FDA Policy/General

9% Budget Boost for FDA, Biggest in Years

With President Trump’s signature into law of a House-Senate final appropriations bill that ended the five-week government shutdown 2.16, FDA received a $269 million (9%) budget boost — the largest increase in several years. According to a House-Senate conferees’ statement, FDA will see $3.08 billion in discretionary funding, an increase of $269 million above the FY 2018 enacted level and $103 million below the President’s budget request. “Overall, total FDA funding, including user fee revenues, is $5.67 billion, which is $468 million above the FY2018 enacted level and $52 million below the request,” it notes.

The Alliance for a Stronger FDA hailed the bill as a huge win for the agency. It said “the usual expectation is that House and Senate will split the difference between their respective numbers. Instead, this is about $35 million above the mid-line, demonstrating Congress’ strong commitment to the agency.” The group says appropriators saw “the needs and the opportunities for the agency to better serve the American public and they backed that with a considerable increase for the agency.”

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