FDA undercuts $375,000 drug in surprise move

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FDA undercuts $375,000 drug in surprise move
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The FDA created a workaround this week that effectively undercuts the $375,000 price tag of a drug that became the poster child for concerns about the pharmaceutical industry

The US Food and Drug Administration created a workaround this week that effectively undercuts the $375,000 price tag of a drug that became the poster child for concerns about the pharmaceutical industry.

The FDA announced Monday that it was approving a separate drug for pediatric patients with a rare, painful neuromuscular disease called Lambert-Eaton myasthenic syndrome, also known as LEMS. The disease weakens and fatigues muscles, causing agonizing pain to the point at which patients struggle to walk. The move sparked celebration in the LEMS community and tanked the stock of Catalyst Pharmaceuticals, maker of the $375,000 drug, called Firdapse.

"Jacobus Pharmaceuticals has taken care of so many LEMS patients over the years through their compassionate use program, and they really deserved this approval," she said.Catalyst spokesman David Schull said the company remains"focused on its continued launch of Firdapse to get this medicine to patients in need, including the many who had no access to any treatment prior to the FDA approval of the drug.

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