Drugs

SCOTUS Won’t Hear False Labeling Case

The Supreme Court has declined to hear an appeal of a 1st Circuit Court of Appeals decision holding that state consumer protection claims that rely on violations of the Federal Food, Drug, and Cosmetic Act (FFDCA) are impliedly preempted. Attorneys Gina Tincher and Stacy Carpenter (Polsinelli) write in an online post that the case involved the Johnson & Johnson dietary supplement Lactaid. “The plaintiff argued Lactaid’s labeling was misleading because the product treats a disease,” the attorneys write, “[and] is therefore a drug rather than a supplement, and the label misled consumers into believing FDA approval of the product was not required. According to plaintiff, Lactaid was a drug that was being deceptively marketed as a dietary supplement.”

The trial court dismissed the claims, based on preemption, and the 1st Circuit affirmed, the post says, finding that state consumer protection claims that rise and fall on violations of the FFDCA are impliedly preempted by FDA’s exclusive statutory enforcement authority.

The attorneys say the Supreme Court’s decision not to hear the appeal “provides an important guidepost for lower courts outside the 1st Circuit that might be presented with similar claims and arguments. While we expect plaintiffs will continue to bring these sorts of claims, the decision provides valuable ammunition for defendant manufacturers faced with claims of FFDCA violations cloaked as violations of 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

Read more

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