FDA Policy/General

Hahn Rejects Animal Biotech MOU

Outgoing FDA commissioner Stephen Hahn said 1/19 that the agency does not support a memorandum of understanding (MOU) signed that day by Department of Agriculture (USDA) secretary Sonny Perdue and HHS assistant secretary Brett Giroir establishing a regulatory environment for agricultural animal biotechnology innovation. In a series of Tweets, Hahn pledged that FDA “remains undeterred in our steadfast commitment to ensure that animal agricultural biotechnology products undergo independent and science and risk-based evaluation by our career experts.”

The MOU outlines responsibilities concerning the regulation of certain animals developed using genetic engineering that are intended for agricultural purposes such as human food, fiber, and labor. It is the latest in several last-minute policy restrictions HHS placed on FDA.

An Agriculture Department statement says that under the MOU framework, USDA “would safeguard animal and human health by providing end-to-end oversight from premarket reviews through post-market food safety monitoring for certain farm animals modified or developed using genetic engineering that are intended for human food. The MOU also allows for the transition of portions of FDA’s pre-existing animal biotechnology regulatory oversight to USDA. USDA would continue to coordinate closely with FDA to fulfill oversight responsibilities and provide the appropriate regulatory environment, ensuring the safety of products derived from new technologies and fostering innovation at the same time. As always, FDA would continue its review of intentional genomic alterations intended for any purpose other than agricultural use, such as biopharma and non-heritable genomic alteration, and the regulation of dairy products, table and shell eggs, certain meat products, and animal food (feed) derived from animals developed using genetic engineering.”

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