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 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 and was reconsidering his decision to resign.

If the allegations in Aurinia’s lawsuit are true, Tidmarsh’s behavior would be egregious for a federal regulator. But already, the claims and other scandals have outsiders concerned that the high-stakes “soap opera” is destroying the agency’s credibility, as Stat reported Tuesday.

“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?”