FDA Policy/General

$229 Million Boost in Senate FDA Budget Bill

The Senate Appropriations Committee has released the fiscal year 2023 proposed budget bill for FDA that increases the agency’s spending by $229 million (7%), but it is $112 million short of what the House proposed in June ($341 million increase).

The Senate proposal sets total discretionary funding for FDA at $3.545 billion, and calls for increases of $43.5 million for food safety; $49.8 million for medical product safety; $15 million for data modernization and enhanced technology; $10 million for device shortages and supply chain; $2 million for drug safety surveillance and oversight; $5 million for medical device cybersecurity; and $15 million for inspections, according to a Senate explanatory document.

The proposal would also target $5 million for ALS (Lou Gehrig’s Disease) to implement “Accelerating Access to Critical Therapies for ALS Act” and to support FDA’s Rare Neurodegenerative Disease Grant Program, which is authorized to provide grants for clinical trials for ALS and other neurodegenerative diseases.

The committee took issue with FDA efforts to accelerate the review and approval of cell and gene therapies for cancer. It urged FDA to work with and provide guidance to industry and the broader research community on how to standardize potency testing requirements for cellular therapies. The committee said it is concerned that there are a number of challenges limiting the widespread development of these treatments. It encourages the agency to “facilitate innovative and flexible regulatory approaches, including expedited programs under section 506, authorities that allow for genetically targeted platform technologies, gene expression biomarkers, novel statistical approaches, external controls and a benefit-risk approach to evaluating manufacturing process requirements.”

Additionally, the committee said it supported FDA’s work to promote the domestic manufacturing of drug and biological products and encouraged it to increase efforts to encourage the pharmaceutical industry to adopt advanced manufacturing technologies that have the potential to improve product quality.

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