FDA Policy/General

Woodcock Heads to Hill Hearing on FDA Budget

FDA acting commissioner Janet Woodcock is scheduled to testify 6/10 before the Senate Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies to address the administration’s budget proposal for the agency. It proposes an 8% ($477 million) boost under a $6.5 billion fiscal year 2022 budget request for FDA. “The request includes $3.6 billion in budget authority — including $343 million in increases — and $2.9 billion in user fees – an increase of $155 million,” an FDA release says. The increased funding will go toward critical public health infrastructure (data modernization efforts), core food and medical product safety programs (inspection and surveillance work), it says.

Medical product safety investments under the budget request include “providing dedicated programmatic funding to strengthen and monitor the supply chain; increasing drug safety surveillance and oversight; and improving animal drug safety and predictive technologies.” FDA says an additional $61 million above last year’s total will go toward increasing safe and secure inspections, promoting health equity and addressing the opioid crisis by supporting development of new therapies and smarter enforcement.

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