This is the fourth installment in a four-part series examining the structural corruption of the FDA and the challenges facing its new commissioner, Dr. Marty Makary.

While much attention may be on the revolving door between FDA commissioners and Big Pharma, conflicts of interest also extend to lower level FDA employees. Working at the FDA, a government agency, is a prestigious position, but it doesn’t pay as much as positions in the private sector. Pharma can successfully court—and thereby corrupt—FDA staff by promising them lucrative jobs once they leave the agency. Regulators know they can have a very financially rewarding career with health-related companies if they play the game properly.

Robert F. Kennedy Jr. (RFK Jr.), now HHS Secretary, emphasized, in an interview with Gary Brecka, host of the Ultimate Human podcast, that it’s not just top officials; other FDA staff also quietly prepare for industry jobs. Jared Fleming tweeted RFK Jr.’s depiction of that process (at about 1:14):

RFK Jr.:

Lower-level division and branch chiefs at the agency … sort of the common course is that they work at the agency until their pensions vest, and then they move on to industry. So, the last three or four years that they're at the agency, they're doing a lot of favors for industry and they’re letting a lot of things go by.

Brecka:

Because they're about to make that move.

RFK Jr.:

And their example then drives, it infiltrates all the lower strata of the agency because the employees see their bosses doing this. (Enphasis added.)

Watch the full interview here.

In 2019, attorney Mark Papantonio and Truth In Media’s investigative journalist Ben Swann discussed the revolving door between the FDA and the pharmaceutical companies (video below). They played a clip (at about 0:37) of former medical brand strategist Laurie Powell, who explained that working at the FDA had become a stepping stone to a job with Big Pharma.

The thing about the FDA is the FDA is not a full-time, career job. It's a few years on the FDA, and then they're being courted by the pharmaceutical companies.

You'll have a Merck going in and saying to somebody on the FDA, “Oh, I'll give you $600,000 if you'll come and work on our regulatory committee to go to bat for us with the FDA.” And they'll say, “Okay, well, I'll think about that.”

And then there'll be, like, a Pfizer coming in and saying, “Well, we'll give you $800,000 a year to come in and work on our regulatory committee..” And so, it becomes like a bidding war.

So the FDA knows that their next jumping-off point, to go from a lower-paying government job to a very lucrative pharma job on the inside—on the manufacturing side—they know that that's part of their career path. So that, I'm sure, weighs heavily into their decision-making process.

Papantonio summed it up:

So it sounds like the loyalty of drug regulators ultimately goes to the highest bidder.

In her ProPublica article (see Part 2), Chen underscored the pro-pharma bent at the FDA since the PDUFA (Prescription Drug User Fee Act) was passed in 1992, with the following graph showing the increasing approval of “novel” drugs (those with new chemical structures) and the decreasing rejection of new drug applications from 2008 to 2017.

Chen emphasized that staffers know they won’t be promoted unless they are pro-industry. Awards are based on drug approvals, not on keeping dangerous drugs off the market.

This tilt [toward industry] is reflected in what senior officials choose to highlight. The agency’s Center for Drug Evaluation and Research gives internal awards to review teams each year, according to [former FDA medical team leader Dr. Thomas] Marciniak and the former FDA employee who requested anonymity. Both said they had never seen an award granted to a team that rejected a drug application. …

Congress is also anxious for drugs to be approved rather than turned down.

Higher-ups would also send congratulatory emails to medical review teams when a drug was approved. “Nobody gets congratulated for turning a drug down, but you get seriously questioned,” said the former staffer, adding that the agency’s attitude is, “.” (Emphasis added.)

FDA accomplishments depend on approval numbers and speed.

Dr. Peter Lurie, a former associate commissioner who left the FDA in 2017, recalled that John Jenkins, director of the agency’s Office of New Drugs from 2002 to 2017, gave an annual speech to employees, summing up the year’s accomplishments. Jenkins would talk “about how many approvals were done and how fast they were, but there was nothing in there saying, we kept five bad drugs off the market,” said Lurie …

Over the course of this series, we’ve gained insight into some of the ways in which the FDA has been captured by the industry it’s supposed to regulate.

Makary has pledged to remove pharmaceutical employees from FDA advisory panels where statutorily possible. Yet pharma also influences other panel members behind the scenes.

Congress’s passage of the Prescription Drug User Fee Act (PDUFA) essentially handed the agency’s strings to pharma, making it nearly impossible for the FDA to navigate the agency’s built-in split priorities of protecting public health while accelerating innovation and supporting the pharmaceutical industry. That split is reflected in the agency’s mission statement, as well. Reversing it will likely require an act of Congress.

Pharma very cleverly captured not only the agency as a whole, but also many of the individuals who work there, including its leadership. Undoing that capture isn’t as simple as revoking the PDUFA and having the government provide all necessary funding of the FDA instead. Breaking pharma’s financial capture of FDA leadership and staff requires cultural reform and individual-level change, a seemingly formidable task.

Yet with RFK Jr. and Makary working together, there’s reason for hope. RFK Jr. has pledged to close the revolving door altogether. Greater transparency and true gold-standard trials could ensure that only truly efficacious drugs are approved, weakening, if not breaking, the industry’s stranglehold on the agency.

In his conversation with Gary Brecka (at 19:22), RFK Jr. described the cultural shift he’s aiming to bring to the FDA and across the HHS subagencies.

So we're reorganizing the agency … most importantly, to redirect and recalibrate its course, so that everybody there knows that every day, if you want your job, you’ve got to wake up in the morning and be thinking:

"How am I going to end the chronic disease epidemic today?"

Everyone is going to be clear on that mission.

We think we’re going to make a huge difference in the first year. But over four years, we’ll be able to correct the course.

Read Part 1, Part 2, Part 3