Drugs

Generic Drug Competition Lowers Prices: FDA Analysis

A new FDA analysis based on two sources shows that greater generic drug competition is linked to lower generic drug prices. An FDA statement says the analysis updates and expands on a 2005 analysis and includes two different sources of wholesale drug prices. It looked at all drug products that had generic entry between 2015 and 2017 and showed that as competition increases, generic drug prices decline, the statement says.

For products with a single generic producer, the generic average manufacturer prices (AMP) reported to the Centers for Medicare and Medicaid Services was 39% lower than the branded drug price before generic competition, compared to a 31% reduction using invoice-based drug prices.

With two competitors, AMP data show generic prices are 54% lower than the branded drug before generic competition, compared to a 44% reduction using invoice-based prices. And with four competitors, AMP data show generic prices are 79% less than the branded price before generic drug entry, compared to a 73% reduction using invoice-based prices.

With six or more competitors, generic prices using both AMP and invoice-based drug prices show reductions of more than 95% compared to branded prices before generic entry.

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