FDA Policy/General

Subcommittee Advances FDA Budget Bill with $184 mil. Boost

A House Agriculture subcommittee has voted to advance a fiscal year 2020 spending bill that would increase FDA’s budget authority by 6% ($184 million) over FY 2019 levels. A House combined press release and statement said: “The FDA receives a total of $3.26 billion in discretionary funding in the bill, $184 million above the 2019 enacted level. Total funding for the FDA, including revenue from user fees, is $5.86 billion.”

The Alliance for a Stronger FDA said it was “very pleased” by the proposed $184 million increase in FDA’s budget authority. “While this is less than the Administration’s request, the proposed 6% increase represents a substantial investment in the agency’s growing mission and importance,” the group says.

The Alliance says it is also encouraged by the budget proposal’s addition of $75 million to the 21st Century Cures Act program. These funds are placed in an Innovation Fund and do not count against budget ceilings. The budget proposal also includes increases for FDA’s drugs program (+$50 million), devices (+$33 million), and biologics (+$22 million). Many program funding details will not be available until a full committee mark-up and the subsequent release of the committee report, which is not expected until after Congress returns from Memorial Day recess (6/4).

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