FDA, FTC probe Hims over Super Bowl ad for weight-loss drugs

Hims Super Bowl ad draws regulatory scrutiny

Hims & Hers Health Inc. is facing questions from the Food and Drug Administration and the Federal Trade Commission following its Super Bowl advertisement. The ad promoted access to compounded versions of weight-loss drugs, a move that has sparked a significant regulatory backlash.

The company received a letter from the FDA expressing concerns that the ad was misleading. Simultaneously, the FTC is investigating whether the telehealth platform engaged in deceptive marketing practices.

The fallout from promoting compounded GLP-1s

The core issue revolves around Hims advertising compounded semaglutide, the active ingredient in drugs like Wegovy. Compounded drugs are mixed by pharmacists and are not FDA-approved, creating a major regulatory gray area.

This incident highlights the intense demand for GLP-1 medications and the lengths companies will go to meet it. Regulators are now forced to clarify the rules for marketing these sought-after treatments in a digital health landscape.

• The FDA stated the ad was misleading regarding the safety and effectiveness of compounded semaglutide.
• The FTC is probing if Hims deceived consumers about the nature of the products being offered.
• This represents a significant crackdown on the marketing of non-FDA-approved weight loss drugs.

Moderna's flu vaccine faces FDA questions

In other regulatory news, Moderna's application for its mRNA influenza vaccine has hit a snag. The FDA has raised questions that will likely delay a potential approval, pushing the decision past its upcoming deadline.

The agency's concerns, which Moderna must address, center on the vaccine's manufacturing process. This setback underscores the challenges of bringing novel mRNA platforms to new disease areas like seasonal flu.

Psychedelic therapy shows mixed results

New clinical trial data for a psychedelic depression treatment has presented a complex picture. Compass Pathways released results for its psilocybin therapy, COMP360, which showed a statistically significant improvement in symptoms.

However, the data revealed a high placebo response and notable side effects, including headaches and nausea. This mixed outcome suggests the path to regulatory approval for psychedelic medicines remains fraught with scientific and perceptual hurdles.

The study found that 25% of patients receiving the therapy experienced a serious adverse event, a figure that will be closely examined by regulators. The debate continues on whether the bar for approving such transformative, but potent, therapies should be different.

A regulatory inflection point for digital health

The Hims investigation signals a potential turning point in how the FDA and FTC oversee direct-to-consumer telehealth companies. As these firms expand into promoting complex medications, regulatory scrutiny is intensifying proportionally.

These concurrent events—spanning weight loss drugs, mRNA vaccines, and psychedelics—illustrate the dynamic and pressured environment of modern drug development and marketing. Regulators are actively defining the boundaries for a new era of medicine.