Biologics

SCOTUS Decisions’ Effect on FDA Analyzed

Six Squire Patton Boggs attorneys say that at the end of the Supreme Court’s 2023-2024 term, the court issued four decisions that “have potentially wide-ranging consequences on federal agency rulemaking, adjudication, and regulatory compliance.” Writing in an online post, the attorneys analyze the impact of the decisions on FDA in terms of pharmaceutical regulation, pharmaceutical exclusivity, pharmaceutical/biological product approvals, biosimilar approvals and interchangeability determinations, medical device regulation, combination product regulation, dietary supplements, regulation of tobacco products, cosmetics, over-the-counter drugs, conventional food, and administrative enforcement through civil penalties.

The post concludes that the decisions significantly changed the legal landscape for challenging agency action, creating new opportunities to challenge agency actions in court and to bypass an agency’s internal adjudication for enforcement actions. “But,” the attorneys continue, “we want to caution that the death of Chevron does not mean the end of all judicial deference. Courts still owe deference to agency interpretations under Skidmore (a 1944 labor standards case), and it is difficult to imagine courts not deferring, at least in part, to FDA on highly complex and technical matters. The playing field between agencies and regulated entities is far from even, but this Supreme Court term creates new opportunities and risks in challenging agency action in court.”

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