FDA Policy/General

House Seeks $308 Million Boost to FDA 2019 Spending

A House Appropriations subcommittee has voted to approve a fiscal year 2019 spending bill that would give FDA a $308 million (10%) boost above the current 2018 spending level. Under the measure, the agency would receive $3.1 billion in discretionary funding, and total funding, which includes user fees, would be $5.57 billion. “Within this total, the subcommittee provides a net increase of $303 million for medical product safety activities, including an increase of $5 million for the new Oncology Center of Excellence,” said a subcommittee summary. “Specifically, the increase covers $30 million to fight opioid abuse, $38.5 million to advance modern drug and biological product manufacturing in the U.S, and $27 million for modernizing generic drug development and review. The bill also appropriates $70 million to accelerate medical product development as authorized in the 21^st Century Cures Act.

The Alliance for a Stronger FDA welcomed the legislation’s advance. The advocacy group said the “added funds would enable FDA to carry out important programs that will advance public health, public safety and an innovation economy.”

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