FDA Policy/General

Spending Bill Gives FDA $102 Million Boost

FDA would see a $102 million (3.2%) boost to its discretionary funding from Congress under a House and Senate Appropriations omnibus bill introduced 3/9 that covers 12 FY 2022 spending bills. Currently, FDA has been operating under a continuing resolution that has kept its spending level at FY 2021 levels.

In all, the omnibus bill would set FDA’s discretionary funding at $3.3 billion. Total funding for the agency, which includes user fee funding, would be raised to $6.2 billion. “Within this total, the Committee provides a targeted increase of $29 million to address the opioid crisis, medical supply chain surveillance, rare cancers, and increasing and strengthening in person inspections of foreign drug manufacturers,” a House bill summary says. The text of the bill (begins page 75) notes that FDA’s Office of Regulatory Affairs would get $8.5 million for pilot programs to increase unannounced foreign inspections.

Additionally, the spending measure “includes a $29.5 million increase to better avoid or more quickly respond to food outbreaks, improve the animal food inspection system, and addresses heavy metals in baby food,” the summary says. “The bill also appropriates $50 million to accelerate medical product development as authorized in the 21st Century Cures Act.”

In response to the omnibus bill, the Alliance for a Stronger FDA said “the $102 million increase (3.2%) is much needed and will strengthen programs throughout the agency… We are certainly aware that both the House and Senate acknowledged greater FDA needs, by proposing larger increases in their separate bills from last summer. However, the FDA increase is in line with the amount of funds available to the Agriculture/FDA subcommittees and reflects continued Congressional support for a strong, well-funded FDA. Once the President’s FY 23 request is submitted to Congress, the Alliance will be hard at work to see the additional needs for this year and new needs in FY 23 are met through increased appropriations.”

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