Drugs

FDA Labeling Health Claim Enforcement Up Under Biden: Attorneys

Three Hogan Lovells attorneys write that a 2/19 FDA announcement of Warning Letters sent to 10 companies for selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health disorders “signals that FDA labeling enforcement on health-related claims is on the rise under the new administration and that we should anticipate similar market sweeps in the future.” The online analysis notes that none of the targeted supplements contained cannabidiol, an FDA enforcement focus in the past, and none made Covid-19 claims.

While specific claims varied among the letters, they generally included claims related to “reduced anxiety,” “relief of temporary depression or occasional feelings of sadness and melancholy,” and “mood support,” within the context of other claims about depression, the attorneys write.

The post says the attorneys expect that the Federal Trade Commission (FTC) will also take a more active role on enforcement matters under the new administration. “Like FDA, the FTC has been predominantly bringing enforcement actions related to Covid-19,” the attorneys say. “We believe FTC may shift its attention toward areas that have been dormant in the last administration, such as health-related claims and environmental claims.”

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