More Abuse Of The Orphan Drug System: Taking Treatment From Free To $80,000 A Year

Catalyst Pharmaceutical Partners, which has just reported what seems like good news for those suffering from Lambert-Eaton Myasthenic Syndrome (LEMS), a progressive, muscle-weakening disease. Catalyst has announced positive results from a final phase trial of a drug called “Firdapse.” As The Street article reports, analysts believe that once approved by the US Food and Drug Administration, Firdapse could cost between $60,000 and $80,000 per year if it is designated an orphan drug, which brings with it seven years of marketing exclusivity. That might seem the going rate for new drugs, but there’s a nasty twist in this tale, as Feuerstein notes:

Firdapse is not a new treatment for LEMS. The active ingredient in Firdapse is a compound known as 3,4-Dap, which has been available in the U.S. for more than 20 years. Doctors treating the small numbers of LEMS patients in the U.S. can obtain inexpensive 3,4-Dap from compounding pharmacies. It’s even given away for free to doctors and patients by a tiny New Jersey drug maker, Jacobus Pharmaceuticals.

That means that Catalyst took no risks with Firdapse. Indeed, it didn’t really do anything at all

Link (Techdirt)

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