Drugs

Appeals Court Finds Lawsuit Against Supplement Maker Preempted

The U.S. Ninth Circuit Court of Appeals has affirmed a district court decision siding with dietary supplement maker NBTY over structure/function claims on its vitamin E supplements claiming to “support cardiovascular health” and to “promote immune function,” “immune health,” “heart health,” and “circulatory health.” In Dachauer vs. NBTY, plaintiff Paul Dachauer argued that the product’s label statements violate two California laws against false advertising because the supplements do not prevent cardiovascular disease and might increase the risk of all-cause mortality.

The appeals court found that FDA’s regulations expressly preempt state-law requirements for claims about dietary supplements that differ from agency requirements. The opinion noted that agency regulations distinguish between “disease claims,” which are not permitted on supplements, and “structure/function claims” that manufacturers make about their products. It further held that FDA’s regulations “preempted plaintiff’s claims to the extent that he argued that defendants’ structure/function claims were false or misleading because their supplements did not prevent cardiovascular disease.”

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