Sen. Bernie Sanders is demanding answers for why a drug that was once free now costs $375,000.
Sanders, an independent who usually votes with Democrats, sent a letter to Catalyst Pharmaceuticals on Monday asking the company to explain the dramatic price increase.
The drug in question, Firdapse, is used to treat Lambert-Eaton Myasthenic Syndrome (LEMS), a rare neuromuscular disorder that affects one in 100,000 people. A drug equivalent to Firdapse, made by Jacobus Pharmaceutical Co., has been available for free for the last 20 years under an FDA compassionate use program that helps patients receive experimental drugs.
After Catalyst acquired rights to Firdapse in 2012, the company made it clear that it would seek full FDA approval of Firdapse and orphan drug pricing. Jacobus, meanwhile, has not sought the additional testing required for commercial FDA approval for its drug. In November 2018, Catalyst won FDA approval for Firdapse along with exclusive marketing rights to the medication.
Sanders reportedly asked Catalyst to explain its reasoning behind the price increase and say how many patients would suffer or die as a result of not being able to pay for the drug.
After Firdapse was approved in November, Catalyst’s CEO, Patrick McEnany, said that FDA approval of the drug would widen access, which was inhibited by doctors not wanting to do the required paperwork involved for the FDA’s program. The company also said that it would help ensure “all patients have affordable access to the drug, minimal copays and minimal out-of-pocket expenses.”
Read the Reuters report.