Drugs

Unapproved Drugs Initiative Hiking Healthcare Costs: Analysis

Healthcare performance improvement consultants Vizient says the FDA Unapproved Drugs Initiative (UDI) will increase healthcare spending by $20.25 billion. In its analysis, Vizient says UDI is an FDA mandate that unapproved drugs that have been in use prior to agency review of safety and efficacy must be approved or removed from the market. The goal of UDI, Vizient says, is to (1) remove potentially unsafe medications to protect the public from direct and indirect health threats, and (2) remove ineffective drugs to protect the public from using the products in lieu of effective treatments.

So far, four of the drugs have been formally approved in recent years — neostigmine methylsulfate, selenium 40 mcg/mL to selenious acid 60 mcg/mL, Vasopressin to Vasostrict, and dehydrated alcohol 98% to dehydrated alcohol 99%.

Vizient says that the products have experienced price increases following approval ranging from 525% to 1,644%. The company says it has identified 19 other unapproved products on the market that could experience similar increases potentially leading to $8.75 billion in added healthcare system costs over five years if manufacturers take similar price increases during their periods of market exclusivity.

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