Drugs

Court Says Eye Drop Case is Preempted

A Massachusetts federal court has ruled that a putative class action suit against a group of drug companies alleging that their prescription eye drops were intentionally designed to dispense more liquid than the human eye can absorb is preempted by federal law. Attorney Michelle Yeary (Dechert) writes in an online blog post that the plaintiffs pushed two theories of liability that they said were not preempted.

While the plaintiffs said the companies could have changed the eye dropper tip, the court held that such a change would be considered a major change by FDA and thus could not happen without agency approval before the drug is distributed.

When the plaintiffs raised several instances in the past in which FDA allowed a container change without prior approval, the court held that FDA’s failure to follow its own procedures on occasion does not cast doubt on the plain language of a 2004 guidance deeming all changes to the size or shape of a sterile product’s container to be major changes requiring pre-approval.

“The regulations and official guidances control over individualized instances where FDA chose not to apply them,” Yeary writes. “The court can’t be guided by internal decision-making processes in one-off situations.”

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