FDA described as a “clown show” amid latest scandal; top drug regulator is out

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 claims its share price fell 20 percent in a matter of hours, dropping $350 million in market value.

“Embarrassing”

Aurinia pushed back in the lawsuit, saying that the drug had undergone a full FDA approval process—not an abbreviated one—and been assessed

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