The FDA is in chaos, and it’s not just insiders who are worried. Imagine a federal agency tasked with safeguarding public health being called a ‘clown show’ by investors and industry leaders. This isn’t just a PR nightmare—it’s a crisis of trust. The latest scandal involves Dr. George Tidmarsh, a top drug regulator, whose recent actions have left many questioning the agency’s credibility. But here’s where it gets controversial: Tidmarsh publicly criticized Aurinia’s drug voclosporin, used to treat lupus nephritis, claiming it lacked ‘hard’ clinical benefits and that the company skipped necessary trials. His startling LinkedIn post sent shockwaves through the industry, causing Aurinia’s stock to plummet 20% in hours, wiping out $350 million in market value. And this is the part most people miss: Tidmarsh’s resignation on Sunday seemed like the end of the story—until he announced the next day he’d fight his exit and reconsidered quitting. Aurinia fired back in a lawsuit, arguing the drug underwent a full FDA approval process, not an abbreviated one, and was assessed using a validated surrogate endpoint widely accepted to predict clinical outcomes. The drug is also approved in 36 other countries, raising questions about Tidmarsh’s claims. If Aurinia’s allegations are true, Tidmarsh’s behavior would be a stunning breach of regulatory ethics. But the damage is already done. Outsiders are calling this high-stakes drama a ‘soap opera’ that’s eroding the FDA’s authority. ‘For the sake of patients, we need a stable and consistent FDA,’ one investor pleaded. A biotech fund manager added, ‘How can I convince investors this sector matters when FDA leaders act this way?’ Is this a one-off scandal, or a symptom of deeper issues within the FDA? Share your thoughts—is the agency still trustworthy, or is this ‘clown show’ too much to overlook?
