FDA Policy/General

FDA FY 2027 Appropriation Report Analyzed

In the first of three planned online posts on FDA’s FY 2027 Appropriations Report, approved by the House Appropriations Committee to explain its agency funding bill, eight Hyman, Phelps & McNamara lawyers say the report “reflects a Congress eager to shape FDA’s regulatory priorities — from promoting artificial intelligence (AI)-driven efficiencies and strengthening foreign inspection programs to restricting clinical trial data from covered nations and addressing women’s health initiatives. Writing in their firm’s FDA Law Blog, the attorneys say the appropriations bill includes provisions that preclude the use of funds for animal research and human embryo research.

The appropriations report contains 143 FDA-related riders, the attorneys write, ranging from support for research and product approvals for specific diseases to clinical trial recommendations, international inspection requirements, and animal testing prohibitions.

A few of the themes the authors call attention to are:

provisions “ordering” the agency to take specific actions with the expectation that agencies will comply, even though the provisions do not have the force of law;
alignment with Trump administration priorities for deregulation, AI-driven efficiency in the approval process, and streamlining product review pathways;
reflecting congressional regulatory priorities centered on diversity in clinical research and the health impacts of medical products on women and minorities, issues that are in tension with administration views;
cross-product provisions involving AI, foreign inspections, China’s role in technology and clinical research, clinical trials, and women’s health.

The lawyers say they will produce additional posts on the report’s drug-specific provisions, including biosimilars, accelerated approvals, and other key areas of pharmaceutical regulation, and on everything else in the appropriations report, including medical devices and outsourcing.

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