Drugs

OTC Shampoo Suit Preempted by FDA Monograph

A California federal court has held that the FDA monograph covering therapeutic over-the-counter shampoo products preempts state law putative class action claims about disclosures, warnings, and the product’s safety and efficacy. The case involved a shampoo containing the active ingredient coal tar, a component of which is benzene, say two Hollingsworth attorneys writing in a Washington Legal Foundation Counsel’s Advisory.

The article says the plaintiff was a consumer who purchased the shampoo and argued that the defendants, Johnson & Johnson Consumer and Kenvue, should have disclosed the presence of benzene in their products and that they misrepresented the products as safe and effective when they failed to do so.

The court agreed with the defendant companies and dismissed the claims with prejudice, finding them preempted because they aimed to place different or additional requirements beyond those imposed by FDA.

The court wrote that the applicable FDA monograph said products containing coal tar are generally recognized as safe and effective and are not misbranded if they meet all regulatory conditions. The monograph does not require that companies include benzene in the label and imposing such a requirement would be inconsistent with agency regulations, it said.

The court also found that FDA guidance does not impose an obligation on the companies to eliminate benzene from the products, and the plaintiff’s claims seeking to do so are not parallel to federal requirements. It further held that even if the guidance were applicable, it is non-binding and without the force of law.

“This decision reflects the role courts play in ensuring that state law tort claims do not impermissibly conflict with the monograph regime established by Congress in the Federal Food, Drug, and Cosmetic Act,” the attorneys conclude.

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