FDA Reagan Udall foundation investigation

As the Reagan-Udall Foundation undertakes its much-needed review of rampant dysfunction at FDA, the agency’s personnel are speaking out – and whey they have to say is shocking. Let’s take a look.

THREAD 🚨🔎

Using the comment portal that RUF set up, FDA personnel describe a broken culture, corrupt political influence, rigged processes, and retribution for anyone that tries to repair it. Their identities have been shielded.

There are courageous whistleblowers here from a variety of offices within FDA, all describing a broad pattern of unethical misconduct at the agency. Here are some of the highlights.

There's a toxic culture permeating the office of science from the OD-IO level to the division leadership level (especially at DNCS) [Division of Nonclinical Science this provides scientific expertise on regulated tobacco products, their toxicity, carcinogenicity, and environmental impact. -ed.]

Ignoring the science and rigging the outcomes:

The so-called leader do not solicit feedback from the actual reviewers, instead, listening to a few of the loudest ducks, who are not the experts in any of the specific disciplines.

 Sounds like a duck quacking into a megaphone to me

Dr. Califf postures as a champion of inclusion and diversity. But in reality:

Favoritism, unconscious bias, racism/sexism, permeating the whole office/division, the minority and women constantly being ignored for their suggestions/feedbacks, although they are the ones who did the most amount of work.

And if the scientific review doesn’t comport with the preconceived outcome that FDA leaders want, they just replace the reviewer:

And unreasonable workload/deadlines ...

Naturally, this leads to infighting and jockeying among the people who are supposed to be doing objective analysis:

The "so-called" leadership also tolerates/ promotes many toxic employees, self-proclaimed "experts", who backstabs/steal credits, which creates even more toxic atmosphere, and more disengaged and disfranchised work force. A thorough cultural change is urgently needed before we lose more real top performers and be left with mediocre and those toxic self-proclaimed "experts".

Corrupt political influence infects that entire process. This is truly outrageous and further confirmation of the complaints we have lodged with HHS Inspector General and the Senate Ethics Committee.

Scientific personnel are being actively and routinely intimidated.

Those personnel wish to do the right thing but the agency prevents them.

They know they system is rigged but there’s nothing they can do.

They also know the agency’s corrupt approach is causing active public health harm but, again, no one will listen to them.

They are proposing fixes to the system but FDA leadership doesn’t care.

Yep.

Those who have tried to speak out internally are swiftly penalized or have their careers derailed.

Leadership at FDA has violated their duty to the American public. This is the appalling culture that Mitch Zeller, Brian King, and Robert Califf have created:

Of course, those personnel are forbidden from dialogue with actual stakeholders. Memo to FDA: you can’t catch Covid over Zoom.

I guess when Senator Durbin or Matt Myers calls the head honcho with their latest demands, ya gotta hop to it.

Infuriating.

What happens when the reviewers concur with an application?

Here’s another and read it closely. Because of political pressure, FDA leadership is *altering* the scientific findings of its own staff and reversing their decisions.

Those personnel also point out that FDA is doing most of this in the absence of formal rulemaking – that is to say, unlawfully. Again, political pressure preventing that.

This deserves to be a major scandal and FDA leadership ought to be truly ashamed. It’s a total disgrace. But the FDA beat writers in the national press have done next to nothing to expose this corruption.

Why is it left to vaping advocates like us to bring this story to light? Why haven’t reporters at NYT, AP, WashPost, CBS, or Reuters tried to cultivate these sources and tell the American public what’s really going on inside that broken agency?

We know why NPR, STAT, TBIJ, and Bloomberg haven’t done it – it’s because they are on the prohibition payroll, taking outright cash payments from billionaires that are engineering the political influence. They condone this corruption and they sold out the public.

These whistleblowers are obviously keen to share their stories and their insight – but apparently no one in the national news media wants to hear it. Those outlets quote unnamed officials at federal agencies all the time. But here? No curiosity, zero effort.

Some people say AVM has been too tough on FDA. But does it still seem “hyperbolic” when we say the agency is rigging the process and is riddled with political influence? Even the agency’s own people can’t engage in a meaningful, constructive dialogue with their own colleagues!

Let’s wrap by applauding the integrity and courage of these FDA staff members. It takes real guts to speak out like this and here’s hoping they continue to stand tall.