"In September, Tidmarsh went after Tang's Aurinia and its drug voclosporin that treats lupus nephritis, a disease in which the immune system attacks the kidneys. In a startling post on his LinkedIn account, Tidmarsh claimed that the FDA-approved drug had not been shown to provide "hard" clinical benefit and that the drugmaker had not performed necessary trials. Such a post from the FDA's top drugmaker turned heads."
"Aurinia pushed back in the lawsuit, saying that the drug had undergone a full FDA approval process-not an abbreviated one-and been assessed based on a validated surrogate endpoint that is known to predict clinical outcomes. Further, the drug has been approved for use in 36 other countries in addition to the US. On Sunday, Tidmarsh offered his resignation, but on Monday, pharmaceutical industry publication Endpoints News reported that Tidmarsh had notified FDA staff that he planned to fight the investigation"
""We are witnessing nothing less than a clown show at FDA right now," one venture capital investor told the outlet. "For the sake of patients, we need a stable and consistent FDA!" "What's happening at the top of the FDA is embarrassing," a portfolio manager at a large biotech fund added. "How am I supposed to convince people, other investors, that this sector is doing important work when the leaders of the FDA are acting this way?""
Tidmarsh publicly criticized Aurinia's voclosporin approval, asserting the FDA-approved drug lacked demonstrated "hard" clinical benefit and necessary trials. Aurinia responded in a lawsuit, stating the drug underwent a full FDA approval process, was assessed using a validated surrogate endpoint known to predict clinical outcomes, and is approved in 36 other countries. Aurinia said its share price fell about 20 percent, erasing roughly $350 million in market value. Tidmarsh offered his resignation, then informed FDA staff he planned to contest the investigation and reconsidered resigning. Investors and industry observers said the controversy undermines FDA credibility and investor confidence in the biotech sector.
Read at Ars Technica
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