Overview

• FDA Commissioner Marty Makary says the agency is issuing enforcement letters to roughly 100 drugmakers and placing thousands more on notice, extending scrutiny to online pharmacies and social media influencers.
• The executive order directs Health and Human Services to require fuller disclosure of side effects across television and digital platforms, seeking to tighten long‑loosened standards.
• The action falls short of the outright ban favored by HHS Secretary Robert F. Kennedy Jr., a step legal experts say would likely falter under First Amendment protections for commercial speech.
• Media and pharmaceutical firms face potential financial strain as direct‑to‑consumer drug advertising totaled about $10.1 billion in 2024, with television taking roughly half of that spend.
• Analysts expect lawsuits challenging the new scrutiny, and observers question whether the FDA—after recent layoffs—has the capacity to sustain a broad crackdown.