Drugs

Court Dismisses FTC Prevagen Case

A New York federal court has granted a motion from Quincy Bioscience and related organizations and individuals seeking dismissal of a Federal Trade Commission (FTC) suit alleging that the company made false and unsubstantiated claims that its Prevagen dietary supplement improved memory. Attorney Riëtte van Laack (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that Quincy argued that the suit brought 1/2017 by FTC and the New York attorney general failed to adequately allege that the Prevagen advertising claims violated the FTC Act.

FTC and the state attorney general had alleged that Quincy relied on a single study that failed to show that Prevagen works better than a placebo on any measure of cognition. They said that after the study failed to show a statistically significant improvement in the experimental group over the placebo group, the company conducted more than 30 post hoc analyses of the results looking at data for smaller subgroups. The attorney says they found some statistically significant differences.

FTC argued that the subgroup analysis did not constitute valid support for the marketing claim because the post hoc analyses increased the probability of finding a significant improvement in a subgroup for one of the parameters.

Van Laack says the court rejected the FTC argument, concluding that the challenge to Quincy’s substantiation was theoretical. “They had no evidence that the claim was not supported,” she writes, “but only showed there was a possibility that the study results did not support defendants’ claims. This mere possibility rather than plausibility did not entitle plaintiffs to relief.” It is possible that FTC and the attorney general will appeal the ruling, she says.

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