Sen. Bernie Sanders, I-Vt., isn’t the only pharma critic shining a light on relatively unknown drugmaker Catalyst Pharmaceuticals. The watchdogs at Patients For Affordable Drugs blasted the company’s $375,000 list price for Firdapse Wednesday and urged industry group BIO to drop the company as a member.
In a letter to BIO president and CEO Jim Greenwood, P4AD founder David Mitchell said the trade group has an opportunity to publicly disavow price-gouging. The case against Catalyst “could not be clearer," Mitchell wrote.
Firdapse treats the rare neuromuscular disorder Lambert-Eaton myasthenic syndrome and won FDA approval late last year. Before the FDA approval, LEMS patients could access the drug for free for decades under the FDA’s compassionate use program, Mitchell wrote. It's sold in Europe by BioMarin.
Catalyst licensed U.S. rights to Firdapse and snagged seven years of orphan-drug exclusivity, and the drug's FDA approval pushes the older version aside. Even after rebates and discounts, Firdapse's price is around $300,000, the company said during a recent earnings call.
“There is no possible moral justification for this move by your member, Catalyst,” Mitchell wrote to Greenwood. “This is abuse of our laws and regulatory framework to exploit patients, consumers and taxpayers.”
BIO didn’t immediately respond to a request for comment.
Catalyst isn’t facing pressure just from patient advocates at P4AD. Sen. Bernie Sanders, who often takes up the issue of drug prices and access, has homed in on the company’s strategy as well. After Firdapse's price made headlines, Sanders wrote to the company, calling its pricing a “blatant fleecing of American taxpayers” and a prime example of “corporate greed.” He asked Catalyst to reconsider.
In its response, the drugmaker contended that there was a large unmet need for an FDA-approved drug before it stepped in to take Firdapse to market. Before the FDA approval, only about 200 of an estimated 3,000 LEMS patients in the U.S. were using the unapproved version, and faced considerable red tape to get it, the company said. With Firdapse's FDA nod, all LEMS patients have access, Catalyst said, and the company has patient-assistance programs that make it affordable. The drug's revenue will help company is continue its research on the drug in other neuromuscular diseases, the company argued.
Catalyst's case wasn’t good enough for Sen. Sanders, though. He recently asked the FDA not to punish pharmacies and manufacturers if they distribute unbranded copies.
The situation carries some similarities to Marathon Pharma's 2017 controversy on Duchenne muscular dystrophy med Emflaza, which had been available overseas for $1,000 for decades. Marathon acquired U.S. rights, did necessary testing to win an FDA nod and secured 7 years of U.S. exclusivity along with the FDA approval.
Marathon then priced the drug at $89,000 and ran into pushback, including from Sen. Sanders. Trade group PhRMA ended up booting the company and reworking its membership criteria. Marathon later sold the drug and shuttered operations, according to reports.