Drugs

FDA Report on Generic Drug Approval Cost Savings

FDA has published a report estimating cost savings from the 2,400 new generic drug approvals in 2018, 2019, and 2020. It says generic drugs approved in 2018 yield annual savings of $17.8 billion, with $4 billion from first-generic approvals.

Savings from 2019 approvals amount to $24.8 billion, it says, with $9.4 billion coming from first-generic approvals. And for 2020, savings from approvals are estimated at $10.7 billion, with first-generic approvals contributing $1.8 billion.

“Over all three years,” the report says, “first-generic approvals account for 29% of the total savings.”

The researchers write that variations in yearly savings are primarily due to the mix of products for which generics were approved in the years. In addition to total savings, the report also highlights the importance of price reductions associated with generic drug approvals. “We observe many instances where, within a year of the first-generic approval, prices fell by more than 75% compared to the brand price,” they say. “For some of these products that serve smaller patient populations, total savings are modest. However, for the patients relying on these drugs, these price reductions are meaningful and can increase their access to important medicines.”

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