FDA Policy/General

FDA Alliance Advocates for Increased FDA Funding

The Alliance for a Stronger FDA is advocating for increased FDA funding in fiscal year 2020 because “growing responsibilities require a budget that grows.” That was the message during an 11/6 Webinar from Alliance deputy executive director Steven Grossman as he discussed FDA’s positioning in the current funding cycle.

Currently in the FY 2020 budget process, the House has passed a $3.25 billion budget for FDA, which is $185 million (6%) more than FY 2019 appropriated levels, according to Grossman. On the Senate side, the appropriations committee just last month passed a $3.15 billion spending level that would give the agency $79 million (about 3%) more than last year, he said. At some point, the disparities in the spending measures will be rectified in a conference committee.

Going forward, Grossman does not expect any budget deals being reached before the current operating continuing resolution (CR) expires 11/21, and so another temporary CR will be approved through 12/21. Grossman also said it is likely that the current budget stalemate will carryover until early next year.

Addressing a question on whether the federal government may experience another shutdown like last year at this time, Grossman said it would be unlikely because unlike a year ago defense spending is unresolved and “in play” this time around. For example, he said a government shutdown this cycle could see 800,000 civilian employees furloughed. The politics of a shutdown or even a move to funding through a full-year continuing resolution is just not there, he said.

If the budget bills stall and the government gets funding through a full-year continuing resolution, then that would be bad news for FDA because it would lose the $79 million to $185 million increases that the House and Senate chambers have proposed to date, Grossman said.

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