Drugs

Trump Orders VA Spravato Purchase

President Donald Trump has told the Department of Veterans Affairs to purchase “a lot” of Johnson & Johnson’s Spravato (esketamine) to help fight veteran suicides. Trump told reporters about the purchase 8/21 as he prepared to go to a national veterans conference in Kentucky.

The McClatchy news service says the VA medical advisory panel voted to classify the drug as “non-formulary,” meaning it was not included on a list of approved medications covered by the agency’s pharmacy benefit. The agency reported 8/22 that the drug’s non-formulary status was unchanged, but that veterans could get access to it through an “individualized treatment plan developed by their provider in collaboration with the veteran.”

FDA approved Spravato in March, despite concerns that during clinical trials the drug had a higher rate of adverse effects than other products currently available, and that there was no indication that Spravato had a higher rate of successful treatment.

Spravato is described as a nasal spray that is intended to treat depression in cases where the patient has not improved under other antidepressants or treatments. McClatchy says the cost for one dose is $295 and patients typically will require 2.5 nasal spray units per treatment, for a cost per day of $737.50. The spray must be administered by a doctor.

“Hopefully we are getting it at a very good cost,” Trump reportedly said. “I guess it’s a form of stimulant where if somebody is really in trouble from the standpoint of suicide it can do something.”

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