Drugs

Federal Court Dismisses AcelRx Pharms Suit

A California federal court has dismissed with prejudice a putative shareholders’ class action suit against AcelRx Pharms alleging that the company made false or misleading statements in marketing materials for its opioid pain killer Dsuvia (sufentanil) sublingual tablets to expand the target market, putting the company at risk for FDA enforcement action. An A&O Sherman online post says the court granted the motion to dismiss with prejudice because the plaintiffs failed to adequately plead scienter (intent or knowledge of wrongdoing) and that further amendment would be futile.

The post says FDA approved the opioid drug product in 2018 with a REMS. In 2021, FDA issued a Warning Letter to the company about its use of a slogan in two promotional materials that allegedly oversimplified the drug’s application and risks. Within days of FDA and the company announcing the Warning Letter, AcelRx’s stock dropped sharply, the post says.

The plaintiffs argued that the company and individual defendants purposefully used false and misleading marketing materials to expand the drug’s target market from hospitals to ambulatory centers. The defendants moved to dismiss the complaint for failure to state a claim and the court agreed.

To allege scienter, the report says, the plaintiffs relied on statements from 12 former employees that:

the individual defendants approved the slogan that drew the FDA letter;
the defendants were aware that FDA was heavily regulating misbranding and knew of internal concerns that the slogan was likely to result in a Warning Letter; and
the defendants still used the slogan because they were motivated to prove the drug’s success to investors and oversimplify its application to expand into ambulatory surgical centers.

“The court found that, taken together, these allegations did not give rise to a strong inference of scienter,” the post says. “It found particularly significant that plaintiffs did not allege that the individual defendants were aware the promotional materials were false or misleading or that they otherwise violated the Federal Food, Drug, and Cosmetic Act or were noncompliant with the REMS.

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