While we’ve talked quite a bit about the horror show that is RFK Jr.’s position as Secretary of HHS, most of the focus of those posts has been around what is happening at the CDC. And for good reason, too. The ongoing measles outbreak, the quick hiring/firing of Susan Monarez, and all the anti-vaxx bullshit going on at ACIP have all occurred at the CDC, which is itself suffering from defunding, staffing shortages, and a morale problem that Kennedy personally appears to occasionally look at from afar while wondering, “Hm, how can I make this worse?”

But fear not, dear friends, because the other agencies under Kennedy are super fucked up, too! The most recent news comes from the FDA, which just lost its chief drug regulator because he appears to have been both extorting a drug company while also running a vendetta campaign against a former colleague.

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.

Aurinia Pharmaceuticals, with Tang on its board, sued Tidmarsh recently over these allegations. And that lawsuit contains details as to what actions Tidmarsh took against Tang and his company. Those actions, if true, are almost too much to be believed.

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.

And then after that, in September, Tidmarsh hopped over to LinkedIn, of all places, to post publicly about how an Aurinia drug for treating lupus, already FDA-approved, didn’t work and that Aurinia hadn’t put the drug through the trials to prove it did. Aurinia’s stock fell by twenty percent that same day. But the drug had gone through FDA trials and was already approved for use in many, many other countries.

Tidmarsh resigned Sunday as the media shitstorm over all of this was kicking up. And that’s good; Tidmarsh has no business being in government in a role that is supposed to serve public health. But what this really represents is yet another data point in the circus that HHS and its child agencies have become under Kennedy’s leadership.

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?”

There’s a solution and we all know what it is. A competent leader at HHS that can yank our public health agencies back into some semblance of professionalism would do wonders here.

But we’re not going to get that so long as RFK Jr. is at HHS.

From Techdirt via this RSS feed