Drugs

Sanders Probing New Firdapse $375,000 Annual Price

Sen. Bernie Sanders (I-VT) is asking Catalyst Pharmaceuticals to explain how it set an annual list price of $375,000 for Firdapse, a drug used to treat Lambert-Eaton myasthenic syndrome, a rare neuromuscular disease. Sanders says that for two decades patients received an unapproved version of the same drug (3,4-diaminopyridine) for free from Jacobus Pharmaceuticals under the FDA compassionate use program. Catalyst recently licensed the rights to the drug and received an FDA orphan drug designation giving it marketing exclusivity for seven years. In 12/2018 it announced the list price.

In a statement, Sanders says that patients across the country “are frightened as to whether or not they will be able to maintain access to a drug they depend upon to survive.”

Sanders’ letter to Catalyst says the company did not invent the drug’s active ingredient and knew that its clinical effectiveness had been established over decades in the U.S. and Europe. He said the pricing decision “is not only a blatant fleecing of American taxpayers, but is also an immoral exploitation of patients who need this medication, Simply put, it is corporate greed. The cost of the formulation ranges from estimates of $1,600 to $6,000 per year. I am profoundly concerned that Catalyst’s actions will cause patients to suffer and die.”

Sanders asks the company for detailed documents and information covering the period from 1/1/2012 to the present on its acquisition of the rights to the drug and its pricing determination. He also asks for information relating to the company’s statement that many patients will pay $10 per month for Firdapse and for the information the company has on how insurers will handle the drug.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome