FDA Policy/General

Senate Subcommittee Gives FDA $200 Million Budget Boost

A Senate appropriations subcommittee has voted to advance FDA’s fiscal year 2022 budget that would give the agency a $200 million (6%) spending boost. The subcommittee approved FDA’s total funding at $3.414 billion, which (XXX SPELLING XXprovides increases for food (XXX DELETE XXand medical product safety activities.

The spending measure would provide an increase of $15 million to enhance inspections of facilities under FDA’s jurisdiction.“ An increase of $14 million is included for maternal and infant health to work on toxic elements in baby food,” a subcommittee release says. “To continue the work the agency is doing to address the opioid crisis, the bill includes an increase of $24 million for international mail facilities for a total of $62 million.” Additionally, the members increased FDA sending on information technology by $25 million.

The Alliance for a Stronger FDA had this to say in reaction to the spending bill: “The subcommittee mark represents a strong commitment by the Senate to FDA’s resource needs and is consistent with the Alliance’s FY 22 request that FDA receive no less than a $200 million increase in BA funding. The Senate subcommittee started with a significantly lower budget allocation than the House. However, both bodies chose to provide slightly more than 13% of their available funds to FDA.”

In contrast, the House has approved $3.471 billion in discretionary funding in its bill, an increase of $257 million (8%) above the FY 2021 enacted level. “Total funding for FDA, including revenue from user fees, is $6.288 billion,” a House committee notice says. “Within this total, the committee provides a targeted increase of $72 million to address the opioid crisis, medical supply chain surveillance, rare cancers, and increasing and strengthening inspections. It also includes a $65 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 bill also appropriates $50 million to accelerate medical product development as authorized in the 21st Century Cures Act.”

The Senate measure is expected to be marked up by the full committee on 8/4.

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’

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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