The Small Men Making a Big Mess at FDA

Turns out that putting Vinay Prasad in charge of regulating drugs and vaccines was a bad idea

The last time there was hope at CBER. Alas, nothing gold can stay.

Since being abruptly run out of FDA and then rehired as the Food and Drug Administration (FDA) Director of the Center for Biologics Evaluation and Research (CBER), Vinay Prasad has kept a low public profile. It had to be embarrassing to do the walk of shame dragging his tattered little red roller bag out of the hallowed halls of the national vaccine regulatory office, particularly considering he resigned after MAGA fanatic Laura Loomer appraised his job performance as incompetent and anti-Trump. Since FDA Commissioner Marty Makary appealed to Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr to reinstate Prasad, he’s been awfully quiet.

Prior to his departure, the Steve Urkel of drug regulation appeared frequently to gab with Makary about their awesome drug evaluation skills on FDA Direct, a taxpayer-supported podcast that provides Makary and Prasad a forum for sanewashing idiotic and ineffective regulatory policy. However, since his return to CBER, Prasad was evidently keeping busy with actual regulatory work, because he was mostly nowhere to be seen. Thanks to some incredible reporting from STAT, we now know what he was keeping busy with: vengeance against his enemies, crushing intra-agency opposition, and unilaterally changing FDA standards and protocols to facilitate fewer drug and vaccine approvals.

A Small Man

I have a great deal of experience dealing with what I call “small men,” whom I have encountered at virtually every job I’ve ever had at every stage of my professional career. “Small” doesn’t refer to their physical stature, but to their capacity for leadership, tolerance for difficulty, and resilience to challenges. These are men in positions of power who are unable to cope with any kind of criticism or perceived threats to their authority. I frequently run afoul of small men, for transgressions ranging from objecting to gender discrimination and sexual harassment to getting invited to speak at conferences instead of them to being featured more prominently in the media than they are.

Small men are characterized by the fragility of their egos, rather than their scientific talent, integrity, or competence. Instead of reflecting introspectively on the validity of critical feedback, supporting their teams, or proactively developing their leadership skills, small men will instead default to anger, portray themselves as victims, and abuse their power to retaliate against their enemies. HHS is replete with small men and Prasad is evidently one of the smallest.

That’s why it was unsurprising when the news broke that Prasad’s second shift at CBER has cultivated a pervasive atmosphere of fear among CBER’s roughly 1100 employees. Bullying is a favorite approach that small men use to eliminate dissent and inflate their own sense of importance. Even professionals with evidence on their side might not speak up if they are being intimidated that it could cost them their job or reputation.

Prasad has made sure that message is crystal clear: he pushed multiple senior agency staffers out without explanation, leading many to conclude that these departures were retaliatory or due to misalignment with the FDA’s new “gold standard” anti-vax position. One of the removed employees, Anuja Rastogi, was in charge of reviewing clinical data about vaccines. Another, Daniel Singer, was in charge of public health and pandemic preparedness. And he removed Richard Forshee, who led vaccine safety and surveillance, and replaced him with himself.

Prasad now has full control of all FDA vaccine safety and surveillance activities, and is not required to transparently disclose how he might alter them. Given that Prasad has repeatedly unilaterally overruled agency reviewers to block vaccine approvals, it’s highly likely he will similarly interfere with vaccine safety and surveillance efforts. Besides its consistency with MAHA anti-vax tactics, small men love nothing more than wielding their power. It is no wonder that the FDA employees reporting to Prasad are fleeing in droves.

Did I Do That?

“Et tu, Vinay?” George Tidmarsh seems surprised that the vipers in the pit bite

Prasad has also attempted to prevent employees from transferring from CBER to the Center for Drug Evaluation and Research (CDER), the FDA center that handles drug approvals. Yesterday, we learned that this was a component of inter-center warfare being waged by Prasad and George Tidmarsh, the CDER director installed in July. Tidmarsh also briefly filled in for Prasad during his two weeks of exile.

Prasad and Tidmarsh had a very non-collegial relationship. Besides people wanting to leave CBER for greener pastures at CDER, Prasad frequently went over Tidmarsh’s head and ordered CDER employees to work for him. Tidmarsh also expressed concerns about the legality of Makary’s pet priority voucher, which is a scheme to shake down drug developers by offering a mechanism for expedited review of licensing applications to preferred applicants. Prasad and Makary did not take kindly to Tidmarsh’s assessment that such review processes would be non-binding.

Prasad, like all small men, did not like having his authority to basically do whatever he wants regarding drug and vaccine regulation questioned by Tidmarsh. He eventually sent an email explicitly threatening him:

“Let me be clear,” Prasad wrote. “If you continue to choose not to do what I tell you. I will spend all of my political capital gets [sic] you fired. Do not take people from my team. When I ask you to ask the reviewers a question you will do so.”

It seems that Prasad did not have to spend all his political capital, because Tidmarsh resigned yesterday as the result of a lawsuit filed against FDA by Aurinia Pharmaceuticals. Lest you think Tidmarsh is a brave hero standing up for the integrity of FDA’s regulatory function, he is being investigated for abusing his power to financially harm his ex-friend’s company by disparaging their drug on LinkedIn.

If the drug is actually dangerous, maybe the CDER Director could do something about that besides issuing clout-chasing subtweets on LinkedIn

Tidmarsh, it seems, is also a small man. He had a falling out with a former friend and business partner, Aurinia Board of Directors chair and majority stakeholder Kevin Tang. Since becoming CDER Director, he has taken shots at Tang’s companies at every opportunity. In addition to the LinkedIn post, he also banned animal-derived thyroid medications used for almost a century, since Tang owns a company called American Laboratories that makes them. Tidmarsh holds an ownership interest in American Laboratories. After announcing the ban, Tidmarsh’s attorney wrote to Tang demanding that an agreement for American Laboratories to pay Tidmarsh be extended by a decade, which Tang (correctly, in my opinion) interpreted as extortion.

It’s pretty clear that this was intentional on Tidmarsh’s part, considering he emailed Tang his LinkedIn post with the subject line “Good luck.” Tidmarsh’s efforts to get back at Tang by playing with his emotions via imposed financial hardship remind me of the federal regulatory version of Big Worm in the movie Friday, except with licensed lupus and thyroid medications instead of street level weed dealing.

“Playing with my money is like playing with my emotions!”
-Big Worm and George Tidmarsh

Tang’s emotions were indeed played with, considering Aurinia’s stock prices fell by 16% as a result of Tidmarsh’s LinkedIn post. Tang complained to FDA, Makary forwarded the complaint to the HHS Office of the Inspector General, and Aurinia filed a lawsuit in US Federal Court. This led to Tidmarsh being informed of the complaint by Makary on Friday, getting suspended from FDA on Saturday, and resigning on Sunday.

Despite being clearly culpable for his vendetta against Tang, Tidmarsh thinks Prasad hastened his exit by leveraging his bestie status with Makary. While that remains to be seen, none of this messy drama speaks highly of the professionalism, integrity, or competency of the people who are in charge at FDA.

Now that Tidmarsh is out, Prasad will have even more power to control drug approvals by virtue of having one less small man to compete with as he carries out his self-serving, grasping efforts at acquiring power. The culture of fear and opacity he has established at FDA is not conducive to dispassionate, evidence-based vaccine and drug regulation and this bodes extremely poorly for American health.

As my colleague and friend Craig Spencer wrote in an excellent essay on the FDA’s history, the agency was established to ensure that medicines are safe and effective. Agency protocols have relied on hard evidence to guide regulatory decisions that determine access to essential vaccines and therapies. With Prasad presiding over drug approvals and applying a subjective “gold standard” rather than an objective evidence-based one, the public can no longer have confidence that drugs are being approved on the basis of their safety profiles and the fact that they actually work. Medications will be regulated based on the whims of a small man with unkempt hair, an axe to grind, and a pathetic slavishness to an administration that is determined to kill as many Americans as possible by neglect and withholding medications, vaccines, and public health data.

The FDA is a hot mess and seems to be going the way of the CDC in terms of its capacity to reliably carry out its functions. This is not how the government is supposed to work. Regulatory processes should not be described as a total shitshow. There should be no place for corrupt, incompetent political functionaries making backroom critical regulatory decisions on medications that mean the difference between life and death for millions of Americans. Prasad must pack up his roller bags and decamp to California permanently. Bye bye, little guy.