Sanders escalates fight with Catalyst, asking FDA to allow unbranded copies of $375K Firdapse: report

After a seemingly vain attempt to appeal to Catalyst Pharmaceuticals’ conscience, Sen. Bernie Sanders, I-Vt., has turned to the FDA, asking the agency to allow cheaper, unapproved versions of Catalyst’ Firdapse to be distributed as they had been over the past three decades. In a bid to circumvent Catalyst's monopoly on the pricey drug, Sanders called on the agency to forego punishing pharmacies and manufacturers that had been providing its equivalent for free, Reuters reported, citing a letter sent to FDA Commissioner Scott Gottlieb, M.D., on Tuesday.
“Catalyst may be the most recent company to exploit their monopoly after receiving FDA approval for an inexpensive old drug, but they were certainly not the first,” Sanders said in the letter, as quoted by Reuters. The pharma has seven-year exclusivity on Firdapse thanks to its orphan drug status. Recently approved by the FDA to treat the rare neuromuscular disorder of Lambert-Eaton myasthenic syndrome (LEMS), Firdapse bears a list price of $375,000. Its active ingredient, 3,4-DAP, was previously distributed by family-owned drugmaker Jacobus Pharmaceuticals at no cost for three decades under the FDA’s compassionate use program.