Patients suffering from a rare disorder previously were able to obtain the treatment for free from a small pharmaceutical company that offered it through an FDA program called “compassionate use.” In November, the FDA allowed Catalyst to distribute the drug, with exclusive rights to market it. The following month the company said it would sell Firdapse for $375,000 a year. In other news, lawmakers are inviting CEOs from seven major drug companies to testify on prices.
The Hill: Sanders Asks Why Once-Free Drug Now Costs $375,000 A Year
Sen. Bernie Sanders (I-Vt.) on Monday asked a pharmaceutical company why a drug that was once free for patients now costs as much as $375,000 annually. Catalyst Pharmaceuticals informed investors in December about the new pricing for Firdapse, which is used to treat the rare neuromuscular disorder Lambert-Eaton Myasthenic Syndrome (LEMS), Sanders wrote in a letter to the company. (Daugherty, 2/4)
Stat: Sanders Calls Price Of A Rare Disease Drug ‘Immoral Exploitation’
In a blistering letter, Sanders accused Catalyst of “corporate greed” for charging a $375,000 list price for Firdapse, which is used to contain Lambert-Eaton myasthenic syndrome, or LEMS. Until December, patients could obtain an unapproved version for free from Jacobus Pharmaceuticals, a small, family-run company, thanks to a compassionate use program overseen by the Food and Drug Administration. A spokesman for Catalyst later in the day wrote us that its “top priority is improving patient care in the LEMS community” and will respond to Sanders “in a timely manner and provide information about Firdapse and the programs that we have in place to raise awareness of LEMS, facilitate accurate and timely diagnosis, and broaden affordable patient access to an FDA-approved treatment.” (Silverman, 2/4)
Burlington Free Press: Bernie Sanders On Drug Prices: Catalyst’s Firdapse Now Costs $375K?
The drug in question is called Firdapse, which was approved by the U.S. Food and Drug Administration in November last year for the treatment of Lambert-Eaton myasthenic syndrome, or LEMS, in adults. The FDA describes LEMS as “a rare autoimmune disorder that affects the connection between nerves and muscles and causes weakness and other symptoms in affected patients.” (Soga, 2/4)
The Hill: Bipartisan Senate Panel Leaders Ask 7 Major Drug Companies To Testify On Their Prices
The top Republican and Democrat on the Senate Finance Committee on Monday invited seven major drug company CEOs to testify at a hearing later this month in what could become a tense confrontation over drug prices. Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) on Monday sent letters to the companies asking them to testify at a hearing on Feb. 26. (Sullivan, 2/4)
Stat: Congress Wants These 7 Drug Company CEOs To Testify About Prices
At a hearing last week, both Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) expressed disappointment that pharmaceutical companies executives had declined their invitations to testify. Grassley, the committee chairman, said then he would be “more insistent” that executives show up at a subsequent hearing. “Pharmaceutical companies receive billions of dollars a year from federal programs like Medicare and Medicaid,” Grassley and Wyden said. “This is an opportunity for companies that produce life-saving treatments to explain how they price these treatments and whether the status quo is acceptable. Patients and taxpayers deserve to hear from leaders in the industry about what’s behind this unsustainable trend and what can be done to lower costs.” (Facher, 2/4)
In other pharmaceutical news —
Stat: Allergan Asks The ITC To Investigate Its New Botox Rivals For Stealing Secrets
As new competition arrives for its best-selling Botox treatment, Allergan (AGN) is asking the International Trade Commission to investigate a pair of rival companies for allegedly stealing trade secrets for a new version of its medicine. In its complaint, Allergan contended a former employee at Medytox, which has a deal to supply the drug maker with a newer wrinkle-smoothing treatment that is still being tested, stole detailed information and provided the material to Daewoong Pharmaceuticals. Late last week, meanwhile, Daewoong and Evolus (EOLS) won Food and Drug Administration approval for Jeuveau, a Botox competitor due to become available this spring. (Silverman, 2/4)
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Source : Kaiser Health