clowns

FDA regulator accused of using position to exact revenge on old business associate.

An alleged extortion attempt, a petty yearslong grudge, shocking social media posts, and ominous text messages make up the latest scandal at the Food and Drug Administration, an agency that industry outsiders are calling a “clown show” and “soap opera” amid the Trump administration’s leadership, according to reporting by Stat News.

Federal health agencies, in general, have taken heavy blows in Trump’s second term. The Centers for Disease Control and Prevention, in particular, has seen the abrupt dismantling of whole programs and divisions—teams that provide critical health services to Americans. CDC staff regularly describe being demoralized over the last year. Their Senate-confirmed director didn’t make it a full month before being dramatically ousted after allegedly refusing to rubber-stamp vaccine recommendations from a panel filled with vaccine skeptics by anti-vaccine Health Secretary Robert. F. Kennedy Jr.

While the CDC is in shambles, the FDA has turned into something of a sideshow, with concern mounting that it remains a serious enough regulator to keep America’s medicines and treatments modern and safe. Many of the scandals are tied to Vinay Prasad, the Trump administration’s top vaccine regulator, who also has the titles of chief medical officer and chief scientific officer. Prasad made a name for himself on social media during the pandemic as a COVID-19 response skeptic and, since joining the FDA, has been known for overruling agency scientists and sowing distrust, unrest, and paranoia among staff. He was pushed out of the agency in July only to be reinstated about two weeks later.

However, the FDA’s latest scandal includes a different Trump-era leader: the top drug regulator, George Tidmarsh, who left the FDA this weekend amid a flurry of events. The drama centers around allegations that, since joining the FDA in July, Tidmarsh used his position to exact petty revenge on an old business associate, Kevin Tang, who had asked Tidmarsh to resign from three companies six years ago, allegedly sparking a long-standing grudge.

Drama

According to reports, Tidmarsh was placed on administrative leave on Friday as an investigation by the inspector general for the Department of Health and Human Services looked into claims that he had used his regulatory authority to target Tang.

On Sunday, drugmaker Aurinia Pharmaceuticals filed a lawsuit against Tidmarsh with the same claims. Tang is the chair of Aurinia’s board, and Tang Capital is the drugmaker’s largest shareholder.

The lawsuit contains brow-raising texts and emails from Tidmarsh to Tang and associates over the last six years, documenting taunts and threats, including “enjoying failure?”, “You will be exposed,” there’s “[m]ore bad karma to come,” “[t]he pain is not over,” and an ominous “I’m Not powerless.”

In early August, soon after joining the FDA, Tidmarsh announced actions that would effectively remove from the market a drug ingredient made by a company associated with Tang. Tidmarsh’s lawyer then sent a letter to Tang proposing that he extend a “service agreement” for “another 10 years,” which would see Tang making payments to a Tidmarsh-associated entity until 2044. The email was seen as attempted extortion, with such payments being in exchange for Tidmarsh rolling back the FDA’s regulatory change.

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?”

Beth is Ars Technica’s Senior Health Reporter. Beth has a Ph.D. in microbiology from the University of North Carolina at Chapel Hill and attended the Science Communication program at the University of California, Santa Cruz. She specializes in covering infectious diseases, public health, and microbes.