The FDA's credibility is under fire, with a recent scandal involving its top drug regulator, George Tidmarsh. In September, Tidmarsh questioned the validity of Aurinia's drug voclosporin, which treats lupus nephritis. He claimed the drug lacked sufficient clinical evidence and that necessary trials were not conducted. This sparked a 20% drop in Aurinia's share price, wiping out $350 million in market value. The company responded by asserting that the drug underwent a rigorous FDA approval process and was assessed using a validated surrogate endpoint. Aurinia's drug has been approved for use in 36 countries, including the US. Tidmarsh initially resigned, but later reconsidered, indicating his intention to fight the investigation. The situation has raised concerns among investors and industry experts, who view it as a damaging 'soap opera' that undermines the FDA's reputation. One investor described it as a 'clown show', emphasizing the need for stability and consistency in the agency's leadership for the benefit of patients.
