FDA Policy/General

House/Senate $41 Million Boost to FDA Appropriations

The House and Senate 3/22 passed a fiscal year 2018 omnibus budget bill that will increase FDA’s budget authority (BA) by $41 million (1.5%) over FY 2017. The Alliance for a Stronger FDA welcomed the increase, noting that any boost to FDA’s bottom line is a vote of confidence in the agency’s public health mission. In an analysis provided to FDA Webview, the Alliance says key changes over 2017 are:

$41 million in addition BA appropriations, with a focus on improvements in food safety, enhancing the Oncology Center of Excellence initiative and managing increased workloads in the animal drugs and feed programs.
$94 million to support expansion of FDA’s role in combatting opioid abuse, using monies provided under a general provision (i.e. does not increase FDA’s BA base funding).

In addition, Congressional appropriators have elected to “support implementation of the 21^st Century Cures Act with $60 million dollars drawn from a pre-paid fund (i.e. not BA) set up by that Act,” the Alliance says. This is an increase from $20 million available in 2017. “While the opioid monies will not increase FDA’s core funding, they should allow the agency to free up some resources that have been pulled from existing programs to help stem the opioid crisis,” it says.

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