Drugs

Court Says Eye Drop Dispenser Suit Preempted

A Massachusetts federal court has ruled that a potential class action suit against manufacturers of prescription eye drops could not proceed because of impossibility preemption. Plaintiffs claimed that the manufacturers used eye drop dispensers that were “intentionally designed to dispense more liquid than the human eye is capable of absorbing.” An online post by attorney JP Ellison (Hyman, Phelps & McNamara) in his firm’s FDA Law Blog says that the suits said the purpose of this unfair practice was to cause consumers to buy more eye drops and thus increase the manufacturers’ profits.

The court determined that the manufacturers could not have marketed droppers that complied with state consumer protection and unjust enrichment laws in the way the plaintiffs requested without FDA prior approval. Central to the court’s reasoning, Ellison writes, were two FDA guidance documents that classified as major changes, and therefore changes that could not be made under the changes-being-effected regulation, any changes to the size and shape of the container for sterile drug products such as eye drops. Based on the guidance documents, Ellison says, the court reasoned that it was impossible under federal law for the defendants to make the changes that plaintiffs alleged were necessary under state law.

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