Sanders calls on FDA to allow low-cost rivals to $375k Catalyst drug

US Senator Bernie Sanders says the FDA should allow pharmacies and generic manufacturers to make low-cost copies of Catalyst Pharma’s rare disease drug Firdapse, which is at the heart of a pricing scandal.

Catalyst hit the headlines earlier this month after it emerged it had hiked the price of Firdapse (amifampridine) to $375,000 per year after getting approval for the drug as a treatment for neuromuscular disorder Lambert-Eaton myasthenic syndrome (LEMS), which affects around 3,000 people in the US.

Prior to Firdapse’s approval, amifampridine was being supplied free-of-charge on a compassionate-use basis by Jacobus Pharmaceuticals. However, the FDA green light last November gave Catalyst several years of market exclusivity under US rules for developing drugs for rare diseases, giving the company a monopoly and license to charge what it likes for the drug.

Sanders has already had a heated exchange with Catalyst CEO Patrick McEnany over the issue. The Senator, already a vocal critic of the biopharma industry’s pricing policies, accused the company in a letter of a “blatant fleecing of American taxpayers [and] and an immoral exploitation of patients who need this medication.”

McEnany’s response followed the usual format in such cases, saying that the high price was necessary to recoup the cost of clinical development and the company had set up a number of financial assistance programmes to make sure patients can afford the drug without significant co-pays.

He also said that it was preferable for the US healthcare system to absorb the cost of a drug that has been tested and approved for LEMS, rather than ask patients with the disease to rely on an unapproved drug under compassionate-use rules, and that having a registered rug would expand access to treatment.

Sanders has now written to the FDA, asking Commissioner Scott Gottlieb to announce that the agency will not take enforcement action against pharmacies and manufacturers that were previously providing the drug to patients, reports Reuters. The FDA and Department of Health and Human Services have said they will respond to the senator.

Catalyst is only the latest in a string of drugmakers to come under scrutiny from Sanders and other US lawmakers over price increases for long-established drugs.

The practice hit international headlines when Martin Shkreli’s Turing Pharma inflated the price of an old anti-infective drug by 5,000% a few years back. There have been several other cases, including Mylan’s decision to raise the price of its EpiPen by more than 400% – a move it was forced to defend in front of Congress in 2016 – as well as products from Valeant, Retrophin and Rodelis Therapeutics that were highlighted in a Senate report in the same year.