FDA’s internal documents to see if political considerations were a factor in Jacobus’ drug being approved and if the FDA did infringe on their Orphan Drug exclusivity.
A similar case in 2012 saw Makena KV Pharmaceuticals lawsuit against the FDA thrown out, in which they alleged the regulator had failed to stop compounding companies selling cheaper versions of their drug.
Conor Kavanagh
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